Pharmaceutical industry, which earns billions of dollars annually, created and marketed in the last decade new drugs that have brought little benefit to patients and produced a lot worse, experts say. The claim that there is “an innovative crisis” in the field of medicine because of the difficulty to discover new drugs and large expenditures involved in this is just a myth promoted by an industry concerned mainly with marketing, scientists added.
The fact that the number of patented new drugs each year remained constant – between 15 and 25 – is contradicting statements of the pharmaceutical industry. But most new drugs bring minor changes to existing ones and aim to capture a small market segment, not to provide real therapeutic innovations. Independent studies show that 85-90% of new drugs offer minimal benefits to existing treatments, and some – such as the painkiller Vioxx and Avandia, for diabetes – have had serious side effects that led to their withdrawal from the market.
Professor Donald Light from the University of Medicine in New Jersey and Joel Lexchin from York University in Toronto, have written in the British Medical Journal that the situation remained unchanged in the last 50 years. Incentives to develop drugs are wrong and have distorted industry behavior. “This is the real crisis of innovation: pharmaceutical research generally resulted in minor variations of existing drugs and most new drugs do not prove superior in clinical trials. They also caused an epidemic of adverse reactions that have raised health costs nationally,” they say.
Companies spend more on marketing (25% of revenue) than for the discovery of new molecules (1.3%). The pharmaceutical industry argues that the introduction of a new drug on the market costs over one and a half billion dollars, an amount excessive and unbearable. The authors say that research funding has increased substantially between 1995 and 2010, by almost $34.2 billion, but revenues have increased six times, by $200.4 billion. Companies are reluctant to mention this “extraordinary gain” because up to 80% of expenses are for advertising, say the authors, calling on relevant authorities around the world to stop licensing new drugs with low therapeutic value. They suggest substantial cash awards for discovery of truly new therapeutic agents instead of protecting patents.
European Medicines Agency, which authorizes drugs in the UK and Europe, keep secret certain information about their safety and effectiveness. And this despite the fact that within 10 years, there have been issued warnings on safe use for 29% of new biological agents approved by the agency.
In another study, researchers at the London School of Economics say that, before being granted the patent, drug manufacturers should be required to demonstrate that their products are superior to existing treatments and not superior to placebo, as is the case now.
“By changing regulatory procedures, manufacturers should be encouraged to focus on developing new drugs in therapeutic areas where there are few alternatives,” they say. “Completing the regulations with approvals and scientific opinions could cause manufacturers to turn their interest and research efforts on priority areas”.
Stephen Whitehead, executive director of the British Pharmaceutical Industry Association, had the following response: “We disagree with the statements in this work. Medical research has always relied on gradual innovation and repeatable results and less on radical discoveries, which are very rare. If treatments for HIV would have not been gradually improved, AIDS would be a deadly disease, rather than be controlled.”
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