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 plunk down our shares of the jaw-dropping figure.

Then, in mid-September, I received happy news. Though Pfizer has a legal right to charge 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 clue how long this will be; however, it feels like a dispensation, and I am grateful for it.

After I got that news, I asked Pfizer to clarify the company’s policy on continuing to provide beneficial medications to patients, and the response cheered me. 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 support access to it after completion of the study. We work with each trial site to help arrange an appropriate option and transition period for each patient.”

He also noted, “study sponsors like Pfizer do not have direct access or communication with patients to maintain confidentiality of clinical trial participation.”

Still, I want to consider the larger picture related to people in trials run by other companies. Surely, we all hope that future researchers will continue creating life-extending drugs. It seems wrong that patients enrolled in their studies must depend on the kindness of pharmaceutical manufacturers, as I do now.

Because patients deserve to benefit from scientific breakthroughs they helped to facilitate, regulatory agencies should ensure that people thriving in clinical trials will continue receiving treatment after trials conclude. Might not a promise of ongoing treatment under these circumstances — written into consent forms — help solve the problem of poor rates of trial enrollments, motivating more people to enlist in much-needed research?

The ethical principles for medical research posted online by the World Medical Association seem to support my view: “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.”

Better minds than mine need to tackle the knotty disparity between legal practices and ethical principles with regard to clinical trials and also the even knottier hitch of the exorbitant costs of new miracle therapies … sooner, please, than later.



First Published at www.nytimes.com on 2020-10-29 14:30:09

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