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Will Tamiflu Shortage Drive U.S. To India's Version?

Published November 10, 2009 1:13 AM

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With demand for the swine flu vaccine outpacing supply, the Centers for Disease Control and Prevention says it is open to considering importing a generic flu drug from India. There's just one problem: Tamiflu, the brand-name drug, is still under U.S. patent.

Flu-related hospitalizations and deaths are still on the rise in the United States. But in some areas of the country, there's a shortage of Tamiflu, the anti-viral medication that can protect against complications caused by the illness.

To deal with the shortage, the CDC has ordered more Tamiflu from Roche, its Swiss manufacturer — but it is not expected to arrive until January.

Antiflu, a generic version of Tamiflu, is made by the Indian company Cipla — despite the fact that Tamiflu's patent is protected under U.S. law until 2016. The Cipla version costs 20 to 30 percent less than the brand-name drug.

Dr. Yusuf Hamied, chairman of Cipla, says he is eager to provide the U.S. market with his generic version of the drug.

"We would keep our factories open night and day, because this is an emergency," he told NPR's Steve Inskeep.

"We would certainly cooperate in whatever way possible."

The U.S. government has already released its last 200,000-some doses of the oral liquid version of Tamiflu for children. The highest hospitalization rate for swine flu is in children age 4 and under.

A recent poll from the Harvard School of Public Health found that only about a third of adults who have tried to get a swine flu vaccine have been able to get it.

Hamied says Antiflu is an exact clone of Tamiflu. It has been approved by the World Health Organization and is already for sale in India.

In 2001, Cipla tried to import its generic version of the antibiotic Cipro — which was stockpiled after the anthrax attacks in 2001.

"The drug was covered under patent," Hamied said.

"And I think what happened — the American government stockpiled Ciprofloxacin and probably made a deal with Bayer [the manufacturer] at a much lower price than what was the prevailing market price at the time."

Hamied said his new plan to export Cipla's version of Tamiflu to the United States faces similar problems.

To import Antiflu before 2016, the U.S. government would have to override patent law, which it would likely only do in a real emergency. And Cipla's drug does not yet have Food and Drug Administration approval.

India is the largest and fastest-growing producer of generic medicines; Hamied's company has a long history of producing generic drugs to sell at cheap prices in the developing world.

The most famous of these is Cipla's generic anti-retroviral drug. It is considered to be lifesaving for HIV-positive people in Africa, because it is available for a fraction of the cost of brand-name anti-retrovirals.

In developed countries, anti-retrovirals cost around $6,000 per patient per year; the Indian generic version is available in the developing world for $800.

All of this has not made Cipla — or Hamied — popular among pharmaceutical companies.

In the interview, Inskeep mentioned that the head of the pharmaceutical giant GlaxoSmithKline has called Hamied a "pirate" and described the quality of Indian generic drugs as "iffy".

"You know what I replied to that, Steven?" Hamied said. "I said, 'We do not break any laws. We live by the laws of the land.' And then I sometimes add that even Robin Hood was regarded as a pirate."

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STEVE INSKEEP, host:

Many Americans who want a dose of Tamiflu can't get it. Swine flu prompted huge demand for the anti-viral drug. That prompted the Centers for Disease Control to at least think about an alternative. It's to find a supplier of a generic drug. The patent for Tamiflu belongs to the Swiss pharmaceutical company Roche.

But another company in India has made a copy. The company Cipla is famous for copying anti-AIDS medicine and selling it cheap in Africa. The head of Cipla, Dr. Yusuf Hamied, contends that if American patent laws allowed it, he could sell Americans his copy of Tamiflu - called Antiflu.

What does Antiflu do?

Dr. YUSUF HAMIED (Chairman, Cipla): Our Antiflu is identical clone to Tamiflu. And our Antiflu is the only generic drug of its kind approved by the WHO.

INSKEEP: How do you go about developing a clone of someone else's drug?

Dr. HAMIED: Well, we study the chemistry of the drug and start producing the drug first in the laboratory, and then scale it out. It's a three to five year cycle to reverse engineer a drug and make an identical clone. It's not so easy. And in this particular case we started this work in 2005, when there was a scare for avian flu.

INSKEEP: Now, have you asked for entry into the U.S. market with your drug Antiflu?

Dr. HAMIED: No. No. There was a write-up in the New York Times the other day. And I was phoned by the reporter from the New York Times. And he said that there was a shortage of Tamiflu in America and asked me - would Cipla be prepared to supply America? And I said of course, and that we would keep our factories open night and day, because this is an emergency. The problem comes that it is still covered under patent in America till 2016, therefore you can only get the drug if you ask for a compulsory license or under emergency.

INSKEEP: So you're not actively trying to get it in the United States, but you're certainly willing if somebody makes the effort�

Dr. HAMIED: We are willing. If we are asked, we would certainly cooperate in whatever way possible.

INSKEEP: If someone were to ask you, how quickly do you think you could get your version of Tamiflu, Antiflu, into the United States and over whatever hurdles there may be?

Dr. HAMIED: We could supply even from tomorrow what is approved by WHO. And it would be important for the American government in an emergency to accept WHO approval.

INSKEEP: Of course that would be a change from the United States, since the Food and Drug Administration insists on its own approval now.

Dr. HAMIED: That's right. But this is an emergency. And I think in an emergency one has to sometimes bend the local laws.

INSKEEP: I want to ask you about some of the harsh statements that are made about your company by some other pharmaceutical firms. For example, the head of the pharmaceutical giant GlaxoSmithKline, which makes AIDS drugs, which you have replicated and sold much more cheaply, described you as a pirate and said the quality of Indian generic drugs as iffy.

Dr. HAMIED: You know what I reply to that, Steven? I said that we do not break any laws. There has not been a single prosecution against Cipla ever in the history of Cipla on these grounds. In India, we abide by Indian laws. In America, we follow American laws, and in Europe we follow European laws. So please tell me what laws have I broken. And then I sometimes add that even Robin Hood was regarded as a pirate. So it all depends how you define the word pirate.

INSKEEP: I'm curious if you think of yourself as Robin Hood.

Dr. HAMIED: It has been quoted - it has recently been quoted in the press.

INSKEEP: Well, Dr. Yusuf Hamied, I've enjoyed speaking with you. Thank you very much.

Dr. HAMIED: Any time - any time you want me, you just pick up the phone and call me.

INSKEEP: All right. Bye-bye.

Dr. HAMIED: Bye.

INSKEEP: This is NPR News. Transcript provided by NPR, Copyright National Public Radio.

Source: NPR

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