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					Woodymatters Updates – October 11, 2005

October 2005

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

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

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

October 8, 2005

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

Click here for the PDF (WASHINGTON POST DROP)

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

To read the article, click here: PDF PINKSHEET DAILY
October 4, 2005

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

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

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

To read the analysis, click here

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

To read the article, click here (PDF Washington Post)
September 30, 2005

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

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

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

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

Click here to read more:

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

September 28, 2005
Reuters reports that GlaxoSmithKline adds birth defect caution to Paxil label
The company is alerting physicians about a study suggesting the company's
antidepressant Paxil may be more likely to be linked to birth defects than similar drugs,
U.S. regulators said on Tuesday.

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

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

Click here to read more,,3604,1579775,00.html

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

Read the entire article PDF - TIME

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

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

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

Click here to read the article, PDF SLATE
September 25, 2005

The New York Times reports that President Bush proposes to appoint Dr. von
Eschenbach to head the FDA while at the same time maintaining his "day job" as head
of the National Cancer Institute.

Click here to read the article. PDF (NYTFDACommisioner)

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

Crawford's tenure was marked by increasing criticism of the agency by those who
contended it had become more interested in politics than in its mission to protect

To read more, click here:

September 20, 2005

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

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

The New York Times reports: “A landmark government-financed study that compared
drugs used to treat schizophrenia has confirmed what many psychiatrists long
suspected: newer drugs that are highly promoted and widely prescribed offer few - if
any - benefits over older medicines that sell for a fraction of the cost.”
September 19, 2005

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

Click here to read the article, PDF Legal TImes

September 12, 2005

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

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

August 2005

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

August 29, 2005
The Seattle Times reports that Wall Street biotech insider gets No. 2 job at the FDA.
Just a month ago Dr. Scott Gottlieb was a Wall Street insider, promoting hot biotech
stocks to investors. Now Gottlieb holds the No. 2 job at the Food and Drug
Administration (FDA), the federal agency that approves new drugs, oversees their
safety and affects the fortunes of companies he once touted. Wall Street likes the
appointment of Gottlieb, 33, who believes in faster drug approval and fewer news-
release warnings to the public about potential side effects of drugs.
August 22, 2005
SSRI Lawyer, Karen Barth Menzies, responds to a New York Times article. According
to her letter to the editor, the FDA's recent warnings regarding suicidality and SSRI
antidepressants were appropriate and long overdue, based on scientific evidence and
the FDA's warning responsibilities to consumers as directed by the Code of Federal
Regulations. The article published in the New York Times on August 6, 2005 by
Gardiner Harris, titled "FDA Responds to Criticism with New Caution," asserts the
erroneous thesis that the FDA simply yielded to criticism and issued invalid warnings,
casting a cloud of doubt over the legitimacy of the warnings. That the FDA finally
stepped up to shield consumers instead of pharmaceutical companies should be
applauded, not undermined with inaccurate reporting. People died as a result of absent
warnings while the SSRI antidepressants were marketed and sold as harmless.

To read the complete response, click here PDF (SSRI LAWYER)

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

Click here to read more:

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

Click here to read the article.
August 5, 2005

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

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

A side note, Cymbalta is the drug where Traci Johnson hung herself in Eli Lilly’s own

Click here to read the article. PDF- WALLSTREET JOURNAL

August 3, 2005

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

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

July 27, 2005

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

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

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

Click here to read

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

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

"It is obvious that state failure-to-warn laws do not pressure manufacturers to include
false or invalid warnings," Judge Rosenbaum wrote. "Instead, they give drug
manufacturers every incentive to warn of real, known risks as soon as they are
discovered! -- even before any FDA action."

Click here to read the article.

Click here to read the press release on Judge Rosenbaum’s ruling.

Click here to read Judge Rosenbaum’s ruling.

July 18, 2005

Senator Charles Grassley makes a statement on the senate floor regarding the
nomination of Dr. Lester Crawford as FDA Commissioner stating he can not vote for
and support this nomination.

Click here to read Senator Grassley’s statement: (PDF-GrassleyCrawford)

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

Click here to read the BMJ article. (BMJEfficiacy PDF)

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

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

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

June 30, 2005

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

Several recent scientific publications suggest the possibility of an increased risk for
suicidal behavior in adults who are being treated with antidepressant medications. Even
before these reports became available, the FDA began a complete review of all
available data to determine whether there is an increased risk of suicidality (suicidal
thinking or behavior) in adults being treated with antidepressant medications. It is
expected that this review will take a year or longer to complete. In the meantime, FDA is
highlighting that:
*Adults being treated with antidepressant medications, particularly those being treated
for depression, should be watched closely for worsening of depression and for
increased suicidal thinking or behavior. Close watching may be especially important
early in treatment, or when the dose is changed, either increased or decreased.

*Adults whose symptoms worsen while being treated with antidepressant drugs,
including an increase in suicidal thinking or behavior, should be evaluated by their
health care professional.

Click here to read the FDA advisory.

June 29, 2005

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

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

June 19, 2005

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

To read the article click PDF TRACYJOHNSON

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

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

June 9, 2005

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

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

Click here to read the article… PDF Chicago Tribune

June 8, 2005

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

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

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

Click here to read more… PDF (NYTVows)
June 8, 2005

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

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

June 8, 2005

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

To read more, click here… PDF PhiladelphiaInquirer.

June 8, 2005

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

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

Click here to read the article.