CHICAGO – At the beginning of May, I wrote a column on the growing importance of safety in the evaluation and development of new drugs and medical technologies. Four major trends were identified as strongly driving the new emphasis on safety:

1. Greater efficacy of medicine: As treatments become more effective, the “blemishes” become more evident.

2. Baby boomer culture: This is a major force in the population. They harbor high expectations and little tolerance for failure.

3. Chronic diseases: When people take drugs or use devices for extended periods of time, what might have been a mere side effect can metamorphose into a significant safety risk.

4. Preventative medicine: When people take drugs or use devices for preventative purposes (e.g. for conditions without symptoms), safety becomes that much more important.

In that column, I promised to keep you posted as this trend evolves and indeed much has happened over the past three months.

One of the biggest stories has been the ongoing courtroom saga involving Merck’s Vioxx painkiller. With the drug maker facing more than 16,000 suits nationwide, the jury is still out (no pun intended) on how Merck will fare overall. However, a majority of the rulings from early trials have been in favor of Merck (five wins in eight trials to date).

Last week, Merck won a case in Los Angeles in which the jury found the company not responsible for a 71-year-old patient who had suffered a heart attack and claimed that it was due to taking Vioxx. This victory followed another one the previous month in New Jersey where a jury found that a 68-year-old grandmother’s heart attack was likewise not due to Vioxx.

Do these verdicts imply that Vioxx is in fact safe or do they repudiate the notion (as outlined above) that safety is increasingly paramount? Put even more bluntly, could this mean that Vioxx may even return to the market?

A Closer Look at the Vioxx Trials

The devil is in the details. Closer scrutiny of the defense strategy revolves not so much around redeeming Vioxx but rather compelling the plaintiffs to prove they took Vioxx continuously for an extended period of time.

The adenomatous polyp prevention on Vioxx (APPROVe) trial that demonstrated the increased cardiovascular events showed these adverse effects beginning after 18 months of continuous treatment. Prior to this trial, there were very few indications for the continuous and long-term use of Vioxx. The number of plaintiffs that can effectively demonstrate they took Vioxx for 18 uninterrupted months is quite low.

The fact that Merck completely withdrew the drug from the market – even for short-term use – actually substantiates the safety trends outlined above. In addition, the fact that patients were being treated for more than a year in the context of cancer prevention means that our shifting emphasis to preventative medicine and chronic diseases brings out safety concerns that potentially would not otherwise have emerged.

If Vioxx had been purely used for occasional use (such as with self-limited aches and pains), it may very well be that these safety issues would not have emerged. As the drug is currently off the market, we may never know whether this would have been the case. Essentially this ambiguity and uncertainty is the reason why Merck has won these past two cases.

In a court of law, ambiguity does not make for a good case. Still, ambiguity in the court of public opinion has definitely fallen on the side of safety. Vioxx will likely remain off the shelves for a long time. Safety ultimately prevails even if Merck’s victories in the courtroom would superficially seem to suggest otherwise.