report adverse drug reactions separate from licensing drugs

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report adverse drug reactions separate from licensing drugs

Postby malernee » Wed Nov 10, 2004 10:45 am

BMJ 2004;329:937 (23 October), doi:10.1136/bmj.329.7472.937




The pharmaceutical industry operates in a way that puts profits before public health, members of parliament (MPs) heard last week. And the regulatory authorities, which are meant to ensure the safety of drugs and protect the public, collude with the industry, they were told.

Testimonies from five doctors and two consumer champions, who were being questioned by the health select committee for its inquiry into the influence of the pharmaceutical industry, built a picture of an industry that creates health anxieties among the public to boost its profits.

At the same time, withholding unfavourable trial results and controlling what research gets published ensures that doctors get the messages that companies want to promote, the committee heard at the second public sitting of its inquiry.

Public awareness campaigns are part of a "multipronged marketing approach" that are commonly employed by drug companies to "gain further control over what medicines are being prescribed and to whom," said Graham Vidler, head of policy at the consumer organisation Which?, formerly known as the Consumers' Association.

"These can often be for quite trivial conditions, such as toenail infections, and they encourage patients to go and see their general practitioner, often in quite strong terms," said Mr Vidler. "At the same time the industry will be advertising drugs to these GPs, and our research shows that GPs often take the path of least resistance and say yes to patients and prescribe the drug even though they feel it may not be the most appropriate thing to do."

GPs can see pharmaceutical representatives on a daily basis, and their influence can lead to changes in prescribing habits, said Des Spence, a GP in Glasgow and spokesman for the No Free Lunch campaign, a group of UK healthcare professionals concerned at the undue influence of the pharmaceutical industry on doctors in promoting drug products.

"Within three or four years [of it being launched] Vioxx [rofecoxib] became 40% of the medicines we were using in my area," said Dr Spence. "The industry has a major influence on healthcare policy. The influence is across the field and affects doctors, nurses, patient organisations, and government agencies. The industry is active in all these fields and has a very clear agenda—that of profit—and that is in direct conflict with the responsibilities of the NHS."



Des Spence: Industry has a clear agenda—namely, profit—which is in conflict with the NHS



Part of the problem is that the industry is charged with policing itself through the Association of the British Pharmaceutical Industry, which is funded by drug companies, said Ike Iheanacho, editor of the Drug and Therapeutics Bulletin.

"A regulatory body needs to punish companies that are responsible for misleading activities and tell people they have been misled. If these are the standards that we would like to see then they are largely absent from the present regulatory system," he said.

David Healy, head of psychological medicine at the University of Cardiff, believes that research articles have a greater influence on doctors' prescribing habits than promotional activities. But again the process of publishing research is rife with pharmaceutical industry influence, he said.

Professor Healy claimed that at least half of articles on drug efficacy that appear in the BMJ, the Lancet, and the New England Journal of Medicine are ghost-written by pharmaceutical companies and that "the most distinguished authors from the most prestigious universities" put their names to them without ever seeing the raw data.

Peter Wilmshurst, a consultant cardiologist at Royal Shrewsbury Hospital, said that in the past he has been offered bribes by a pharmaceutical company not to publish unfavourable research results. Dr Wilmshurst also claims that he knew of three professors of cardiology who were told their results were aberrant and were persuaded by the pharmaceutical company who had sponsored the study not to publish.

"I suspect this is as common now as it ever was," said Dr Wilmshurst. He also told the committee that key opinion leaders can be paid in the region of £5000 ($9000; 7000) for an hour's talk about a drug they have no experience of using, and their influence can have a big impact on practice.



Richard Brook resigned from an expert group over delays in warning the public about SSRIs



Dr Spence added, "The amount of hospitality received by doctors compared with other public services is a disgrace. If policemen, teachers, or MPs received this level of hospitality there would be a public outcry."

Also giving evidence to the committee, Richard Brook, chief executive of the charity Mind, called for greater transparency in how the Medicines and Healthcare Products Regulatory Agency operates and for disclosure of any links between people working in the agency and people in the drug industry.

Mr Brook resigned from the agency's expert group investigating the safety of selective serotonin reuptake inhibitors (SSRIs) after he discovered that the agency waited many years before disclosing the evidence about withdrawal effects of these drugs and their potential to pre-dispose children to suicide.

Many of the agency's key personnel have longstanding links with the pharmaceutical industry and own shares in companies, said Mr Brook. "For a number of reasons I was very concerned that there was no robustness [at the agency]. We want to see a better way to do health research and people with consumer and legal interest serving on the agency," he said.

Andrew Herxheimer, emeritus fellow at the UK Cochrane Centre, Oxford, called the relationship between the industry and the agency "a closed, inbred community where the industry is the client and the client must be looked after" and where a "culture of secrecy" permeates.



Andrew Herxheimer: The regulatory agency feels it must "look after" the drug industry



He called for the reporting of adverse drug reactions to be separated from the business of licensing drugs.

Witnesses also called for stronger enforcement of formularies in general practices, declaration by pharmaceutical companies of their contact with and payments to doctors, and regulation of the industry's influence on consumers.

Commenting on Professor Healy's comments after the hearing, Dr Kamran Abbasi, acting editor of the BMJ, said: "The BMJ takes the issues of transparency and accountability very seriously. We believe that authors must accept full responsibility for the integrity of their research—including having the idea, collecting and analysing the data, interpreting the results, and writing the paper—and we have several policies in place to ensure this."
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