A problem that is endangering lives worldwide

I was reading a news account relating to the dangers of counterfeit drugs that seem to be rampant and found all over the world. In Southwestern China a person called Hu sought relief at a hospital after several days of feeling tired and weak. A doctor prescribed a blood protein called Albumin, which Hu purchased from the hospital pharmacy. But his condition became much worse and he had to be admitted to the hospital, where an intra venous drip was started. Within a few hours Hu became desperately sick with Diarrhea, labored breathing and abdominal cramps and severe pain. A day later he dies of toxic shock and multiple organ failure. On investigation it was found that Albumin was actually an unknown liquid that was lethal when it entered his bloodstream.

Similarly, in another part of the world, in Brazil, A transportation worker Gomes was diagnosed with Prostate cancer and treated with what was believed to be Androcur tablets. But the drug was counterfeited and did nothing to arrest the cancer and eleven months later Gomes was dead. Hu and Gomes are two victims of a global menace. The proliferation of counterfeit drugs is a fast rising problem in the developing world. In fact, mounting evidence suggests that developing nations are awash in fake pharmaceuticals. According to available statistics 12 % of pharmacies on an average sold counterfeit medicines. There have been cases where no active ingredient was found in life saving drugs which proved fatal for those who used it. There was also a case in Columbia where anti histamine pills were actually dyed cement!

The counterfeit pharmaceuticals industry is estimated to be a billion-dollar industry, and some have estimated it to be vastly larger almost like the cocaine industry another illegal money spinner.

Millions in peril

Most often counterfeit drugs prolong suffering because they fail to provide a cure. They can also cause further illness because of toxic substances which definitely become fatal. According to a public health report, few thousands of people died in Nigeria in 1995 after taking an inactive meningitis vaccine containing only water in it. Similarly, in 1997 at least 6 people died in Argentina after taking a fake drug designed to treat Parkinson's disease. There have also been many fake drug related deaths reported in India, China ,Philippines and South American countries like Brazil and Peru..

There are no hard statistics on the scope of this crime because so much counterfeiting goes totally undetected. Nevertheless, authorities agree that the health of millions of Asians, Africans and Latin Americans are in peril. According to Dr Lembit Rago, drug coordinator for the World Health Organization in Geneva, Switzerland " When you look at customs seizures, intelligence reports from law enforcement agencies, investigations from the pharmaceutical companies and the few definitive studies, you have to conclude that in the developing world, anywhere from 10 to 30 percent of the drug supply is counterfeit"- quite a scary scenario !

Counterfeit drugs cause Death

According to many investigators, counterfeit pharmaceuticals are often extremely hard to detect, they also come in a bewildering variety of forms. Fake drugs may contain no true ingredients or too little of the true ingredient. The fake drugs may be harmless or they may have impurities, contaminants and even toxic substances. They could be rejected or out of date formulations withdrawn from the market by manufacturers. Sometimes, apparently a trace amount of the legitimate ingredient is included to add deception. The fakers are very smart – an anti malarial drug like chloroquine is bitter. If they don’t put a little chloroquine in people will know, so, instead of 200mg, they will put 41 mg. That is what investigators have found out from their analysis of such drugs.

According to statistics there are more than 300 million cases of Malaria each year, and about one in million deaths and anti-malarial drugs are among the most widely counterfeited drug in the developing countries. According to a study published in a British medical journal ‘The Lancet’ a breathtaking 38 percent of the frontline anti-malarial drug with the chemical name Artesunate in Southeast Asia was fake. The result was that a substantial number of malaria sufferers died who would have otherwise survived. In fact one of the victim to such counterfeit crime was Sam Veasna, the internationally respected head of Cambodia’s Wildlife Protection office. While Veasna was searching for a rare wild cow in a malaria infested area, he contracted the dreaded disease and began taking medication. Instead of recovering, he fell into a coma and died.

Recycled Hospital Waste

I was going through some old medical and news reports and journals regarding the counterfeit drugs and came across this particular news item that was horrifying . In March 2006, Royal Thai Police and American custom officials raided a Bangkok apartment. They found a man and a woman producing fake steroids and Viagra in a filthy kitchen with very little sanitation conditions. The lady handling the fake drugs, was apparently a prostitute and the male partner with her was ill with infectious hepatitis and yet handling the drugs. The counterfeits were being prepared for sale on the internet and also elsewhere in other developing countries .

Another account that was mentioned was in Ho Chi Minh city in Vietnam, where hospital staff workers spotted a batch of suspicious looking syringes filled with an antibiotics, with yellow stains on the labels. The manufacturer was alerted and later it was found that the syringes had been scavenged from hospital waste, carefully dismantled and reassembled into an apparently intact and unused product and except for the small mistake they made in leaving a stain on the syringe, the entire mal practice and crime would have gone undetected.In fact when the investigators removed the plastic flip off, they found puncture marks in the rubber plug, confirming not only previous use, but also failure to clean off the degraded residues!

Some drug counterfeits are like these small-time opportunists who play with human lives. But, there is also an international pharmaceutical underworld, that is much more organized, much harder to detect and capable of doing damage on a much larger scale. Typically such counterfeit operations begin with unscrupulous wholesalers ordering fake drugs in bulk from factories in China and India. The wholesalers in turn sell to small manufacturers, who produce the finished tablets and then have deals with black marketers, unsuspecting smaller hospitals and pharmacies. Some of the phony drugs are sold on the internet.

The bulk of these counterfeit drugs are shipped with fake labels, often mixed in with legitimate ones to make it all the more difficult to detect them. Because of the relatively small dimensions of the shipments, they could even be sent through air cargo or can even be carried by passengers. From China and India they are normally sent to busy ports like Amsterdam and Hong Kong, where it is impossible for custom officials to check each and every container in a shipment. Some time back, Investigators for Bristol-Myers Squibb Company, for example found some fake versions of its anti-inflammatory drugs that originated from India, which were being sent to several European countries and finally shipped to Mexico. Luckily they were seized by the custom officials before they could do any harm, but this was just one success against hundreds of such shipments that slipped through the custom net and found its target.

Like for example, in Haiti, 89 children aged between one month and 13 years died after taking counterfeit version of a liquid acetaminophen, normally used to combat high fevers. Apparently, the Glycerin that was used as a thickening agent in the compound turned out to be a mixture of sugar and automobile anti freeze liquid. After investigating further investigators determined that the fake glycerin originated at a factory in China, where it was purchased by a German company which sold it to a Dutch company, which in turn sold it to a Haitian company and so on..and each time , each of the firms had the same thing to say, that they were unaware of the bogus nature of the product.

Not  easy to fix the problem

With time, practice, experience and also technology counterfeiters have become extremely sophisticated, duplicating packaging, holograms, company logos and bar codes that even law enforcement agencies and the drug companies themselves cannot identify as fakes.

And, as it is very well know , the payoff is substantial. Apparently a few years ago counterfeit of version of the drug Serostim was reported by its manufacturers Serono, Inc. A standard 12 week course of this anti-HIV/AIDS drug costs about $23,000 in the legitimate market. And, the counterfeit artists are able to manufacture a single pallet of a fake version worth thousands of dollars for a few dollars and sold at a fraction of the legal price and still make a huge profit.

They are smart and concentrate their effort on the appearance of the product and its packaging – this according pharmaceutical securities personnel, it can be virtually impossible for consumers to tell the difference between a counterfeit and a genuine product. Even pharmacists, doctors and government regulators can be fooled, so good is their work. Unless lab tests are carried out one can never be sure if the drug is genuine or fake or whether there are impurities in the drug or whether the product is expired.

What can be done?

Until strict controls are put in place there will be more deaths among the unwary and grief among their survivors. Although counterfeit drugs are beginning to show up in North America and Western European countries, the problem is nowhere as severe as it is elsewhere. This is the result of tight regulations, vigorous law enforcements and harsh penalties meted out to the culprits. In the developing world, however, drug counterfeit is still not considered a serious offence.

According to officials from GkaxoSmithKline Pharmaceuticals Limited, India –Although , Manufacturing, distributing, selling, stocking or exhibiting counterfeit drugs is a criminal offence in India with punishments ranging up to life imprisonment, this is just on paper. In practice, court cases drag on for ever and even when there is a conviction, the accused usually gets off rather lightly. Unfortunately, our criminal justice system doesn’t deter counterfeits in the slightest. Even when the counterfeits are caught red handed and arrested, most of the time they are merely fined and set free within a few hours. So a lax legal system does nothing to improve matters in India, in fact it encourages the counterfeit criminals to carry on with their work more vigor and enthusiasm. In India we also lack enforcement power and don’t have trained inspectors. And even the few that are there must seek the approval of local officials and if the person accused has political connections, the approval may not be granted by the local officials , so the criminals get away very easily.

The case is somewhat similar in China until a few years ago when Chinese authorities had discovered that an anti bacterial drug given to a patient was counterfeit and contained harmful bacteria that could have killed. But the seller was given a four month prison sentence and fined $7,000. However, of late they have been following regulations and enforcing the counterfeit law strictly with severe punishment and the results show that China is slowly lessening the harmful effects of this evil.

Compare the above cases to that of what happened in the United States. A couple of years ago when a pharmacist who diluted cancer drugs with spring water was caught, he was tried and was straight away sentenced to 30 years in prison. So, when such measures are taken it is but natural that sales of counterfeit drugs are kept at a minimum in North America and Western Europe. Most prescription drugs are dispensed under the watchful eyes of a licensed pharmacist. These pharmacists play an essential role in ensuring the integrity of the medicines they dispense. They are a far cry from the informal street sales of pharmaceuticals in many regions of the world especially in developing countries in Asia, Africa and South America.

How to protect yourself

Even experts have trouble telling harmful fakes apart from real drugs. But the following tips may help keep you safe

1. Make sure that you only buy drugs from licensed pharmacies and drug outlets, and be wary of internet offers however genuine they may sound. Don’t buy from peddlers or market places.
2. Be always suspicious of heavily discounted drugs. They are either old or possibly counterfeited or both.
3. Insist on a receipt always although this does not help much if the outlest is unaware that it is counterfeit, but one can at least trace the counterfeit drug peddler through them. Also, check that the packaging is properly sealed.
4. Ensure that the packaging indicates the batch number, manufacturing date, expiry date and the manufacturer’s name. Check that the names of the drug and the manufacturer are spelt correctly.
5. Report any lack of improvement in your health after taking a drug to your doctor. Don’t wait for too long since most drugs tend to take effect within 24 hours at the most. But, the very fact that a drug is not working is a clear indication that it is not genuine.

Finally to conculde we must realise that until strict controls and measures are put into place, there will be more deaths among the unwary and grief among the survivors. Counterfeit drugs are ruining people’s lives every single day all over the world. They will never disappear unless the central government and state governments take strong and strict measures against them.