Sen. Paul Offers Amendment to Rein in FDA Abuses

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You can eat whatever you want—if you want to eat raw nightshade berries picked fresh from your garden, you can do so.
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Oh, if this were only true, but sadly it is not. If I find pot on my property, it is against the law for me to smoke it, not that I want to. If I find magic mushrooms it is against the law for me to eat them, again not that I want to or would suggest it a good idea for anyone else do eat them.

The French economist Bastiat told us that economics is about the totality of the effects of an action, both the seen and the unseen. Further, people who love big and bigger government never think that their beloved bureaucracies could ever be banal, incompetent, hard-headed, biased or just plain wrong. They always attribute only selflessness and a clean-hearted desire to carry out the law that is only meant for our common well-being. We give them guns to make sure their decrees are carried out but they would never use them wrongly.

I am tempted to claim that liability issues have been far more effective in improving the safety of food and medical products than any government action. But if the example of Jack in the Box’s contaminated beef is of no interest then you would not care to consider any other references that I might provide to back this claim up. I am not fooled by the facade and mirage of competence of any government agency. I do not waive any of my unalienable rights when it comes to the sovereignty of my own body. And thanks to the net I have just as much access to the latest research as any government bureaucrat does.

In my youth, it was not uncommon to hear the rejoinder, “its a free country”. I no longer hear that any more because it is not a free country. My father in law died to preserve his granddaughter’s freedom. If he could see the Leviathan State today, I am not sure he would volunteer for that duty again.

“The FDA isn’t perfect, but it is still the best mechanism we have for ensuring that the benefits of any drug/device sufficiently outweigh its risks.”

You have immense and misplaced trust in the FDA. There are so many studies and commentaries on how the FDA is riddled with conflicts of interest. The board members of FDA are mostly former employees of pharmaceutical companies.

Look how the drug companies are allowed to leave out studies which show side effects and non-efficacy. FDA approval has become a complete joke.

Look at how many drugs were introduced after approval and later turned out to be deadly under normal use. Then it turns out that the negative information was known before approval.

The FDA needs serious reform. At least Rand Paul understands that.

You have immense and misplaced trust in the FDA. There are so many studies and commentaries on how the FDA is riddled with conflicts of interest. The board members of FDA are mostly former employees of pharmaceutical companies.

FDA board memberships are a matter of public record, and are readily available at the FDA website. On the current FDA Science Board, I only see one person listed as a pharmacologist, and he is actually a university professor. I do not see a single person whose professional qualifications suggest past employment at a pharmaceutical company. The FDA makes public the laws and regulations regarding who may sit on a committee, and there is a specific guidance that addresses conflicts of interest. If people with a financial interest in the outcome of any drug review panel's decision choose to misrepresent themselves so as to gain membership on the panel, they are breaking the law--you can't claim that the FDA condones or supports their actions.

Look how the drug companies are allowed to leave out studies which show side effects and non-efficacy. FDA approval has become a complete joke.

They're not "allowed" to leave out studies. Companies that choose to omit relevant data are, in fact, breaking the law. You can't blame the FDA for criminal acts committed by persons not affiliated with the FDA.

Look at how many drugs were introduced after approval and later turned out to be deadly under normal use. Then it turns out that the negative information was known before approval.

Please provide a list of these drugs, along with the evidence that the FDA was complicit in allowing companies to flout the law so as to gain regulatory approval.

Since stage 3 clinical trials typically enroll from 1,000 - 3,000 patients, it is very likely that a drug that causes lethal complications in 1 out of 10,000 patients won't be caught during clinical trials. That is why there is a post-approval stage 4 trial, and the FDA maintains an adverse event reporting system. The fact that FDA withdraws approval from drugs that later turn out to be too risky in relation to the benefit they provide is an indication that the FDA is doing its job.

Anyone developing a drug with intent to gain regulatory approval is required to register the clinical trials with the FDA. These trials are all publically available at www.clinicaltrials.gov. Likewise, you can examine all the relevant regulations, procedures, etc., etc., at the FDA website. It is, IMHO, a very user friendly site.

The FDA needs serious reform. At least Rand Paul understands that.

The only "reform" I would agree that the FDA needs is actually a reform of the politicians trying to use the FDA to force people to conform to a diet the politicians approve of. Trying to control the amount of salt or saturated fat one consumes is way outside of the FDA's regulatory purview and constitutional mandate, and should remain so.

I've also looked at Rand Paul's proposal, and see a combination of grandstanding and relaxing of current regulations. If you're upset that it is possible for companies to break the law and misrepresent their drug to the FDA to gain approval, it makes no sense that you would want the regulations weakened--logically, you'd want mechanisms for stronger enforcement of the regulations. Rand Paul's "Part I: Health Freedom Act" weakens the regulations with this provision: Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to deem a food to be misbranded only when its label includes a claim adjudicated to be false and/or misleading. That would mean that the FDA would actually be required to go to court to force manufacturers to remove false claims from their product. Under current regulations, the FDA sends a warning letter, giving the manufacturer the option of voluntarily changing their product labeling; only if the manufacturer persists in making false claims will the court route be taken. By requiring that the court route be the first recourse, many manufacturers will be able to get away with false claims, since the court option is time-consuming and costly, limiting the number of false claims the FDA can actually deal with.

A couple of examples of Rand Paul's grandstanding are these, also found in "Part I":

■ Stops the FDA from censoring truthful claims about the curative, mitigative, or preventative effects of dietary supplements.
■ Stops the FDA from prohibiting the distribution of scientific articles and publications regarding the role of nutrients in protecting against disease.

The FDA does not censor truthful claims. A claim that is supported by solid peer-reviewed studies (which are publically databased over at www.PubMed.org) won't be censored. For example, the Quaker Oats company is well within its legal right to claim that consumption of soluble fiber (such as that found in oats) may help heart health, because numerous peer-reviewed studies support that claim. Nor does the FDA prohibit the distribution of scientific articles and publications. These are all publically available through PubMed. There may be copyright issues with distributing scientific literature without the consent of the copyright owner--but that concerns a different governmental agency, not the FDA.

You have immense and misplaced trust in the FDA. There are so many studies and commentaries on how the FDA is riddled with conflicts of interest. The board members of FDA are mostly former employees of pharmaceutical companies.

Funny, isn't it, how many people think that what is commonly known must, therefore, be true?

Some of the FDA's problems may actually result from having folks that don't know enough about what they're attempting to regulate. As far as reform goes, most of the troubles we're having in the United States right now have come as a result of reform movements pushed by progressives and other leftists.

The French economist Bastiat told us that economics is about the totality of the effects of an action, both the seen and the unseen. Further, people who love big and bigger government never think that their beloved bureaucracies could ever be banal, incompetent, hard-headed, biased or just plain wrong. They always attribute only selflessness and a clean-hearted desire to carry out the law that is only meant for our common well-being. We give them guns to make sure their decrees are carried out but they would never use them wrongly.

There is a middle ground between an all-powerful authoritarian government and the libertarian ideal of no government at all. The challenge is to keep government agencies restricted to their constitutional functions while giving them enough power to perform those functions. I don't think many people object to the FDA, USDA, and EPA acting within the scope of their narrowly defined missions. As far as I can tell, the objections arise when liberal politicians appoint socialist ideologues to head these agencies, who then eagerly use the agencies' resources to enforce an authoritarian agenda. Because I support the FDA's mission to ensure a safe food supply and want it to have the teeth to perform its mission does not mean I want FDA goons showing up at restaurants and forcing chefs to stop using salt. Ditto with the EPA--it is simply wrong to use regulatory mechanisms meant to minimize air pollution to try to shut down industries that unavoidably produce CO₂ as a by-product.

I am tempted to claim that liability issues have been far more effective in improving the safety of food and medical products than any government action. But if the example of Jack in the Box’s contaminated beef is of no interest then you would not care to consider any other references that I might provide to back this claim up. I am not fooled by the facade and mirage of competence of any government agency. I do not waive any of my unalienable rights when it comes to the sovereignty of my own body. And thanks to the net I have just as much access to the latest research as any government bureaucrat does.

This is a little bit complicated to answer. The legal profession has a role, in that lawyers enforce the liability laws, but the lawyers themselves don't have the statistical or scientific analytical skills to determine whether, for example, an adverse event following the use of a prescription drug is actually related to the drug use or is coincidental. I also do not see how lawyers could write effective liability laws regarding technical products without a great deal of scientific input.

As far as the example of contaminated beef at Jack in the Box goes, I really didn't see a need to comment. All issues of contamination that cause serious illness are investigated, at least by state officials, and by federal officials if necessary. And how do we know that an issue warrants investigation? Because food-borne illnesses serious enough to cause someone to seek medical attention are reported to state authorities, who then report the illnesses to the CDC. And state and federal scientists then examine the circumstances of the illness to determine if it is an isolated event (which may not warrant an investigation) or part of a pattern (in which case an investigation is initiated). (Yes, state and federal CDCs track just about every medical complaint--patient anonymity is preserved--look up the MMWR, it's where that info is published.)

Yes, you do have the net. Do you know how to assess whether the information you find on the net is valid or not? Can you discern which of these two websites www.rawmilk.org or www.realrawmilkfacts.com is presenting profit-motivated scientific quackery and which one is presenting accurate scientific data? I'm afraid that without some sort of regulation and government oversight, the legitimate info would completely disappear in the sea of quackery. As it is, it's difficult enough for a layperson to find the legitimate info. Oh, and one way to tell if the info is legitimate is through the references--most quacks make a great deal out of one reference that fits their story, but most legitimate info is supported by many references, with almost every sentence footnoted.