U.S. DISTRICT COURT GIVES FDA A SORELY NEEDED DRUBBING

The story behind the story is that FDA utterly refuses to comply with the Pearson decision and with that case's progeny. A short time after Pearson v. Shalala was decided, I was informed by an FDA employee in the know that the FDA would "never abide by that court decision, never, ever." He meant to dissuade me from future litigation on the notion that it would be costly and futile given the fact that FDA would continue to censor claims, regardless of what the courts ruled.

In other words, that FDA employee put me on notice that an agency of the government that regulates about one-quarter of the economy viewed itself as unconstrained by final and binding constitutional mandates from the United States Court of Appeals for the District of Columbia Circuit. The statement shook me to my core and has been a source of recurrent reflection for me as I have watched that agency defy federal court orders and flout statutory requirements again and again. For me, it confirmed that this agency's refusal to abide by the court orders it disliked was the product of bureaucratic incompetence but was by design. There can be no rule of law, no constitutional limit on the exercise of government power, and no ethics in government service if those who rule powerful federal agencies, like the FDA, so disrespect the authority of the federal courts that they will ignore or circumvent the courts' orders. There can be no meaningful separation of powers if the FDA can with impunity violate and circumvent court orders as if it, not those courts, were the final arbiter of the legality of agency action.

That agency hubris and lawlessness has in fact been operative since Pearson v. Shalala was decided in 1999. Political forces dominant within the FDA, and in particular within its all powerful Center for Drug Evaluation and Research, are committed to protecting the pharmaceutical industry from competition that would otherwise arise if the public understood the disease risk reducing effects of a host of nutrients. FDA routinely censors accurate claims concerning the state of nutrition science in disease risk reduction. The political aim prompting the censorship is to preserve a monopoly on therapeutic claims for the drug industry.

Those who work closely with this agency, as I have over the years, know well that it is a captive of the drug industry. Agency whistleblowers, not least of which is David Graham, the Associate Director of the FDA Office of Drug Safety, have stated repeatedly to Congress that FDA views its mission as approving as many drugs as possible, excoriates and ostracizes agency medical reviewers who contend a drug too unsafe to be marketed, and considers the drug industry not a true regulatee but, rather, the agency's "client."

The drug industry jealously guards its FDA-enforced monopoly over the right to make therapeutic claims and views dietary supplements as annoying sources of potential competition if ever allowed to inform the public of disease risk reducing effects arising from ingestion of certain food elements. By serving as the industry's agent in condemning nutrient health claims, the FDA ensures that consumers turn first to drugs rather than to elements in the food supply when seeking a disease risk reduction or prevention strategy. Maintaining a public mind set that associates drug treatment as the sole source of meaningful health maintenance pays huge dividends when, for example, consumers choose to ingest non-steroidal anti-inflammatory drugs to dull the pain associated with osteoarthritis rather than the dietary supplements glucosamine and chondroitin sulfate to repair that cartilage; choose to ingest anti-clotting drugs as a preventive of heart disease when omega-3 fatty acids appear quite effective and safe for that same purpose; and choose to apply over-the-counter drugs for relief of common sun burn when vitamin E and aloe may be superior to those drugs and far less toxic.

While profitable to the government protected drug industry, maintenance of the false mindset that drugs are the only answer to disease prevention increases risks to human health because synthetic drugs typically beget side effects that elements in the daily diet do not. Thus, it would behoove all of us to adopt a healthy dietary regimen, replete with certain dietary supplements that at above RDI levels beget health and disease risk reduction benefits, than to proceed ignorant of emerging science concerning health effects of the diet and depend instead on crisis intervention with toxic drugs only after diseases that could have been prevented come to the fore. We can do so only if we are well enough informed, but it is the aim of the FDA to keep us in the dark so that its favored regulatee, the drug industry, can enjoy an absolute monopoly on the dissemination of therapeutic information.

I remember too well the horror stemming from FDA's rigid refusal for over 4 years to allow a folic acid-neural tube defect risk reduction claim to reach the market. The CDC and NIH were trumpeting to doctors for over two decades that 400 micrograms of folic acid when consumed daily by women of childbearing age before they became pregnant could cut the risk of spina bifida or anencephaly by as much as 40 percent. Former FDA Commissioner David Kessler, a pediatrician, refused to let that information appear in the market on folic acid containing dietary supplements and foods. The consequence was that women were first hearing of the risk reduction when they approached their obstetricians with a pregnancy, not before when the supplement has to have been ingested to achieve risk reduction. Thus, some 2,500 preventable neural tube defects occurred each year as women unaware of the need to consumer folic acid daily before pregnancy suffered the monstrous realization after the fact that their newborns were so afflicted (many many more chose to abort their NTD-afflicted fetuses). To protect the drug approval process from competition, Dr. Kessler condoned the sacrifice of thousands of children.

Even when political pressure ultimately forced Kessler to back down, he chose to allow the claim only for foods, not for supplements, and yet supplements were the only reliable means to impart folic acid at the 400 microgram or above level, daily. Vegetables and other foods containing folate lose large quantities of that folate during normal shelf life, chopping, cooking, and steaming. That reality did not deter the agency from maintaining its drug supportive bias.

People would surely look at a dietary supplement as a potential disease preventive if the agency allowed supplements containing folic acid to be viewed as neural tube defect risk reducers. So, the agency reluctantly allowed the claim for foods. Only after my firm sued the FDA (and ultimately defeated it), did the agency finally allow the claim to be made for dietary supplements. Since the claim has entered the market there has been a steady reduction in neural tube defect births in America. Women are getting the message and it is proving to be a life saver.

The selenium case just won is another excellent case in point. Judge Huvelle brilliantly saw through the FDA's manipulation of the science, noting contradictions and false representations in the agency's analysis, and she strongly defended the First Amendment against the agency's attempt to negate it. We now await to see if FDA will finally accept constitutional limits on its power or will balk yet again, choosing lawlessness to the rule of law. If history is our guide, FDA will continue to be a brigand.