Monday, May 2, 2011

SWSLHN and Bowral's Health - 4


Take two, see your drug company
June 30, 2007

Business-class airfares, swanky hotels and expensive dinners - never has the relationship between pharmaceutical companies and doctors been so profitable. Steve Dow reports.

IT'S A bountiful life for many an Australian specialist doctor. Dinners at Sydney's finest restaurants. Business- class airfares and a week in New Orleans, Amsterdam or Atlanta. Tickets to Jose Carreras concerts and a dinner cruise, and time for a spot of golf. No need to reach for the wallet. It's all absolutely free.

More than half of Australia's physicians are "confident engagers" with the pharmaceutical industry, recent evidence to the Federal Court shows. They're very comfortable receiving big pharma's gifts of travel, entertainment and a little "education" - drug company information on new medications. A patient's disease no longer determines which pill gets popped; commerce firmly guides the doctor's arm when reaching for the prescription pad.

Here's how it works, says Ian Haines, an oncologist with Melbourne's Cabrini Hospital. Drug companies will fund research in various countries. They'll pick the results they want and bury the other studies. The medical researchers lucky enough to have their results anointed will be paid by drug companies to travel and spread the word. "In medical publications, a lot of the authors now are employees of drug companies," Haines says. "We never saw that 10 years ago."

Sometimes specialists in their field have their expenses picked up just to sit in the audience and hear these filtered views. In June 2004, for instance, Haines accepted sponsorship from Novartis Pharmaceuticals to attend a scientific meeting in New Orleans. Haines received a $10,000 business-class airfare, five days in the Hampton Inn in downtown New Orleans - valued at $2000 - lunch and dinner each day, and day excursions worth about $1000. All for free. He didn't even have to present a paper.

But for Haines, enough was enough when Novartis sent him a $3000 cheque last year and an invitation to another scientific meeting in Atlanta. He banked the money but had a change of heart. Haines made out a cheque for $3000 to Novartis and sent it back with a "no thanks". He also turned down an offer by Roche to fly him to Amsterdam last June. In November Haines told the Federal Court, in a case brought by the Australian Competition and Consumer Commission, he was "increasingly concerned that I was compromising my independence and integrity".

The pharmaceutical industry was dealt a bitter blow this week when a three-member panel headed by Justice Robert French ruled that Medicines Australia, the industry body covering more than 90 per cent of drug companies in Australia, could only continue to self-regulate its code of conduct if all drug companies twice a year forwarded complete information on hospitality: the venues, the number and types of professionals invited, the total cost of food, travel, accommodation and entertainment. This information would be published on a freely accessible internet database.
A Medicines Australia monitoring committee will be empowered to carry out random spot checks on drug company information at the end of each financial year and to request further information. Professor David Henry, a Newcastle University academic who has published extensive research on Australian doctor and drug company relationships, hails the judgment as "strong", but says drug companies should be naming the doctors who receive their hospitality.

"The medical profession defends its involvement in activities sponsored and paid for by the drug industry on the grounds they are primarily educational," Henry says. "If that is true, then doctors should have no difficulty offering their name to be on the register, and if they don't want their name to appear, they must be concerned about the nature of their activity."

The Medicines Australia chief executive, Ian Chalmers, labelled the ruling as "disappointing". Chalmers says the industry's code of conduct is strong and claims members of the public lack the ability to "assess the appropriateness" of hospitality information. Last November counsel for Medicines Australia, Stephen Gageler, argued in the Federal Court that once hospitality data was published it would be "fodder for sensational reporting in the media" and provide information to drug company competitors that would lead to "tacit collusion".

Justice French and colleagues this week determined that public interest far outweighed such concerns, warning of a "real risk" that without public disclosure and regular reporting of the nature, frequency and scale of hospitality to medical professionals, some drug companies "will test the boundaries and offer inappropriate benefits".

Perhaps there will be a sense of relief among drug companies following the French decision - a new level playing field has been created - but it is doctors who will have cause to panic. The Herald understands some doctors have become so emboldened by a culture of lavish pharmaceutical hospitality that they threaten to not prescribe certain drugs if the manufacturer does not stump up cash sponsorship for their symposia.

"That's arisen because at its heart they've been brought up on the teat of the pharmaceutical industry and they've become dependent on it," Henry says. "The [drug company] income supports their recreational activities, whether it's skiing, golf days or whatever."

A new study of 52 Australian medical specialists co-authored by Henry and recently published in the Journal of Bioethical Inquiry found Australian specialists each received an average 42 gifts and "educational items" over eight weeks. A 2005 survey co-authored by Henry in the Archives of Internal Medicine found 23 per cent of Australian medical specialists were on drug company advisory boards, with the companies often paying their travel and expenses for meetings at upmarket hotels locally and internationally. The fee for sitting on such boards was less than $5000 in 80 per cent of cases.

While most members were primarily motivated by peer recognition of expertise rather than financial reward, this "close and collegial" relationship with drug companies may "blur the doctors' sense of their primary responsibilities".

Another study published by Henry and colleagues in the 2005 Medical Journal of Australia found 338 out of 823 specialists participated in industry-funded research. But 21 per cent of those with a drug company research relationship reported "possibly serious research misconduct" by the company, including delayed publication or refusal to allow publication of findings. Drug company staff will often write first drafts of researchers' reports.

Doctors increasingly have multiple ties with the pharmaceutical industry in Australia, Henry says, and are therefore more likely to advocate for the inclusion of drugs for government subsidy under the pharmaceutical benefits scheme. Professional ethics have been compromised globally.

The Harvard University-based former editor of the prestigious New England Journal of Medicine, Marcia Angell, wrote in The New York Review of Books in 2004: "Over the past two decades the pharmaceutical industry has moved very far from its original high purpose of discovering and producing useful new drugs. Now primarily a marketing machine to sell drugs of dubious benefit, this industry uses its wealth and power to co-opt every institution that might stand in its way. Most of the industry's marketing efforts are focused on influencing doctors, since they must write the prescriptions."

It's a culture that afflicts ordinary doctors in Australia, too. Harry Nespolon, a Sydney general practitioner and the Royal Australian College of General Practitioners' nominee to the Medicines Australia code of conduct committee, said in an affidavit to the Federal Court that while it was possible for healthcare professionals to inform themselves about prescription medicines without attending drug company "educational" events, few general practitioners referred to National Health and Medical Research Council clinical guidelines on a regular basis. Textbooks and drug company information approved by the Federal Government's Therapeutic Goods Administration were also "not necessarily up to date".

"Personally," Nespolon said, "I find speaking with representatives from pharmaceutical companies and attending events conducted or sponsored by pharmaceutical firms to be helpful. Often the speaker has also attended the latest international meeting and is therefore aware of new international developments in treatments."

As for independent, professional peer-reviewed periodicals such as the British Medical Journal, The Lancet and the Journal of the American Medical Association, "it is unlikely that any general practitioner requires the depth provided in these articles. The journals are not widely available", Nespolon said. (All of the journals update weekly or fortnightly, and the material is available on the internet for free or a small fee.)

Nespolon says he doesn't own the latest copy of the regularly updated Australian Medicines Handbook, produced by his college and the Pharmaceutical Society of Australia, the pharmacists' industry group. Nespolon - who sits on a committee charged with examining ethical conduct breaches by doctors and drug companies - claims pharmaceutical industry hospitality has been "reduced" over the past 20 years.

A report last year into the enforcement of Medicines Australia's code of conduct showed the majority of complaints came from rival drug companies and predominantly concerned promotional campaigns such as advertisements or claims made when drug company representatives visited doctors. Henry says there are rarely complaints about company-sponsored functions involving guest speakers, because "competitor companies are not present at the meetings and are therefore unaware of the details", while the doctors bestowed with gifts, food and entertainment are unlikely to raise a complaint.

Ian Haines, meanwhile, hopes this week's decision is a first step to a more independent medical profession. "We need to uncouple this relationship, this gravy train, and get more independent doctors back to making independent decisions about research," he says.

Dubious dealings

Aggressive marketing of the now-withdrawn Cox-2 inflammatory drug Vioxx to doctors led to a rapid rise in prescriptions but risked "serious net harm" for many Australian patients, Professor David Henry says. The side-effects included increased risk of thrombosis, heart attack and stroke.

Biogen treated Melbourne neurologists and nurses to a $180-a-head 10-course meal at the Flower Drum restaurant, says a complaint by a rival company, Schering. But Biogen says it was an educational night and there were only seven courses.

Novartis paid $13,000 to sponsor the oncologist Ian Haines to attend a medical conference in New Orleans in 2004.
Local drug companies work in conjunction with overseas associations such as the American Society of Clinical Oncology to send Australian doctors to US meetings that include dinner events organised by drug companies and free tickets to baseball games, cruises and concerts by performers such as Jose Carreras.

Source: Affidavits to the Federal Court in the case of the Australian Competition and Consumer Commission v Medicines Australia