Unpleasant and often dangerous side-effects of drugs used in the treatment of serious diseases are well-documented. Patients and clinicians often have the tremendously difficult task of weighing the side-effects of a drug against its efficiency before deciding whether or not to pursue a course of treatment.
So would you recommend prescribing a drug whose known side-effects include nausea, vomiting, dizziness, appetite loss, diarrhea, liver and kidney toxicity to a patient who was perfectly healthy?
That is the controversial decision taken by the US Food and Drug Administration (FDA) in the case of the HIV drug Truvada. The drug, already approved for the treatment of AIDS in conjunction with other drugs, does not rid the body of HIV but rather inhibits its replication in the body. Now the FDA has approved the drug as a preventive measure for uninfected men who have sex with men, for an uninfected person whose sexual partner is HIV positive and (most controversially) for individuals who engage in “risky sexual behavior” which could result in HIV infection.
The 22-strong FDA committee heard representations from over 40 healthcare professionals, AIDS advocates and patients, most of whom advised strongly against the drug’s approval. But after assessing data from studies conducted inBotswanaandKenya, they came down on the side of approval, though not unanimously.
Supporters of the decision included Kirk Myers, CEO of Abounding Prosperity Inc and himself HIV-positive, who said: “People need to be given the option to choose. This drug is wanted.”
But Robert Elliott, a registered nurse, stated: “There is no question that, if efforts on using [Truvada] are widespread, condom use and other means of preventing HIV infection will decrease.”
Michael Weinstein, president and founder of the AIDS Healthcare Foundation described Truvada’s approval as a preventive measure a “reckless act”.
AIDS activist Miki Jackson said: “To knowingly recommend a drug as powerful as Truvada with such serious side-effects and given to people who are perfectly healthy is frightening.” adding that giving the drug approval was “akin to issuing an engraved invitation for lawsuits.”
