Should Patients Have to Pay for the Drugs They Helped Test?

Here is an interesting situation that I learned about recently, and it has me asking a question I hadn’t thought of before: What is our obligation to those who participated in and benefited from clinical trials but then are charged huge copays to continue taking the drugs they helped develop when the medi­cines get approved and go on the market?

As organizations, pharmaceutical companies and government, we are so focused on encouraging folks to participate in clinical trials that I doubt many of us spend much time thinking about this.

My interest started with someone I know who is a long-term survivor of a usually fairly quickly fatal met­astatic cancer. My friend, who had a particular genetic mutation, was eligible for a clinical trial of an experi­mental targeted therapy and decided to participate.

Lo and behold, the treatment worked well. The cancerous lesions disappeared or shrank — and stayed that way. My friend remains nearly fully functional, with a reasonable quality of life and the ability to continue business pursuits and await the birth of a new grand­baby. I think we can all agree that is a true blessing.

Now it is several years later, and the drug has been approved by the Food and Drug Administration. It will be available to other patients with the same mutation, and I pray they will all have excellent responses.

However, for my friend and others who participated in the trial, literally risking their lives to help others and advance the drug’s research to a successful conclusion, there is a catch: Now that it is approved and their insur­ers will cover the medicine, they are being asked to come up with huge copays, along with their copays for the follow-up scans that are no longer being done as part of the research study.

So I ask: Shouldn’t we at least have the courtesy to supply the drug at no cost to those who took it as part of the trial?

I understand if you are asking why these patients should be treated differently from others who have to figure out how to get access to the drug. However, I ask in return: Can’t we be at least a little compassion­ate in our thinking? After all, these people stepped up on behalf of a lot of other patients, took a huge risk of serious (and possibly even fatal) side effects, and were poked, prodded and scanned for years. Companies will make significant profits off these drugs. Can’t we share a little of the wealth with those who helped make it happen?

I don’t know the right answer. Maybe someone will tell me that providing free drugs to patients after clini­cal trials isn’t ethical or is an inducement to patients to participate. I would be glad if you shared your thoughts: Let me know if you agree or disagree.

I know my friend experienced an incalculable ben­efit from taking the risk involved with that clinical trial. And although having life, and a quality one, is priceless, I think we could be just a bit more gracious in success.

Len Lichtenfeld, M.D., is acting chief medical officer of the American Cancer Society.