Docs and drug money

You’re at the doctor. A half-hour later, you are in the pharmacy picking up a prescription medicine. It’s pretty pricey, but you bite the bullet: "The doctor must know what he is doing." But there might be something you need to know...

We expect our doctors to think only of our health. We expect their advice to be based on the best, most reliable and unbiased evidence available.

But in recent years we've heard an increasing number of disturbing reports (mostly from the US) about relationships between doctors and the pharmaceutical industry, and between researchers and industry. Your doctor, these reports suggest, might not be entirely independent of outside influences and conflicts of interest.

A number of top researchers have been busted for secretly receiving millions in payment from pharmaceutical companies. Of these, the case of Professor Joseph Biederman, head of psychiatry at Harvard Medical School, was a particular eye-opener. According to Marcia Angell, editor of the New England Journal of Medicine, "thanks largely to Biederman, children as young as two years old are now being diagnosed with bipolar disorder and treated with a cocktail of powerful drugs, many of which were not approved by the Food and Drug Administration (FDA) for that purpose, and none of which were approved for children below ten years of age”.

Biederman, it was reported, had received $1.6 million in consulting fees from drug companies between 2002 and 2007. Some of these funds were from the companies making the drugs in dispute (read the New York Times article on the case).

SA schmooze
The pharmaceutical schmooze might be more subtle. The South African Lymphoma Patient Group, for instance, invites doctors, patients and journalists to a World Lymphoma Day dinner. There are a few short presentations. During one of them, a doctor speaks glowingly about a drug that just happens to be manufactured by the company which is sponsoring the event. The drug probably deserves the praise – but you get where this is going.

It is not unusual for drug companies to sponsor such events; nor is it unusual for them to sponsor continuing professional development (CPD) events – which doctors are obliged to attend to keep up to date. What are the companies getting in return for their sponsorship spend? Critics argue that they are “buying” a scientifically unjustifiable advantage for the products; and that in the end the consumer pays the price.

Not so, says the Pharmaceutical Industry Association of South Africa (Piasa). It argues that marketing is important for the education and empowerment of healthcare professionals. "Pharmaceutical marketing provides a useful service, ensuring doctors are aware of new products available to them, as it would not be possible for practicing doctors to keep informed only by reading about new developments in the many professional journals currently published."

There are legitimate questions, though. Big pharma is a high-stakes, competitive world: can we get a balanced view when the supplier of information is specifically talking about his own product, with a view to increasing market share? In some cases, at least in the US, more expensive drugs are selling better than cheaper drugs, despite the fact that they have not been proven to be more effective – a phenomenon widely credited to the vigorous marketing of the more expensive drugs.

In part to counter this kind of thing, US President Barack Obama has committed $1.1 billion in economic stimulus money for comparative effectiveness research. This will compare the effectiveness of different drugs, treatments and procedures for a wide range of medical problems, and by so doing help cut costs in the long run.

The rules
Whereas there are serious differences about the details, all agree that some policing of pharmaceutical marketing is required. To this end, Piasa has a marketing code for members which, it claims, "provides clear guidelines for marketing based on ethics as well as clear scientific evidence from peer reviewed medical journals”.

The Piasa code doesn't allow payments to be made directly to healthcare professionals for marketing activities, as the following two clauses from the code indicate:

• Inappropriate financial benefit or material benefits including excessive hospitality cannot be offered and/or extended to healthcare professionals.
• For product launches, no sponsorship or payment of travel and accommodation can be extended to healthcare professionals.

Claims made in advertising material must be limited to the information in the package insert approved by the Medicines Control Counsel (MCC), based on the scientific and clinical evidence submitted when the product is evaluated and registered, and are further guided by the code.

The Piasa code, though a good start, is not binding on non-Piasa members and doesn't have any legal muscle. For that, we will have to wait for the new government code to come into affect – currently it is still in draft form.

Targeting doctors
Whereas the new South African code and the Piasa code target industry, doctors are regulated by the Health Professions Council of South Africa (HPCSA), and in particular its “perverse incentives” policy.

The policy states that: "The HPCSA requires that health care practitioners should at all times act in the best interests of their patients and regard the clinical needs of their patients as paramount. To this end, a health care practitioner should always try to avoid potential conflicts of interest and maintain professional autonomy, independence and a commitment to the relevant professional and ethical rules and policies applicable. Any conflicts of interest, incentives or forms of inducement that threaten such autonomy, independence or commitment to the appropriate professional and ethical rules and policies or that do not accord first priority to the clinical needs of patients, are unacceptable."

Whereas HPCSA regulations regarding CPD activities are relatively strict, the lines become less clear in relation to marketing activities. When asked whether doctors are under any obligation to disclose to the HPCSA that they are receiving payment from pharmaceutical companies, Marietjie de Villiers, chair of the HPCSA's CPD committee, replied, " No, but they are under obligation of displaying ethical behaviour as is set out in Council guidelines."

Subtle influence
The HPCSA seems to place a lot of responsibility on the ethical behaviour of doctors, without actually providing strict rules as to the exact details of how they are expected to conduct themselves.

A recent article by Dr Bruce Psaty in the Journal of the American Medical Association bears out how doctor-industry links can often be governed by subtle influences rather than the explicit and intentional contravention of ethical codes. Psaty relates how a pharmaceutical company invited him to present his findings at a sponsored conference, and how he was then asked to help develop a set of slides. He felt a social duty to reciprocate the kindness and soon found himself endorsing the company's studies.

Psaty points out now that conflicts of interest are often hard to recognise, and that most people are comfortable with just a little bit of cheating without thinking of themselves as dishonest. Even though many doctors think they are immune, Psaty argues that subtle conflicts of interest nevertheless still colour decision-making.

If Psaty is right, and if this effect applies to doctor-industry links more broadly, then the HPCSA's lack of specificity may be a problem. After all, if you ask doctors to act ethically, and they believe themselves to be acting ethically, you are unlikely to pick up the subtle kinds of influence Psaty is talking about.

Getting friendly
A remarkable article published in 2007 in the journal PLoS Medicine outlines some of the tactics used by pharmaceutical sales representatives in their efforts to influence prescribing patterns. In their conclusion, the authors write, "every word, every courtesy, every gift, and every piece of information provided is carefully crafted, not to assist doctors or patients, but to increase market share for targeted drugs".

And when you take into account that in 2000 more than $4.8 billion was spent on the one-on-one promotion of drugs to doctors by drug reps in the US, it is clearly very serious business.

According to the authors, gifts create both expectation and obligation. “The importance of developing loyalty through gifting cannot be overstated,” they quote a former drug rep as saying. Pharmaceutical gifting involves carefully calibrated generosity, write the authors. Many prescribers receive pens, notepads, and coffee mugs, all items kept close at hand, ensuring that a targeted drug's name stays uppermost in a physician's mind. High prescribers receive higher-end presents, for example, silk ties or golf bags. As a former drug rep states, “The essence of pharmaceutical gifting… is ‘bribes that aren't considered bribes’."

Clampdown in the US
The American Psychiatric Association (APA) recently announced that it is phasing out industry-supported symposia and industry-supplied meals at its annual meetings. When Health24 contacted the South African Society of Psychiatry (Sasop) to ask whether it would consider similar measures, a spokesperson said that Sasop is studying the facts regarding the APA's decision.

And that’s where we are. Whether organisations like Sasop will disentangle themselves from industry, remains to be seen.

(Marcus Low, Health24, April 2009)

Sources:

Drug companies and doctors: A story of corruption by Marcia Angell (Editor of the New England Journal of Medicine). New York Review of Books. January 2009.

Following the script: How drug reps make friends and influence doctors by Adriane Fugh-Berman and Shahram Ahari. PLoS Medicine. April 2007.

Researchers fail to reveal full drug pay by Gardiner Harris and Benedict Carey. New York Times. June 8, 2008.

Docs and drug money (The original Reuters story we ran on Psaty's article in the Journal of the American Medical Association.)