Conflicts of interest: How Big Pharma influences the FDA's drug

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http://www.newstarget.com/015741.html

 

 

NewsTarget.com

 

 

Originally published December 13 2005

 

Conflicts of interest: How Big Pharma influences the FDA's drug

approval process at the expense of public safety

 

In a recent eight-to-one vote, an FDA panel recently recommended

approval of the diabetes drug Pargluva, despite concerns that it could

cause potentially serious heart problems. Astoundingly, the decision

was made without the help of a cardiologist, since the panel's lone

heart expert declined to participate due to a potential conflict of

interest.

 

The vote marked the second time in a one-week period that questions

arose over conflicts of interest at the FDA. Prior to the advisory

panel's recommendation on the Bristol-Meyers Squibb drug Pargluva, a

separate panel, with some of the same members as the Pargluva panel,

voted to approve Exubera, an inhaled form of insulin made by Pfizer in

partnership with Sanofi-Aventis and Nektar Therapeutics.

 

Following the Exubera recommendation, an analysis by the Center for

Science in the Public Interest showed three of the panel's nine voting

members had previously consulted with or spoken for Pfizer or Nektar

Therapeutics, and the panel chairman – although he voted against

approval of the drug – held stock in Pfizer. Some of these same

members participated in the panel that approved Pargluva, and despite

their vested interests in the drug industry, one of the panel members

was given a waiver that allowed him to vote on Pargluva. Two other

panel members were granted waivers to vote on both Exubera and

Pargluva, according to the CSPI analysis.

 

In addition to those who received waivers, another member of the

Pargluva advisory panel declined to participate because of a potential

conflict of interest. Dr. Jorge Plutzky, the Pargluva advisory panel's

sole cardiologist, opted out of the approval process because he had

conducted extensive research on PPAR-agonists, the type of drug

subject to approval.

 

However, while Dr. Plutzky may have removed himself to avoid problems

with conflict of interest, the fact that a conflict of interest

existed in the first place posed problems, since his absence meant the

panel lacked the expertise of a heart doctor. This is particularly

troubling since the main argument against Pargluva is that it might

double the risk of cardiovascular disease in diabetics.

 

An Oct. 20 article in the Journal of the American Medical Association,

by Drs. Steven E. Nissen, Kathy Wolski and Eric J. Topol, points to

the significant cardiovascular risks posed by Pargluva. After

reviewing the same briefing documents presented to the advisory panel,

the article's authors concluded that the drug more than doubled the

risk of potentially fatal heart attacks (2.11 percent of diabetic

patients taking Pargluva experienced cardiovascular problems like

congestive heart failure, stroke, heart attack and death, compared to

0.81 percent of patients taking a placebo). The nature of these risks

makes the absence of a cardiologist in the drug's approval process a

significant concern.

 

In the wake of these and other FDA decisions that have brought

conflicts of interest to light, the fiscal year 2006 Agriculture/FDA

appropriations bill will allow for advanced public notice when a

scientist with a conflict of interest is to serve on an advisory

panel. According to an Oct. 27 CSPI press release, the bill will

require the public be given 15 days notice when the FDA wants to put

an individual with a potential conflict of interest on one of its 30

advisory panels. Waivers granted to scientists, along with their

potential conflicts, must be published for public viewing. Up to now,

these items have been kept secret from the public for years.

 

Although the CPSI hails the provisions of this new bill as a " step in

the right direction, " it also recognizes that it is not enough. While

public disclosure gives the public the power to evaluate FDA activity

more carefully, many argue that what the FDA needs is a group of

scientists free from all conflicts of interest.

 

The CSPI continues to push for this, saying in the press release,

" CSPI believes the FDA can find qualified scientists without conflicts

of interest to serve on all of its advisory panels. That's why the

waivers should be disallowed entirely. At the least, the present

disclosure bill could have been made stronger by forbidding scientists

with waived conflicts of interest from voting at the conclusion of a

committee's deliberations. "

 

After the Vioxx scandal left so many individuals questioning the

legitimacy of the FDA's drug approval procedure, it is clear that the

FDA has a long way to go in smoothing out this process. When advisory

panels are tainted with conflicts of interests, it becomes difficult

to trust the decisions these panels make, and this has major

implications for public health. The bottom line is, there should be a

divide between the individuals approving drugs and the companies

making those drugs. Individuals with financial ties to the drug

industry should not be approving drugs for public use. It should be

important to all of us that the FDA find honest, independent

scientists and researchers who work for the public, not the

pharmaceutical industry.