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Drug Makers Fears Backlash but Push to Ease Off-Label Rules
Wall Street Journal
The Wall Street Journal reports (below) that pharmaceutical companies fear backlash in the wake of drug scandals. Their immediate goal is to remove the legal prohibition against off-label drug marketing--which is a crime.
The FDA, ever the servant of the pharmaceutical industry has proposed a rule change that would allow companies to disseminate ghostwritten industry propaganda masquerading as science in medical journals.
*Of note, the WSJ reports that a coalition of ten major drug companies, including Pfizer Inc.; Bayer Corp., the U.S. unit of Bayer AG; AstraZeneca PLC; and Johnson & Johnson--and industry's subsidized patient-advocacy groups, the National Alliance on Mental Illness (NAMI) and the National Organization for Rare Disorders (NORD) are lobbying the FDA and Congress to legitimize illegal marketing of drugs for untested, unapproved, off-label uses.
"The group supports the ability of companies to disseminate articles from peer-reviewed medical journals to physicians and hospitals to inform them of new conditions for which drugs already on the market could be used but which the FDA hasn't formally approved."
**Of note, the group has retained former FDA Chief Counsel Daniel Troy, to lobby the FDA. Troy is working with public-relations giant APCO Worldwide Inc.
To appreciate what's at stake, two articles just published by the Journal of American Medical Association, reveal the scope of deceptive practices, providing the rationale for NOT changing the prohibition against off-label marketing. The case at hand is Merck and its false claims about Vioxx in "peer reviewed" published reports.
One study, "Reporting Mortality Findings in Trials of Rofecoxib for Alzheimer Disease or Cognitive Impairment: A Case Study Based on Documents >From Rofecoxib Litigation" by Bruce M. Psaty MD; Richard A. Kronmal MD, revealed that Merck had reported false safety findings in two published studies (2004 and 2005), claiming that Vioxx was "well tolerated" among the Alzheimer's patients. See here.
One article (published in 2004) reported 11 "non-drug related deaths" (9 deaths among 346 rofecoxib patients and 2 deaths among 346 placebo patients).
Another article ( published in 2005) reported 39 deaths (24 among 725 rofecoxib patients and 15 among 732 placebo patients) An additional 22 deaths were reported in the off-drug period (17 in rofecoxib patients and 5 in placebo patients). However, the authors note, "these articles did not include analyses or statistical tests of the mortality data, and the 2 articles concluded that regarding safety, rofecoxib is "well tolerated."
Those "findings" contrast sharply with the company's internal documents dated, April 2001 showing subjects taking Vioxx in one trial had been four times more likely to die as those getting a placebo. And Merck's intention-to-treat analyses of pooled data from these 2 trials identified a significant increase in total mortality, with overall mortality of 34 deaths among 1069 rofecoxib patients and 12 deaths among 1078 placebo patients.
**** The authors report that "These mortality analyses were neither provided to the FDA nor made public in a timely fashion." Failure to report adverse events to the FDA is a crime punishable by prison.
"The findings from this case study suggest that additional protections for human research participants, including new approaches for the conduct, oversight, and reporting of industry-sponsored trials, are necessary."
A second report in JAMA, "Guest Authorship and Ghostwriting in Publications Related to Rofecoxib: A Case Study of Industry Documents From Rofecoxib Litigation," by Joseph S. Ross, MD, MHS, Kevin P. Hill, MD, MHS, David S. Egilman, MD, MPH Harlan M. Krumholz, MD, SM. The authors reviewed over 20,000 pages of drafts reports uncovered during litigation.
"This case-study review of industry documents demonstrates that clinical trial manuscripts related to rofecoxib were authored by sponsor employees but often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support. JAMA. 2008;299(15):1800-1812.
Both studies were made possible by the authors' access to industry documents through litigation which presents a rare (probably the only) opportunity to explore the relationship between the medical profession and the pharmaceutical industry.
***** Of note, the primary goal of industry and stakeholders in the business who are clamoring for "federal preemption" to immunize pharmaceutical companies from product liability lawsuits, is to cut off access to internal secret documents so that lethal drugs such as Vioxx, could continue to be marketed.
****** Borrowing an observation from the Chinese: a rotten fish smells from the head down. FDA has relied on fraudulent industry studies to judge safety.
An investigation by Rep. John Dingell, chairman of the House Committee on Energy and Commerce, and Rep. Bart Stupak, who leads a subcommittee, into the use of Bisphenol A in cans containing baby formula and other products aimed at infants and toddlers, uncovered evidence that further erodes trust in the FDA.
The Milwaukee Journal Sentinel reports that Stephen Mason, FDA's acting assistant commissioner for legislation, confirmed the allegation that the FDA ignored hundreds of government and academic studies showing a chemical commonly found in plastic--Bisphenol A--can be harmful to lab animals at low doses. FDA determined the chemical was safe based on just two industry-funded studies whose results didn't find harm. Those studies were sponsored by the Society of the Plastics Industry, a subsidiary of the American Chemistry Council.
What's more, according to the Sentinel, one of the studies has never been published, and therefore never subjected to peer review; the second has been heavily criticized by researchers who say the results are inconclusive because of flawed experimental methods.
Does anyone care about the consequences of science and medicine corrupted by industry?
Contact: Vera Hassner Sharav
THE WALL STREET JOURNAL
Drug Makers Push Easing Off-Label Rules
Industry Fears Backlash In the Wake of Scandals;
A Chilly Capital Climate
By ALICIA MUNDY
April 18, 2008; Page A14
WASHINGTON -- Drug-industry representatives are descending on the capital to protect their freedom to advertise their wares directly to consumers and to push for looser government restrictions on their ability to promote off-label uses of their medicines.
The industry has become worried about a potential regulatory backlash following recent scandals over the marketing of Vioxx and Vytorin, as well as voter concern about increasing drug prices. All three presidential candidates have been criticizing drug makers about pricing. Meanwhile, three congressional committees are pursuing investigations of drug-industry marketing practices.
"We have to be concerned that Congress will act too quickly in this atmosphere, without considering the problems they can cause the public by limiting the information flow to consumers," said Bob Hogan, chief executive of Cognito Communications, a Connecticut health-care marketing-strategy firm.
Ten major drug companies, including Pfizer Inc.; Bayer Corp., the U.S. unit of Bayer AG; AstraZeneca PLC; and Johnson & Johnson have formed a coalition to push for looser restrictions on off-label marketing. They will submit their arguments Friday to the Food and Drug Administration, which has been soliciting comments on its proposed off-label promotion guidelines. They are represented by former FDA Chief Counsel Daniel Troy, who is working with public-relations giant APCO Worldwide Inc.
Mr. Troy's group includes patient-advocacy organizations the National Alliance on Mental Illness and the National Organization for Rare Disorders. The group supports the ability of companies to disseminate articles from peer-reviewed medical journals to physicians and hospitals to inform them of new conditions for which drugs already on the market could be used but which the FDA hasn't formally approved.
The FDA said it isn't loosening the rules for industry, but clarifying them. Randall Lutter, the agency's deputy commissioner for policy, said the guidelines mandate full disclosure of any conflict of interest by journal authors in articles used in off-label promotion.
The push for off-label changes came just as the Journal of the American Medical Association suggested in two reports that Merck & Co. played down the potential risk to Alzheimer's patients of heart attack from its now-withdrawn painkiller Vioxx, and said the company had ghostwritten many academic articles favorable to that drug.
Drug-industry worries about new rules and a chilly climate in Washington were reflected at a conference here Thursday. More than 60% of participants polled during the annual conference sponsored by drug-marketing magazine DTC Perspectives said they think Congress may move to place limits on television advertising by pharmaceutical companies. Drug makers spend about $5.4 billion annually on TV ads, according to Nielsen Monitor-Plus.
One idea the drug marketers don't like: A proposal that ads contain a phone number that consumers can call to make complaints to the Food and Drug Administration.
Separately, the promotion of Vytorin, a cholesterol drug marketed jointly by Merck and Schering-Plough Corp., is under scrutiny by congressional investigators who have alleged the companies delayed release of a study that raised doubts about Vytorin's effectiveness. The companies have denied any strategy to withhold information, and said the delay in publishing the study was the result of efforts to resolve problems with certain data.
Drug manufacturers are concerned that marketing strategies could be trimmed after the 2008 elections if Democrats strengthen their control in Congress or take the White House. But there are indications that some politicians won't wait that long.
The chairman of the House Committee on Energy and Commerce, Michigan Democrat John Dingell, plans to announce a hearing on direct-to-consumer advertising, to take place in a few weeks. Mr. Dingell's panel will look at Vioxx, Vytorin and an ad blitz for Pfizer's cholesterol drug Lipitor that used medical inventor Robert Jarvik.
"Drug companies should know that they will be held accountable for inappropriate behavior and inaccurate representations made in their ads," Mr. Dingell said in a statement.
Sen. Chuck Grassley of Iowa, the ranking Republican on the Finance Committee, and Rep. Henry Waxman, a California Democrat who is chairman of the Oversight and Government Reform Committee, are both investigating drug marketing.
--Louise Radnofsky contributed to this article.