The drugs that prescribe profits, not benefits for the patients

Having long suspected the rash of new medicines which come on to the market each year might not be all their cracked up to be, the American professor yesterday pinned his colours to the flag.

Accusing drug companies of conning the public by hyping patented medicines with little new to offer while downplaying their side-effects, Prof Light also claimed an estimated 85 per cent of new drugs offer few if any new benefits while having the potential to cause serious harm.

Warming to his theme, he went one further by describing the entire pharmaceutical industry as a "market for lemons" – where the seller takes advantage of a buyer who knows much less about a product.

"Sometimes drug companies hide or downplay information about serious side-effects of new drugs and overstate their benefits," says Prof Light. "Then, they spend two to three times more on marketing than on research to persuade doctors to prescribe these new drugs. Doctors may get misleading information and consequently misinform patients about the risks. It's really a two-tier market for lemons."

It's a phenomenon he calls pharma hype and alleges evidence for it can be seen in the rise of the cholesterol-busting drugs statins.

"Company-supported clinical researchers and medical writers created a global market for controlling cholesterol with statins," argues Prof Light. "There is a complex set of relationships between heart disease, saturated fats and cholesterol, but that has been converted into the simple message that 'cholesterol kills'.

"Yet two major trials of statins has found little evidence that

the drugs reduce the risk of

heart attacks. In contrast, they showed an increased total risk of harm to health and death from the drugs despite the lowering of cholesterol levels.

"Another trial led by a statin manufacturer was stopped early so that adverse side-effects were not recorded."

Prof Light may well find himself fighting a losing battle. While a report by the University of Nottingham earlier this year did call for more careful prescribing of statins after discovering a range of unintended side-effects, including liver problems and kidney failure, they also concluded the benefits for many people outweighed any adverse effects.

However, Prof Light remains unconvinced and his book The Risk of Prescription Drugs, due out later in the year, also highlights mental illness and diabetes as two other areas where the use of some drugs may cause more harm than good.

"The bar which new drugs have to cross to prove effectiveness has been set relatively low," he says. "Yet toxic side-effects and misuse of prescription drugs has made medicines a significant cause of death.

"Hyping of drugs began with clinical trials designed to minimise evidence of harm and published literature that emphasised its advantages. Pharmaceutical companies staged massive campaigns to sell the product instead of controlled limited launches, which would have better allowed evidence of side-effects to be gathered.

"Physicians inadvertently became 'double agents' – promoters of the new drug, yet trusted stewards of patients' health. When patients complain of adverse reactions, studies show that doctors are likely to discount or dismiss them."

Prof Light, a visiting lecturer at University College, London, also claims companies are guilty of conducting a "swamp the regulator" policy – bombarding the bodies that award drug licences with large numbers of "incomplete, partial, sub-standard clinical trials".

One study of 111 final applications for approval found that 42 per cent were missing data from adequately randomised trials, 40 per cent were supported by flawed testing of dosages, 39 per cent lacked evidence of clinical efficacy, and 49 per cent raised concerns about serious adverse side-effects.

"Companies control the generation of scientific knowledge and which findings will go to licensing authorities," he says. "The result is that drugs get approved without anyone being able to know how effective they really are or how much serious harm they will cause.

"Current incentives for research produce a few drugs that substantially improve patients' chances of getting better or avoiding death but sadly many are little better than dummy placebos."