After the Vioxx fiasco and more recent revelations about Hoffman LaRoche's acne medication, Accutane, pharmaceutical companies don't have any feet left to shoot themselves in.
The next bullet is going to go into the industry's collective brain. Just weeks after Merck withdrew its blockbuster painkiller Vioxx from the market in response to charges that it was linked to heart disease and stroke, news broke that Hoffman had disregarded a company doctor's recommendation that users of Accutane be monitored for signs of depression and that a warning be added to the drug's labeling. According to a lawsuit filed in Florida, Hoffman rejected the doctor's advice after marketing executives said that discussing the link between the drug and depression could cost the company sales or provoke lawsuits like the ones that have deluged Merck - and will now, surely, hit Hoffman just as hard. It should be a given that the pharma industry - a life or death business - hold itself to the highest standards of integrity and transparency. But events of the past few months - including stories showing that drug companies often hide the results of clinical trials that do not support marketing goals - have led to a spiraling decline in trust. Pharma executives argue, rightly I think, that both their researchers and managers are good people, dedicated to producing life-saving, life-enhancing products. They also make the case - again, not without justification - that even controversial products like Vioxx help many more people than they hurt and that litigation has the potential to stifle innovation. But it's hard to support industry appeals for tort reform amid overwhelming evidence that pharma companies consistently refuse to share pertinent information with interested parties: shareholders, who should be aware of potential liabilities, and consumers who have a right to know of potential risks. With the FDA apparently abdicating its responsibility to ensure the safety of the nation's drugs, individual pharmaceutical companies must show some leadership and go beyond what regulations call for to restore faith in the system. That means sharing everything they know (through company-sponsored clinical trials) and everything they suspect (through internal questions like the ones raised by Hoffman's medical experts). The argument that the public might overreact to warnings about potential risks is understandable, but no longer sufficient. If companies are going to earn the trust of consumers, they are going to have to show some trust of their own, and take the time and effort required to put safety warnings in their proper context to avoid hysteria. In today's environment of suspicion and mistrust, nothing less than complete transparency will do to restore confidence in a vital industry.PAUL HOLMES: In order to regain the public's trust, pharma companies must display trust in the public
After the Vioxx fiasco and more recent revelations about Hoffman LaRoche's acne medication, Accutane, pharmaceutical companies don't have any feet left to shoot themselves in.
