Close on the heels of 9/11 came the infamous anthrax attacks that sent Americans scrambling for Cipro, an expensive, obscure, anti-biotic used to treat bladder infections. The news reports portrayed anthrax as a potential threat to everyone: a terrorist-concocted disease sent through the mail. There were dire warnings to watch for powdery substances and envelopes with bad handwriting from unknown senders. The anthrax attacks had killed--gasp- five people. Who knew how fast it could spread--just like the panic du jour, Bird Flu.
The anthrax "attack" proved to be boon for beleaguered drug manufacturer Bayer which was suffering from its own "attack" of diminishing profits. Practically overnight Bayer went from scrambling in search of a buy-out partner to scrambling to ramp up production of Cipro in order to jump aboard the the Bush administration's $643 million antibiotic stockpile train. Ultimately, Cipro would be a pox on Bayer. The same year Cipro's patent expired--2003--Bayer agreed to pay the government $257 million and pled guilty to a criminal charge in what federal prosecutors said was a scheme to overcharge for the antibiotic Cipro in the largest-ever Medicaid fraud settlement. The five-year scheme actually predated the 2001 anthrax scare was disclosed by a former Bayer executive who blew the whistle on the cozy deal between Bayer and Kaiser Permanente, one of the nation's largest health care organizations.
Fast-Forward to 2005 and the new Bird Flu threat. This time the savior is alleged to be Tamiflu yet another outrageously expensive drug manufactured by yet another European big-pharma company, Roche. Not only does Roche stand to reap windfall profits from the bird flu scare so does Donald Rumsfeld and other politically connected investors in Gilead Sciences, the California biotech company that actually owns the rights to Tamiflu.
According to a recent article in Fortune, Rumsfeld served as Gilead's chairman from 1997 until he joined the Bush administration in 2001, and still holds a stake in Gilead valued at between $5 million and $25 million. Learning from the mistakes of Senate Majority Leader Bill Frist and his seeing eye trust, Rumsfeld sought the advice of the Department of Justice, the SEC and the federal Office of Government Ethics and finally a private securities lawyer, who advised him that it was safer to hold on to the stock. Selflessly, Rumsfeld had the Pentagon's general counsel issue instructions detailing how he could and could not be involved in if there were an avian flu pandemic if the Pentagon was required to respond. Former Secretary of State George Shultz, a member of Gilead's board, unburdened by such inconvenient conflicts of interest, has sold more than $7 million worth of Gilead since the beginning of 2005
Despite Rumsfeld's recusal from all things Tamiflu, the Pentagon ordered $58 million worth of the treatment for U.S. troops around the world, and Congress is considering a multi-billion dollar purchase making the he federal government one of the world's biggest customers for Tamiflu. Roche expected 2005 sales for Tamiflu to be about $1 billion, compared with $258 million in 2004. Not bad for a drug with disappointing sales since its introduction in 1999.
Predictably, when a brand name is repeated over and over there's a consumer stampede to get it--especially if it's supposed to protect from the latest biological bogeygerm. Scoring some Tamiflu has become the latest drug craze with Internet websites springing up to cater to desperate. In fact, Roche claims that run on Tamiflu was the reason the company suddenly decided to stop distribution, supposedly to prevent hoarding by increasing its own inventory. Maybe that's because in order to keep its deal with the U.S. government, it's going to have to stockpile the drug. By Roche's own account it's not exactly pharmacology 101 to make Tamiflu. The primary ingredient is Chinese star anise a plant used in eastern medicine for centuries, a plant that is difficult to cultivate and matures at a glacial pace requiring six years of growth before it flowers. Not only that, it is grown in only four provinces in China and is harvested between March and May. Roche has already used some ninety per cent of the world's supply of star anise in manufacturing Tamiflu, and scientists have estimated that it will take 10 years to gather the number of fruits needed to produce enough to treat a fifth of the world's population.
With murmurings that other companies should be allowed to manufacture Tamiflu, Roche went on the defensive proclaiming that only they and their selected partners had the expertise to manufacture it. For "security reasons" Roche spokesman, Alexander Klauser, said the company wouldn't disclose the names of the manufacturers it planned to work with. "The production of Tamiflu is a complex, 10-step process, which takes about a year," Klauser said. "From the beginning, we've been working closely with outside manufacturers who have the expertise to ensure the quality of the product."
Enter the outsource champion, technology whiz kid, and patent busting renegade India and one company's claim "We can make that drug in a month." What about a shortage of nearly unavailable star anis? Pooh, pooh. According to Dr. Yusuf K. Hamied, chairman of Cipla Ltd. "We have been able to synthesize it." Not only that, Hamied said his company's generic version, oseltamivir, would be much cheaper than Tamiflu. Hamied didn't say how and where he plans to sell his product, but insisted he won't "break the law."
Predictably, Roche declined a direct comment on Cipla's announcement.
Ironically, it was India that raced to "generasize" Cipro during the anthrax scare. The Bayer monopoly price for a course of Cipro necessary to treat anthrax was $350. The cost of the Indian generic? About $20.
Regardless of availability and price the real question is how effective would Tamiflu be should there actually be a bird flu epidemic and not just talk of the possibility of one. According to a brief article in the Oct. 20, 2005 journal Nature, a young girl, provided with a prophylactic dose of Tamiflu after experiencing mild influenza symptoms, developed a strain of the virus that was highly resistant to the drug. Hmmmm. That doesn't sound promising.
Corporate media ominously announce that bird flu has killed between 50 and 60 people in Asia. Those killed were in close contact with birds that are characteristically raised in cramped filthy conditions. In terms of death from other diseases in the region from such things as simple diarrhea, 60 people is not even a nanosecond bleep on the health radar.
So the real question seems to be, is bird flu yet another media event and opportunity for big pharma to reap largesse from out-of-proportion-panic to a situation that doesn't exist and may never exist, or is it a legitimate concern? Even more chilling, how many MacNews nugget nibblers rushed to eBay or an online pharmacy to score Tamiflu after hearing president Bush describe the intelligent design version of Bird Flu: "Not only does the reporting need to be on birds that have fallen ill but also tracing the capacity of the virus to go from bird to person. Uhh...that's when it gets dangerous...when it goes bird, person, person."
Then again, maybe anthrax will make a comeback so the government can use up all the stores of Cipro to make room for Tamiflu.