Last week, Abbott Laboratories announced it will not market any new medicines in Thailand. The decision sounds harsh, but it was provoked by the refusal of Thailand’s military-appointed government to honor a patent for Abbott’s AIDS drug, Kaletra.
#ad#Activists around the world, including the prestigious Medicins Sans Frontieres (Doctors Without Borders), have applauded the Thai government for breaking patents to drive down prices. Poor patients’ health should take precedence over intellectual-property rights, they argue, reasoning that private profits are at the expense of public health. They couldn’t be more wrong.
Drug patents give companies a powerful financial incentive to invest in the risky and expensive process of drug development; without patent protection, the pipeline of new medicines would be severely reduced. This would be an enormous tragedy for public health — including global efforts to fight AIDS.
A decade ago, the prospects for taming the AIDS virus through antiviral drugs seemed much brighter. Starting in 1996, the use of combination antiretroviral drug “cocktails” for AIDS patients (what scientists call Highly Active Antiretroviral Therapy or HAART) slashed mortality rates, with AIDS deaths dropping by over 40 percent in just a single year.
Unfortunately, scientists quickly realized that the AIDS virus mutates so rapidly that it can quickly become resistant to even the newest antivirals. Today, some researchers estimate that in the U.S. up to “50 percent of patients receiving antiretroviral therapy are infected with viruses that express resistance to at least one of the available antiretroviral drugs.”
Furthermore, there are serious side-effects associated with the use of many antiretroviral medicines, meaning that many patients routinely skip or miss doses of medicine, giving the virus enough “breathing room” to develop drug resistance.
As antiretroviral treatments are increasingly used in the developing world, poor patients will face the same drug resistance phenomenon as patients in wealthier nations. And since the vast majority of AIDS patients reside in poor or middle income nations with minimal health-care infrastructure, the problem of resistance there is likely to occur on an even larger scale.
To combat AIDS globally, access and drug innovation must go hand in hand. Thankfully, the industry is not resting on its laurels, and is investing heavily in the development of new AIDS medicines — nearly 80 treatments are in development today, including 19 vaccines.
Indeed, one new class of drugs, called CCR5 inhibitors, may have found a way to slow the development of viral resistance. In 1996, when drug cocktails were revolutionizing AIDS treatment, researchers also noted that some patients exposed to HIV never developed AIDS because of a missing protein receptor on the surface of their CD4 immune cells (the cells that the virus attacks when it invades the body). Without access to this receptor, the virus couldn’t hijack the cells to make more viral copies.
Researchers then theorized that it might be possible to use a drug to block the initial “handshake” between the HIV virus and the receptor. Since then, several companies have worked hard at developing CCR5 inhibitors, with mixed results. One drug, aplaviroc, from GlaxoSmithKline, was withdrawn from development in 2005 after severe liver toxicity reactions developed in some patients.
Two more drugs, one from Pfizer (maraviroc) and another from Schering Plough (vicriviroc) are in late-stage testing, with Pfizer’s drug likely reaching the market first — it will receive “accelerated review” at both the FDA and its European counterpart, the EMEA.
Maraviroc, if approved by the FDA, will represent a breakthrough treatment — the first time that a marketed drug has targeted a human protein rather than an AIDS viral protein. This is a key factor because it should (at least in theory) help slow the development of drug resistant strains of the virus. But almost nothing is certain in drug development.
This brings us back to Thailand’s dangerous precedent. While Thailand isn’t a wealthy nation, it isn’t a desperately poor one either. It can afford to pay more for AIDS medicines than many countries in, say, Africa. And, unlike Africa, the AIDS epidemic in Thailand is largely under control thanks to aggressive prevention efforts undertaken in the 1990s.
Finally, while the government cries penury, its defense budget has increased by over 30 percent. The issue, then, isn’t about a “public-health emergency” but about how much the Thai government wants to spend on health care.
Drug discovery is unpredictable, expensive, and time consuming. On average, it takes about $1 billion and over a decade to successfully bring a single new product to market. This enormous expense includes the cost of testing thousands of failed compounds (like aplaviroc), which companies must recoup through a handful of successful medicines. And they must do this during the effective patent life of the drug (about ten years), before generic competitors enter the market.
If every time a country decided that it wanted to reduce public-health spending it broke patents on medicines for diseases like AIDS — or cancer, diabetes, and heart disease — pharmaceutical investors would seek out a less risky industry in which to invest their hard-earned capital.
Rather than punishing companies that produce life-saving medicines, developing countries like Thailand should make a special effort to ensure that they respect intellectual-property rights, limit compulsory licensing to true public health emergencies, and work with companies to determine a fair price for their products relative to the local economy.
This is a recipe for long-term success — both for the industry and for global health.
– Paul Howard is a senior fellow at the Manhattan Institute’s Center for Medical Progress.