Pharma's New Face - Pharmaceutical Executive


Pharma's New Face
PhRMA's new president says his mission is to restore the reputation of national treasures. That's not just a PR goal. It's a recipe for reform.

Pharmaceutical Executive

I think that's exactly how it came across.

Exactly. The truth is that safety concerns are real and growing. We know the trade in counterfeit drugs is growing. We know the customs office has confiscated drugs at test sites in Miami where 95 percent of the drugs were counterfeit. Sooner or later we are going to be importing death. I don't believe people yet get that.

We have three jobs to do. One is somehow to make this safety argument real in people's lives. They have to see the danger. They have to understand that if you are worried about Al Qaeda shipping in anthrax, you better think about whether you want to really open up our borders to unlimited importation. Second, we have to make drugs accessible and affordable in America. If we do, no one will want to take a chance on buying a drug on the Internet. It's as simple as that. Third, we have to work with FDA to make drug safety in this country as good as it can be and to continue to build the confidence of Americans in that process, in spite of some of the news they recently received.

Actually, importation is less attractive today as an issue. The margin between Canadian prices and American prices has thinned, and when you put American discount cards on the table, the margin shrinks even more. The currency exchange has shrunk the margin. The entry of generics will shrink the margin even more—and there will be a lot more generics entering the marketplace soon. Finally, the Surgeon General report helps you focus on what you give up when you go after that thinner and thinner margin. You give up the right to know where the drug came from, how it was handled, and whether it was packaged properly. And here is the most important thing: You give up the right of legal redress when something goes wrong. Who do you sue when you order something over the Internet and it comes from a basement lab in Indonesia? In America, if you didn't like what Merck did, there are a lot of class action lawyers ready to talk to you.

Do you see the industry getting together with leaders on the Hill and developing some kind of a bill that would somehow make the issue go away?

I don't know yet. In my mind, making the issue go away is only possible when we really address the issues of access and affordability. Privately, people tell me they know importation is a bad solution. They say, "This is not the right answer. But if you don't give us a better answer, we are going to continue to vote for it."

You are talking about political realities. Another one has to do with the tort reform. As near as I can tell, 100 percent of the people getting ready to sue Merck at some point in their lives held in their hands the packaging insert that had 750 words describing a clinical trial in which people taking Vioxx had an increased rate of cardiac problems.

That's a classic case where the system worked correctly, where drugs were approved correctly and risks were properly identified. For the uses the drug was intended, it worked correctly. It was only when the drug was tested as a cancer drug at much higher doses and prolonged use that problems developed. And when they did, Merck took the precaution of pulling the product off the market. Things worked correctly, and yet this company finds itself embroiled in incredible litigation.

That's a terrible signal to every other company. If you do something right, you ought not get burned. You ought to be rewarded. That's the way most of us raise our children.

But the Vioxx situation is exactly the opposite. Here is a company embroiled in litigation, having followed all the rules and having taken the extraordinary step of pulling their product off the market when there were indications that in extraordinary-use cases it might cause problems. And this company, let me make it clear, is a national treasure. If ever this country had a national treasure, it is NIH and companies like Merck. They have found some incredible medicines for our population. And they do not deserve what they are going through.


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