As members of the Patient, Consumer, and Public Health Coalition, we are writing to express our views as consumers, physicians, scientists, and public health experts regarding S. 2912, the Trickett Wendler Right to Try Act of 2016. We strongly urge you to NOT co-sponsor this bill. This bill is bad for patients, bad for doctors, bad for drug development, and bad for science.
As you may know, the history of the FDA is a history of Congress responding to medical tragedies by requiring FDA to do more to protect patients from harmful medical products. Thalidomide birth defects and deaths and infertility from the Dalkon Shield IUD are just two of many examples. Although the AIDS crisis resulted in a more flexible approach for deadly diseases for which there were no treatments, today’s HIV/AIDS advocates are among the FDA’s strongest supporters, because the scientific evidence that FDA required of pharmaceutical companies resulted in effective treatments and prevention strategies. The FDA’s essential role continues to be to achieve a balance between patients’ rights and societal good. It is critical that, in your role as a Senator, you support the agency in upholding this delicate balance.
The idea behind this bill and other Right to Try laws is to give terminally ill patients access to experimental drugs that have passed phase I testing – testing that is often done on healthy volunteers, not people with serious illnesses. While this type of legislation promises cures, it offers false hope. Since most phase 1 trials include less than 30 patients and are designed only to identify the most immediate side effects, they provide very little information about the drug’s safety and effectiveness. In fact, most drugs with promising phase 1 test results are later found to be too risky or ineffective for patients to use. This is especially true for cancer drugs. Under the proposed bill, desperate patients are likely to be exploited by unethical companies that want to sell their unproven treatments at prices that would bankrupt many families. Health insurance companies will not pay for these unproven treatments – if they did, insurance premiums would skyrocket as patients harmed by unproven treatments required more expensive remedial care.
In the recent past, access to experimental bone marrow transplants for breast cancer was expedited due to an early benefit seen in preliminary data. It was not until many women were harmed and some even died that researchers realized a terrible mistake had been made. If doctors and patients can be fooled into trying such a painful and toxic treatment, imagine how often patients would be fooled by treatments that are less painful but ineffective and expensive snake oil.
This legislation would subject patients to a great risk of harm and they would have no legal recourse if things go wrong. In fact, this bill and similar state Right to Try laws reflect the libertarian philosophy of the Goldwater Institute that created them: the patient is on his or her own without any protections or safeguards. The bill explicitly states that drug and device companies as well as physicians cannot be held liable for any tragic outcomes, even if the company or a physician misled the patient. Even worse, if a patient suffers a terrible medical complication from a Right to Try treatment, the insurance company would not need to pay for the medical care that is needed to treat that complication. The only thing worse than a terminal illness is being terminally ill and suffering a major complication as the guinea pig in an experimental treatment that you had to pay for.
There are many other problems with the bill, but perhaps the most important thing for you to know is that the FDA’s current compassionate use program already provides patients with the opportunity to try experimental drugs, while offering some protections to patients and society. For example, while physicians and drug companies are required to report the outcomes of experimental treatments obtained through the FDA’s compassionate use program, Right to Try laws do not carry such stipulations. Indeed, this bill strips all protections from patients who would use it. Bypassing the oversight of the FDA is not in the best interest of patients or the public health.
The one shortcoming of the FDA’s current compassionate use (“expanded access”) program is also in the Right to Try bill: the company is not required to provide the experimental drug to the desperate patient. In some cases, that’s because the company doesn’t have enough doses to provide to patients not in a clinical trial, and in other cases, the company believes that the patient is more likely to be harmed by the product than helped by it.
In conclusion, Right to Try laws such as S. 2912 will do more harm than good for patients and society. The bill is opposed by experts in the field as well as by legitimate drug companies. We urge you to oppose the Trickett Wendler Right to Try Act of 2016.
American Medical Women’s Association
Connecticut Center for Patient Safety
Jacobs Institute of Women’s Health
National Center for Health Research
National Physicians Alliance
The Patient, Consumer, and Public Health Coalition can be reached through Tracy Rupp at 202-223-4000 or firstname.lastname@example.org.