Government Reform and Oversight Committee
February 12, 1998 Representative Peter DeFazio (D-Oregon)Thank you, Mr. Chairman, Mr. Waxman and members of the committee for giving me the opportunity to testify before you this morning. I would like to state for the record that I am not here to discredit or undermine the mandate of the FDA, NIH or the NCI. Nor am I here to advocate for a particular medical modality or interest group.
To me, the issue is very clear. Patients all over this country are being denied access to beneficial health care treatments by our government despite significant consumer demand. These treatments are readily available in Europe and elsewhere. In 1993, the New England Journal of Medicine found that one out of every three Americans are using some form of alternative medicine.
A recent nation-wide study conducted last November by Interactive Solutions on behalf of Landmark Healthcare Inc, an HMO found that over 42 percent of American consumers use some form of alternative medicine. 67 percent surveyed believe that the availability of alternative care is an important factor when choosing a health plan. The background memo prepared by the minority staff of this committee stated that over 80 percent of American consumers have used some form of alternative medicine at least once in their life-time.
A wide range of treatments are being used by millions of American consumers but will not be researched or certified in an official manner. Most of these products are not patentable in the U.S. because they are made from essential nutrients and other natural substances.
Sadly, none of these products are compatible with the current FDA approval process because the system is only designed to give approval to pharmaceuticals. Natural medicinal products should be offered a separate approval track similar to the one used in Germany, where manufacturers submit their product for approval and undergo a different set of scientific reviews for safety and efficacy. American consumers in growing numbers are using these products regardless of whether they are approved or not. Its time for the FDA to develop a two track approval system one for natural medicine and one for commercial pharmaceutical products and devices to meet consumer demand.
THE GERMAN MODEL FOR APPROVAL OF HERBS AND NATURAL SUBSTANCES.
* Commission E in Germany uses an approval process for medicinal herbs and phytomedicines that is separate from the conventional medical process. It is used to approve medicinal herbs and phytomedicines. Manufacturers and medical researchers are able to get approval for their plant-based medical products without having to submit to the extraordinary rigors, requirements, conditions and huge expenses needed for the approval process for pharmaceuticals.
* The Commission is composed of an expert panel of physicians, pharmacists, pharmacologists and biostatisticians. It is the German government's equivalent of the FDA and is charged with reviewing plant-based products based on bibliographic literature that is actively gathered. This bibliography contains information on chemical data, pharmacology, toxicology, clinical studies, traditional and historical use, epidemiological studies and patient case records. Members of the Commission assess this data on a doctrine of absolute certainty for safety but reasonable certainty for efficacy.
* This bibliography is used as a guide to consumers, doctors, pharmacists, professors and practitioners. Over 70 to 80 percent of general practitioners prescribe herbal medicine approved by the German government.
* Statutory language contained in the Dietary Supplement Health and Supplement Education Act (DSHEA) authorized the creation of a Presidential commission on dietary supplements. This past November, the commission recommended that the FDA review herbs for possible approval as over the counter drugs (OTC), which alluded to the Commission E model in Germany.
THE BENEFITS GARLIC IN TREATING HIGH CHOLESTEROL LEVELS.
* A recent study published in the American Journal of Clinical Nutrition demonstrated that cholesterol levels may be reduced when taking both fish oil and garlic. This basic nutritional combination contains significant health benefits to individuals suffering from high blood cholesterol levels. For centuries garlic has been used as a natural antibiotic and a powerful immunostimulant. This simple and low cost combination has the potential for preventing curable conditions and could be used as an alternative to commercial products. Unfortunately, it will never be approved under the current process.
TREATMENT FOR BPH: THE COST AND SIDE EFFECTS OF SAW PALMETTO VS. PROSCAR.
* There is a significant amount of evidence indicating that saw palmetto, pumpkin seed extract and an herb called Pygeum Africanum are far safer, less costly and more effective that the current, FDA-approved allopathic treatment for an enlarged prostate due to benign prostatic hyperplasia (BPH).
* This condition afflicts one in every 11 American men per year. The current FDA approved treatments for BPH are Proscar or finasteride. Both treatments costs around $75 per month and can cause dangerous side effects such as impotence, insomnia, urinary track complications and urogenital birth defects.
* According to Lanh Green, Diane Wysowsi and Jean Fourcroy of the FDA, Proscar also causes gynecomastia, which is excessive development of the male breast. This condition is also known to cause breast cancer in men. Merck, the manufacturer of Proscar grosses more than $1 billion in sales annually for the product.
* Numerous medical studies conducted throughout Europe demonstrate that the extract of saw palmetto (serena repens) is far safer and more effective in reducing pain and swelling in the prostate than both allopathic treatments approved by the FDA. There are no known side-effects associated with saw palmetto and it is widely used around the world. It was rejected by the FDA even after its efficacy was proven through numerous clinical trails. The FDA reported that these results were statistically significant but denied the health claim because the results were not medically significant.
THE BENEFITS OF TREATING DEPRESSION WITH ST. JOHNS WORT OVER PROZAC.
* St. Johns Wort is the preferred therapy over pharmacological medication for mild depression in Germany. It is reported to enhance the immune system, increase antiviral activity and relieve seasonal affective disorder. The British Medical Journal published an overview of 28 clinical trials in 1996 conducted by Ludwig-Maximilian University in Munich which confirmed that in 1,757 patients St. Johns Wort was as effective as commercial antidepressants. The studies also noted that the herb produced minimal side effects.
* Prozac, the preferred alternative to St. Johns Wort in the U.S., is known to cause nausea, anxiety, insomnia, diarrhea, dizziness, headaches, sexual dysfunction, and difficulty with concentration. St. Johns Wort also costs about $10 per month whereas Prozac costs, on average, $80 per month. In Germany, the leading St. Johns Wort product outsells Prozac by seven to one.
* NIMH in conjunction with OAM will be conducting a four-month double-blind study of 330 patients on the effectiveness of St. Johns Wort in treating clinical depression compared to Zoloft and a placebo. The coordinating research site will be Duke university. The study will cost $4.5 million and it will come out of the OAM budget.
THE BENEFITS OF USING VALERIAN ROOT OVER HALCYON.
* Valerian root is commonly used all over the world as a sleep aid. It is also used to treat fatigue, jet lag, nervousness and is an approved therapy in France, Germany and the U.K. Valerian has also been listed in the European pharmacopeia since 1973 and has been proven safe and effective in numerous pharmacological studies. Several double-blind clinical studies have proven the benefits of Valerian root in improving sleep quality.
* In 1994, the European American Phytomedicine Coalition submitted a citizens petition to the FDA for approval of Valerian as a night time sleep aid. To date, their petition is still pending and they haven't received a response from the FDA regarding the status.
* Halcyon, the FDA approved, pharmaceutical counterpart to Valerian, contains benzodiazepine which is known to cause nausea, dizziness, insomnia, panic, depression, headaches, anxiety, and deprives patients of REM sleep which disrupts normal sleep patterns.
* When I came to Congress in 1986, Halcyon was commonly prescribed to Members of Congress for jet lag and sleep disorders. Halcyon was also the substance that was implicated in the incident where former President George Bush vomited at an official dinner hosted by the Japanese Prime Minister.
ACUPUNCTURE ONCE CONSIDERED "QUACKERY" NOW A LEGITIMATE MODALITY ENDORSED BY A GROUP OF PHYSICIANS SPONSORED BY AN NIH COMMITTEE AND CHAIRED BY DR. DAVID RAMSEY, PRESIDENT OF THE U. OF MARYLAND MEDICAL SCHOOL.
* The history of acupuncture in the U.S. demonstrates the inflexible bias of the mainstream medical community even after it was widely accepted by American consumers. Acupuncture has been used by one fourth of the world's population for the last 2500 years. However, in the U.S. it was considered "quackery" by a majority of physicians and surgeons until recently.
* In a recent NIH consensus development meeting, a 12-member committee of independent doctors and scientists determined that acupuncture was a satisfactory treatment for chronic pain, vomiting and nausea related chemotherapy, nausea from pregnancy and postoperative dental pain, back pain and post stroke care.
* A report published by the NIH committee on acupuncture stated that "while conventional medical practices are often thought to be utilized because there is substantial research evidence to support them, this is frequently not the case. But this does not mean that these treatments are not effective. The data in support of acupuncture are as strong as those for many accepted Western medical therapies."
* According to the American Cancer Society information database, acupuncture is described as "simple and often works. It has few side effects or complications and the cost is low. For these reasons, it can be a good choice for some problems that have no underlying cause which can be treated.
A CALL FOR ACTION ON THE PRACTICE OUTCOMES MONITORING AND EVALUATION SYSTEM (POMES).
* This summer, the OAM and the NCI convened a meeting called the Practice Outcomes Monitoring and Evaluation System (POMES) to consider how to better evaluate the practices of doctors who use unconventional methods to treat cancer. However, most of the participants of the meeting were puzzled and somewhat discouraged by the lack of attendance among the top FDA and NCI officials, especially since the meeting was sponsored by NCI. Dr. Klausner, Director of NCI and his Deputy, Dr. Wittes were both absent from the meeting.
* A consensus was developed at the meeting that called for the creation of an Oversight Board led by a body of experienced medical professionals that would help guarantee a level playing field for research in the area of alternative practices. Unfortunately, since the meeting, NCI and NIH has done nothing to facilitate the consensus decisions that were made. I urge the committee to put pressure on the NCI to follow through with the POMES meeting.
GENERAL FACTS ABOUT CANCER.
The NCI has spent over $10 billion in research over the past five years, yet cancer patients are still left with the same limited treatment options such as radiation, chemotherapy or surgery -- all very costly and physically debilitating, and there has been little increase in life expectancy during that time period. Very little has changed in the last 20 years. Let's take a look at some well-known facts:
* Roughly 1.5 million Americans are diagnosed with cancer each year.
* By the year 2000, two out of every five Americans will be diagnosed with some form of cancer.
* I ask my colleagues, why are we spending so much taxpayer money exclusively on conventional medical research when we have so little to show for it. I would urge my colleagues to request the NCI to begin to conduct studies on alternatives that are being used by practitioners and doctors in the U.S. and around the world. It seems to me that we aren't being fiscally responsible in our fight against these deadly cancers.
BREAST CANCER
* In 1962, over 63,000 women were diagnosed with breast cancer
* In 1971 when President Nixon launched the "war on cancer," this number reached 69,000, and a woman's lifetime risk of contracting breast cancer was one in fourteen.
* Since 1960, nearly 2 million American women died from breast cancer. This is an outrageous figure and yet the NCI and the NIH still spend billions of taxpayer dollars. This level of mortality is not acceptable and the NCI and the NIH should spend a portion of their research funding on researching promising alternative therapies
WHAT IS WRONG WITH THE CURRENT FDA DRUG APPROVAL PROCESS.
* According to a report by the Office of Technology Assessment (OTA), the FDA approval process costs an applicant over $500 million dollars and about 8 to 12 years before a new drug receives approval.
* I ask my colleagues, does it make sense for a medical researcher who is not affiliated with a multinational pharmaceutical company to seek FDA approval for a product if they cannot obtain a patent for it? If their product is non-patentable they are unable to recoup the financial losses involved with seeking approval. How could they ever expect to obtain FDA approval if they cannot obtain the amount of capital involved? The answer is that many manufacturers and medical researchers do not seek approval due to these cost barriers.
* In his testimony before the House Commerce Committee on September 23, 1997, Dr. Michael Friedman, the Lead Deputy Commissioner of the FDA expressed the same concerns. He said that "collectively we need to address how to promote research on possible effective remedies where market incentives may not work."
* Our current system still forces many Americans to seek treatments outside the U.S. Patients are also forced to obtain medications without any official monitoring or content review. This leaves chronically-ill patients with no other choice but to circumvent the law by obtaining treatments which are unapproved.
WHAT IS WRONG WITH THE FDA REFORM BILL THAT PASSED LAST YEAR?
* Despite claims to the contrary, the FDA modernization act provides no new mechanisms for expanded patient access to investigational drugs and therapies. Instead, the Act continues to let the FDA make the final word on whether a seriously-ill patient receives access to an investigational drug despite the pleas of doctors, scientists and other medical professionals. Specifically, Section 561 of the Act:
1) requires FDA to conduct a detailed and time-consuming administrative review for chronically ill patients seeking alternative treatments in emergency situations.
2) permits the FDA to second-guess the judgement of attending physicians and scientific experts regarding the safety and efficacy of an unapproved treatment, thus enabling the government the last word in denying patient access.
After reviewing the provisions in this Act, I am amazed that my colleagues remain convinced that this bill provides all the access necessary to critically ill patients and their families. I choose to stand with patients and families who are fighting for fairness and low cost, effective treatment options that are currently absent from our health care delivery system. It is time for our government to defend the rights of American patients and consumers. The discussion of a consumer bill of rights, which is not within this committees jurisdiction, should correct the flaws of the FDA modernization bill.
I urge you all to remember the words of one of our great leaders, a crusader for fairness and freedom, Abraham Lincoln when he said "the legitimate object of government, is to do for a community of people whatever they need to have done, but cannot do for themselves in their separate individual capacities. In all that the people can individually do as well for themselves, government ought not to interfere." (Collected Works of Abraham Lincoln July 1, 1854)
I look forward to working with this committee and the FDA in making patient access to medical breakthroughs a reality for millions of Americans.