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Risky Behavior
It's Bush's critics who are putting ideology before science and health.


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BANGKOK–Activist groups and some Democrats have vigorously criticized the Bush administration’s response to the global AIDS problem. Presidential aspirant Sen. John Kerry has accused the president of putting ideology before science. But the reality is quite different. Indeed, as the Fifteenth International AIDS Conference kicks off this week in Thailand’s magnificent capital city, it is becoming increasingly clear that it’s the activists and opportunistic Democrats who are putting ideology first.

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Just two years ago, a group of agitators loudly jeered Department of Health and Human Services Secretary Tommy Thompson during a speech he presented to the Fourteenth AIDS Conference in Barcelona. They waved signs reading “Wanted: Bush and Thompson for murder and neglect of people with AIDS.” The charge is nonsense. No world leader has pledged more in resources to fighting AIDS than President Bush, who established a plan to provide $15 billion in American taxpayer dollars to the cause.

Much of that money will go to procure anti-retroviral medicines (ARVs) for victims in poor countries. ARVs are the life-saving drugs developed in recent years by American and European pharmaceutical companies. When administered properly, ARVs can transform HIV/AIDS from a death sentence to a manageable chronic illness.

Instead of applauding this generous plan, White House critics are now charging that the administration is blocking the flow of cheap ARVs to poor countries. Copycat versions of the patented ARVs have been developed by companies in India and South Africa. The Bush critics say these copy drugs are perfectly adequate for treating AIDS victims. The World Health Organization has approved many of these drugs for use on its “prequalification” list of AIDS-related medicines, and they are being administered around the globe.

What’s more, the administration critics point out, some of these copycat manufacturers offer combinations of up to three drugs in one pill. Global-health activists are thrilled by these combination pills: They potentially make it easier to treat patients in poor countries, since there are fewer pills to take. The health-activist group Doctors Without Borders said in a March briefing note: “Fixed-dose combinations (FDCs) of ARVs [that is, pills containing two or three AIDS drugs in one tablet] are widely recognized as being a key element in efforts to scale up AIDS treatment in developing countries.” The combination drugs currently being used, they say, are effective and safe.

So why isn’t the U.S. buying these drugs as fast as it can and distributing them? Current U.S. policy wisely insists that the American dollars allotted to fight AIDS be used to purchase drugs that have undergone rigorous Food and Drug Administration inspection, which these copycat drugs have not yet done. For AIDS victims to get good treatment, any copycat versions of the ARVs would need to be bio-equivalent to the innovator drugs in terms of active ingredients, strength and dosage, safety, quality, and performance. Insisting on bio-equivalence is a keystone to responsible global healthcare administration. Anything short of that is risky and imprudent.

That’s especially true with treating AIDS. If patients take drugs of poor quality, they run a heightened risk of mutating the virus, in turn making it more deadly and–it is critical to note–significantly more expensive and difficult to treat in the future. So U.S. health officials want to make sure AIDS patients are getting the best care possible. That means getting them drugs of high quality.

In response to pressure to procure the copycat drugs in its global AIDS fight, the Bush administration recently called the activists’ bluff: The U.S. agreed to a plan that would fast-track a review of AIDS medicines, including copycat drugs, once manufacturers provided the necessary documentation proving safety and effectiveness. Approval of the drugs would take as little as two to six weeks (the process usually takes from six months to up to two years). According to the Associated Press, “the FDA is waiving a $500,000 filing fee, and also is willing to review generic versions of medicines that are still under U.S. patent, as long as they are only marketed abroad.” In other words, the debate over patented medicines vs. copy medicines is over: If companies show AIDS-related products are safe and effective, the U.S. will buy them no matter who makes them.

These are sensible measures designed to expedite safe treatment. The New York Times, long critical of the administration’s AIDS policy, even lauded the step, saying “the Bush administration has finally come to its senses and found a way to provide cheap generic drugs and single-pill combinations of drugs to millions of people….”

But despite all this, the more strident critics will not be placated. “The Bush policy is a red herring that is thrown out by the U.S. to get people to buy brand-name drugs,” said Jennifer Brant with the NGO Oxfam America. Rep. Henry Waxman (D., Calif.), the influential member of the Committee on Government Reform, has blasted the administration, accusing it in a letter last week of insisting on “unnecessary delays.” The critics point to the World Health Organization’s list of “prequalified” AIDS drugs, which includes many of the copycat drugs. They say the WHO’s standards are sufficient for U.S. policymakers, so the U.S. should start buying them right away.

But it’s that WHO prequalification list that is rightly giving some American health officials pause. Back in June, WHO took the extraordinary step of removing two drugs made by the Indian company Cipla–lamivudine and zidovudine–from its list. WHO had approved the drugs in 2002 and 2003, but removed them after the data provided by the company failed to demonstrate bio-equivalence. The now-unlisted drugs are components of some of the most popular combination-drug treatments that groups such as Doctors Without Borders are administering in less developed countries.

This removal of the Cipla drugs from the WHO’s approved list is scary stuff: AIDS victims around the world are currently taking medicines whose bio-equivalence is not known. AIDS patients deserve better from politicians, activists, and global health officials.

The Bush administration isn’t eager to spend U.S. taxpayer dollars on medicines whose safety and efficacy it can’t verify. That’s common sense. It may turn out the drugs are fine, but until American health officials are confident they are, they will rightly continue to insist that AIDS victims get the best treatments available. Doing otherwise would be putting ideology before science.

Nick Schulz is editor of TechCentralStation.com.



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