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Just a few weeks ago, Hollywood honored Matthew McConaughey with the Academy Award for Best Actor in the movie Dallas Buyer’s Club. Matthew plays Ron Woodroof, a real-life Texas electrician and rodeo rider, who discovers that he has contracted AIDS after sex with an infected drug user. The doctors tell him he has only 30 days to live. The year is 1985, and no treatment is available on the US market.
Woodroof quickly discovers in a very personal way just how deadly the FDA’s consumer protection regulation can be. His doctor offers him a place in a clinical trial, which was designed to test how effective AZT (zidovudine) is against HIV. AZT will eventually become the first drug available in the US for the treatment of AIDS.
However, going into the clinical trial doesn’t guarantee that Woodroof will get AZT. Until the trial is over—and his 30 days is already up—Woodroof won’t know if he is getting placebo (a sugar pill) or AZT. The FDA requires the drug maker to give placebo to half of the patients, so that AZT’s effectiveness can be “proven.” Woodruff is appalled that he and other desperately ill people are being used as guinea pigs in this way.
Rather than enter the clinical trial, Woodroof sets out to find himself a cure. First, he bribes an employee to raid the hospital’s supply of the AZT used in the trial. When that source dries up, Woodroof researches what’s available in other countries, starting with Mexico. He finds that other nations with less stringent regulations already have anti-viral drugs in their pharmacies that might work against the AIDS virus. Woodroof finds a doctor who uses clean living and nutrition, along with some of these other options, to stabilize his condition.
Like several other HIV positive-individuals across the U.S. (see Jonathan Kwittney’s book, Acceptable Risks for some other stories), Woodroof sets up a Buyer’s Club to help other patients gain access to drugs available outside the country. The FDA goes after Woodroof, even though the agency has mostly ignored clubs in California and New York. The FDA confiscates his inventory without a trial, keeping potentially life-saving treatments from suffering AIDS patients. Woodroof fights back.
Back in the mid-1980s, AIDS patients lived less than two years after being diagnosed. Using drugs available overseas, some of which are still not marketed in the US, Woodroof beats the odds.
While Woodroof was fighting the FDA, I was working at a major pharmaceutical firm (Upjohn) to research the next generation of anti-AIDS. By the time that the FDA gave us permission to test our drugs in people, every AIDS patient in the country who wanted them had already tried them. The Buyers Clubs either obtained them overseas or hired black market chemists to make them. Much valuable information about how these drugs worked—or didn’t work—could have been obtained from these Clubs if their operations hadn’t been in legal limbo.
Woodroof’s abhorrence to entering a clinical trial where he might get a placebo has been echoed by many ethicists since the FDA started to demand placebo-controlled trials in the early 1970s. Instead, concerned ethicists recommend using “historical controls” (untreated patients) instead of placebo-controlled trials with the terminally ill. The FDA’s insistence on giving placebos robs today’s terminally ill of their chance to live in the hopes that future patients will have a better chance of survival.
The FDA does not allow terminally ill to choose whether or not to make this sacrifice; it is forced upon them by making other options illegal. Consequently, cancer patients recently sued the FDA in order to gain access to drugs that had been tested for safety in humans, but not effectiveness. Had access been granted, cancer patients would have been able to try new drugs that wouldn’t be market for another 3-6 years. However, the courts ruled that the “right to life” guaranteed by the US Constitution does not include saving our lives with unapproved drugs.
Dallas Buyers Club illustrates how FDA regulators quite literally rip life-saving drugs out of the hands of the desperately ill, forcing them into the black market when they are at their most vulnerable. Death by regulation is the price we pay for the FDA.