August 23

More Drugs Slapped with Lawsuits_Science Misconduct Blog

Lawsuits against pharmaceutical companies totaled 17, 027 last year,  more than all other industries with significant liability suits combined: 3,236 (Manufacturing); 2,875 (Chemicals); 2,717 (Construction); 2,636 (Financial services); and 1,926 (Insurance).

"The lawsuits," says researcher Thomson West,  "raise questions about whether drugmakers and the FDA pay ample attention to patient safety. Since
2000, more than 65,000 product liability lawsuits have been filed against prescription drugmakers, the most of any industry."  No one even knows how
many people have died as a result.

The fact that FDA does not prevent lethal drugs from being brought to market and that FDA allows such drugs to be aggressively advertised-even when their deadly effects are known to the FDA-have resulted in such lethal drugs to become the most profitable blockbusters. The profitability of lethal drugs has encouraged companies to market toxic drugs.

The fact is the profits far outweigh the cost of defending against product liability law suits.

One also notices the high rate of recidivism among the companies that are repeatedly found in violation of federal and state laws-nothing is done to
stop the (at times) criminal violations.  Why is this industry given so much privilege when its modus operandi cause preventable deaths and injury?

Dr. Aubrey Blumsohn, who blew the whistle on the misrepresentation of clinical trial data from Proctor & Gamble’s osteoporosis drug, Actonel, has
created an internet blog posting documents not usually seen by the public 

The blog focuses on research misconduct and the collusion between the pharmaceutical industry, academia, government oversight agency, and scientific journals.

Among the documents posted, are graphs showing how data vanishes from sight and from data analysis and a letter from the University of Sheffield where Dr. Blumsohn was a senior lecturer in metabolism.   The letter from Professor Eastell  was written in response to two letters from Dr. Blumsohn (also posted). The letter is a demonstration of shameful capitulation by a university to Big Pharma and the university’s abdication of its foremost responsibility to protect the integrity of science. The letter
1. attempts to rationalize why it was appropriate for authors to be refused access to critical raw data
2. suggests that the first author (Blumsohn) would be removed even as a coauthor unless prepared to sign a journal declaration in the absence of
data The documents can be found on Dr. Blumsohn’s blog is at:

Contact: Vera Hassner Sharav
More drugs get slapped with lawsuits

By Julie Schmit



Drug makers faced the most product liability lawsuits last year of any industry.
Industry                                            Cases
Pharmaceutical                               17,027
Manufacturing                                  3,236
Chemicals                                        2,875
Construction                                    2,717
Financial services                           2,636
Insurance                                        1,926

Source: Thomson West

A new batch of drugs faces a barrage of lawsuits claiming that the drugs injured users and that manufacturers are to blame.

More than 6,000 lawsuits have been filed in recent years against four drugs taken by millions of patients: hormone-replacement drug Prempro, birth-control patch Ortho Evra, anti-psychotic Seroquel and anti-seizure drug Neurontin.

The plaintiffs claim drugmakers failed to disclose the drugs’ risks or failed to properly test them, or both. The claims are similar to those against Merck’s painkiller Vioxx, which faces 14,000 lawsuits. Unlike Vioxx,these drugs are still being sold, and the Food and Drug Administration considers their benefits worth their risks.

The first trials have begun or are near for Prempro and Neurontin. Johnson & Johnson has started settling some Ortho Evra cases, plaintiffs’ lawyers say.

The lawsuits raise questions about whether drugmakers and the FDA pay ampleattention to patient safety. Since 2000, more than 65,000 product liability
lawsuits have been filed against prescription drugmakers, the most of anyindustry, says researcher Thomson West.

The pace isn’t likely to slow, given the number of drugs on the market, themillions of consumers taking them and the skill of plaintiffs’ lawyers in finding consumers who suffered adverse reactions, says professor Lars Noahof the University of Florida College of Law.

"The lawyers have created almost an assembly-line approach to use …against an industry that’s in tobacco-land in terms of how much people hate it," Noah says.

Drugmaker Wyeth faces more than 5,000 cases for Prempro and Premarin,hormone-replacement drugs for menopausal symptoms. The first trial started
Monday in Little Rock. Plaintiff Linda Reeves alleges she developed breast cancer as a result of taking the drugs from 1983 through 2000. Breast cancer
accounts for the majority of claims.

Wyeth and plaintiffs’ lawyers refused comment, citing a judge’s gag order.Wyeth has said it did nothing wrong and that the drugs’ warnings reflected available scientific data and FDA requirements.

A study halted in 2002, the Women’s Health Initiative, found that Prempropatients had a higher risk of breast cancer, stroke and heart disease. Later that year, Wyeth added a boldface warning on Prempro, which combinesestrogen and progestin, and on Premarin, an estrogen, regarding the study.

In 2003, the warnings were put in a box, making them more prominent. Thedrugs’ combined sales fell to $909 billion last year from $2 billion in 2001.

In March, Wyeth won the first state case when a New York judge issued asummary judgment, saying the drugs’ warnings were adequate. The case is
being appealed, the plaintiff’s lawyer says.

Wyeth’s exposure is not likely to be nearly as large as the $21 billion it’spaying to settle tens of thousands of claims over former diet drug fen-phen, linked to heart and lung problems. Not only are there fewer cases, but alsoit’s difficult to prove that a drug caused someone’s cancer – a key hurdle in most drug lawsuits, Noah says.

Plaintiffs in the Neurontin lawsuits face a similar challenge, says lawyerMike Papantonio of Levin Papantonio Thomas Mitchell Echsner & Proctor, which does not represent any Neurontin plaintiffs.

Neurontin plaintiffs’ lawyer Andrew Finkelstein has advocated that the FDArequire a black-box suicide warning on Neurontin, which has been taken by more than 10 million people and is widely prescribed for pain and bipolarsufferers. Drugmaker Pfizer says there’s no scientific evidence linking Neurontin and suicide.

"It’s a difficult thing to get your arms around," Papantonio says. "Like thehormone-replacement therapy cases, there are so many complicating factors."

In December, Pfizer changed Neurontin’s label to list "suicide" and "suicideattempt" as infrequent adverse events as opposed to "suicide gesture" as a
rarer event. Pfizer says it made the change because of adverse event reportsfiled to the FDA. The reports do not prove a drug was to blame.

Warning raised

In the Ortho Evra birth-control patch cases, plaintiffs allege that thecompany failed to adequately test the patch’s safety. Many of the women claim they suffered blood clots as a result of using it.

"The plaintiffs tend to be younger women, and you don’t normally see strokesor blood clots in that population," Noah says.

The FDA last year required a warning on the patch, saying users will beexposed to 60% more estrogen than with typical birth-control pills. The warning came after the FDA and the drugmaker compared estrogen levels forthe patch vs. pills. The FDA also said increased estrogen may raise the risk of clots.

When the FDA approved the patch in 2001, however, an FDA approval documentsaid the risks were "similar to the risks of using birth-control pills."

The patch delivers more estrogen into the bloodstream. With pills, someestrogen is lost in the digestive tract.

Ortho-McNeil Pharmaceutical, and parent Johnson & Johnson, refused tocomment specifically on the lawsuit allegations. In a general statement, it said that more than 5 million women have used the patch and that, when usedas labeled, it is safe.

Settlements’ cost

Last year, drugmaker Eli Lilly took a $1 billion charge to settle about 10,500 lawsuits claiming anti-psychotic Zyprexa caused diabetes or high blood glucose.

Similar claims have been made against AstraZeneca Pharmaceuticals’ Seroquel,the No. 1 anti-psychotic, with more than 16 million users since its 1997
launch. Plaintiffs’ lawyers claim AstraZeneca downplayed the diabetes risksand hid important safety information from the FDA.

AstraZeneca is confident in the drug and plans to defend itself, saysspokesman Jim Minnick. He says the same lawyers who filed suit against Zyprexa are coming after Seroquel hoping for a similar result – a chargeplaintiffs’ lawyers deny.

Lawsuits’ effects

Professor Noah says the threat of litigation will do little to stop companies from pursuing future drugs with such big markets.

Seroquel had 2005 sales of $2.8 billion. Neurontin, pre-generic competition, also posted annual sales in excess of $2 billion, as did the hormone-replacement drugs.

But Lisa Rickard, president of the U.S. Chamber Institute for Legal Reform, says litigation costs not only eat into research funds but change consumer behaviors. She cites a 2003 Harris Poll, commissioned by her group, that found that almost four out of 10 doctors had patients stop taking necessary
medications after they heard a drug was involved in a liability lawsuit.

She says plaintiffs’ lawyers jam courts with so many lawsuits, many frivolous, that firms settle to avoid the expense and uncertainty of fighting them. "The situation has gotten out of hand," says Rickard, whose group is affiliated with the U.S. Chamber of Commerce.

Lawyer Papantonio says law firms stand to lose $3 million to $5 million by bringing drugmakers to trial and don’t pursue frivolous cases. "If a product hurts enough people, it gets the attention of the lawyers."

Four drugs whose alleged risks have made them the targets of many product-liability lawsuits.
Drug Prempro and Premarin  Ortho Evra  Seroquel  Neurontin
Maker Wyeth  Johnson & Johnson  AstraZeneca  Pfizer
Use Hormone replacement for menopausal women  Birth-control patch  Anti-psychotic  Anti-seizure, some pain
Lawsuits More than 5,000 for 8,300 women  500  380   About 300
Allegation Failed to adequately test for and warn of potential risks, including breast cancer.  Failed to properly test for and falsely downplayed risk of blood clots, other factors.  Overstated benefits of drug and minimized risk of developing diabetes.  Caused suicide or suicide attempt.
Status First federal trial started Monday.   No trials scheduled; J&J reportedly settled some cases.  No trials scheduled.  First trial possible this fall.
FDA approved  Prempro, 1994; Premarin in use since 1942.  2001  1997  1993
2005 sales $909 million   $416 million*  $2.8 billion   $639 million
* — U.S. sales only.  Sources: Company SEC filings, IMS Health, plaintiffs’ lawyers

Posted 8/23/2006 2:37 AM ET

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