An ad attacking the AIDS drug Trizivir ran in the Washington Blade Aug. 29 and is scheduled to run in Frontiers in Los Angeles. It carried a bold red headline 'Trizivir Warning' and advised in smaller black type that the drug should not be taken alone.
The AIDS Healthcare Foundation ( AHF ) , based in Los Angeles, placed it as part of their ongoing feud with the pharmaceutical giant GlaxoSmithKline, which manufactures Trizivir. AIDS doctors and service organizations reacted to the ad and AHF's efforts against the drug with concern and frustration.
Trizivir is a combination of three nucleoside analogs, AZT, 3tc and abacavir. The single pill taken twice a day is easy to use and is the fifth largest selling AIDS drug in the United States.
In March of this year the NIH stopped the Trizivir arm of a clinical trial because it was 'inferior' to arms that contained Sustiva. It found that after 32 weeks, 21% of the Trizivir group but only 10% of the Sustiva group experienced virologic 'failure,' which was defined very conservatively as a viral load greater than 200. Those with detectable viral loads who were on Trizivir also was more likely to have developed viral mutation resistance points to nucleoside analogs.
In a letter to the FDA Aug. 19, AHF asked that agency to withdraw market approval of Trizivir, banning its sale. It charged that the drug 'has been shown to have minimal effectiveness ... that renders it unsafe.' It also wants to stop the company from advertising it as a one-pill regimen.
AHF executive director Michael Weinstein acknowledged in a phone conversation that their pharmacies continue to stock Trizivir. He said, 'We don't interfere in the practice of our individual physicians,' even though their letter to the FDA claims that the drug is unsafe.
Not only does AHF stock the drug in its pharmacies, according to Glaxo's numbers, AHF physicians prescribe Trizivir at rates that are higher than the national average.
Weinstein said they placed the ads in Washington and Los Angeles because 'people who are getting Trizivir are not being properly notified what the concerns are ... . People who go to doctors who don't see many AIDS patients are not going to be up on these things.'
However, he conceded that most people who read the ads in gay papers in those two cities probably do go to AIDS specialists.
'The other reason why we're running the ad is to put additional pressure on the FDA to move on this as quickly as possible.' Weinstein argued that with the large arsenal of approved HIV medications available for combinations, 'These fixed dose combinations really ought to be held to a higher standard.'
'I have a problem with Glaxo,' Weinstein said. 'I think that they are a rogue company. I think that they committed the original sin in AIDS drug development by pirating AZT from the NIH [ a court decided this was not the case ] and then charging 32 times the cost of production. I think that they are responsible for millions of lives being lost the world over by pricing at those levels.'
'The bottom line is that Glaxo dominates the market and they never discovered anything. And they continue to peddle stuff that is harmful.' AHF has filed lawsuits and taken other action directed against GSK over the last few years.
'We believe that AHF is acting very irresponsibly be petitioning the FDA to take Trizivir off the market,' said GSK spokesman Nancy Pekarek. 'Essentially this would deny patients and physicians a very important tool in the fight against AIDS.'
'The biggest concern that we have is that patients who are on Trizivir and are being very well managed will be misled by what are inflammatory comments by AHF and will stop treatment,' she said.
'The call to remove Trizivir form the market is not supported by the data,' said Gregg Gonzales, policy director with the Gay Men's Health Crisis ( GMHC ) in New York City.
There is a great difference between the NIH saying that one drug regimen is less effective than another, and AHF's charge that the drug is 'unsafe.' And by the time it ran the ad, AHF had tempered its language to say, 'Trizivir didn't protect patients as well as some other combinations of medicines.'
'It's irresponsible and dangerous to put out medical advice in press releases and sensational ad campaigns,' added Bob Huff, a New York City activist who edits the GMHC health publications. 'How might people who are doing well on Trizivir react when they see this ad? Stop taking their meds? Panic?'
There are anecdotal reports that some patients have reacted that way after seeing AHF's news release asking the FDA to withdraw Trizivir. It was distributed by some AIDS listservs on the Internet.
Princy Kumar, an AIDS physician at Georgetown University, acknowledged that Trizivir 'may not be the gold standard,' but she called it 'a valuable drug for a lot of my patients' because of issues of safety, compliance, side effects, drug interactions, and co-payments. 'I have problems with every drug,' she said, that's why it is necessary to have a variety of options available.'
Douglas Ward, a physician in Washington, D.C., with a large HIV practice called the ad 'sensationalism which is counter-productive. I've never been a big fan of a triple nuc regimen, I never start a naive patient on one, though I do have some patients that I have 'simplified' to a triple nuc regimen,' he said. 'There is a place for Trizivir in certain patient populations, and the success rate in other trails is not all that bad.'
Ken Haller, president of the Gay and Lesbian Medical Association, questioned the way that GSK is marketing Trizivir, and also the 'inflammatory' AHF ad. 'If they feel that Glaxo's ads are misleading, then perhaps they should look at their own ads, and try to raise the level of discourse a bit.'