The nature of Woody’s death did not add up. It started a long journey with lots of endless nights without sleep, researching this issue. It is our goal to provide you with the research on and knowledge about these drugs. All in one place. No one should have to experience what his friends and family did. Be smart. Be informed.




September 19, 2007
Congress agreed to drug safety reforms in final FDA bill.  A compromise was reached today by the Senate and House to reconcile differences between the two drug safety bills (S1082 and HR2900) passed earlier this year.  The legislation passed the House by a wide margin - 405 to 7. The Senate is expected to vote by end of week. 

According to pharmalot blog, a few highlights include:  

- "Clinical Trial Results: Drugmakers will be required to place technical summaries on the Internet within a year. And lay summaries may be made available in three years if the FDA can develop rules to ensure these aren’t promotional or misleading;

- Preemption: The Senate version included preemption, which would have provided drugmakers with immunity from product-liability lawsuits in state courts, but the language doesn’t seem to appear here;

- Conflicts of Interest: Over five years, the number of FDA advisory panel members with conflicts of interests will be reduced by 25 percent. This falls short of the complete ban FDA critics sought, given that waivers are offered regularly.

- DTC Ads: The FDA will be able to make drugmakers submit TV ads for prior review if there are safety issues, and there are $250,000 fines for running misleading ads (these can go higher in some circumstances). Print ads, but not TV ads, will include a toll-free number and a web site for reporting side effects."
Click here to read more:  

September 18, 2007
A posting on Pharmalot.com asks, "Does a clinical trial database belong on the internet?".
"As the Sept. 21 deadline for renewing PDUFA draws ever closer - and with it, the threat of layoffs of nearly 2,000 FDA employees - the behind-the-scenes squabble over creating a clinical trial database apparently remains unresolved. The White House opposes the House version of the FDA reform bill, because it claims the FDA and NIH wouldn’t be able to validate the accuracy of the trial results posted; results data is too technical, and lay summaries may have too much bias.The House bill would require a public technical trial results database, as well a lay summary of a drug trials, on the Internet. Negotiations are under way over other issues as well, such as preemption. The White House opposition, however, comes after a stretch in which various drugmakers have been accused of hiding data. The push for the House proposal follows the logic that more information is better than less. But would that be true in this case? What do you think?"
Click here to read more:

September 18, 2007
Bloomberg News reports that ADHD drugs are going to be studied for increased heart risks.  The new study will be conducted by the FDA and the Agency for Healthcare and Quality.  In February 2006, an FDA advisory committee voted to add Black Box warnings to psychostimulant drugs prescribed for a controversial "disorder"--Attention Deficit Hyperactivity Disorder (ADHD) when it was disclosed that there were 25 reported deaths. The drugs include: Ritalin, Adderall and Concerta.  Panelist Dr. Steven Nissen, a renowned cardiologist at the Cleveland Clinic, told the panel: "We have got a potential public health crisis. I think patients and families need to be made aware of these concerns." "This isout-of-control use of drugs that have profound cardiovascular consequences. We have got a potential public health crisis. I think patients and families need to be made aware of these concerns."
Click here to read more: 

September 18, 2007
Forbes reports that New York State and New York City have joined together to file lawsuit against Merck, the maker of Vioxx, which withdrew the painkiller from the market in 2004 because of concealing the dangers of Vioxx.  Several other states have filed similar lawsuits against Merck.
Click here to read the article:

September 17. 2007
The Kaiser Network reports that Congress, industry experts and advocacy groups continue to disagree on how best to create a system for releasing clinical trial data to the public, a measure that is part of broader legislation that would expand FDA oversight of prescription drug safety and reauthorize the Prescription Drug User Fee Act, the Los Angeles Times reports. PDUFA expires on Sept. 30. Currently, the government does not require full disclosure of trial data, and there is no easily searchable, central database that logs trial data. 
Click here to read the article:

September 17, 2007
Congressional Daily reports that FDA overhaul negotiations are slowed down over disagreements over drug safety and lawsuit provisions.   Conference negotiators are wrangling over a provision in the Senate bill (S 1082) that would undermine the ability of consumers to sue in drug safety cases. The House bill (HR 2900) has no such provision.  Bill Vaughan, a senior policy analyst at Consumers Union said, “We are extremely concerned about the issue. . . . Anything that weakens the obligation of a drug company to tell consumers about safety problems would negate much of the good the bill otherwise does."

September 15, 2007
More information to consider on the CDC report that youth suicides have increased since the blackbox warnings were added to antidepressants.
Click here to read more: Concerning CDC

September 14, 2007
The New York Times reports that experts are questioning the study on youth suicide rates.  The disputed study was funded by the National Institute of Mental Health and
Pfizer, manufacturer of the antidepressant, Zoloft (Sertraline) and published in the official journal of the American Psychiatric Association.
Click here to read more:

September 14, 2007
The authors reported a sharp 8% increase in suicides among youth (aged 10 to 24) between 2003 and 2004, the largest single-year increase in 15 years.
They attributed the rise to reduced antidepressant prescriptions for that age group following FDA-required Black Box warnings that went into effect in 2005.
In October 2004, Pfizer's direct to consumer Zoloft advertisements--such as appeared in The New York Times
magazine--failed to include ANY of the FDA required warnings.  As late as December 23, 2004, SSRI drug manufacturers were still haggling with the FDA about the wording of the warnings.
Not until 2005, did the companies actually add Black Box warnings acknowledging that evidence from controlled trials links these drugs to increased risk for suicidal acts.
Click here to read more:

September 13, 2007
Evelyn Pringle, a columnist with OpEd News reports that studies find more health risks with Avandia.  A new study in the September 11, 2007 Journal of American Medicine that found Avandia increased the risk of heart attack by 42% and doubled the risk of heart failure has researchers at Wake Forest University in North Carolina, led by Dr Sonal Singh, an assistant professor of internal medicine, once again calling for the removal of the drug from the market.
Click here to read more:

September 12, 2007
The US Senate Judiciary Committee holds hearing on `Regulatory Preemption: Are Federal Agencies Usurping Congressional and State Authority?
Click here to read more: 

September 4, 2007
A federal court in Utah ruled against Eli Lilly which sought to absolve itself of Zyprexa liability. The State of Utah sued Eli Lily alleging that the State had paid for
inappropriate, unnecessary and unauthorized off-label use of Zyprexa, and that it was entitled to relief including the future costs of care for Medicaid recipients allegedly harmed
by the drug.
Click here to read more:

September 6, 2007
An article titled, "Sidelining Safety - The FDA's Inadequate Response to the IOM"  in the The New England Journal of Medicine reports how the FDA is responding to the IOM report regarding drug safety issues.
Click here to read more:

September 5, 2007
Bloomberg News reports that sales for children of antipsychotic medicines made by Johnson & Johnson, AstraZeneca Plc and Pfizer Inc. have exploded, fueled by a 40-fold increase over nine years in the number of children diagnosed with bipolar disorder.
The number of prescriptions for children doubled to 4.4 million between 2003 and 2006, according to data provided to Bloomberg by Wolters Kluwer NV, a drug-tracking company. The expanded use of bipolar disorder as a pediatric diagnosis has made children the fastest-growing part of the $11.5 billion U.S. market for antipsychotic drugs. 
Click here to read more: 

September 5, 2007
Evelyn Pringle, a columnist with OpEd News reports that experts say birth defect risks outweigh benefits of antidepressants.  Although drug makers looking to increase profits with the sale of antidepressants to pregnant women claim that untreated depression poses a grave risk to the unborn fetus, a new study reports that the use of antidepressants, and not the depression itself, increases the risk of lower fetal age and preterm birth.
Click here to read more:  

September 3, 2007
The New York Times reports that the number of American children and adolescents treated for bipolar disorder increased 40-fold from 1994 to 2003 according to an analysis of national outpatient medical records documents.  The increase in adults diagnosed with bipolar during that period is twofold. 
Click here to read more:   

September 2007
Gwen Olsen spent fifteen years as a drug sales rep calling on doctors. Her story has a tragic sequel. Her beloved niece, Megan, was prescribed a heavy dose of an SSRI. She wound up as an apparent SSRI suicide victim. Megan first attempted to hang herself from a ceiling fan and failed. She then set herself on fire and died with burns over 90% of her body.  To read more on the arcane art of prescription drug pushing, and Megan's tragedy, read Gwen's book, titled Confessions of an Rx Drug Pusher.  
Visit her website: http://www.gwenolsen.com

AUGUST

August 27, 2007
The St. Paul Pioneer Press reports that one in three Minnesota psychiatrists has received funding from drug manufacturers in the past five years, including seven past presidents of the Minnesota Psychiatric Society, two state drug policy advisers and 17 faculty psychiatrists at the University of Minnesota.  While drug company funding is hardly limited to mental health providers, a review of the latest Minnesota public data shows a much higher proportion of psychiatrists receiving money for research, lectures and consulting than other medical specialties.  Drug companies reported $2.1 million in contributions to Minnesota psychiatrists in 2006, up from $1.4 million in 2005.  This is a unique law in Minnesota that is gaining national lawmaker attention in DC to make doctors disclose the funding they receive from drug companies.
Click here to read more:

August 22, 2007
According to a report filed with the Senate's Office of Public Records, PhRMA has spent more than $10.7 million on lobbying in the first six months of 2007.  
For more information about industry lobby efforts, click here:www.opensecrets.org

August 21, 2007
Forbes reports that the FDA plans to study TV drug ads to see if the visual content distracts consumers from warnings about the drugs' risks.  
Click here to read more:

August 21, 2007
Evelyn Pringle, a columnist with OpEd News reports that medical experts have long known that the side effect associated with the class of antidepressants known as the selective serotonin reuptake inhibitors most likely to drive people to suicide or violence against others is "akathisia".  Akathisia is but one in a long list of side effects that SSRI makers were able to keep hidden, as they settled thousands of lawsuits out of court, by obtaining court orders to seal documents produced in litigation. For instance, a 1984 Eli Lilly document showed akathisia occurred in at least 1% of patients long before Prozac was approved.  In a paper entitled, "Suicides and Homicides in Patients Taking Paxil, Prozac, and Zoloft: Why They Keep Happening - And Why They Will Continue," Dr Jay Cohen points out that, as soon SSRI's arrived on the market in the late 1980s, reports of sudden, unexpected suicides and homicides by patients taking the drugs began to come in. 
Click here to read more: 

August 18, 2007
In the current issue of British Medical Journal, the topic of a head to head debate by two Australian psychiatrists regarding whether doctors are over-diagnosing depression. Dr. Gordon Parker professor School of Psychiatry, University of New South Wales, notes that it is normal to feel depressed.
Click here to read more:

August 16, 2007
Judicial Watch and the National Vaccine Information Center (NVIC) have separately issued updates involving serious adverse event reports about
Merck's HPV (Gardasil) vaccine.   Most serious are a statistically significant risk linking Gardasil when co-administered with other vaccines, in particular, meningococcal vaccine
(Menactral).  NVIC reports: "as of May 31, there have been 2,227 Gardasil adverse events filed with VAERS, including 13 suspected or confirmed cases of GBS (two more GBS reports were made in June for a total of 15) and 239 cases of syncope
(fainting with temporary loss of consciousness), many of which resulted in head injuries and fractures. Seven deaths have been reported after receipt of Gardasil."
Click here to read the advisory release:  http://www.nvic.org/

August 7, 2007
Boston Globe reports that US Rep Maurice Hinchey (D-NY) attached language to an agriculture appropriations bill that would call for the FDA to end all conflicts of interest on advisors who have financial ties to the drug industry.
Click here to read more: Boston Globe PDF

August  2007
The New England Journal of Medicine documents in three reports the colossal power of drug advertising.   As real spending on direct-to-consumer advertising increased by 330% from
1996 to 2005 (Table 1), growing at an average annual rate of 14.3% from 2002 to 2005, FDA failed to rein in rampant misleading (fraudulent) drug
advertising. The most illuminating finding of this analysis of drug advertising / drug sales data is documentation showing FDA's retreat from its mission and
regulatory responsibility: "helping the public get the accurate, science-based information they need to use medicines and foods to improve their health."
Click here to read more:

August 2007
Whistleblower, a national publication, has published an entire issue on what psychiatry and its programs are doing to society. The issue, featuring the cover story entitled "Mania: The Shocking Truth About Psychiatric Drugs and Their Link to Suicide, Violence and Mass Murder" is a compilation of articles on topics such as psychiatric drugs causing violence, mental health screening of school children, the dangers of behavior modification, the FDA's failure to warn of the documented risks of psychiatric drugs and an article on how psychiatric drugs can strip individuals of their own conscience. 

JULY

July 22, 2007
A New York Times front page story titled, "Drug Safety Critic Hurls Darts From the Inside" runs a profile of Dr. Steven Nissen, a leading cardiologist whose probingquestions about drug safety succeeded in challenging authority.  "Admirers laud him not only for raising safety questions about Avandia, butalso for sounding early warnings about the painkiller Vioxx, as well as other drugs. By digging deeply into companies' own clinical trial data -information that used to be available only to federal drug regulators who did not always mine it as aggressively - Dr. Nissen is among a new cadre ofactivist scientists demanding greater vigilance on drug safety."
Click here to read more:

July 20, 2007
Pam Martens, formerly of The Wall Street Journal, reports about the incestuous nature of corporate sponsored "integration" reporting that undermines  journalistic integrity. A new breed of media "doctors" such as Dr. Sanjay Gupta (CNN) have used their medical degrees to provide the veneer of credibility to unseemly corporate marketing campaigns. The public is largely unaware about the financial conflicts of interest that undermine theprofessional integrity of these media "doctors."
Click here to read more:  

July 9, 2007
CNN reports that antidepressants are the most prescribed drug in America.  
Click here to read more:  

JUNE

June 30, 2007
The Associated Press reports that FDA officials are criticized for secrecy after a review by Congressional Republican staff revealed that "for years, the public calendars of FDA's Drs. Janet Woodcock and Steven Galson were largely blank--devoid of the required detail about their contacts with the industry they regulated."  Dr. Woodcock occupied two top positions between 1999 and 2006--as director of the Center for Drug Evaluation and Research (CDER) and then Deputy Commissioner. Dr. Galson replaced her as head of CDER.  Federal regulations require the FDA to maintain a public calendar that details all "significant meetings" between its top brass and anyone outside the executive branch.
Click here to read more: 

June 29, 2007
Bloomberg News reports that Eli Lilly may face more Zyprexa lawsuits alleging it failed to warn users that the drug was linked to diabetes after they received a letter from the FDA.  The FDA told Lilly in March it would delay the approval of Symbyax for hard-to-treat depression because they wanted more information about the risk of diabetes in the medicine's prescribing label. Symbyax combines antipsychotic pill Zyprexa and the antidepressant Prozac.
Click here for more:

June 12, 2007
Consumers Union holds press conference with victims of drug safety (including Woody's widow) to talk about the need for stronger FDA reform in the House.
Click here to read press release:  CU Press release

June 12, 2007
FDA holds hearing in Washington DC on need for Patient Medguides.  Woody's widow addresses the FDA and tells Woody's story and why the need for Medguides should accompany these drugs for patients and family members.  

June 6, 2007
The US House Subcommittee on Government Reform and Oversight held a hearing about FDA's Role in Evaluating Safety of Diabetes Drug.   FDA Commissioner, Andrew vonEschenbach, MD will be asked about how the agency fails to protect the American public from lethal drugs--and how its top brass administrators use brass knuckles when dealing with FDA safety officers who seek to inform physicians and the public about drug safety hazards.

The New York Times reveals that FDA administrators "ordered" a supervisor in FDA's drug safety division, Dr. Rosemary Johann-Liang, "to retract her approval" of the recommendation by FDA safety reviewer to
add Black Box warnings for diabetes drugs, Avandia and Actos, alerting physicians that these drugs posed a risk of unusual swelling that could lead to heart failure.
Click here to read more:

MAY

May 31, 2007 
The New York Times in an article titled, "FDA Still Unsettled in Wake of New Questions", reports that in a briefing on Wednesday, FDA Commissioner Dr. von Eschenbach said his agency needed to collaborate more closely with drug companies. "The point is that we need to look at the role of the F.D.A. in being a bridge to the future, not a barrier to the future."   Not everyone agrees.   "Safety is just not a high priority for them," said Dr. Curt Furberg, who serves on the F.D.A. Drug Safety and Risk Management Advisory Committee.
Click here to read more:  

May 30, 2007
Dr. Scott Gottlieb, resident fellow at the conservative think-tank, the American Enterprise Institute, who was Deputy Commissioner of the FDA, wrote an OpEd piece in
The Wall Street Journal in which he resorts to Orwellian double speak in his defense of the drug industry and the FDA regarding user fees and drug safety issues.  
Click here to read the Wall Street Journal OpEd:  http://online.wsj.com/article/SB118040903759116875.html
Click here to read an analysis:

May 22, 2007
The Wall Street Journal ran an article titled, "Sequel for Vioxx Critic: Attack on Diabetes Pill.  Glaxo Shares Plunge As Dr. Nissen Sees Risk To Heart From Avandia" discussing the similarities between Vioxx and Avendia.
Click here to read more:

May 22, 2007 
Ed Silverman on Pharmalot reports that Johnson & Johnson is dispensing its toxic antipsychotic drug, Risperdal as a freebie in a dual packet aimed, we suspect, at the pediatric market. The dual packet contains Risperdal in one portion and POP Corn!!!!  Yes, POP CORN in the other.   Ed Silverman free associated along the lines pharma marketing divisions do: "Think of the possibilities - Risperdal popcorn could be sold in vending machines in mental-health clinics and hospitals. The packaging could carry printed coupons for discounts on resorts favored by doctors. This could be a new profit center...."
Click here to read more:  

May 22, 2007
According to OpEd written by Professor Henry Greenspan, Faculty Scholar at the Program in Integrative Medicine at the University Michigan Medical School and the Founder of Justice in Michigan, he characterizes the Senate's FDA Revitalization Act as the "victory of cosmetology"--or lipstick reform.  The state of Michigan is the drug industry's "model" for "tort reform" which it seeks to achieve nationwide: pharmaceutical companies are entirely immune from civil liability in the state of Michigan if their product is "in compliance" with FDA regulations. Michigan has accepted the specious FDA preemption argument which holds that the FDA is immutable.
Click here to read more: 

May 21, 2007
Evelyn Pringle, a columnist with OpEd News reports that the FDA protects the makers of antidepressants with misleading suicide warnings.  On May 2, 2007, the FDA announced its most misleading warnings to date about selective serotonin reuptake inhibitor antidepressants when it said the drug makers would revise the current black box warning of an increased risk of suicidality in children and adolescents to include adults, but only young adults ages 18 to 24. Apparently at the ripe old age of 25 the increased risk no longer exists.
Click here to read:  

May 19, 2007
The annual American Psychiatric Association Conference opens in San Diego and its theme, "Addressing Patient Needs: Access, Parity, and Humane Care."
Click here to read more:

May 19, 2007
Michael Moore's long awaited movie, SICKO, which is causing much trepidation both among Big Pharma execs and public policy officials. America's broken health care system is about to be stripped down to reveal the skeletons when the movie is debuted at the Cannes Film Festival.
Click here to read more:

May 18, 2007
USA Today reports that the Senators that weakened the FDA drug safety reform bill got millions from the pharmaceutical industry.
Click here to read:  USA Today

May 17, 2007
The Associated Press reports that Chicago Cubs unveil partnership with Pfizer and its antidepressant Zoloft that will make the pharmaceutical company the Cubs' foremost advertiser and sponsor.

In a statement, Manager of Sponsorship Sales Matthew Wszolek said the partnership will target the immense, untapped market of depressed Cub fans. "This deal was a no-brainer, and it's really unfortunate that we didn't think of it earlier. Had we realized sooner that the fluctuating emotions, sadness, irritability and cynicism that characterize so many of our fans was actually depression, not passionate fandom, we'd have joined forces with Zoloft years ago."

May 13, 2007
As the 20th anniversary of Prozac is approaching, The UK Guardian's Anna Moore provides an excellent review about how Prozac was launched, how Eli Lilly's marketing campaign changed our perception of depression / mental illness--and most importantly, how a failed drug with toxic adverse effects can become a mega block buster through marketing.
Click here to read more:  

May 9, 2007
The US Senate passes 93-1 the FDA reform bill  -- "The Enhancing Drug Safety and Innovation Act of 2007".
Click here to read more:  

May 9, 2007
United Press International reports that the FDA/drug safety debate continues at a House hearing days after the Senate passed their version.  The House lawmakers are focused on how to up the safety after drugs hit the market. Lisa VanSyckel, an advocate after her daughter tries to commit suicide on Paxil, tells her story before the House Health subcommittee.
Click here to read more:

May 5, 2007
More background on FDA's new warning to expand the current black box warning on antidepressants.
Click here:

May 4, 2007
Law Journal reports that the FDA's self-proclaimed preemption rule splits the courts.   Nearly one year after the FDA issued a pre-emption on filing failure-to-warn actions over federally approved drugs, rulings across the nation show a clear division over the issue.
Click here to read more:

May 3, 2007
Baum Hedlund issues a press statement, "FDA’s new antidepressant suicide warning for young adults gives a false perception that it’s safe for older age group, says antidepressant injury lawyer Karen Barth Menzies" in response to the FDA new warnings issued for antidepressants. According to Karen Barth Menzies, "It is unrealistic and unwise to think that a person is at risk the day before their 25th birthday, but then safe and no longer at risk of becoming suicidal while taking these drugs one day later. This obviously problematic interpretation was a significant concern raised by some FDA advisory committee members who met on December 13, 2006 to discuss the FDA’s analysis of suicidality in adults taking antidepressants. Parsing out the data in an effort to draw lines around particular age groups appears to be designed to salvage certain markets for the drugs, nothing more."
Click here to read more: Baum Hedlund PR

May 2, 2007
The FDA announced that it has asked antidepressant manufacturers to expand the current black box warnings concerning the increased risk of suicidality in children and adolescents to include young adults (ages 18-24). 
Click here to read more:   

May 2, 2007
According to a news report in The Corporate Crime Reporter, law schools are the latest target for Big Pharma.  "For decades, the pharmaceutical industry has marinated the medicalprofession in millions of dollars of free samples, lunches, trips, and fees.The goal - influence, power, profits. Now, the industry has another target - the legal profession. notes that Seaton Hall has been showered with a $9.1 million."   Schering-Plough Corporation, sanofi-aventis, Johnson & Johnson and Bristol Myers Squibb and the pharma law firm Gibbons
PC - announced that they will donate a total of $9.1 million to establish the Center for Health & Pharmaceutical Law at Seton Hall Law School in Newark, New Jersey.
Click here to read more:

May 2007
An article titled, "Bitter Pill" in the May issue of Minnesota Monthly profiles Woody's widow and the activism around Woody's death by suicide while taking Zoloft prescribed for insomnia.  
Click here to read article:

APRIL

April 16, 2007
Bloomberg News reports that some patients oppose stricter drug safety measures for fear of limiting access drugs.  Kim Witczak, Woody's widow was interviewed about how stronger safety is needed and could have prevented Woody's death.
Click here to read more:  

April 3, 2007
According to Pharmalog (Star Ledger) blog, no sooner than the FDA trumpeted its new conflict of interest guidelines than it already waived the restrictions for panelists reviewing Merck's new arthritis drug.
"These waivers were granted at the same time the FDA was getting ready to trumpet its new proposed conflicts policy, which would ban outside experts with more than $50,000 in ties to drug and device makers - grants, consulting, stock - from serving on advisory panels."
To read more:

April 2, 2007
Within a couple of days, Peroglide (approved for Parkinson and promoted for "restless legs syndrome") and Zelnorm (approved for irritable bowel syndrome) were withdrawn from the market after fast-track approval in 2003.  
Click here to read more:

April 2, 2007
60 Minutes tells the story of how pharmaceutical industry lobbyists literally wrote the historic Medicare Prescription Drug Bill and twisted arms to get the necessary votes to have it passed in the middle of the night. Correspondent Steve Kroft documents how many of the congressmen and staffers who worked on the bill later went on to work for the drug companies their legislation helped enrich.  
Click here to read more:

April 1, 2007
The Associated Press reports that Office of the Inspector General of the department of Heath and Human Services is reexamining the conflict of interest cases against 103 scientists of  the National Institutes of Health. Rep. John Dingell, D-Mich., chairman of the House Energy and Commerce Committee, says the action suggests that the earlier investigations were mishandled: "The inspector general is taking a much-needed closer look. Even if only a few of those cases result in criminal prosecution, it is clear that NIH bungled the investigation the first time around."
Click here to read more:

April 1, 2007
The Washington Times reports that spending on antidepressants and other prescription drugs to treat mental disorders climbed from $7.9 billion in 1997 to $20 billion in 2004, an increase of more than 150 percent, a new federal report says. 
Click here to read more:   

April 1, 2007
The Center for Public Integrity issued a report that manufacturers of pharmaceuticals, medical devices, and other health products spent nearly $182 million on federal lobbying from January 2005 through June 2006 according to disclosure records.
Click here to read more:

MARCH

March 29, 2007
LA Times reports that major US study finds that antidepressants don't help bipolar patients.   "A new generation of drugs is needed," said Dr. Thomas R. Insel, director of the National Institute of Mental Health. "It is clear from this data that antidepressants are not the answer."  Dr. Insel admits that another major treatment outcome evaluation study sponsored by NIMH, "Effectiveness of Adjunctive Antidepressant Treatment for Bipolar Depression," the largest study yet, confirms that the widespread practice of prescribing antidepressants lacks clinical justification.
Click here to read more:

March 23, 2007
A front page report in The New York Times describes how Eli Lilly, whose diabetes producing drug, Zyprexa, has cost the company  $1.2 billion in court settlements, has penetrated state Medicaid programs in two dozen states to ensure that Zyprexa sales--amounting to $4.6 billion annually in U.S.--are not adversely affected by the controversy surrounding this drug.
Click here to read more:

March 22, 2007
CNN reports that the controversial ADHD drug, Addreall, an amphetamine approved for ADHD is being prescribed by some doctors for overweight children. Critics say the off-label use, while legal is questionable and too risky.  This is a very dangerous practice as the drug can cause cardiac arrest. The drug also causes psychiatric symptoms that often escalate into mania, leading to the prescription of ever more toxic drugs, including antipsychotics.
Click here to read more:  

March 22, 2007
The Washington Post reports that the FDA moves to try and reduce conflicts of interests on its advisory boards.  
Click here to read more:

March 21, 2007
American Medical Association reports that there are two states that have disclosure laws that provide insight into pharmaceutical company payments to physicians, but it's limited.  The authors found that the laws enacted by Vermont and Minnesota fail to provide the public with easy access to information about payments from pharmaceutical companies to physicians and other health care professionals.
Click here to read more:

March 9, 2007
Dr. Robert Sptizer, professor of psychiatry at Columbia University, the architect who compiled the international Diagnostic and Statistical Manual of Mental Disorders, psychiatry's "authoritative" diagnostic guide,  who had lent an air of legitimacy to the invented diagnosis, ADHD, now acknowledges in a BBC documentary that the classification has led many people to be misdiagnosed when their mood swings and behavior were simply normal feelings of happiness and sadness.  Furthermore, Dr. Spitzer says that between 20% and 30% of mental disorder diagnoses may be incorrect.
Click here to read more:

March 2007
Internal Eli Lilly Zyprexa documents recently made public can be found at  http://www.furiousseasons.com/zyprexadocs.html

March 2007
Gwen Olson's article titled "The Physical, Emotional and Psycho-social Impact of Psychotropic Drugs on the Development of Children" appears in March/April 2007 issue of Well Being Journal.
Click here to read:  wellbeing journal
 
March 2007
Dr. David Healy issues a paper on the dependence and withdrawal of SSRI antidepressants.  It's a must read.
Click here to read more: Dependence on Antidepressants

March 2007
CCHR issues a timeline of legal actions against antipsychotic manufacturers like Eli Lilly, Bristol-Myers Squibb, Janssen and Astrazeneca.
Click here to Timeline of legal actions.

March 14, 2007
Kim Witczak to testify at US Senate hearing on drug safety/FDA reform.
Consumer's Union press release: http://www.consumersunion.org/pub/core_health_care/004312.html
Kim Witczak's written statement: http://www.consumersunion.org/KimWitczakWrittenStatement.pdf

January 29, 2007
BBC airs the third in a series of investigative reports by the BBC-Panorama, The
Secrets of Seroxat.   It will tackle The Secrets of the Drug Trials.

The first in this series, aired in 2002, was the spark that ignited the
public debate about the hazards of  antidepressants--in particular, the
selective serotonin reuptake inhibitors. BBC-Panorama has focused on the
hazards of Seroxat / Paxil and the corrupt marketing practices by the
British drug manufacturer, GlaxoSmithKline--but the practices uncovered are
no different from the other Big Pharma companies.

The latest Panorama report focuses on how GSK promoted the drug for the
treatment of children--despite evidence of it offering no benefit, while
increasing the risks of serious harm--including self-harm and homicidal
behavior. According to Joe Collier,  "the picture
painted is one of a conspiracy orchestrated by the company in which doctors
have been misled, regulators duped, journals exposed, and children harmed."

Click here to watch:  http://news.bbc.co.uk/2/hi/programmes/panorama/default.stm

January 4, 2007
The New York Times reports that Eli Lilly to pay up to $500 million to settle claims for 18,000 lawsuits from people who claimed they developed diabetes or other diseases after taking Zyprexa, Lilly’s drug for schizophrenia and bipolar disorder.  Documents provided to The New York Times last month by a lawyer who represents mentally ill patients show that Lilly played down the risks of Zyprexa to doctors as the drug’s sales soared after its introduction in 1996. The internal documents show that Lilly’s own clinical trials found that 16 percent of people taking Zyprexa gained more than 66 pounds after a year on the drug, a far higher figure than the company disclosed to doctors. The documents also show that Lilly marketed the drug as appropriate for patients who do not meet accepted diagnoses of schizophrenia or bipolar disorder, Zyprexa’s only approved uses. By law, drugmakers may only promote their drugs for diseases in which the Food and Drug Administration has found the medicines to be safe and effective, although doctors may prescribe drugs in any way they see fit.
<<Click to learn more>>
<< Click here to learn more on NYTimes.com >>

December 13, 2006
FDA holds public hearing to share findings of meta analysis of link between antidepressants and suicide in adults.  It was recommended to increase the age for blackbox warning from 18 and under to now 25 and under.  

December 12, 2006
Woodymatters cosponsors two press briefings the day prior to the FDA public hearing on antidepressants and suicide link in adults.  The briefings are planned to demonstrate the multiple flaws in FDA's methodology and to provide credible science-based information.
PRIOR to the FDA public hearing on Wednesday, Dec. 13, leading medical experts whose critical analyses have been VALIDATED through independent peer review--and by FDA's partial acknowledgment of the suicide risk-- will comment about FDA's data analysis and about data the FDA has OMITTED from its analysis.  Internal FDA and drug company documents dating back to the mid-1980s, that have been under court-ordered seal will be shown. They tell the hidden story of the antidepressant suicide risk. Families who have suffered tragic losses of loved ones to drug-induced suicide will share their experience and their frustration in attempting to deal with FDA officials who remain impervious to the human tragedy that they contribute toward.
<< Click here to read press release:  mediaadvisory.pdf >>

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:
www.house.gov/apps/list/press/ny22_hinchey/morenews/101606crawfordcourtfiling.html

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:
http://www.washingtonpost.com/wp-dyn/content/article/2006/10/06/AR2006100601391.html

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 advan