|October 23, 2001||atimes.com|
India has the medicine to aid US anthrax fight
NEW YORK - As anonymous letters containing powdered anthrax spores sow fear in the United States and abroad, companies in India are waiting in the wings to make treatment for the deadly bacteria more widely available in the US.
The antibiotics to fight anthrax can be bought in most pharmacies in the US without a prescription, although stocks are insufficient to treat a major outbreak. A vaccine also is available, but the entire US stockpile is owned by the Department of Defense and is not available to civilians.
The German company Bayer AG currently holds a patent until December 2003 on the anthrax antibiotic ciprofloxacin, known by the brand name Cipro. Under mounting pressure to permit generic production of the drug, Bayer says that it can handle demand and plans to triple production of Cipro in the US to more than 200 million tablets, which would be enough to meet the dosage needs of 1.7 million people. US officials, though, want to stockpile enough medicine to treat 12 million people.
In India, the country's largest pharmaceuticals company, Ranbaxy Laboratories Ltd, says that it is ready to increase production of a cheaper, generic form of Cipro as soon as it receives the necessary approval, adding that it could supply 20 million generic ciprofloxacin tablets a month to the US from December.
Anthrax can be transmitted by skin contact, by inhaling spores, or by eating meat from infected livestock. It is most virulent when inhaled. It causes blistery lesions and flu-like symptoms and, if left untreated, kills about one-fifth of those infected. However, antibiotics have proven effective if taken shortly after infection.
Ranbaxy made the offer after inquiries from New York Senator Charles Schumer, asking whether the company could supply the medicine swiftly. Schumer has appealed to Washington to increase emergency stocks of the anti-anthrax drug. Presently, Ranbaxy makes about 6 million ciprofloxacin tablets a month. Another Indian drugmaker, Cipla Ltd, has also offered to sell a generic version of the anti-anthrax drug.
However, a Bayer spokesperson has said that the company "takes patent infringement very seriously, and we are prepared to consider all options in order to defend our patents" - leaving open the possibility of a lawsuit should any other company start introducing the medication on the US market.
Earlier this month, India's top three pharmaceuticals, Ranbaxy, Glaxo and Cipla, agreed to co-market Ranbaxy's once-a-day formulation of ciprofloxacin. This dosage form of the broad-spectrum anti-bacterial is from Ranbaxy's Novel Drug Delivery Systems (NDDS) research pipeline. The product will be marketed under individual brand names - Cifran OD (Ranbaxy), Ciplox OD (Cipla), while Glaxo will launch it under the brand name C-OD.
Ranbaxy, which has cold and other drugs on sale in the United States, is well positioned to sell ciprofloxacin there as its generic once-a-day pill already has US Food and Drug Administration (FDA) approval for sale once Bayer's patent ends. Ranbaxy, listed on the Mumbai Stock Exchange and founded in 1961, has ground operations in 25 countries and manufacturing operations in six. It achieved a turnover of US$502 million for the year 2000, moving closer to achieving a target of $1 billion by 2004. Ranbaxy Laboratories Ltd posted a net profit of 891 million rupees ($18.58 million) for the quarter ended September 30, 2001, compared to 531 rupees million for the same period in 2000.
International patent rules generally have provisions that allow governments to ignore patents in the event of a national emergency, so if the US does resolve that the anthrax crisis is such an emergency, companies like Ranbaxy will be well placed. A two-month dosage of ciprofloxacin in the US - the amount of time needed to treat someone testing positive to anthrax exposure - costs about $600. In India, it sells it for the equivalent of $20. Indian law allows only patent of processes by which drugs are made. As a result, firms can make drugs that are under patent in the West as long as the process differs from the original.
Although the US so far has rejected overturning Bayer's patent on Cipro, a bill is currently moving through Congress that would require drug companies to disclose patent settlement deals - agreements whereby they essentially pay off competitors not to market generic versions of brand-name drugs. Such deals could violate US anti-monopoly laws, in addition to costing consumers hundreds of millions of dollars, according to the US Federal Trade Commission.
The US government introduced in 1998 a mandatory anthrax vaccination program for all US troops as part of a multibillion-dollar bio-warfare defense plan. But the shots - six initially, followed by annual boosters - became highly unpopular when about 3 percent of those inoculated experienced vertigo, joint pain, headaches and other, more severe side effects, such as lupus and gastrointestinal paralysis.
More than 400 members of the armed forces have refused the vaccine, leading to prosecution in military court and early discharge from service. A survey by the General Accounting Office of the US Congress found that one-fourth of personnel who left the Air National Guard and Air Force Reserve cited apprehension about the anthrax program as the biggest factor in their decision.
Critics also have alleged a link between the vaccine and Gulf War Syndrome. Last year, a Congressional panel recommended that the anthrax vaccinations be suspended until proven safe. The Pentagon rejected this advice but was forced to halt the program in July due to dwindling supplies.
The only US anthrax vaccine maker is BioPort Corp, which has applied to the FDA for approval to distribute the vaccine after a three-year hiatus due to quality control problems at its manufacturing plant. The average FDA response time is four months, but this could be stepped up due to the urgency of the situation.
Critics of the BioPort vaccine, including former and current military personnel, promptly filed their own petition with the FDA last week asking the agency to classify it as Category II - unsafe, ineffective, or misbranded - and to declare the current stocks adulterated.
Kathryn Hubbell, president of the Anthrax Vaccine Network, a support group for members of the military, calls the BioPort vaccine "illegal" and "nothing less than medical experimentation upon the troops".
The company says that renovations at its plant have solved the problems and Defense Secretary Donald Rumsfeld has said that although "things have not been going swimmingly" for BioPort, it would get "one more crack at getting the job done".
Meanwhile, other companies are cashing in on public concerns about bio-terrorism. Two US companies that are working on anthrax vaccines, Avant Immunotherapeutics, Inc and Corixa Corp, have seen their stock prices soar by 50 percent since the start of the month. Rubber glove companies in Asia also have also been given a boost since the terrorist attacks on New York and the Pentagon on September 11 heightened fears of bio-warfare.
The US military and the National Institute of Health are developing their own anthrax vaccines, which they say will be ready for clinical trials in the next few months.
No-one knows where the anthrax originated. There are dozens of labs around the United States - no-one knows exactly how many - that have anthrax stores for research, mostly veterinary. At least 24 countries around the world have stockpiles of anthrax, and many others hold it surreptitiously.
Although some of the letters reportedly contained references to Allah, the Federal Bureau of Investigation says that it is not convinced that they are connected to the September attacks and is still "looking strongly" at the possibility that domestic right-wing extremists are involved.
Vincent Cannistraro, a former counter-terrorism expert with the Central Intelligence Agency, says that "it just doesn't have the fingerprints of a [suspected terrorist Osama] bin Laden operation".
Bin Laden's network Al-Qaeda wants to inflict mass casualties and kill as many people as it can. Sending individual, targeted mailings is not going to accomplish that," Cannistraro said. "This might turn out to be someone else trying to fly in under the radar."
And on Sunday, US President George W Bush said that investigators have found no link between the anthrax attacks in the US and Al-Qaeda. "We do not yet know who sent anthrax to the United States Capitol or several different media organizations," Bush, in Shanghai for an Asian-Pacific summit, said in a radio address to the nation. "We do not, at this point, have any evidence linking the anthrax to the terror network that carried out the attacks of September 11."
(Asia Times Online/Inter Press Service)
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