TCS Daily

Lou Dobbs, Call Your Office

By James K. Glassman - July 14, 2004 12:00 AM

BANGKOK - If Lou Dobbs, the fair-trade crusader, only knew about this one!

A few months ago, activists and journalists were blasting the U.S. for plans to buy only branded drugs, made by companies like Merck, to treat patients in poor countries under the president's $15 billion AIDS relief program.

American authorities responded to the pressure in May with a policy guaranteed to outrage opponents of "shipping U.S. jobs overseas," as Dobbs, the TV anchor and commentator, often puts it.

The result is that the way has been paved for U.S. taxpayers to spend billions to buy drugs made in India that are copies of medicines invented in the United States.

Here's the deal: The U.S. global AIDS program will buy medicines made anywhere in the world -- as long as they're deemed safe and effective -- in an especially generous emergency approval process. The U.S. Food & Drug Administration has agreed to review the drugs within two to six weeks (rather than the usual year or more) and even waive fees.

"We're going to buy the least expensive drugs that we can find without regard to country of origin, patented or generic," Randall Tobias, the top U.S. official at the giant 15th International AIDS Conference here in Thailand's capital, said. (In fact, the drugs in question are not "generics," which are precise copies of a drug that has gone off patent. They are, more precisely, copies, or knockoffs, of drugs that are currently patented in developed nations.)

Let's be clear. This unprecedented policy gives a big boost to companies in developing countries that specialize in ripping off U.S. drugs while those drugs are still on patent. How fair is that?

The most notorious of the copycat drug companies is Cipla, based in India and headed by the flamboyant Yusif K. Hamied. Time magazine recently cited his "gold-plated standard of living." His wealth is pegged at $550 million.

The U.S. is even soliciting business from the knockoff artists. "We sent people from our office to Cipla and Ranbaxy in India and Aspen in South Africa," said Tobias. "We asked, 'Are you going to apply?'"

These companies stand to win enormously lucrative contracts to make medicines abroad that are now being made in the United States by companies that spent vast sums to develop them in the first place. The President's Emergency Plan for AIDS Relief, which Tobias heads, will spend $2.5 billion to $5 billion on AIDS drugs in 15 poor countries over the next five years.

Apparently, advocates of "balanced" trade, as Dobbs likes to say, are unaware of the new policy of vigorously seeking Indian copy drugs for purchase.

Americans, however, needn't worry about a loss of jobs just yet. Despite the American offer, not a single company making knockoff drugs has asked the FDA to review its products. It makes you wonder how safe and effective these drugs really are.

Knockoff drugs, under close scrutiny, may not measure up to standards of safety and effectiveness required in Europe, the U.S. and Japan. Consider that two months ago, the World Health Organization (WHO) de-listed two knockoff AIDS drugs made by Cipla: Lamivudine and Zidovudine.

Cipla responded that the de-listing was a mere clerical error. India's secretary of health, J.V.R. Prasada Rao, was quoted in a Thai newspaper as saying, "That had nothing to do with the quality of the drugs, but purely to errors in submitting documentation."

Cipla, however, is now engaged in new tests, according to a WHO official. This is no paperwork goof-up.

The de-listing was a serious step, but, incredibly, there has been almost no follow-up. The WHO maintains a list of drugs it "pre-qualifies" for use around the world. The list is used by nations and organizations that provide medicines to poor people as a certification of quality -- even though the process does not involve review of clinical research and other rigorous tests.

When drugs are de-listed -- in this case, because of lack of proof that they are "bioequivalent" to the innovator drugs on which they are based -- the consequences could be dire for those taking the drug.

If, in the United States, for example, the FDA withdrew approval of two drugs, the makers of those drugs -- in addition to fending off lawsuits -- would immediately track down patients using them, recall the medicines from the supply chain and broadly inform the public.

In the case of the two drugs de-listed by the WHO, however, there has been no recall. A WHO official in charge of pre-qualification said at a session here that the organization, which is an arm of the United Nations, informed UN groups such as UNICEF but took no other action.

This lack of follow-up disturbed few of the radical activists at this conference, who are too busy bashing the United States to notice, but it alarmed the AIDS Responsibility Project, a Los Angeles-based group, which is circulating a petition here, demanding "safe, effective drugs for the developing world" and "no double standards."

Specifically, Abner Mason, who heads the group and also serves as a member of the Presidential Advisory Commission on HIV and AIDS, demanded that...

  • Cipla "notify all patients using the two de-listed drugs, recall all such drugs, and provide alternative treatments for patients at no cost."

  • Cipla and other makers of knockoff AIDS drugs demonstrate "through proper clinical trials" that their drugs are just as safe and effective as patented drugs and true generics in use in developed countries.

  • The WHO perform "new inspections and audits of all other Cipla drugs."

  • The WHO warrant that all the drugs on its pre-qualification list are safe and effective.

The WHO appears to be adopting a cavalier attitude. The organization publishes the list and issues a disclaimer that says that it does not warrant that the drugs are safe and effective. But, very clearly, groups that treat poor people in Africa and elsewhere consider drugs on the list as "approved" -- that is, safe and effective.

The AIDS Responsibility Project was especially worried about Triomune, a fixed-dose combination three-in-one drug made by Cipla, one of whose components is Lamivudine. Triomune has been widely boosted by activists here at the conference, but the de-listing casts serious doubt on its efficacy.

Mason's petition concludes, "Poor people in the developing world should not be treated with false hope and false medicine but with drugs as safe and effective as those in the developed world. Any other policy is dangerous and will promote resistant strains of HIV, untreatable with current anti-retrovirals."


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