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12.09.2006

Russia's new specialty: Fake pharmaceuticals

Time and again, Dr. Boris Merkeshkin pricked his patients' arms with a needle and injected a drug intended to ease cardiovascular ailments. He did it for six months this year, and his patients recovered smoothly.
 
They may not be so lucky next time. Merkeshkin, the chief physician at a large research hospital in Siberia, and his colleagues had unknowingly administered roughly 3,000 doses of fake Cavinton. The drug, made in its genuine form by Gedeon Richter of Hungary, is one of the more common counterfeit pharmaceuticals circulating in Russia, according to the police.
 
Merkeshkin said he was grateful that the substitute medicine was similar to the intended one and did no harm to the patients. "If that were not the case, we would have a tragedy," he said.
 
Russians, already adept at burning pirated DVDs, rolling their own Marlboro cigarettes and printing knockoff Nike T-shirts, have turned to the more delicate art of making fake prescription medicine.
 
Counterfeit prescription drugs are proliferating in Russia, and in many other countries, according to industry experts and the Food and Drug Administration.
 
They say fake drugs are also being smuggled to Europe and the United States, the world's most lucrative prescription drug market, though so far in smaller amounts.
 
So far, the biggest problem presented by the fake drugs is violation of intellectual property rights, cutting into the profits of pharmaceutical companies. There do not appear to have been major injuries from the drugs.
 
Drug counterfeiting is different from the production of generic medicines. Some developing countries, as part of a principled stance in a broader public health debate, will allow their manufacturers to make certain generic medicines, for example, for AIDS patients, without paying license holders.
 
Counterfeiters, in contrast, operate illegally for profit, and the contents of the fake drugs can be different from the originals.
 
The variety of fakes range from crude mixtures of glue, chalk and sugar to nearly exact chemical replicas of complex pharmaceuticals, like Lipitor by Pfizer or the anti-impotence pill Viagra, both of which have been the targets of anti-counterfeiting prosecutions.
 
Counterfeiters operate in India, China and elsewhere. Russia's underground prescription medicine market is distinguished for being at the forefront of a new trend of exceedingly high-quality fakes.
 
Private investigators from Pfizer surveying the Russian market found fakes that were, by the company's own admission, of exceptional quality.
 
"The counterfeits we got in the survey were the finest counterfeits I've ever seen," John Theriault, vice president for global security at Pfizer and a former FBI agent, said in a telephone interview. "The stuff we saw in the Russian market wasn't made in a garage. We don't know where it was made."
 
If they are good enough, doctors and patients may not suspect or notice they are using fakes. "If the product looks like American product, how do you know where it came from?" Theriault asked.
 
In a statement to Congress in July, the associate food and drug commissioner for policy and planning, Randall Lutter, said the quantity of counterfeit prescription drugs intercepted by customs officials suggested that such smuggling was on the rise. Agents opened 58 cases in the United States in 2004, up from 30 the previous year.
 
Statistics on fake drugs are difficult to obtain. "The sophistication and precision of some counterfeit copies of legitimate drugs make a reliable estimate of the number of counterfeits impossible," Lutter said, according to a transcript.
 
The Coalition for Intellectual Property Rights, an independent group, surveyed the Russian market in 2003 and found that 12 percent of pharmaceuticals were counterfeited, though local industry groups say the number is lower, perhaps as little as a fraction of 1 percent.
 
Typically, pharmaceutical trade associations, which represent companies with reputations and sales that could suffer if information on counterfeit products became public, offer lower estimates. The World Health Organization has estimated that counterfeiting pharmaceuticals, on a global basis, is a $32 billion business.
 
Inside Russia, the high quality of the counterfeit drugs has blunted any sense of outrage or urgency by authorities to make arrests, according to two industry groups in Moscow.
 
"There's a perception around here that if nobody's harmed, what is the problem?" said Sergei Boboshko, executive director of the Association of International Pharmaceuticals Manufacturers, an industry group in Moscow representing 46 large drug companies.
 
The industry is more worried about publicity over counterfeiting, fearing that sales will fall if customers are alarmed by the prevalence of counterfeited medicine.
 
Industry groups like Boboshko's and other authorities are also at odds over how to enforce the law; the Russian government has played up several high-profile raids on backyard medicine shops as talks continue about Russia's entry into the World Trade Organization.
 
Boboshko says the raids are merely window dressing because industrial scale producers continue to operate almost openly.
 
Last autumn, the Moscow police department's 18-man economic crime squad broke down the door of a rented warehouse. They found a cat and a dog - along with eight illegal immigrants from Moldova who were mixing chalk and wheat flour into aspirin, Fillip Zolotnitsky, a spokesman for the economic crime division, said in a telephone interview.
 
"The walls were covered with mold," Zolotnitsky said. "It was a standard abandoned room". The raid netted five million tablets packaged as aspirin. The suspects are awaiting trial. If they are convicted, they could be sentenced to 10 years in prison.
 
Roszdravnadzor, the Russian equivalent of the U.S. Food and Drug Administration, recently published on its Web site penalties for licensed manufacturers who violate patents, including possible suspension of their license or a fine.
 
The best counterfeits are made at legitimate plants, which might run an extra night shift to make fakes, according to Boboshko.
 
Detectives tracing the trail of the Cavinton that turned up in Merkeshkin's hospital were led to a Moscow warehouse registered to Tatyana Bryntsalova, the wife of Vladimir Bryntsalov, a pharmaceutical magnate who ran as a dark horse candidate for president of Russia in 2004, according to police records.
 
Calls to Bryntsalov's company, Ferein, were not returned. In the Russian media, he has denied wrongdoing. His company operates licensed factories that produce 10 percent of Russia's legitimate pharmaceuticals.
 
The growing proliferation of fake drug supplies around the world has led U.S. regulators to consider an expensive new radio tagging system for tracking prescription medicine in the United States. The system, now in a trial phase, is considered the most significant change in drug packaging since tamper-proofing was developed in the 1980s.


Source:  www.iht.com

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