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Assuming The Risk Of A Dangerous Drug

Under normal circumstances, most patients would not take a drug or rely on a medical device that had not been properly tested and approved. But there are situations where a patient may be desperate enough to consider a risky treatment with little guarantee of improvement. When it comes to deadly illnesses with no known cure, patients have little to lose in volunteering to be test subjects. One particular case has drawn attention and led to questions about a patient's right to try an unapproved course of treatment.

Right To Try Laws

The Food and Drug Administration has the power to allow doctors to prescribe unapproved drugs through a special application process. The process is relatively quick and the FDA claims to approve the vast majority of these applications. Many states have passed laws to make this step unnecessary. More than 30 states have "right to try" laws protecting doctors who choose to provide unapproved therapies in certain circumstances. These laws vary by jurisdiction and it is unclear to what extent doctors are aware of them. Some are pressing for a federal law meant to protect terminally ill patients and their doctors in cases where the medication in question has passed minimum safety testing requirements. 

Putting The Patient First

Advocates and critics of right to try laws face a similar problem: how to ensure that patients are not mistreated by pharmaceutical companies. If a drug is designed specifically to treat a terminal illness, would it suddenly be free from the FDA approval process? Would pharmaceutical companies use this as a tool to expand their profits through off-label use of existing drugs? How can you get terminally ill patients access to experimental treatments that could help them in cases where the pharmaceutical company is reluctant to cooperate? This last issue has arisen in several cases where a patient wants a drug, but the company making it refuses due to potential liability or fear of negative press.

Patient safety is of critical importance. The medical and pharmaceutical industries have questionable histories when it comes to putting patients first. Right to try laws protect doctors from losing their licenses, but they may be ineffective in getting patients experimental drugs in a timely manner. Any federal measure would need to consider the rights of all patients and ensure that the exceptions do not become the rule when it comes to assumption of risk.

Source: MedCity News, "As right-to-try laws gain wider adoption, is stronger federal legislation needed?" by Liz Szabo, 3 October 2016 

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