Christine Gee: Pharma fallacies

FILMS such as Side effects and Love and other Drugs satirise the pharmaceutical industry, presenting it as corrupt, aggressively profit-seeking and devoid of sympathy for patients.

Lighthearted though these films may be, they do seem to capture prevailing views held by many in the medical profession. A recent debate in the BMJ went so far as to liken pharma to the tobacco industry and questioned whether journals should publish research funded by the drug industry, given the controversy over its integrity.

As a doctor who has worked in the pharma and medical device industries in Australia in recent years, my experience suggests we should reassess these views.

Cases of fraudulent activity by pharma have been widely publicised. But does the whole industry deserve to be tarnished?

In Australia, the promotion of prescription medicines is highly regulated. The industry operates under a self-governing code, the Medicines Australia Code of Conduct, which is authorised by the Australian Competition and Consumer Commission (ACCC). Member companies face significant fines (and, possibly, reputational disrepute) if found to be in breach of the Code’s standards for the ethical promotion of medicines.

The Code is revised periodically, becoming stricter at each iteration. For example, the next amendment is likely to require member companies to improve disclosure of payments made to doctors — an onus which was previously left on recipients to declare when deemed required.

Punitive measures for regulatory breaches seem an effective deterrent — regardless of motive, no employee wants responsibility for bringing such action upon the organisation. Company practices are frequently audited — by both internal and external parties — to ensure compliance with the myriad applicable regulations. Such is the extent of this control that companies often have entire departments dedicated to ensuring compliance.

In my experience working in medical and marketing departments in the pharma industry, promotional materials and campaigns were subject to rigorous internal scrutiny to ensure they were supported by the best available data. Off-label promotion was prohibited, regardless of the available evidence.

The evidence itself? Yes, much of it is funded by pharma but regulators, including the US Food and Drug Administration, the European Medicines Agency and the Therapeutic Goods Administration, demand certain studies are undertaken before they will approve a new product.

If pharma didn’t fund these trials, who would? What would happen to innovation?

It has been observed that research funded by pharma is more likely to report a positive outcome than unfunded research. This is not surprising, since less promising compounds are unlikely to attract the interest of the industry and progress through the development cycle.

Investigator bias is certainly possible but is not confined just to pharma. In fact, a recent study suggested that retractions due to misconduct were actually less likely to be funded by pharma than those that did not declare such support.

Regardless of the funding source, clinicians should always scrutinise research outcomes.

An unfortunate consequence of the strict regulation of the pharma industry is the implied notion that without these constraints, the devious motives of the industry would flourish. But just as not all doctors enter the profession “to help people”, not all pharma employees are driven by the acquisition of money and success at any cost. I’ve met many people in the pharma industry who are actually motivated by positive patient outcomes.

Perhaps at the root of this misperception is that pharma is an isolated commercial player in an environment where the majority of stakeholders (doctors, regulators, patients) are all publicly funded. Inherently, each does not understand the other.

However, if the right medicines are used in the right patients with positive outcomes, isn’t this mutually beneficial for all parties?

I’m not suggesting we blindly trust pharma. It is important for doctors to maintain some degree of scepticism and ensure they make their own informed decisions — as they would for any other purchase.

The representative sitting in your waiting room is not necessarily a wolf in sheep’s clothing. They might just have the same aspirations as you.
 

Dr Christine Gee is a deputy medical editor of the MJA, who has worked in the pharmaceutical industry.