20 June 2009

Marisa de Andrade reports on tactics aimed at financing and implementing drug research. 

A meeting at Gleneagles to recruit doctors to sign up patients for a drug trial – a necessary sweetener in the interest of public health or an unethical practice?

Thirty five doctors from 25 practices across Scotland travelled to Perthshire earlier this year to hear why they should sign up for a study involving Celecoxib - the ‘super-aspirin’ used mainly by arthritis patients for pain relief, which has been found in some studies to increase the risk of heart attacks and strokes, particularly if used for a long time.

Approximately 600,000 patients are prescribed the painkiller in the UK, but it has been closely monitored by the health regulator since 2004 when refecoxib (Vioxx), a drug in the same class, was pulled for causing serious heart problems. Both drugs are cox-2 inhibitors – drugs to reduce pain while minimising gastrointestinal problems.

The Standard Care versus Celecoxib Outcome Trial (Scot) is now underway in Scotland to evaluate the safety of the drug in comparison to similar painkillers like ibuprofen. Doctors aren’t paid if they recruit patients for the trial, but their practice gets £1000 if they join - and a further £5 every two months per patient for reporting progress.
 

The study is aiming to recruit 16,000 people by 2012 in Scotland and Denmark. So far about 700 patients have signed up, but the trial sponsor, Dundee University, plans to increase numbers by running the trial in England and another EU country, possibly the Netherlands.
 
Europe’s health regulator, the European Medicines Agency (EMEA), agreed to keep the drug on the market if its manufacturer, Pfizer, carried out a global study to confirm its long term effects on the heart.
 
In March, a leading US researcher who supported the used of Celecoxib admitted to fraud. Dr Scott S. Reuben from Massachusetts revealed that data for 21 studies he had authored for the efficacy of the drug was fabricated. He also confessed to doing the same for refecoxib and was a paid Pfizer spokesperson.
 
Pfizer, which markets the drug under the brand name Celebrex, sponsors a similar trial in America called Precision, which compares the drug’s safety to that of ibuprofen or naproxen. The company is also providing £26million for the study in Scotland.
 
A spokesperson for the company says: ‘We have provided financial support to the Scot study, but it is managed and operated independently of Pfizer. The University of Dundee – the sponsor of the trial - is managing the study in partnership with the Universities of Glasgow, Edinburgh and Aberdeen. In addition, it is in collaboration with leading professors from Nottingham University and the University of Southern Denmark.’
 
The spokesman adds: ‘This meeting was not organised by Pfizer or on Pfizer's behalf and it was solely the initiative and responsibility of Prof Tom MacDonald and Dundee University. All meetings organised by Pfizer or on our behalf are conducted to the
highest standards of compliance with the Association of the British Pharmaceutical Industry (ABPI) Code of Practice.’
 
So why the controversy? Principal Investigator Prof Tom MacDonald, denies anything unethical is going on - and defends Dundee University’s strategy to entice GPs to enlist patients. As the sponsor, the university receives a multi-million pound grant from Pfizer. It sets the rules, and reports findings back to the pharmaceutical company weekly. The university is also responsible for persuading doctors to get patients to participate so it can reach its target of 16,000 people.
 
Dr Des Spence from No Free Lunch UK, an organisation campaigning for a public register of all hospitality and payments received by health professionals, thinks that even though this form of sponsorship may bypass the code of practice, it is still unethical.
‘The code may technically not apply in this case because Pfizer is not the direct sponsor of the trial – Dundee University is,’ he says. ‘But then the drug company should make absolutely clear what the sponsor’s responsibilities are.’
 
The ABPI Code of Practice makes it clear that such meetings should be held in appropriate venues - lavish or deluxe venues must not be used.
 
So why were  doctors sipping on pre-dinner drinks at Gleneagles, before dining on seared Loch Duart salmon, braised shoulder of lamb and Valhona ‘Guanara’ chocolate?
 
Prof MacDonald says the venue was chosen in an attempt to get doctors to attend: ‘To get the practices signed up has been a challenge for whatever reason. But they are coming if we set up meetings at the weekend at Gleneagles. If they come a long way, they’ll get accommodation paid for and their travel reimbursed.’
 
They also get dinner and drinks the night before, breakfast and lunch - a cost-cutting measure, according to Prof MacDonald: ‘This still works out better for us. The whole deal we get from the hotel is a lot less than £300. You could say the recession has helped us do the study.’
 
His argument is, doctors have to be paid a locum fee of £350 a day if these meetings are held during the week and one partner would have to leave the practice. Thirty five doctors were at Gleneagles. Four GPs represented the same West Lothian practice, three came from the same surgery in Stenhousemuir and three were from one practice in East Kilbride. Some doctors were present even though their practices had already signed up to the trial.
 
‘Some practices have more than 50 patients,’ says Prof MacDonald. ‘That’s quite a lot of money, but it goes to the practice. Dundee University does not sign any cheques for doctors.’ Prof MacDonald also stresses the independence of the trial: ‘The funds come from Pfizer. They pay for it. But Dundee University is the sponsor responsible for the trial integrity. We wrote the protocol. There is no marketing for this trial. No Pfizer reps ever turn up at the trials. We just give them an update about once a week. This study will help us draw some solid conclusions to benefit arthritis sufferers.’

He also thinks it will have benefits for future patient treatment: ‘The outcome of the trial isn’t as important as setting up a research network so we can carry out similar trials in the future,’ he says.

Out of courtesy, the drug company is also contacted within 24 hours if a patient experiences a serious adverse effect.
 
Prof MacDonald adds: ‘This isn’t a commercially viable trial for Pfizer. It’s not going to help their business model. They’re doing this because they have to fill a regulatory EMEA commitment.’

An EMEA spokesperson has a different view: ‘You cannot force anyone to conduct clinical trials, but if a company wants its product to stay on the market then we need to be convinced that it should be there. It is in Pfizer’s commercial interest to do it.’

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First published in The Scotsman on 16 June 2009.