Thousands of Americans per year suffer from incurable diseases. With scientific research continuously underway, citizens often search for innovative procedures to obtain relief. Recently, the House passed the Right to Try Act of 2017 in a 250 – 169 vote, which was accepted by the Senate nine months prior. The bill may offer hope to those struggling with life-threatening afflictions.
President Trump is a significant advocate of Right to Try, stating:
“We also believe that patients with terminal conditions, terminal illness, should have access to experimental treatment immediately that could potentially save their lives.
People who are terminally ill should not have to go from country to country to seek a cure. I want to give them a chance right here at home. It’s time for Congress to give these wonderful, incredible Americans the ‘right to try.’”
Will the legislation create an impact on healthcare in America?
What is Right to Try?
The new act permits those with life-threatening diseases to sample medications that are still in clinical trials and have not yet received approval from the Food and Drug Administration, according to Liberty Nation’s Andrew Moran. To obtain admittance to the Right to Try program, individuals must receive authorization from a physician and the makers of the requested treatment.
The particular drug is also to have passed Phase I clinical trials that demonstrate safety, but not necessarily efficacy. It takes several months to gain Phase I, with nearly 70% of studies achieving this rank but less than 10% ultimately receiving FDA approval.
For what reason is it necessary to bypass the government agency? Previously, physicians and patients were required to petition for access to experimental treatments. Over 100 hours of paperwork was obligatory to obtain care, while diseased citizens awaited authorization and suffered.
However, since 2009, states across the country have been enacting a system similar to Right to Try, called “expanded access” or “compassionate use.” These state legislations pressured the FDA to decrease the time spent completing the process to 45 minutes, according to the Brookings Institute, a century-old research organization.
Currently, the maximum amount of time the agency spends evaluating any request is 30 days. However, the decision is typically made within a few hours, passing over 99% of applications.
Today, the expanded access or compassionate use methods are present in 40 states which have rid patients of obstacles placed by federal agencies. Being that state legislation already pressured the FDA into shortening its requirements, is Right to Try a redundant provision?
The answer is yes. However, Americans will still struggle to obtain access to potential cures.
The Real Concern
According to New York University, drug manufacturers limit access to experimental sessions due to the scarcity of available medication and considerable potential risks. There is currently no data on the exact number of manufacturers that deny patients access to experimental drugs, but many are hesitant to provide treatment as harmful side effects may prompt others to avoid clinical trials and negatively impact corporations financially.
National Public Radio reports that pharmaceutical companies may be the most substantial obstacle to individuals in need. Right to Try does not mandate these establishments to administer experimental sessions to patients. Thus, federal enactment will not result in many changes to the present system unless future modifications to the bill include regulations that affect drug enterprises.
Arguably, such provisions may lead to government overreach and potential dangers to patients. Although many with terminal illnesses search for a cure, Phase I only detects acute side effects among a small sample size. Also, it is possible that overriding the discretion of both the FDA and pharmaceutical companies may lead to some participants receiving therapies that are unfit for their conditions.
Furthermore, the results may additionally corrupt science at the expense of innocent lives, by taking decisions out of the hands of professionals and into those of unqualified politicians.
Expanded access and compassionate use have pressured the FDA to uphold the interests of Americans by streamlining the process for citizens to more freely make their own medical decisions. Right to Try is a redundant act, and drug manufacturers will continue to deny the terminally ill access to clinical trials without intervention.
What are the thoughts of our readers? Do you believe Right to Try should be modified to include regulations to pharmaceutical companies?