Sunday, October 16, 2005

Nobel prize-winner Sir John Sulston calls for patent reform

Sir John Sulston, winner of the Nobel prize for medicine for his work on the human genome, said on Oct. 14, 2005, that patent laws were an obstacle to faster and wider access to Tamiflu, a potentially life-saving antiviral flu drug.

Intellectual property legislation gives Tamiflu's manufacturer, Roche, a monopoly on sales and marketing of the drug, which is now in huge and urgent demand around the world as the threat of an avian flu pandemic is perceived to be increasing.

Britain has ordered more than 14m courses, but so far has 2.5m and delivery of the rest will not be completed for another year. The drug is not a cure for flu, but reduces the severity of a bout as long as it is taken within the first 48 hours of the onset of symptoms, and could therefore save lives.

"A major problem in the decision-making processes of governments is that drugs are very highly priced. This is because of the way the intellectual property system works," he said on BBC Radio 4. The system rewarded companies for the investment they made in creating drugs by allowing manufacturers to set high prices without competition, but it did not help get universal access to needed medicines.

"I think that if we can reform intellectual property so as to separate the creative process of research and development from the production of drugs, thereby making them cheaper, we will be a great deal better off," he said.

An article in the San Francisco Chronicle discusses other aspects of the tamiflu matter:

Tamiflu, a pricey antiviral pill invented in a Bay Area lab and made in part from a spice used in Chinese cookery, has emerged as the world's first line of defense against bird flu should the deadly strain begin its feared spread among human beings.

As nations begin to stockpile the drug in anticipation of a flu pandemic, calls are mounting for countries to sidestep patents on the drug -- as Brazil first did for AIDS medications -- and make their own generic versions.

But Swiss pharmaceuticals giant Roche, which acquired rights to the drug from Gilead Sciences Inc. of Foster City in 1996, said Wednesday it had no intention of letting others make it.

"Roche ... fully intends to remain the sole manufacturer of Tamiflu,'' said company spokesman Terry Hurley.

The immediate problem is not the cost of Tamiflu, which runs about $60 for a 10-pill course of treatment, but a staggering gap between the sudden demand for it and the capacity of its sole manufacturer to produce it.

Although Roche has increased production of Tamiflu eightfold in the past two years, it will take $16 billion and 10 years to make enough of the drug for 20 percent of the world's population, said Klaus Stohr, director of the World Health Organization's Global Influenza Program, in comments to reporters in San Francisco last week.

"Something has to be done,'' said Ira Longini, an Emory University professor whose computer model of a potential avian flu pandemic shows that an outbreak could be snuffed out within a month by rushing antiviral drugs to the place where it started. "When you think of the potential damage a pandemic flu could do, and how little drug we have, the situation is quite absurd.

"It makes sense to do something along the lines of what was done with AIDS drugs.''

James Love, director of the Consumer Project on Technology in Washington, D.C., said that during the anthrax bioterrorism scare in 2001, both the United States and Canada had threatened to bypass the patent of Bayer Corp.'s antibiotic Cipro to assure a sufficient supply of the drug. The Tamiflu problem is similar.

"The WHO should buy stockpiles from generic suppliers,'' he said. "If patents are in the way, the WHO should ask the manufacturing country to issue the appropriate compulsory licenses. The patent owner will receive royalties, but we will have the stockpiles."

U.N. Secretary-General Kofi Annan has signaled a willingness to consider generic production of flu drugs and vaccines. During remarks at the World Health Organization headquarters in Geneva last week, he said drug companies should be "helpful" by not letting their patent claims interfere with access to medicines. "I wouldn't want to hear the kind of debate we got into when it came to the HIV anti-retrovirals,'' he said.

Roche will not release its Tamiflu production figures, deeming it "commercially sensitive" information, said Hurley, the company spokesman. However, he said the company produced "many hundreds of millions" of the pills annually. In response to WHO concerns about bird flu this summer, the company agreed to donate enough Tamiflu to treat 3 million people.

Although public awareness of the pandemic threat posed by the bird flu has blossomed in recent weeks, scientists have been warning since 1997 that the rogue influenza strain known as H5N1 could be the one that triggers a pandemic rivaling the devastating Spanish flu of 1918 -- which killed 50 million.

Tests on laboratory mice strongly suggest that Tamiflu -- and a lesser-known inhaled antiviral, Relenza -- are the only medications that can treat infection with the H5N1 strain.

Tamiflu has not been effective in the treatment of the small number of people who've contracted the H5N1 virus in Asia. Of 116 people infected since 2003, half have died. However, most of those patients were admitted to hospitals days or weeks after they became ill. Tamiflu is thought to work best within 36 hours of symptoms.

"Late treatment is clearly ineffective,'' said Dr. Frederick Hayden, a University of Virginia expert on flu drugs.

As a treatment for ordinary flu, Tamiflu has been effective, but in a Japanese study of children treated with the drug, about 1 in 6 patients developed strains of flu resistant to the drug, though the new flu strains were much weaker, causing less illness.

The U.S. appetite for Tamiflu, however, may quickly outstrip the capacity of any one company to make it. A draft proposal by the National Vaccine Advisory Committee, charged with developing a federal response plan to a pandemic, envisions distribution of nearly 90 million courses of antiviral drugs. The pills would be rationed according to need, with hospital patients and health care workers who treat them at the top of the list.

In addition, Stohr said, the starter ingredient for Tamiflu is a Chinese spice called star anise, whose seeds are used in flavorings, medicines and cooking oils. Most of the world production of star anise is located in four provinces of China, and the supply of it has been back ordered, primarily for drug production.

Meanwhile, the shortage of Tamiflu has begun to trickle down to American hospitals, which normally keep small quantities of the drug to treat garden variety influenza each winter.

Dr. Roger Baxter, director of Kaiser Permanente's flu surveillance program in Northern California, said the health care giant had stopped prescribing the drug to patients who wanted it for their own personal stockpiles, or sought it for travel abroad.

"Kaiser has a very small supply,'' he said. "We don't have a stockpile that would cope with a major outbreak.''

Only patients with so-called B-strains of influenza -- which like H5N1 do not respond to older line flu drugs -- and those who are hospitalized will be considered for Tamiflu, he said.

Shares of BioCryst Pharmaceuticals surged more than 43% the week of Oct. 11, 2005 amid escalating concerns regarding a potential avian flu pandemic. Investors are betting on the company's flu treatment, peramivir, as a potential government stockpiling candidate. The small-molecule drug was previously co-developed by Johnson & Johnson.

"We can't get a large amount of oseltamivir for stockpiling, even if we wanted to,'' he said.


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