CAPALDI: We should add to your list a moratorium on research, because we're on information overload. We could ask the entire pharmaceutical
industry not to come up with anything new for the next 10 years, so that doctors and patients can catch up with everything
we have now. When you put it that way, it's transparently ridiculous.
CLINTON: But even if we did that, it wouldn't work: No physician can keep up with all the drugs. But it's more manageable than other
things—for instance, putting the results of every clinical trial into a database, where presumably every doctor would have
a legal and moral obligation to look at every clinical trial for every drug he prescribes. That's a terrible idea, and yet
we found ourselves in this situation because people perceive drug companies and the FDA as having played too close to the
line on pediatric uses of antidepressants.
If you apply for an additional indication for a drug and you're turned down, you don't have to reveal it and FDA can't reveal
it. That means people can continue to use your drug off-label, not knowing that it was turned down on either safety or efficacy.
And I think that's wrong.
COHEN: Well, the nondisclosure of safety data certainly raises questions in the civil arena. The decision not to approve an
indication probably raises a whole lot less, because doctors have always been free to pick and choose the drugs that they
want to prescribe, whether their indication is approved or not. As long as the pharma company is not promoting the drug for
off-label use, there's minimum exposure. The risk always is what happens when the sales rep is out there talking about something
he or she shouldn't be talking about.
LOUIS: Back when the Human Genome Project was a big deal, I saw a slide that said, "Every drug an orphan drug." What that meant
was that a very small subset of the population that's taking it actually has genetic twist. Trying to figure out drugs that
are that finely tailored is a challenge. When you're mass producing drugs, you're going to end up with some unforeseeable
consequences. Do you pull it because 5 percent of the people have bad reactions? It's a tough choice.
COHEN: I want to ask about internal guidelines. What policies or programs should pharma companies adopt to raise the expectation
that personnel from the lowest chemist or biochemist in R&D, to the salesperson, to the regional director for marketing, to
regulatory and disclosures and compliance, make decisions in an ethical way?
PEREA-HENZE: It has to come from the top. If not, you end up in a situation in which managers say, "Regardless of how you sold a product,
as long as you meet your numbers, we're not going to look at how you got there."
But if there's very clear directive from the top that says, "We care that you make your numbers, but we also very much care
about how you got there," that sends a very strong message throughout the organization.
SODEN: Remember in school when the teacher would wax eloquently about a subject, and at the end somebody would say, "Is that going
to be on the test?" That's what people are concerned about: how their performance is going to be measured. Until we make this
an internal part of the whole process—and we know that part of our performance measure will be "Show us how you upheld the
ethics that we believe in this company and document how you internalized that in your work group or management decisions"—then
I think that we've missed the boat.
LOUIS: We do that now at Genzyme. We have an external vendor who provides us with training. There are five or six modules, and every
person in the sales and marketing organization needs to go through that training or he or she doesn't get a bonus at the end
of the year.