Treatment Issues: Newsletter of Experimental AIDS Therapies - Volume 14, Number 3/4, Spring 2000
Theo Smart

Despite Dr. Miles concerns that early antiretroviral therapy may be harming some patients, as noted in the Celia Farber article, he thinks that the drug bashing has gone a little too far. He is concerned that some patients who should be on treatment are quitting, and others afraid to start.

"Sometimes I'd like to give the community Lithium, because we go from 'Oh, therapy is terrible,' to 'therapy is wonderful,' to 'therapy is terrible' and back again.

"I have an oncologist colleague who draws a bell-shape curve to describe the community's response to new treatments. The curve starts at zero and you begin going up with phase I data that is promising, then there is a huge shift with good phase II data and the start of phase III studies and open label access programs. The highest point is reached when people realize that the one percent, toxicity that seemed minor before is actually causing problems in a significant number of people. At that point, the curve starts to descend and you go below zero when the drugs are bashed as horrible. But then the curve starts going back up again, as people begin to get an honest appraisal of the drug's benefit.

"The real problem I see now is patients who really ought to be on drug but who have quit treatment since February and early March [after the Retrovirus Conference and the Gear article respectively]. That's the really devastating thing. People who should be on therapy are telling their doctors that everything is okay and then go home, and never pick up their scrips. There are large groups of patients who have heard about the toxicity, heard about treatment interruptions and have taken home the message that it is okay to go off treatment.

"In LA, there were 20,000 fewer prescriptions filled in March because patients stopped taking their medications, and in April, another 8,000 stopped.

"The pendulum has swung back, partly because of drug company marketing where one company is bashing the other companies' drugs as toxic. You just don't do that. It's like negative campaigning in an election. All the voters stay home."

At the same time, Dr. Miles thinks that drug companies should be able, on the basis of controlled clinical trials, to report whether their drugs are less toxic than those of their competitors.

"Manufacturers ought to be able to amend their product labeling, when data show that their product is less toxic than their competitors', because it would encourage them to do more toxicity research and to develop less toxic drugs. We need to find ways to use better tolerance as a differentiation feature for accelerated approval, and put less emphasis on efficacy."

His message to manufacturers: "The war is not over — we've got to come up with new medicines, new drugs that are less toxic."

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