Woody Matters

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.

Today
New link on Woodymatters.com >> What FDA and Drug Companies Knew

November 6, 2008
APRIL-UK (Adverse Psychiatric Reactions Information Link) is hosting a conference in London titled, “Adverse Psychiatric Side Effects – What’s Our Responsibility?” Dr. David Healy will be presenting at conference.

For more information: http://www.april.org.uk/

November 3, 2008
US Supreme Court to hear preemption case of Wyeth vs. Levine. They will ask the Supreme Court to test the legal issue of whether an FDA approval alone preempts state laws that allow its citizens to sue for damages in prescription drug related product liability litigation. The decision is likely being handed down sometime early next year. If the Court upholds the FDA's preemption policy, it might prevent all injured parties in suits of this type from seeking redress through this kind of litigation.

Until recently preemption has only been used twice in the entire history of the FDA. And these instances were in response to extraordinary circumstances involving public safety. For example, the FDA used this presumed authority to force the industry to pack their consumer products in tamper-proof containers in response to the Tylenol poisonings in 1982.

With the current administration, the FDA has routinely filed amicus briefs with the state courts involved in this type of litigation in support of the drug and medical device makers who were defendants in these suits.

Click here to read more:
http://www.pharmalot.com/2008/08/the-right-to-sue-making-a-case-against-preemption/

To read amicus briefs in support of Levine, including one by Kim Witczak and Sara Bostock, click here:

http://www.abanet.org/publiced/preview/briefs/nov08.shtml

To sign petition against preemption, click here:
http://www.ipetitions.com/petition/fdapreemptionbadmedicine/index.html

October 16, 2008
Harvard psychiatrists, Drs. Joseph Biederman and Timothy Wilens, who have violated government and university conflict of interest rules by failing se
failure to disclose their substantial financial ties to drug manufacturers (over a million $$ each) are continuing to produce industry-friendly junk "studies."

In their latest promotional article published in the Archives of Pediatrics & Adolescent Medicine, which is co-authored by Stephen V. Faraone of (NYSSUNY) [1] they make the dubious claim that amphetamines are "protective" against smoking and substance abuse: "Stimulant therapy does not increase but rather reduces the risk for cigarette smoking and SUDs in adolescents with ADHD." http://archpedi.ama-assn.org/cgi/content/short/162/10/916

One has to ask, can this study be trusted when these doctors receive millions of dollars from drug industry??

October 14, 2008
Atlanta Journal Constitution reports that Emory psychiatry professor Dr. Charles B. Nemeroff is stepping down from university research projects funded by the National Institutes of Health, as
the federal agency cracks down on the school's handling of potential conflicts of interest, university officials said. The NIH has frozen funds for a $9.3 million project on depression led by Nemeroff, acknowledged Ron Sauder, a university vice president. The project had been under way for two of its proposed five years.

Click here: http://www.ajc.com/services/content/metro/dekalb/stories/2008/10/14/nemeroff

October 14, 2008
Judith Warner, a New York Times blogger, referring to the discredited pillar of US psychiatry, Dr. Charles Nemeroff, one of the most influential psychiatrists notes that Dr. Nemeroff's machinations are but "another iteration of the ever-unfolding saga of greed and how the deregulation of absolutely everything has brought our country to this painful season of reckoning. Because Nemeroff's story - which is hardly unique - belongs uniquely to this time in our nation's history. It is a product of legislative and cultural changes that have altered the practice of medicine, the work of research universities and the relationship between those universities and industry. And it is marked, like so much of what's gone off the rails in our era, by the failure of our government to step in
to protect citizens."

Click here: http://warner.blogs.nytimes.com/2008/10/09/diagnosis-greed/

October 6, 2008
The authors of a Harvard study just published in the journal Pediatrics, express concern about the kinds of drug samples that physicians dispense for
use in children. The pharmaceutical industry's practice of distributing "free drug samples" to doctors is but a market expansion ploy that puts consumers at risk.

According to a survey by the US Centers for Disease Control and Prevention, doctors dispense these "free samples" without knowledge about the serious risks these (all-too-often) inadequately tested drugs pose--especially for children.

Click here: http://www.nytimes.com/2008/10/06/health/research/06sample.html

October 4, 2008
New York Times reports that the pillar of psychiatry, Dr. Nemeroff failed to report his drug company ties to Emory University.
Sen. Grassley has nailed one of the most powerful pillars of psychiatry, Dr. Charles Nemeroff, chairman of psychiatry at EmoryUniversity, who failed to disclose at least a half-million dollars in payments from GlaxoSmithKline for promoting GSK drugs in speeches to doctors around the country. Not coincidentally, Dr. Nemeroff was the main investigator on a federally funded trial of Glaxo drugs.

Click here to read: http://www.nytimes.com/2008/10/04/health/policy/04drug.html

September 28, 2008
Use of antidepressants and antipsychotic were higher in US kids vs. other kids around the world. In a comparison study of the use of psychotropic drugs in children, Dr.
Julie Zito and a team of researchers found that the annual prevalence of psychotropic drugs among U.S. children was "significantly greater than in either the Netherlands or Germany."

In the US, 6.7% of children were taking these drugs, compared with 2.9% in the Netherlands and 2% in Germany.

Use of antidepressants and stimulants (i.e. amphetamines) was three or more times higher in the US than in the Netherlands or Germany. Use of antipsychotic drugs was 1.5 to 2.2 times greater in the US than in either of the other countries.

Click here: http://www.capmh.com/content/2/1/26/abstract

September 26, 2008
The FDA warned five drug makers over their promotion of ADHD products overstates efficacy, omits important information regarding the risks, and broadens the indication for the products by suggesting uses that have not been approved. From the warning letters, these pieces are false or misleading because these ads raise significant public health and safety concerns through their overstatement of efficacy and omission of important safety information.

Click here to read more: http://www.pharmalot.com/2008/09/fda-warns-five-drugmakers-over-adhd-ads/

September 26, 2008
Dr. David Healy wrote an article about the censored medical journals and how the bias affects the kind of articles appearing in medical journals and its impact on medicine.

Click here to read more:
http://www.msmonographs.org/text.asp?2008/6/1/244/39302

September 25, 2008
A new study finds that American children are three times more likely to be prescribed psychotropic medications for conditions such as ADHD and bipolar disease than European children are.

To read more:
http://news.yahoo.com/s/hsn/20080926/hl_hsn/uskidstakemorepsychotropicdrugsthaneuropeans

September 17, 2008
Congressman Henry Waxman (D-CA) sent a letter to FDA Commissioner Dr. vonEschebach after receiving internal FDA emails about agency decisions over a couple of years. His conclusion, "Political appointees at the agency may be promoting industry priorities at the expense of FDA's core public health mission, " according to Waxman.

http://www.pharmalot.com/2008/09/waxman-to-eschenbach-whose-side-are-you-on/

September 16, 2008
A government sponsored study comparing an old and two most prescribed new antipsychotic (i.e. major tranquilizers a.k.a neuroleptics) in children aged 8 to 19, confirms that widely promoted second generation neuroleptic drugs--Zyprexa and Risperdal--pose even higher risks of harm for children's health than the old neuroleptic (Molindone).

The authors report in The American Journal of Psychiatry: "Risperidone and olanzapine did not demonstrate superior efficacy over molindone for treating early-onset schizophrenia and schizoaffective disorder. Olanzapine and risperidone were associated with significantly greater weight gain. Olanzapine showed the greatest risk of weight gain and significant increases in fasting cholesterol, low-density lipoprotein, insulin, and liver transaminase levels. Molindone led to more self-reports of akathisia."

Click here to read:
http://www.nytimes.com/2008/09/15/health/research/15drug.html

September 15, 2008
New York Times reports a new government study has found that the medicines most often prescribed for schizophrenia in children and adolescents are no more effective than older, less expensive drugs and are more likely to cause some harmful side effects.

Prescription rates for the newer drugs, called atypical antipsychotic, have increased more than fivefold for children over the past decades and a half, and doctors now use them to settle outbursts and aggression in children with a wide variety of diagnoses, despite serious side effects.

September 10, 2008
A growing portion of state Medicaid budgets is being eaten up by antipsychotic for children. Several states, in fact, have sued one or more drugmakers for allegedly withholding side effect info or improperly promoting their meds, prompting Medicaid overpayments.

September 6, 2008
FDA announces list of drugs that they are investigating for potential safety problems, which includes AstraZeneca's antipsychotic drug Seroquel.

The list of drugs posted by the U.S. Food and Drug Administration under the requirements of a new law offered little information except for the potential risks the agency was examining.

September 2, 2008
Psych Rights Law Project, headed by Jim Gottstein, Esq, filed an important, potentially landmark lawsuit against the State of Alaska to Stop the massive use of harmful brain-altering psychiatric drugs on Alaskan children.

The suit seeks Declaratory and Injunctive Relief for the administration of psychotropic medication to children and youth in the custody of, or paid for by, the State of Alaska.

See: http://psychrights.org/states/Alaska/PsychRightsvAlaska/PsychRightsvAlaskaKidDruggingComplaint.pdf

August 30, 2008
Two different British epidemiological studies of patient medical records examined the clinical outcomes of patients prescribed antipsychotics (neuroleptics) compared to those not. [Abstracts below]
The studies confirm that these "major tranquilizers" increase the risk of stroke and diabetes--both severely disabling medical conditions hasten premature death.

Click here to read British Medical Journal: http://www.bmj.com/cgi/content/abstract/337/aug28_2/a1227
Click here to read Bio Med Central Journal: http://www.biomedcentral.com/1471-244X/8/67

August 26, 2008
Pharmalot reports that Merck's internal memo nails the company's crass attempts to disguise marketing practices as science. Insiders in the company clearly knew that Vioxx was a hazardous drug, so they set about to pay doctors to try it on their patients pretending it was a clinical trial---That's called "seeding" the market to promote future sales. Its one of many corrupt practices of the pharmaceutical industry.

Click here: http://www.pharmalot.com/2008/08/it-may-be-a-seeding-study-but-lets-not-call-it-that/

August 6, 2008
The News Journal reports that attorneys general in three states have filed suit against AstraZeneca charging Seroquel's rise was "fueled by an illegal marketing campaign designed to promote the powerful drug for unapproved uses -- for children, for seniors with dementia and for sleeping disorders, to name a few."

Despite lack of evidence of their clinical effectiveness--as documented in the 18 month CATIE antipsychotic patient outcome study--and a mountain of evidence documenting their severe debilitating adverse effects, the second generation neuroleptics (so-called atypical antipsychotics) account for about 19 of every 20 prescriptions written for antipsychotic drugs in the
U.S., according to data from health care research firm IMS Health. Their inexplicable popularity has helped make antipsychotics the third best-selling class of drugs in the country.

August 4, 2008
ABC News story asks, "Will the failure of psychopharmacology revitalize psychotherapy?" Although the failure of psychoactive drugs to provide clinically significant benefits is documented in controlled trials, psychiatrists cling to these drugs. But then, psychiatrists are paid far more for a patient's 15 minute prescription visit than for spending 45 minutes on psychotherapy.

Click here: http://abcnews.go.com/print?id=5511707

July 31, 2008
The Wall Street Journal reports (below) that Sen. Charles Grassley and Rep. John Dingell are taking the lead in calling for revamping the FDA which is recognized as being "too cozy with the companies they regulate."

"The lawmakers say an FDA restructuring should build a much taller wall between the agency and the industry it regulates. The FDA would gain authority to recall drugs, which it can't do today, and to impose significant fines on drug companies for safety violations. The lawmakers also want the FDA to inspect generic-drug makers before approving a new product. Perhaps most importantly, they want the next president to appoint a tough FDA commissioner completely independent from the industry."

Click here: http://online.wsj.com/article/SB121737384985295017.html

July 28, 2008
The Vermont Attorney General report on Pharmaceutical marketing disclosures revealed that $3 million was spent on drug promotions in Vermont in 2007, with 11 psychiatrists receiving 20% of the total amount, $630,000, a 25% increase from what psychiatrists were paid in 2006. The report also reveals that 7 of the top 10 drugs that companies paid prescribing fees for were psychiatric drugs. An article in the Vermont Rutland Herald, quoted Vermont Attorney General Bill Sorrell, "It is particularly troubling that the industry is paying large sums of money to influence prescribing practices involving psychiatric drugs." This is the second consecutive year in which Vermont psychiatrists have topped the list. The only other state that requires Pharmaceutical companies to disclose payments to doctors, Minnesota, had identical results; psychiatrists received the most Pharma funding over all other doctors.

July 22, 2008
Glaxo hires former FDA Chief Counsel, Daniel Troy as their Sr. Vice President and General Counsel. He laid the groundwork for the current legal battle over preemption, which says FDA approval supercedes state law claims challenging safety, efficacy, and labeling. Its a platform the FDA continues to use today.

July 21, 2008
Oakville Beaver runs a story about Sara Carlin, a beautiful 18 year old woman and another victim of antidepressants. Sara was given Paxil for anxiety. Suffering from the side effects of a powerful anti-depressive drug, Sara grabbed a piece of electrical wiring, fashioned a crude noose and hanged herself in the basement of her parent’s house.

Read her story:
http://www.oakvillebeaver.com/news/article/192960

July 13, 2008
An OpEd piece in the San Francisco Chronicle by pediatrician, Lawrence Diller, MD, chastises Harvard's chairman of child psychiatry, Joseph Biederman, MD for his irresponsible promotion of psychotropic drugs for children, noting that "The ambiguities of children's mental health and illness make child psychiatry the most vulnerable branch of medicine open to such influence."

"The science of children's psychiatric medications is so primitive and Biederman's influence so great that when he merely mentions a drug during a presentation, tens of thousands of children within a year or two will end up taking that drug, or combination of drugs. This happens in the absence of a drug trial of any kind - instead, the decision is based upon word of mouth among the 7,000 child psychiatrists in America."

Click here to read: http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/07/13/IN7G11L6TL.DTL

July 12, 2008
According to The New York Times, Senator Charles Grassley "is demanding that the American Psychiatric Association give an accounting of its finances."
Last year, drug manufacturers provided the APA with at least $62.5 million.

Sen. Grassley is peeling away psychiatry's layers of deception about the efficacy and safety of its treatments and its commercially influenced dubious diagnostic criteria: "I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions."

July 10, 2008
The FDA convenes a hearing with two advisory committees--Peripheral and Central Nervous System Drugs Advisory Committee
and the Psychopharmacologic Drugs Advisory Committee--to consider adding "Black Box" warnings about the risk of suicide linked to 11 epilepsy
(anti-seizure) drugs.

Click here to read more: http://online.wsj.com/public/article/SB121556144610237551.html?mod=2_1566_le

June 27, 2008
CBS News airs story about doctors on the take. CBS focused on psychotropic drugs such as Zoloft that is implicated in
the suicide of 12-year old Candace Downing and the prescribing doctor who had ties with Pfizer.

To watch video: http://www.cbsnews.com/sections/i_video/main500251.shtml?id=4214033n

June 27, 2008
DTC Perspectives (the leading DTC training, publishing, analytics and consulting company) reports (below) that only 26% of consumers have a favorable opinion of the pharmaceutical industry:

Click here to read more: http://www.dtcperspectives.com/article/Industry-Reputation-Declines-Again/73

June 26, 2008
Business Week runs article about the ties between doctors and drug companies. It focused on the controversy over Pfizer's antismoking drug , Chantix, that like Zoloft has been implicated in suicides.

Click here to read more: http://www.businessweek.com/print/magazine/content/08_27/b4091042383124.htm

June 26, 2008
The latest prominent psychiatrist to be outed for concealing financial conflicts of interest by Senator Charles Grassley's investigation is the chair of Stanford University department of psychiatry, Alan Schatzberg MD. According to Sen. Grassley, Dr. Schatzberg disclosed ownership of more than $100,000 of stock in Corcept, manufacturer of the abortion pill, RU-86
(mifepristone) which Dr. Schatzberg is testing and promoting for the treatment of depression.
http://ahrp.blogspot.com/2007/12/contemporary-hucksters-in-psychiatry.html

June 25, 2008
An article in The New York Times provides a case example confirming that the use of antipsychotics on elderly patients with dementia is contrary to patients' best interest. Antipsychotic use in nursing homes is an abusive use of these highly toxic drugs which diminish patients' quality of life and cut short their lives.

Click here: http://www.nytimes.com/2008/06/24/health/24deme.html?_r=1&scp=1&sq=antipsychotics&oref=slogin

June 20, 2008
The Wall Street Journal reports that a Justice Department investigation of Glaxo's handling of the marketing and safety research of its antidepressant, appears to be widening. GSK confirmed that a previously disclosed Colorado-based Justice Department investigation of marketing practices also includes the US Attorney's office in Boston and is being coordinated by the agency in Washington.
At a meeting convened in Boston by an agency prosecutor last year, plaintiffs' lawyers representing families suing Glaxo say they were asked about info, documents and depositions concerning Paxil's potential link to suicidal behavior in adolescents and adults, and how the company portrayed that risk to doctors and the FDA, the Journal writes.

Click here to read more:
http://www.pharmalot.com/2008/06/us-investigation-into-glaxo-and-paxil-widens/

Read article: click here wsjpaxil.rtf

June 12, 2008
Senator Grassley, R-IA, wants the agency to createfully scrutinize the information from Glaxo after reviewing a report about suicide risks among adults using the antidepressant. The report cited by Grassley was prepared by Dr. Joseph Glenmullen, a Harvard psychiatry professor, for litigation in federal court in California over Paxil side effects. The report, which was unsealed earlier this year, asserts that Glaxo obscured suicide risks associated with Paxil for 15 years or more.

Read article:
http://www.pharmalot.com/2008/06/grassley-probes-paxil-suicide-risks/

June 9, 2008
The New York Times expose documenting legal violations by Harvard psychiatrists--Dr. Joseph Biederman and Dr. Timothy Wilens--who failed to disclose their financial ties to drug manufacturers--poses a serious threat to Harvard's reputation. The astounding 'bipolar' epidemic among America's children has no scientific-epidemiological explanation. It is generated by financially-compromised child psychiatrists who "diagnose" normal, but irritable children whose behavior may be disruptive. Such children are misdiagnosed as having a severe, chronic, disabling condition--the current diagnosis du jour is bipolar.

Click here to read more:
http://ahrp.blogspot.com/2008/06/front-page-article-in-new-york-times-by.html

May 22, 2008
Representative Rosa DeLauro (D-CT) introduced legislation that would give FDA stricter authority over direct-to-consumer advertising of drugs and medical devices. One of the bill's provisions would require that all drug television ads, and some device ads, include a toll-free phone number or Web address for reporting side effects, a DeLauro spokesperson said, but the FDA said recently that it needs years to study whether such a requirement is feasible.

May 15-16, 2008
FDA’s Risk Communications Advisory Committee hosted a two-day public meeting to discuss direct-to-consumer (DTC) advertising of prescription drugs. Kim Witczak along with Liz Foley from Consumer Union testified before the committee about the need for FDA medwatch 800#/website information to be included in television commercials.

May 7, 2008
CNN reports that according to CDC, antidepressants are the most prescribed drug in America. In its study, the U.S. Centers for Disease Control and Prevention looked at 2.4 billion drugs prescribed in visits to doctors and hospitals in 2005.
Of those, 118 million were for antidepressants. High blood pressure drugs were the next most-common with 113 million prescriptions. The use of antidepressants and other psychotropic drugs -- those that affect brain chemistry -- has skyrocketed over the last decade.
Read more: http://www.cnn.com/2007/HEALTH/07/09/antidepressants/index.html?eref=rss_topstories

May 7, 2008
The New York Times reports that an examination by CSPI. Integrity in Science, found that the panels that crafted the new DSM-psychiatry's diagnostic "Bible"-is as riddled with financial conflicts of interest as the previous panels had been: "More than half the 28 new members of writers of the next edition of the American Psychiatric Association's (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM) have ties to the drug industry."

Click here to read more: http://www.cspinet.org/integrity/watch/200805051.html#4

May 6, 2008
A new video exposing the conflicts of interest between the American Psychiatric Association (APA) and the pharmaceutical industry was released today on a newly launched website, www.psychconflicts.com, to coincide with the 161st anniversary of the APA and its annual convention being held in Washington DC. Widespread psychiatric drugging of children has become an increasingly contentious issue, with pharma-funded psychiatrists at the center of the controversary.

Click here: http://www.psychconflicts.com

May 6, 2008
Slate reports that more doctors are shilling for drug companies on public radio. In April NPR stations were treated to an episode of the award-winning radio series The Infinite Mind called "Prozac Nation: Revisited." The segment featured four prestigious medical experts discussing the controversial link between antidepressants and suicide. In their considered opinions, all four said that worries about the drugs have been overblown.
Host Dr. Fred Goodwin, a former director of the National Institute of Mental Health, interviewed three prominent guests, and any radio producer would be hard-pressed to find a more seemingly credible quartet. Credible, that is, except for a crucial detail that was never revealed to listeners: All four of the experts on the show, including Goodwin, have financial ties to the makers of antidepressants. Also unmentioned were the "unrestricted grants" that The Infinite Mind has received from drug makers, including Eli Lilly, the manufacturer of the antidepressant Prozac.

Read story here: http://www.slate.com/id/2190775/

April 18, 2008
The Wall Street Journal reports that pharmaceutical companies fear backlash in the wake of drug scandals. The FDA has proposed a rule change that would allow companies to disseminate ghostwritten industry propaganda masquerading as science in medical journals. The WSJ reports that a coalition of ten major drug companies, including Pfizer Inc.; Bayer Corp., the U.S. unit of Bayer AG; AstraZeneca PLC; and Johnson & Johnson--and industry's subsidized patient-advocacy groups, the National Alliance on Mental Illness (NAMI) and the National Organization for Rare Disorders (NORD) are lobbying the FDA and Congress to legitimize illegal marketing of drugs for untested, unapproved, off-label uses.

Click here to read: http://online.wsj.com/article/SB120848517961025323.html

April 15, 2008
The New York Times article asks, “Who Are We? Coming of Age on Antidepressants”. It looks how many people have been on antidepressants for years as in one woman, age 31. She has been on antidepressants since age 14 and is now asking how the drugs might have affected her psychological development and core identity.

Click here:
http://www.nytimes.com/2008/04/15/health/15mind.html?_r=1&adxnnl=1&oref=slogin&adxnnlx=1208451936-uVw7E0PHQKmsZLT/lS5wgA

April 9, 2008
The Legal Intelligencer reports that in the 3rd U.S. Circuit Court of Appeals has ruled that the makers of Paxil and Zoloft cannot be sued for failing to warn of a risk of suicide because the Food & Drug Administration has explicitly refused to order such warnings. (NOTE: Preemption has been a legal defense by the drug companies.)
Click here to read more: http://www.law.com/jsp/article.jsp?id=1207651600398

April 3, 2008
House Democrats, Consumer Union and Woodymatters press FDA on Drug Direct to Consumer Ad study.

See coverage from press event:

LA Times:
http://www.latimes.com/news/nationworld/nation/la-na-drugs3apr03,1,5940027.story
WSJ blog:
http://blogs.wsj.com/health/2008/04/02/consumer-group-says-tv-drug-ads-should-carry-fdas-number/?mod=WSJBlog
WebMD:
http://www.webmd.com/news/20080402/lawmakers-ask-fda-for-drug-ad-changes
Bloomberg:
http://www.bloomberg.com/apps/news?pid=20601124&sid=ab0D1IfId8BU&refer=home
UPI:
http://www.upi.com/NewsTrack/Health/2008/04/02/most_unaware_fda_tracks_drug_side_effects/6163/
Congressional Quarterly:
http://www.cqpolitics.com/wmspage.cfm?parm1=1&docID=hbnews-000002695949
Marketing Daily:
http://publications.mediapost.com/index.cfm?fuseaction=Articles.showArticleHomePage&art_aid=79848
Kaiser Network:
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=51333

March 8, 2008
Congressman Jim McDermott (D-WA), Chairman of the Subcommittee on
Income Security and Family Support, announced a hearing to examine the use of psychotropic drugs for children in the foster care system. The hearing will take place on Wednesday, March 12, 2008, at 2:00 p.m. in room B-318 Rayburn House Office Building.

March 5, 2008
At the request of Senator Charles Grassley, the Government Accountability Office has agreed to investigate FDA's review and approval process for two blockbuster drugs: GlaxoSmithKline's, Avandia for diabetes, and Merck and Scherring Plough's cholesterol lowering drug, Vytorin.

In a statement issued by Sen. Grassley, he notes: "There's enough of a pattern of problematic drugs to ask for an independent review of how the FDA follows up on the effects of medicines that it's approved."

Click here to read Senator Grassley's statement: <http://www.senate.gov/~finance/press/Gpress/2008/prg030408a.pdf> .
Click here to read article: http://www.pharmalot.com/2008/03/gao-to-investigate-fda-review-process/

February 28, 2008
An alarming report by Sweden's National Board of Health and Welfare reveals that 80% of all adult suicides (18-84) reported in 2006 to the National
Board of Health and Welfare, were committed by persons "treated" with psychiatric drugs: 50% of those who committed suicide were on an SSRI, 60%
had been on an antipsychotic.

The number of women who committed suicide in 2006, was 377. Of these, 197 (52%) had filled a prescription for antidepressants within 180 days before
their death; and 29 women (8%) had filled a prescription for antipsychotics within 180 days before they committed suicide.

Click here to read more: http://www.transworldnews.com/NewsStory.aspx?id=33878&cat=10

February 2008
In an New Scientist article titled, “Did GSK trial data mask Paxil suicide risk?”, it reports that an inappropriate analysis of clinical trial data by researchers at GlaxoSmithKline obscured suicide risks associated with Paxil aka paroxetine, a profitable antidepressant, for 15 years.

This discovered in court documents (897kb, requires Acrobat Reader) released last month. Not until 2006 did GSK alert the public to raised suicide risks associated with the drug, marketed as Paxil or in UK as Seroxat.

Click here to read more: http://www.newscientist.com/article/mg19726424.600-did-gsk-trial-data-mask-paxil-suicide-risk.html

February 15, 2008
The Associated Press reports that Representative Bart Stupak, D-Mich., who heads an investigative panel that conducts oversight of the agency, said in an interview with them that FDA Commissioner Andrew von Eschenbach should step down because "it's just a total lack of leadership."
Stupak, chairman of the Subcommittee on Oversight and Investigations, said he had lost confidence in the commissioner and other top FDA officials over the handling of inspections and oversight by the agency.

Click here to read more:

January 30, 2008
Consumer Union along with Woodymatters announces their petition to collect over 50,000 signatures demanding that the FDA make it easier for patients to report problems with their medications. The petition seeks to FDA Medwatch #800 and web address be added to all TV commercials.

Click here to read release: CU Press release.doc

January 17, 2008
Wall Street Journal reports on a new analysis in the New England Journal of Medicine that looks at the efficacy of selective antidepressant trials. According to the article, the effectiveness of a dozen popular antidepressants has been exaggerated by selective publication of favorable studies, according to a review of unpublished data submitted to the FDA. As a result, doctors and patients are getting a distorted view of how antidepressants really work.

For New England Journal of Medicine journal article, click here: NEJM Selective Pub.pdf

For Wall Street Journal article, click here: WSJ.doc

December 17, 2007
Fox News Hannity’s America features Douglas Kennedy exploring link between antidepressants and school shootings.

To watch program: http://youtube.com/watch?v=gUchjOKxKY8

November 23, 2007
Alex Berenson wrote recently in The New York Times about the delay in reporting the results of the Vytorin "Enhance" trial of the cholesterol-lowering drug, ezetimibe. His article contains a quick review course of most everything that is wrong with drug company sponsored clinical trials.

To read: http://brodyhooked.blogspot.com/2007/11/here-we-go-again-everything-thats-wrong.html

November 21, 2007
St. Petersburg Times reports increased off label use of antipsychotic drugs in elderly to treat dementia could cause the ultimate side effect: death.

To read:
http://www.sptimes.com/2007/11/18/Worldandnation/Dementia_relief__with.shtml

November 17, 2007
Healthbeatblog reports on ADHD and the medication feeding frenzy in America. It talks about the overuse in our country.

http://www.healthbeatblog.org/2007/11/adhd-and-the-me.html

November 7, 2007
Merck has reached a $4.85 Billion settlement in 27,000 suits covering about
47,000 plaintiffs, three years after withdrawing Vioxx from the market when
the public learned that a clinical trial proved that the drug increased the
risks of heart attacks and strokes. Its sales in 2004 reached $2.5 Billion.

The settlement does not end the government investigations that Merck faces,
which include both civil and criminal inquires from several states and the
Justice Department.September 28, 2007

The New York Times reports that the US Inspector General of the Dept. of
Health and Human Services has issued a new report slamming the FDA for its
failure to ensure the safety of human subjects in clinical trials. The IG
report shows that FDA has essentially done NOTHING to improve its oversight
and enforcement of clinical trials since the IG last investigated in the year 2000.

Click here to read more:
http://ahrp.blogspot.com/2007/09/inspector-general-report-assails-fda.html

October 16, 2008
Harvard psychiatrists, Drs. Joseph Biederman and Timothy Wilens, who have violated government and university conflict of interest rules by failing se failure to disclose their substantial financial ties to drug manufacturers (over a million $$ each) are continuing to produce industry-friendly junk "studies."

One has to ask, can this study be trusted when these doctors receive millions of dollars from drug industry??

October 14, 2008
Atlanta Journal Constitution reports that Emory psychiatry professor Dr. Charles B. Nemeroff is stepping down from university research projects funded by the National Institutes of Health, as
the federal agency cracks down on the school's handling of potential conflicts of interest, university officials said. The NIH has frozen funds for a $9.3 million project on depression led by Nemeroff, acknowledged Ron Sauder, a university vice president. The project had been under way for two of its proposed five years.

Click here: http://www.ajc.com/services/content/metro/dekalb/stories/2008/10/14/nemeroff

Click here: http://warner.blogs.nytimes.com/2008/10/09/diagnosis-greed/

October 6, 2008
The authors of a Harvard study just published in the journal Pediatrics, express concern about the kinds of drug samples that physicians dispense for
use in children The pharmaceutical industry's practice of distributing "free drug samples" to doctors is but a market expansion ploy that puts consumers at risk.

Click here: http://www.nytimes.com/2008/10/06/health/research/06sample.html

October 4, 2008
New York Times reports that the pillar of psychiatry, Dr. Nemeroff failed to report his drug company ties to Emory University.
Sen. Grassley has nailed one of the most powerful pillars of psychiatry, Dr. Charles Nemeroff, chairman of psychiatry at Emory
University, who failed to disclose at least a half-million dollars in payments from GlaxoSmithKline for promoting GSK drugs in speeches to doctors around the country. Not coincidentally, Dr. Nemeroff was the main investigator on a federally funded trial of Glaxo drugs.

Click here to read: http://www.nytimes.com/2008/10/04/health/policy/04drug.html

October 2007
In a Reason magazine article titled, “Is Industry-funded Science Killing You?” about the overrated risks and underrated risks of pharmaceutical research “conflicts of interest”.

To read: http://reason.com/news/show/122020.html

September 24, 2007
Shyness an illness?
Alison Bass hits the bulleyes her readers in an Op Ed column in The Boston Globe by exposing corporate psychiatry's manipulation of suicide rates as a public relations tool.

Similarly, an Op Ed in The New York Times by Christopher Lane (below), a professor of English at Northwestern, the author of the forthcoming "Shyness: How Normal Behavior Became a Sickness," skewers psychiatrists who are pathologizing normal children's behavior in order to medicate them. "It may seem baffling, even bizarre, that ordinary shyness could assume the dimension of a mental disease. But if a youngster is reserved, the odds are high that a psychiatrist will diagnose social anxiety disorder and recommend treatment."

Click here: http://ahrp.blogspot.com/2007/09/alison-bass-hits-bulls-eye-in-op-ed.html

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
selectiv