New PA Bill Gives Terminally Ill Patients Hope

Bridget Seelinger

DUSNA Publicity Chair

A controversial, bipartisan piece of legislation that would allow easier access to experimental treatment options for patients with terminal illnesses was introduced on the Pennsylvania state floor in early May of this year. Titled HB 1104, this bill is among other bills across the nation that are known as “Right to Try” bills.

In an interview with US News1, Victor Riches of the Goldwater Institute which is spearheading the campaign for Right to Try nationally, says that this legislation can save lives. The law allows patients with terminal illnesses to request drugs that have passed the first clinical trial, but have not been approved by the FDA. From there, the patient’s physician then discusses the risks and benefits with the drug companies and manufacturers to determine if the drug is safe to use for the given patient. In short, this piece of legislation allows patients and physicians to bypass the bureaucracy of the FDA’s compassionate use provisions and allow them freer access to experimental medications.

Supporters of this legislation argue that the FDA’s compassionate use provisions take too long and delay treatment. Take Josh Hardy, a seven year old suffering from an adenovirus infection in the ICU at St. Jude’s Hospital. A new therapy had become available that could possibly save his life, but the company that distributed the therapy had stopped taking compassionate use requests because of the concern that they may be unable to get full FDA approval. After an intense national campaign by Josh’s family to have the company accept their request including appearances on CNN and the hashtag #SaveJosh on Twitter, finally the company accepted the request and after receiving treatment, Josh recovered. The issue at stake with this example is how the compassionate use provisions were preventing a seven year old child to receive treatment. Advocates for Right to Try say that there are many more cases like Josh’s out there, but their families lack the resources that Josh’s family had. Craig Handzlik of the Goldwater Institute says, “Right to Try is something that will help people all over the country.”2

Drug companies, however, are hesitant to distribute products unless they are approved by the FDA. “We have an obligation to follow federal laws,” Kellie McLaughlin of Janessen Biotech, a pharmaceutical company, says. Since this law does not require drug companies to sell their drugs to patients requesting the drugs, some worry that Right to Try will have no effect on whether patients get the drugs or not.

Others, such as Dr. David Gorski, a surgeon blogger argue that Right to Try is just bad health policy. “The entire justification for “right to try” laws seems to rest on a misperception that there are “miracle drugs” out there that we will have to wait years for because the FDA is too slow to approve them…right to try” laws risk undermining our entire clinical trial enterprise, which is a major part of the scientific basis for evidence-based medicine…“right to try” laws are far more likely to harm rather than help patients with cancer and terminal diseases.”3

Darcy Olsen, the CEO of the Goldwater Institute says, “This is about saving lives…People know that when their mortality hangs in the balance they ought to have the right to try these potentially lifesaving drugs, no question.”

1, http://www.usnews.com/news/articles/2014/11/18/right-to-try-laws-allowing-patients-to-try-experimental-drugs-bypass-fda

2, http://www.nytimes.com/2015/01/11/us/patients-seek-right-to-try-new-drugs.html?_r=0

3, http://healthaffairs.org/blog/2014/08/27/rescue-me-the-challenge-of-compassionate-use-in-the-social-media-era/

4, https://www.sciencebasedmedicine.org/right-to-try-laws-and-dallas-buyers-club-great-movie-terrible-public-policy/

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