by Ethan A. Huff

staff writer
August 18, 2011

from NaturalNews Website

At a time when drug industry corruption is reaching a pinnacle of public exposure, the US Food and Drug Administration (FDA) is actually proposing eliminating one of the few pseudo-effective measures in place that restricts the agency from becoming a full-blown Big Pharma "rubber stamp" consultant.

In a recent announcement, FDA Commissioner Margaret Hamburg stated that the agency may next year loosen certain conflict of interest restrictions that prevent scientists with financial ties to the drug industry from becoming members of FDA advisory panels.

There are 45 different FDA advisory committees that, according to the FDA's own website, are supposed to obtain,

"independent expert advice on scientific, technical, and policy matters."

In other words, these panels are purportedly to be composed of objective, unbiased individuals that do not have financial or other ties to the very companies about which they are advising.

Makes sense, right?

Well, in the eyes of Commissioner Hamburg, these common sense restrictions, which at least give the illusion that the FDA conducts honest regulatory work on behalf of the people, are unreasonable and must be eliminated.

Hamburg apparently believes that drug industry-funded "scientists" are vital to the FDA's work, having stated publicly that allowing Big Pharma shills to serve on advisory committees is essential if the agency is to get the information it needs to make decisions.

"We have to be sure that FDA has subject-matter experts that we need for our important decision making," stated Hamburg.

But expecting to receive "independent expert advice" from industry-sponsored consultants posing as scientists rather than actual independent scientists, however, is the epitome of inane - and this is precisely what Hamburg is suggesting as a correct form of FDA policy.
 

Does the FDA have the power to change its own regulatory restrictions?

Aside from Hamburg's senseless and illogical opinions about how best to obtain crucial decision-making information, the other glaring elephant in the room is the fact that the FDA can apparently change its own regulatory restrictions at will.

What is the point of an agency having conflict of interest restrictions placed on it when that very same agency can simply change them when they are no longer convenient?

Last time we checked, Congress was still in charge of creating and passing laws, not the FDA. But Commissioner Hamburg seems quite sure of herself, presumably because of expressed congressional support, that the FDA's conflict of interest laws will soon be history.

And it appears, based on the FDA's released draft guidance, that the FDA is actually the one in charge of amending its own policies.

The FDA claims that it needs to loosen or eliminate the conflict of interest policies from its advisory committee procedures because it is unable to find enough members to serve on its committees. According to a recent Bloomberg report, only 77 percent of FDA advisory committee positions were filled as of March 2011, which leaves 138 vacant positions out of 608 total.

But if the FDA is having a hard time filling these positions, perhaps it would do best to begin looking for eligible candidates in other places.

And Robert Weissman, president of the non-profit consumer advocacy group Public Citizen, agrees, having stated that the rules should not change because the FDA is unable, or unwilling, to find independent scientists to fill its ranks.

"We need strong protection rather than less," state Weissman, following Hamburg's statements to his group about needed to relax or change the law.

A study published back in March by researchers from the University of Pennsylvania's School of Medicine discredits the FDA's claim, having found that about 44 percent of cardiologists have no ties to the drug industry.

Eric Campbell, an associate professor of medicine at Harvard University and one of the study's authors, stated that the study,

"flat out dismisses this idea that there are no experts who don't have relationships," a claim being made by the FDA in support of its proposed new guidelines.

"There are lots of people out there who are smart and who don't have conflicts of interest," said Sid Wolfe, also with Public Citizen. "It just takes much more work for the FDA to find them. But the result is you have much less tainting of the panel discussion."

Tell the FDA to do its job, not tailor laws to suit the agenda of special interests

According to the FDA's draft guidance, the agency published a final rule on February 2, 1998, requiring clinical investigators who submit marketing applications for drugs or medical devices to also disclose whether or not they have financial ties to the companies who make the products they reviewed.

Current guidelines also limit who can serve on advisory committee positions.

Both of these policies can work, at least as long as the FDA is willing to put in the work necessary to find qualified individuals who are not on the payrolls of drug and medical device companies.

But the agency is demonstrating a pure unwillingness to do this, and instead is planning to cave to the drug industry and to certain lawmakers who are pushing to have the law amended instead.

Though the official comment period for the FDA's proposed new guidance for financial disclosure by clinical investigators ended on July 25, it is still crucial to contact the FDA and tell it to stop catering to special interests, and to leave be the conflict of interest policies that help preserve what little integrity remains in the agency's advisory committee process.

You can contact the FDA to oppose the new draft guidance by writing to:

Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 10-61
Rockville, MD 20857

Or calling: (888) 463-6332

Be sure to reference Docket No. FDA-1999-D-0792

To contact FDA Commissioner Margaret Hamburg directly, you can call her: (301) 796-5000

Or email her:

Office: Margaret.Hamburg@fda.hhs.gov
Personal: margaretahamburg@aol.com

You can also contact your representatives by visiting: http://www.congress.org
 

Sources

• http://www.federalregister.gov/articles/2011/05/24/2011-12623/draft-guidance-for-clinical-investigators-industry-and-fda-staff-financial-disclosure-by-clinical

• http://www.bloomberg.com/news/2011-07-25/conflict-of-interest-rules-may-be-relaxed-in-2012-hamburg-says.html