Feature

Fake Medicines

In Siberia, last year, a one-month old child died after being given what was suspected to be a fake version of an inhaler.

This and other cases, including at least one other suspicious death, hushed up in the face of bribes or threats, underline the ineffectiveness of the Russian legal system and the ability of some laboratories to analyse and document pharmaceutical products which may be deadly fakes.

There have been some successes in the fight against fake pharmaceuticals however. In the Moscow regional district of Serpukhov, earlier this year, the director of a warehouse was given a five-year conditional sentence after a court found her guilty of polluting the environment by outdated and reject drugs though the prosecution failed to prove that she sold repacked outdated medicines and rejects.

Last spring the Ministry of Health’s Chief Sanitary Officer ordered the nationwide withdrawal of children’s vitamin tablets manufactured by the Kemerova company, Vicherfarm, after scores of children and adults taking the pills in Nizhny Novgorod and Kemerova areas were hospitalised with symptoms of headaches and sleepiness. An analysis of the tablets found they contained phenazepam, a powerful sedative and muscle relaxant with sleeping effect, usually administered only under a doctor’s supervision. Possible effects include drowsiness, muscle weakness, dizziness and stomach discomfort.

This is tip of the ice-berg. Fake, counterfeit and look-alike drugs have swept Russia since the 1998 economic crisis and are currently worth an estimated $350 million a year. While this is a tiny proportion of the country’s $6.35 billion total pharmaceuticals market which is expected to reach $8.65 billion by year-end drug manufacturers and Russian health authorities and Interior Ministry commanders take a zero tolerance view.

Dominique Winther, coordinator of the Moscow-based Coalition for Intellectual Property Rights (CIPR) says estimates of the penetration of counterfeit pharmaceutical in the Russian market range from 10% to 40%. “Optimistic statistics say about one pill in fifteen is fake, while pessimistic valuations estimate it closer to one in

Optimistic statistics say about one pill in fifteen is fake, pessimistic – one in five

five. Government officials tend to have the most optimistic statistics,” she told Passport. She quoted Ramil Habriev, Head of the Federal Service for Monitoring Healthcare and Social Development, as officially stating that counterfeit pharmaceuticals represent 10% of the market.

“He also says that of that 10%, about 80% of the counterfeits are of foreign brands of medicine,” she said.

The Ministry of the Interior, which has been in the front line of anti-counterfeit drug programs, believes that fakes can bring in returns of 100% or more.

Around the world, fake pharmaceuticals are big business resulting in widespread loss of life.

CIPR’s Winther, says, “Counterfeit medicinal products may present an obvious danger to human health, because people may become seriously ill, show considerable side-effects, never recover from curable diseases or, in the worst outcome, die.”

“For example”, she goes on, “counterfeits of antibiotic and antiviral medicines can cause resistance and inefficacy of life-saving products. However, proven cases of people dying after ingesting counterfeit drugs are practically non-existent in Russia. Our court system is not sufficiently developed to handle such proof after a person’s illness.”

Sergey Reshetnikov , Director of External Affairs of the drug manufacturers’ organisation, AIPM, says, “Counterfeit drugs are becoming increasingly sophisticated, making it very difficult to distinguish between counterfeit and original products”.

CIPR’s Winther says “Product counterfeiting is still a growing threat to the pharmaceutical industry, as are bad-faith registration of trademarks and packaging, as well as patent infringements.”. Robert Young, M.D., a senior doctor with the American Clinic in Moscow and a member of the American Chamber of Commerce healthcare committee told Passport, ”Most illnesses are multi-factorial. Even if it isn’t what it’s supposed to be, how do you prove it’s the source of the problem?” he asks.

Jose Flores,MD, the International SOS clinic’s American internist, says “To determine the incidence and effects of fake medicines in Russia would be a massive and expensive project. It would require large scale testing of medications from a variety of resources including pharmaceutical centres, pharmacies, and so on.”

Doctors from the main Moscow clinics, that many foreigners go to, concur they have never experienced a patient suffering because of fake medicine.

The SOS Clinic’s Flores says,” In the seven years I have worked as a physician in Moscow I have never experienced a treatment failure that I could attribute to a fake drug when the medications are purchased from our in-house pharmacy. I have also not seen a conclusive case of treatment failure based solely on a “fake” medication from another source. I have seen many cases of treatment failure that I could attribute to other factors, such as poor medical practice, inappropriate self-treatment and inappropriate medication choice.

American Clinic’s Young, agrees, “I have never seriously considered drug substitution to be a factor in any case I have treated in the more than seven years I have been practicing in Russia.”

“However,” he notes, “Over the last two or three years it’s been a big topic among patients. I have had a dozen concerned they are not feeling well and attribute it to the medication they are taking. When we investigate, factors other than taking fake medicine emerge and we treat these.

An assistant at the European Medical Centre, EMC, reported after polling medical staff, “We never had patients who would discuss with us problems with health they got because of taking fake medicines. We safeguard against fakes, by only working with suppliers who have a firm standing on the market and excellent reputation, and work with manufacturers directly. Also, every medicine we purchase has a certificate of conformance.”

Be careful where you buy

Where you buy medicines seem to be a determining factor in the quality of the drugs you are taking. Dr Flores says,” The key point is prevention. I recommend to my patients to avoid small pharmacy points such as in the underground and to always purchase their medications from pharmacies with good reputations and a long history of reliability. In the case of the International SOS Clinic in Moscow the pharmacists are familiar and versed in both western medications and Russian medications. They always purchase from reliable sources and it would be possible to track medications.”

Dr. Young agrees, “My clientele is not typical of the Moscow healthcare market. They are not generally shopping around to find the cheapest source of a particular medication. Pharmacy chains such as 36.6 have a reputation for quality and are very careful about where they source their supplies.”

Artem Bektemirov, the CEO of publicly traded 36.6 chain, asserted to Passport, “We share the concern about fake drugs distribution in Russia and the possible consequences of their consumption.”

36.6, with 291 pharmacies in eight Russian regions is the leading health and beauty product chain in the country. Bektemirov said, ”In the past, we have seen government efforts to end it, firstly, through established controls and improved distribution and accountability systems.

“At present, the channels are narrowing and fake drugs can only be delivered either at remote pharmacies or no-name kiosks. Lower price appears to be the only advantage this kind of retailers can offer. Unfortunately, in the distant regions in the country, this problem remains and is yet hardly traceable.

While the 1998 financial crisis helped spur the market for counterfeit medicines as people sought to reduce their regular expenses, it also facilitated improved control over pharmaceutical channels by manufacturers. Victoria Marakina, a spokesperson for Pfizer, told Passport, “In 1998 the distribution system was shaken to its core and has now been thoroughly re-vamped.”

Makarina claimed Pfizer, whose Viagra and Norvasc brands have been counterfeited in other countries, has never encountered a counterfeiting situation with its products in Russia.

“Six years ago, when we were aware of global counterfeiting of Viagra, we started monitoring the situation very closely. According to our information, there is no instance of fake Viagra in the distribution chain in Russia.”

One reason may be is that unlike many countries, no doctor’s prescription is required for the blue pill in Russia, where it is freely available in all classes of pharmacy.

Many fakes are purely an intellectual property rip-off because they are — chemically speaking — identical to the real products. These are known as look-alikes, sometimes marketed under legally registered but very similar brand names to the originals. Most of the time counterfeits pose a health threat. According to the British consulting firm Reconnaissance International, more than half of all counterfeit drugs contain no active ingredients or the wrong ones. Nearly 10 percent contain contaminants.

One of the most counterfeited medicines in Russia is the anti-spasmodic analgesic, No Spa from Sanofi. A survey conducted for CIPR in 2003 found 27% of people who had encountered fake medicines had noted counterfeit No Spa.

No Spa is a victim of look-alike medicines. Vladimir Bryntsalov’s Moscow region Ferein plant markets a product under the Nosh Bra name. The AIPM lists a number of similar instances where patents have been givento drugs with a look-alike name to an international brand, including Aventis’ anti-biotic Claforan (Clafobrin) and Schering Plough’s anti-histamine drug, Claritin (Clarifer).

AIPM’s Reshetnikov says,” The lack of effective coordination between the Ministry of Health and Rospatent facilitates the registration of look alike names.”

CIPR’s Winther noted that “Mr. Bryntsalov is still a leader in producing look-alikes. He calls this “import substitution,” saying that since foreign brands are so expensive, he produces the same medications with a similar name, but at half the price”.

“Currently, Bryntsalov is producing 40 look-alike brands of pharmaceuticals.”

AIPM and 36.6 pharmacy chain agree that most fake medicines sold here are manufactured in Russia.

Imported fake drugs from the third world countries do not usually come over the Russian borders.”

The 36.6 CEO also told Passport, “We have approached our peer-pharmacy chains through the Russian Association of Pharmacy Chains (RAPC), to initiate and introduce good pharmacy practice at all of the outlets of those chains. We also appealed to other market participants to join. Nowadays, most of the chained drugstores adhere to the high-quality product policy”.

The Union of Professional Pharmaceutical Organizations (SPFO), brings together 49 major domestic distributors, foreign and domestic manufacturers and a number of pharmacy chains, which account for over 50 percent of the drugs market in Russia.

Gennady Shirshov, Executive Director of the Union, says that much of its work is to coordinate the industry, disseminate best practice and provide expert support for government agencies.

This and the activities of individual companies have enabled authorities to make successful sweeps across all pharmacies in a number of regions, including Moscow, where the incidence of fake medicines has been virtually eradicated over the last two years.

Unfortunately, the farther you travel from the capital and particularly in regions with large segments of the population living on or below the poverty line, the greater the chances of encountering fake medicines which can harm your health.

In conclusion, eradicating the problem is difficult because many fakes are now difficult to distinguish form the real thing in both packaging and quality and the courts are not very well equipped to handle the situation. Counterfeit manufacturers may simply pay a fine, or bribe a laboratory worker to lose test results and carry on business as usual. While many Russians will tend towards a cheaper product substitute for an expensive original

...many fakes are now difficult to distinguish form the real thing in both packaging and quality.

one, the CIPR consumer survey revealed that medicines were the exception, and 84% said counterfeit medicines were ‘absolutely unacceptable.”

Lastly, follow the advice of the doctors interviewed for this article and always buy from reputable pharmacy chains, avoiding kiosks and Pharmacy points.

Bad medicines

Incidents of counterfeit drugs around the world include:

An estimated 192,000 people died in China in 2003 because of fake drugs.

The World Health Organisation estimates that 200,000 of the one million people dying from malaria annually might be saved if the medicines were “effective, of good quality and used correctly”. More than 100,000 malaria tablets bought by a charity in south-east Asia turned out to be fake.

From Argentina to, Haiti, Bangladesh to Nigeria, many thousands have been killed from such fakes as an analgesic syrup containing anti-freeze, fake vaccines, and repackaged anti-depressants to look like AIDS drugs.

In the UK, the Royal Pharmaceutical Society found in 2004 that half of all drugs sold online for erectile dysfunction were fake. Customs and Excise seized 231,151 counterfeit Viagra tablets in a single year.

In Canada, the deaths of eight heart patients are being investigated after fake versions of the drug Norvasc – made of talcum powder – were found on sale in chemist shops this July.

Norvasc, made by Pfizer, is a popular drug used to treat hypertension, high blood pressure and certain types of angina.