October 22, 2006
An article in The Scotsman, titled, “Pfizer Boss Admits:  Our Image Stinks”, reports that a senior Pfizer executive has admitted the drug industry suffers "crippling cynicism" from the public about its motives and the huge profits it makes. Pfizer Vice President of Medical and Regulatory Affairs for Europe, Latin America, Africa and the Middle East, Jack Watters, said drug companies were partly to blame because "they have failed to promote the positive contributions they make to society." 
<< Click here to read more:  http://www.business.scotsman.com/index.cfm?id=1562152006 >>

October 17, 2006
The Associated Press reports that the former FDA Commissioner, Dr. Lester Crawford, who mysteriously resigned last fall just two months after being confirmed as new FDA Commissioner will plead guilty to charges that he lied under oath and hid his ownership of stock in food and drug companies that the FDA regulated. 
<< Click here to read more: www.nytimes.com/2006/10/17/washington/17fda.html >>

October 17, 2006
NY Congressman Maurice Hinchey issued a statement on former FDA Chief conflict of interest calling for "a serious overhaul" of the FDA.

"Senior officials at the FDA have led the agency down a dark road into a state of crisis. Today's court filing against Lester Crawford underscores the fact that the FDA, which is one of the most important protectors of public health and safety, is in need of a serious overhaul. By blatantly ignoring the law on financial holdings and conflicts of interest, Lester Crawford used his position as the head of the FDA to send all the wrong signals to other FDA employees and the American public. It is not possible for the FDA to fairly and impartially regulate the food and drug industries when the commissioner of the agency has a vested financial interest in the results.

"We do not know the full ramifications of Lester Crawford's misbehavior, which is why it is imperative that the HHS Inspector General finalize his investigation. Based on Lester Crawford's apparent disregard for the law, we must find out what other improper actions he took while leading the FDA, which may not necessarily have been illegal, but were inappropriate or unethical. The American public has the right to know what else Lester Crawford may have done in office that could have lasting, detrimental effects on the FDA. "

Click here to read statement:

October 14, 2006
Newsweek interviews head of FDA’s Center for Drug Evaluation (CDER), Dr. Steven Galson, about the needed changes at the FDA following several recent studies like the stinging findings of FDA's drug safety performance by the Government Accountability Office (GAO), then the Institute of Medicine report (IOM), followed by the recommendations of five highly respected scientists who are former and current members of FDA's drug safety advisory committee. Their recommendations were recently published in the archives of Internal Medicine.
<< Click here to read content of Newsweek interview >>

October 12, 2006
A New York Times article states that the New England Journal of Medicine reports that "the drugs most commonly used to soothe agitation and aggression in people with Alzheimer's disease are no more effective than placebos for most patients, and put them at risk of serious side effects, including confusion, sleepiness and Parkinson's disease-like symptoms, researchers are reporting today."

The drugs tested in the study - Zyprexa from Eli Lilly; Seroquel from AstraZeneca; and Risperdal from Janssen Pharmaceutical - belong to a class of medications known as atypical antipsychotics. The drugs are used to treat schizophrenia and other psychoses, and are commonly prescribed for elderly patients in long-term care facilities.

About a third of the estimated 2.5 million Medicare beneficiaries in US nursing homes have taken the medications, researchers found. And the use of atypical antipsychotics in the elderly accounts for an estimated $2 billion in the annual sales of the drugs, much of the cost paid by Medicare and Medicaid.
<< Click here to read more: http://www.nytimes.com/2006/10/12/health/12dementia.html

October 11, 2006
The recommendations of five highly respected scientists who are former and current members of FDA's drug safety advisory committee regarding the current drug safety system were published in the Archives of Internal Medicine. According to the authors, the current FDA system of regulating drug safety has serious limitations and is in need of changes. The major problems include the following:
1) the design of initial pre-approval studies lets uncommon, serious adverse events go undetected;
2) massive underreporting of adverse events to the FDA post-marketing surveillance system reduces the ability to quantify risk accurately;
3) drug manufacturers do not fulfill the majority of their post-marketing safety study commitments;
4) the FDA lacks authority to pursue sponsors who violate regulations and ignore post-marketing safety study commitments;
5) the public increasingly perceives the FDA as having become too close to the regulated pharmaceutical industry;
6) the FDA’s safety oversight structure is suboptimal; and the FDA’s expertise and resources in drug safety and public health are limited.

To address these problems, they urge Congress, which is ultimately responsible for the FDA’s performance, to implement the following 5 recommendations:
(1) give the FDA more direct legal authority to pursue violations,
(2) authorize the adoption of a conditional drug approval policy, at least for selected drugs,
(3) provide additional financial resources to support the safety operations,
(4) mandate a reorganization of the agency with emphasis on strengthening the evaluation and proactive monitoring of drug safety, and
(5) require broader representation of safety experts on the FDA’sadvisory committees.
<<To read the article, click here: http://www.iom.edu/CMS/3793/26341/37329.aspx >>

October 9, 2006
The FDA suspends an ADHD drug safety study that would further review the use of Risperdal in autistic children. A body of scientific evidence--from both pre-and post-marketing study reports—shows that the drug increases the risk of severely disabling adverse drug effects and premature death in adults and children for whom it has been used off-label. The FDA approved expanded use of Johnson & Johnson’s drug, Risperdal (risperidone) approved for treating psychosis in adult patients with schizophrenia and manic-depression (for short term use). FDA approved its use to control aggression and other bad behavior in autistic children. 

The current drug label indicates: “Safety and effectiveness in children have not been established.”  This exceptionally hazardous drug as well as Eli Lilly’s Zyprexa carries a black box warning that Risperdal “increased mortality in the elderly.” Most deaths primarily due to “cardiovascular (e.g., heart failure, sudden death). ”

The drug has no known therapeutic benefit for autism: it is used as a chemical restraint to disable children and control their behavior. J & J acknowledged: “The anti-psychotic drug is not a cure for autism, nor does it treat the condition itself.” According to the FDA’s MedWatch reporting system, they received reports that at least 45 children have been killed by Risperdal and the other ‘atypicals’ between 2000 and 2004. The youngest, a four years old, died of diabetes complications.
<< Click here to read more, LATimesRisperdal.doc >>

October 8, 2006
ELIZABETH J. ROBERTS, a psychiatrist who treats children and adolescents and the author of Should You Medicate Your Child's Mind?'' published an editorial in The Washington Post. In this article, she states, "The changes I've seen in the practice of child psychiatry are shocking. Psychiatrists now misdiagnose and overmedicate children for ordinary defiance and misbehavior. Temper tantrums are increasingly being characterized as psychiatric illnesses. Using such diagnoses as bipolar disorder, attention-deficit hyperactivity disorder (ADHD) and Asperger's, doctors are justifying the sedation of difficult kids with powerful psychiatric drugs that may have serious, permanent or even lethal side effects."
<< Click here to read the article:

October 4-5, 2006
Hofstra University Law School holds a two-day conference debating the impact of conflicts of interest on medicine. An impressive array of speakers whose strongly held opposing views will address key issues in the current heated debate about: The Pharmaceutical Industry and Its Relationship With Government, Academia, Physicians and Consumers.

The timely topics to be addressed:

- Has funding of biomedical research by the pharmaceutical industry affected the reliability of information derived from that research?

- How does industry funding affect the integrity of the research, researchers, Academic institutions, government agencies, physicians, professional organizations, medical journals?

 - How does the law protect the credibility of information from industry-funded biomedical research?

**Click here for agenda and list of speakers, http://www.hofstra.edu/pdf/law_biomed.pdf
**Click here to read one attendees notes from the conference:  verasnotes.doc

September 30, 2006
A front page article in The New York Times reports: "Bayer AG, the German pharmaceutical giant, failed to reveal to federal drug officials the results of a large study suggesting that a widely used heart-surgery medicine might increase the risks of death and stroke.”

The Times reports that despite Bayer's failure to reveal the results: "Nevertheless, the agency did not change its advice about whether patients should be given the drug. Instead, it restated previous warnings that Trasylol's use should be limited to patients in whom the risks of blood loss outweighed the drug's risks."  
<< Click here to read article: NYTBayer.doc >>

September 22, 2006
The long awaited Institute of Medicine (IOM) report on the FDA was made public. The IOM, a nonprofit organization created by Congress to advise the federal government on health issues, conducted the study at the request of the FDA.

The New York Times reports that according to the long-anticipated study of the FDA, the IOM finds that the nation’s system for approving and monitoring the safety of medicines is inadequate and needs far-reaching reforms, and the FDA is plagued with poor management and persistent internal squabbling. The IOM report is likely to intensify a debate about the safety of the nation’s drug supply and the adequacy of the FDA’s oversight. The debate began when Merck  withdrew its popular arthritis drug, Vioxx.

The IOM panel made important recommendations that would put the agency back on track to fulfill its mission of protecting the public health instead of industry's cash flow:

- Put a symbol on the packages of new drugs to denote that the medicine's benefits and risks may not be fully understood. It would remain in  pace  for two years.
- Ban advertising directed at patients during that two-year period.
- Review the risks and benefits of all new drugs after five years.
- Bolster the Food and Drug Administration's safety staff and give it an integral role in drug approval.
- Give FDA legal authority to order drug companies to conduct safety studies and to institute other precautions to protect patients.
- Modernize and extend the FDA's databases for tracking serious reactions to prescription drugs.
- Create an internet registry to post results of clinical drug trials.
- Adopt stronger policies to minimize conflicts of interest among outside advisors who serve on the panels that guide much of the FDA's  work.
- Establish a six-year term for the FDA Commissioner, who now serves at the pleasure of the President, to provide stable leadership.
<< Click here to download the IOM report: http://www.iom.edu/ CMS/3793/26341/37329.aspx >>

September 13, 2006
During the latest Congressional hearing probing the conduct of NIH scientists and administrators, Congressman Joe Barton, Chairman of the House Energy and Commerce Committee, rendered a stinging appraisal of the NIH today: "This is really an ethical Potemkin village, where a hollow system appears to provide the illusion of integrity, but transgressors never leave." 

The hearing was the sixth since January 2004, focusing on the scientists' refusal to give up their competing business ventures while employed as public servants. Specifically, the focus of this hearing was the agency's failure to take action following an investigation of conflicts of interest by an NIH appointed panel. Despite the panel's recommendation to terminate two senior NIH scientists whose activities on behalf of drug companies tainted their government research constituting, "serious misconduct" and violation of federal law and regulation, no action has been taken.

The Los Angeles Times reports:   "A congressional subcommittee chairman and a top administrator of the National Institutes of Health agreed on at least one point Wednesday: Private financial deals between drug companies and NIH scientists that have come to light in recent years have posed the worst scandal in the agency's history."
<< Click here to read more: LATimesNIH.doc >>

The Associated Press reports: "Most of the federal scientists who improperly accepted personal money from drug or biotechnology companies walked away with reprimands or were allowed to retire unscathed. Only two of the 44 scientists found to have violated rules governing private consulting deals are being investigated for possible criminal activity, and they remain on the government payroll."
<< Click here to read more: Associated Press NIH.doc >>

September 12, 2006
The New York Times reports that Stanford University to ban drug makers’ gifts to doctors. Stanford University announced that it is adopting a strict conflicts of interest policy. Following a series of investigative reports by Paul Jacobs in The San Jose Mercury News, documenting financial conflicts of interest by 700 of the medical school faculty as well as the school’s department heads, and administrators, Stanford announced its new policy. The policy is intended to limit industry influence on patient care and doctor education. No more free lunches, no more free drug samples.

The New York Times reports, “the new policy does not cover consulting agreements between faculty members and companies aimed at developing drugs or medical devices. Those are governed by an existing conflict-of-interest policy. Such interactions are especially important at Stanford, where many professors have been involved in starting or advising companies in nearby Silicon Valley.”
<< Click here to read article: NYTStanford.doc >>

September 11, 2006
The Associated Press reports that UK pharmaceutical giant, GlaxoSmithKline, has settled the largest tax dispute in IRS history.  GSK shareholders will have to shell out $3.4 billion to settle with the IRS. The dispute involved transfer pricing, an illegal accounting scheme for evading US income tax.
<< Click here to read the article: APGlaxo.doc>>

September 11, 2006
Canadian Free Press runs a story involving a former pharmaceutical sales rep who is blowing the whistle on the hazards of psychotropic drugs in her book, Confessions of an Rx Drug Pusher: God's Call to Loving Arms.  Her own niece set herself on fire after inability to get off an antidepressant.

Author Gwen Olsen is warning parents of the dangers of some antidepressants and psychotropic drugs. After spending 15 years in the pharmaceutical industry, selling some of the drugs she now says can be deadly, Olsen has blown the whistle on her old employers and published her book. "I had a moral responsibility to tell people everything I knew”, said Olsen.
<< Click here to read the article: Freepress.doc >>

September 2006
A new website -- www.ssristories.com has been launched providing public access to more than 1,000 news reports, mainly criminal in nature, that have appeared in the media or that were part of testimonies before FDA advisory committee meetings in 1991 or 2004. The website creators, Rosie Meysenburg and Sara Bostock note: “Even these 1000 documented stories only represent the tip of an iceberg since most stories do not make it into the media.”
<< Click here to read more: www.ssristories.com >>

September 2006
A scientific review exposes link between antidepressants and violence in an article titled, “Antidepressants and Violence: Problems at the Interface of Medicine and Law,”  by Drs. David Healy, Andrew Herxheimer, and David B. Menkes published in PLoS Medicine. 

This is a scientific review of evidence found in 1) the premarketing controlled clinical trial data submitted by manufacturers to regulatory agencies (MHRA in the UK and FDA in the US); 2) data from the UK Drug Safety Research Unit (DSRU); 3) reports from 1,374 viewers who responded by e-mail after a BBC Panorama broadcast in 2003; and 4) evidence from specific medico-legal cases involving homicide. The authors state, “Our main finding is that unselected sets of placebo-controlled trials of antidepressants show evidence for an increased relative risk of aggressive behaviours on treatment, although such outcomes apply to only a small subset of patients.” Manufacturers, with support from high ranking regulatory agency officials, have for years denied evidence of drug-related risks of harm, and downplayed the significance of a unique adverse drug effect profile of second generation psychotropic drugs. In contrast to the older tricyclic antidepressants, SSRIs induce akathisia, emotional disinhibition, emotional blunting, and manic or psychotic reactions. The authors suggest that it is these drugs’ recognized mechanisms of action—not an underlying condition—that may trigger violence: “There is good evidence that antidepressant treatment can induce problems such as these and a prima facie case that akathisia, emotional blunting, and manic or psychotic reactions might lead to violence.” The signs of violence and suicidality were there since the first SSRI antidepressant, Prozac (fluoxetine) was tested in pre-marketing trials.
<< Click here for article: http://medicine.plosjournals.org/archive/15491676/3/9/pdf/10.1371_journal.pmed.0030372-L.pdf 

September 8, 2006
PBS launches a new investigative series whose first report, “A Bitter Pill” airs based on the November 2005 Bloomberg Markets Magazine documenting corruption at every level of current practices. Bloomberg News report titled, ‘Big Pharma’s Shameful Secret" is a ground breaking, six-part investigative report. The team of Bloomberg reporters--David Evans, Liz Willen and Mike Smith--won the prestigious Polk Award for their investigative reporting. Check your local PBS station for date and time.
<< Click here to see first of six-part report of Big Pharma's Shameful Secret with links to entire series: http://www.ahrp.org/cms/content/view/335/29/

September 1, 2006
Science magazine reports that the editor of American College of Neuropsychopharmacology (ACNP) journal -- Neuropsychopharmacology will relinquish his post following a stir over his failure to list commercial ties in a July article about a new treatment for depression on which he was primary author.
<< Click here to read more: SCIENCE.doc >>

September 1, 2006
Wall Street Journal article titled, “Drug Firms Use Financial Clout to Push Industry Agenda at FDA” describes the transformation of the FDA from watchdog to lapdog. It all started with the passage of the Prescription Drug User Fee Act passed in 1992. "For most of its history, the FDA was funded entirely by Congress. But in the early 1990s, companies unhappy with the pace of drug approvals agreed to pay the FDA millions of dollars in annual fees to help speed its performance. Because the industry and the agency renegotiate every five years over the size of fees -- and what they can be used for -- drug makers can have considerable input into which programs receive funding." Wall Street Journal’s Anna Wilde Mathews reports: "In fiscal 1993, the industry's $8.9 million in user-fee money accounted for just 7% of the FDA's drug review budget. The deal has since been renewed twice, with fees increased both times. The $232 million in fiscal 2004 represented 53% of the total drug-review budget."
FDA officials have been huddling at the bargaining table with the pharmaceutical and biotech trade organizations--PhRMA and BIO--"bargaining with the pharmaceutical industry for an increase in fees, giving the industry a greater role in shaping the priorities of its regulator."

August 30, 2006
Associated Press reports that Schering-Plough is the latest drug company to plead guilty to conspiracy and overcharging Medicaid. Schering-Plough were fined $435 million for promoting off-label use of their drugs.
<< Click here to read more: APSchering.doc >>

August 29, 2006
The Scientist’s follow-up to news report about the conflict of interest scandal that has engulfed not only Dr. Charles Nemeroff, former president and editor in chief of the official Journal of the American College of Neuropsychopharmacology, but the College itself.
<< Click here to read more: www.the-scientist.com/news/daily/24445/ >>

August 23, 2006
USA Today reports that last year the pharmaceutical industry "faced the most product liability lawsuits of any other industry." Lawsuits against pharmaceutical companies totaled 17, 027 last year, more than all other industries with significant liability suits combined: 3,236 (Manufacturing); 2,875 (Chemicals); 2,717 (Construction); 2,636 (Financial services); and 1,926 (Insurance).

"The lawsuits," says researcher Thomson West,  "raise questions about whether drugmakers and the FDA pay ample attention to patient safety. Since 2000, more than 65,000 product liability lawsuits have been filed against prescription drugmakers, the most of any industry."  No one even knows how many people have died as a result. The fact that FDA does not prevent lethal drugs from being brought to market and that FDA allows such drugs to be aggressively advertised-even when their deadly effects are known to the FDA-have resulted in such lethal drugs to become the most profitable blockbusters. The profitability of lethal drugs has encouraged companies to market toxic drugs. Drug company profits far outweigh the cost of defending against product liability lawsuits.

August 22, 2006
The New York Times reports that after months of foot dragging, the FDA has finally issued additional warnings on the labels of widely prescribed psychostimulant drugs--Ritalin, Adderall, Concerta.

These drugs are prescribed for at least 4 million people (mostly children) who are diagnosed with the controversial "condition"-- . “The new warnings are not as strong as those approved in February by an advisory committee for the FDA, but they significantly strengthen the risk information already on the drugs."
<< Click here to read more: NYTFDAWARNING.doc >>

August 11, 2006
The Indianapolis Star reports that 8, 362 consumers of Eli Lilly's top-selling drug, Zypreza that produces diabetes--among other life-threatening effects--can expect between $5,000 to "well over $100,000 a person" depending upon the harm suffered. Eli Lilly’s $700 million settlement covered about 75 percent of the known Zyprexa claims against Lilly. But hundreds more have flooded into federal and state courts. Lilly has set aside another $300 million to cover potential liability from the unsettled cases, which it has said it will fight in court.
<< Click here to read more: INDY STAR.doc >>

August 8, 2006
The Boston Globe report focuses on three recent reports in the Journal of the American Medical Association (JAMA) by Harvard researchers who violated the journal’s disclosure policy by failing to disclose their financial ties to companies that had the most to gain from their purported findings. Leading researchers from powerful and prestigious academic institutions routinely fail to disclose conflicts of interest to readers of JAMA and other leading medical journals. The article notes, “At issue is the danger that researchers who receive money from for-profit companies -- whether for speaking fees, consulting, or conducting drug trials -- may, consciously or unconsciously, be biased by that money.”
<< Click here to read more: Globe.doc >>

August 7, 2006
An article titled, Antipsychotic Therapy for Childhood Schizophrenia Lacks Evidence Base: Child and Adolescent Psychiatry Viewpoint, ran in Medscape Psychiatry & Mental Health.

The FDA has not approved any antipsychotic drugs for treating childhood schizophrenia, yet clinicians routinely use medications for this disorder. The authors reviewed a meta-analysis of first generation neuroleptics / antipsychotics (FGAs--e.g., Haldol, thorazine) vs. Second generation so-called 'atypical antipsychotics' (SGAs--Zyprexa, Risperdal, Seroquel, others). Industry's blockbuster sellers--the atypical antipsychotics performed WORSE than their cheaper, non-patented precursors. And the atypicals had MORE adverse side-effects such as, acute weight gain and somnolence.  Both the typical (FGAs) and the atypical (SGAs) caused extrapyramidal side effects in 57% of children. The authors acknowledge a flaw in the meta-analysis is "exclusion of unpublished data, omission of which may have, conceivably, led to over-estimation of response rates."

August 2006
The Office of the Inspector General (OIG) recently released the results of their report on the FDA’s monitoring of adverse safety reports (ASRs) of marketed drugs.  According to the report, "These latest revelations have further damaged the FDA's reputation, already tarnished after its involvement in high-profile safety lapses such as with Vioxx, the inflammatory drug withdrawn in 2004 after risks of heart attack and stroke were identified, as well as Ketek, an antibiotic found to have links to liver failure that was allegedly approved on the back of fraudulent clinical evidence." The FDA acknowledged its lack of effective management information systems for monitoring post-marketing study commitments.

Here are a few exercpts:
- "FDA cannot readily identify whether or how timely postmarketing study commitments are progressing toward completion."
- "About one-third of ASRs were missing or incomplete."
- "FDA reviewers indicated to us that monitoring postmarketing study commitments is not generally considered a top priority at FDA. Our analysis showed that FDA validated only 30 percent of ASRs submitted in fiscal year 2004; five review divisions did not validate any ASRs"
<< Click here to read the report: http://oig.hhs.gov/oei/reports/oei-01-04-00390.pdf

August 1, 2006
In-Pharma reports the findings from a survey recently released by the Union of Concerned Scientists (UCS). It reports that according to the UCS, the survey “demonstrates a pervasive and dangerous political influence of science at the FDA.” Almost 20% of the nearly 1,000 scientists who responded anonymously to the survey said they had experienced their work manipulated or suppressed, having been "asked, for non-scientific reasons, to inappropriately exclude or alter technical information or their conclusions in an FDA scientific document."
<< Click here to read more: http://www.in-pharmatechnologist.com/news/ng.asp?n=69555-fda-ucs-survey-viox

July 30, 2006
The American Society of Health System Pharmacists reports that the FDA "directed all makers of ADHD stimulants in May to strengthen the wording in the "Warnings" section of the labeling "with regard to serious cardiovascular events and psychiatric events."
<< Click here to read more: http://www.ashp.org/news/ShowArticle.cfm?cfid=16918989&CFToken=67604765&id=16199

July 29, 2006
A letter published in the British Medical Journal takes the FDA officials to task for scurrying to find ways to protect the manufacturers of tainted drugs they approved without disclosing
life-threatening risks. Instead of coming clean to the public—FDA officials are putting their efforts into burying documented suicides and attempted suicides that occurred in controlled clinical trials of antidepressants.

According to the letter’s author, Dr. David Healy, "In 2003, the FDA first presented an analysis of suicide from clinical trials of antidepressants, most of which had been completed a decade
Previously.  Analyses of suicides and suicide attempts in antidepressants trials had been published previously by others, each showing that antidepressants increased the risk of suicide. This result hid for years behind a statistical smokescreen with the claim that the increased risk of
suicide with antidepressants should be disregarded because it was not "statistically" significant But the FDA, with a database of more than 40,000 patients in trials from all of the antidepressant manufacturers, found an increased risk of suicide with antidepressants that was "statistically significant."

"Instead of concluding that their analysis confirmed the increased risk, which would necessitate warnings on the drugs and admit the fallacy of their pre- emption argument (currently being defended in litigation with millions of dollars hanging in the balance), the FDA concluded that with a few clever statistical adjustments, all of the increased risk disappeared."
<< Click here to read more:  BMJHealy.doc

July 28, 2006
The law firm of Baum Hedlund filed a lawsuit against GlaxoSmithKline, the maker of the antidepressant, Paxil, for causing severe heart defects in the newborn son, of a woman prescribed Paxil during her pregnancy. The risk posed by antidepressants, such as Paxil, Prozac, Zoloft, and the other SSRIs and SNRIs has been documented for years, and this month the FDA issued additional warning advisories about the risk these drugs pose for developing babies in the womb. 
<< Click here to read more: http://www.paxilbirthdefect.com/lawsuit.shtml

July 27, 2006
Bloomberg News reports Forest Laboratories Inc, makers of Lexapro and Celexa, was sued by Utah woman who blames the suicide of her 11 year old daughter on Lexapro.  She hung herself after being on the antidepressant for several weeks.  The suit is one about 24 claiming that Lexapro and Celexa caused patients to attempt or commit suicide.

July 26, 2006
A Seed Magazine article titled, “The FDA is a Cauldron of Discontent” reports on Union of Concerned Scientist survey of FDA scientists findings and features Woody’s story. Reporter Michael Stebbins writes, “Whenever there is a hearing on a health issue on Capitol Hill, patient advocates are asked to present horrifying personal stories of people who've been affected--a very powerful tool to tug at the heartstrings of politicians and staff. Only, it doesn't seem to work when it comes to drug safety. For instance, Woody Witczak's widow, Kim, has traveled to Washington 17 times since her husband died, and yet there has been no serious action on the part of Congress, the FDA leadership or the administration to make sure that scientific findings are not hidden from the public; neither have any steps been taken to ensure that FDA scientists can take action when they see a risk to public health.”
<< Click here to read more: http://www.seedmagazine.com/news/2006/07/the_fda_is_a_cauldron_of_disco.php?page=1

July 21, 2006
Bloomberg News reports that Senator Charles Grassley has asked the Inspector General to investigate collusion between FDA officials and Merck. Citing handwritten notes prepared by a Merck executive document a meeting with FDA division director, Brian Harvey, suggesting a joint effort "to get the message out" to discredit  Dr. David Graham who blew the whistle on the lethal Vioxx effect.  FDA officials then tried to prevent Dr. Graham from testifying in a deposition in the context of Vioxx litigation. Their interference was overruled by the judge.
<< Click here to read more: BloombergGrassley.doc

July 20, 2006
Woody’s widow, Kim Witczak, spoke at press conference held by Union of Concerned Scientists to release the findings of their survey of FDA scientists. Other speakers included: Dr. Francesca Grifo, Senior Scientist and Director, Scientific Integrity Program --Union of Concerned Scientists, and Dr. Susan Wood, former Director of the Office of Women's Health, Food and Drug Administration. Woody’s story was a reminder that these findings have real human life consequences.
<< Click here to read press release: BHPressrelease.doc

July 20, 2006
Union of Concerned Scientists (UCS) released the findings of a survey of  FDA employees (1,000 out of 6,000). The UCS-PEER survey confirms that the integrity of science is being undermined for political and commercial reasons. FDA scientists report being afraid to speak frankly about safety concerns and feel constrained in their roles as scientists.

* Almost one in five (18 percent) of those who responded, "I have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or my conclusions in an FDA scientific document."
* More than three in five (61 percent) knew of cases in which "Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions."
* Three in five (60 percent) also knew of cases "where commercial interests have inappropriately induced or attempted to induce the reversal, withdrawal or modification of FDA determinations or actions."
* Fifty percent also felt that non-governmental interests (such as advocacy groups) had induced or attempted to induce such changes.
* One-fifth (20 percent) say they "have been asked explicitly by FDA decision makers to provide incomplete, inaccurate or misleading information to the public, regulated industry, media, or elected/senior government officials." In addition, more than a quarter (26 percent) feel that FDA decision makers implicitly expect them to "provide incomplete, inaccurate, or misleading information."
* Two in five (40 percent) said they could not publicly express "concerns about public health without fear of retaliation." More than a third (36 percent) did not feel they could do so even inside the confines of the agency.
<< Click here to read more on the UCS findings: http://www.ucsusa.org/scientific_integrity/interference/fda-scientist-survey.html

July 20, 2006
The FDA issued new warnings about two additional life-threatening risks induced by SSRI antidepressants: Serotonin Syndrome and Persistent Pulmonary Hypertension in newborn babies.
<< Click here to read the FDA public advisory: http://www.fda.gov/cder/drug/advisory/SSRI_SS200607.htm

Serotonin Syndrome is another term for drug toxicity (poisoning): FDA described the life-threatening effects of Serotonin Syndrome: “restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting and diarrhea.” Doctors who have been prescribing a combination of SSRIs (or the newer SNRIs, such as Effexor and Cymbalta) and medications for migraine headache have put patients at significant increased risk of drug toxicity (Serotonin Syndrome).

Persistent Pulmonary Hypertension in newborns has been documented for years but the FDA did nothing to warn doctors or the public. A February 2006 report in the New England Journal of Medicine reported a six-fold increased risk for infants.
<< Click here to read more: APMigraine.doc

July 19, 2006
Associated Press reports that following an investigative report in The Wall Street Journal which revealed that psychiatrists from Harvard, UCLA and Emory, whose report published in the American Medial Association (JAMA) urged pregnant women to continue taking antidepressants, had financial interests in making those recommendations.  Dr. Catherine DeAngelis admitted that JAMA published the report without disclosing authors' ties to the manufacturers of the drugs they recommended for pregnant women.
<< Click here to read more: APJama.doc

July 16, 2006
A front page article in The New York Times reports: "The breakfast buffet at Camp Echo starts at a picnic table covered in gingham-patterned oil cloth. Here, children jostle for their morning medications: Zoloft for depression, Abilify for bipolar disorder, Guanfacine for twitchy eyes and a host of medications for attention deficit disorder." The Times reports, 20%  of children in sleep-away-camp take asthma and allergy drugs and "about a quarter of the children at camps are medicated for attention deficit disorder, psychiatric problems or mood disorders." As one camp owner--who does not approve--states "This is the American standard of care now."

The reporter does not question the commercial interests that have resulted in this medically inexplicable practice. Dr. David Fassler, a spokesman for the American Psychiatric Association as well as the American Academy of Child & Adolescent Psychiatry, who invariably reassures the public with unsupported claims:

"Exacting diagnoses and proper treatments enable some children to go to camp who otherwise could not function in that environment, said Dr. David Fassler, a child and adolescent psychiatrist and a professor at the University of Vermont College of Medicine. Dr. Fassler said that children with one behavioral or mood disorder often “have a second or even a third diagnosis.” A child with A.D.D. may also be depressed and anxious, he said, a combination of symptoms that can make such children pariahs in the close quarters of a summer camp cabin without the proper combination of remedies."

The article glosses over the body of evidence showing that psychotropic drugs cause severe, debilitating adverse effects--both physical and mental. They carry FDA-mandated black box warnings for scientific reasons. It notes that "some doctors, nurses, and camp directors are uneasy about giving children so-called off-label drugs.”
<< Click here to read more: NYTcamp.doc

July 2006
The cover story of July/August issue Harvard Magazine, "Psychiatry by Prescription: The Myth of Psychiatric Scientism," by Ashley Pettus, offers much insight by opposing Harvard experts who offer opposing views about the nature and validity of the proliferation of psychiatric diagnoses.

"At the heart of a debate over epidemiological statistics are deep misgivings about the way psychiatry defines and measures mental illness. Despite major advances in the treatment of psychiatric symptoms in recent years, there are still no definitive clinical tests to determine whether someone has a given disorder or not.”

Among those quoted is Dr. Steve Hyman, Harvard University Provost, and Professor of Neurobiology at its Medical School, who served as Director of the National Institute of Mental Health (NIMH), and before that was the Director of Psychiatry Research at Massachusetts General Hospital. Dr. Hyman is a molecular biologist who has specialized in neurotransmitter action--thus, he knows how psychotropic drugs work.

When asked about the level of knowledge about psychiatric diagnoses Dr. Hyman responded:  “We have no equivalent of a blood-pressure cuff or blood test or brain scan that is diagnostic...The DSM IV [psychiatry's diagnostic manual] has not given us validity...The proliferation of disorders in a single person,” he says, “suggests there is something wrong with the number of discrete diagnoses.” 
<< Click here to read more:  http://www.harvardmagazine.com/on-line/070646.html

July 11, 2006
The Wall Street Journal documents how psychiatry’s treatments are shaped by "opinion leaders" whose professional recommendations are compromised by their substantial, largely undisclosed, financial ties to drug companies. The article documents violations of influential academic psychiatrists who promote psychotropic drugs for pregnant women that will cause harm to their developing infants.   Specifically, thirteen leading drug industry-financed psychiatrists from Harvard, UCLA and Emory, published a report in JAMA (2006) whose aggressive promotion in the local and national media was designed to frighten pregnant women and to dissuade them from stopping antidepressants during pregnancy.

The authors emphasized a (previously unreported) risk of relapse, disregarding a body of evidence (documented since 1993) demonstrating that exposure to serotonin (SSRI antidepressants) in utero has caused birth defects, cardiac malformation, respiratory distress, and severe withdrawal syndrome in infants. The authors even disregarded manufacturers’ disclosure on SSRI-SSNRI drug labels which acknowledge that the drugs pose risks of harm to neonates who “have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding."
<< Click here to read more: WSJPregnancy.doc

July 2006
For almost two decades Eli Lilly, manufacturers of the first SSRI Prozac on the market, has denied that evidence exists demonstrating that its antidepressant Prozac induced violence and suicidality.

Baum Hedlund reproduces the time-line presented to the jury in the Forsyth v. Eli Lilly Trial during closing arguments by the plaintiffs. The time-line comes from Lilly's internal documents. The plaintiffs alleged that the documents show that Lilly knew about Prozac-induced suicidality and violence (even before Prozac was approved for marketing in the United States) and that this vital information was withheld from clinicians and the public. 
<< Click here to read more: EliLillyTimeline.doc

July 2006
An PLoS article titled, “Do Antidepressants Cure or Create Abnormal Brain States?’ by Dr. Joanna Moncrieff of University College London and Professor David Cohen of Florida International University in Miami, challenge the "disease-based" paradigm in psychiatry, arguing that the class of drugs known as antidepressants, and indeed all psychotropic drugs, produce their desired effects by creating abnormal brain states.   Psychotropic drugs induce sedation, or stimulation, or indifference, or a "plethora of psychobiological states," and may thus coincidentally relieve symptoms of psychiatric disorders. The authors write that this in no way suggests that patients have "chemical imbalances" and they warn that these drug-induced states, though usually short-lived and may create more problems than they solve. Drs. Moncrieff and Cohen argue that psychiatry's dominant "disease-centered model"-which holds that drugs correct "biochemical imbalances"-is far from established
<< Click here to read more: http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10%2E1371%2Fjournal%2Epmed%2E0030240

June 29, 2006
Consumer union holds press event with members of Congress and family
members who lost loved ones to highlight stalled FDA improvement
legislation. << Click here to

June 26, 2006

BBC reports that top pharmaceutical companies are using unscrupulous marketing practices to promote their drugs, according to a European Consumer International report. The industry uses unscrupulous, systemic promotional practices to influence opinion and prescribing practices. "These include the sponsoring of patient lobby groups, funding disease awareness campaigns and use of hospitality packages for medical experts." Industry's claims about the cost of research and development are contradicted by industry's spending on marketing:  "The pharmaceutical industry spends nearly twice as much on marketing as it does on research and development, yet consumers know next to nothing about where [$60 Billion] this money is going."
<< Click here to read more: http://news.bbc.co.uk/go/pr/fr/-/2/hi/europe/5116312.stm

May 26, 2006
Health Canada warns heart patients to AVOID ADHD drugs. "All ADHD drugs stimulate the heart and blood vessels ... The effects are usually mild or moderate, but in some patients this stimulation may -- in rare cases -- result in cardiac arrests, strokes or death," said Health Canada.
<< Click here to read more: HealthCanadaADHD.doc
<< Click here to read what the FDA is doing on this issue:

May 26, 2006
The Associated Press reports that the U.S. Centers for Disease Control and
Prevention has issued a report estimating that nearly 3,100 people prescribed psychostimulants--such as, Ritalin, Concerta and Adderall--landed in hospital emergency rooms! The evidence from clinical practiceconfirms the concerns raised by cardiologists on the basis of clinical trial data.

These drugs are causing children and adults to suffer severe adverseside-effects, including cardiac problems, chest pain, stroke, high bloodpressure and rapid heart beat. The CDC report confirms earlier evidence that children who are prescribed psychoactive drugs--such as stimulants or antidepressants are at increasedrisk of suffering severe adverse drug effects requiring emergency hospitalization.
<< Click here to read more: http://www.ahrp.org/cms/content/view/175/52/

May 26, 2006
GlaxoSmithKlines's acknowledgement refutes the recent claims made in the American Psychiatric Association’s The American Journal of Psychiatry.
In the wake of the extraordinary acknowledgement earlier in month by GlaxoSmithKline that the clinical trial evidence shows that not only children and adolescents are at increased risk of suicidal behavior if they take its antidepressant, Paroxetine / Paxil (or any other "new generation" antidepressant), adults too are at increased risk of suicide if they take Paxil. The risk is six-fold compared to those given a placebo.

May 19, 2006
United Press International reports on the controversial Teen Screen Program which is part of a presidential task force to help prevent teen suicides. It recommends school screening of young school aged children for tell-tale signs of emotional and behavioral trouble.
<< Click here to read more: UPITeenScreen.doc

May 16, 2006
The Wall Street Journal documented report by David Armstrong talks about the illusion about The New England Journal of Medicine as a bastion of scientific and moral integrity.
The evidence brought to light by the WSJ reveals that a culture change at the NEJM mirrors the prevailing culture within the pharmaceutical industry. Neither the scientific integrity of its published reports nor the professional conduct of those who review the reports can be trusted. Among the documents for which the Wall Street Journal provides links, is to a Seattle public radio broadcast ( Aug. 14, 2001) in which pharmacist Jennifer Hrachovec called in and challenged NEJM editor, Dr. Jeffrey Drazen, about the inaccuracy of the published Vioxx-VIGOR study.
<< Click here to read more: http://www.ahrp.org/cms/content/view/168/55/

May 12, 2006
GlaxoSmithKline and the FDA notified healthcare professionals that there is a risk of suicidality in young adults on Paxil.
<< Click here to read more: http://www.ahrp.org/cms/content/view/166/28/
<< Click here to read GlaxoSmithKline letter to healthcare professionals.
<< GSKmay1.jpg
<< GSKmay2.jpg

May 3, 2006
An investigative report in USA Today documents the truth about antipsychotic drug-induced harm being perpetrated on America’s children. Marilyn Elis of USA Today reviewed FDA's Medwatch adverse event report database (from 2000 to 2004) and found "at least 45 deaths of children in which an atypical anti-psychotic was listed as the "primary suspect." One-fourth of the cases in the database did not list the patient's age.  In addition, there were 1,328 reports of bad side effects, some of them life-threatening. The FDA Medwatch database represents only 1% to 10% of drug-induced side effects and deaths. Expert clinical pharmacologist Alastair J.J. Wood (Vandebilt University) suggests it represents, "maybe even less than 1%."
<< Click here to read more: USATODAYmedwatch.doc

April 28, 2006
An article in PLos Medicine (Public Library of Science) reports that disease-mongering turns healthy people into patients, wastes precious resources and causes iatrogenic (medically induced) harm. Like the marketing strategies that drive it, disease-mongering poses a global challenge to those interested in public health, demanding in turn a global response.”
<< Click here to read more: http://collections.plos.org/diseasemongering-2006.php  

April 27, 2006
HBO’s Bill Maher wrote an OpEd piece in The Los Angeles Times, in which he skewers the drug industry's methods of marketing invented “diseases;” doctors who jump at every free (expensive) dinner invitation and honoraria for listening to sales pitches;  and the complicity of the FDA and Congress who, as he says, are also accepting bribes: “Drug companies are pushers, and Congress and the FDA are the cop on the beat who's been paid off to look the other way.” “Just in the last two years, the drugs that have made the headlines under the category "Prescription Medicines That Hurt People" have included Vioxx and Ambien. And yet it was marijuana last week that was declared by the FDA to have no known medical value. Actually, what marijuana has is no known lobbying value.”
<< Click here to read more: http://www.ahrp.org/cms/content/view/159/29/

April 24, 2006
The Government Accountability Office (GAO) released its findings on FDA. According to a Los Angeles Times article titled, “Drug Safety Still Seen as Lagging a Year After announcing Reforms”, the FDA still doesn't have a reliable system to keep track of developing problems. The GAO found that a new Drug Safety Oversight Board and other FDA initiatives were "unlikely to address all the gaps" in the agency's system for monitoring the long-term safety of prescription drugs approved for market.
<< Click here to read more: LATIMESGAO.doc

April 20, 2006
According to an article titled, “Top Mental Health Guide Questioned” in The Chicago Tribune, reports most of the experts who prepared the world's leading medical guide to mental illness (known as the Diagnostic and Statistical Manual of Mental Disorders aka DSM) had undisclosed financial relationships with drug companies that presented potential conflicts of interest. This is according to a new report published Thursday in the Journal Psychotherapy and Psychosomatics. The study is the first to document extensive monetary connections between drug companies, psychiatrists and other scientists responsible for the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders. The DSM, as it's commonly called, defines all the mental illnesses recognized by psychiatry and outlines the criteria used to determine whether a person has one of these conditions. Medical professionals refer to it as the "bible of mental health" in the U.S.
<< Click here to read more: ChicagotribuneDSM.doc

April 14, 2006
The Portland Tribune reports that a study examining Oregon's Medicaid plan found that 246 preschool children are being drugged with toxic anti-psychotics and/or antidepressants.  The drugs are unapproved for use in children under 18, and they carry black box warnings of lethal risks.
<< Click here to read more: http://www.portlandtribune.com/news/story.php?id=34841

April 11 – 13, 2006
The “Disease Mongering” conference will be hosted by the Newcastle Institute of Public Health and School of Medicine and Public Health at the University of Newcastle, Australia.  An international group of experts will address the commercialization of disease and medical conditions, and such public policy issues as: “When does legitimate promotion of public health become mongering of disease for profit?” 
Speakers will also discuss non-medical implications—such as economic and social ramifications of medicating developmental “conditions” and medicalizing normal life experiences.
<< Click here to read more: http://www.diseasemongering.org/downloads/program.pdf

Three recent UK press reports address different aspects of the issue:

1) The Times World News: “Drug Companies ‘Inventing Diseases to Boost Their Profits” by Mark Henderson.
Click here to read more: http://www.timesonline.co.uk/article/0,,3-2128371,00.html

2) Guardian: “Glaxo Denies Pushing ‘Lifestyle’ Treatments” by Fiona Walsh
Click here to read more: http://business.guardian.co.uk/story/0,,1763199,00.html

3) Guardian: “Depression is UK's Biggest Social Problem, Government Told” by Sara Boswell
Click here to read more: http://society.guardian.co.uk/print/0,,329467273-106049,00.html

April 1, 2006
An editorial, “Carefully Weigh Drug Firms Claims”, runs in The Shreveport Times that talks about the truths about the pharmaceutical industry and its corrupting influence on high ranking lawmakers and the near-total subversion of the FDA is spreading to the American hinterland.
<< Click here to read: www.shreveporttimes.com/apps/pbcs.dll/article?AID=/20060401/OPINION03/604010311/1007

March 30, 2006
The Center for Public Integrity reports that FDA officials circumvent the prohibition on accepting trips from drug and medical device manufacturers. They accept trips from nonprofit associations "that draw their members, their boards and even some of their funding from medical and pharmaceutical-related companies paying for the travel of hundreds of FDA employees." The major sponsor of FDA staff travel expenditures was the Drug Information Association which paid for more than 600 trips of FDA employees.
<< Click here to read more: publicintegrity.doc

March 23, 2006
A national class action was filed against GlaxoSmithKline for Paxil-induced suicides in youths. The lawsuit charges the company with fraud, negligence, strict liability, and breach of warranty in its marketing of Paxil (Seroxat) by concealing the risk of suicide.
<< Click here to read more: BHpressreleasePaxil.doc

March 16, 2006
The Associated Press reports that a just released study that found that a staggering, two and half million children in the U.S. are being prescribed antipsychotics annually--that's 40 out of every 1,000 children. The released study by Dr. William Cooper of Vanderbilt Children's Hospital found that two and half million children in the U.S. are being prescribed antipsychotics annually. That's 40 out of every 1,000 children are being exposed to highly toxic drugs that have never been approved for use in children.  The drugs damage the central nervous system, the metabolic system, trigger hyperglycemia, acute weight gain, diabetes, cardiac arrest, cognitive impairment, and are linked to insulin suppression in children. The drugs carry black box warnings.
<< Click here to read more: APADHD.doc

March 10, 2006
Dr. Peter Breggin's sealed expert medical report in a Paxil liability case is now in the public domain. Newly released information contained in sealed expert medical witness report demonstrates that the manufacturer of Paxil withheld key data concerning the risks associated with its antidepressant Paxil when taken by adults. 

In a press release issued by Dr. Peter Breggin states,  "The drug company Glaxo SmithKline failed to release its complete data concerning rates of suicidality on Paxil.  In the information that was originally provided to the FDA, the number of suicide attempts on the antidepressant Paxil was under-reported and the number of suicide attempts on placebo was inflated. The drug company also hid the stimulating effects of the drug that pose a potential risk for causing violence."
<< Click here to read more: http://www.breggin.com/courtfiling.pbreggin.2006.pdf

March 2006
The March issue of Oprah magazine contains an article titled, “Valley of the Dulls.”
It reports that a stunning 157 million prescriptions for antidepressants were dispensed in 2005.  Not everyone is helped by antidepressants.  Some complain that the drugs take the edge off their memory, concentration, creativity, and drive.  The article asks, “Are the wrong people getting the medication?”
<< Click here to

February 22, 2006
An article in Psychiatric Times, titled, “Conservative Groups Press Currie on Teen Screening”, reported about a meeting attended by several "conservative interest groups" of concerned citizens with Charles Currie, the Administrator of the Substance Abuse and Mental Health Services Administration (SAMHSA).

The groups who were represented raised concerns about the government policy of mass mental screening of America's school children—often without valid, informed parental consent. Mental screening is the first step in an orchestrated expansion program that increases patient rolls.  Children who screen "positive" are labeled with psychiatric disorders, followed by prescriptions for psychotropic drugs.

Now the public will have the opportunity to hear the debate between Dr. David Shaffer, head of Child and Adolescent Psychiatry, Columbus University who helped found Teen Screen model and Vera Sharav, founder of AHRP, who opposes Teen Screen. It will be held in Washington DC.
<< To read more, click here >>

February 20, 2006
As reported in the Tacoma News Tribune, the British Medicine and Healthcare Products Regulatory Agency (equivalent to the FDA) has identified new safety concerns with ADHD drug Stattera.  The British authorities have associated Strattera with seizures and a potentially dangerous lengthening of the time between heartbeats, called QT interval prolongation, in a handful of the more than 3.7 million people who have used the drug since it hit the market in November 2002.

The report was obtained by The News Tribune after a Swedish court ordered it released to a drug-safety activist in that country.

Though the number of seizures and heart-rhythm problems is small, the British agency said problems could be under-reported, and warned doctors and consumers that the drug should be used with caution in people prone to such problems. In particular, they warned about potential heart problems when Strattera is combined with antidepressants like Paxil and Prozac.  They are updating the drug’s label in the UK to warn of the possible problems.

Though the FDA and Strattera’s maker, Eli Lilly, are aware of the issues raised by the British authorities, they are being handled differently in the US.    They have stated that no warnings are planned at the moment to U.S. doctors and patients, and the U.S. label for Strattera contains no warning of seizures.
<< Click here to read the article >>

February 15, 2006
A press release reported out of Sweden, a not yet released discussion paper from the British Medicines and Healthcare products Regulatory Agency (MHRA) reveals 130 reports of suicidality in one month from treatment with Strattera.

In addition, the paper tells about 766 spontaneous reports of cardiac disorders and 172 of liver injury, and about 20 completed suicides.

The press release further states Strattera is a failed antidepressant, which Eli Lilly didn’t succeed to get approved. It was recycled and used as an “ADHD medication,” and marketed as the first “non stimulant medication for ADHD.”

February 13, 2006
In a TIME Magazine article, Dr. Steven Hayes concludes that after decades of drug side effects, only marginal gains have been seen in public mental health.   As the article points out: "For a time, in the 1990s, we seemed to think that curing mental illness was a matter of manipulating a couple of brain chemicals. But after decades of side effects and the recent debate over whether antidepressants carry suicide risk for teens, we have seen only marginal gains in public mental health. A 2002 study in Prevention & Treatment found that approximately 80% of the response to the six biggest antidepressants of the '90s was duplicated in control groups who got a sugar pill. So we may be ready for something different."

Also: "Cognitive therapy was also shown to be somewhat superior to antidepressants."

And: "Among more severely depressed patients, behavioral techniques like setting up new routines and scheduling activities worked as well as an antidepressant and significantly better than cognitive therapy.”
<< Click here to

February 13, 2006
Reuters reports that some outside advisers criticized a major part of the government's efforts to improve drug safety, saying a new drug safety oversight board needs independent voices and should consider meeting in public.  The Drug Safety Oversight Board was announced a year ago as a step to help regulators quickly respond to signs of unexpected side effects after a drug reaches the market.  Currently, board members are senior FDA officials, plus experts from other government agencies. They meet periodically in private to discuss how to address emerging issues. Brief summaries are released to the public.
<< To read more, click here >>

February 13, 2006
In the wake of the fraudulent cloning reports published in the medical journal, Science, a report in the New York Times Business section surveyed science reporters in several major newspapers and found that newspaper reporters are beginning to express doubt about the credibility of reports published in peer-reviewed science journals.

Rob Stein, science reporter of The Washington Post, acknowledged: "My antennae are definitely up since the whole thing unfolded."  The Boston Globe "instituted guidelines last July requiring reporters to ask researchers about their financial ties to studies, and to include that information in resulting articles. In its weekly health and science section, The Globe outlines any shortcomings of a study under the heading ‘Cautions.’”
<<To read more click here >>

February 13, 2006
An Op-Ed piece in The Boston Globe by Dr. Jerome Kassirer, distinguished Professor at Tufts, a former editor of the New England Journal of Medicine, and author of "On the Take: How Medicine's Complicity With Big Business Can Endanger Your Health," writes how drug lobbyists influence doctors and should make taxpayers and Congress stop and consider.

"While lobbying groups spend about $2 billion to convince politicians to do their bidding, pharmaceutical companies spend nearly 10 times that much to influence the nation's 600,000 to 700,000 physicians to prescribe the newest and most expensive drugs. I imagine that many people who regularly watch television assume that the companies are spending most of their advertising budget to influence consumers, but no. Nearly 85-90 percent is spent on doctors, for free drug samples, speaker's fees, consultation fees, and ''educational grants."

So, while much is being written about Big Pharma's lobbying influence on legislators and direct to consumer advertising, the amounts spent on those ads pales when compared to the amount spent by Big Pharma--close to $20 billion--on influencing those who are licensed to write Rx.
<< Click here to

February 10, 2006
An article in TIME noted that FDA officials at a meeting regarding ADHD medications, such as Ritalin, were taken by surprise when the committee “in an unexpected twist” took safety seriously, reasoning that “the evidence of serious risks was so great that a strong new warning — not just more research — was needed.”

The article reports that cardiologist, Dr. Steven Nissen of the Cleveland Clinic, who was among the early warners on the risks of Vioxx, made a motion for a black box warning on the drugs due to cardiac risk.  He was concerned that the 25 cases of reported deaths might be just the tip of an iceberg. “There’s no mandatory reporting of these cases.”

Dr. Nissen noted that the stimulants in question are known to raise blood pressure and heart rate. “Raising blood pressure of a child or adult continuously over many years worries me,” Nissan told TIME. “There is a linear relationship between increased blood pressure and adverse cardiovascular events.” Nissan further notes that two stimulants that are related to the Ritalin class of drugs—ephedra and phenylpropanolamine (PPA)—have been banned from the market because of cardiovascular risks.”

Another panel member, Dr. Curt Furberg, concurred, stating: it would be "inappropriate, unethical behavior" for the FDA not to disclose to doctors and patients that there was uncertainty about the safety of ADHD drugs.
<< To read more, click here >>

February 10, 2006
Since the passage of a 1995 law under then Governor John Engler, Michigan is the only state in the nation in which citizens are fully prohibited from filing liability claims against drug companies. The prohibition includes state courts and federal courts, individual actions and class actions. And so Michigan citizens (or their survivors) who have been seriously injured or killed by drugs like Redux ("fenphen"), Rezulin, Baycol, or Vioxx—a few of the sixteen drugs that have been withdrawn because of safety problems since 1997—have been shut out of court.
As Dr. Henry Greenspan points out in his editorial to Justice Caucus, it’s not about whether a drug "has dangers" or, indeed, may cause serious injury or death. Lawsuits are about a company's "failure to take reasonable and timely action to make a drug’s risks known — above all, to the FDA and to physicians—when that company became aware of those risks.  The goal of immunizing drug and vaccine manufacturers is to protect them from the consequences of their deliberate concealing of the hazards they had knowledge of.”

And, as PhRMA spokesman, Alan Goldhammer, let slip, liability is what leads drug manufacturers to be concerned about safety issues--without the threat of liability, there will be NO INCENTIVE to worry about drug safety issues.
<< Click here to

February 9, 2006
AP reports Ritalin and other stimulant drugs for attention deficit hyperactivity disorder should carry the strongest warning that they may be linked to an increased risk of death and injury, federal health advisors said at the conclusion of their 2-day long meeting.

The FDA advisory panel voted in favor of the "black box" warning after hearing about the deaths of 25 people, including 19 children, who had taken ADHD drugs. The vote was 8-7, with one abstention.
<<Click here to

February 9, 2006

The Boston Globe reports that the Food and Drug Administration is again considering revising labels of popular antidepressants, this time in response to an article in the New England Journal of Medicine that linked use of drugs like Paxil, Prozac, and Zoloft late in pregnancy with a condition that can endanger infants' lives. The condition is called persistent pulmonary hypertension of the newborn.
The FDA called the results of a study cited in the article "very concerning."   The agency will issue a public health advisory within days, said Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs. Its regulatory options include updating drug labels, searching public and private databases to corroborate the drug link to the lung condition, and requiring additional trials from drug manufacturers.
<< Click here to read more: >>

February 6, 2006

An independent review by a team of German analysts published in the American Journal of Psychiatry confirms that corporate bias is ubiquitous in clinical trials. The credibility of company sponsored tests of the so-called 'atypical' antipsychotic drugs (neuroleptics) including Johnson & Johnson subsidiary Janssen's Risperdal (risperidone), Lilly's Zyprexa (olanzapine), Novartis' Clozaril (clozapine), Pfizer's Geodon (ziprasidone) and Sanofi-Aventis' Solian (amisulpride) is totally undermined by corporate bias at every step of the process--from design, subject selection, data analysis, and journal reports.

Dr. Stephan Heres and colleagues (Technical University, Munich) found that 90% of company-sponsored clinical studies found the company's drug more favorable than its competitors. "Different trials comparing the same two drugs have had contradictory conclusions," the study notes.  The reported results seem to be much like partisan politics—the drug favored depended upon who paid for the trial. A total of 42 clinical trial reports were identified.  Of these, 32 were (fully or partially) funded by pharmaceutical companies.
<<To read the original recap of study as published in The Pink Sheet, click here:>>

February 6, 2006

Weighing the Benefits and Risks of SSRI Antidepressants for Youth
Parents, physicians and the public attempting to make sense of the controversy about antidepressants are torn between unproven claims and counter-claims about the drugs’ benefits and risks.  People cannot make an informed treatment decision unless they know the demonstrated risks and benefits.  Following the FDA-mandated black box warnings (October 2004) of a twofold increased risk of suicidality in children—4% in those on an antidepressant compared to 2% in those on placebo—there was a dramatic 20% to 25% drop in SSRI prescriptions for children under 18.
<<To read more, click here>>

February 2, 2006

An editorial in The New York Times acknowledges what has been noted by some observers for the past decade: "the medical profession has sold its soul in exchange for what can only be described as bribes from the manufacturers of drugs and medical devices."   "It is long past time for leading medical institutions and professional societies to adopt stronger ground rules to control the noxious influence of industry money on what doctors prescribe for their patients."
<<Click here to read more>>

February 2006
CNN Money reports that antidepressant sales have been slowing ever since the 2004 warning went into effect. Deutsche Bank analyst Barbara Ryan wrote that "the antidepressants market remains flattish following suicide relabeling."
<<To read more, click here>>

February 2006
Consumer Union recognizes Woody’s widow and brother-in-law for all their advocacy work on drug safety and antidepressant issues on the national and state level.
<<To read more, click here:>>

February 9-10, 2006

The FDA hearing set to address drug safety issues for ADHD drugs (i.e. Ritalin, Adderal, Concerta) linked to death and heart attacks.

February 1, 2006
Prescription Drug & Pharmaceutical News reports that drug companies like GlaxoSmithKline, Merck, and Sepracor are currently developing a new class of antidepressants called,  "triple reuptake inhibitors."  These new drugs will inhibit the reuptake of serotonin, norepinephrine and dopamine are expected to hit the market in 2009.  According to Natalie Taylor, an analyst with Decision Resources, Inc., a pharmaceutical research and advisory firm,"In order to establish a presences in this market, novel antidepressants drugs will need to be clearly differentiated from the large numbers of generic first line-therapies, and will need to be aggressively marketed to primary care physicians if they are to attain sales that approach the blockbuster status enjoyed by Pfizer's Zoloft and Wyeth's Exfexor." 
<< Click here to read the article >>

January 25, 2006
Stephen Pizzo, an investigative journalist for 25 years compares Big Pharma to Big Tobacco in his article titled, “Shielding Big Pharma”.  He points out:

1) Both Big Tobacco and Big Pharma produce and sell products that often cause injury or death when used as directed.

2) Both industries knew that some of their most profitable products were injuring and killing people, and either hid such evidence, lied about it or both.

3) Both industries hired their own experts to produce often phony, always misleading non-peer-reviewed, “research” designed solely to cast doubt on any genuine research by outside experts that came to conclusions that could hurt sales.

4) Both industries attacked, slandered and punished those within or associated with their industries who broke the company stonewall by trying to sound a warning.

5) Finally, both industries enjoyed overly cozy relationships with government—relationships that enabled them to maximize profits for as long as possible, regardless of the harm such products were known to be causing. (In this regard, Big Pharma has gone even further, by compromising the FDA, the very federal regulatory agency that is supposed to protect consumers.)
<< Click here to read the article >>

January 24, 2006
Consumer Alert, a Portland, OR consumer advocacy group launches anti DTC drug ad website.
They hope to educate the public about the dangers of prescription drug advertising and to mobilize thousands of Americans to voice their opposition to the ads  The FDA is accepting public comment on DTC advertising until February 28, 2006.
<< Click here to check out the site >>
<< Click here to see a sample of Pfizer’s most recent advertising for Zoloft >>

January 19, 2006
The Washington Post reports that the FDA's controversial assertion of "federal preemption" was included as a preamble to long-awaited guidelines designed to make drug-labeling information more accessible and readable for doctors and consumers. Agency officials said that, although the preemption policy does not have the weight of law or formal regulation, they hope state judges will accept their position. 

According to Scott Gottlieb, FDA’s Deputy Commissioner for Medical and Scientific Affairs, "We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge."
<< To read more, click here >>

January 15, 2005
The Insurance Journal reports that the National Conference of State Legislatures has accused the FDA of attempting to preempt state prescription drug product liability laws despite Congress and the courts’ refusal to grant them such power.  The state group says the agency is trying to expand its own authority by sneaking language into a revised prescription drug labeling rule.
<< Click here to

January 14, 2006
The Wall Street Journal reports that the FDA's plan for revamping drug labeling rules would carve in stone the agency's former chief counsel, Daniel Troy's pre-emption argument.  The pre-emption argument holds that the authority of the FDA (and other federal regulatory agencies) pre-empts any state consumer protection laws.

Drug companies like Merck would be free from liability even as the body count from its pain killer, Vioxx, reaches tens of thousands.  The White House, drug companies, lobbyists and sycophants are attempting to frame the argument in terms of "tort reform" falsely creating the impression that the only ones who would lose would be plaintiff attorneys. 

In truth, the FDA, whose legal mandate is to protect the public from drugs that have not been scientifically proven safe and effective, is proposing a rule to protect the manufacturers of hazardous drugs instead.
<< Click here to read the PDF >>
<< Click here to read article online >>

January 12, 2006
LA Times reports that in an effort to try and increase the number of new drugs that make it to market, the FDA issued guidelines today allowing investigators to test minute doses of experimental drugs on people, to see if the results are promising enough to warrant full-scale clinical testing. Scientific researchers and the industry welcomed the FDA action, but some agency critics said they were concerned that it could increase hazards for volunteers, or facilitate the approval of drugs before their risks are fully understood.
<< Click here to

January 11, 2006
The New York Times reports that the Senate Finance is cracking down on drug industry "educational grants" to physicians, medical associations and "patient advocacy" groups. Such payments are, in fact, kick backs for these groups' promotional services encouraging doctors to prescribe drugs off-label--a practice manufacturers are forbidden by law from doing.

The article reports that “Twenty-three drug makers spent a total of $1.47 billion in 2004 on educational grants, or an average of $64 million per company, according to the Senate Finance Committee. That number was a 20 percent increase from the total in 2003, which was $1.23 billion.”
<< Click here to read the article >>

January 9, 2006
Dr. Robert Temple, FDA Medical Policy Director of the Center for Drug Evaluation & Research dismisses the claimed findings of a flawed, but highly trumpeted recent SSRI study published in the American Journal of Psychiatry.  The study was sponsored by the National Institute of Mental Health. Dr. Temple is quoted in the FDA "Pink Sheet" stating: "The new study bears only a tangential relationship at best to the previous information…. the new study doesn't have an untreated group. They have no information at all about what would have happened to those people had they not been treated. It simply sheds no light at all on the particular point raised in the labeling or the analysis of those trials."

Unfortunately, most media swallowed the promotional hype dished out by the American Psychiatric Association (whose financial dependence on SSRI manufacturers renders its pronouncements biased and not credible). Most media did not bother to examine the actual study or to notice that the claimed findings were NOT substantiated.
<< To read the FDA’s “Pink Sheet”, click here >>

January 7, 2006
LA Times reports how drug profits infect medical studies.  First, the New England Journal of Medicine made public its concerns about crucial data having been withheld from its 2000 report on a study sponsored by Merck exaggerating the safety of its blockbuster drug Vioxx, now withdrawn. Then the news that a Johnson & Johnson subsidiary failed to include the deaths of two patients in a clinical trial of its new drug for heart failure, Natrecor, in an article published in the Journal of Emergency Medicine.
<< Click here to

January 3, 2006
A Brandeis University study reviewed clinical practice (doctor office visits) and found that drug prescriptions for the treatment of depression, anxiety and mood or attention disorders in teenagers (14 to 18) increased by 250% between 1994-2001: the rates of doctor visits that resulted in a psychotropic drug prescription increased from 3.4% in 1994-1995 to 8.3% in 2000-2001.The authors note that the greatest leap in psychotropic drug prescriptions occurred in 1999--when direct to consumer drug advertising really took off.  "We believe that direct-to-consumer advertising and other marketing strategies are key in encouraging greater use of psychotropics, particularly for the increased use found after 1999.” Advertisements for medications for ADHD, social phobia, and depression are now common in various public media. Overall spending by the pharmaceutical industry on television advertising increased sixfold to $1.5 billion dollars between 1996 and 2000, with the trend accelerating after 1997 (31). Such drug industry promotion combined with the practice of detailing to physicians may affect both the public and physician.
<< Click here to read study >>

January 2, 2006
The Tallahassee Democrat reports on a paper by Florida State University graduate student arguing that drug company ads have confused consumers by oversimplying the causes of and ways to treat depression.
<< To read article, click here >>

January 1, 2006
An editorial titled, “Psychiatry's Sick Compulsion: Turning weakness into diseases” in the Los Angeles Times by Dr. Irwin Savodnik, a psychiatrist and philosopher writes, "Unlike the rest of medicine, psychiatry diagnoses behavior that society doesn't like." 

"The erosion of personal responsibility is, arguably, the most pernicious effect of the expansive role psychiatry has come to play in American life. It has successfully replaced huge chunks of individual accountability with diagnoses, clinical histories and what turn out to be pseudoscientific explanations for deviant behavior."
<< To read, click here >>  

January 2006
An article titled, “Product Testimonials:  The problem with ‘true stories”, runs in Consumer Reports.  It reports that the problem with testimonials is that it's hard to tell which ads are true, which varnish the truth, and which are out-and-out lies. It highlights a Zoloft ad featuring Joanne M.'s story, which is "not based on actual person," according to a tiny footnote.
<< To read the article, click here >>
<< To see new Zoloft testimonials currently running, click here >>

December 29, 2005
Another Federal Court (District of New Jersey) rejects Pfizer’s preemption defense in a Zoloft suicide case (McNellis v. Pfizer). 
<< Click here to read the ruling >>

December 28, 2005
The Wall Street Journal reported that the Journal of Thoracic and Cardiovascular Surgery has taken a major step toward full disclosure of authors' conflicts of interest.

"With conflicts of interest increasingly casting doubt on the credibility of medical research, a leading surgery journal is cracking down on authors who fail to disclose links to industry, threatening to temporarily blacklist them."

The crackdown means that neither scientists found violating disclosure requirements, nor their institutions will be allowed to publish their findings in the journal. Disclosing industry connections is critical because many physicians make treatment decisions based on data published in medical journals, and need to be able to evaluate their credibility.

December 22, 2005
38 U.S. Senators with about $13.4 million in pharmaceutical stock holdings approved a sweetheart deal absolving the drug / vaccine industry from liability.  The New York Times reported that Senator Bill Frist (Majority Leader) inserted this shield from legal liability to his favorite industry "even if they are negligent or reckless."
<< Click here to

December 16, 2005
Following the abrupt resignation of Lester Crawford as chief of the FDA--after just 2 months in office--several Congress persons asked  the Office of the Inspector General to investigate the circumstances. Reuters reports the IG has subpoenaed three financial institutions after: "Financial disclosure forms filed in June 2005 show that as late as 2004, Crawford or his wife owned stock in companies with products regulated by the FDA."
<< Click here to read more >> 

December 13, 2005
Wall Street Journal reports that “ghostwritten” medical research reports – written by professional medical writers hired by PR firms under contracts to pharmaceutical companies are passed off as the work of senior academic scientists who are paid to pen their names.  Ghostwritten articles are published in major scientific journals thought to be authoritative.
<< To read more, click here >>

December 7-8, 2005
The FDA will hold a Public Hearing on the Center for Drug Evaluation and
Research's (CDER) Current Risk Communication Strategies for Human Drugs in Washington DC. The stated purpose of the hearing is to obtain public input on CDER’s current risk communication tools, identify "stakeholders" for collaboration and implementation of additional tools, and obtain greater understanding of the strengths and weaknesses of CDER's existing risk communication.

December 6, 2005
As reported in the Irish Independent, Irish doctors argue that depression “should not be seen as a disease.”  One in five people in  Ireland  was prescribed antidepressants last year- In their book, "Depression: An Emotion not a Disease," psychiatrist Dr. Michael Corry (of Clane General Hospital) and Dublin psychotherapist Dr Aine Tubridy, question the widespread use of drugs
to treat depression, saying it is more "band-aid" than cure. They recommend getting back to basics: "The authors emphasise the need to look at a range of treatments for depression - such as sleep, exercise, nutrition, acupuncture.”
<< To read more, click here >>

November 28, 2005
Fortune Magazine article titled, “Prozac Backlash” reviews the controversy surrounding Prozac and the SSRI class of antidepressants, acknowledging that “the drugs have been among the most controversial in the history of medicine. Bitter disputes about side effects have seethed for more than a decade, usually out of sight of the mainstream media--in supermarket tabloids, on websites, and in professional gatherings of scientists, regulators, and shrinks.” That battle has finally spilled into the major media-- providing the public an opportunity to judge for themselves.

Woody’s story is at the center of the article.  As Fortune reports, “her lawsuit is likely to spotlight the disturbing information that drug companies and U.S. regulators have been aware of for years – but that most doctors prescribing the drugs have known little or nothing about”.

November 28, 2005
A front page story in the New York Times sheds light on yet another unseemly pharmaceutical industry strategy for pushing brand name drugs. The industry's most effective drug marketing strategy is to hire cheerleaders as sales reps whose "educational" methods can be relied upon to sell drugs--"There's a lot of sizzle in it."  Indeed, demand for cheerleaders by the pharmaceutical industry has led one enterprising entrepreneur to form Spirited Sales Leaders.
<< Click here to read the article >>

November 25, 2005
Antidepressants are under scrutiny in a homicide case in Wisconsin. 
<< To read the article, click here >>

November 21, 2005
An article, “Bitter Pills: Antidepressants Prescribed to Millions, But Do They Work?  Worth the Risk”, runs in TIME Asia Magazine reports that skepticism is growing among "a small but growing international chorus" of professionals who, having analyzed the scientific data, have come to the conclusion that "a thorough reevaluation of current approaches to depression and further development of alternatives to drug treatment."

The dark side of the drug industry's cash cows, the antidepressants, is tumbling out of psychiatrists' closets and the profession is losing control. TIME describes the travails that a young Australian woman, who was misdiagnosed with "postnatal depression" and for three years was prescribed one after another SSRI antidepressant by her psychiatrist who kept increasing the doses as she kept getting worse.  Her cure? She secretly weaned herself off all the drugs, recovered, and watched as her psychiatrist congratulated himself on his skill "to concoct precisely the right drug regimen."  Time reports: "the honeymoon is over. Even doctors who swear by SSRIs and newer variants concede that 1-2% of patients have a severe negative reaction to these drugs. That's a small percentage. But it's a small percentage of a very large number.”
<< To read the article, click here >>  

November 16, 2005
USA Today reports, “At FDA, Graham is still the whistle blower.” On Nov. 18, 2004, Dr. David Graham, FDA's associate director for science and medicine, blew the whistle in testimony before the Senate Finance Committee, on FDA's "profound regulatory failure" to protect the public against lethal prescription drugs. One year later, Dr. Graham told USA Today:

"Today, the United States of America is worse off when it comes to drug safety than it was a year ago when I testified. That's because the FDA's recent drug safety initiatives serve only as window dressing, diverting attention away from real solutions, such as an independent Office of Drug Safety."  Among the most harmful marketed drugs are the so-called atypical antipsychotics which were approved for schizophrenia but are being prescribed primarily off-label, mostly to control behavior in children and the elderly-- despite the fact that they are linked to severe, irreversible harm, including hyperglycemia, diabetes, and death.   Dr. Graham says "FDA has known about this for two or three years." He estimates that off-label use of antipsychotics may cause up to 62,000 excess deaths a year.
<< To read the article, click here >>

November 16, 2005
Stanford University researchers reported in the December issue of Journal of Adolescent Health that their study found that the number of children 7 to 17 years old who are prescribed SSRI antidepressant drugs increased from 47% in 1995-1996 to 52% in 2001-2002, including increases in the off-label use.   “The use of psychotherapy/mental health counseling decreased. The increasingly prevalent off-label use of SSRIs, as well as possibly inappropriate use of medications in substitution of psychotherapy/mental health counseling as first-line therapy, raises concerns about physicians' adherence to evidence-based medicine."

November 15, 2005
A New York Times’ Science section article titled, “A self-Effacing Scholar is Psychiatry’s Gadfly” features a profile of Dr. David Healy.  He has worked tirelessly to bring the long concealed, unpublished evidence about the hazardous effects of SSRIs to public view.
<< To read more, click here >>  

November 14, 2005
The National Institute of Mental Health (NIMH) offers grants to researchers to study the SSRI relation to Suicidality at the same time the FDA is planning a year long study of the evidence of SSRI antidepressants and the risk of suicide in adults.

November 10, 2005
Virginia Tech hosts a public debate / discussion, “On Prozac: Debating the New Technologies of Mind”, about the controversies surrounding the largely inappropriate use of antidepressant and other mind altering drugs. 

Recently when experts who are critical of the unsubstantiated claims made about antidepressants, antipsychotics, and the other mind altering drugs that are currently widely prescribed from cradle to grave--without any evidence that the drugs improved people's lives--the psychiatry department at various universities boycotted the speakers. Robert Whitaker, author of the prize winning, seminal book, Mad in America was boycotted by Harvard Dept. of Psychiatry. Similarly, the Department of Psychiatry at Columbia University boycotted a presentation by the internationally acknowledged expert psychiatrist / psychopharmacologist, Dr. David Healy, whose research and analysis of the concealed clinical trial data, brought to public light the suicide risks of Prozac and the other SSRI antidepressants, and brought to light the utter lack of science behind the anti-depression bandwagon.

November 8, 2005
In yet another federal case (Zikis v Pfizer) involving Pfizer’s failure to warn physicians and the public about the increased risk of suicide effects for pediatric patients prescribed Zoloft, the court rejected Pfizer's argument that it didn't need to warn if the FDA did not require it to issue a warning.

Some of the key language from the Court’s order:

1) "Pfizer has yet to point to any tangible conflicts between the claims in the instant action and the FDCA.  For instance, Zikis alleges that prior to December 2002, Pfizer had sufficient information to determine that there was an association between Zoloft and an increased risk of suicide.  Zikis argues that Pfizer could have provided the FDA with the information and such information would have caused the FDA to alter its position sooner. Zikis argues that it was Pfizer's obligation to notify the FDA about the data showing an increased risk of suicide.  Pfizer has not pointed to any statutory authority or regulation that would have prevented Pfizer from disclosing the data to the FDA prior to December 2002, and thus has not shown any conflict in this regard.  The Amicus Brief provides nothing more than a historical summary of the FDA's position in the absence of the information that Pfizer was allegedly withholding in order to further the sales of its product." (P. 7-8.)

2) "Thus, a drug maker is expressly provided with the authority to unilaterally, without prior approval by the FDA, add warnings that 'add or strengthen a contraindication, warning, precaution, or adverse reaction. [Cites omitted.]  The FDCA was designed primarily 'to protect consumers from dangerous products.'  [Cites omitted.]  That purpose is clearly served by the provision in 21 CFR 314.70(c)(6)(iii)(A), which allows for an amendment to a label without extended delay when a drug manufacturer learns of new dangerous side effects of a drug." 
(P. 9.)

3) "The fact is that Pfizer did not seek to supplement its label, which it could have done in accordance with the regulations."  (P. 10.)
<< To read the complete ruling, click here >>  

November 7, 2005
Consumer ads for a class of antidepressants called SSRIs often claim that depression is due to a chemical imbalance in the brain, and that SSRIs correct this imbalance, but these claims are not supported by scientific evidence, say researchers in PLoS Medicine.

The researchers--Jeffrey Lacasse, a doctoral candidate at Florida State University and Dr. Jonathan Leo, a neuroanatomy professor at Lake Erie College of Osteopathic Medicine--studied US consumer advertisements for SSRIs from print, television, and the Internet. They found widespread claims that SSRIs restore the serotonin balance of the brain. "Yet there is no such thing as a scientifically established correct 'balance' of serotonin," the authors say.  For instance, the widely televised animated Zoloft (setraline) commercials have dramatized a serotonin imbalance and stated, "Prescription Zoloft works to correct this imbalance."
<< Click here for more information >>

November 4, 2005
A petition by 200 US medical school professors addresses the problems of direct to consumer drug marketing. As reported in the current issue of the BMJ in an article titled, “Professors speak out against advertising directly to consumers:”

The drug industry's "onslaught of advertising to promote prescription drugs... does not promote public health" and "increases costs and unnecessary prescriptions." The professors signed a petition organized by Commercial Alert, an Oregon based nonprofit organization that seeks to "protect communities from commercialism." The petition was sent to the US Food and Drug Administration in response to a call for public comments before an FDA advisory committee's hearing on direct to consumer advertising held Tuesday and Wednesday: "Prescription drug advertising pressures health professionals to prescribe particular medications, and often the ones that may be less effective and more expensive and dangerous. This intrudes on the relationship between medical professionals and patients, and disrupts the therapeutic process."
<< To read more, click here >>

November 3, 2005
An article in the Law Gazette (UK) reports that "pharmaceutical companies are prepared to spend huge amounts of money on teams of specialist lawyers to protect the billions that they invest in research and development to discover the next wonder drug. A new survey of 98 in-house legal departments across Europe recently found that companies in the sector were spending the most on legal services.  In fact, pharmaceutical companies spend in the region of 2.6 million euro (£1.8 million) a year, which compares with ¤1 million in the manufacturing sector and 700,000 euro in the transportation area."
<< To read more, click here >>

November 2, 2005
Ad Age, an advertising trade journal, reports that the $4 Billion DTC drug ad fight finds a human face ..  The widowed ad exec delivered an impassioned speech about the suicide of her husband -- a death she believes was triggered by his use of the antidepressant drug Zoloft, from Pfizer.
<< To read more, click here >>  

November 2, 2005
NPR’s Marketplace does a story on the FDA’s Direct-to-Consumer Advertising Hearings being held in DC.  Marketplace reporter interviews Kim Witczak who testified at the hearings and told the FDA and audience members how she believes DTC advertising played a role in her husband, Woody, being given Zoloft by his general physician. 
<< Click here to listen >> 

November 1, 2005
USA Today article titled, “Drug testing halted by early success doesn’t help patients”, reports that an analysis by Mayo Clinic’s Dr. Victor Montori of 143 published randomized clinical trials that "were stopped early," whose investigators reported in journal articles that the trials were stopped because "the treatment looked so effective"-- turned out NOT to be effective: "Unfortunately, what looks too good to be true often is."
<< To read more, click here >>

November 1, 2005
The Swedish Academy of Pharmaceutical Sciences (SAPS) journal article titled, "Lilly is hiding negative information about Zyprexa." features an interview with  Dr. Curt Furberg,  Professor of Public Health Sciences Wake Forest University Baptist Medical Center.  Dr. Furberg has seen secret Eli Lilly documents about the antipsychotic Zyprexa (olanzapine) in his capacity as an expert witness. He stated that the most hazardous effects of Zyprexa are hidden from prescribing physicians and the public. The hidden evidence on Zyprexa's hazards are said to be "worse than all else have seen" -- worse than those revealed about Vioxx. Dr. Furberg's interview provides insight as to why Lilly agreed to a $690 million Zyprexa settlement.
<< To read the full text in Swedish, click below >>

November 2005
A six part special report, “Big Pharma’s Shameful Secret” by Bloomberg News reveals that "Every year, drug companies spend $14 billion to test experimental substances on humans. Across the U.S., the centers that do the testing--and the regulators who watch them--allow scores of human test subjects to be injured or killed."

The report provides corroborating evidence about corrupt clinical trial practices and a dysfunctional system that protects the drug companies while sacrificing both the integrity of research findings and the safety of human subjects--whether they are patients or healthy volunteers.
<< To read more, click here >>

October 25, 2005
Ten families from across the United States have joined forces to bring wrongful death and personal injury suits against the drug giant Wyeth alleging that their respective family members committed impulsive acts of violence - mostly suicides-or attempted them-shortly after taking Wyeth's best-selling drug, Effexor.

The suit was filed in Federal Court in Philadelphia, near Wyeth's corporate headquarters in Collegeville, Pa. The suit alleges that Wyeth's drug Effexor-an antidepressant-was responsible for the deaths of eight people and for injuries to three other teenagers. The average length of time that the patients took the drug before their deaths was ten days. << To read more, click here >>  

October 25, 2005
A Cleveland Plain Dealer article titled, “The FDA isn’t well.  Clinic researchers find another drug-approval mistake, but this time before the pill puts the public at risk” reports that the researchers at the Cleveland Clinic have found serious fault with a drug the FDA considers suitable for market.  Data available to the FDA show that in clinical trials, patients taking Pargluva, an anti-diabetes pill developed by Bristol-Myers Squib and Merck, doubled their risk of heart attack, stroke or other cardiovascular problems.

October 20, 2005
Dr. David Healy will be giving a presentation titled, "Psychopharmacology in Turmoil: A Scientific or Ethical Crisis?" at Columbia University Medical Center in NYC.  Dr. Healy will demonstrate how current clinical practice guidelines that purport to be "evidence-based" are not based on scientifically valid evidence at all. 

Dr. David Healy has completed an analysis of previously undisclosed company data from SSRI drug trials that contradicted the published reports about these trials. His findings of a drug-induced suicide risk challenged the mindset and prescribing practices of the psychiatric establishment in the UK, Canada, Australia, and the US.  By bringing the undisclosed hazards to public notice, the debate about the efficacy and safety of SSRIs--and the validity of the process by which they were tested--reached a crescendo.

A copy of Dr. David Healy’s 2003 Grand Rounds presentation at UCLA, Neuropsychiatric Institute, "How Pharmaceutical Companies Mold our Perceptions of Mental Illness"  (October 28, 2003) can be viewed at: <<click here>> 

October 18, 2005

Wall Street Journal reports that that FDA is considering requiring drug makers to perform longer-term studies of many psychiatric medications before they can be approved for marketing in the U.S.  It reported that the FDA said for the past six months, it has been asking manufacturers to provide "longer-term efficacy data" for psychiatric drugs that treat chronic conditions. But the shift has met with resistance from companies and some researchers, who have said it will slow the process of developing new drugs, said Thomas Laughren, acting director of the agency's division of psychiatry products.  The move toward longer-term studies of antidepressants comes as the FDA has been under pressure to show that it places a strong emphasis on drug safety -- though the push for new data for the psychiatric drugs is focused largely on how well they work.
<< To read the article, click here >>

October 15, 2005

A documentary written and directed by Roberto Manciero called, Prescription:  Suicide? was premiered in Florida.  It is a documentary film featuring real stories of families whose children were prescribed antidepressants and later went on to die of suicide.  One story is about Candace Downing, a 12-year old girl who was anxious about school tests.  A child psychiatrist prescribed the antidepressant, Zoloft, and soon after she committed suicide with no history of depression. 
<< To read more:  click here >> 

October 12,2005

Former FDA Commissioner, Dr. David Kessler (who served under both former President George Bush and Bill Clinton) and is now dean of the University of California at San Francisco, told National Public Radio (on All Things Considered) that the FDA's credibility is at the lowest level he has ever seen. He said that  FDA's credibility is at its lowest level among physicians and the public. The failure to appoint an acting commissioner from within the professional ranks of the FDA leads Dr. Kessler to say, he's "not sure the White House trusts the FDA." 
<< To Listen to audio click here >> 

October 8, 2005
The Washington Post reports that prescriptions for antidepressants for children have dropped an unprecedented 20% in the US. A continuing series of substantiated reports and Black Box warnings about an increased risk of suicide, have overturned public misperceptions about the safety and efficacy of these drugs.<<Click here for the PDF>>

October 7, 2005
The Pink Sheet Daily, a daily pharmaceutical / biotech newsletter reports that consultants for Eli Lilly dismiss the significance of suicide risk on ADHD drug, Strattera even when both the company and FDA will issue Black Box warning of this risk on its label. 
<<read the article, click here>>

October 4, 2005
Richard Smith, the former editor of the BMJ (for 25 years), currently the Chief Executive of United Health Europe, examines key points of the Parliament committee report in PLoS Medical (an Open Access Peer Reviewed Medical Journal).   He reports that Britain's House of Commons Health Committee has recently recommended a fundamental realignment of the relationships between the pharmaceutical industry and government, regulators, doctors, the health service, and patients….

The committee's report makes clear that reducing the influence of the industry would be good for everybody, including paradoxically the industry itself, which could concentrate on developing new drugs rather than on corrupting doctors, patient organizations, and others. It is not in the long term interests of the industry for prescribers and the public to lose faith in it, says the report.

The fundamental problem, says the committee, is that the pharmaceutical industry's influence is too pervasive: The industry affects every level of healthcare provision, from the drugs that are initially discovered and developed through clinical trials, to the promotion of drugs to the prescriber and the patient groups, to the prescription of medicines and the compilation of clinical guidelines.<<To read the analysis, click here>>

October 1, 2005
The Washington Post reports that not only is the newly appointed FDA commissioner Eschenbach an outspoken advocate for faster drug approvals--which is what Big Pharma wants—but there is his close relationship with Big Pharma as the vice-chairman of the board of directors of C-Change, a "non-profit" headed by George H.W and Barbara Bush, whose board includes BristolMyersSquibb and Johnson & Johnson. Members of C-Change include: Chiron Corp, AstraZeneca Pharmaceuticals, GlaxoSmithKline, OSI Pharmaceuticals. It is reported that Eschenbach  is only temporarily giving up the top job at NCI. <<To read the article, click here>>

October 2005
Federal Judge Rosenbaum denied Pfizer’s attempt to get the court to reconsider his previous ruling on Pfizer’s preemption defense in light of an amicus curiae brief filed by the U.S. government in a similar case in Utah federal court.  Pfizer sent a letter to Judge Rosenbaum on Sept. 23, arguing that his finding that Kimberly Witczak's failure to warn claims are not preempted is ripe for reconsideration based on the contents of the government's amicus brief in Kallas v. Pfizer Inc.

September 30, 2005
Etopia Media Medical News Network reports FDA’s “pre-emption” intervention thwarted, Zoloft wrongful death/suicide lawsuit against Pfizer will proceed.

Click here to listen and read more about Pfizer’s claim that even if Pfizer wanted to warn about suicide risk, FDA wouldn’t let it on grounds that the FDA did not believe a scientific link existed at the time and therefore the warning would have been “false and misbranding.”

September 29, 2005
Associated Press and Reuters reports that FDA warned doctors about reports of suicidal thinking in some children and adolescents who are taking Strattera, a drug originally studied to treat depression, but which ended up being used to treat attention deficit hyperactivity disorder, since ADHD is NOT associated with suicidal behavior.

Manufacturer Eli Lilly & Co. announced that a black-box warning would be added to the drug's label in the United States. Such a warning is the most serious that can be added to a medication's label, and similar warnings will be added to the drug's labels in other countries.
<<Click here to read more>>

September 28, 2005
Reuters reports that prescription drug labels will be easier to read and updated quickly on the Internet as part of an effort being launched later this year to improve information for doctors and patients, a U.S. health official said on Wednesday. Regulators have been promising a major revamp of prescribing instructions for years. Labels for physicians now run several pages and have side-effect information scattered throughout. It can take months for new warnings to be added.

September 28, 2005
Reuters reports that GlaxoSmithKline adds birth defect caution to Paxil label 

The company is alerting physicians about a study suggesting the company's antidepressant Paxil may be more likely to be linked to birth defects than similar drugs, U.S. regulators said on Tuesday.<<To read more>>

September 28, 2005
The UK National Institute for Clinical Excellence (Nice) formulated new guidelines that told UK doctors to stop prescribing antidepressants for children under 18, because of the serious risks the drugs can make them feel suicidal.

The Guardian reports: "The new NHS guidance marks a watershed in the treatment of children's mental health. It shifts the focus sharply away from the psychiatric drugs that around 40,000 children are thought to be taking for depression, anxiety and other problems. Children with mild depression should be given advice on diet and exercise, the guidance tells GPs. Those with moderate and even severe depression should be offered a three-month course of counseling."
<<Click here to read more>>

September 27, 2005
TIME reports about the serious concerns raised both at the FDA and Congress about Scott Gottlieb, MD, a young doctor whose lack of expertise in matters of drug safety evaluation does not justify his being appointed to the # 2 position at the FDA. Those concerns are magnified by Gottlieb's prior ties to the drug industry, which he acknowledges were "quite extensive"—nine companies including Eli Lilly, Roche and Proctor & Gamble--and his lack of expertise in drug safety evaluation.<<Read the entire article>>

September 27, 2005
An article titled, “What the FDA isn’t telling you” appears in SLATE.  Jeanne Lenzer has uncovered evidence demonstrating FDA culpability in helping drug manufacturers  conceal vital, life-saving information from the public. In this case, undisclosed suicides in clinical trials testing Eli Lilly’s drug, duloxetine (trade names: Cymbalta sold as antidepressant; Yentreve, when tested for incontinence). The company and the FDA refused to disclose the suicides that occurred in clinical trials testing duloxetine for incontinence in non-depressed patients and volunteers—such as 19-year old Traci Johnson who committed suicide at Lilly's laboratory. 

Although the drug is sold for incontinence in Europe, Lilly withdrew its application in the US and refused to divulge what happened in the US trials.  The scandal is that the FDA, a government agency, also invoked “trade secret” as an excuse for failing to disclose a twofold increased suicide risk in middle-aged women taking duloxetine. Slate reports: “middle-aged women taking duloxetine had a suicide attempt rate of 400 per 100,000 person-years, more than double the rate of about 160 per 100,000 person-years among other women of a similar age.”

Lenzer reports “In its Web-site database, Eli Lilly initially listed no suicides and two deaths among patients enrolled in seven clinical trials of Cymbalta for depression."
<<Click here to read the article>>

September 25, 2005
The New York Times reports that President Bush proposes to appoint Dr. von Eschenbach to head the FDA while at the same time maintaining his "day job" as head of the National Cancer Institute. <<Click here to read the article>>

September 23, 2005
FDA Commissioner Lester Crawford resigns.  His surprise resignation, effective immediately, gave no specific reason for his departure. "It is time at the age of 67, to step aside," he wrote in his resignation letter.

Crawford's tenure was marked by increasing criticism of the agency by those who contended it had become more interested in politics than in its mission to protect consumers.
<<To read more, click here>>

September 20, 2005
The findings of a $44 million government sponsored study, CATIE, published in The New England Journal of Medicine, comparing an older generic antipsychotic to four new atypical antipsychotics, undercut the legitimacy of psychiatry’s treatment and practice guidelines for schizophrenia.

The Washington Post reports: “Expensive new antipsychotic drugs that are among the most widely prescribed pills in medicine are no more effective and no safer than an older, cheaper drug that has been largely discontinued, according to the most comprehensive comparative study ever conducted.”

The New York Times reports: “A landmark government-financed study that compared drugs used to treat schizophrenia has confirmed what many psychiatrists long suspected: newer drugs that are highly promoted and widely prescribed offer few - if any - benefits over older medicines that sell for a fraction of the cost.”

September 19, 2005
Legal Times reports:At FDA, Change In Name Only; Legal Business; New counsel keeps industry-friendly policies put in place by his predecessor .  The new FDA Chief Counsel, Sheldon Bradshaw signed off on a brief agreeing with Pfizer Inc.'s claim that three years ago the FDA would not have allowed the drug company to warn consumers about a link between suicidal behavior and the use of its best-selling antidepressant, Zoloft, by adolescents, an argument Pfizer is using to ward off liability. 

The FDA filed this amicus brief in the Kallas v. Pfizer case in Utah. <<Click here to read more>>

September 12, 2005
The New York Times reports that months before the FDA issued a safety alert in June about problems with Guidant heart devices, the agency received a report from the company showing that some of those units were short-circuiting, agency records obtained by The New York Times show.  But the agency did not make that data public at the time because it treats the information it receives in such reports as confidential. While the agency has a policy of reviewing the reports within 90 days, it is unclear when regulators did so within that time frame or how they first interpreted the information.

The Times reports that Dr. Daniel G. Schultz, the director of the F.D.A.'s Center for Devices and Radiological Health, "said in an interview Friday that it would tie up too many resources to review hundreds of filings the F.D.A. receives each year and determine which data could be routinely released and what should be treated as confidential."

August 2005
A federal judge in Utah has asked the FDA to explain its position as it relates to the association between antidepressants and suicidality in children and adolescents. The case involves a 15-year-old girl, Shyra Kallas, who was prescribed Zoloft (sertraline) by her primary care doctor for warts.  While taking Zoloft, she shot and killed herself . (Kallas v Pfizer, Case No. 2:04-CV-00998 PGC)

August 29, 2005
The Seattle Times reports that Wall Street biotech insider gets No. 2 job at the FDA.  Just a month ago Dr. Scott Gottlieb was a Wall Street insider, promoting hot biotech stocks to investors. Now Gottlieb holds the No. 2 job at the Food and Drug Administration (FDA), the federal agency that approves new drugs, oversees their safety and affects the fortunes of companies he once touted. Wall Street likes the appointment of Gottlieb, 33, who believes in faster drug approval and fewer news-release warnings to the public about potential side effects of drugs.

August 22, 2005
SSRI Lawyer, Karen Barth Menzies, responds to a New York Times article.   According to her letter to the editor, the FDA's recent warnings regarding suicidality and SSRI antidepressants were appropriate and long overdue, based on scientific evidence and the FDA's warning responsibilities to consumers as directed by the Code of Federal Regulations. The article published in the New York Times on August 6, 2005 by Gardiner Harris, titled "FDA Responds to Criticism with New Caution," asserts the erroneous thesis that the FDA simply yielded to criticism and issued invalid warnings, casting a cloud of doubt over the legitimacy of the warnings. That the FDA finally stepped up to shield consumers instead of pharmaceutical companies should be applauded, not undermined with inaccurate reporting. People died as a result of absent warnings while the SSRI antidepressants were marketed and sold as harmless.
<<To read the complete response, click here>>

August 21, 2005
A new study just reported in The British Medical reports the antidepressant Seroxat (Paxil in the US) has been linked to an increase in suicide attempts among adults. Researchers suggest that patients and doctors should be warned of the propensity to suicidal thoughts while on the drug. "In the new study of 916 adults on the drug, seven attempted to take their own life. Dr Ivar Aursnes and colleagues at the University of Oslo compared these findings with 550 patients taking a placebo, of which one tried to commit suicide. Their conclusions are published in the journal BMC Medicine." << Click here to read more >>

August 8, 2005
Newsweek reports on the SSRI antidepressants withdrawal. For some getting off SSRI antidepressants can be difficult. Withdrawal symptoms can range from the bewildering (vivid dreaming) to the debilitating (dizziness, diarrhea) to the life threatening (suicidal thoughts). It was reported that as many as 50 percent of the people who stop using antidepressants will have some withdrawal symptoms. Manufacturers of the major drug brands acknowledge that the drugs can have withdrawal symptoms, but say in most cases they are mild.
<<Click here to read the article>>

August 5, 2005
The Wall Street Journal reports that not only do drug manufacturers control what the public is told about patented drugs, but companies, such as Eli Lilly and Pfizer dictate by contract what doctors are told--more accurately, the contract stipulates what doctors may NOT be told about the hazardous side effects of drugs they are expected to prescribe.

By offering discount prices to large purchasers--such as HMOs and hospitals, the companies control the information distributed to doctors about their drugs.  The Wall Street Journal specifically highlights Eli Lilly's contract with the Minnesota Multistate and CYMBALTA® EQUAL ACCESS UPFRONT DISCOUNT PROGRAM. 

A side note, Cymbalta is the drug where Traci Johnson hung herself in Eli Lilly’s own laboratory.
<<Click here to read the article>>

August 3, 2005
Reuters reports that Eli Lilly received a subpoena in June from Florida's Medicaid Fraud Control Unit of the Attorney General office that seeks documents pertaining to the marketing of Zyprexa.  Lilly said "it was possible that other Lilly products could become subject to the investigation and that the investigation could lead to criminal charges, fines or penalties against the company."

The Pennsylvania AG's office has been investigating Lilly's marketing of Zyprexa and Prozac.

July 27, 2005
An article in the Columbia Journalism Review examines pharmaceutical industry hype and the media's role in helping that industry create false impressions about the safety and benefits of newly marketed drugs: “stories trumpeting new drugs are an easy way to get on page one or on the air.”

Front page news reports in the major press about a new drug's benefits are no more credible than the manufacturer’s promotional hype.  “the press too often is caught up in the same drug-industry marketing web that also ensnares doctors, academic researchers, even the FDA, leaving the public without a reliable watchdog."

Trudy Lieberman, the author of the CJR article has nailed the media’s drug advertising income: “In 1999, the five networks, including CNN and Fox News, received $569 million in advertising revenue from pharmaceutical companies, according to TNS Media Intelligence.  In 2004, that number had nearly tripled, to $1.5 billion. Drug ad revenue is less for print outlets, but still nothing to dismiss. At the end of 2004, for example, drug-company ad revenue for Time magazine totaled $67 million; for Newsweek $43 million; and for The New York Times, $13 million.”
<<Click here to read>>

July 21, 2005
The Star Tribune reports that James Rosenbaum, US Chief District Judge in Minnesota, overturned FDA-supported pre-emption arguments in their entirety in the case of Witczak v. Pfizer.

Pfizer asserted that FDA regulations pre-empted stronger failure-to-warn state statutes. Judge Rosenbaum ruled that FDA warning standards are minimum standards.

"It is obvious that state failure-to-warn laws do not pressure manufacturers to include false or invalid warnings," Judge Rosenbaum wrote. "Instead, they give drug manufacturers every incentive to warn of real, known risks as soon as they are discovered!  -- even before any FDA action." << Click here to read the article >> << Click here to read the press release on Judge Rosenbaum’s ruling>>

July 18, 2005
Senator Charles Grassley makes a  statement on the senate floor regarding the nomination of Dr. Lester Crawford as FDA Commissioner stating he can not vote for and support this nomination. <<Click here to read Senator Grassley’s statement>>

July 15, 2005
An article titled, “The Efficacy of Antidepressants in Adults” appears in the British Medical Journal.  It looks at the efficacy of SSRI antidepressants over placebo and finds that recent meta-analysis show SSRIs have no clinically meaningful advantage over placebo. 
<<Click here to read the BMJ article>>

July 3, 2005
The Star-Ledger reports that Merck failed to disclose Vioxx lethal effects to the FDA. Sheldon Krimsky, a science policy expert at Tufts University states: "if there was evidence the drug was dangerous and they didn't report it, they violated their fiduciary responsibility to consumers."

The article reports that Dr. Krimsky noted that the issue "is an extension of the recent debate over disclosing clinical-trial data. A controversy arose last year after it became known that some drug makers failed to report adverse events in their clinical trials for antidepressants."

July 1, 2005
The Wall Street Journal reports that the FDA posted information about patients who displayed suicidal tendencies during trials of Eli Lilly's antidepressant Cymbalta (duloxetine), when tested for stress-related urinary incontinence. The FDA site says a "higher-than-expected rate of suicide attempts was observed" in the studies after the formal portion of the trials had concluded. Indeed, according to an investigative report by Jeanne Lenzer and Nicholas Pyke, a review of the FDA adverse drug report data shows that there have been 13 suicides and 41 deaths reported among patients taking duloxetine (Cymbalta). However, five suicides that had occurred during Cymbalta clinical trials-including that of Traci Johnson, the 19 year old Bible student--are being concealed and are unavailable when requested under the Freedom of Information Act from the FDA. [1] The WSJ reports that the FDA acknowledged Lilly's efforts to prevent the agency from posting safety information about Cymbalta. Lilly questioned FDA's authority, raising "legal issues including our use of confidential commercial data."   The Journal reports: "The agency took the action despite earlier objections from Lilly."

June 30, 2005
The FDA issues a public health advisory alert titled,  “Suicidality in Adults Being Treated with Antidepressant Medications”

Several recent scientific publications suggest the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications. Even before these reports became available, the FDA began a complete review of all available data to determine whether there is an increased risk of suicidality (suicidal thinking or behavior) in adults being treated with antidepressant medications. It is expected that this review will take a year or longer to complete. In the meantime, FDA is highlighting that:

*Adults being treated with antidepressant medications, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior. Close watching may be especially important early in treatment, or when the dose is changed, either increased or decreased.

*Adults whose symptoms worsen while being treated with antidepressant drugs, including an increase in suicidal thinking or behavior, should be evaluated by their health care professional.
<<Click here to read the FDA advisory>>

June 29, 2005
The Wall Street Journal reports that THE FOOD AND DRUG Administration said it plans to add information about possible psychiatric side effects to the labels of a drug category that includes Concerta and Ritalin, which are widely used treatments for attention deficit hyperactivity disorder -- and it will investigate other ADHD medicines for similar problems.

In a document posted yesterday on its Web site, the FDA said it has received reports of patients experiencing psychiatric events such as hallucinations, suicidal thoughts and psychotic behavior as well as aggression and violent actions while using forms of methylphenidate, which is the generic name for Ritalin. Concerta, made by Johnson & Johnson, is a long-acting form of methylphenidate. Ritalin, made by Novartis AG, is widely prescribed as a generic.

June 19, 2005
A UK Independent article titled, “Was Traci Johnson driven to suicide by antidepressants? That’s a trade secret, says US officials.” reports that the FDA considers deaths and suicides--and who knows what other severe adverse drug effects to be trade secrets and the FDA as well as the federal Office of Human Research Protections routinely conceal drug related deaths from physicians and the public. <<To read the article click>>

June 10, 2005
Senators Chuck Grassley and Max Baucus of the Senate Finance Committee issued a Press Release stating that they have asked a number of large drug makers to explain their practice of giving money to state governments and other organizations in the form of “educational grants.” The senators are concerned that the grants are more focused on product promotion than education:

"We need to know how this behind-the-scenes funneling of money is influencing decision makers," Grassley said, "The decisions result in the government spending billions of dollars on drugs. The tactics look aggressive, and the response on behalf of the public needs to be just as vigorous."

June 9, 2005
The Chicago Tribune reports that the American Medical Association is seriously considering adopting a resolution proposed by a contingent of the American Psychiatric Association (APA) calling for the AMA to take a position AGAINST the FDA required Black Box warnings on antidepressant labels about the increased suicide risk for children prescribed an antidepressant.

"Those behind the proposal say it is designed to combat a recent, rapid decline in prescriptions" for children. Medco reported a 10% decline in prescribing SSRI antidepressants since disclosure of the suicide risk. <<Click here to read the article>>

June 8, 2005
An article by Alex Berenson in The New York Times, "Despite Vow, Drug Makers Still Withhold Data," corroborated the untrustworthiness of drug manufacturers. Their public pronouncements and promises to fully disclose their clinical trial data-including adverse drug effects--is demonstrably nothing more than a public relations ploy. 

"There are a lot of public statements from drug companies saying that they support the registration of clinical trials or the dissemination of trial results, but the devil is in the details," said Dr. Deborah Zarin, director of clinicaltrials.gov

The article noted that "Merck, Pfizer and GlaxoSmithKline, three of the six largest drug companies, say that they disclose their largest trials, which determine whether a drug will be approved. Though they would not discuss their policies in detail.." << Click here to read more>>

June 8, 2005
The House passed an amendment
introduced by Congressman Maurice Hinchey (NY) to rein in pharmaceutical industry influence on FDA advisory panels whose recommendations have resulted in the approval of lethal drugs.

According to Merrill Goozner,: "The vote punctuates six months of intensive research, education and lobbying work by the Center for Science in the Public Interest's Integrity in Science project, which I direct. The issue gained national attention in February when the New York Times, relying on CSPI research, reported that 10 of 32 scientists sitting on the FDA advisory panel evaluating Cox-2 painkillers had ties to manufacturers of the drugs. Had their votes been eliminated, two of the three drugs in the class would have received a thumbs down vote from the panel."  Congressman Hinchey's press release states: "recent FDA actions have created serious doubts about whether committee members are serving only the public interest and, as a result, industry biases now taint many advisory panel decisions.  Today, we took a giant step forward to squash those doubts."

June 8, 2005
The Philadelphia Inquirer reports that drug companies pay universities to put on the classes as well as they increasingly pay outside companies to write them. An estimated 100 for-profit medical-education and communication companies are now producing education courses on order for the pharma industry.”  Arnold Relman, former editor of the New England Journal of Medicine, who has been outspoken in his criticism of the pharmaceutical influence on medicine, asks the obvious question:
"Why would the industry want to support continuing medical education to the extent of billions of dollars if it were not for the belief that it promotes sales?" << To read the article, click here>>

June 8, 2005
The Washington Post reports that FDA safety officer Dr. David Graham, who blew the whistle on FDA's failure to protect the public from lethal drugs such as Vioxx, reviewed the makeup and structure of the new FDA Drug Safety Oversight Board, and concluded that the panel is "severely biased in favor of industry" and that "the FDA cannot be trusted to protect the public or reform itself."

Senator Charles Grassley wrote a critical letter to FDA commissioner, Lester Crawford, pushing for the establishment of an independent drug safety board. Grassley notes that 11 of the 15 drug panelists convened by the FDA are from the Center for Drug Evaluation and Research (CDER), the division that approved the drugs whose safety the board is supposed to monitor. This presents a conflict of interest.<<Click here to read the article>>

June 8, 2005
According to the Washington Post, Senator Charles Grassley (R-IA) and FDA Safety Officer, Dr. David Graham are criticizing the new FDA Drug Safety Panel. The new drug safety board established by the Food and Drug Administration to restore confidence in the nation's drug supply will actually set back efforts to improve the safety of the medications Americans take and will not make it any easier to take dangerous drugs off the market, After reviewing the makeup and structure of the Drug Safety Oversight Board, Dr. Graham concluded that the panel is "severely biased in favor of industry" and that "the FDA cannot be trusted to protect the public or reform itself." Grassley notes that 11 of the 15 drug panelists convened by the FDA are from the Center for Drug Evaluation and Research (CDER), the division that approved the drugs whose safety the board is supposed to monitor. << To read the article, click here >>

June 8, 2005
Senator Charles Grassley continues to push for transparency, accountability and independence at the FDA. Senator Grassley is questioning the make-up of the new drug and safety board set up by the FDA to provide independent review of FDA-approved medicines. In a letter sent to the Acting Commissioner of the nation’s drug safety agency, Grassley asked for assurances that the board could act in an unbiased way given its composition and said the deliberations of the panel should be more transparent in order to improve accountability at the Food and Drug Administration.
<< Click here to read the contents of Grassley’s press release and letter to the FDA >>

June 3, 2005
Psychiatry News reports that the U.S. Food and Drug Administration (FDA) has told Pfizer Pharmaceuticals to cease distribution immediately of a direct-to-consumer advertisement for the company's serotonin reuptake inhibitor antidepressant, sertraline (Zoloft), because it does not carry the proper warning information. It did not included a warning that "patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases."

The revised label also includes a reminder that families and caregivers of patients taking the medication should be alerted to look for emergence of "agitation, irritability, and other symptoms," as well as "the emergence of suicidality, and to report such symptoms immediately to health care providers." This is for ALL ages not just children under 18.<<Click here to read more>>

June 2005
A journal article titled, “"Antidepressant Drug Use and the Risk of Suicide"” by David Healy & Graham Aldred from the North Wales Department of Psychological Medicine, Cardiff University appears in the International Review of Psychiatry Journal. << Click here to read the article >>

May 26, 2005
It was reported that the FDA will convene an advisory committee within the next few months to assess the risk of suicidality in adults using selective serotonin reuptake inhibitors, Johnson & Johnson Senior VP and Therapeutic Area Head-Internal Medicine Joanne Waldstreicher said May 26. Click here to read article

May 26, 2005
Wall Street Journal reports that Jeffrey Drazen, editor of the New England Journal of Medicine, who once had extensive financial ties to the drug industry, wants disclosure for the pharmaceutical industry.  .

Drazen said: "This isn't about poking a stick in the eyes of the drug companies," he said, adding that his only mission is to "help physicians do their jobs better and help patients get better information." He adds that one of the things that got the editors of the major medical journals together to try to establish guidelines is that "we've all had these experiences" in which drug researchers "weren't giving us the straight story." << Click here to read more >>

May 12, 2005
KSTP-TV reports that Blue Cross and Blue Shield of Minnesota and 18 other insurers are suing GlaxoSmithKline alleging manipulation of the federal patent system to keep cheaper generic alternatives to its anti-depressant Paxil off the market.

The lawsuit filed in federal court in Minneapolis alleges that GlaxoSmithKline violated federal and state antitrust laws and fraud laws and engaged in deceptive trade practices. << Click here to read more >>

May 11, 2005

New Jersey Ledger reports that the American Psychiatric Association has invited the actress who plays a psychiatrist on the Sorprano's--and who is a spokesperson for Pfizer--to be a featured speaker at the APA convention in Atlanta and is expected to tout antidepressants as useful medications, despite some controversy.

The drugs now carry warnings about links to suicide in youngsters, a move that occurred after it was revealed some drug makers failed to disclose clinical-trial data. << To read more, click here >>

May 10, 2005

TheStreet.com reports in their second installment of a five-part series examining conflicts in the drug industry.  TheStreet.com examines how big pharmaceutical companies heavy pressed the popular antidepressants through marketing into service in spite of lingering questions of their safety.  They report on how internal documents have surfaced highlighting concerns that date back to their early clinical trials.    As a result, their reputations and market value and shares are starting to fall. Click here to read the article

May 6, 2005
FDA Says Pfizer Zoloft ad left out suicide information and says Pfizer must immediately stop using the ad or similar ones, which it termed "false and misleading."
<< Click here to read the FDA letter to Pfizer >>

April 27, 2005
UK Doctors were told not to give Prozac to children by the European Medicines regulator, ruling out the one antidepressant of its class that the British authorities had allowed to be prescribed to under-18s due to suicidal thoughts and gestures.  Until now, Prozac was the only SSRI antidepressant approved for use in children under 18.<< Click here to read more >>

April 27, 2005
Dow Jones Newswire reported that the Senate Finance Chairman Grassley, R-Iowa, and Sen. Christopher Dodd, D-Conn., introduced a bill Wednesday that would give the FDA new powers to order drugs off the market and make changes to drug labels without having to negotiate changes with pharmaceutical companies. The bill also would move the agency'ss drug-safety office into a new center for post-market review that would report directly to the FDA commissioner. The drug-safety office is currently housed under the same branch that evaluates and decides whether to allow new drugs and other products on the market.
<< To read more, click here >>

April 27, 2005

A University of California-Davis study finds physicians were more likely to prescribe anti-depressants when the patient made a general request for medication, Patients who request anti-depressant medications because of advertising are more likely to get the drugs they want, University of California researchers say.

The study used trained actors who went to physicians complaining of either depressive symptoms or an adjustment disorder to gauge the impact of the $3.2 billion direct-to-consumer pharmaceutical advertising industry. In both groups that requested heavily advertised medication, doctors prescribed it 53 percent of the time.
<< To read more, click here >>

April 26, 2005
USA Today provides a glimpse into the way the pharmaceutical industry controls health care policy by buying influence at the highest level of government, and underwriting professional and lay healthcare organizations whose spokespersons parrot industry's agenda. Executives and employees of the pharmaceutical industry donated more than $17 million to candidates for federal office in the 2004 election.
<< Click here to read the article. (PDF – USATODAY) >>

April 25, 2005
The European Medicines Agency (EMEA) completed its review of antidepressants related to the potential risk of suicidal behavior in children and adolescents. The EMEA concluded that, not only is there an increased risk of suicidality, but that “hostility (predominantly aggression, oppositional behavior and anger) were more frequently observed in clinical trials . . . compared to those treated with placebo.” The EMEA therefore recommends that strong warnings be issued and that the drugs not be prescribed to children and adolescents except for approved uses and only as needed.
Click here to read the first article:
Click here to read the second article:

April 20, 2005
The Boston Globe reports that the FDA has finally sent letters to 14 manufacturers of anticonvulsant/epilepsy drugs, such as Pfizer's Neurontin to examine the suicide data from these drugs. Consumer Advocacy Attorney Andrew Finkelstein began his campaign in March 2004 to get the FDA to issue Black Box warnings about the suicide risk posed by Neurontin, whose sales reached $2.6 billion with 17 million prescriptions. At that time, he had evidence that more than 100 people prescribed Neurontin had committed suicide and 2,000 had attempted suicide. Today, the number of known completed suicides on this drug is 271.
To read more click here:

April 19, 2005
Another Pfizer ad appears in major consumer magazines. This one tells the story of Kathy, age 41, from Irvine, CA in cartoon format whose daughter told her “Mommy, you’re no fun anymore.” Kathy goes onto find on the internet that Zoloft is the number one most prescribed brand so she asked her doctor about it. Note: the disclaimer copy line in cartoon that states story not based on actual person.
To see ad, click here: (PDF: ZOLOFTAD2)

April 15, 2005
A report in Psychiatric News states that European and Canadian doctors have been warned since September 2004 that patients prescribed the injectable form of the Zyprexa (olanzapine) were at risk of lethal side effects: "at least 49 adverse events, some relating to cardiac and respiratory depression, some of which have been fatal." "The question is why the same information was not given to American physicians?" The reason: the FDA has not required it.
To read more, click on the following:

April 15, 2005
The latest report of collusion and cash payments between public officials and pharmaceutical companies, comes from the Pennsylvania State Ethics Commission which found Steven Fiorello, the chief pharmacist of the Pennsylvania Department of Welfare, guilty of colluding with Pfizer Pharmaceuticals.
To read this story, click here:

April 14, 2005
An investigative reporter uncovers facts behind Columbia University’s TeenScreen, the aggressive marketing scheme that targets America's school children who are being "screened" for undetected mental problems-even though no accurate diagnostic screening tool for mental illness in children exists-only a subjective questionnaire. Per the findings, "The truth is, the only beneficiaries of TeenScreen are the drug makers, politicians with campaigns funded by the industry, and the mental-health-provider-complex made up of psychiatrists, psychologists, mental institutions, and the pyramid of front groups, which all have a vested interest in broadening the drug customer base." None of those involved sees anything wrong with labeling one in four children as "mentally ill" requiring drug "treatment."
To read the report, click here.

April 14, 2005
A class action lawsuit by US investors has been filed against GlaxoSmithKline in the US federal District Court in New York, alleging violation of securities laws. The suit charges GSK of issuing "false or misleading public statements" about the antidepressant, Paxil (Seroxat).

April 9, 2005
Star Tribune article runs about Pfizer trying to get Zoloft suicide case thrown out on grounds of FDA preemption.
Click here to download article. (PDF: PREEMPTION ARTICLE)

April 8, 2005
Federal Judge James Rosenbaum hears arguments on preemption in Witczak v. Pfizer in Minneapolis, MN.

April 6, 2005
In his column, Follow the Money, in The Wall Street Journal, Scott Hensley, cautions physicians: "make no mistake, the soul of the medical profession and the primacy of doctors' duty to their patients is under siege." Efforts to lay blame on the media for exposing systemic drug safety failures that killed people, rings hollow. Public trust will not be restored as long as the medical profession won't cut the financial strings that tie medicine to the drug industry.
Click here to read more: (PDF: WSJARTICLE)

April 6, 2005
The British House of Commons’ Health Committee report released, titled "The Influence of the Pharmaceutical Industry." This landmark document is not just of value to UK health care officials, it provides American officials and analysts an intelligent road map for examining the much larger scope of the factors that undermine the health and safety of the American people who consume far more prescription drugs than do the British.
To read the 42-page document, click on the following link:

March 30, 2005
Two federal courts (US District Court in Louisiana and US District Court in Texas) have rejected Pfizer’s motion for summary judgment on the grounds of FDA preemption.
With assistance from the FDA’s former Chief Counsel, Daniel Troy, Pfizer argued that state courts have no right to decide that a drug manufacturer can be held liable for not disclosing severe-- even lethal--adverse side effects to physicians and the public, if the FDA did not require such warnings. Pfizer and Troy claimed that FDA’s judgment preempts any other jurisdiction.
The preemption argument has confounded families, preventing them from seeking justice.
Two federal courts rejected the preemption argument: Both cases involve suicide by patients who were prescribed Pfizer’s SSRI antidepressant Zoloft (sertraline).
As one of the Court’s pointed out, the law "allows, even encourages, manufacturers to be proactive when learning of new safety information related to their drug. ... Manufacturers, not the FDA, are tasked with the responsibility of taking proactive steps once a manufacturer learns of ‘reasonable evidence of an association of a serious hazard with a drug.’" The Court stated that Pfizer has been aware of the suicide risk "for many years."

March 25, 2005
A variety of articles appear in the Mealey’s Litigation Report on MN Attorney General filing brief.
Click here to read. (PDF: MEALYS2)

March 21, 2005
Minnesota Attorney General Mike Hatch filed a legal brief today with the Federal District Court in Minneapolis arguing that the Food and Drug Administration's regulations regarding prescription drugs do not preempt stronger state laws. Pfizer, the maker of Zoloft, filed a motion arguing that it should be immune from liability for failing to warn about dangerous side effects associated with its drug because the FDA approved Zoloft for use.
Click here to read press release about this filing: (PDF: PRESSRELEASE)
Click here to read brief filed by the MN Attorney General. (PDF: MNAGBRIEF)

March 10, 2005
Senator Grassley remarks before the Consumer Federation of America on the FDA and Prescription Drug Safety.
Click here to read Senator Grassley’s comments.(PDF: GRASSLEY’SCOMMENTS)

March 10, 2005
The Boston Globe reports that the FDA is scrambling to put out one drug crisis after another, doing a poor job in both its areas of responsibility: medicine and food. FDA acting chief, Lester Crawford, cancelled testimony March 9th before members of Congress who will write the section of a bill that provides funds for the agency's 2006 budget. US Representative Maurice Hinchey (NY) said he would have pressed Crawford on poor leadership and allegations that Crawford silenced critics within the FDA who pointed to unsafe drugs while permitting inappropriately close ties to the drug industry. To read more, click here:

March 10, 2005
In an Op Ed in the Boston Globe, Dr. Marcia Angell, former editor of The New England Journal of Medicine, puts the FDA squarely on the docks for its failure to ensure that the drugs it approves don’t pose greater risks of harm than benefits. She states that the FDA’s hasty evaluation and approval process for drugs with lethal side effects and unproven clinically significant benefits has substantially increased industry’s profits at a cost in sacrificed lives. Even when the FDA knew about a drug’s lethal adverse effects, it allowed it (e.g., Vioxx) to stay on the market for four years “after a clinical trial showed it was probably more likely to cause heart attacks or strokes than to prevent stomach ulcers.” Furthermore, FDA routinely allows drug manufacturer to misrepresent the risk/ benefit ratio of their products in beguiling advertisements that conceal the hazardous effects—“it’s a beautiful morning...” Click hear to read further.

March 5, 2005
Dr. Joseph Glenmullen, a Harvard psychiatrist, takes on a Kansas psychologist who claimed antidepressants are not dangerous for teenagers. In his opinion column, he states that antidepressants do carry risks. Click here to read the context:

March 2, 2005
A report published in the British medical journal, The Lancet, was a follow up to the first report on the published and unpublished SSRI antidepressant clinical trial data involving safety and efficacy for children. The authors show that the influence of the pharmaceutical industry in withholding negative findings continues to confound the integrity of psychiatric reports by American College of Neuropsychopharmacology
To read more, click here:

March 1, 2005
Karen Barth Menzies, a lead attorney with Baum Hedlund working on Zoloft-induced suicide cases and other antidepressant side effects such as withdrawal, was recognized in the annual California Lawyer Attorneys of the Year Awards as one of 30 attorneys in California whose work has had a profound, far-reaching impact in 2004 or whose achievements in 2004 are expected to have such an impact in the coming years.
To read more, click here to download (PDF: KARENATTORNEYOFYEAR)

March 1, 2005
Bloomberg News reports that the Center for Science in the Public Interest had identified 27 panelists on FDA’s advisory panel who had financial ties to COX-2 drug manufacturers, not 10 as originally reported by the New York Times to keep the drugs on the market despite serious safety concerns.
Click here to read more:

March 1 and March 3, 2005
US Senate Committee on Health, Education, Labor & Pensions holds a hearing in Washington DC on the FDA’s drug approval process and where to go from here.

March 2005
New Zoloft print ad is launched in major consumer magazines. It tells the story of Denise, age 39, from Trenton, NJ in cartoon format who is “feeling an octave lower before Zoloft”. Note the disclaimer copy line in cartoon that states story not based on actual person.
Click here to see PDF of the ad disclaimer. (PDF: ZOLOFTADDISCLAIMER)
Click here to see PDF of the ad. (PDF: ZOLOFTAD)

February 28, 2005
A Time Magazine article asks, “Can the FDA Heal Itself?”.
Click here to download PDF of the article. (PDF:TIME)

February 25, 2005
The New York Times reports that 10 of the 32 FDA Advisory Board panelists deciding on the fate of Vioxx, Celebrex, and Bextra had financial ties to the makers of the drugs being discussed for safety swung the votes last week in favor of allowing the continued marketing of painkillers that induce fatal heart attacks and strokes.
Click here to read the article:

February 24, 2005
Chicago Tribune article titled, “Drug-ad limits could spread. Pressure on FDA may bring back rules on consumer ads” reports that an FDA advisory panel's recommendation to ban drug makers from marketing certain pain medicines (as a result of the Vioxx situation) directly to consumers could be the first step toward limiting a lucrative privilege the government granted the drug industry eight years ago. The FDA's 1997 decision made it easier for drug companies to tailor commercials for the public and opened up the advertising floodgates.
Click here to read more:

February 18, 2005
Media from around the world is reporting about how popular antidepressants may make some adult patients suicidal as a result of the drug based on 3 new study reports from the British Journal of Medicine.
To read this study, click here: (PDF: FERGUSSON)

1) A New York Times article titled, “Antidepressant safety debate may include adult patients,” reports the yearlong debate over whether antidepressant drugs increase the risk of suicide in some children may soon widen to include adults, as English and Canadian scientists are reporting findings from three new analyses of suicide risk in people over age 18 who have taken the medications. Click here to read the article.

2) The Guardian UK reports that a new study in UK finds that adult patients taking modern antidepressants may make patients twice as likely to try and kill themselves than if they were not taking any pills at all. Click here to read article:

3) China News reports the increased risk of suicide for adults taking antidepressants such as Paxil, Prozac and Zoloft based on new study findings just released. It states, “The results ‘should make doctors aware that SSRIs and tricyclics may induce or worsen suicidal behavior during the early phases of treatment,’ said Andrea Cipriani, a psychiatrist at the University of Verona in Italy and John Geddes, a psychiatrist at Oxford University in a comment. "They should also discourage the routine prescribing of antidepressant drugs in children and adolescents." To read more, click here:

February 12, 2005
New York Times reports that Senator Grassley charged that top FDA regulators intended to suppress an important study on Vioxx and other COX-2 Inhibitors.
Click here for read article.

February 11, 2005
New York Times reports that a day after Canadian officials suspended the use of a hyperactivity drug, Adderall, amid reports of deaths associated with its use, Senator Grassley of Iowa contended that FDA had asked the Canadian regulators not to do so.
To read the article, click on the following link:

February 10, 2005
Associated Press reports Canadian regulators have withdrawn Adderall, a psychostimulant drug prescribed for children with ADHD that has been linked to 20 sudden deaths linked to the drug—of which 14 were in children. “The adverse reactions were not associated with overdose, misuse or abuse of the drug, the department said.”
To read the article, click here to download. (PDF: CANADAADDERAL)

February 2005
An FDA approved medication guide for all antidepressants is being distributed to pediatrician offices throughout the country. It lists 4 important things that parents/guardians need to think about when their child is being prescribed an antidepressants: 1) There is a risk of suicidal thoughts and actions; 2) How to try and prevent suicidal thoughts or actions; 3) To watch for certain behavior signs; and 4) Outlines the risks and benefits of antidepressants.
To download the PDF, click here: (PDF: MEDGUIDE)

February 3, 2005
FDA bows to drug company pressure by toning down the language in the SSRI black box warning. With no explanation, the FDA has significantly modified the wording describing the association between antidepressants and suicidal thoughts and behaviors. The FDA initially requested a statement that “A causal role for antidepressants in inducing suicidality has been established in pediatric patients.” The new warning deletes this language. The first sentence in the black box has also changed. The October draft's sentence initially read: "Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders." The newly negotiated label states: “Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders.”
To read more, click on the following link:

February 3, 2005
The National Institute of Health Conflict of Interest Regulations goes into effect. 94% of the top paid NIH scientists failed to report their financial deals with pharmaceutical companies.
The new rules are meant to root out conflicts of interest and prevent major ethical abuses affecting the safety of patients and the integrity of medicine. The new rules will bring NIH staff scientists in line with federal legislation prohibiting government employees from having conflicts of interest or using insider information for self-enrichment.

January 16, 2005
FDA issues class suicidality labeling language for antidepressants.
To read, click here to download, (PDF: FDALANGUAGE).

January 9, 2005
The Boston Globe reported that after last year's commitment by members of the Pharmaceutical Research and Manufacturers of America, the industry's Washington lobbying organization, has resulted in a total of 26 drugs listed on the clinical trials results website (www.clinicalstudyresults.org). The Globe found that this voluntary approach failed miserably. Drug companies disclosed new information about just 5 out of 10,800 prescription drugs! Dr. Drummond Rennie, associate editor of the Journal of the American Medical Association said: ''It's pathetic. 'They get all the publicity from saying they will do it, and then they don't." To read the article, click here:

January 6, 2005
Congressman Maurice Hinchey calls on FDA’s acting commissioner, Dr. Lester Crawford, to investigate the revelations in the Eli Lilly/Prozac documents immediately to determine what the FDA and Eli Lilly may have known about the relationship between Prozac and increased suicidality; when they knew it; and what they did to protect the public? >>Click to read more

January 5, 2005
USA Today reports that lives were threatened and Americans treated like "guinea pigs" because Eli Lilly & Co. officials lied 15 years ago in denying there was any evidence that the antidepressant Prozac could cause suicidal behavior. Harvard psychiatrist Martin Teicher said the American people were "guinea pigs" for Lilly. To read the article, click here:

January 4, 2005
CNN posts the Eli Lilly documents showing the link between Prozac and suicide in adults. 3.7% of patients testing Prozac attempted suicide compared to 0.2% to 0.8% patients given an older tricyclic. Click here to download document:

January 9, 2005
The Boston Globe reported that after last year's commitment by members of the Pharmaceutical Research and Manufacturers of America, the industry's Washington lobbying organization, has resulted in a total of 26 drugs listed on the clinical trials results website (www.clinicalstudyresults.org). The Globe found that this voluntary approach failed miserably. Drug companies disclosed new information about just 5 out of 10,800 prescription drugs! Dr. Drummond Rennie, associate editor of the Journal of the American Medical Association said: ''It's pathetic. 'They get all the publicity from saying they will do it, and then they don't." To read the article, click here:

January 6, 2005
Congressman Maurice Hinchey calls on FDA’s acting commissioner, Dr. Lester Crawford, to investigate the revelations in the Eli Lilly/Prozac documents immediately to determine what the FDA and Eli Lilly may have known about the relationship between Prozac and increased suicidality; when they knew it; and what they did to protect the public? >>Click to read more

January 5, 2005
USA Today reports that lives were threatened and Americans treated like "guinea pigs" because Eli Lilly & Co. officials lied 15 years ago in denying there was any evidence that the antidepressant Prozac could cause suicidal behavior. Harvard psychiatrist Martin Teicher said the American people were "guinea pigs" for Lilly. To read the article, click here:

January 4, 2005
CNN posts the Eli Lilly documents showing the link between Prozac and suicide in adults. 3.7% of patients testing Prozac attempted suicide compared to 0.2% to 0.8% patients given an older tricyclic. Click here to download document:

December 30, 2004
The British Medical Journal obtained long “missing” Eli Lilly company documents, suggesting “a link between the drug fluoxetine (Prozac) and suicide attempts and violence” in adults who tested the drug in the 1980s. Lilly scientists knew about this link 16 years ago during adult trials. The FDA has agreed to review confidential drug company documents that went missing during a controversial product liability suit more than 10 years ago. Click here to read more:

Forbes reports that Prozac maker, Eli Lilly, knew of problems in 1988. Confidential company documents suggest that drug giant Eli Lilly & Co. was aware that its antidepressant Prozac was linked to troubling side effects as far back as 1988, the same year the drug was introduced to the U.S. market. To read more, click here:

December 26, 2004
Proposed tort reform bill would shield some drug firms/medical device manufacturers from punitive damages. A provision in medical malpractice legislation now before Congress apparently would protect drug manufacturers from punitive damage awards as long as it is approved by the FDA. It would be another disincentive for pharmaceutical companies to disclose drug safety problems. To read more, click here:

December 23, 2004
New Jersey Star-Ledger reports that three months after a panel of government scientists called on drug makers to add "black box" warnings to their antidepressants, the changes have yet to be made. When questioned by the NJ Star Ledger, Robert Temple, director of the FDA's Office of Medical Policy, said: "I'm sympathetic to the idea that you don't want to let a lot of time go by. But we ask the companies to modify labeling that they own. ... The right to disagree (over the wording) is reasonable." Click here to read more:

December 22, 2004
Los Angeles Times provides an important reminder that the FDA is not the only government healthcare agency to have betrayed the public trust and lost its credibility. While the FDA has lent its seal of approval to unsafe drugs that killed people, senior scientist at the National Institutes of Health have lent the agency’s prestigious name to recommendations for the use of these unsafe, even lethal drugs. Doctors have long relied on the NIH to set medical standards. But with its researchers accepting fees and stock from drug companies, will it change. To read the article, click on the following link:

December 20, 2004
Lawyers Weekly names Karen Barth Menzies, One of the Top Ten Lawyers of 2004. Karen Barth Menzies, a Los Angeles litigator with Baum Hedlund, who has spent the past 14 years trying to prove to the public, doctors and federal regulators that antidepressants increase the risk of suicide in children and adults.

December 19, 2004
The New York Times' front page article focuses on the pernicious role direct to consumer marketing of drugs has had on exposing millions of people to hazardous drugs as if they wre “lollypops." Click here to read the article:

December 18, 2004
Senator Chuck Grassley who has taken the lead in investigating FDA’s performance is calling for "a comprehensive review of drug safety and of how federal government agencies oversee drug research and approve, license and regulate drugs" by an independent commission a la 9/11 commission. Senator Grassley made the following statement, "At this point, no one can say with confidence whether the worst drug safety problems are behind us or ahead of us." To read more, click here:

December 17, 2004
Congressmen Barton and Dingle, members of the House Energy and Commerce committee, ask Pfizer for documents on Celebrex safety issues. Click here to read letter sent to Pfizer Chairman, Hank McKinnell.

December 13, 2004
Forbes magazine has named Dr. David Graham the ‘Face of the Year’ for his"steadfast advocacy of drug safety and his willingness to blow the whistle on his bosses" at the FDA. He was responsible for blowing whistle of Vioxx safety in 2004. In addition, he also questioned the validity of Prozac efficiacy in 1990. Click here to read the article:

December 15, 2004
ABC's Primetime airs a follow up to the antidepressant story. Dr. Joseph Glenmullen, a clinical instructor in psychiatry at Harvard Medical School discussed the often unrecognized side effects of antidepressant drugs. He answered viewer questions. To read the transcript, click on the following link:

December 10, 2004
Senator Charles Grassley, R-IA, a top senate republican on health care issues, plans to introduce legistation early in 2005 that would require pharmaceutical companies to register all drug trials and report their results in a public database. Click here to read more:

December 9, 2004
ABC's Primetime Thursday uncovered documents unknown to regulators and many doctors. Uncovered documents suggest Glaxo SmithKline, makers of Paxil failed to disclose important information about the possibility of an increased risk of suicidal behavior as well as serious withdrawl symptons. To read the transcript, click here:

December 6, 2004
The BBC reports that doctors have been issued with new guidance on the prescribing of antidepressants. The National Institute for Clinical Excellence called on doctors to exercise more caution in prescribing the drugs. Read more>> or listen to radio program>>

December 6, 2004
The New York Times front page article provides a historical perspective to the shift in FDA?s focus (in 1992) from watchdog safeguarding the public against hazardous drugs, food and medical devices, to its current role as the drug companies marketing facilitator. Read more>>

December 5, 2004
UK's drug regulatory agency, MHRA, warns General Practitioners against prescribing antidepressants with moderate depression or anxiety. Read more>>

December 4, 2004
Pfizer must hand over concealed documents in the criminal case against Christopher Pitman, a teenager who, at the age of 12, shot his grandparents while on Zoloft. Read more>>

December 4, 2004

Glaxo SmithKline is facing a class action lawsuit in Britain by 1,700 claimants alleging "withdrawal problems and/or aggression and/or suicidal acts" while on Seroxat (aka Paxil in US). Read more>>

December 4, 2004
Tommy Thompson, the Secretary of Health and Human Services, announced that he was resigning. Freed from the constraints of administration policy, Mr. Thompson said he tended to favor creation of an independent office to monitor the safety of prescription drugs after they are approved for sale to the public. Read more>>

December 1, 2004
Associated Press reports in a sharp pivot, many medical authorities are questioning the fundamental safety guarantees for American drugs, threatening to dull the national appetite that has demanded and devoured pharmaceuticals at a faster clip for nearly a generation. The editor of the Journal of the American Medical Association, Dr. Catherine DeAngelis, now compares the American FDA drug safety system to a dangerous building:"This building is on very shaky ground. Would I condemn it? No, but I would tell people, 'You go in at your own risk.'" Download PDF>>

November 30, 2004
An editorial response in The New York Times focused on the culpability of academic researchers and their prestigious medical institutions in undermining the integrity of published medical research reports. The editorial notes that academic medical centers ?will have to clean up their own practices to help prevent suppression of information about the safety and efficacy of drugs.? Download PDF>>

November 29, 2004
New York Times' front page article focuses on academia?s role in keeping mum about the unpublished antidepressant clinical trial results. The unnamed focus of the article is the industry-supported American College of Neuropsychopharmacology (ACNP) whose members?leading academic psychiatrists?have been caught aiding and abetting industry?s concealment of negative test findings. One of the major players in the pediatric antidepressant debacle is University of Texas child psychiatrist, Dr. Karen Wagner (who refused to be interviewed by the Times). Download the PDF>>

November 27, 2004
The opening line of an editorial in the British Medical Journal reads, "Something is rotten at the heart of the FDA". Read more>>

November 23, 2004
Read a response letter sent to the editorial staff at New York Times after the NYT ran 11/21/04 Sunday magazine cover article, "The Antidepressant Dilemma", by Jonathan Mahler. Download PDF>>

November 16, 2004
Daniel Troy, chief legal counsel for the FDA resigns from office. Under Daniel Troy's leadership, the FDA intervened on behalf of pharmaceutical companies claiming that the FDA's authority pre-empted all others in matters of drug safety--even when they concealed lethal drug effects.

November 4, 2004
Local Washington DC ABC affiliate airs a story on serious allegations that the FDA may be putting the interests of major drug companies ahead of consumers. It focuses on a new position within the FDA's chief legal counsel, Daniel Troy's office. Read more>>

November 1, 2004
Alliance for Human Research Protection filed a complaint about a two-page Pfizer advertisement for their antidepressant drug, Zoloft, which appeared in the Sunday New York Times Magazine (October 24, 2004). The ad failed to include ANY of the FDA required warnings about the increased suicide risk for patients taking Zoloft. The ad claims that Zoloft is working to correct the chemical imbalance, stating: "Side effects may included dry mouth, insomnia, sexual side effects, diarrhea, nausea and sleepiness." The FDA Division of Drug Marketing, Advertising and Communication requires that companies that advertise directly to consumers MUST include ALL risk information in a product's approved label...In addition to the specific disclosure requirements, advertisements cannot be false or misleading or omit material facts. Read more>>

October 27, 2004
Newsweek/MSNBC.com runs a story talking about the adult risk in light of the new blackbox warnings for children under 18 titled, "People Have a Right to Know - The FDA has required bold new warnings about the risks of suicide in kids and teens who take antidepressants. Are adults also at risk?" Read more>>

October 15, 2004
FDA announced that all antidepressants must come with "black box" warnings explaining that the drugs increase the chances of suicidal behavior in some children and teens.In addition, the drug makers must all state whether the drug has, or has not been, cleared for use by children. Only Eli Lilly and Co.'s Prozac is FDA-approved for treating pediatric depression.
Read more>>

October 14, 2004
"Unsatisfied with answers and explanations from agency officials during the second hearing, at least two committee members, Rep. Diana DeGette (D-Colo.) and Rep. Bart Stupak (D-Mich.), threatened to introduce legislation banning the prescribing of antidepressants to anyone under age 18 "if the FDA didn't act forcefully and swiftly to protect America's children."
Read more>>

October 7, 2004
Top-rated TV show, Law & Order, runs storyline about antidepressants and suicide. Two college students take flying leaps to their deaths, Detectives Fontana (Dennis Farina) and Green(Jess L. Martin) discover that both students were participants in a secret testing program on a new anti-depressant run by a large drug manufacturer that has yielded a high rate of suicides -- and more attempted suicides. A.D.A. McCoy (SamWaterston) decides to vigorously pursue the CEO of the pharmaceutical firm (guest star Peter Strauss) for second-degree murder but his case hinges on convincing the judge to admit guarded clinical trial info.Click here to read the Law&Order episode guide: Read more>>

October 4, 2004
Click here to read summary of the FDA September 13th and 14th Advisory board meeting minutes. Members of Woody's family testified in front of the panel and told his story. Read more>>

October 3, 2004
BBC airs a follow up investigative report on the safety of antidepressants. This special BBC investigation exposes huge failings in the system of medicines regulation that is supposed to monitor drug safety. It reveals how patients' lives have been put at risk as a result. Panorama takes a unique journey inside the secret world of the medicines regulator and discovers that it's been sitting on crucial safety information about one of Britain's most widely-prescribed antidepressants for over a decade. Read the transcripts>>

October 3, 2004
Denver Post ran an article about the various families of victims that have
been working hard to make changes in Washington DC. Click here to read
the article: Read more>>

October 1, 2004
Glaxo SmithKline is facing more flak over its controversial antidepressant Paxil (also known as Seroxat in Europe). The company is getting it in the neck over a leaked memo urging sales staff to withhold sensitive information on the drug from doctors in the US. And a Panorama investigation for the BBC will reveal that regulators have known for 13 years of the treatment's link with suicide. To add to its woes, filmmaker Michael Moore has his lens trained on the pharmaceuticals giant for a documentary on corporate America. Read more>>

September 16, 2004
Top Officials at the FDA have decided to re-evaluate whether the drugs can cause adults to become suicidal, too. Dr. Janet Woodcock, the FDA's deputy commissioner of operations said, "I think there might be more to be learned, based on what we learned from the pediatric studies." Read more>>

September 15, 2004
"Black- box" warnings should be added to labels on antidepressants to caution that the drugs can increase the risk of suicidal behavior in children, an advisory panel to federal drug regulators voted Tuesday. Dr. Delbert Robinson, a psychiatrist and advisory board panel member said, "If we're really talking about a potential fatal side effect in 2 to 3 percent of the population (that takes the drugs), I think we have to make sure that information gets out". Read more>>

September 13th and 14th, 2004
The FDA Pediatric will reconvene to hear the results of the independent
Columbia Study reviewing initial clinical data for link between suicide and use in children. There will be testimony from families, medical experts as well as media coverage. Read more about the hearings: Read more >>

September 12, 2004
The risks of Prozac are revisited in this article by the Denver Post, which featured a front-page investigative article on the FDA approval (and lack thereof) of anti-depressants.

“Despite repeated concerns about whether drug makers had sufficiently examined the risk of violent reactions, the FDA never commissioned research that looked directly at the issue or instructed drug companies to do so." Read more>> OR Download article>>

September 10, 2004
Texas Representative, Chair of the House Energy and Commerce Committee blasts FDA for stonewalling and incompetence.

"... The FDA's lack of cooperation "makes me wonder if this is sheer ineptitude or something worse," Barton said. He told FDA official Janet Woodcock, who spoke at the hearing, to advise FDA Acting Commissioner Lester Crawford: "If you folks can't fix it, we'll fix it for you." Read more>> OR Download article>>

September 9, 2004
The House Energy and Commerce Committee will hold their first hearing on the publication and disclosure issues in antidepressant pediatric clinical trials. They will be interviewing drug company executives under oath. For more information: Read More >>

In addition, there will be another House Energy and Commerce Committee hearing on September 23rd on the FDA's role in protecting the public health. They will examine the FDA's review of safety and efficacy concerns in antidepressant use by children. To learn more: Read more >>

September 4, 2004
A great article runs in Forbes business magazine titled, "Prozac Nation? Is the Party Over? There are three stages in the life of a new mental health drug: euphoria, then medical doubts, then lawsuits." Read now >>

September 1, 2004
Vote on whether you think Congress should ban drug advertising by going to: http://www.vote.com/vote/60255342/index.phtml?cat=6834290 They'll send your vote to Congress and Bottom Line's Daily Health News. It's easy -- takes just a few seconds!

August 25, 2004
Pfizer finally updated Zoloft prescribing information to include warning of suicidal behavior. In addition, there was an additional section added to the updated product information for:

“Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric to be alerted about need to monitor patients for the emergence of agitation, irritability, and the other symptoms described, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers."

It is buried on page 13 of 27 page product information document. Please make sure you ask your doctor about it too.

Download updated Zoloft prescribing information now:

August 4, 2004
Senator Grassley asks drug makers what they told the FDA about anti-depressants and suicide among young people. Read Grassley's latest letter to the drug companies now: Read more >>
July 27, 2004
Doctors across the European Union are expected to be issued tough guidelines about prescribing a popular antidepressant, amid fears it boosts the risk of suicide and causes withdrawal symptoms amongst children and young adults, according to recommendations made by the EU's drugs agency. Read more >>

July 26, 2004
Doctors will be required to warn all patients under 30 of the suicide risk posed by the antidepressant Seroxat (known in the United States as Paxil) following an investigation into the drug by a European medical agency, it emerged today. Read more >>

July 25, 2004
New York Times runs an article titled "Push to block consumers' right to sue ; In switch, FDA sides with companies instead of the public". Woody is mentioned in the article.

This article was also picked up in several other major market newspapers including Seattle and Dallas Ft. Worth. Read More >>

July 23, 2004
California Private Attorney General files a consumer protection lawsuit against Pfizer for concealing evidence and misleading doctors and patients about the safety and effectiveness of Zoloft. CA Attorney General stepped in because FDA has failed California Consumers. See press release >>

July 21, 2004
U.S. Representative Maurice Hinchey sent a letter to U.S. Food and Drug Administration Acting Commissioner Lester Crawford, demanding documented answers to ten questions regarding FDA Chief Counsel Daniel Troy. Hinchey has raised concerns about Troy's unprecedented practice of assisting drug and medical device companies in civil suits. Read more >>

July 21, 2004
Representative Greenwood, head of House Energy & Commerce subcommittee on Oversight and Investigations who organized the hearing, announces that he’s not seeking reelection and is considering a job offer as president with annual salary of $800,000 with Biotechnology Industry Organization. This organization includes pharmaceutical houses and companies involved in human genome research. Read more >>

July 20, 2004
House of Representatives Energy and Commerce Committee was supposed to hold their first hearing where drug company executives and FDA officials would be asked questions under oath about the suppressed data and clinical studies that show link between suicide and drugs. It was postponed to later date due to Representative Greenwood

July 13, 2004
Told Woody's story at New York Representative Maurice Hinchey's press conference exposing the conflict of interest behavior of the FDA's chief counsel Daniel Troy by writing unsolicited “friend of the court” amicius briefs on behalf of the drug companies, specifically Pfizer, a former client. Read more >>

Later in the afternoon, Hinchey proposed an amendment in the appropriations committee to reduce the budget of FDA Chief Counsel's office by $500,000. It passed unopposed by both sides. Read more >>

June 18, 2004

We went to Washington DC to meet with various members of Congress (i.e. NY Rep Hinchey, CA Rep Waxman, MN Senator Dayton, MA Senator Kennedy) to tell them about Woody’s life and death and how it relates to the FDA and drug companies covering up the suicide link.

June 17, 2004
Senator Grassley issued another letter to the FDA addressing what he has learned to date through his office investigation. In addition, he states his concerns over the relationships that exist between the FDA’s Office of Drug Safety and Office of New Drugs.

June 14, 2004
The Guardian in London reported that the British Committee on Safety and Medicines, which was first to issue warnings back in December 2003 about the potential suicidal risk for children prescribed an antidepressant of the SSRI class, are now about to issue similar warnings for use in adults.

June 6, 2004
The London Times reported in an article titled, "Glaxo faces criminal action in Britain over 'suicide' pills", that GlaxoSmithKline is facing a potential criminal prosecution for allegedly failing to inform British health regulators about the suicide risks associated with Seroxat (known in the United States as Paxil).

June 3, 2004
Health Canada (Canada’s FDA equivalent agency) strengthens antidepressant warnings stating that doctors, patients, families should be on the lookout for signs of suicidal thoughts, or worsening depression or increased hostility, anxiety, or insomnia, especially when a patient begins the drug therapy or whenever the dose is changed.

June 2, 2004
Eliot Spitzer, the New York State Attorney General, filed lawsuit against GlaxoSmithKline, makers of Paxil. The suit charges GlaxoSmithKline with having "engaged in repeated and persistent fraud by concealing and failing to disclose to physicians information about Paxil, one of the SSRI drugs used to treat depression."

May 26, 2004
Pfizer Canada issues a Dear Doctor memo stating the risks of akathisia, self-harm and violence in relation to Zoloft.

May 20,2004:
WCCO-TV, a local Minneapolis CBS affiliate, airs an investigative report on accusations that drug companies have known for years about the risk of suicide, but failed to warn the public. It featured Woody's story.

Woody's widow filed a lawsuit against Pfizer for negligence, strict liability, fraud and breach of warranty.

was launched. The web site is dedicated to using Woody's life and death to save others. The goal is to provide the research on and knowledge about the SSRI class of drugs, all in one place. No one should have to experience what his family, friends and, most of all, Woody did on August 6, 2003.

May 12, 2004
Senator Grassley further presses the FDA for information.

May 2004
We are continually working with our Representatives, pushing to make sure that Congress holds the FDA to its task of protecting the American public.

April 30, 2004
With the help of Representative Jim Ramstad's office, we were able to meet with lead counsel from the Committee of Energy and Commerce in Washington. We had the opportunity to tell Woody's story. Although the current investigation is focused on children, we were there to represent the adult, healthy population.

April 2004
The British Medical Journal publishes an article by Jureidini, Menkes et al. titled "Efficacy and safety of antidepressants for children and adolescents," which points out that: "[T]he efficacy of newer antidepressants in childhood depression have exaggerated their benefits"; "Adverse effects have been downplayed"; "Antidepressant drugs cannot confidently be recommended as a treatment option for childhood depression," and; "A more critical approach to ensuring the validity of published data is needed."

April 2004
In the same issue of the Lancet, a study by Whittington, Kendall et al. is published titled "Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data," which found that hidden and unpublished data from the clinical trials of antidepressants show an unfavorable risk benefit profile for these drugs in children and adolescents (i.e., they lack efficacy and the risks are too great).

April 2004

A medical journal editorial is published in The Lancet wherein the editors state: "The story of research into selective serotonin reuptake inhibitor (SSRI) use in childhood depression is one of confusion, manipulation, and institutional failure." The editors also
pointed out that, despite the UK regulator's actions prohibiting the treatment of children and adolescents with antidepressants, "the [FDA] in the USA appears last week to have failed to act appropriately on information provided to them that these drugs were both ineffective and harmful in children."

March 25 2004
Senator Grassley from Iowa opens the Senate side of the investigation into the FDA and anti-depressant suicide. http://finance.senate.gov/press/Gpress/2004/prg032504b.pdf

March 24 2004
The US House of Representatives requests information from the FDA on antidepressants and suicide. They also want to know why a leading FDA scientist was not allowed to present certain data at the February 2nd Meeting.

March 23, 2004
StarTribune runs Woody’s story

March 22, 2004
FDA asks antidepressant makers to issue warnings concerning suicide risk in both children and adults. http://www.fda.gov/cder/drug/antidepressants/AntidepressanstPHA.htm

February 3, 2004
Attended a private meeting at FDA headquarters in Bethesda Maryland.
Along with a few other families, we watched Dr. Healy present further evidence to FDA of SSRI linked suicides in children and adults. Among those present were Dr. Temple (Director of FDA’s Office of Drug Evaluation) and Peter Pitts (Appointed Associate Director for External Relations.)
See: Letter dated February 13, 2004 regarding this meeting: http://baumhedlundlaw.com/media/ssri/paxil/FDAHearing/TierneyLetter.htm

February 2, 2004
Attended the FDA hearings on Antidepressant/Suicide and Children. We also told Woody’s story at a press conference. There were over 64 families and most told stories similar to Woody’s. At the end of the advisory committee meetings, the panel recommended to the FDA that they warn the public and doctors about the risk of suicide for all patients first going on SSRI anti-depressants and coming off.
See http://fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Committees/Anti-Infective+Drugs/020204_Suicide/020204_SuicideR.htm



February 2, 2004
KSTP Television runs Woody’s story

December 2003
The UK equivalent to the FDA banned the use of
antidepressants, with exception of Prozac (although Prozac is “not recommended” for children and adolescents in the UK), to treat children. Pressure
started to mount for the FDA and they were forced to hold hearings on this
very issue. See: http://www.guardian.co.uk/uk_news/story/0,3604,1103563,00.html and

October 2003
Retained LA-based national law firm, Baum Hedlund. This firm has been at the forefront of fighting the antidepressant wrongful death/failure to warn legal cases for over 13 years.

August 6, 2003
Woody was found hanging from the garage rafters.

Woody’s death did not make sense. It was completely out of character. Immediately after Woody was found, we started the journey of trying to find out how this happened. Many, many sleepless nights were spent researching this issue. Over the course of a couple of months, we had all the information we needed to confidently say that Woody died of drug-induced suicide. Through this discovery, we decided something had to be done to prevent this tragedy from happening to anyone else. The FDA and drug companies have long failed to fully disclose all risks associated with these drugs.