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China's Killer Headache: Fake Pharmaceuticals
Dr. Venkat Appaji | Wednesday, September 18, 2002, 08:00 Hrs  [IST]

They knocked down the door. Inside, scattered across the floors of four concrete rooms, investigators found evidence of China's lucrative and deadly trade in counterfeit pharmaceuticals -- antibiotics made of talcum powder, birth control pills filled with rice flour. China has become the world's largest purveyor of counterfeit drugs, according to private investigators, law enforcement officials and Western diplomats.

An estimated 192,000 people died last year in China because of fake drugs, according to the Shenzhen Evening News, a government-controlled newspaper. Some die from toxins in counterfeit medicines, and others from infection because they are swallowing bogus pills instead of antibiotics.

According to a British consulting firm Reconnaissance International, more than half of all counterfeit drugs contain no active ingredients or contain the wrong ones. Nearly 10 percent contain contaminants. Most of China's fakes are consumed in China, but some make their way around the globe. A study published last year in the Lancet, a British medical journal, found that a third of antimalarial drugs on sale in Cambodia, Laos, Burma, Thailand and Vietnam -- a region in which malaria is a voracious killer -- contained no active ingredient.

Both the U.S. Customs Service and the Food and Drug Administration acknowledge that Americans are unwittingly bringing in counterfeit pharmaceuticals from Mexico, though they cannot quantify the amount."We have found counterfeit pharmaceuticals sourced from China all over the world," John D. Glover, vice president of corporate security at Bristol-Myers Squibb Co., said in congressional testimony last year. When people get caught, they are mostly liable only for civil fines. And even in criminal cases, the maximum sentence for counterfeiting is seven years. Selling fake drugs can result in a death sentence if people are harmed, but such cases are rarely brought. Overall, the federation estimates, 1 to 2 percent of the world's pharmaceutical sales involve counterfeit products.

The World Health Organization says fakes account for as much as 8 percent of the global supply. That would mean trade in bogus drugs could be worth as much as $32 billion a year. In developing countries, as much as 25 percent of pharmaceuticals are fake. Two years ago China created a State Drug Administration and it has stiffened penalties while increasing police authority to carry out raids and conduct criminal prosecutions. Authorities closed 1,300 factories last year and investigated 480,000 cases involving counterfeit drugs worth $57 million, according to the state-run newspaper China Daily. Much of the initial investigation is handled by private security companies that are hired by pharmaceutical.

Another complication is that China's military is involved in the trade, investigators say. Despite the formal removal of the People's Liberation Army from many businesses, old networks remain, with many operations controlled by retired military. In the bogus drug trade, the highest profit margin is enjoyed by the last person in the chain who knows the goods are fake and sells them to the first person who thinks they are real. In some cases, wholesalers buy fake drugs and mix them with real pharmaceuticals, passing them off to unwitting middlemen.

Stop insulin and remain insulin free -- one year later

Four out of five patients with type 1 diabetes now insulin independent may no longer need daily injections -- after islet-cell transplant. The catch: there aren't enough pancreas donors. Islet cells are the cells in the pancreas that produce insulin. They are destroyed in people with type 1 diabetes. Reports at the 19th International Congress of The Transplantation Society show how very far islet-cell transplantation, an experimental treatment, has come. Still needed is safer immune system suppressing drugs, which transplant patients must take for life.

Most of all, there's a need to make better use of the life-saving islet cells, which come from deceased donor organs. As recently as 1997, islet cell transplants reversed diabetes for only one in 10 patients. The improved transplant technique known as the Edmonton protocol has become successful worldwide. Four out of five patients no longer need to take insulin.

The Edmonton technique requires two donor pancreases for each patient. That makes it more expensive, and wasteful, than direct pancreas transplant. Currently it's used only in patients who are close to death from diabetes. Twelve children aged 11-17 received transplants of pig islet cells to treat their type 1 diabetes. 12 patients have no evidence of any disease from the pig transplants, and in six of them the transplants are functioning,. Perhaps the most amazing part of the trial is that the children needed no immune-suppressing drugs. That's because the children also received cells from the pigs' testes. These special cells, called Sertoli cells, keep the immune system from attacking the pig islet cells. "It has been known for many years that the testes are what we call immunologically privileged,. Testes cells can be transplanted anywhere and they are not rejected. It is Sertoli cells that give the testes this privilege. Islet cells can be used in combination with Sertoli cells to protect them against attack by the immune system.

Magnesium Sulphate helpful in Life threatening Asthma Treatment

IV administration of magnesium sulfate appears to be useful adjunct to standard treatment in certain patients with acute severe asthma,. The treatment may not be helpful in patients with mild-to-moderate asthma. The researchers studied 240 patients seeking emergency department asthma treatment. On arrival they had lung function (FEV1) of 30% or less predicted. All were given nebulized (Salbutamol) at regular intervals and IV methylprednisolone. In addition, half an hour after arrival in the emergency department, patients were also treated with 2 g of IV magnesium sulfate or placebo. At 4 hours, FEV1 rose to a mea of 48.2% predicted in the magnesium-treated patients and 43.5% predicted in placebo-treated patients. Further analysis showed that that the effect was greater in patients with greater airway compromise. If the initial FEV1 was less than 25% predicted, the final FEV1 was 45.3% predicted in the magnesium group and 35.6% predicted in the placebo group, a significant difference.

However, in patients with an initial FEV1 of 25% or more predicted, magnesium administration was not beneficial. Furthermore, use of magnesium did not reduce hospital admissions. Commenting on these findings, Dr. Silverman told Reuters Health that "the bad news is the benefits of intravenous magnesium are limited to those who present to the hospital with acute, severe life-threatening asthma. The good news is that we now have another safe and inexpensive treatment to offer to patients with the most severe form of acute asthma." In an accompanying editorial, Dr. Marc Noppen of the free University of Brussels, Belgium, agrees, pointing out that this and other studies have shown that such infusion "undoubtedly improves" pulmonary function, "albeit only in the most severe cases." Chest 2002;122:489-497.

DCPP to help developing countries for making health policies

The Disease Control Priorities Project (DCPP) is a new three year effort launched to assess disease control priorities and produce science-based analyses and resource materials to inform health policy making in developing countries. The DCPP is a joint project of the Fogarty international Center (FIC) of the National Institutes of Health (NIH), the World Health Organization (WHO), and The World Bank. It is funded by a $3.5 million grant by the Bill & Melinda Gates Foundation.

"This project pushes disease-control studies into the 21st century by bringing scientific, demographic, and epidemiological advancements to bear on disease-control research and strategies in developing countries,. The DCPP will collaborate with partners around the world to generate information for national and international policymakers as they determine their health strategies and investments. "For prevention and treatment programs to work, policymakers must have access to the best possible research and analysis to ensure that their health investments save as many lives as possible,. The DCPP will help developing countries establish health priorities and cost-effective health interventions based on careful analysis of the cost of disease burden and the cost of treatment and prevention. The demographic, epidemiologic and economic information produced by DCPP will be shared through its new products, events, and tools including:
* technical workshops involving experts and policymakers from developed and developing countries on estimating burden of disease and cost-effectiveness analysis;
* interactive online discussions of the work in progress;
* online, universally accessible DCPP working papers and other publications, available at www.nih.gov/fic/dcpp;
* demographic, epidemiologic, and econometric information and materials to increase the capacity of developing countries to determine national priorities;
* the second volume of Disease Control Priorities in Developing Countries, which will be available in print and online in 2005.
* About DCPP

In 1993, The World Bank published the first edition of Disease Control Priorities in Developing Countries with contributions from WHO,.The volume examined the priority of 25 conditions based on their public health significance and the cost-effectiveness of preventive and patient management interventions in low- and middle-income developing counties. It was a companion document to The World Bank's 1993 World Development Report Investing in Health. The combined impact of the two publications was to stimulate national and international debate on health-sector investments, and to catalyze extensive work on the estimation of the disease burden and the cost-effectiveness of specific health interventions. Both documents have become reference works used extensively by policymakers, international development agencies and academic institutions. In 2005, the new DCPP will publish an expanded second edition of Disease Control Priorities in Developing Countries.

In the past decade, conditions in many countries have changed; knowledge has been gained about effective healthcare interventions and strategies and about the role of households, communities, and health systems in improving health conditions. For example, mortality rates for children under age 5 continue to decline in most countries, but in some countries they are increasing due to the emergence of HIV/AIDS and the breakdown of the public health infrastructure. The global health picture has been transformed by the HIV/AIDS pandemic, and some regions, such as Sub-Saharan Africa, have also experienced an increase in tuberculosis and malaria. More is known today about the global disease burden brought about by tobacco, alcohol, psychiatric disorders, and injury, which account for an increasing proportion of deaths. In addition, recent advances in molecular genetics, immunology, informatics, and other areas of science and technology facilitate development of improved methods to prevent or reduce illness and disability. Yet health policies, both in developed and developing countries, are too often based on little data or evidence of questionable reliability, and lack careful analysis of the value to be derived from health investments.The DCPP will take stock of lessons learned and the increasing knowledge base to develop recommendations applicable to current health conditions. It will also consider the potential for biomedical research to contribute to disease control and assess research allocations as part of national and international priority setting.

Herbal Supplement For Prostate Cancer adulterated with synthetic drugs

A chemical analysis of PC-SPES, a recently recalled herbal dietary supplement commonly used to treat advanced prostate cancer, has shown that the supplement was contaminated with the synthetic drugs warfarin, diethylstilbestrol and indomethacin. Diethylstilbestrol and indomethacin have known anticancer properties. Later preparations of PC-SPES, which contained less diethylstilbestrol and indomethacin than earlier preparations, showed a corresponding decrease in anticancer potency by as much as sixfold. The findings appear in he Journal of the National Cancer Institute. PC-SPES is a mixture of seven medicinal herbs plus saw palmetto; It was introduced in the United States as a dietary supplement in 1996. Early studies suggested that the preparation was effective in reducing levels of prostate-specific antigen (PSA, a marker for prostate cancer) in both hormone-responsive and hormone-resistant prostate cancer patients. However, concern grew because of evidence that the preparations were being contaminated with synthetic drugs, says Jeffrey White, M.D., of the National Cancer Institute, in an accompanying editorial. Subsequent studies found that PC-SPES contained the synthetic estrogen diethylstilbestrol, the anti-inflammatory drug indomethacin, and the blood thinner warfarin.

Earlier this year, BotanicLab, the California-based manufacturer of PC-SPES, voluntarily recalled the product and has since gone out of business. In this analysis of eight lots of PC-SPES manufactured at different times between 1996 and 2001, it was found that all lots contained indomethacin and most of the lots contained diethylstilbestrol. Warfarin began appearing in varying amounts in lots manufactured after July 1998. In his editorial, White says that "herbal research is complicated enough without having to deal with the added problem of potential product adulteration."He says that preclinical and clinical trial research of promising herbal interventions should continue. However, he urges investigators to consider regular quality control evaluations by independent laboratories throughout the course of their research.

US Clears Kids' Diabetes Monitor

A wristwatch-looking device that uses tiny electric currents to painlessly monitor diabetics' blood sugar now is officially available for children to use. The Food and Drug Administration first approved the GlucoWatch last year for adult diabetics. The FDA said GlucoWatch maker Cygnus Inc. proved the device works in diabetic children ages 7 to 17, too, and allowed the company to begin marketing the watch for pediatricians to prescribe. The GlucoWatch is not perfect, so it doesn't replace those painful finger-prick blood tests that diabetics must do to check their blood sugar levels, the FDA warned.

It said people should never use insulin or make medication adjustments without first double-checking a GlucoWatch reading with a fingerstick test. But by supplementing finger testing with up to six painless glucose measurements an hour, the GlucoWatch allows more frequent monitoring, which may help prevent dangerous diabetes complications. Plus, the GlucoWatch sounds an alarm if blood sugar hits dangerous levels - possibly lifesaving if that happens while a child is asleep. To use the GlucoWatch, patients slide a thin plastic sensor onto the watch's back. Small electric currents extract a tiny portion of glucose from fluid in skin cells instead of blood, measuring it every 20 minutes. The GlucoWatch costs $595, plus a $4 to $5 disposable sensor that the patient must replace every 12 hours. To get a doctor's prescription for a watch, the FDA requires that patients be trained to use it and pass a quiz.

Compiled from WWW by Dr. Venkat Appaji Padmanabhuni


email : appajipv@hotmail.com

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