The video Pfizer doesn't want you to see

Pharmaceutical giant Pfizer has asked a judge to order that a video be take off YouTube, saying it could prejudice juries in upcoming court cases.

It's the latest twist for a company caught for months in allegations of ghostwriting.

The video, entitled Prempro News Segment, was made by the law firm behind a $78 million (US) court-ordered settlement in the fall of a lawsuit brought against the company. The Philadelphia jury found that Wyeth, a division of Pfizer, failed to warn women that taking its hormone drug Prempro could cause breast cancer.

“Plaintiff’s counsel should be compelled to remove this video from the Internet and refrain from making any further inflammatory and prejudicial public statements” until the litigation is resolved, Pfizer’s lawyers said in a motion filed yesterday in Philadelphia Common Pleas Court.

More than 6 million women have taken hormone-replacement medicines to treat menopause symptoms such as hot flashes, night sweats and mood swings. Until 1995, many patients combined Premarin, an estrogen-based drug made by Pfizer’s Wyeth unit, with progestin-laden Provera, made by Upjohn, another subsidiary of Pfizer, the world’s largest drugmaker.

Wyeth scientists later combined the two hormones in its Prempro pill. The drugs are still on the market. New York-based Pfizer completed its $68 billion purchase of Wyeth in October.

The video was produced by lawyer Zoe Littlepage, who had her staff post it to YouTube. It is made to look like a TV news segment. In it, she accuses Wyeth of hiding the drug's dangers.

“Wyeth chose to not do studies, and even worse, chose to downplay and suppress any evidence of breast cancer and these drugs,” Littlepage says on the video, which doesn’t include a response to the allegations from Pfizer.

The video also features a man identified as a jury foreman in an already-concluded trial over the menopause drugs who calls Wyeth “despicable” and declares that the company is more concerned about profit than about the health of patients.

Documents in the case, filed by Connie Barton, a medical office assistant in Peoria, Ill., have now been unsealed, and used by the New York Times to track the marketing of hormone replacement therapy to women.

The documents that have surfaced in the Wyeth cases offer a rare glimpse inside the file cabinets and hard drives of a major drug company. And the cases demonstrate the importance of litigation in detailing exactly how drug makers operate their businesses, says Dr. Jerome L. Avorn, a professor of medicine at Harvard Medical School who has written about the subject in The Journal of the American Medical Association.

“The information coming out in litigation helps us understand how a belief in a ‘protective benefit’ of estrogens on the heart was able to spread like wildfire through the medical community,” says Dr. Avorn, who is not involved in the Wyeth litigation.

“Thousands of doctors prescribed the drugs for millions of women on that basis,” he says, adding that studies later contradicted the belief. “It will be very interesting to see whether the courts are able to connect the dots and make it clear whether this was a kind of medical ventriloquism on Wyeth’s part.”

Chris Loder, a Pfizer spokesman, says Wyeth acted responsibly by including a clear warning about a breast cancer risk on Prempro labels and by updating the warning as new evidence emerged. He said Pfizer plans to appeal every product-liability case on menopausal drugs it loses, including Barton’s.

 

 

 

Paxil costs Glaxo $1 billion or more: report

Settling lawsuits over its controversial anti-depressant Paxil has cost Glaxo SmithKline some $1-billion in court-ordered and out-of-court settlements, Bloomberg News reports.

“I don’t think this is within the boundaries of current assumptions for analysts.” Navid Malik, an analyst at Matrix Corporate Capital in London, is quoted as saying.

Another analyst, Savvas Neophytou, a Panmure Gordon analyst in London, says a $1.5 billion liability is possible.

The settlements result from suits in which people taking the drug caused them to contemplate suicide or birth defects in their children. In each of the cases, the plaintiffs allege that Glaxo knew of the dangers.

As part of the total, Glaxo, the U.K.’s largest drugmaker, so far has paid $200 million to settle Paxil addiction and birth-defect cases and $400 million to end antitrust, fraud and design claims, according to the people and court records.

The $1 billion “would be worse than many people are expecting,” said Navid Malik, an analyst at Matrix Corporate Capital in London. “I don’t think this is within the boundaries of current assumptions for analysts.”

The London-based company hasn’t disclosed the settlement total in company filings. It has made public some accords. Glaxo’s provision for legal and other non-tax disputes as of the end of 2008 was 1.9 billion pounds ($3.09 billion), according to its latest annual report. This included all legal matters, not just Paxil. The company said 112 million pounds of this sum would be “reimbursed by third-party issuers.”

The drugmaker has reduced its insurance coverage to contain costs, “accepting a greater degree of uninsured exposure,” the annual report states. “Recent insurance loss experience, including pharmaceutical product-liability exposures, has increased the cost of, and narrowed the coverage afforded by, insurance for pharmaceutical companies generally,” Glaxo said.

Glaxo declined to confirm the $1 billion figure. “Paxil has been on the market in the U.S. since 1993. Like many other pharmaceutical products, it has been the subject of different kinds of litigation over the years,” said Sarah Alspach, a spokeswoman for Glaxo, in an e-mailed statement. “It would be inappropriate and potentially misleading to aggregate payments in these various types of litigation.”

Chief Executive Officer Andrew Witty has moved to replace revenue lost to generic versions of drugs such as Paxil. Worldwide, Paxil generated about 514 million pounds in sales last year, or 2.1 percent of the total. Glaxo closed up 5 pence to 1,303 pence in London trading Dec. 11, down 8.8 percent from a year ago.

About 450 suicide-related Paxil cases were settled. Only about a dozen haven’t been, the people said. The $1 billion total doesn’t include more than 600 claims that Paxil caused birth defects.

A Philadelphia jury on Oct. 13 found the drugmaker should pay $2.5 million to the family of Lyam Kilker, a 3-year-old boy born with a heart defect after his mother took Paxil while pregnant. Based on that outcome, an analyst estimated the company may potentially face additional verdicts in birth-defect cases waiting to be tried in Pennsylvania.

“A liability totaling $1.5 billion is possible,” wrote Savvas Neophytou, a Panmure Gordon analyst in London, in a note to investors the day after the Kilker verdict. He still recommended buying Glaxo shares because a likely appeal may reduce the amount paid by the company.

 

Pfizer conflict controversy continues

The controversial appointment of Pfizer Canada executive Bernard Prigent to the Canadian Institutes of Health Research was the lead item on the CBC's national morning radio show, The Current.

A podcast of the show is available.

In the show, Francoise Baylis, Canada Research Chair in bioethics at Dalhousie University, says it is impossible for Prigent to avoid a conflict of interest in the new posting because his job as a Pfizer vice president is to sell as many drugs as possible. The job of the CIHR, however, is to ensure public safety. The two are not always the same thing, she said.

Dr. Jean Rouleau, dean of medicine at the University of Montreal and a member of the CIFR's governing council told the CBC's Anna Maria Tremonti that the group needs to hear from people in the pharmaceutical industry.

Baylis said such input, when needed, could be had by calling Prigent and other industry executives to make submission to the CIHR, without giving them a voice in the decisions made by the group.

Meanwhile, a former member of the CIHR, Saskatchewan researcher Steven Lewis lashed out at the appointment, citing the industry's past marketing scandals and saying the appointment gives Pfizer a competitive advantage over other companies.

"The industry's greatest innovations have occurred outside the lab," he wrote. "Expensive junkets for docs-for-hire to shill for their products to their peers; the purchase of previously distinguished academics to affix their names to ghostwritten papers; the suppression of unfriendly clinical trials and adverse effects data; the publication of the same data in different journals to bias systematic reviews and meta-analyses; etc. ad infinitum."

Lewis said it is "hardly irrelevant that the company to which Dr. Prigent owes his livelihood and his allegiance has owned up to sleaze that stands out even among its shady peers."

Since 2004, Pfizer, the world's largest drug company, has paid $2.75 billion in criminal fines and penalties, Lewis said. "Most recently (Pfizer paid) a whopping $2.3 billion for fraudulently marketing Bextra, a painkiller withdrawn from the market in 2005, and three other drugs."

He questioned how Prigent would respond if the council were asked to support research showing a Pfizer drug is dangerous or identifies the massive public subsidies that flow to drug companies.

As a member of the governing council, Lewis said Prigent will have access to information that his competitors do not and "he can exert a steering effect where they cannot."

CIHR president Dr. Alain Beaudet, who recommended Prigent for the appointment, has said he will bring a private-sector voice to the council and help ensure wise spending.

An online petition against the appointment has now collected almost 4,000 names.

 

 

Pfizer Canada facing two conflict fights

Drug giant Pfizer Canada finds itself at the centre of two conflict of interest controversies after one of its executives was appointed to the Canadian Institutes of Health Research and it signed a deal to provide $780,000 for the Canadian Medical Association to set up educational programs for doctors.

The controversies have also touched the Canadian Medical Association, which is coming under fire for taking $780,000 from Pfizer to set up the education programs.

“My feeling is that the pharmaceutical industry has no business at all educating doctors,” said Arnold Relman, professor emeritus at Harvard Medical School and former editor of the New England Journal of Medicine. “There's no question that if you're paying the piper, you influence the tune that the piper is going to play.”

Heather Bisset, Pfizer Canada's manager of corporate communications, said it simply wants to “improve education that's provided for doctors across Canada.”

Meanwhile, as of this writing, more than 3,100 people had signed an online petition against the appointment of Dr. Bernard Prigent, vice president and medical director of Pfizer Canada, to the governing council of CIHR.

Francoise Baylis, Canada Research Chair in bioethics at Dalhousie University calls Prigent's appointment "an intractable conflict of interest."

To quote from one of the signatories, “You don’t put the rooster in charge of the hen house.” The duty of pharmaceutical companies (e.g., Pfizer) is to make money for their shareholders. The duty of CIHR is to promote the public interest. The interests of shareholders and the interests of Canadians are not one and the same.

CIHR was created in 2000 as an arms-length federal agency responsible for funding health research in Canada. The 2009-2010 total budget for CIHR was just under a billion dollars. This is a lot of money and it is important that Canadians understand how their tax dollars are being spent.

CIHR president Alain Beaudet said Prigent's experience in innovation and commercialization will “fill a major expertise gap” on the board.