Monday, August 07, 2006

Key Opinion Leaders: Down Under, and Elsewhere

The Australian newspaper The Age has run a revealing article on how pharmaceutical companies use key opinion leaders (KOLs) to market drugs in Australia. I would suspect that much in the article applies to other countries as well.

Key quotes about key opinion leaders:

For years, drug companies have targeted the cream of Australia's medical profession — so-called 'key opinion leaders' — to work as paid consultants or to sit on company advisory boards.

Doctors with financial ties to drug companies are now in every corner of medicine. They write guidelines that dictate how thousands of patients are treated. They speak to the media and teach other doctors with power-point presentations finessed by drug companies. They are the well-respected heads of patient groups, foundations and professional bodies. They are gatekeepers for hospital pharmacy lists, where decisions to favour one drug over another could mean thousands of extra taxpayer dollars. A few spend weeks, sometimes months, away on drug company business, even though they are employed by the public purse in universities and hospitals.

'I think I would be right in saying that almost every chairperson raised it as a common issue,' says Professor Tattersall, chairman of the Australian Drug Evaluation Committee for the past decade. 'The issue of buying the key opinion leaders is so overt these days.'

For the medical elite, the result is a spreading ambiguity and erosion of professional independence. For the public, the issue is whether the advice given in media interviews — or even by their doctors — is tainted by drug company influence.

An ophthalmologist, who spoke to The Age on condition of anonymity, said the drug companies were teaching key opinion leaders how to 'push poll' other doctors. 'The opinion leaders become product champions,' he says. 'This is what will slowly kill the profession and its standing in the community. It has gone way beyond a couple of endorsed pens and umbrellas.'

The issue has recently become so hot within the profession that new voluntary Royal Australasian College of Physicians guidelines have called on institutions to track and, when necessary, act to reduce the doctors' conflicts of interest. The Age can reveal that several major Melbourne hospitals, including the Peter MacCallum Cancer Institute and Southern Health, are reviewing their policies.

One senior pharmacist at a major hospital says that there is now a 'clinical drug trial circuit'. Doctors who criticise a company are unlikely to get free stocks of a new drug, be asked on an advisory board or participate in a clinical drug trial, so there is pressure to maintain 'reasonable working relationships'.

Many specialists are insulted at the suggestion that they have lost independence and insist that advisory boards are purely scientific. But there are clues that hint at another agenda. On, a website of marketing tips for the pharmaceutical industry, it is all spelt out. One article provides the tip that companies ditch key opinion leaders (KOLs) if they are 'over-exposed, over-paid and over-the-hill' and replace them with 'up-and-coming rising stars' who will inject a fresh "enthusiasm and support for your brand". When identifying KOLs, the guide says, all bases must be covered, from the editorial committees of scientific journals, to professional and patient group leaders. 'Although you might be talking to a world expert, they still need to be clearly briefed and understand the data and what is required of them,' the website says.

The independence of clinical guidelines is a matter of great controversy in the US and a 'fundamental concern' in Australia, Paul Komesaroff says. 'I am not saying that everyone's opinions are contaminated, but I think many people's opinions are potentially contaminated.' He also believes that heads of foundations should be at arms length' from industry.

Professor Tattersall says greater transparency is required and suggests doctors have their conflicts of interests listed in waiting rooms or on letterheads. It should be no different from the requirement on financial planners to disclose their interests, he says.

This is unfortunately more evidence about the pervasiveness of conflicts of interest in health care. Although the pharmaceutical companies, and the medical education companies with whom they work cannot escape responsibility for these conflicts, neither can my physician colleagues who agree to be key opinion leaders.

So regrettably, in this case, we have, as Pogo once said, "met the enemy and he is us."

At a minimum, I would urge all my colleagues who are key opinion leaders to fully acknowledge, in detail, their financial relationships with pharmaceutical and device companies, and with any other organizations with similar vested interests, whenever they express their opinion leadership.

If such disclosure would create the feelings of discomfort, consider whether the discomfort is being engendered by the relationships being disclosed. If so, maybe it is time to think about ending those relationships.

Thanks to PharmaWatch for the tip.


Anonymous said...

This shift away from drug reps to opinion leaders has been highlighted in a number of recent WSJ articles. Pharma is planning for the coming rules limiting food deliveries to doctors. Plus a number of doctors do not allow drug reps into their offices so they loose penetration.

A Dr. Gleason's experience should be kept in mind for those doctors wishing to make it big on the speaking circuit. The short version is after writing a large number of prescriptions for off label use of a depression drug he was offered a chance to speak, for a fee, at a number of conferences, lunches and dinners. He soon gave up his practice.

The FDA started monitoring his speeches and found he had broken a number of rules. The drug company immediately dropped him and is assisting the FDA in his prosecution. With no practice, and no income, he has been forced to move to a new area and defend himself out of his personal funds.

Pharma has no conscience. Pharma is not your friend. Like so many fables with the same ending," You know what they are when you go to work for them." You will not change pharma's nature.

Steve Lucas

Anonymous said...

Other relationships exist between medical centers and vendors. I draw your attention to the Aug. 8, WSJ article Cleveland Clinic Defends Gift From a Vendor. While I am sure the Cleveland Clinic finds no issues with receiving $100,000 per year from a vendor as a research gift it does not pass my smell test.

Steve Lucas

Anonymous said...

I took zyprexa which was ineffective for my condition and gave me diabetes.

Zyprexa, which is used for the treatment of psychiatric disorders, such as schizophrenia and bipolar disorder, accounted for 32% of Eli Lilly's $14.6 billion revenue last year.

Zyprexa is the product name for Olanzapine,it is Lilly's top selling drug.It was approved by the FDA in 1996 ,an 'atypical' antipsychotic a newer class of drugs without the motor side effects of the older Thorazine.Zyprexa has been linked to causing diabetes and pancreatitis.

Did you know that Lilly made nearly $3 billion last year on diabetic meds, Actos,Humulin and Byetta?

Yes! They sell a drug that can cause diabetes and then turn a profit on the drugs that treat the condition that they may have caused in the first place!

I was prescribed Zyprexa from 1996 until 2000.
In early 2000 i was shocked to have an A1C test result of 13.9 (normal is 4-6) I have no history of diabetes in my family.
Daniel Haszard