Pharma: Tame Watchdogs Not Protecting Public Health
In a recent article, The Guardian has exposed the unhealthy relationship between Big Pharma and the UK "watchdog", the MHRA or Medicines and Healthcare products Regulatory Agency, which appears to be a pharma-controlled promotional agency, rather than a provider of checks and balances on the work of this incredibly profitable industry.
The "revolving door syndrome" which Professor Abraham sees in the UK, closely parallels the analogous situation in the US, where the FDA has long been shown to be more close to the interests of the pharmaceutical and food industries than to the health of patients and consumers, approving drugs and toxic additives such as the synthetic sweetener Aspartame, often overriding the better judgement of scientists. One of the problems seems to be industry financing of these so-called watchdogs, which of course stymies any possibility of effective control.
Another article in the Guardian's series details how researchers and doctors are in Big Pharma's pockets, although most of them do not seem to think that gifts and travel expenses as well as speakers' fees have any influence over how they evaluate the usefulness of pharma's drugs. In the accompanying editorial, titled appropriately "The Need for Openness", quips that the question "Is academic medicine for sale?", asked four years ago in the New England Journal of Medicine, should really ask about all of medicine. The answer: No, it isn't (for sale) as the current owners could not be happier. In other words, the sale has long been concluded and Big Pharma is in no mood to let go.
Here is a copy of The Guardian's courageous piece:
The drugs industry and its watchdog: a relationship too close for comfort?
Rob Evans and Sarah Boseley
Monday October 4, 2004
It would appear to be a happy and satisfying relationship. "Our priorities are aligned," says one document. There have been "notable successes" says another, citing "another example" of where the two sides "cooperated well". In business partners, this would seem to indicate a harmony of views. The documents obtained by the Guardian, however, relate to meetings between the drug industry and the watchdog body set up by government to police it.
Critics say the drug regulator and the industry are too close. Their proceedings have long been shrouded in secrecy because of the drug companies' insistence on the commercial sensitivity of information relating to their products.
Today, documents obtained by the Guardian under the open government code reveal the reality of relations between the Medicines and Healthcare products Regulatory Agency (MHRA) and the trade association of the industry it regulates. The documents show that:· the regulator and the industry have been engaged in a joint lobbying campaign in Europe;
· the industry privately drew up its own detailed blueprint of how the MHRA should be run;
· the industry has been pushing for higher level representation at the MHRA against ministers' wishes.
Since 1989, when the then prime minister, Margaret Thatcher, took drug regulation out of the hands of the Department of Health, the MHRA has been 100% funded by the pharmaceutical companies.
The MHRA's chief executive, Kent Woods, appointed in January, has no drug company background, but critics say the agency continues in the unquestioning belief that the regulator and the industry are working together in the mutual interests of public health.
John Abraham, professor of sociology at Sussex University, who is well respected for his books on drug regulation, says that in 1989 there was a reconstruction of the regulators' mission alongside the new fees relationship. The MHRA came to believe the interests of public health are coherent with the promotion of the industry.
"The criticism of the old Department of Health medicines department in the 70s was that it didn't have any teeth. Not only does it now not have any teeth, but it is not motivated to bite," he said.
The MHRA told the Commons health select committee inquiry into the influence of the industry that it does not consider the fee relationship to be a problem.
"I would suggest to a lay person there is a big problem with the concept of independence from industry of a body that is fully funded by industry," said Professor Abraham. The UK's regulatory agency competes with those of other countries to approve drugs for the whole of Europe.
But Professor Woods says that neither industry funding nor close liaison is a problem. "It is important that the regulator understands the regulated industry.
"I have to say that our areas of overlapping interests are not 100%. There are some things where we have common cause but our prime responsibility is to ensure we protect public health. These are aims which the industry shares. I don't think there is a necessary antipathy between what the ABPI [The Association of the British Pharmaceutical Industry] is trying to achieve and what we are trying to achieve. But there are other areas in which we can't agree."
Richard Ley, spokesman for the ABPI, denied that the ABPI had the MHRA "in its pocket". "The objective of the MHRA is to ensure that medicines are assessed to be effective and as safe as possible. Those are also our aims. We have an absolute desire to have good quality medicines."
The documents record the regular meetings and dinners between the MHRA and the ABPI over the past year.
Among the "notable successes" of its close collaboration with the industry, the MHRA paper cited how it "cooperated well" with the trade association to lobby other European governments and the European commission on a review of legislation governing drug companies. It was, according to the briefing paper, "another example where the Association of the British Pharmaceutical Industry and the MHRA worked closely together".
Minutes of a meeting between the ABPI and senior MHRA officials in April record that the "ABPI thought there was a remarkable concordance between MHRA and their priorities..."
At their meeting with the MHRA top officials in June, the ABPI presented an eight-page blueprint detailing how it thinks the MHRA should be run to "build upon the excellent working relationship" between the industry and the regulator. According to this document, "our priorities are aligned [ABPI/MHRA]".
Following this meeting, Nicky Lilliott, the ABPI's head of regulatory affairs, wrote to Professor Woods, to confirm that, as agreed, the ABPI would develop an action plan to discuss a wide range of issues for the future of the agency. "I would propose that over the summer the ABPI drafts an action plan and this is then circulated to yourself and colleagues for comments, with the intention to agree the action plan at our meeting in September."
"The action plan would need assigned topic leaders, joint ABPI/MHRA, in order to achieve the agreed objectives/milestones. The main driver for the actions and timelines for these issues will be the implementation (of) the new pharmaceutical legislation by October 2005". Professor Woods said the action plan related to establishing a framework for bilateral meetings. The documents show the ABPI is unhappy at proposed changes to the structure of the MHRA. It used to have three people on the ministerial advisory board and two on the Medicines Commission, the drug licensing appeal body.
In a letter to Professor Sir Alistair Breckenridge in January, Dr John Patterson, the ABPI president, wrote: "We remain concerned at the lack of representation of the pharmaceutical industry at board level within the MHRA ... As the only regulatory agency that is fully industry-funded, we believe it is essential that we have a say on a variety of issues, not least financial matters relating to fees and service levels."
After more pressure, MHRA officials discussed alternative arrangements. Roy Alder, a senior MHRA official, suggested in March that "there could be scope for industry to make a similar input to MHRA business and operational policy" through other ways. He wrote: "Ministers are clear that the MHRA board should have no current industry people. There seems no option on this issue." He suggested someone recently retired from the industry could possibly be put on the board, "but ministers may want to avoid any perception of industry interests at board level."
The Committee on the Safety of Medicines (CSM), made up of independent experts, advises the MHRA on which drugs to license after studying clinical trial data on safety and efficacy. Its members are supposed to declare any sponsorship or payments they receive for lectures or advice from industry. The last complete declaration of interests of CSM members, for 2001, shows 17 out of 36 members had personal financial links to the industry, while others have declared non-personal interests such as research grants.
The documents show that industry has been agitated about ministers' "unrealistic" plans to tighten the rules on conflicts of interests. The ABPI complained ministers were "being too restrictive in the requirement for experts to not hold any personal interests in the pharmaceutical industry."
Professor Abraham claims there is too much of the "revolving door" syndrome at the MHRA. Not only do CSM members take fees from industry, but many agency officials used to work for drug companies, such as the former head of worldwide drug safety at GlaxoSmithKline, who is now the MHRA's head of licensing.
See also related:
Drugs companies are defrauding healthcare systems, conference hears - British Medical Journal - 23 October 2004
Panorama: Taken on Trust - BBC One, Sunday, 3 October 2004
We take it on trust that the drugs our doctors prescribe are safe and effective. But this special investigation exposes huge failings in the system of medicines regulation that is supposed to monitor drug safety. It reveals how patients' lives have been put at risk as a result.
Massive medical fraud exposed: pharmaceutical company paid doctors to prescribe drugs and run sham clinical trials - and other articles on pharma fraud...
Drugs licensing flaws exposed - Special report: Pfizer advised on how to get antidepressant approved by member of body deciding on application - By Sarah Boseley Monday October 4, 2004 - The Guardian
Makers 'ghost' drugs reviews
By Rosie Murray-West (Filed: 15/10/2004)
The pharmaceutical industry routinely bribes doctors and "ghostwrites" articles about drugs in major medical journals, MPs were told yesterday. Professor David Healy, of the University of Wales, told the Commons health select committee that as many as half the articles published in journals such as the British Medical Journal and The Lancet were written by members of the industry who had a vested interest in selling the drugs involved.
Sharper teeth for medicines watchdog
By Sarah Boseley, health editor - Friday November 12, 2004 - The Guardian
The government yesterday announced sweeping changes to the medicines watchdog body after years of criticism and pressure, banning those who sit on its central licensing committee from having any personal or financial interests in pharmaceutical companies.
USA Today 19 Dec 2004: Can Americans trust their medicine?
Boston Globe: What ails the FDA? Payola
By Marcia Angell Â -Â March 10, 2005
LET'S FACE it. The FDA is doing a poor job of ensuring that prescription drugs are safe and effective. It approves drugs that offer only minimal benefit, and then sometimes leaves them on the market long after they've been shown to be dangerous.
posted by Sepp Hasslberger on Thursday October 7 2004
updated on Tuesday December 21 2010
URL of this article:
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