JAMA: "Drastic action" needed to prevent drug companies from withholding data.

[pnwmom]

http://www.cbsnews.com/stories/2008/04/15/health/webmd/main4018030.shtml

(WebMD) Two studies appearing in the Journal of the American Medical Association have prompted the journal's editors to call for "drastic action" to prevent drug companies from misrepresenting data from clinical trials.

The two investigations involve the pain medication Vioxx, which was taken off the market in 2004 after being linked to an increased risk of heart attacks and strokes among long-term users. The revelations are the latest to come to light from lawsuits brought by people who claimed they'd been harmed by Vioxx.

Researchers charged that the drug's manufacturer, Merck, withheld key data from Vioxx trials from federal regulators and misrepresented the Vioxx research. The JAMA editors agreed, but they added that the problems are pervasive within the industry and not confined to Merck.

"The (two studies) document how one company, Merck & Co. Inc., apparently manipulated dozens of publications to promote one of its products," the journal's editor in chief and executive deputy editor write. "But make no mistake -- the manipulation of study results, authors, editors, and reviews is not the sole purview of one company."

SNIP

[varkam]

1. K&R

IMO, Pharm companies get a bit of a bad rap, but when it comes to things like this they aren't doing themselves any favors. There is definitely a need for greater transparency in the research and approval process in order to hopefully avoid future debacles akin to Vioxx.

[pnwmom]

2. Thank you, varkam.

Another point -- there's some pressure now on Congress to make a law that if the FDA approves something, then the manufacturer is released from liability. There's no way Congress should approve a law that releases companies who withhold data from liability.

[varkam]

5. I'm of two thoughts on this...

on one hand, increased exposure to liability could result in a downturn for R&D, yet on the other hand consumers do deserve protection and recourse should a company act ethically. I would think the best solution would be give a limited release from liability insofar as the manufacturer doesn't do anything unethical (such as withholding data).

[lonestarnot]

6. They are really working that one.

[phillysuse]

3. This is not new!

NPR reported in 2006 that the physician consultant panel knew in 2001 BEFORE Vioxx was approved that it increased the risk of heart disease. This All Things Consider Program discusses some of the conflicts of interest that impacted on the decision to approve Vioxx.

This is on the NPR site.


VIOXX Inquiry, Part Two
by Snigdha Prakash

Listen Now <8 min 14 sec> add to playlist

All Things Considered, June 8, 2006 · Documents obtained by NPR show that five years before Vioxx was pulled off the market, doctors monitoring the safety of the drug knew that it increased the risk of heart attacks. These doctors were part of a panel overseeing a study of Vioxx. Independent experts tell NPR that the study should have been stopped at the first sign that Vioxx increased the risk of heart attacks and strokes. They say that would have prevented tens of thousands of deaths. The safety panel and Merck say it wasn't clear whether Vioxx was causing the problems. A report from NPR's Snigdha Prakash continues

[phillysuse]

4. NPR has the timeline for Vioxx

Timeline: The Rise and Fall of Vioxx
by Snigdha Prakash and Vikki Valentine

NPR.org, November 10, 2007 · Shortly before the FDA approved Vioxx in 1999, drug maker Merck launched a study it hoped would prove that Vioxx was superior to older painkillers, because it caused fewer gastrointestinal problems. Instead, the study would eventually show Vioxx could be deadly, causing heart attacks and strokes.

Five years after Vioxx's launch, Merck withdrew the drug from the market. By that time, Merck had sold billions of dollars of the drug worldwide. A timeline of Vioxx's rise and fall:

November 1998: Merck asks the Food and Drug Administration (FDA) for approval of Vioxx, having tested the drug on 5,400 subjects in eight studies.

January 1999: Merck launches the Vioxx Gastrointestinal Outcomes Research study (VIGOR). With more than 8,000 participants, it is the largest study ever done of the drug. Half take Vioxx and the other half take naproxen. The clinical trial is designed to see whether Vioxx is safer for the digestive system than naproxen, an older painkiller.

May 1999: The FDA approves Vioxx, making the drug available by prescription in the United States.

October 1999: First meeting of the VIGOR study's data and safety monitoring board (DSMB). Study results as of Oct. 1, 1999, show that Vioxx patients have fewer ulcers and less gastrointestinal bleeding than patients taking naproxen. It looks as if the study will be a success for Merck.

November 1999: At the second meeting of the VIGOR safety panel, the discussion focuses on heart problems. As of Nov. 1, 1999, 79 patients out of 4,000 taking Vioxx have had serious heart problems or have died, compared with 41 patients taking naproxen. The minutes of the panel's November meeting note that "while the trends are disconcerting, the numbers of events are small." The panel votes to continue the study and to meet again in a month.

December 1999: The safety panel holds its last meeting. It's told that as of Dec. 1, 1999, the risk of serious heart problems and death among Vioxx patients is twice as high as in the naproxen group.

continued on the npr.org website