'It's a whole new world out there since Vioxx," Terence Young, chairman of the consumer group Drug Safety Canada, said earlier this week.
And how right he is.
The withdrawal of the blockbuster drug -- a painkiller popular with arthritis sufferers -- last Sept. 30 has opened the murky world of drug regulation to unprecedented scrutiny.
How is it, the public wondered, that a drug touted as a safe alternative to Aspirin could cause heart disease and, by some estimates, contribute to the death of as many as 61,000 Americans (and another 4,000 to 7,000 Canadians) during the five years it was on the market?
How is it that regulators could fail to act on safety concerns when they were raised in the medical literature over a period of almost five years? And how is it that, when Vioxx was withdrawn, its competitors, Celebrex and Bextra, could engage in massive marketing campaigns when the very same questions were being raised about those drugs?
These questions are discomfiting, and the answers more so.
The relationship between regulator and regulated is often far too cozy. The process for reviewing and approving drugs is too secretive. The bar for approving new medications laughably low -- a new drug does not have to work better than one already on the market, it just has to work better than nothing. The surveillance of drugs, once on the market, is sorely inadequate.
Thankfully, change is afoot.
This week, in Washington, the U.S. Food and Drug Administration is holding public hearings on the risks and benefits of Vioxx and other cox-2 inhibitors, hearings that will be watched closely by regulatory officials from many countries, including Canada. Federal Health Minister Ujjal Dosanjh has also announced that he wants to revamp the drug regulatory process.
The changes he is proposing include publishing the deliberations on drug reviews; the appointment of outside advisers to cast a critical eye on safety data; public hearings on the safety of some drugs both prior to approval and post-approval; bolstering the reporting of adverse events (perhaps even making reporting of reactions to drugs mandatory) and the possible creation of an independent agency to review drug safety (an initiative the U.S. announced this week).
While Mr. Dosanjh's plan is one of the boldest initiatives by a health minister in many years, beefing up the regulatory process is just one part of what needs to be done to ensure consumer safety.
The U.S. National Institutes of Health has, in the wake of the Vioxx scandal, started to talk openly about one of the thorniest problems that exist in our health system -- conflicts of interest.
One of the reasons that drugs that cause harm can continue to sell in staggering proportions is that physicians profit handsomely from prescribing them. They get wined and dined by drug reps, lavished with trips to conferences, some in exotic locales, and they are bombarded by advertising. (In Canada, prescription drugs can be advertised to physicians but not the general public, except in some circumstances.)
Doctors are paid handsomely to enroll patients in studies, many of which are blatantly promotional. Research published last year showed that drug companies spend up to $350 per doctor per drug on marketing, a staggering amount. Make no mistake, these perks can cloud clinical judgment, as demonstrated by the gross overprescription of Vioxx.
The drug industry's influence in the research community is even more pervasive. Scientists often depend on pharmaceutical companies for research money, their bread and butter. They receive speaking fees and consulting fees from Big Pharma. To market their discoveries, they create biomedical companies that forge alliances with big drug companies.
These financial inducements skew the kind of research that is done and influence what is published -- and they can entice experts to bite their tongues, to the detriment of the public good.
"I came to the conclusion that we have a systemic problem," Dr. Elias Zerhouni, director of the U.S. National Institutes of Health, said in explaining why he thinks a new set of ethical guidelines needs to be drawn up.
These omnipresent conflicts of interest should also serve as a reminder of the importance of the regulator, Health Canada, as a bulwark, safeguarding the public interest.
Drug companies are not the enemy of consumers but, if recent history has taught us anything, it is that they cannot be given free rein. With massive budgets and a significant proportion of physicians and researchers working for the drug industry, directly and indirectly, Health Canada must provide the counterweight, as the voice of the consumer.
It must be a champion of openness and a pit bull on the issue of safety. The regulator must not only aim to protect public safety, but to inform the public, in a no-nonsense manner, on the benefits and risks of prescription drugs, to help individuals make sound personal decisions.
As Mr. Dosanjh said: "Information should be available to the public -- good, bad and ugly."