As We See It
From The Desk Of: Roderic M. K. Dale, Ph.D.May 2000
By William Faloon
February 25, 2000
Life Extension Foundation
PO Box 229120
Hollywood, FL 33022
Dear Mr. Faloon:
I have read with great interest of your battles with the FDA. It would appear that the FDA believes that it is above the US constitution and that it can intimidate, threaten and enforce inherently flawed authoritarian regulations and even regulate what people can say. This last point was of course, documented in court in the lawsuit that was brought by Pearson and Shaw charging that the FDA was guilty of suppressing truthful and non-misleading information. As you know, the courts agreed with Pearson and Shaw and the appellate court voted 11 to zero not to hear an appeal by the FDA.
The frustration that our company has experienced stems from yet another aspect of the FDA’s activities. Our company, Oligos Etc. Inc., is a contract manufacturer that has established itself as a premier source for the highest quality nucleic acids for research, diagnostics, nucleic acid arrays, cosmetics, nutritional supplements and therapeutics. Over the past several years we have been pursuing a research program using internally generated funds. These studies have led to the development of several truly innovative formulations based on our extensive experience with nucleic acid synthesis as well as novel chemistries and processes for the manufacture of nucleic acids that we have developed (patents pending). Therapeutic formulations of these compositions could be extremely valuable in inflammatory conditions such as psoriasis, asthma, arthritis, rosacea and eczema. Other compositions could be easily developed for issues ranging from hair loss, ED, IBD, cardiovascular function and cancer, to aging.
Originally we thought that we might pursue the development of clinical formulations of some of our compositions. However, we discovered that the therapeutic approval process that the FDA has created is extremely expensive ($200 to $500 Million) and incredibly time-consuming (8-12 years) for a single product. It is a process that allows only the large multinational drug companies to participate. Ultimately, a small company like ours would have to sell off its ideas to one of the pharma giants to get a product through the new drug application process (NDA). However, the large pharmas are resistant to new approaches. Even if they express interest in a new drug, they are as likely to bury it as they are to develop it, especially if it threatened to compete with one of their existing product lines. We spoke to numerous consultants including former FDA lawyers, business lawyers and officers of other biotech companies who recommended that from a business perspective we would be better off if we considered looking at cosmetic or dietary supplement formulations. This view was confirmed after seeing what happened to companies like Shaman Pharmaceuticals and Procyte. Both of these excellent biotech firms initially pursued clinical development of their products only to be frustrated, and eventually, after spending tens of millions of dollars, opted for nutritional supplement and cosmetic formulations, respectively.
As we began to look into the possibilities of other approaches we encountered the FDA regulations concerning cosmetics and nutritional supplements that essentially prevent the presentation of scientific research in support of product claims. We were astounded to find a US agency openly violating the first amendment right of free speech. The FDA has seemingly made itself the sole arbiter of what may be said in the US regarding food and drugs. As we began to read about health care in the USA it became apparent that the situation involved other players as well as the FDA.
The FDA working with the drug companies and the medical establishment has become a major impediment to both disease prevention and novel drug development and the principal cause of the horrendous medical costs both the country as a whole, as well as individuals, must bear. It is necessary to develop legislation to totally revamp the way we approach health care in the USA. The current medical system is basically not functioning well in disease prevention or drug development, and has flaws in the area of treatment while still costing a fortune. We do not need to spend more on health care. Those payments are basically subsidies for the major drug companies. The medical establishment has become largely an insensitive entity more interested in treating disease than in preventing or curing it. Please consider the following points.
As discussed above, the FDA has made the new drug approval process so expensive in both dollars and time as to preclude all but a small private club of very large and wealthy multinational pharmaceutical companies. The costs for drug development in Japan are reportedly about 10% of those in the U.S. This is not impossible to believe given that the cost for development of a new drug for the U.S. veterinarian market is between $0.25 and $2.0 Million. This is 1% or less of the cost to develop a drug for human use. It should be possible to develop new drugs for human use for similar costs.
At one time the documentation for a new drug application (NDA) would fill one or two 3-ring notebooks. Today, because of the FDA’s approach that more data is always better, it is possible to fill an entire tractor-trailer with FDA mandated documentation.
Despite the exponential increase in all this expensive documentation, the number of adverse drug reactions (ADRs) to new drugs has remained essentially constant for the past 32 years according to an article in the April 14th, 1998 issue of the Journal of American Medical Association. The authors Bruce H. Pomeranz, M.D., Ph. D.and his colleagues at the University of Toronto, observed that ADRs to FDA approved drugs account for more than 100,000 deaths a year and are between the 4th and 6th leading cause of death in the United States. If one includes errors of administration the death toll may be 140,000 people per year (JAMA Vol.277, No. 4, January 22/29 1997, pgs.301-306). According to the New England Journal of Medicine (Vol. 339, No. 25, December 17, 1998, pgs. 1851-1854), “Overall 51% of [FDA] approved drugs have serious side effects not detected prior to approval.” Clearly, the FDA has succeeded in driving up the costs for new drug development while providing no more safety than existed when the costs were a fraction of today’s costs.
Unfortunately, a triumvirate has developed among the FDA, multinational drug firms and the established medical community that benefits from perpetuation of the current situation. The large pharmaceutical companies begin giving “gifts” to future doctors while in medical school. (When is a Gift Not a Gift?, JAMA, January 19, 2000, Vol. 283, No. 3, pgs. 373-380). According to the New York Times (January 11, 1999, A1 “Fever Pitch: Getting Doctors to Prescribe is Big Business”) over 6 billion dollars are spent every year to “educate” doctors about the new drugs developed by the large drug firms. The multinational drug companies also pay nearly $1 billion annually, in user fees to the FDA (The Durk Pearson and Sandy Shaw Life Extension News, Vol. 3 No. 1, February 2000). As mentioned above the costs for the studies required by the FDA can really only be covered by the big drug companies ensuring that the circle is complete.
The structure of the triumvirate is also such that what is addressed is the treatment of disease—not prevention or cure. The ideal drug product from the perspective of the large drug companies is one that is used daily for the rest of a person’s life. For example, developing vaccines, unless needed yearly, is not interesting financially. There has also been a major effort by all the members of the triumvirate to restrict both information about alternative and preventive medical approaches as well as products such as nutritional supplements in the form of vitamins and herbal products. Long before it became open knowledge that the daily use of aspirin could lessen the chances of a heart attack it had been documented in clinical studies that this was the case. However, the FDA forbade manufacturers of aspirin from making those claims. It has been estimated that as many as 800,000 lives could have been saved over a 10 year period if this information had not been kept hidden by the FDA (Interview with Durk and Sandy, online at http://irc.lycaeum.org/~maverick/p&s.htm).
Another area that is truly absurd is the limitation the FDA places on the claims that can be made for supplements that pass through the intestinal tract. Although it has been shown that there is often better adsorption of nutritional supplements through the mucosal tissue in the mouth and nasal passages, according to the FDA, these routes of administration turn a dietary supplement into a drug. This goes under the heading of magic or perhaps madness. Likewise, although administration of many herbal remedies over the centuries has involved topical application of extracts, it is also forbidden by the FDA to make any claims if a supplement is applied to the skin. Again this regulation is clearly counter-intuitive, but then the rules of logic do not seem to apply to FDA regulations.
The FDA, many doctors and the drug companies object to herbal and nutritional supplements arguing either that the herbalists and others are dishonest or that the reports are all anecdotal and have not been rigorously and scientifically shown to be beneficial. The FDA has therefore decreed that before any therapeutic claims can be made an herbal or supplement must be run through the FDA controlled $200 - $500 million-dollar drug approval processes. They also argue that people might forgo FDA approved medical treatment if they had ready access to alternative sources of medicinal treatment. Given the Adverse Drug Reaction data it could easily be argued that a person has a better chance at recovery and avoiding death if he or she avoids many of the FDA approved drugs. The former head of the FDA, Dr. Kessler asserted that, “The FDA should be the sole authority on health and nutrition.” He also is reported to have said that if people were allowed to make health choices themselves there would be no need for the FDA. Exactly, and at that point people would have free access to information about ways to prevent many diseases, herbal and supplement therapies as well as novel approaches developed by innovative biotech firms, all for a fraction of the current health care costs. This brings up other points.
- There are charlatans in every field, but that is hardly a reason for denying access to an entire area that has shown successes for several thousand years. Most medicines were initially derived from herbal remedies. After that most drugs were synthetic analogs of the compounds found in nature that appeared to be the active component. Unfortunately, pulling out one specific ingredient from a complex mixture can result in a toxic medicine. Many beneficial effects seen with herbal treatments may be the result of the interactions of several components. It is only relatively recently that the central approach to new drug development has lost all touch with botanical and other natural sources of medicines. The principal method of finding new drugs is to screen tens of thousands of chemically synthesized compounds in the hope of finding one that has the desired effect. As seen above, however, they frequently have other undesirable effects, such as death.
- People are looking for non-allopathic medicinal solutions because modern medicine has become insensitive and distant to the people it ostensibly serves. Anyone knows this who has had the misfortune of either being in a hospital or having a loved one in a hospital.
The alternatives frequently offered to people are a modern day version of the pit and pendulum. Given the large number of deaths due to adverse drug reactions, doctors, the FDA and the large drug companies’ assertion that people need to get these treatments has a hollow self-serving ring. By contrast, there are very few deaths that can be attributed to nutritional supplements or herbal remedies.
- If the costs for getting substances approved for medicinal use were not so exorbitant it would be economically feasible to take herbal treatments through the process. As it is, there are numerous excellent scientific studies showing both safety and efficacy that have been done outside the FDA arena. However, the FDA does not permit the inclusion of that data with the supplements.
There is a need for a new structure to handle drug development in the 21st century, one that is more open and far less costly. It might be well to restrict the FDA’s activities to monitoring the food supply. A variety of ideas have been put forth. Perhaps the NIH and/or the CDC would establish standard tests for toxicity and a toxicity scale of 1 to 10 that would be included on every drug/supplement. The NIH could review the results of the studies, and assign a score to the particular drug. The company sponsoring the drug would then be able to conduct clinical efficacy studies. The cost of taking a new compound or herbal through the pipeline could be reduced to 1% or less of the current costs.
If it were possible to freely pursue alternative approaches to medicinal therapies that would include a healthy dose of preventive efforts, and include herbal and other supplements, and also to develop and market new drugs at lower costs, the entire crisis in health care costs could fade away. To restructure the current system will require formation of a coalition of the various groups involved in non-traditional approaches, as well as those opposed to the current drug regulatory process. These groups must pool their resources and efforts, join together and work with those members of congress interested in addressing the health care crisis to pass the appropriate legislation. If this happens we could see a new age of reduced health care costs coupled with improved health and longer more productive lives.
- The FDA, Drug Companies and the medical community derive mutually rewarding financial and control benefits from the current system. The triumvirate seems determined to fight any changes that would jeopardize their respective positions.
- The current system has proven to be ineffective and counterproductive. It fails to address prevention and seeks treatments rather than cures for diseases, treatments that are often more dangerous than proven alternatives.
- The costs associated with the system do not afford protection of the public from dangerous drugs but simply serve to ensure control of the system by the large pharmaceuticals, the medical community and the FDA.
- The system has and continues to cost the lives of over 100,000 people per year in the USA.
- The FDA, large drug companies and the medical community are the principal reason for the enormous health care costs that threaten the financial and physical health of the country.
- While offering no solutions, the trio aggressively opposes freedom of individuals to pursue their own health care and the dissemination of truthful non-misleading scientific information about alternative and traditional medicines.
- The current FDA drug approval process is so outrageously expensive that it prevents all but the inner circle of large drug companies from developing new drugs as well as making it too expensive to demonstrate the value of traditional medicines not covered by patents.
- Limit the FDA’s authority to monitoring the safety of food and delete all drug regulatory activities from their charter.
- Ask the National Institutes of Health to establish a standardized series of toxicity studies with relative toxicity ratings from 1 to 10. All dietary supplements and drugs would be required to be evaluated and rated by independent labs and marked on labels.
- Let the FTC continue to judge whether the claims made for a product are properly substantiated.
- Reduced Health Care Costs - through reduced development costs of drugs and the use of alternative herbal and nutritional supplements.
- Improved health through prevention of disease. This also reduces costs and improves the quality and length of people’s lives.
- There will be a greater number of innovative drugs made available at far lower costs addressing not only the major diseases, but the aging process itself.
Roderic M. K. Dale, Ph.D.
Oligos Etc. Inc.