Durbin and Waxman Strike Again!November 22, 2011
Their latest move targets supplements while giving drugs and vaccines a free pass. New Action Alert!
Senator Dick Durbin and Congressman Henry Waxman are trying a new tactic in their attack on supplements after previous legislative failures. They have asked the Government Accountability Office (GAO) to review adverse event report data—but only for supplements. The GAO operates at the call of Congress, so some action on this request is inevitable. Here is their letter.
In a statement, Sen. Durbin said, “The FDA has the tools necessary to determine which supplements can cause and have caused severe health problems—they should use them effectively.”
This is nonsense. There is no evidence that legitimate supplements, those that comply with existing law, have caused severe health problems. What the FDA needs to do is not evaluate and approve each supplement, but rather enforce existing law.
Durbin’s idea that the FDA has the expertise to evaluate all supplements is pure fantasy. They aren’t set up for it and would fail even if they were. The agency is biased against supplements to boot, because it wants them to go through the drug approval process and thereby contribute to the agency’s budget. Supplements, not being patented, cannot afford all these costs, as the FDA and Durbin and Waxman know well. The end result of this mindset will simply be to clear the shelves of supplements.
If consumer safety is really Sen. Durbin’s motivation, we have to ask—why aren’t he and Rep. Waxman also asking the GAO to review adverse event report (AER) data for vaccines and drugs, which are far more dangerous and have far more reported adverse events? Just look at the number of adverse events reported for 2008 alone:
- Supplements: 1,080 adverse events, of which 672 were considered serious;
- Vaccines: 26,517 adverse events, of which 3,923 were considered serious; and
- Prescription drugs and “therapeutic biologics”: 526,527 adverse events, of which 275,421 “had serious outcomes.”
Note that the above figures should be used with caution. Although a serious adverse event is defined by statute, other adverse events are not. What may be considered an adverse event for one category may not be for another. If an FDA-approved drug has listed in the product labeling that it can cause fainting or nausea, or chest pains or seizures, then it is considered to be within the range of expected outcomes! In this case, the adverse event should be reported, but the report is not considered “urgent” and may be delayed for up to a year. At the same time, USA Today noted, when it comes to supplements, what the FDA considers an adverse event can be “anything from a concern that a supplement isn’t working to a serious illness that follows consumption.”
Please note also that while the vaccine data we reported above comes from a separate Vaccine Adverse Event Reporting System, the prescription drugs figures may or may not include vaccines, since vaccines are technically therapeutic biologics. The government doesn’t say.
What is clear, however is that there are over 487 times more AERs for FDA-approved prescription drugs than there are for supplements, and 409 times more serious events for drugs than supplements. And Durbin thinks it’s supplements that are endangering the public? The following graph makes the difference obvious:
Ultimately, these latest tactics are meant to move us closer to a pre-approval regulatory system for supplements, which will remove many—or perhaps most—supplements from the market, giving even greater power to the pharmaceutical industry.
We believe that Congress shouldn’t look into supplement AERs unless they actually pay attention to major vaccine and drug AERs. The lack of attention to vaccine AERs is a particular scandal, as we pointed out in an earlier story about the cover-up of HPV vaccine adverse events. As you may recall, the Institute of Medicine says it will only look at peer-reviewed research on vaccine AERs, but won’t sponsor any. They then conclude that vaccines like the dangerous HPV shots are “safe” because there is no “evidence” otherwise. If we lived in a sane world, this kind of Orwellian logic wouldn’t be allowed for a moment.
We are in discussion with several Capitol Hill legislators to get GAO to investigate and review drug and vaccine AERs if they do supplements—and we’re asking you to write your senators and your congressional representative and make the same request. Please take action today!
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