Healthy Skepticism Library item: 4523
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
One-third of drug safety advisers in U.S. show conflicts of interest: study
CBC News Online 2006 Apr 25
http://www.cbc.ca/story/science/national/2006/04/25/fda060425.html
Notes:
Ralph Faggotter’s Comments:
In recent times we have seen conflicts of interest amongst the authors of the important DSM reference handbook (psychiatric manual), conflicts of interest amongst the owners of medical journals ( CMAJ), dubious practices by some medical journals and researchers, misrepresentation of research results by drug companies, misleading drug advertising, compromised prescribers, and now conflicts of interests amongst FDA advisory panel members!
So who can you trust?
Full text:
One-third of drug safety advisers in U.S. show conflicts of interest: study
Last Updated Tue, 25 Apr 2006 16:31:23 EDT
CBC News
Industry ties are common among advisers to the U.S. Food and Drug Administration’s panels, but their votes wouldn’t change the overall decision to approve or reject a new drug, a new study suggests.
A consumer group, Public Citizen’s Health Research Group, reviewed the financial ties of 221 panellists at regulatory meetings from 2001 until 2004.
The FDA turns to outside experts for advising on approving new drugs.
Of the nearly 3,000 panellists appointed based on their drug expertise, 28 per cent disclosed a financial relationship with the company making the drug under review or a competitor, the consumer group reports in Wednesday’s issue of the Journal of the American Medical Association.
The FDA is not required to follow the recommendations made by outside experts on approving a new drug, although it usually does.
The review of common conflicts of interest found:
* 19 per cent of consulting involved over $10,000. * 23 per cent of contracts or grants exceeded $100,000. * 30 per cent of investments were over $25,000.For all three types of involvement, excluding those with conflicts would have reduced the margin by which a drug was approved at the majority of meetings, but the majority opinion would remain the same, the team concluded.
“Ideally, all panels of scientific experts advising a federal decision making body would be free of financial conflicts of interest with the affected companies,” the authors wrote.
“Certainly, advisory committee members who have conflicts of interest with higher dollar values should not be allowed to participate.”
For those with smaller conflicts of interest, the study’s authors recommend full disclosure several days before the meeting.
The FDA weighs potential conflicts of interest of panellists against their expertise, a spokeswoman said.
“The FDA is committed to a strict code of ethics and transparent process,” Susan Bro said in a statement.
Reviewing drugs on the market
The analysis did not include panel meetings in February 2005 on the safety of COX-2 inhibitors such as Vioxx, which has been linked to heart problems. It was recalled by its manufacturer in 2004.
On Tuesday, congressional investigators recommended the FDA gain the power to review the safety of prescription drugs that are already on the market.
“[The] FDA lacks clear and effective processes for making decisions about and providing management oversight of, post-market safety issues,” said the report by the Government Accountability Office.
