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MANY Government advisers on the safety of medicines have close financialties with the pharmaceutical giants who produce the controversial measles, mumps and rubella jab.
A Sunday Express investigation has found that nearly a third of the 181 experts who sit on the Medicines Control Agency (MCA) committees are linked to GlaxoSmithKIine, Aventis, Pasteur or Merck, Sharpe and Dohme.
Fifty-one members either hold shares in these companies or are dependent on them for consultancy fees or research grants.
The MCA has continued to endorse the triple measles, mumps and rubella (MMR) jab despite concerns linking it to autism and stomach disorders.
But the extent of the MCA members' financial ties to MMR manufacturers raises questions about potential conflicts of interest.
Liberal Democrat health spokesman Nicholas Harvey said the matter should be looked into. "If these experts have pecuniary interests in the companies, we can't be confident they are making objective decisions," he said.
Members of the MCA are also concerned. Joe Collier professor of medicines policy at St George's Hospital Medical School in London, said many committee members are too close to drug companies. He claims there is an "institutional bias" which makes the experts ready to take the industry's point of view. Health experts also argue that MCA meetings are secret and therefore not open to public scrutiny.
Jackie Fletcher from the campaigning group JABS which is highlighting the possible health risks of MMR, said: "Monitoring bodies keep saying that they are independent but what is the definition of independence when they have shares and interests in the companies that manufacture and distribute the vaccines?"
The size of the members' shareholdings is confidential because they are not required to disclose on the MCA's register of interest how many shares they own. But our research – based on drug companies' share registers from April last year – found several experts have substantial investments.
Dr Michael Denham, a retired consultant in geriatric medicine and a member of the Committee on Safety of Medicines External Advisory Panel, owned £250,000 worth of shares in GlaxoSmithKline.
Professor Roderick MacSween, a professor of pathology at Glasgow Western Infirmary had nearly £26,000 worth of shares in GlaxoSmithKline.
Dr Michael Donaghy a brain specialist at Oxford's Radcliffe Infirmary Hospital, who sits on the MCA, had £19,000 worth of shares.
Eleven professors and doctors have received fees for research from Aventis Pasteur.
Warning Signs on Doctors' Roadshow
Guardian, February 15, 2001,
Sarah Boseley, health editor
While the NHS is strapped for cash, the pharmaceutical companies have money to woo.
There is a group of eminent British cardiologists who are referred to, by a certain drug company's sales reps in irreverent moments in the pub, as the Roadshow. They spend a considerable amount of time travelling around the UK and abroad, promoting the company's heart drugs. Some of them earn more from this than their annual salary from their hospital or university.
It may well be that these consultants are totally convinced of the value of the medicines and would do it out of conviction even if they were not sometimes paid as much as £3,000 – £5,000 a time for an evening lecture which lasts around an hour. But the fact that they receive such large payments undermines the credibility of their opinions.
Peter Wilmshurst, consultant cardiologist at the Royal Shrewsbury hospital who has been a constant critic of the relationship between drug companies and doctors, believes the huge sums of money washing around have the potential to skew people's judgments.
"Some members of the Roadshow have spoken fortnightly for the company...some also receive fees from other companies. It would be naive to imaginethat the size of fees do not affect the statements of opinion leaders," he wrote in a letter to the Lancet last summer.
There is no suggestion that doctors will promote a drug that will do any harm, but they may persuade themselves to promote one drug over another that is just as good.
There are always going to be tensions between the altruism inherent in healing the sick and the baser human imperative that drives the pharmaceutical industry to make money. But there are those who say that in parts of British medicine today, the one is being distorted by the other.
While the NHS is strapped for cash, the pharmaceutical firms have billions to invest in research and marketing. Doctors from early in their career are under subtle pressure to accept the financial support of the industry. Many see nothing wrong, others feel uncomfortable but shrug it off as the prevailing culture, and some consider that there is a real conflict of interest.
Dr Wilmshurst's eyes were opened to the potential for abuse when he was a relatively junior doctor involved in the clinical trials of a new drug for heart failure called amrinone. His team at St Thomas's hospital in London found some patients suffered gastrointestinal disturbances, liver failure and problems with their immune system. "The company asked us not to publish our adverse findings. Then when we said we had to publish, they threatened us with legal action," he says. "When you are threatened by a multinational with infinite amounts of money, some people might find that a good reason not to go ahead."
His team published. Others with similar results did not, he says, after senior cardiologists told them their findings were out of line with everyone else's. The drug was withdrawn on safety grounds in 1984, but was sold over the counter in the Philippines and Africa until 1986.
Dr Wilmshurst believes little has changed and that the largesse of the drug companies is a malign influence on doctors. "I don't think it is the majority of the medical profession, but the big problem is often with the big earners. The big earners are offered the biggest amounts of money."
The Association for the British Pharmaceutical Industry (ABPI) disagrees. Doctors, often those who have run trials on a drug, are certainly asked to speak and are paid for it, said spokesman Richard Lay. "I think that is right and proper. What we do not control is what they actually say."
He claims it is not unusual for a doctor to dissent from the company line. "Companies are not in the position of paying doctors to say what they want them to say. These are top people in their field. I would be astonished to hear that people like that are going to give misleading information to an audience of professionals who are intelligent and well-informed in their area."
Few academic departments could keep going without the revenues from drug company clinical trials. But the money, power and influence games are most noticeable at medical conferences. On the micro level there are corporate logos, ring binders, notepads, pens and bags in which to keep the literature. But that is not all. "The whole system of paying for doctors to go to conferences by drug companies is corrupt, because a company will not only pay for the air fare, the hotel and the registration fee but also for all the entertainment during the conference," says Richard Horton, editor of the Lancet.
"The payback is that they will make sure that doctor goes to all the symposia that promote their drugs. At the major cardiology conferences, almost no doctor will ever pay for any of those things him or herself. It is all paid for by the industry. The whole thing is one massive promotion."
The ABPI points to its code of practice which says hospitality must be a subsidiary part of a bona fide meeting. "If there is any suggestion that it is just a good jolly, that is not allowed," says Mr Lay.
Even so, Dr Horton is concerned by the growing number of these symposia at medical conferences. A study of the published articles that came out of symposia, carried out by Lisa Bero and colleagues in 1992, found that they had "strong promotional attributes" and warned that readers should "approach symposium issues that are sponsored by a single pharmaceutical company with scepticism".
It is hard to step out of line and those who do, such as Dr Wilmshurst, find their careers take a slide. "You wouldn't get money to do clinical trials if you didn't go along with it," says Dr Horton, "but you are making a Faustian pact by doing so.
"The days of pharmaceutical companies taking doctors out on holiday are over. You can't do that any more – it's been banned. But the way it is done now is very, very heavy."
Those at the very top of the profession, whose work is readily funded by the Medical Research Council or the Wellcome Trust, do not have to depend on the generosity of drug companies, he says. "But for people in the middle rank it is very difficult. It starts very young. They are junior doctors and along comes a friendly drug company rep who takes them out to dinner every week. Immediately you become very sympathetic to industry."
He does not think the UK is any different from America. "I think it is in some ways worse. The reason is that when you are working in a bit of a downtrodden NHS and along comes the rich company that will take you to wonderful cities at the weekend, you become very susceptible. It is just too easy. It is sad."
In his recent book, "Don't Tell the Patient", Professor Bill Inman, who started the NHS "yellow card" scheme for doctors to report to the Department of Health the side effects of the medicines they prescribe and later founded the Drug Safety Unit at Southampton, alleges that drug company "post marketing surveillance" schemes, where GPs are paid for filling in forms on the side effects experienced by patients on a new drug, are nothing more than covert marketing.
As a result of his campaigning, industry guidelines called Samm (safety assessment of marketed medicines) were agreed, stipulating that no inducement must be offered to a GP. But, says Prof Inman, he has seen a letter from one company doing a so-called Samm study for angina, offering a doctor £275 to treat four patients with the new drug to be compared with two given the old one. The letter says GPs may enrol up to 18 on the new drug "but the ratio [new drug to old] will be maintained".
Prof Inman believes it is wrong that the Committee on the Safety of Medicines, the government advisory body responsible for drug safety in the UK, should have so many members with links to industry. So does Charles Medawar of the watchdog body Social Audit. "I to some extent buy the argument that it is difficult to recruit top people who don't at least have indirect interests," he said, "but the scale is distinctly unhealthy." In the latest declaration of interests from the CSM, 15 out of 36 had either shareholdings, fees or paid consultancies from drug companies.
"The very fact that they insist the chairman should have no ties indicates that they think it is significant," he said. The present chairman, Alastair Breckenridge, resigned from the advisory board of SmithKline Beecham to take the job.
Members leave the room when a drug from a company they have interests in is being discussed. But Joe Collier, professor of medicines policy at St George's hospital school of medicine, says there is "institutional bias" – so many on the committee are close to drug companies they cannot help but take an industry point of view.
A top executive at one of the world's leading pharmaceutical companies is to become director of drugs licensing at the medicines control agency, raising questions about the independence of the MCA from the industry that it is supposed to police.
Ian Hudson will take up his new job in February. He has worked in the drugs industry for the past 11 years and until recently was director and vice-president of Worldwide Clinical Safety, at SmithKline Beecham, and was to have led the worldwide drug safety group after the merger of SKB with Glaxo Wellcome, which came into effect yesterday.
The MCA rebuts any suggestion that the appointment of Dr Hudson to head the drugs licensing division will reinforce the already close links between the MCA and the drugs industry.
"These very senior positions within the agency do not come along very often and it would be regarded as an exceptional opportunity to play a leading national and international role in public health through medicines regulation," said a spokeswoman. She added that the MCA had "previously attracted high-calibre candidates from industry", including its chief executive, Keith Jones. Dr Jones was formerly a director of Merck, Sharpe and Dohme Rahway in the United States.
But there will be concerns over the appointment among consumer groups and those who are critical of the MCA's secretive ways of operating.
Although the MCA claims to be moving towards greater openness, few details have been divulged about evidence given that has meant approval or otherwise for drug licences.
The agency argues that the data it sees from clinical trials are commercially sensitive and must be kept secret to assure protection from competitors to the companies developing the drugs.
The MCA makes its decisions following advice from the committee on safety of medicines, a group comprising doctors and scientists, the majority of whom have links to the drugs industry in the form of research grants, consultancies or other financial support.
All members of the CSM are asked to declare both personal interests in drug companies, such as shares or fees, and non-personal interests, such as funding for clinical trials. Any member with a personal financial interest is expected to leave the room when the CSM starts to discuss drugs connected with the company involved.
Critics say, however, that the problem runs deeper than personal interests because most of the scientists are steeped in a culture which does not tend to question the drugs industry.
Paul Flynn, MP for Newport West, considers this culture "defensive, pro-industry and anti-consumer". He says that those responsible for advising and granting licences for medicines should be wholly independent of the industry and rejects the argument that the scientists who are employed and backed by drugs companies are the best in their field.
"They tell you these people are the only ones who can do it, which is not true. There are plenty of independent people who could do it," he said.
While it was not uncommon for top figures in other industries to move into Whitehall, such as the Department of Trade, he said, "matters of life and death" hung on decisions that affected the licensing of medicines.
Clare Mackay, principal policy adviser to the Consumers' Association, said it was probably inevitable that there would be movement between the industry and the regulatory body. She said the issues were about conflicts of interest when people "crossed over", and the need for guidelines to be in place to manage it. Also his appointment sent out a message about "the priorities for the MCA".
The drugs regulatory system is facing a review within Europe which may lead to the end of separate licensing bodies for countries. Ms Mackay said she was aware that it would be a challenge to get the public/patient perspective taken on board.
Links:
Drug firms accused of distorting research, The Guardian, September 10, 2001.
Drug testers warned. Industry-funded research must prove independence, Montreal Gazette, September 10, 2001.
GPs 'failing to report drug side-effects', The Independent,15 April 2001.
Schools forcing children to take drug, parents say, Health fears ignored as Ritalin prescriptions soar, The Observer, Sunday April 22, 2001.
Zyban: Smoking pill link to 35 deaths. Inquest told of pill's adverse effects, The Guardian, Thursday April 26, 2001.
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