Vioxx

No monitoring for Vioxx-takers, court says

Tracy Staton — Wed, 04 Jun 2008 21:24:10 -0400

Slowly but surely Merck is working its way off the Vioxx hook. First, the successful fight-em-one-by-one strategy, then the big settlement, then a few key overturned verdicts--and now, the New Jersey Supreme Court has ruled that the drugmaker doesn't have to monitor Vioxx patients for future health problems. The 5-1 decision nullifies a class action lawsuit, filed by Vioxx users who don't have symptoms but wanted to be tested for any hidden problems.

The ruling states that patients can't pursue claims for medical monitoring unless they show "harm." Because these plaintiffs had no injuries to report, no harm done--in a legal sense, anyway.

- check out Merck's release
- read the Los Angeles Times story
- see the article in the Star-Ledger

Did Merck settle too soon?

Tracy Staton — Fri, 30 May 2008 10:22:10 -0400

Yesterday, we reported that two appeals courts--in Texas and New Jersey--overturned multimillion-dollar verdicts against Merck in Vioxx cases. The Jersey court's reasoning: A state product liability law was pre-empted by federal law.

Wait a minute: Isn't pre-emption that big legal debate the Supreme Court intends to rule on later this year? The one that says FDA approval, being federal, should shield drugmakers from state liability? Yes and yes. If the Supremes decide pre-emption is the way to go, patients will find it difficult to sue drugmakers at all, and the companies will have a stronger position in settlement negotiations.

So, the Wall Street Journal Health Blog asks, did Merck jump the gun when it offered the big $4.85 billion settlement last year? At the time, it seemed like a good deal for the company. But in light of the overturned verdicts, and the possibililty of pre-emption, it seems Merck might have been able to get off even more lightly if it had waited a bit longer.

- read the post at the Health Blog

Merck swears off ghostwriting in settlement

Tracy Staton — Wed, 21 May 2008 10:37:00 -0400

Merck made a $58 million deal to settle claims of deceptive Vioxx advertising with a 29 attorneys general. The states had alleged that Merck deceived consumers by concealing the "increased risks" linked to the now-withdrawn painkiller. Of course, $58 million pales next to the $4.85 billion Merck has agreed to pay to Vioxx patients (and survivors) who can prove they had heart attacks, strokes, or other serious side effects.

One interesting facet of the deal: Merck has pledged to give up ghostwriting. Yep, that's right--about a month after the Journal of the American Medical Association said some published Vioxx studies were written, not by their prestigious bylined authors, but by hired guns, Merck is promising not to do that anymore. At the time, Merck defended the practice, saying the JAMA accusations were false and misleading. (And the company didn't admit any wrongdoing as part of the settlement, either.) For its part, the journal called ghostwriting--not just as practiced by Merck--"bad science and bad research practice." We wonder whether other drugmakers might volunteer to go cold turkey, too.

- see the WSJ Health Blog item
- check out the article in the Star-Ledger
- read the Washington Post story

Pfizer starts settling Celebrex claims

Mon, 05 May 2008 06:59:58 -0400

Pfizer is starting to settle the thousands of lawsuits over painkillers Celebrex and Bextra, the Wall Street Journal reports. Three groups of plaintiffs who allege that the meds caused heart attacks and strokes--some 200 claimants in all--are involved in the tentative settlement deals. Just in time, too; the first Bextra trial was set to begin today, but was postponed to allow time for negotiations.

One lawyer said Pfizer had offered an average of $200,000 per client in Bextra cases and $40,000 to $50,000 on average for Celebrex claims. Pfizer lawyers have said that the company will pay up to $500 million to resolve all the cases. Pfizer hasn't yet commented on the settlement news.

Rather than coming up with a blanket deal like Merck did in with Vioxx litigation, Pfizer is said to be working out its Celebrex/Bextra cases on a law firm-by-law firm basis. (Of course, Merck started out defending its Vioxx claims on a case-by-case basis.) The three drugs are all Cox-2 inhibitors; Celebrex is the only one still sold in the U.S. The other two were taken off the market amid safety concerns.

- read the story in the Wall Street Journal
- see the WSJ Health Blog item

Merck CEO: 'I can't blame the media'

Fri, 02 May 2008 06:59:57 -0400

A triad of Merck news today, including one item about the news. We'll start with that: CEO Dick Clark (photo) worried publicly about the media at a Morgan Stanley conference yesterday. In response to a question about the negative bent to Merck coverage these days, Clark said Merck and Big Pharma as a whole need to "do a better job...I don't think we're aggressive enough in getting our stories out there." He also used his new buzz-phrase "trust deficit" to describe the cloud hanging over the industry. Pressed, he said, "I can't blame the media. I have to blame us."

That's quite a turnabout for Clark, who blamed "media hype" for misleading folks to an unfairly negative view of Vytorin, the combo cholesterol drug that delivered disappointing results in the now-infamous Enhance study.

Meanwhile, the company and FDA have agreed on a labeling update to RotaTeq, the infant vaccine to prevent rotavirus infection. The new label will include the report of one vaccinated infant's death from a bowel obstruction. Back in February 2007 the FDA warned that 28 infants developed intussusception after taking RotaTeq, but the rate of that condition didn't exceed what's commonly seen among un-vaccinated babies. Merck reiterated that conclusion in announcing the labeling change.

And finally, Merck is giving Vioxx users more time to cough up documents that show they took Vioxx and then had a heart attack or stroke. The new deadline is June 30, instead of May 1.

- see the item in the Wall Street Journal Health Blog
- check out the vaccine news at MarketWatch
- find the Vioxx update in the Daily Record

Ghostwriting fuels foes of FDA rule change

Mon, 21 Apr 2008 06:59:56 -0400

Last week, we reported on Big Pharma's march on the capital in support of new off-label marketing rules. Now, opponents of those rules are drawing on another of last week's news events for support: the Vioxx ghostwriting story.

You'll recall that last week's Journal of the American Medical Association included an article showing that Merck used ghostwriters to produce journal articles supporting the now-withdrawn painkiller Vioxx. You'll also recall that the proposed FDA rules would allow drugmakers to distribute journal articles supporting off-label uses of their products.

Critics of the proposal say that if the credibility of journal articles can't be guaranteed--and in fact might have been skewed by the drugmakers--then why should they be exempt from off-label marketing prohibitions? Even before the Vioxx story broke, Blue Cross Blue Shield had written the FDA to question the marketing proposal, citing the possibility that ghostwritten articles could be used to bolster off-label uses, the New York Times reports. And New York State's health commissioner weighed in with similar concerns, referring to Pfizer's use of journal articles to promote off-label use of Neurontin; Pfizer later paid $430 million to settle off-label marketing claims. (Funny, there was a Neurontin story last week, too.)

"We just have so many concerns," Commissioner Dr. Richard F. Daines told the NYT. "You don't know the publication's true peer-review standards and transparency."

- read the NYT story

Related Articles:
JAMA: Merck paid docs for bylines. Ghostwriting report
Could full data disclosure avert scandal? Report
Positive data more likely to find its way to public. Report

Pharma fighting back in Washington

Fri, 18 Apr 2008 06:59:56 -0400

Call it the backlash against the backlash. In the wake of the recent Vytorin and Vioxx marketing scandals, drugmakers are banding together to prevent a Congressional crackdown on their power to promote. Ten companies, including Pfizer, Bayer, AstraZeneca, and Johnson & Johnson, have formed a coalition to push for looser restrictions on off-label marketing, previously proposed by the FDA. Drug marketers also want to fight any proposed limits on DTC ads, including a new proposal to require the FDA's phone number in every ad. "We have to be concerned that Congress will act too quickly in this atmosphere," one marketing-strategy firm told the Wall Street Journal.

The Big Pharma coalition--which also includes the National Alliance on Mental Illness and the National Organization for Rare Disorders--will submit their arguments for new off-label promotion guidelines to the FDA today. You'll recall that the FDA wants to allow drugmakers to distribute journal articles that support unapproved uses for their drugs. Advocates say the practice educates physicians about new ways to treat difficult illnesses.

The atmosphere in the capital isn't altogether friendly, though. Several congressional investigations of drugmakers are underway, and Rep. John Dingell, chair of the House Committee on Energy and Commerce, plans to call hearings on DTC ads in a few weeks. "Drug companies should know that they will be held accountable," he said in a statement.

- read the WSJ article

ALSO: Two Harvard doctors are balking at the idea of banning any drugmakers' gifts to docs in Massachusetts; in a Boston Herald column, the physicians argue that the bill goes too far and would interrupt communication. One blogger notes, however, that the doctors misrepresent the provisions in the bill, and the WSJ points out that one of physicians is a director at Pfizer. Report | Report | Column

Related Articles:
Grand jury probes Vioxx marketing. Off-label report
Rep decries off-label marketing "loophole." Report
Ex-Pfizerite indicted in off-label case. Pfizer report
Should FDA's info be in all DTC ads? FDA report
Survey: No doubt DTC ads work. DTC report
Watchdogs circling DTC drug commercials. DTC report

JAMA: Merck paid docs for bylines

Wed, 16 Apr 2008 06:59:58 -0400

Merck wrote its own articles on Vioxx research and then paid prestigious doctors to append their bylines, according to a new story in the Journal of the American Medical Association. Of course, Merck isn't alone: the JAMA article notes that ghostwriting appears to be widespread in the pharma industry. "It almost calls into question all legitimate research that's been conducted by the pharmaceutical industry with the academic physician," said the study's lead author, Dr. Joseph S. Ross of the Mount Sinai School of Medicine.

But the ghostwritten Vioxx research is noteworthy because the drug went on to become a best-seller--and then a fiasco, as Merck withdrew it because of links to heart attacks and, most recently, agreed to pay $4.85 billion to settle related lawsuits. It's also interesting because those very lawsuits unearthed documents that shine a bright light on the way Merck promoted Vioxx data. Usually, those documents are kept in drug company filing cabinets and never meet the public eye. Also, the JAMA reports allege that Merck dragged its feet when reporting data on safety risks that arose during two studies of Vioxx in dementia patients.

Now, these JAMA articles relied only on the legal documents and published studies; none of the authors were contacted. Since the reports were published, some expert authors have defended their roles in the Vioxx articles, saying that they didn't simply come in after the fact and add their names, but participated in the research itself. "It's simply false that we didn't contribute to the final publication," one said. But that same professor told USA Today that he never had all the statistical analyses for that study; his role in it was to judge the accuracy of participants' Alzheimer's diagnosis, not the effect of the drug, he said.

We may get some more public documents to pore over soon, however: Sen. Chuck Grassley has put one of the ghostwriting companies--Scientific Therapeutics Information--on the hot seat, asking the company about its dealings with Merck.

Plus, expect to see debate over JAMA's proposals for reform. They include a half-dozen bids for increased transparency in clinical trials and study publication.

- check out Merck's response to the JAMA articles
- find the JAMA abstract
- see Grassley's letters
- read the Boston Globe story
- see one researcher's conflicting accounts of a Vioxx study at Pharmalot
- check out JAMA's recommendations

Related Articles:
Could full data disclosure avert scandal? Report
Vioxx plaintiffs sign on, deal proceeds. Vioxx report
Positive data more likely to find its way to public. Report

Forbes to Big Pharma: Fess up

Fri, 04 Apr 2008 07:59:55 -0400

Big Pharma looks more and more like a big ostrich these days, Forbes suggests. The brouhaha over Vytorin and Zetia this week is a case in point. If the controversial Enhance study had proven Vytorin to be a veritable roto-rooter for arteries, Merck and Schering-Plough would have trumpeted the news to the sky. Instead, Vytorin--a combo of Zocor and Zetia--failed to show any benefit over Zocor alone. So the companies have done all they could to pooh-pooh the results.

That's a reaction common to drugmakers these days. "Positive results are taken as proof that a medicine works," Forbes says. "Catastrophic failures are explained away. Companies split hairs over side effects instead of recognizing them head-on." And in doing these things, pharma companies simply hurt themselves, raising doubts about their own veracity. Examples? Vioxx side effects weren't acknowledged for years. Ditto Zyprexa's. You can think of more.

- read the article in Forbes

Related Articles:
Publishing negative data is harder than it seems. Report
Positive data more likely to find its way to public. Report
More feedback on negative data publishing. Report

Could full data disclosure avert scandal?

Mon, 24 Mar 2008 07:59:58 -0400

New calls for old drug data in the U.K. have experts second-guessing big drug-safety scandals. If scientists and regulators had had access to every bit of data on Vioxx from the get-go, for instance, would heart attacks and strokes have been averted? Ditto Avandia? "People might have realized that the claims being made for the drug were overblown and coy to the point of being fraudulent," one expert told the Associated Press.

These questions are arising in the wake of a British investigation into GlaxoSmithKline and its antidepressant Seroxat. The government concluded that GSK withheld information on the med's suicide risk for teens, but could not prosecute because withholding that data wasn't illegal under British law because Seroxat wasn't approved for use in kids, just adults. (GSK maintains that it didn't withhold info, anyway.) Officials say they intend to strengthen legislation governing clinical trial info by year's end.

The worry is that safety risks aren't being reported by drugmakers until they absolutely have to. "It would be unwise to assume that this particular case was anomalous," a journal editor said. But other observers emphasized the fact that some side effects aren't known until a drug hits the market and is administered to millions of people instead of a few thousand as in a clinical trial.

- read the story in the International Herald Tribune

Related Articles:
UK patients sue for Paxil withdrawal. Report
Study highlights link between Paxil and suicide. Report
Top 10 Drug Warnings and Recalls of 2007. Report