Medical Finds Queue For Official Approval (Press, 22 September 1987)

On 22 September 1987, it was reported that a new cholesterol treatment, lovastatin, produced by Merck, has been approved by the United States Food and Drug Administration (F.D.A.). This innovative drug has shown the ability to reduce blood cholesterol levels by 18 percent to 34 percent during human clinical trials, suggesting that it could significantly aid approximately 10 million Americans struggling with high cholesterol that has not improved through diet or exercise. However, lovastatin's approval is just one breakthrough among many awaiting evaluation by the F.D.A. The agency is currently facing a backlog of applications for various promising new therapies. These include treatments that could dissolve blood clots responsible for heart attacks, slow down the progression of A.I.D.S. (acquired immune deficiency syndrome), and combat various cancers. Other experimental drugs may also help with issues like hair loss, weight control, and alcohol dependency. The slow progress of drug approvals has been attributed to several factors, including recent budget cuts and staff reductions that have further delayed the regulatory process. The F.D.A.'s cautious approach in evaluating the safety and effectiveness of new medications, particularly against potential side effects, is also a significant reason for slow approvals. This is especially notable in the case of A.I.D.S., where the urgency for new treatments has led to criticism of the F.D.A. for its perceived sluggishness. Larry Kramer, co-founder of the Gay Men’s Health Crisis Centre, voiced concerns to a presidential commission about the agency's outdated regulatory framework and the urgent need for quicker action. Currently, only one drug, A.Z.T. by Burroughs Wellcome, has been approved for A.I.D.S. in the U.S., which does not cure the disease but helps manage its symptoms. In mid-August, the F.D.A. had approved human testing for an A.I.D.S. vaccine developed by MicroGenySys, with other potential vaccines expected to follow, although experts warn that developing a viable vaccine could take time. Another controversial treatment awaiting F.D.A. decision is T.P.A., a genetically-engineered agent that helps dissolve blood clots and potentially prevents heart attacks. Despite showing promise in human trials, its final approval has been stalled due to calls for more data, leading to dissatisfaction in the medical community. The F.D.A. is also evaluating minoxidil, a blood pressure medication shown to stimulate hair growth, which sparked public interest. Although an expert committee previously supported its approval, the agency indicated it may take additional months for any final decision. Additionally, there is speculation about the potential approval of fluoxetine, an antidepressant by Eli Lilly, which may have beneficial side effects in reducing overeating and excessive drinking. It is expected that fluoxetine will gain approval later in 1987 for treating depression, but doctors might also utilise it for other purposes.

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