Government Reform and Oversight Committee
February 4, 1998
Chairman Dan Burton
"Patient Access to Alternative Treatments: Beyond the FDA"
Good morning. Today we will begin a series of hearings to examine issues and problems related to alternative medical treatments for millions of desperately ill Americans. We will also look at deep-seated flaws in the process of the Food and Drug Administration (FDA) that governs access to some of these treatments.
These issues are at times controversial. My purpose in holding these hearings is to lay the issues out on the table, and deal with them in the most reasonable and balanced way. I want to stress that in no way is this a partisan issue. Dedicated Members from both parties have raised concerns about patient access. We owe it to the millions of patients, their families and loved ones who are not satisfied with conventional treatments.
Health is the first of all liberties. And each person is the proper guardian of his or her own health. Yet in our system of health care, personal choice in treatments is all too often not an option. The FDA often comes in the way of our choices of alternative medicines.
Medicine is a matter of weighing the benefits of a treatment against any possible harm that might result. At times, federal health care agencies seem to put much more energy and effort into avoiding harm than we do into weighing the benefits. This, despite the fact that conventional medicine sanctioned by the FDA offers some highly toxic, extremely expensive and, at times, only marginally successful treatments for most deadly illnesses.
For example, more than 25 years have passed since President Richard Nixon first declared war on cancer. He predicted a cure within five years. So far, cancer has won. We have no cure, and made only little progress in developing cures. Meanwhile, we know that half a million people will die from cancer this year. There are growing numbers among them who will depart from conventional treatments because they are too toxic, too expensive and less effective.
The same can be said of other serious diseases, such as multiple sclerosis, hepatitis C, arthritis, asthma and many others. The meager advances by conventional medicine in the treatment of these diseases has made alternative and complementary therapies overwhelmingly popular. Indeed, more than 45 percent of Americans will use some alternative therapy this year. And, they will pay for it out of their own pockets. Who can blame them for searching against hope for a cure?
More and more doctors are having tremendous success in using alternative treatments together with conventional treatments. Others are succeeding with time-proven natural preparations in ways that are less toxic, less damaging and often less expensive than typical conventional therapy.
Despite the growing popularity and success of alternative treatments, some of our government institutions are fighting that trend. The FDA dictates what treatments doctors can use in treating serious illnesses, but most of those are toxic and often dangerous to already weakened patients. Meanwhile, our government agencies have spent untold billions of dollars trying to find elusive cures. In addition, the FDA has harbored a culture of intimidation and sometimes harassment against those looking for alternative cures. Today we will hear from a researcher who is at an impasse with the FDA after spending his career searching for a cure for cancer. He found himself so overwhelmed by FDA paperwork requirements that, as an individual researcher, he simply could not comply. Today, his research is on hold with no hope to resume.
It is sometimes done under the guise of defending good science, and weeding out fraud. But frequently it undermines the practice of good medicine and the potential for greater advances in possible cures. Many doctors are truly healing patients through innovative, safe and effective measures.
At the same time, doctors who use alternative treatments often do so at great peril to their reputations and their right to practice medicine. It is because of the tremendous courage of many of these doctors and their patients, that some progress has been made with respect to alternative treatments in this country.
They are not alone in history. It seems that all great discoveries were met for a period of time with skepticism and ridicule. For instance, Louis Pasteur was ridiculed for his germ theory of disease. Dr. Ignaz Semmelweis spoke to his colleagues about the importance preventing the passing of infection to women in childbirth by washing their hands after an autopsy. He was similarly ridiculed and died an early death without recognition. Finally, there was Jonas Salk, a young doctor with the only hope against polio. He produced a vaccine that was initially forbidden by the medical establishment.
If anything, history teaches us that, in the long-term, those who are ridiculed for their discoveries are often eventually proven right. If we don't learn from history, we're doomed to repeat it. And that makes progress difficult.. What's clearly needed is a shift in thinking, from Government knows Better, to The People Know Better. At least there needs to be more of a balance.The FDA process for access to new treatments is a good example of this need. That is why today, we will examine options available to seriously ill patients for promising new treatments, and also the barriers to getting access. Access to a treatment in the development process that is not approved by the FDA generally requires participation in a clinical trial. But many patients do not qualify under the strict guidelines of a trial.
The FDA then makes a life or death decision as to whether a patient can have the treatment under a special exception. If the answer is "no," their access is shut off, with no appeal.
Under those conditions, patients must apply through an FDA regulatory process to try to gain access to their desired treatment. This can be lengthy, trying and frustrating, especially for someone who is terminally ill. And for those who do not have the stamina, family support, sometimes legal fees, or even congressional help, it can be a dead end.
We know from the FDA's own records that in 1996, about 500 cancer patients were given access to an experimental drug through the FDA, compared to half a million who died that year. We will hear compelling testimony from some of those patients about how the FDA process is broken. If that is true, then the Congress is obliged to find a way to fix it.
We know that the FDA process cannot accommodate half a million people. So, in essence, we as a government are deciding who gets treated, and how they are treated and everyone else is on their own. We cannot tolerate that in an open society where choice and the right to a healthier life is the first liberty.
These hearings will also explore ways to help those hundreds of thousands who get left out of the FDA-sponsored experimental treatments, and, therefore left out in the cold. We will hear from patients, families, who had lost hope, and facing death, who were up against a massive bureaucracy which seemed to have little understanding of their pain, suffering and desperation.
I believe that if a patient is terminally ill, he should have access to any experimental treatment on the market. He should not have to wade through red tape, he should not have to fight against a bureaucracy, he should not have to spend thousands of dollars. If someone is fighting for their life, the government ought to be helping them find new alternatives not throwing up roadblocks.
A truly compassionate society will help find solutions to greater access to new and promising treatments. Good health and medicine require it.