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NGOs welcome revised procedure for updating WHOs Model List of Essential Drugs
Dr. Venkat Appaji | Friday, February 15, 2002, 08:00 Hrs  [IST]

The Essential Drugs list (EDL) is one of the most important public health tools. Essential drugs are those that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in the appropriate dosage forms, and at a price that individuals and their communities can afford. The essential drugs concept guides countries as well as non-governmental organizations (NGOs) in selection of drugs, decisions about procurement and pricing policies, and rational drug use. Health Action International (HAI), MSF and Oxfam had welcome the revised procedure for updating WHO''s Model List of Essential Drugs as outlined in document EB109/8. The procedure ensures an independent, transparent, and evidence-based process for revising the EDL. The organizations appreciated particularly the fact that expensive essential drugs will no longer be excluded from the list solely because of price. However, the expansion of the EDL should go hand-in-hand with measures to ensure that these medicines become affordable for the individuals and communities who need them most. The NGOs suggested that WHO should actively support strategies that lead to equity pricing of essential medicines.

An equity pricing system should include measures to increase generic competition, differential pricing, global/regional procurement and distribution, local production through compulsory or voluntary licensing, and technology transfer. WHO should support the dissemination of drug pricing information and provide developing countries with support for across-the-board price negotiations.. WHO should play an active role at the TRIPS Council to ensure that countries without production capacity can procure low-cost medicines elsewhere, and should provide countries with examples or models of intellectual property legislation. It is the international community''s responsibility to address the lack of research and development for neglected diseases.

US FDA approves first Cholesterol Combo drug

Kos Pharmaceuticals USA announced that it received FDA approval to sell its combination tablet Advicor. (extended release niacin/lovastatin ) to treat high cholesterol. Niacin is a B vitamin that, when given in high doses, helps improve the body''s cholesterol and triglycerides another blood fat. It drops triglycerides and LDL, or bad cholesterol, while it raises levels of HDL, or good cholesterol. Lovastatin is one of the statin drugs that help keep cholesterol at healthy levels. Kos says that when used together, people may have a greater improvement in their cholesterol than if they took either lovastatin or niacin by itself. The tablet will be available in different combinations, delivering 500 mg, 750 mg, or 1,000 mg of niacin with a constant lovastatin dose of 20 mg. The maximum recommended dose is 2,000 mg/40 mg, which is two 1,000 mg/20 mg tablets. Kos notes that with the maximum recommended dose of Advicor, LDL and triglycerides dropped more than 40% each, on average. HDL increased by up to 30%. Drug Company fined $3m for abusing its dominant position.

An UK drug company must pay a fine $3m;for abusing its dominant market position to drive out competitors, the competition commission''s appeal tribunal ruled. In its first case the tribunal, set up under the Competition Act 1998, upheld a ruling last March by the director general of fair trading against Napp Pharmaceuticals, Cambridge, makers of MST Continus, a slow release morphine tablet taken by terminally ill patients with cancer. But the tribunal cut the £3.2m fine imposed by the director general to £2.2m. The tribunal upheld orders to reduce the price of the drug, limit discounts to hospitals, and pay compensation to the NHS, backdated to May 2001.Napp discounted its prices by as much as 90% to hospitals, which are seen as a crucial gateway to the GP market, because most family doctors continue to prescribe drugs given to the patient in hospital. The director general of fair trading ruled last March that Napp had supplied the drug to patients in the community at high prices while supplying hospitals at discount levels that blocked competitors.

The Office of Fair Trading estimated that the action would save the NHS £2m a year. The case, the first brought by the Office of Fair Trading under the Competition Act 1998, resulted from a complaint by Peter Bradley, Labour MP for the Wrekin. He said he started looking into the question after a meeting with a health authority. "My anxiety has been and continues to be that if Napp was making excess profits of £2m on a single drug, how many other cases arethere and what is the total cost to the NHS?

Taking Aspirin every day; who should - and who shouldn''t.

If taken by everyone who needed it, aspirin could save tens of thousands of lives, British researchers say. And now a panel of U.S. experts says everyone at risk of heart disease should ask their doctors about taking the common but powerful drug. So should everybody be taking a little aspirin every day? Not so fast. Aspirin can cause serious bleeding in the gut and brain. The risk of this is small, but may be much greater than the risk of heart disease in relatively healthy people. That''s why researchers are struggling to find out exactly who should -- and who shouldn''t -- take aspirin every day. Baigent, a scientist at the U.K. Medical Research Council led a group of researchers who analyzed all available data on the abilityof aspirin to prevent heart disease. The findings appear in the the British Medical Journal. They show that for every 1,000 patients at high risk of heart disease, aspirin could prevent up to 20 heart attacks. One or two of these patients, however, would have brain bleeding and stroke -- and as many as four would have major gastrointestinal bleeding. These high-risk patients are people who already have underlying heart disease, who have had a heart attack, stroke, or mini-stroke; or who have high blood pressure.

Coincidentally, the U.S. Preventive Services Task Force (USPSTF) -- an independent panel of medical experts - has also issued its own recommendations for the use of aspirin

to prevent heart disease. This report, published in the Annals of Internal Medicine, says that men over 40 and women over 50 should see their doctors to find out about their heart-disease risk. If it''s high, they should take aspirin only if their doctor says they should. The easiest thing is to take a small dose of aspirin every day. Aspirin isn''t a magic shield against heart attack, but for those at high risk it cuts that risk by about one fourth The big question is when aspirin''s benefits outweigh its risks. The British researchers recommend aspirin for everyone who has at least a 1-in-20 chance of a heart attack over the next five years. The USPSTF is a bit more conservative - it advises aspirin for those with at least a 1-in-33 chance of heart attack in the next five years."

Saliva Test For Ovulation

Saliva may be the answer for women who want to know when they are fertile. The Food and Drug Administration has approved the first in-home test that uses saliva to detect when a woman has ovulated. The TCI Ovulation Tester, developed by TCI Optics, was found to be more than 90 percent accurate at predicting ovulation. To find out if she is fertile, a woman would take a small sample of her saliva, place it on a slide, and examine it with a handheld microscope to detect certain types of salts. As ovulation approaches and estrogen levels rise, so does the salt level in saliva. So, the greater the amount of salt in the sample, the closer to ovulation a woman is, The Associated Press reports. The test will be available for purchase from the manufacturer''s Web site and toll-free number in a few weeks, the AP says.

TB Diagnosis Patch May Offer Alternative to Mantoux Test

Sequella Inc announced that its Transdermal Patch for active tuberculosis (TB) was successful in diagnosing the disease in late stage clinical trials. The Transdermal Patch is applied to the forearm before it delivers a soluble TB protein directly to the skin. Unlike the existing Mantoux TB skin test, the Transdermal Patch distinguishes active TB disease from latent TB infection or prior BCG vaccination. The distinction is important for physicians because about 85 percent of infants born worldwide are vaccinated with BCG, and an estimated one- third of the world''s population has a latent TB infection, according to Sequella. Latent TB patients do not need drug intervention, while active TB patients must be treated. The Transdermal Patch demonstrated a sensitivity of 88 percent, an efficiency of 93 percent and a specificity of 100 percent during the late stage clinical trials conducted at the Philippine General Hospital in Manila. The trial also suggested that the Transdermal Patch for Active TB might be useful in monitoring the success of TB chemotherapy, according to Sequella. Sequella is a biotechnology company dedicated to commercializing therapeutics, vaccines and diagnostics for infectious disease.

Compiled from WWW by Dr. Venkat Appaji Padmanabhuni

e-mail : appajipv@hotmail.com

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