The Attack Dog: The Role of The FDA Racketeering in Medicine - The Suppression of Alternatives by James P. Carter, M.D., Dr. P.H. "The thing that bugs me is that the people think the FDA is protecting them. It isn't. What the FDA is doing and what the public thinks it's doing are as different as night and day".- Dr. Herbert Ley, FormerFDA Commissioner, 1970 The FDA was created at the beginning of the century by government, with input from the AMA, to govern the safety of foods, drugs and cosmetics. It had no legal power to test drugs for safety, however. The following account of the history of the FDA's role has been taken from a talk entitled "The Rise of the Cult of Pseudoscience," given by Dr. Charles Harris, a pathologist, to the American College of Advancement in Medicine a few years ago. In 1927, the FDA became a separate agency required to test drugs for safety. In 1959, Senator Estes Kefauver (D-Tenn.) launched an investigation into the pharmaceutical industry which had already been accused of gouging the public. In the midst of the investigation, the thalidomide tragedy occurred. Some historians say this tragedy was significant in that it slowed the development of new drugs, because of the additional bureaucracy which resulted. (Actually, thalidomide remains a useful drug in the treatment of leprosy; it also stimulates the immune system. Instead of teaching doctors how to use thalidomide properly, as it did in the case of the new acne drug Acutane, the FDA prohibited the use of thalidomide altogether.) Also during this time, unethical medical research was uncovered in New York City. Cancer cells were being inoculated into nursing home patients to determine what would happen to them, unbeknownst to the patients or their relatives. These events caused opposition to human experimentation, which became severely regulated. A stronger FDA emerged, which was required to guarantee not only safety, but effectiveness as well. This meant that human subjects had to be involved in order to accomplish this. Otherwise, proof of efficacy would be impossible. The pharmaceutical companies then began to offer medicines and monies to the universities to conduct the necessary clinical trials to show efficacy. The academics began to worship at the altar of clinical trials. The result, tragically, was that the double-blind crossover study became the "double-cross blindover study". . .the real cult of Pseudo-science was born. The new rules and regulations pushed by the FDA resulted in these disadvantages: Slower development and delivery of new drugs An intimidated pharmaceutical industry (until they began to win friends and influence people) Medical services that had been offered voluntarily in connection with clinical trials now made mandatory, either executed or enforced by the FDA Refusal to look at alternatives Sluggish response times; lost new drug applications; bribery; indifference; promotion of generics leading to a generic drug scandal, and a total lack of flexibility THE AMA CAUGHT RED-HANDED COLLUDING WITH THE FDA The government-sponsored chelation studies (covered in an earlier chapter) at Walter Reed and Madigan Army Hospitals did not originate from any burning desire for scientific inquiry on the part of the FDA, academia or pharmaceutical corporations. What, then, motivated them to help design and approve a controlled study to evaluate the safety, effectiveness, and dose-response curve of EDTA in the treatment of peripheral vascular disease? The answer lies in the comments of Stuart Nightingale, Asst. Commissioner for Health Affairs of the FDA, when he went on record at a meeting of the House of Delegates of the AMA in Honolulu, Hawaii, seven or eight years ago, telling AMA delegates, "We can't put these chelation doctors out of business by ourselves. We have to work closely with you, the AMA, and other groups, to put them out of business." It happened that a leading chelation doctor, Garry Gordon, was in the audience intending to plead the case for using chelation in the treatment of arteriosclerosis and its complications. Dr. Gordon hoped to convince the AMA to at least allow time for independent scientific inquiry and to not ban the therapy outright. Dr. Gordon recorded Dr. Nightingale's remarks and later shared them with Attorney Greg Seeley, legal counsel for the chelation doctors' professional organization, AAMP, now called ACAM. Mr. Seeley observed that the FDA should not be in the business of putting doctors out of business for using an approved drug for an unapproved purpose, which is common medical practice. The attorney drafted a letter to the FDA protesting Dr. Nightingale's remarks. He also requested an explanation as to why chelation doctors should be "put out of business" for treating heart disease when chelation is already sanctioned as a medical procedure to remove heavy metal, usually lead poisoning. Attorney Seeley had the AMA over a legal barrel. The FDA reply did not mention the obvious illegality of Nightingale's remarks, but suggested that a delegation from AAMP meet with FDA officials to discuss controlled clinical studies. A working relationship was established between Dr. Ross Gordon, brother of Dr. Garry Gordon, and Dr. Lawrence Lepickey, chief of the cardio-renal division of the FDA. Working together with his designates, Dr. Ross Gordon developed the research protocol now being used to evaluate the efficacy of EDTA in the treatment of peripheral vascular disease and to determine a dose-response curve. The reader will recall the statement by Organized Med's mouthpiece, Victor Herbert, in his Ontario address, "that the most effective method" of getting rid of a therapy like chelation therapy is by taking the practitioner to court and that the second way to fight the problem is "by lobbying for anti-quack legislation." He added, "In New York State we are putting them out of business." This legal strategy has gotten out of hand. The definition of a quack is too vague and generalized for the courts to be involved in resolving questions and conflict in science. The legal system should be used only to stop someone who is causing harm to the public. The debate over the safety and effectiveness of chelation therapy (after nearly 500,000 people have been treated) and the debate over the safety or toxicity of evening primrose oil (after some eighteen countries have generally recognized it as safe, safe enough in fact to be added to infant formula in Japan) should not be argued in court. The Walter Reed Army study will be much larger in scope than the study that was conducted in Heidelberg, West Germany, by Dr. Gerhard Schettler and the study conducted by Dr. Anthony Gotto and his associates at Baylor University and Methodist Hospital in Houston, Texas, neither of which has ever been published. The Danish study published in August, 1991, as we have seen, is patently flawed in that there was obvious manipulation of the sample study. Dr. Efrain Olszewer and I published our study in the April, 1990, issue of the Journal of the National Medical Association. Dr. Lepickey has also remarked that Dr. Gotto should not have conducted his independent study without clearing it with him and others in the Cardiorenal Division of the FDA. This is strange. Isn't respected, competent Dr. Gotto, researcher and administrator, capable of doing his own research? When all of the studies have been completed, most likely a meta- analysis will be performed. This type of analysis determines mathematically what the weight or preponderance of the evidence shows, an unnecessary hassle to determine what should have been obvious at first glance. The investigations and expenditures are unavoidable in a scientific and legal sense, however, as long as "liars can figure" and as long as people like Victor Herbert can be paid by Organized Med to haul practitioners into court on accusations of fraud, pretending to argue valid science before naive and scientifically-illiterate panels and judges. THE GENERIC DRUG SCANDAL - THE TIP OF THE ICEBERG The American Academy of Family Physicians warned in 1989 that generic drugs may at times be inferior, even dangerous, especially for persons with asthma, diabetes, or heart disease. Nevertheless, generic drugs are now an annual $3 billion dollar industry. The FDA branch chief for generic drugs, Mr. Gerald Chang, accepted thousands of dollars in illegal pay-offs from generic drug companies, whose applications he approved. He facilitated those who paid him off and inhibited the others. Mylan Labs Pharmaceuticals became suspicious because its drugs were not getting approved. The CEO for Mylan, Mr. Roy McNight, hired a private detective who conducted a one-year surveillance, which included going through Chang's garbage, to find evidence of this government scandal. They found plenty! Companies had submitted fake data and cheated, and there were pay-offs. The generic company Vitarin sent in bogus data and submitted the original drug for testing, claiming it was their generic version. The FDA system of approving generic drugs was subverted by the very industry it was supposed to regulate. This scandal certainly raises questions about the safety and effectiveness of generic drugs and how they are regulated. A generic drug is usually a discount-version of the name-brand drug. The generic supposedly uses the same active ingredient as the name-brand. However, some companies substituted brand-name drugs for their own generic brands, just to get FDA approval; then they proceeded to manufacture poor quality and/or ineffective generic substitutes. One-third of all drugs sold in the U.S. today are generic. The generics industry claims to offer the same quality as brand-name drugs, at substantially lower prices. Certainly there are ethical generic companies now under serious question, but the challenge lies in determining who cheats and who doesn't. Congressman John Dingle's sub-committee conducted the investigation and broke the story. In June, 1990, Marvin Seife, the former head of the FDA's generic drug division, was the fifth FDA official to be indicted by a federal grand jury on charges of perjury. This indictment resulted from a two-year investigation of improprieties between FDA officials and generic companies. Four of Seife's former employees at FDA have already been convicted on corruption and racketeering charges. Five industry executives, three companies and one consultant have been convicted of similar charges. Some thirty generics were asked to re-submit abbreviated New Drug Applications. Other evidence uncovered refusal of the FDA to hear complaints coming in from generic companies who were playing it straight and not getting their drugs approved. The Division of Generic Drugs, in this instance, was guilty of criminal misbehavior. Congressman Dingle stated he could not "vouch for the safety of generics." Former FDA Commissioner Frank Young re-organized the Generic Division, prior to leaving office, uncovering more evidence of fraud, bribery, substitution, and false reporting. Where does it end? Not with the Generic Drug Division. Read on, please. ADVICE FROM THE PRESIDENTIAL ADVISORS PANEL, 1990 In August, 1990, a Presidential Advisory Panel reported to President Bush at the White House that the federal government should speed up approval of experimental AIDS and cancer drugs, by requiring less evidence of effectiveness before they are put on the market. The chairman of the nine-member advisory panel was Dr. Lewis Lasagna, Dean of the School of the Graduate Biomedical Sciences at Tufts University. Dr. Lasagna warned that thousands of lives are lost each year from delays in approvals and marketing of AIDS and cancer drugs. The report stated, "Desperately ill patients are prepared to accept the greater risk inherent in the use of such medications. Faced with the consequences of a lack of therapy for AIDS and cancer, an expanded mechanism for early access to investigational drugs is morally, ethically and scientifically justified." Dr. Lasagna and the panel suggested that approval of a new drug could be postponed until after the drug is on the market, provided two types of studies are done first. One study measures the effectiveness of new drugs in comparison with those which are already on the market; the second assesses whether or not a given drug prolongs life. The panel recommended that the government should not insist that a drug company demonstrate "prolongation of life, if a drug can improve the quality of a patient's life." "For cancer and AIDS patients, time is running out, and they are understandably upset with delays in obtaining the pharmacotherapy which represents their only hope," the panel noted. For these life-threatening diseases, it added, the government should approve new drugs at the earliest possible point in their development, and, in any event, earlier than previous time frames. At a subsequent news conference, Dr. Lasagna pointed out that the FDA often demands more data than are required by either federal law or scientific criteria for judging the value of new drugs. It now takes twelve years and costs $231 million to research, test, and get approval for a new drug, according to a Tufts University study which was released in the spring of 1990. This report by the Center for the Study of Drug Development noted that, even accounting for inflation, this estimate is twice what the Center had found when it did a similar study in 1979. The Tufts study was based on a random selection of ninety-three drugs developed by twelve pharmaceutical firms and tested on humans between 1970 and 1982. The cost figures were then adjusted for inflation to 1987 dollars. Both Congressman Waxman of California and Congressman Wyden of Oregon were critical of the FDA in 1990. They described a steadily deteriorating ability of the Agency to carry out its mission and functions. During the previous decade, the Agency was underfunded and understaffed; there was a lack of information and a lack of independence. This set the stage for the generic drug scandal. Congressman Wyden accused the agency of putting politics before science. These criticisms are only the tip of the iceberg. Further congressional scrutiny into the agency's association with drug companies is certainly warranted from the evidence surfacing. Why do representatives from drug companies make up more than 50% of some FDA drug-advisory boards? This creates a bias in favor of prescription and over-the-counter (OTC) medicines over natural remedies or herbal products. The new Food and Drug Commissioner, David Kessler, has been given a mandate to (1) develop food labeling guidelines and (2) increase the Agency's scrutiny over medical devices. Although laudable, these objectives have nothing to do with the change that is needed in the agency's orientation - from working for the industry it is supposed to regulate, to working objectively for medical advances in the best interests of those who pay FDA salaries, the American taxpayer. In addition, if the proposed new regulations for medical claims for foods are any indication, then the Agency appears to be going backwards in regard to their first mandate. They are proposing that only two foods and/or nutrients be recognized as having a direct effect on the occurrence of disease: (1) calcium (osteoporosis), and (2) dietary fat (cardiovascular disease and cancer). The first of these is probably not even a direct effect in terms of treatment or prevention. The fact that they consider all of the other relevant research on nutrition and health inadequate for making clinical claims suggests that, as least as far as food labeling is concerned, business is worse than usual. These decisions are obviously not based on science. The pharmaceutical boys just don't want to open the door to this kind of competition, and they are using their FDA lackeys to help keep it shut. Only a public outcry and/or pressure from Congress and the White House can turn this situation around. The late comedian Lenny Bruce's takeoff on an American politician, "I'm not a crook - elect me!" came to mind when Dr. Kessler took over the FDA in November, 1990, and said, "I am not going to protect crooks." Jack Anderson, in his commentary "High Noon for the New Sheriff at the FDA," noted that this was something most federal agency heads don't have to say when they take the job. Anderson commented, "[when Kessler takes over] it should be something like grabbing the helm of the Exxon Valdez after it hit the bottom." Dr. Kessler's predecessor, Frank Young, had been forced to resign after the generic drug scandal surfaced under his watch in 1989. The agency's credibility was at an all-time low. It was accused of prematurely approving life-support medical devices, and allegations also surfaced that FDA agents were using insider information on drug approvals to play the stock market. Anderson's congressional sources provided this insider observation: "There is a big concern on Capitol Hill that Kessler doesn't get captured by any of the bad elements that linger on in the FDA." They went on to say that he should let it be known "that there's a new sheriff in town." His tolerance for the old way of doing business at the FDA remains to be seen. No one should hold his breath, however. This is probably bigger than what one man can do, no matter how well-intentioned. Racketeering in Medicine: The Suppression of Alternatives Copyright © 1992, 1993 by James P. Carter, M.D., Dr. P.H. Published by Hampton Roads Publishing Company, Inc.891 Norfolk Square, Norfolk, VA 23502. Tel.: (804) 459-2453 Fax: (804) 455-8907. ISBN: 1- 878901-31-X