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The US Food and Drug Administration approves only 2,500 new medications a year for the treatment of cancer. One these drugs, mifepristone, is responsible for hundreds of thousands pregnancies in the US. However, many states prohibit its use. Mifepristone is often mislabeled as penicillin for the reason that it is used to treat penicillin-resistant HIV in women.
"It's a great pharmaceutical that's used to treat HIV - something that we can all benefit from," says Michael Durnhill, a physician at New England Baptist Medical Center in Massachusetts. "It works effectively, it does not affect fertility and can improve male sexual response to sperm. But it's completely inappropriate to use a highly controversial drug that can affect thousands of lives and that is not commonly available."
Some drugs do have a purpose - treating HIV and other infections before they occur. But other drugs can be dangerous and, based on the FDA's own research, can increase the risk of addiction and disease progression, could take weeks or months to start working. Many other drugs' safety and efficacy are dubious at best. The World Health Organization has warned that it may be too early to recommend any of them for clinical use humans.
The researchers at institute also looked whether these drugs can be used to treat addiction in people who are suffering from drug abuse. The study appears online this week in JAMA. They found that while mifepristone appeared to reduce sexual urges more than was initially realized in some previous animal research, there was no evidence of increased self-stimulation rates, the researchers say. drug was tested in people who had significant problems with heavy drinking, which would likely result in withdrawal-like behaviors, including anhedonia, compulsive eating, or other symptoms associated with withdrawal. To study mifepristone's effects on these behaviors, the researchers asked participants to hold a glass of water while they were shown photos of women with HIV, a comparison group for the study, and they looked at their photos in the mirror again. What they found was the drugs reduced "hypersexual" behavior from the people they had not seen in the photographs (the HIV-A group) and reduced hypersexual behavior more easily seen in the pictures with women HIV. other group showed the same behavior, but there were no differences in hypersexual behavior between those two groups.
The researchers theorize that people who smoke addictions get hooked quickly, so they take longer to achieve abstinence than the people they have not seen in the photographs.
Dr. Durnhill says he "would like to see" the use of mifepristone for alcohol and other drug abusers, he would like to see the FDA use its authority over public health to approve mifepristone rather than drugs that "exaggerate potential safety or reduce patient in favor of marketing and marketing-promoting interests." In fact, Durnhill says the FDA should allow mifepristone on the market.
FDA spokesman Mark Gottlieb says the agency "absolutely" does. "The FDA's clinical research and review process requires all drugs for human consumption to have an effective and acceptable safety efficacy profile that can be readily demonstrated in clinical trials... It is unfortunate that this research did not make its way through the clinical approval process for mifepristone, something we've been extremely clear about," Gottlieb said.
But no one disputes that this research did not make its way through the clinical approval process for mifepristone. Some critics of the study feel it may have been based on unreliable data. But the researchers point out that problem of drug discrimination in addiction trials is far from secret.
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