The legal right to medical decision-making

Hi, readers!  Long time, no blogging.

In the few years, there has been a huge push to legalise assisted suicide. Brittany Maynard became a national figure for the right to assisted suicide before she took her life.  Several states have legalised it.  Proponents of assisted suicide have argued that dying individuals, not the State, have a right to determine their medical care, and that swift death can be a compassionate alternative to prolonged, hopeless suffering.  (For the record, I do not find these arguments to be persuasive.)

Given that Americans are embracing this logic, it’s ironic that the same logic does not apply to the F.D.A.’s approval and clinical trial process for experimental, potentially life-saving, drugs.  The New York Times (hat tip) reported that the FDA is streamlining the process after its oncology chief, Dr. Richard Pazdur, lost his wife to ovarian cancer.

The F.D.A. has a notoriously slow approval process for new drugs.  This is largely a result of the thalidomide crisis in the 1960s, when pregnant women who took an anti-nausea drug gave birth to children with severe deformities (including flippers instead of arms).   F.D.A. medical officer Dr. Frances Kelsey refused to approve the drug after he found that it had not been tested on pregnant animals.  As the drug was never approved in the United States, American babies avoided the devastating harm that other children faced in countries where thalidomide had been approved.  The F.D.A.’s cautiousness in approving the drug has been used to justify its slow approval process in the half-century since the crisis.

Much of the problem with thalidomide was that its costs were out of proportion with its benefits: it reduced nausea, but could cause lifelong severe deformities.  As a general rule, we are more willing to approve drugs that cause a lot of harm if they also do a lot of good (e.g. a drug that has chemotherapy’s side effects would never be approved to reduce headaches, but is fine when it could save someone’s life). As such, the F.D.A. has a “compassionate use” programme, wherein severely ill people can apply to take unapproved drugs in the hope of saving their lives.  The rationale is that the patient will probably die anyway, so the additional risk of taking the unproven drug is minimal.  As the NYT explains,

That decision was made in a separate category of “compassionate use” drug approvals for individual patients. Every year, the F.D.A. receives about 1,000 similar applications from terminally ill people seeking experimental medications, and agency officials say they approve 99 percent of them. The approvals are distinct from those for drugs that have gone through clinical trials and that are for broad distribution.

So every year, about a thousand people apply for “compassionate use” drugs.  Every year, over a half-million people die from cancer.  Obviously, many of those people pass away from types of cancer that are not the target of any drugs in clinical trials or the approval process; but whatever that percentage of cancer patients who could benefit from a drug in the pipeline is, it is probably higher than 0.5%.  In fact, the number of people who apply for and receive permission for “compassionate use” of an experimental drug is approximately equal to the number of people who undergo euthanasia every year in America (even though assisted suicide is limited to a small number of states).

In effect, we are a country wherein a cancer patient is just as likely to commit suicide via a lethal dose of legal drugs as he is to receive experimental, potentially life-saving medical treatment.  Analytically, the laws governing each are different: the “drug cocktail” that is used for assisted suicide is an off-label use and therefore not governed by the F.D.A., and state law, not federal law, governs assisted suicide.  But in a discussion about the policy that governs the approval process for potentially life-saving medication and the availability of compassionate use, it is damning that Americans are just as likely to use legal drugs to kill themselves as they are to apply for life-saving ones.

 

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Filed under Bioethics, Law, Reforming health care

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