Classical Values :: When regulators are in bed with those they regulate, woe to the unregulated!

February 25, 2010

When regulators are in bed with those they regulate, woe to the unregulated!

Quite foolishly in my view, Senator John McCain has introduced new legislation that would give broad new powers to the FDA to regulate the vitamin and dietary supplement industry -- right on down to your corner store.

Steven Joyal looks into why McCain would do such a thing, and concludes it's because of baseball:

Most people take nutritional supplements to assure themselves that they are getting their recommended daily amount of vitamins and minerals to help prevent illness and disease. They have a right to purchase those products that they believe will keep them healthy.

During American Heart Month, there is good reason to believe that right is likely to be taken away by the McCain-Dorgan bill that is being considered by the Senate. For years, Sen. John McCain (R-Ariz.) was a staunch opponent of the giant pharmaceutical companies' that wielded their financial power and bought influence on Capitol Hill. In turn, those corporations attacked him directly for opposing their tactics of buying votes in the Senate and House. Why has this great American hero suddenly yielded to the drug makers and co-sponsored legislation that puts the FDA's thumbscrews to the nutritional supplement industry? The answer: Baseball.

Apparently, because some baseball players were caught taking steroids (already illegal unless prescribed by a physician), McCain (and Dorgan, the Democratic lame duck cosponsor) think the FDA should be give draconian (and unconstitutional, IMO) new powers which would broaden the scope of regulation of the already regulated dietary supplements industry. Their bill -- The Dietary Supplement Safety Act (DSSA), S. 3002 -- would subject ordinary retailers to the extraordinary complexities of FDA licensing and regulation.

"It is big government that has a proven track record of not protecting the public. And it is big government that is seeking to take away yet another individual freedom, the right to choose one's own treatment," said JBS.org, a group dedicated to protecting freedom and the free market.

"An onerous burden would be placed on the shoulders of suppliers and retailers of dietary supplements, as they would have to "obtain written evidence" from the seller that the product is registered as required by law, and keep that documentation on file. Monetary penalties for non-compliance "may, in addition to other penalties imposed in this section, be fined not more than twice the gross profits or other proceeds derived from the manufacture, packaging, holding, distribution, labeling, or license of such dietary supplement," they added.

"The McCain bill would change existing mandatory serious adverse reporting regulations, requiring minor adverse effects to be reported as well so that the FDA could arbitrarily pull supplements off the shelves or reclassify them as drugs. This immediate recall authority would be granted to the "Secretary upon determination," that there is a "reasonable probability" that the product is "adulterated" or "misbranded.""

Relying on the FDA to regulate and control more of our free market, fraught with all kinds of safety concerns themselves, is an outrageous infringement on the freedom of consumer choice.

It certainly is, and it appears that the motivation is not protecting the public, but making money. Back to Steven Joyal:

Pharmaceutical companies are pushing for the adoption of the McCain-Dorgan bill so they can get their share of the dietary supplement pie. Consider the hundreds of millions of dollars that would go to the company that gets FDA approval to be the exclusive marketer of omega-3 fatty acids like EPA and DHA found in purified fish oil, an important cardiovascular supplement that many cardiologists prescribe to their patients a steep pharmaceutical profit. Clearly, the senators have been duped by the pharmaceutical lobbyists to think that the FDA is powerless. Instead, the FDA serves as the enforcement arm of the pharmaceutical industry.

That's a clear conflict of interest, yet nothing is done about it. Pharmaceutical executives and drug company researchers make lucrative career moves back and forth from the FDA to the private sector, gaining power and influence and ever higher salaries with each move. They are in bed with each other, and this bill is their attempt to squash small businesses and the consumers who depend on them. (Some of the latter might want to opt out of the allopathic medical system entirely. It might sound kooky, but isn't that their right as free citizens?)

What is encouraging is that this bill is being opposed by a broad spectrum of the public, from right to left. I guess when it comes down to the simple right to keep and bear vitamins, a lot of people can agree. (I said "right" because it is one of those rights which the founders reserved to the states and the people.)

Politically, I am very disappointed in McCain. I never thought he was perfect, and I hated McCain-Feingold, but this just adds insult to injury. Why is he doing this when facing a serious challenge by J.D. Hayworth? Were I Hayworth, I'd be all over this.

Moreover, from a purely personal standpoint, I am also very worried that this bill could wipe out the Chinese herbal medicine market completely. That pisses me off big time, because the last time I had a sinus infection, I cleared it right up with Pe Min Kan Wan.

And I stopped a cold dead in its tracks with Yin Chiao, which is sold here, and which Chinese have relied on for centuries. I'm not sure the Western pharmaceutical industry would ever bring it to market as "Honeysuckle and Forsythia Clean Toxin Pill," though. They'd probably do what they did with Red Yeast Rice -- synthesize the active ingredient, rename it, and then make the original natural source ingredient illegal.

In the late 1970's researchers in Japan were isolating lovastatin from Aspergillus and monacolins from Monascus, the latter being the same yeast used to make red yeast rice. Chemical analysis soon showed that lovastatin and monacolin K were identical. An article "The origin of statins" summarizes how the two isolations, documentations and patent applications were just months apart.[2] Lovastatin became the patented, prescription, drug Mevacor for Merck & Co. Red yeast rice went on to become a contentious, non-prescription, dietary supplement in the United States and other countries.

I couldn't make this up if I tried. Anyway, the FDA basically now acts as corporate police, and bans the sale of the naturally occurring substance which has been marketed as a Western "breakthrough":

In 1998, the US Food and Drug Administration (FDA) placed a ban on the sale of dietary supplements derived from red yeast rice, which naturally contains lovastatin, arguing that products containing prescription agents require drug approval.

So I would expect the FDA to use their new powers in much the same way. If it turns out that a dietary or herbal supplement works and the active ingredient can be isolated and synthesized, license it, and then ban it in its natural form! I think such behavior is corrupt and scandalous

While I think the whole scheme is an unconstitutional outrage to begin with, they certainly have enough power already without giving them more.

They can have my Yin Chiao and my Pe Min Kan Wan when they pry it from my cold, dead hands.

MORE: Post title changed to reflect embeddedness.

UPDATE: Per Donna Barber's request, here's a link to the bill.

posted by Eric on 02.25.10 at 05:04 PM

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Comments

A link to the bill? (Nevermind, I'll look it up for myself!)

As one who constantly battles my elderly and not so elderly relatives and their inclination to ditch prescription drugs for their "witch doctor's" homeopathic remedies, I'm not sure this bill is not a good thing.

As far as money-making goes, Big Supplement is at the very least an adequate match for Big Pharma.

Donna B. · February 25, 2010 08:17 PM

Donna B.,

Congress could just outlaw stupidity and have done with it. Think of the possibilities.

M. Simon · February 26, 2010 03:27 AM

The first possibility that comes to mind is that would have just outlawed themselves :-)

Donna B. · February 26, 2010 04:02 AM

You're drinking the cool aid of conspiracy theories. Never complain about liberals parroting their instructions from their corporate masters, now that you've been tricked into doing the same thing. Dietary supplements are currently not regulated. The seller must make a determination that it is safe, and notify FDA that they've entered into interstate commerce. The government does not make sure the supplement is safe, or even what is in it.

When people die, hospitals report it, CDC notices, and eventually contacts FDA. The proposed regulation is body-count driven. FDA has been fighting the good fight against Chinese and African dietary supplements that a) don't have the ingredients they claim to have, b) what they have has no history of human consumption and c) is toxic. How many plants on this planet are safe for consumption? Relatively, how much money can be made if you just harvest whatever is already growing and pack it into tablets and supplement bars? Buy a bar at the local store, end up in the hospital pissing blood along with 50 other people - yes Virginia, that falls under the legitimate scope of regulation.

FDA stops a dietary supplement importer from selling poison, and informs consumers in the hospital that they have an easy lawsuit, of course the importer is going to exercise their First Amendment rights enthusiastically.

Then, reporters and bloggers with prejudices every bit as close-minded as the left, breathlessly complain.

dustydog · February 26, 2010 07:30 AM

Is that herbal decongestant of yours really herbal? I googled around a bit, and found a report that Pe Min Kan Wan, from more than one supplier, had been found to be "contaminated" with phenylpropanolamine hydrochloride, chlorpheniramine, and acetaminophen.
Funny how an herbal congestion remedy would just happen to be contaminated with, er, Contac.

Eric Wilner · February 26, 2010 11:26 AM

Eric, I first took Pe Min Kan Wan in the 1980s when the doctors wanted to operate on my chronically infected sinuses and I went to an acupuncturist for a second opinion. In addition to the needles, he gave me Pe Min Kan Wan, and within six weeks, my sinus long-running infection cleared up. It still can flare up occasionally after a cold has run through me, but the Pe Min Kan Wan always works. I don't think it's from the alleged contamination with "phenylpropanolamine hydrochloride, chlorpheniramine, and acetaminophen," because I have taken the latter drugs for many years, and they do not clear up infected sinuses. And what is meant by the term "contamination" anyway? Minute traces as a result of sloppy manufacturing techniques? That would hardly cause clinically significant amounts of the drugs.

DD, you accuse me subscribing to liberal conspiracy theories, yet you do not explain where or why you think I am wrong. If you think I am wrong about statins, please explain. (Red Yeast Rice has been used for centuries, yet the FDA claims they have the right to ban it.) Furthermore, you ignore one of my central premises, which is that the government has no constitutional right to tell me what I can and cannot put in my body. That is an outrage, and not a conspiracy theory.

Eric Scheie · February 26, 2010 01:56 PM

Also, Eric, I checked into the contamination issue, and from what I can see, it relates to a 1999 warning from the FDA about the Pe Min Kan Wan manufactured by United Pharmaceutical:

http://www.rxlist.com/script/main/art.asp?articlekey=79491

http://www.drshen.com/chinesepatentwarnings.htm

Frankly, I am glad that this was spotted, but it really shouldn't reflect on the medicine itself. There are many companies that make Pe Min Kan Wan, and many are certified to the GMP standard. People who are concerned should consult knowledgeable practitioners of traditional Chinese medicine. The brand in the picture was chosen arbitrarily out of a Google search, and it is not the one I bought (nor is it made by United Pharmaceutical), although I suspect most of them are the same. This is a bit like generic drugs in this country (many of which are now made in China....); the fact that there are occasional contamination problems does not render the drugs themselves suspect.

Uncontaminated Pe Min Kan Wan contains the following herbs:

Xanthium Fruit, Centiped Herb, White Peony Root, Licorice Root, Wild Chrysanthemum Flower, Eclipta Herb, Fang-Reng Root, Tribulus Fruit, Fragrant Angelica Root, Arisaema Rhizome and Rhubarb Root and Rhizome, Mentha, Patchouly

Eric Scheie · February 26, 2010 02:36 PM

What is the point? Most people I know say "the average American is too stupid and trusting to make decisions regarding their health/mortgage/whatever i feel like regulating right now" and thinks we need this bill, they don't care that pharmaceutical companies and pro sports pay bribes to Congress to pass these, it's ok because putting herbs in your body is not an "important" right. (Hell they don't think free speech is important apparently).

I think of the crappy food pyramid the government gives us, and read in "Eat, Drink, and Be Healthy" how doctors were against it for being "too simplistic" but the government authorities though people "would get confused" by telling them about good fats and bad fats. So instead they tell people avoid fat, and now we have high omega-6 diets, trans fats, and monstrous increases in diabetes, heart disease and obesity. If the government just shut up and never gave out bad info thinking we were too stupid, the average person might have been better off, even if they didn't understand why they ate what they ate.

This protecting people from themselves is the paving on our road to hell. None of these Statists gives a damn, they think it's all peachy and I'm somehow evil.

I am officially giving up, if I had survival skills I could at least move to the mountains. I can't even do that.

plutosdad · February 26, 2010 03:27 PM

dustydog

Those abuses you mention are already illegal. Why do you think we need yet another law to stop it?

plutosdad · February 26, 2010 03:28 PM