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Medicines drug companies peddle as safe aren’t always. from

We can’t trust drug companies to wine, dine and educate doctors about the drugs they prescribe

If a drug company treats a doctor to a nice lunch and a presentation on their newest products, is prescribing affected? Doctors generally think not, but the research evidence overwhelmingly says yes. And if these events do affect doctors’ decisions on patient care, should we be worried?

An exposé last week described over A$43 million worth of industry spending on health professionals in Australia over just six months. This included big-ticket items such as a “A$176,000 junket to Vancouver for nine dermatologists”.

The response, unsurprisingly, is divided. The Australian Medical Association’s president describes industry-sponsored educational events as “in the best interest of patients”. Medicines Australia, the industry trade association, defends the industry’s role because: “No one knows medicines as well as those who make them”.

On the other hand, the Consumer Health Forum raises concerns that such industry largesse may lead to prescribing that is “…not in the best interests of patients”.

What the research says

A study by investigative journalism group Pro Publica released in March provides important insights into the influence of industry payments on prescribing. The study combined reports of payments to doctors under the US Sunshine Act with prescribing records.

The more money doctors received, the more brand-name drugs they prescribed. Those who were paid to speak at conferences or sponsored events prescribed more brand-name drugs than those just getting free meals.

Newer, on-patent, brand-name drugs are overwhelmingly the medicines that companies actively promote. And whether patients pay for medicines themselves or have them covered by a public or private insurance, less expensive, equally effective alternatives are often available.

Beyond the higher price, rapid uptake of new medicines is often not in patients’ best interest. When a medicine is first approved, little is known about rare or longer-term harmful effects. Serious harmful effects often become known during the first few years of use. Older people, and those with several serious health conditions, are usually not included in pre-market studies.

This happened with dabigatran (Pradaxa), an anticoagulant that was used to prevent stroke. Despite lack of pre-market testing in people over 85, it was soon commonly prescribed to this age group. Older, frail people are at higher risk of bleeding, a harmful drug side-effect, and dabigatran rapidly became a leading cause of reports to regulators of life-threatening bleeds.

We expect newer products to be better than the ones they replace. But this is not a requirement for a new medicine to be approved. The manufacturer needs only to show effects compared to a placebo or “sugar pill”. Many new medicines are no better or even worse than existing treatments.

Prescrire International, a French independent bulletin, evaluates every new medicine. Over the past ten years, it found that only 7% of 1,035 offered even modest treatment advantages. More than twice as many were less safe or effective than existing options. Most of the rest were no better or worse.

Doctors get a very different message in drug promotion. Colleagues in Canada, the United States, France and I studied the safety information doctors get from sales representatives. More than 250 doctors participated in the study, reporting on nearly 1,700 drug-specific promotions during sales visits.

Fewer than 2% of promotions included “minimally adequate” information for safe prescribing in any of the three countries.

We carried out this study just before the use of the diabetes drug rosiglitazone (Avandia) was restricted due to heart attack risks. Nearly all of the promotional claims were of safety: “Avandia is safe even in patients with heart disease”; “new studies indicate safety”.

What about ‘educational events’?

There are many reports of educational events also leading to bias in documents that have become public in US legal cases on fraudulent marketing. For example, sponsored education was a major tactic used by Parke-Davis to promote the epilepsy drug gabapentin (Neurontin) for a range of unapproved uses.

And it is hard to see a dinner event on “The Anxious, Depressed Patient”, sponsored by AstraZeneca in August 2014 at Kimberly Gardens in St Kilda, as anything but promotional when the invitation features the same image as an advertisement for quetiapine (Seroquel).

Such events often feature physician “key opinion leaders”. This is one of the most insidious forms of promotion, as it’s harder for the audience to clearly see that this is sales.

A first step towards change would be a firewall between continuing professional education and industry sponsorship. Australian doctors can access excellent independent medicines information through NPSMedicineWise, the Australian Medicines Handbook and Therapeutic Guidelines. Funding for independent continuing professional education could also be expanded.

The view of many doctors that “I don’t let myself be influenced” might be the biggest barrier to change. But A$43 million in six months is a lot of money for drug companies to spend if they’re having no influence.

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