The Anxious Conclusion of a Scientific Trial

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The Stressful Conclusion of a Clinical Trial

"What does the drug actually cost?" I finally asked him.

"More than $ 15,000 a month."

"You're kidding," I said, wondering how long Medicare and I could afford to slump our stakes in the gorgeous figure.

Then, in the middle of September, I received good news. Although Pfizer has the right to bill me for the commercially available drug, the company has decided to keep me (as well as the handful of other women in my situation) on the study drug for the time being. I have no idea how long this will take; However, it feels like a dispensation, and I'm grateful for that.

After receiving this message, I asked Pfizer to clarify the company's policy on continuing to provide useful medicines to patients, and I was cheered by the response. Steven Danehy, Pfizer's director of global media relations, wrote in an email: “When a clinical trial participant benefits from a study drug, our intention is always to encourage access to that drug after the study is complete. We work with each trial site to find a suitable option and transition period for each patient. "

He also noted, "Study sponsors like Pfizer do not have direct access or communication with patients in order to maintain the confidentiality of clinical trial participation."

Still, I want to look at the bigger picture that relates to people done in studies by other companies. We all certainly hope that future researchers will continue to develop life-extending drugs. It seems wrong that patients enrolled in their studies have to depend on the kindness of drug manufacturers, as I do now.

Because patients deserve to benefit from the scientific breakthroughs that have facilitated them, regulators should ensure that people who succeed in clinical trials continue to receive treatment after the trials are completed. Couldn't the promise of continued treatment in these circumstances – written in informed consent – help solve the problem of poor enrollment rates and motivate more people to get involved in much-needed research?

The ethical principles for medical research published online by the World Medical Association seem to support my view: “Prior to a clinical trial, sponsors, researchers and host country governments should make post-trial access arrangements for all participants who require intervention identified as beneficial in the study. This information must also be shared with participants during the informed consent process. "

Better minds than mine need to address the gnarled discrepancy between legal practices and ethical principles in relation to clinical trials and the even gnarlier link between the exorbitant cost of new miracle therapies … sooner rather than later, please.

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