New Drugs Are Often Bad For Patients, Great For Pharma

Pharma has developed all sorts of devious tricks to extend the duration of its patent monopoly on older drugs and also works hard to develop new "me too" drugs that provide no advantage to patients, but protect its monopoly pricing power.
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The business model that generates huge profits for the drug industry depends on planned obsolescence. The big bucks are earned when a drug is still on patent, free of competition, and can be outrageously priced.

Pharma has developed all sorts of devious tricks to extend the duration of its patent monopoly on older drugs and also works hard to develop new "me too" drugs that provide no advantage to patients, but protect its monopoly pricing power.

Pharma research has failed to produce much real progress in fighting disease, largely because curing disease is not its mission. Instead, most Pharma research is tied to marketing and lobbying- with the primary goal of generating profit, not helping patients.

New drugs are launched with an astoundingly large marketing budget to convince doctors and patients that they are better than the old drugs. Their obscene profitability gives the drug company the motive and the means to aggressively and misleadingly peddle them as a major breakthrough, when in fact there is nothing special about them and sometimes they are downright harmful. Old, off-patent (now inexpensive) pills no longer have any marketing muscle.

The result- new pills that are no better, sometimes worse, and always outrageously expensive drive the old stand-by pills off the market. Greed triumphs over science, sound economics, and patient welfare.

Dick Bijl is a world's expert in exposing this kind of Pharma chicanery. He is President of the International Society of Drug Bulletins (ISDB). ISDB is a world wide network of bulletins and journals on drugs and therapeutics that are financially and intellectually independent of pharmaceutical industry. It was founded in 1986, with the support of the WHO Regional Office for Europe.

Dick is also chief editor of the Dutch member of ISDB, the Geneesmiddelenbulletin. The objective of the Geneesmiddelenbulletin Foundation is to promote rational pharmacotherapy, which may be regarded as the practical application of the principles of 'evidence-based medicine'. Rational pharmacotherapy can be defined as prescribing the right medication to individual patients or populations, at the time when it is needed, using a dosage scheme that corresponds to the most suitable profile in terms of efficacy, side-effects and costs. The Geneesmiddelenbulletin tries to achieve this aim by providing independent and objective information about drugs to all those involved in prescribing and providing them. The website is accessible without charge.

Dick uses the history of birth control pills as a specific illustration of the how the profit motive drives the development of bad new drugs, but the same sad story could also be told about most classes of drugs.

He writes: "The introduction of the first combined oral contraceptive pill in the 1950's was a milestone in the management of birth control and also in the development of drugs.

This was a great example of basic research translating quickly and directly into clinical practice. Knowledge of the mode of action and pharmacology of the estrogen and progestogen hormones in the physiology of reproduction led to the development of a practical form of contraception. Most of this work was done in the USA with private funding from Margaret Sanger and Katharine McCormick.

Combined oral contraceptive (COC) pills work predominantly by inhibiting hormones in the brain to prevent ovulation in the ovary.

Initially, the estrogen component contained 150 mcg ethinylestradiol, but when it was shown that lesser amounts did not reduce contraceptive activity, the dose was lowered progressively to 100, 50, 35, 30, and even to 20 mcg.

The progestogen component of the pill has been changed much more in the evolution of COC pills. The first generation progestogens were lynestrenol, and norethisterone. The 2nd generation progestogens were levonorgestrel or norgestrel. The 3rd generation contained desogestrel, gestodene or norgestimate. 4th generation COC pills contained nomegestrel and drospirenone.

A simple observation published by an English general practitioner in the Lancet in 1961 cautioned that COC pill use is associated with venous thrombosis- which can lead to the potentially fatal pulmonary embolism. Although its prevalence is low, venous thromboembolism is the most serious adverse effect of contraceptive use.

You might think the newer pills would be safer than the older ones. You would be wrong. Independent researchers have repeatedly published studies showing that the newer 3rd and 4th generation contraceptive pills have an estimated risk of venous thromboembolism that is almost two times higher than that of standard second generation pills. These studies also showed that the risk of thrombosis increases with the estrogen doses.

Doctors who prescribe these newer contraceptive pills should inform their patients of this increased risk, especially since it is not counterbalanced by increased efficacy.

The drug industry has rejected these studies and has produced its own studies showing that the risk of the newer pills is comparable to the standard pills. Their claims are shallow. In recent years, regulatory authorities have admitted that COC pills other than the 2nd generation are associated with an increased risk of venous thromboembolism.

The conclusion is that all COC pills increase the risk of venous thromboembolism. The newer pills are more dangerous, but no more effective."

Thanks, Dick. You are fighting an admirable, one sided struggle to replace Pharma greed with rationality and devotion to patient welfare. The world would be a safer place, and patients would be much better off, if doctors spent more time reading your bulletins and newsletters and less time accepting the falsely seductive blandishments of drug salesmen.

Allen Frances is a professor emeritus at Duke University and was the chairman of the DSM-IV task force.

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