The Role of the FDA: Avastin and Other Drugs at What Price?

This week’s breast cancer headline: the FDA Oncologic Drugs Advisory Committee voted unanimously to withdraw Avastin as a treatment for metastatic breast cancer, though it remains to be seen whether FDA Chair Margaret Hamburg will ultimately suspend Avastin. Genentech, as well as patients and doctors are still pushing, and Medicare has announced that it will continue to pay for the drug for breast cancer patients. Avastin will remain available for the treatment of other cancers, and can ultimately be prescribed “off label,” though it may no longer be covered by private insurance if the FDA withdrawal comes to pass.

I deeply appreciate this heart-wrenching controversy, and the perspectives of both the women who stepped up to testify that the drug saved their lives, and the families of those were lost due to side effects. Ultimately, we want a cure for this disease, and we want it yesterday…

While the jury is still out and the Avastin debate rages on, it led me to think about our expectations as health care consumers. The truth is we want the perfect drug. We want it to work all the time. We want it to arrive on the market thoroughly tested, safe and effective, quickly and broadly available, and at a reasonable cost. We want it to have limited or no side effects. And at the end of the day, when something goes wrong, we want the right to sue for damages. Reasonable?

The role of government is to protect the masses. In order for that to happen, we must relinquish some measure of freedom in exchange for collective protections. But the “greater good” sometimes stands in contrast to the good of the individual. There is always a tension. A safe food and drug supply, by definition, means limited or controlled access. There is little doubt that individual patients, breast cancer and others, have benefited from Avastin. But there is also a cost: in lives and in freedoms. The mission of the FDA is to protect us. To that end, we confront certain realities:

1. What freedoms are we willing to give up in exchange for the protections offered by a regulated drug system?

2. When it comes to drug safety, what risks are acceptable? In an unregulated market any number of deaths are tolerable. Are we prepared to live with the loss of a life for each one saved? Is there a acceptable ratio?

3. Does a free-market economy not suggest that pharma can take whatever risks they deem financially acceptable? Are we okay with that?

4. What is the obligation of physicians regarding informed consent? Are physicians obligated to disclose any and all and treatment options, regardless of how remote their success might be?  Can the risks and benefit ever be fully disclosed/explained?

5. And if so, how do we avoid mandating a formulaic doctor-patient exchange, or do we?

There are no right or wrong answers…just an ongoing struggle. I look forward to hearing from you!

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2 Comments (+add yours?)

  1. DrAttai
    Jul 05, 2011 @ 06:21:53

    No right or wrong answers, just a lot of very good questions, and a lot of frustration on the part of physicians and patients alike. We all want the perfect drug. Or in an ideal world, the perfect preventative therapy. I would like to see more research in the area of drug response, so that we can more reliably predict which patients will benefit from a particular medication, but this will take time and money. And each individual, and each individual cancer is different – there are no easy answers. In the meantime, lots of discussion and struggles trying to balance overtreatment, side effects (sometime fatal), and saving lives. Thanks for keeping the discussion going!

    Reply

  2. TalkAboutHealth
    Jul 05, 2011 @ 16:31:09

    So many wonderful questions. And thank you for keeping the discussion going. Great summary of many of the issues our society is grappling with regarding medications and health.

    I believe that the tension between the constituents you mention is healthy and as we discuss and debate, we will understand better the different perspectives.

    I appreciate the process and debate that is ongoing.

    Reply

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