Is the FDA Corrupt?

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September 24, 1:38 PM

by Tracy Woolrich, RN HHP, Tampa Bay Wellness Examiner

 

 

     First of all…who is the FDA? The FDA is an agency within the United States Department of Health and Human Services that is responsible for protecting and promoting the nation's public health. It is organized into several subdivisions that focus on different areas of regulation. It works in conjunction with the Department of Agriculture, the Drug Enforcement Administration and the Consumer Product Safety Commission. With all of the issues with melamine and lead contamination found imported into the U.S. as well as food contamination you know that they are not always able to protect us. We would like to think that at the VERY least they do a thorough job of evaluating new drugs before they are allowed to be on the market. With continued conflict of interest issues however, I am not sure how good of a job they are doing with that either.

     In August of 2008 the FDA revised its guidance on conflicts of interest and participation in FDA advisory committee meetings. Why? I suspect that there was pressure due to obvious and continued conflict of interest that caused continued “waivers” be administered.  According to the FDA (18 U.S.C. 208(b)(3))

“Where such a conflict exists, the agency may grant a waiver allowing participation in an advisory committee meeting when statutory criteria are met; for example, when the need for the individual's services outweighs the potential for a conflict of interest created by the financial interest involved.”

     This had been put in place in 2000 in the Waiver Criteria 2000 guidance that was an attempt to address comprehensively the multiple variables that can be applied in reaching a determination about an individual advisory committee member. In addition Congress has mandated new rulings that encourages FDA to focus efforts on recruitment of advisory committee members with fewer potential conflicts of interest and caps the numbers of waivers that the agency may grant in a given year.

     Section 712(c)(2)(C) requires that FDA reduce the rate of waivers the agency issues each year by 5 percent, beginning with fiscal year 2008. By 2012, the agency may issue waivers at a maximum rate of 75 percent of the rate issued in 2007.

 www.fda.gov/oc/advisory/GuidancePolicyRegs/ACWaiverCriteriaFINALGuidance080408.pdf

      In MSNBC online today, an article indicates that Eli Lilly will become the first to disclose how much money it paid doctors for consultations and Services. Starting in 2009 they will disclose payments of more than $500 to doctors for their services such as consultants or speakers. In later years (no date set yet) they have agreed to disclose payments such as entertainments, travel and non monetary gifts. This is a step in the right direction however, is it enough? They are only one of numerous pharmaceutical companies that have come forward to address this issue so far and will it really prevent doctors from sitting on panels that have large amounts of stock at risk?

www.msnbc.msn.com/id/26858255/

      Remember the ordeal with Celebrex, Bextra and Vioxx in 2003? What if some of the doctors convened by the FDA had material conflicts of interest that might have swayed their votes? That could have happened. For years some experts with conflicts, such as having received fees for lectures from drug companies or owning stock in them, have been allowed to sit on the panel. This is only to occur when the doctor's expertise is considered irreplaceable to the FDA. However according to Sidney Wolfe, of the watchdog group Public Citizen "The FDA has a pretty high threshold for conflict of interest.” In at least one case, a panelist owning tens of thousands of dollars in one drug firm's stock was allowed to give advice about a competitor. In fact according to Public Citizen during one meeting no disclosures were read at all. Instead, the panel's secretary read a statement explaining why they weren't necessary.

     So I offer the suggestion of buyer beware. Before you swallow that next latest and greatest pill that your doctor just prescribed do your research. Remember it may have been allowed on the market via a flawed FDA panel only to be marketed by a cheerleader or model without any science degree to your doctor. (I will write more about this issue in a future article). Knowledge is empowering. Know what you are taking and why.

Healthy Blessings,

Tracy Lynn

Here is a video that spells out the FDA/Big Pharma connections pretty well.

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