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HIV drug resistance brings calls for new medicines
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AIDS officials endorse patent protections for drug companies
By JOE CREA
Dec. 12, 2003
washingtonblade.com
David Reznik said he cannot imagine what it would be like to lose a second partner to AIDS. Having lost his first partner, Eric White, in 1994, Reznik, chief of Dental Services at Grady Health System in Atlanta, remembers all too well the painful trial of the tragedy.
"When AZT failed, he became paralyzed on the left side of his body as a result of brain cancer," Reznik said. "He also had trouble with his vision. He was an artist and because of the disease, he could no longer be that. Dealing with it was awful the first time around and I don't know how I would react to losing another partner."
But now Reznik is facing just such a possibility. His current partner of eight years, Hugh, who has been HIV positive since the early 1990s, is resistant to all existing HIV drugs.
"Our family is out of options," Reznik said.
New strains of HIV, resistant to all of the commonly prescribed HIV drugs, are growing. There are hundreds of documented cases in the United Kingdom of patients who do not respond to existing HIV drugs, according to figures from Britain's Health Protection Agency. In 2001, 154 people were told they were resistant to the three available classes of drugs. In 2000, it was 115.
There are no current figures for the United States suggesting an increase of resistance to HIV medicines. But AIDS activists and officials say it is a problem that will grow, especially in light of recent Centers for Disease Control & Prevention figures showing HIV infections in the United States are climbing.
The likelihood of increased resistance to HIV drugs underscores the need for pharmaceutical companies to develop new drugs while also providing access to existing drugs, officials say.
Abner Mason, executive director of the AIDS Responsibility Project and member of the Presidential Advisory Council on HIV/AIDS (PACHA), said one way to provide for such research is to provide drug manufacturers with incentives by strengthening intellectual property rights and patent protection for pharmaceutical companies.
"Intellectual property rights and patent protection are really essential to the fight against HIV because the only tool we have to really save lives are the drugs," Mason said. "The drugs we currently have will only work for a certain period of time because of resistance. And the only thing that produces new drugs is incentives."
Recognizing the growing drug-resistance problem, PACHA unanimously passed a Trade Related Intellectual Property (TRIPS) Resolution in August asking President Bush and Tommy Thompson, secretary of Health & Human Services, to support strong intellectual property rights policies and other financial incentive issues for pharmaceutical companies. They hope the move will encourage companies to invest in new research.
While recent figures from the Pharmaceutical Research Manufacturers Association (PhRMA) show that 83 drugs or vaccines are currently being developed, AIDS drugs development has fallen by nearly 30 percent in the past five years, according to Roger Bate, a visiting fellow at the American Enterprise Institute. In a recent column, Bate criticized groups like Act Up and Doctors Without Borders for attacking "corporate greed" which has resulted in companies escaping "the no-profit zone that AIDS research has become."
"These groups take a very hostile position because they see people around them dying who can be saved," Bate said. "While they were very instrumental, and wisely so, in putting enough pressure on the drug companies to lower their prices they have gone beyond that and essentially want the companies to give drugs away for free."
Mark Grayson, vice president of communications for the Pharmaceutical Research Manufacturers Association said that price controls take away the incentives for companies to develop new drugs.
"Companies need to have reasonable returns on their investment and unfortunately, people need incentives," Grayson said. "It's difficult to come up with new medicines without them. And to come up with new medicines, someone has to take the risks. It's not easy building a factory, especially for AIDS drugs. Those things are extraordinarily expensive. So, some will say, 'Well, we'll get generic drugs instead,' and I say, 'Have you ever seen a generic manufacturer make protease inhibitors?'"
Dr. Arthur Leonard Caplan, chair of the medical ethics department at the University of Pennsylvania, said that companies have not escaped the "no-profit zone" and added that "attacks in the name of the impoverished are not attacks, they are demands."
Mason criticized the practice of selling drugs at unreasonably low costs adding that it is "a short-term solution to a problem that causes a bigger problem in the long-term."
"Some say, 'just force the drug companies to charge less.' Well, if you do that, it takes away the incentives to produce new drugs," Mason said. Why would a potential investor invest in a particular company that isn't making any money? We need to save lives today by using patented drugs that may cost slightly more but encourage new investment in drugs for the future."
Caplan said he partly disagrees with Mason's assessment, saying that it is impossible to "gauge people price wise and use that to charge people whatever you want."
"Companies haven't been forthright about what their prices are and incentives doesn't mean they can have unleashed, unbridled, unrestricted incentives," Caplan said. "You need to set some limits, reasonable limits, on prices. Because if we don't, we foot the bill for AIDS research for the world because the rest of the world won't pay our prices."
PACHA member Brent Minor said that the pharmaceutical companies should not drop the price of drugs but work to cover the costs of drugs.
"I've argued from the beginning that the solution should not be lumped onto the shoulders of one entity," Minor said. "Everybody has to pitch in and do their fair share. The main goal is to get people on drugs and that need is greater than the petty concerns of everyone else."
New drug too expensive
Fuzeon, a new drug developed by Roche Laboratories Inc., which stops HIV from entering healthy cells, is available but the drug is expensive and is not easily accessible because of the cost, Minor said.
"The last thing a state needs is a drug, like Fuzeon, that's going to cost $22,000 a year," Minor said. "Some states are not putting it on their formula because they can't afford it while people need access to these drugs that combat AIDS."
Reznik said his partner Hugh started taking Fuzeon as his last option but he's currently showing resistance to that drug as well. Reznik said that Hugh's HIV has mutated over the years and as a result his body has exhausted all existing therapies.
"He's gone through the successful, succeeding/failing therapies that are the practice of medicine," Reznik said. "He first went on medicines in the '90s before researchers knew about resistance. We didn't know what worked and what did not. But, he was able to receive some short-term benefits."
Mason and Bate agreed that patent rights must be protected. Bate said a patent system is like a democracy - "far from perfect but the best thing we have at the moment." However, Caplan said that for patents to work properly, drug companies must exploit their product.
"Let's say I own the Mona Lisa," Caplan said. "I could put it in my basement and never let anyone see it. Or I could set it on fire and use it for fuel or I could say people can come look at it but I will charge them an exorbitant fee. "Now, patents are great but they are privileges society gives to encourage innovations but at the same time, if you don't exploit your innovation or take patents to prevent someone from exploiting their innovations, then I would say that's an abuse of your patent."
Another lost generation?
Reznik expressed frustration with the apathy he says many young gay men seem to have toward HIV. He said that one of the problems for gays is that "we don't have children."
"I'm Jewish and most of my family died in the Holocaust and one of the things you heard constantly growing up was, 'We can never allow such a thing to happen again,'" Reznik said. "I would tell children the same thing. Even though we can manage the disease better, it still does not discount the fact that it is a devastating disease. It is a serious impact on public health that takes an incredible level of expertise to manage. All of my patients who have the disease say they do not want it. The apathy must go away. We lost a generation of talented young people. We can't allow that to happen again."
Community Commentary Anonymous
THE KEY TO INCENTIVES FOR DRUG DEVELOPMENT IS BECOMING MORE RE-IMBURSEMENT THAN PRICING. HIGHER PRICES FOR DRUGS FAIL TO PROVIDE EFFECTIVE RESEARCH INCENTIVES WHEN THE MAJOR RE-IMBURSEMENT POTS, SUCH AS ADAP OR MEDICAID, REMAIN FLAT FUNDED. MOREOVER, SINCE THE COST OF PRODUCTION IS A SMALL PART OF THE PRICE OF PHARMACEUTICALS, IF DRUG PRICES ARE CUT IN HALF SO THAT THE MARKET CAN TRIPPLE IN SIZE (ONLY POSSIBLE WITH BETTER REIMBURSEMENT) DRUG COMPANIES WILL MAKE HIGHER OVERALL PROFITS ON LOWER PRICES. GOVERNMENTS PAY FOR AN INCREASING SHARE OF TOTAL RE-IMBURSEMENT---CONGRESS JUST ENACTED A HUGE EXPANSION IN THE MEDICARE DRUG BENEFIT. AS WE SHIFT FROM A FREE MARKET WITH MILLIONS OF CUSTOMERS TO A MARKET LIMITED MAINLY TO GOVERNMENTS AND LARGE INSURERS, INCENTIVES SHIFT FROM PRICING LEVELS TO LEVELS OF RE-IMBURSEMENT. AIDS ACTIVISTS WOULD GET BETTER RESULTS OVERALL BY ADVOCATING FOR MORE RE-IMBURSEMENT RATHER THAN LOWER PRICES; BUT WHEN THE RE-IMBURSMENT POT DOES NOT KEEP PACE WITH THE NEED, PRESSURE FOR LOWER PRICES IS INEVITABLE.
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