February 24, 2017
United States Senate
Washington, DC 20510
As members of the Patient, Consumer, and Public Health Coalition, we are writing to thank you for not co-sponsoring the Trickett Wendler Right to Try Act of 2017 (S. 204), introduced by Sen. Ron Johnson (R-WI). We urge you to strongly oppose this measure.
This bill purports to help dying patients gain access to experimental treatments that can save their lives. However, patients already have this access through the FDA’s Expanded Access Program, which gives patients access to experimental drugs if their doctor believes it is appropriate and the company making the drug agrees to provide it for that use. The bill instead does something much more dangerous: It would remove the FDA’s role in protecting many millions of patients from unsafe or ineffective treatment options – patients who already have safe and effective treatment options.
While we all greatly sympathize with the need for terminally ill patients to receive the best medical treatments as quickly as possible, the right-to-try approach of this legislation would:
➢ Hinder patients’ ability to obtain the experimental drugs that are more likely to help them.
➢ Enable companies to charge for experimental drugs, instead of providing them for free in clinical trials.
➢ Reduce or eliminate the incentive of pharmaceutical companies to do scientific studies to prove that their medications are safe or effective, and for whom. Why would companies agree to spend time and money researching their product when the company can spend that money on marketing it instead?
➢ Due to the lack of incentive to conduct clinical trials, could make it impossible to scientifically prove if a medication will make the patient feel better or live longer, and what dosage the patient should take.
➢ For the same reason as above, could make it impossible to scientifically prove if the side effects are so debilitating or dangerous that they outweigh the risks for most patients.
This scenario would take us back to the early twentieth century, when “snake oil salesman” peddled untested home remedies and “cures” to patients who had no access to information about whether the product would help or harm them. Indeed, tragedies arising from those “right to try” laissez faire and harmful medical policies were the very reason that the FDA was created.
While this Senate and House legislation calls for access to experimental drugs which have completed Phase 1 clinical trials, and remain under investigation in a clinical trial approved by FDA, Phase 1 trials are conducted with only small groups of healthy volunteers or patients to determine safe dosage range and identify relatively frequent, short-term side effects. These very preliminary trials are only the beginning of safety testing, and do not test for effectiveness.
As noted above, the FDA already has a program in place to expedite access to experimental and unapproved drugs for which there is some evidence of safety and efficacy and some knowledge about the appropriate dosage. The FDA Expanded Access Program routinely utilizes what the agency terms “compassionate use” for patients when doctors request such access. As would also be the case under all Right-to-Try laws, access to the treatment is determined by the company; if the company doesn’t want to provide the experimental treatment to the individual patient, it does not have to do so. Under current law, when the company agrees to provide the drug to the patient, the FDA quickly agrees to allow the patient access more than 95% of the time. Moreover, in urgent circumstances, the FDA had made such a decision within 1 or 2 days.
Currently, the most difficult part of the process is for doctors to obtain permission from the company. The FDA is working to facilitate access by ensuring that companies make it easier for doctors and patients to quickly identify the contact person or persons at each company who is in charge of the Expanded Access Program. The drug companies are also asked to make their policies regarding access to specific experimental drugs easily available to the public.
It is important to note that insurance companies generally do not pay for experimental treatments. This is not a problem in clinical trials or under the FDA’s Expanded Access Program, because in those cases, treatment is almost always free. However, there is reason to be concerned that pharmaceutical officials will be unwilling to make experimental treatments available for free if they are more frequently requested under the proposed Right to Try Act.
No Evidence that Lives Will Be Saved
In addition to other problems with the legislation, it does not clearly define “terminally ill” patient, or who makes that determination. How many patients with cancer or heart disease would be considered terminally ill, since those serious illnesses can cause death? It is not always possible to predict how long a seriously ill person will live, and patients could be easily manipulated by scam artists and others who are motivated by financial gain to convince patients to “try” the “latest” experimental treatment. Such problems have long been documented regarding unproven treatments sold at outrageously high prices in Mexico, where patients have been irreparably harmed by such treatments.
Bioethics experts and many physicians also point to the following problems with the law:
✓ Desperate patients will be vulnerable to false or misleading promises about likely benefits and failed to be warned about the risks, which may include dying earlier and more painfully than they would without the experimental treatment.
✓ Despite patients’ hopes, there is no evidence that access to experimental treatments through humanitarian exemptions helps more patients than it harms.
✓ There is no evidence that various state right–to-try laws have saved lives or improved patient outcomes.
✓ A survey conducted by Modern Healthcare in late 2015 found no evidence of patients receiving an experimental therapy as a result of state right-to-try laws, despite the fact that more than 20 states already had such laws in place.
✓ If a federal Right to Try Act were to become law, even small companies that make prescription drugs would need to develop complex policies to make such treatments available.
We urge you to strongly oppose S. 204 because it would undermine the successful program already in place to enable patients to have access to experimental drugs for free or at cost. The proposed law would potentially harm many patients and family members, including seriously ill patients who could be harmed by scam artists in a treatment environment with no checks and balances. This legislation could open the floodgates to undermine the scientific requirements that made FDA approval the gold standard for the world.
National Center for Health Research
American Medical Women’s Association (AMWA)
Association for Medical Ethics (AME)
Breast Cancer Action (BCA)
Breast Cancer Consortium
Breast Implant Victim Advocacy
Center for Medical Consumers
Jacob’s Institute of Women’s Health
Mothers Against Medical Error (MAME)
MRSA Survivors Network
National Consumers League (NCL)
National Physicians Alliance (NPA)
National Women’s Health Network (NWHN)
Our Bodies Ourselves
Quinolone Vigilance Foundation
Washington Advocates for Patient Safety
For more information, please contact Jack Mitchell at email@example.com.