The government and judiciary are largely to blame for keeping vital drug safety information concealed from physicians and the public. Consumers, who have no way to protect themselves when a doctor prescribes a medicine, bear the tragic consequences of ingesting hazardous drugs that cut short their lives.
The St. Petersburg Times reports (below) that AstraZeneca, manufacturer of the antipsychotic, Seroquel, "is battling to keep information about the drug out of the public’s view for the public’s own good."
Seroquel is approved only for schizophrenia and bipolar disorder but the drug has been prescribed for more than 22 million patients. Its $4.5 billion in sales last year put it among the top-selling drugs in the world.
But Seroquel is a dangerous drug: it is not approved for children. It has a double black box warning about death for elderly patients and a suicide warning for children, adolescents and young adults. See FDA drug label here: http://tmap.wordpress.com/the-drugs/
Doctors who lack accurate and complete information about drug safety and efficacy-are prescribing this dangerous drug for use for everything from depression to insomnia to ADHD in kids. AstraZeneca has a huge financial interest in keeping doctors and the public ignorant about the hazards of their blockbuster seller.
So, in the absence of a credible argument to keep vital drug safety information secret, lawyers representing AstraZeneca are resorting to a fraudulent line of argument. In a recent filing in federal court, they claim that disclosure of vital drug safety information "could jeopardize public safety by causing confusion and alarm in patients, who may then discontinue their medication without seeking the guidance of a medical professional."
The St. Pete Times reports that the FDA reportedly sent AstraZeneca two letters in late December, telling the company to strengthen Seroquel’s warnings about diabetes. The drugmaker declined to comment, saying its communications with the FDA are confidential. The letters remain sealed in Orlando’s federal court."
Later this month lawyers for the drugmaker will argue that unsealing company documents, including unpublished clinical trial data and letters from the FDA, could harm "a vulnerable patient population."
Even officials of the Peanut Corporation of America (PCA) who pleaded the Fifth Amendment before a congressional hearing last week, did not resort to the specious argument that public disclosure about the Salmonella outbreak at its peanut butter production plant "could jeopardize public safety."
posted by Vera Hassner Sharav
http://www.tampabay.com/news/health/article976067.ece
St. Petersburg Times
Seroquel maker wants to seal info from you, "for" you
By Kris Hundley
Sunday, February 15, 2009
AstraZeneca, maker of the blockbuster anti-psychotic Seroquel, is battling to keep information about the drug out of the public’s view for the public’s own good.
Later this month in Orlando, lawyers for the drugmaker will argue that
unsealing company documents, including unpublished clinical trial data
and letters from the FDA, could harm "a vulnerable patient population."
"This (disclosure) could jeopardize public safety by causing confusion
and alarm in patients, who may then discontinue their medication
without seeking the guidance of a medical professional,”
lawyers for the drugmaker said in a recent filing in federal court.
Seroquel is approved only for schizophrenia and bipolar disorder, but
its use for everything from depression to insomnia to ADHD in kids is
so widespread that the drug has been prescribed for more than 22 million
patients. Its $4.5 billion in sales last year put it among the
top-selling drugs in the world.
In light of Seroquel’s popularity, the argument that hiding information protects
patients has public health advocates nearly swinging from the rafters.
Dr. David Egilman, facing possible criminal charges, admitted in
writing that he violated a court order to keep Lilly documents secret.
"They don’t want anybody to know about the side effects of their drug,
and they’re keeping secret the results of studies from patients, their
doctors and the FDA,” said Dr. David Egilman, clinical associate
professor at Brown University’s Department of Community Health.
"Saying they’re protecting the patient is a self-serving, fraudulent
argument."
Though Egilman is merely an observer of the Seroquel proceedings, he
knows the power of sealed documents in drug liability cases. He
played a key role when similar lawsuits were lodged against another
mega-selling antipsychotic, Eli Lilly’s drug Zyprexa. As in the Seroquel cases,
thousands upon thousands of patients claimed Zyprexa caused weight
gain and diabetes.
Hired as an expert witness for the plaintiffs in Zyprexa cases,
Egilman was given access to reams of internal Lilly documents that had been
sealed by the court. The documents showed that the drugmaker had ignored
evidence of diabetes among patients while pushing Zyprexa’s off-label use for
anxiety and dementia.
Egilman defied the judge’s orders and helped leak thousands of
damaging Lilly documents to the New York Times. Egilman ended up paying a
$100,000 fine to Lilly for releasing the sealed documents.
The leaked documents, meanwhile, helped the U.S. Department of Justice
build a criminal case against Lilly. The company pleaded guilty to marketing
Zyprexa illegally and last month paid a record $1.4 billion fine. Though a
landmark amount, Lilly’s fine amounts to about 3.5 percent of the $39 billion
in revenues Zyprexa has posted since the FDA approved it 1996.
Seroquel’s parent, Astra-Zeneca, has a similarly valuable franchise to
protect. The anti-psychotic accounted for 14 percent of AstraZeneca’s
sales of $31.6 billion last year. Avoiding negative publicity – one of
the reasons the company wants to seal documents in the Orlando cases
is critical as it seeks to maximize sales before Seroquel loses patent
protection in about three years.
The skirmish over document disclosure in Orlando is part of a hornet’s
nest of litigation against AstraZeneca, a British company with U.S.
headquarters in Wilmington, Del. More than 15,000 patients have filed
over 9,000 personal injury lawsuits. About 40 percent of these claims
have been consolidated for pretrial motions in U.S. District Court for
the Middle District of Florida.
Plaintiffs say the company knew as early as 2000 that Seroquel caused
diabetes, weight gain and other health problems, but failed to
adequately warn patients and doctors.
Dr. William C. Wirshing, a California psychiatrist, has lectured
doctors on AstraZeneca’s behalf and has prescribed Seroquel
to as many as 5,000 patients. Though he has been a paid consultant for
the drugmaker, in a pretrial deposition he left no question about the
links he sees between the drug, weight gain and diabetes.
"You literally just got to watch them get bigger, it was riveting to
me," said Wirshing who estimated that several hundred of his patients
developed diabetes.
AstraZeneca denies the allegations and has spent more than $500
million defending itself against Seroquel claims. Key to the company’s
strategy has been its insistence that millions of pages of documents
produced in discovery should remain under seal, out of the public eye.
To Egilman, such blanket agreements in drug liability cases are
outrageous. "Confidentiality agreements that prohibit disclosure of
important information that may impact public health to state and
federal authorities should be illegal,” he said. "The court should at
least send all discovery in drug cases to the FDA and DOJ (Department of
Justice) for review if they intend to seal them."
The upcoming hearing is expected to focus on specific items that the
plaintiffs’ lawyers say have no legal right to secrecy. Among them:
unpublished results of several drug studies, sales reps’ notes on
Seroquel’s marketing strategies and letters from the FDA.
The drugmaker also hopes to keep under seal information about sexual
relationships that Dr. Wayne MacFadden, AstraZeneca’s former U.S.
medical director for Seroquel, had with an independent researcher as
well as with a woman who wrote papers supporting the drug’s safety and
efficacy. Correspondence shows that MacFadden, who was also director
of clinical research for neuroscience drugs, "promised sexual favors in
exchange for intelligence on AstraZeneca’s competitors."
The plaintiffs say the affairs "can create bias which can affect the
integrity of the science.”
Lawyers for the drugmaker counter that the affairs are not relevant to
the lawsuits. Other disputed documents, they say, contain trade
secrets, could taint the jury pool and could "harm public health."
AstraZeneca’s lawyers say the information to be discussed at the
hearing scheduled Feb. 26 is so sensitive that the court
should be closed to the public. "The potential harm of dissemination of
documents at this stage in the litigation far outweighs the public’s
right of access, particularly when trials in these cases are
on the near horizon,” company lawyers said in a filing Feb. 6.
"The whole picture will be presented to the public at once."
The judge has not ruled on the request.
There’s a good chance that many of these cases will never come to
trial, and the underlying documents will never become public. In a victory
for Astra-Zeneca, the judge dismissed the first two cases in late January,
saying plaintiffs had not sufficiently established that their health
problems were caused by Seroquel. Up to nine trials are slated for
2009.
In the Zyprexa litigation, Lilly paid $1.2 billion to settle injury claims
involving 31,000 patients. Damaging company documents were never
released by the court, though they were available on the Internet after
Egilman leaked them and excerpts appeared in the New York Times.
Egilman is well aware of the big money in liability lawsuits, having
made $2.3 million as an expert witness in Vioxx cases. He contends
that patients’ lawyers are motivated by maximizing their share of any
settlement, which can be 30 percent or more. He says attorneys should
be required to get their client’s approval before agreeing to seal documents.
"The client may be more interested in making sure that health information
gets to their doctor than money," he said. "They have a real interest and
it’s called their health."
Gary Farmer, a Fort Lauderdale lawyer who represents more than 100
Seroquel patients, said Egilman has a point. "If we can get the documents
to win the case and get compensation, you have to ask yourself,
‘Is it necessary to make that information public?’" he said.
Whether the mountains of Seroquel material now sealed in Orlando’s
federal court ever see the light of day may depend on the progress of
related cases. Four states – Pennsylvania, Montana, Arkansas and South
Carolina – are suing Astra-Zeneca for off-label marketing of Seroquel.
The company said it is aware that the U.S. Attorney’s Office in
Philadelphia is investigating Seroquel’s marketing practices, most
likely based on whistle blower complaints.
Regulators also seem to be taking note. In December, the FDA sent
AstraZeneca a warning letter after learning a sales rep had pitched
Seroquel to a doctor as a treatment for depression. Though doctors can
prescribe a drug for any use, it is illegal for pharmaceutical companies
to promote such uses.
The FDA also reportedly sent AstraZeneca two letters in late December,
telling the company to strengthen Seroquel’s warnings about diabetes.
The drugmaker declined to comment, saying its communications with the
FDA are confidential. The letters remain sealed in Orlando’s federal court.