Transparency is the prescription to ensure success for potential Vioxx reintroductionMerck is apparently considering a plan to reintroduce its anti-inflammatory medicine, Vioxx, which it voluntarily pulled from the market last September after studies suggested a link to increased risk of heart attack.
On the whole, I think that's a good decision - especially for patients - but it also raises some major PR and corporate responsibility issues that the company needs to think through before it makes a final decision.
The fact is that Vioxx - despite the problems identified by clinical studies - is a valuable medicine for arthritis patients and others for whom it was originally intended. Patients dealing with acute pain who have found no relief from over-the-counter or traditional painkillers should have the option of a drug that helps alleviate that pain - as long as they are in full possession of the facts pertaining to the drug's safety and possible side effects.
That means Merck, like other pharma companies, will need to be a good deal more candid, sharing all the information gathered at clinical trials - not just the information that makes its product look good - with physicians and patients.
But one of the big problems with Vioxx - and with other drugs in the same category, like Pfizer's Celebrex - is that it was apparently used by many patients without arthritis as
a "super-strength" painkiller. There was no medical reason for these patients to receive Cox-2 inhibitors, and most of them didn't understand - or give a moment's thought to - the risks involved.
Pharma companies can claim that the decision to prescribe a product to someone for whom it is not indicated rests with the physician, but recent history suggests that many drug makers either encourage off-label prescriptions or - just as reprehensible - don't do anything to discourage them.
Consider the advertising for erectile dysfunction drugs. Watch carefully and tell me whether you think these drugs are being marketed to people with a serious medical condition or as recreational drugs that will improve sexual performance in males with no real problems? Or consider the story of Fen-Phen, a cocktail of weight-loss drugs that caused heart problems. The companies that manufactured these products did not market them for use in combination, but it's inconceivable that they didn't know how they were being used. Their failure to prevent the abuse of their products is morally indefensible.
So Merck will have to be more careful in marketing Vioxx and it must take responsibility for monitoring both how physicians prescribe and how patients use the drug. If it does so, and practices full transparency, there's no reason why Vioxx should not stay on the market for a long time, alleviating pain and suffering as it was designed to do.