Don’t Kill Cancer Drugs

A drug that has proven effective in fighting cancer might cause heart troubles. Gleevec, as national news sources widely reported late this summer, has been linked to 10 cases of congestive heart failure. Gleevec has also, as has been less widely reported, been linked to thousands of lives saved. Concerns about “another Vioxx” may be blindly accepted, leading the Food and Drug Administration (FDA) to increase regulation and make it harder for patients to get access to live-saving medication.

But why should we give more weight to the risks of taking a positive action—in this case, consuming a potentially useful drug—than to the risks of inaction? Why is it scarier that a drug will cause us heart trouble than that not taking a targeted cancer-killer will result in our deaths? Rationally speaking, it’s not: A death from a heart attack is not much worse than a death from colon cancer. So, if I have cancer and Gleevec makes it 20 percent less likely that I will die from that cancer but it also makes it 10 percent more likely that I will die from heart failure (in fact, it’s estimated that only 0.1 to one percent of Gleevec users will be affected), I would still rather take the drug.

And, indeed, that is what many of the more careful news reports recommend. The report that found the 10 cases of heart problems noted at the same time that Gleevec is a “wonderful drug and patients with these diseases need to be on it.” But, in general, recent coverage of the adverse side effects of certain drugs tends to generate calls for more stringent—and thus longer and more expensive—FDA screening.

Drugs already get a lot of government scrutiny—too much, in fact. A 2001 study by the Tufts Center for the Study of Drug Development showed that once drug development was initiated, it took an average of $802 million and 10 to 15 years for a drug company to win the right to offer their product to American consumers. During those years, every American that could have benefited from the drug—either by having a higher quality of life, or by being alive at all—has not, while her cohorts in less draconian countries have been living better and longer. Every time the FDA approves a new drug, as it just did for Symbicort, a new asthma medication, and touts the drug’s benefits, it ignores that its delay in approving the drug has deprived Americans of those benefits for as long as it spent in the pipeline.

Further, the tremendous sum that it costs to get a drug approved severely constrains the number of drugs companies are willing to develop. If a pharmaceutical company cannot expect to make back their costs—which could reach over $1 billion—in sales from a drug, it will not even go to the trouble of submitting the drug for FDA approval. This limits the options available to those with rare diseases, because the FDA creates a huge disincentive to make drugs that will only help a “niche” market. That explains why we have seen such a large decline in the number of drugs introduced per year since the FDA got serious about regulating the market.

This is very bad news for patients with terminal illnesses. Certain that they are going to die if a treatment for their disease is not made available quickly, terminally ill patients are generally quite willing to try anything that might work, even if the drug is risky. When patients have little to lose, it seems completely unreasonable for the FDA to not even let them try. That may be why the federal appeals court for the D.C. Circuit, the court that hears cases about regulatory agencies, ruled on May 2 that “a terminally ill, mentally competent adult patient’s informed access to potentially life-saving...new drugs” is a right that “warrants protection under the Due Process Clause.”

This breakthrough case told the FDA that it may not be constitutional for the government to make patients’ decisions for them. The case takes a step to recognizing that people have a right to choose what medication they want to take. They have a right to weigh the potential risks and benefits of drugs for themselves, with the advice of independent analysis, and decide whether it’s worth it to them. The D.C. Circuit’s ruling is a victory for our rights and a victory for our health. We should applaud it, and tell the FDA that it must allow terminally ill patients to take Gleevec or whatever other medications might save their lives.

Alexander N. Harris ’08 is a Social Studies concentrator in Winthrop House. He is the President of the Harvard Libertarian Forum.