Editorial:

Kessler’s Legacy to the FDA

If you haven’t already heard, David Kessler is resigning as Commissioner of the FDA. Sadly, it isn’t because the FDA is now back on track and his job is done. It’s because of scandal. David Kessler was caught with his hand in the cookie jar. It seems Congressional investigations are now pending.

Is Kessler being investigated for illegal expenditure of millions of dollars of FDA resources from the budget of the Commissioner’s Office for a pet project that did not have Congressional approval? No. It seems that David Kessler may have billed the Government for hotel expenses he never made and cab rides for which he had no receipts. When AP reporters closely examined his cab expense claims, they found that he had billed $28 for cab rides from LaGuardia Airport to two nearby New York hotels, a ride which costs no more than $8 according to hotel management (not to mention the “free” airport shuttle service that both hotels provide). It now appears that more than 50 of his trips from his suburban home to the National Airport were overbilled by at least $5 and more likely by $10 apiece. What is the total amount of this “cabgate” scandal? $5,000.

Can we put this in perspective? To be as critical of Kessler as possible, we should point out that former FDA Commissioner Alan Hayes was forced to resign for $59 in misbilled expenses and a double-billed airline ticket. To be as fair to Kessler as we can, Kessler has been devoting half of the entire budget of the Commissioner’s Office to his personal goal of regulating tobacco.

Tobacco?

The interesting thing about tobacco regulation is that Congress had clearly delegated it to a different agency. In other words, the FDA had no authority from Congress to regulate tobacco. David Kessler had no authority, as established by the US Constitution, and delegated to the Executive branch through acts of Congress, to devote any FDA resources to the regulation of tobacco. And since authority had been assigned to another agency, Kessler took it upon himself to subvert Congressional intent in that regard, and use US tax moneys to accomplish his personal goal. One might think that such activities are a bit more “unethical” then billing for a few thousand dollars in undocumented expenses. After all, I’m pretty sure that when David Kessler was sworn in during the Bush administration, he did not qualify his oath to “protect and defend the Constitution” with “except where tobacco is involved.”

Fortunately for Kessler, he was able to convince Donna Shalala (Secretary of Health, Education and Welfare) and Hillary and Bill Clinton that tobacco was sufficiently evil to warrant an Executive Order declaring tobacco to be an addictive drug, and thereby establish FDA jurisdiction by fiat. His crime has now been “pardoned” for all intents and purposes. Maybe this is an example of the better-late-than-never principle in action.

Unfortunately for US citizens, David Kessler’s shining example of how best to undermine the US Constitution is not unique. It is, in fact, business as usual for the FDA. Several examples:

• The FDA has systematically undermined Constitutional protections of free speech by requiring prior approval for what companies can say about any products requiring FDA approval. Prior restraint of truthful “commercial” speech is unconstitutional. Yet the FDA insists that this is a “non-negotiable” issue.
• The FDA regularly violates equal-protection provisions of the Constitution by “retaliating” against companies that have voiced public concerns about FDA activities. The FDA categorically denies that retaliation is a significant problem, even in the face of several egregious examples having been investigated and confirmed by recent Congressional investigations. The opposite activity—favoritism towards certain “friendly” companies—is equally unconstitutional. The FDA denies that they play favorites, but the absence of any objective standards for the drug approval process and the lack of internal controls over what is essentially a string of arbitrary decisions seriously undermines their credibility. Basically, their solution to the problem is to pretend that the problem does not exist.
• The FDA regularly “redefines” legal terms to serve their political ends. They redefined nutrients to be “food additives” when combined with other nutrients or foods, and then prosecuted supplement manufacturers for violating food-additive regulations. They redefined nutrients to be drugs when the nutrients were being used for medical purposes, even when such uses were not on the label. And twice, the FDA tried to redefine all above-RDA nutrients to be drugs. According to Constitutional law, definitions are established by Congressional legislation and clarified by judicial review of legislative intent.

The FDA’s latest Constitutional abuse is directed towards Dr. Stanislaw Burzynski, a researcher and clinician. The FDA’s vendetta against Burzynski dates back decades, but he has continued to “work through channels” to get FDA approval for antineoplastons—natural metabolic byproducts that show anti-cancer activity. Although antineoplastons were novel entities twenty years ago when Burzynski was first working with them, they are now mainstream. There are now several medical journals entirely devoted to their study. Antineoplastons have been so successful that Burzynski is now conducting clinical trials—FDA-supervised Phase 2 clinical trials no less—as required for obtaining FDA approval.

Now we find the FDA raiding Dr. Burzynski’s clinic and prosecuting him in court. It seems they do not like the fact that Dr. Burzynski is treating patients outside of the FDA-sanctioned studies as part of his private practice. Their objection is not that antineoplastons do not work. Far from it. They now openly admit that Dr. Burzynski’s antineoplastons are saving lives. This fact, however, is fundamentally irrelevant to the FDA. Prosecutors are strongly arguing that the Court should prevent the jury from visiting Burzynski’s clinic because it would expose them “to the specter of Dr. Burzynski in the act of saving lives.” The prosecutors stated, “Such a visit will certainly infect the jury’s consideration of the real issues with irrelevant emotional, prejudicial and misleading concerns regarding whether anti-neoplastons work and the unfortunate fate of Dr. Burzynski’s patients.”

If antineoplastons do work, then what is the “real” issue? The FDA does not approve of the fact that Dr. Burzynski is practicing medicine with antineoplastons. In other words, how dare Burzynski treat patients with antineoplastons before the FDA has given him permission to do so?! But what is the FDA to do? There are 200 years of Supreme Court precedent establishing that the individual states have the sole power to regulate the practice of medicine. The FDA regulates only through interstate-commerce provisions of the Constitution (see sidebar), and since interstate commerce is not involved in the practice of medicine, the FDA has no jurisdiction.

What the FDA is doing is redefining the practice of medicine to include any prior traveling of the patient. In other words, since most of Burzynski’s patients traveled from other states to receive treatment, Burzynski’s medical practice is within their interstate-commerce jurisdiction! Supreme Court sensibilities and 200 years of precedent be damned!

The Burzynski case is a perfect example of FDA retaliation in action. By treating patients in private practice against the FDA’s wishes, the FDA now finds it necessary to persecute Burzynski to set an example for every other FDA-associated researcher who might be tempted to use a treatment prior to FDA approval to save their patients’ lives. In this case, FDA retaliation has involved the seizure of private medical records, the disruption of Burzynski’s clinic, the interference in the medical treatment of his patients and a stream of negative national publicity about Burzynski in the major media. Such is the price one must pay for following medical ethics over FDA politics.

The Burzynski case also illustrates the arbitrary nature of the decision-making process regarding drug approval. Without explanation, the FDA decided that lymphoma patients needed to have a 50% reduction in tumor size by the end of 6 months of antineoplaston therapy to continue treatment. Is there a rational or scientific basis for this requirement? Why six months? Is there a toxicity concern with long-term antineoplaston treatment?

Sadly, there is no satisfactory justification for such a requirement. It is now well established that antineoplastons are non-toxic and well tolerated with long-term use. Furthermore, slow-growing cancers (like lymphomas) tend to shrink much more slowly. They often take years to resolve completely. There is no rational basis for a 50% reduction in 6 months—other than to foist ethical dilemmas on Dr. Burzynski. Should he stop treating a patient who has had only a 44% reduction in her tumor after six months of therapy in accordance with FDA requirements and risk her untimely demise? Personally, I strongly object to my taxes being used to endanger people’s lives. If the FDA were treated the same as every other citizen of the US, they’d be up on charges of reckless endangerment and, eventually, manslaughter.

The most basic right that the FDA violates tens of thousands of times a day is the right to self determination. As Thomas Jefferson so aptly wrote in the Declaration of Independence: government’s only just purpose is to preserve the inalienable rights of its citizens, among which are life, liberty and the pursuit of happiness. But since the Constitution does not specifically state that life means health, or that liberty involves the ability to choose one’s foods, nutrients and therapies, or that happiness means what makes us happy (without harming others), the FDA will continue to trample the rights of US citizens in its never-ending search for more power and influence. That’s the bad news.

An Opportunity for Reform

The good news is that David Kessler has resigned and that a new Commissioner must be appointed by the Clintons and approved by the Senate. This provides an opportunity for citizens to voice their concerns and specify what kind of leadership the FDA really needs. We certainly do not need another dictatorial authoritarian with a thin skin, no patience for filling out expense reports, and a lack of respect for due process of law as established by the Constitution, Congress, and the courts.

After Congress reconvenes in March, you can call your Senators and Representative through the US Capitol switchboard: 800-972-3524 and 800-962-3524 (if you do not know their names, give your location and zip code, they’ll tell you). Or write to: {Senator’s name}, US Senate, Washington, DC 20510 or {Representative’s name}, US House of Representatives, Washington, DC 20515. {William Jefferson Clinton or Hillary Rodham Clinton}, The White House, Washington, DC 20500 [phone: 202-456-1111 or 456-1414 and fax: 202-456-2461]. Generally, Representatives are the most accessible and responsive to the public—especially in their local district offices (when they’re not in Washington).

And while you’re feeling generous this holiday season, please feel free to donate to the Burzynski Legal Defense Fund, P.O. Box 1770, Pacific Palisades, CA 90272.