Pharma Accused Of Misleading Regulators
“The pharmaceutical industry is a ‘market for lemons’; a market in which the seller knows much more than the buyer about the product and can profit from selling products less effective and less safe than consumers are led to believe”.
This controversial comment comes from a press statement issued by the American Sociological Association about a study — Pharmaceuticals: A Two-Tier Market for Producing ‘Lemons’ and Serious Harm —that was presented at the associations annual meeting, which was held earlier this week. The study, authored by Donald Light, a professor of comparative health policy at the University of Medicine and Dentistry in New Jersey (USA), claims that about 85% of new drugs offer “few if any” new benefits and claims that drug companies sometimes hide or downplay information about side effects and overstate the drug’s efficacy.
It’s a harsh statement against pharma, as is Light’s claim that pharma companies spend “two to three times more on marketing than on research”. After a quick look at some third-party takes on the story though it seems that not everyone is shocked by the claims being made.
“I’d like to tell you this comes as a shock. But like every other doctor, I remember sitting in pharmacology lectures at medical school, being taught how drug companies would try to trick us into prescribing their latest wonder drug, and poring over the statistics to try to work out how they had manipulated the research to produce a positive result,” wrote Max Pemberton, a doctor who writes for the UK’s The Telegraph.
According to Light, there are three reasons why the pharma industry is producing “lemons”:
- having companies in charge of testing new drugs
- providing barriers of legal protection to hide information about the harm or effectiveness of drugs
- the low bar set for drug efficacy in order for a new drug to be approved.
He also claims that some pharma companies “swamp the regulator” with large numbers of “incomplete, partial substandard clinical trials”. In the press statement he said: “In one study of 111 final applications for approval, 42% lacked adequately randomized trials, 40% had flawed testing of dosages, 39% lacked evidence of clinical efficacy and 49% raised concerns about serious adverse side effects.”
According to the UK’s The Independent, the study has initiated a response from the Association of the British Pharmaceutical Industry (ABPI). The ABPI is claimed to have released a statement saying:
“Professor Light is long on accusation and woefully short on hard evidence. There is now much greater transparency in clinical trial results. The UK pharmaceutical industry also adheres to a strict code of practice on the sales and marketing of its products.
“The patient information leaflet provided in every pack with a medicine details the side effects which have been reported in clinical trials and reviewed by the regulator.”