Penna feels that there are too few outcomes studies, and those that are done are not always very good. Often they are biased, if done by a drug company with a clear intent in mind.
"I'm not an outcomes expert," he said. "If I want a really good analysis I'll take it to an expert. When we evaluate a study, we look to see if the results seem to be reasonable and feasible-are the analysis and the conclusions laid out in a logical, easy to follow sequence."
In response to negative consumer reaction to drug formularies, Penna was emphatic that P and T committees have patients' best interests in mind.
"First of all," he said, "P and T committees consist of physicians and pharmacists. We don't have accountants or administrators who are looking at the financial bottom line. We have health care professionals making the decisions. We have experts draft summaries of the drugs, we review the published scientific literature and present it in an unbiased format for a committee to review and draw conclusions.
"There is active debate within these committees about what is the right thing to do: is the evidence good enough? Most consumers think, 'If the FDA approves it, it must be OK. Why don't you cover these drugs?' We're trying to get away from a [physician] saying, 'I like this drug because I tried it on two patients and it was wonderful.' The anecdotal information is interesting, but it's not scientific information; the next 20 patients could all die from this drug.
"The second point," Penna said, "is that P and T committees are conservative! We tend to ask a lot of tough questions, we tend to say 'Let's wait and see; let this product be used for six months in the general community and get some experience with it, and then we'll add it.' My view of pharmaceuticals is that conservative is better. I've seen too many cases where the new wonder drug crashes and burns real fast."Doing What Is Best
"A third point," Penna added, "is if from a practical standpoint, a new drug is significantly better than an older drug and it cures people, keeps them out of the hospital, does all those things but costs a lot of money, we'd be fools to keep it off the formulary. Ultimately, what saves us the most money is providing the best quality care.
"The fourth point is purely financial. These last few years have been increasingly profitable for pharmaceutical companies. A couple of watchdog groups have determined that the reason drug companies are so profitable is that managed care makes it easier for the general population to have access to drugs. Managed care actually adopts drugs faster than the general community. Over one-half of the people in the United States have a pharmacy benefit. This means they can get drugs with little financial disincentive. The alternative, if we don't manage pharmacy costs and make some tough decisions, is that the drug benefit is going to get priced too high and those who provide coverage will begin dropping it. So, I think that formularies in managed care programs-while it means that some people may not get the drug that they've just seen advertised on TV-means that more people have access to more drugs than they've ever had before."