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America considers offering 'untried remedies' to people with AIDS

America considers offering 'untried remedies' to people with AIDS

作者:贺酮  时间:2019-02-26 08:04:00  人气:

By CHRIS VAUGHAN in WASHINGTON DC POTENTIAL anti-AIDS drugs could be offered to patients in the US after only the most basic safety trials if the Food and Drug Administration decides to adopt a policy currently under discussion. The policy, which has been forwarded to the FDA for final review by the government’s Department of Health and Human Services, could dramatically change the way that the US approves drugs for the treatment of many other diseases, according to James Allen, of the government’s National AIDS Program. Health officials have come under increasing pressure from patients’ rights groups to make drugs available before clinical trials are completed. Last August, Larry Kramer, one of the founder members of ACT-UP, the AIDS Coalition to Unleash Power, threatened that activists would sabotage clinical trials of drugs against AIDS if the FDA did not relax the approvals process. It can take up to 10 years of exhaustive clinical trials before a conventional drug gains the FDA’s approval. The proposed programme of so-called ‘parallel-track’ trials would allow AIDS patients access to new drugs that had been tested for safety in between 20 and 80 healthy volunteers. At the same time, these drugs would undergo full clinical trials. The proposal is part of a trend at the FDA towards relaxing the regulations on new drugs for life-threatening diseases where there is currently no therapy for the disease. In recent years, the FDA has occasionally allowed small numbers of terminally ill patients access to unapproved drugs under a separate policy of ‘compassionate use’. The difference with the parallel-track policy, however, is that it would allow nearly all people with AIDS to receive new drugs earlier in the review process than ever before. Patients’ advocacy groups have hailed the move as a major benefit for the many people with AIDS who cannot participate in clinical trials because they are too sick or they do not fit the protocol. ‘In a perfect world there would be no parallel track because everyone would be in a clinical trial,’ says James Eigo, a member of ACT-UP. But in an imperfect world, he says, the parallel-track programme is the best way to ensure that people can get drugs as soon as they pass the first safety tests. Critics of the proposal say it is irresponsible to allow people to take drugs that have undergone only minimal tests and which could do more harm than good. ‘Parallel track is a misfortune for AIDS patients,’ says Paul Meier, a professor of statistics at the University of Chicago who is a member of an advisory panel to the FDA. ‘The arguments for parallel track are much like the arguments for other untried remedies that experience has shown do not help and in fact hurt.’ Susan Ellenberg, a statistician at the National Institutes of Health, says she is nervous about the idea of releasing a drug to hundreds of patients when there are data on its safety from only a small group of people. According to Ellenberg, even if a drug reveals no toxic effects in a safety test involving 20 people, it is statistically possible that the drug will be toxic to 17 per cent of the population at large while it is still within the 95 per cent confidence level. Some physicians are concerned about how closely patients will be monitored on parallel-track trials. Jeffrey Laurence, a physician at the New York Hospital-Cornell Medical Center, says one of the biggest problems is the difficulty of coordinating information about an experimental drug’s side effects. This nervousness was echoed by many scientists following the announcement earlier this month that far fewer patients have died on the clinical trial of DDI, a second potential drug for AIDS, than among those taking the drug through an ‘expanded access’ programme similar to the proposed parallel track. Out of 700 people on the clinical trial of the drug, two have so far died, compared with 290 of the 8000 people on the expanded access programme. However, only 7 of the 290 deaths were directly proven to be attributable to the drug. Defenders of the expanded access programme argue that such comparisons are not valid because people on the programme are often those who are too sick to be in the clinical trial, and therefore more likely to die anyway. This week at a meeting of the advisory panel in Washington DC, Meier will propose that the FDA undertake very large-scale clinical trials instead of a parallel track programme. Meier says such trials would concentrate on a very few questions and make the monitoring process simple,