Dangerous Drugs

This is a partial transcript of "Special Report With Brit Hume," Dec. 20, 2004, that has been edited for clarity.

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DR. DAVID GRAHAM, FDA WHISTLEBLOWER: The FDA wasn’t concerned about Vioxx and would not have removed it from the market if Merck hadn’t. And yet, 100,000 patients had heart attacks because of Vioxx. The fact that the FDA says now that it’s concerned about Celebrex (search) to me is a serious signal. I would be very concerned. Indeed, I don’t think that I would prescribe Bextra or Celebrex to my mother-in-law.


BRIT HUME, HOST: For millions of Americans with arthritis, this year’s version of the Grinch who stole Christmas was word that the wonder drug that have taken their pain away may themselves be taken away. Vioxx, as we’ve just heard is already off the market. Two other wonder drugs in the same category: Celebrex and Bextra have been found to cause possible heart problems.

Is this the story of an under reaction, an overreaction. What?

Well, for answers, we turn to Scott Gottlieb, a doctor who has also been a government advisor and regulator. He now writes an investment newsletter.

Well, Dr. Gottlieb, we now have a warning, just minutes ago from the FDA (search) about Naproxen, otherwise known over-the-counter as Aleve. Which has been taken — that’s an old drug, if I’m not mistaken. It’s been around for years. This is also on the question of heart trouble.

What to make of all of this, if you are, as I am an arthritis sufferer who takes one of these medications?

DR. SCOTT GOTTLIEB, FMR. SENIOR FDA OFFICIAL: That’s right, Brit. The FDA just issued an advisory that a clinical study looking at Naproxen for the prevention or treatment of Alzheimer’s disease, against a sugar pill or placebo, showed increased cardiovascular risks with people who are taking Naproxen. So this is one of the old NSAIDs, one of the traditional NSAIDs if you will.

HUME: What’s an NSAID.

GOTTLIEB: A non-steroid anti-inflammatory drug.

HUME: Sort of like aspirin, you mean. Sort of aspirin or Tylenol?

GOTTLIEB: Yes. Similar to aspirin, not similar to Tylenol. But the drug Celebrex and Vioxx, which are very much in the news, were an innovation over drugs, like Naproxen because they were selective in that they treated the pain but did not cause some of the G.I. discomfort that’s associated with drugs like Aleve or Naproxen.

HUME: That’s stomach pain, right?

GOTTLIEB: Right. Exactly.

HUME: So the idea — let me see if I have this right. These newer drugs, the Cox-2 inhibitors, the virtue in them was — and that includes Celebrex, Bextra, and Vioxx, was that you could take them in strong enough doses to effect the pain but it wouldn’t upset your stomach?

GOTTLIEB: Right. It blocked the pathways that caused pain but didn’t block the pathways that were responsible for helping you protect the lining of your stomach.

HUME: Got you.

GOTTLIEB: The interesting news right now that just came out of FDA is the risk might be what we call a class effect. So it might be associated not just with the drugs associated with drugs, like Vioxx and Celebrex, which are these selective drugs. But it might be associated with all NSAIDs, the whole class.

HUME: All right. Now, who’s at risk here? I mean I’m 61 years old, recent physical I had little bit of an elevated blood pressure. I had been taking Bextra and before that Celebrex for a while. I’ve also tried Naproxen in the past. Should I worry that I’m going to have heart trouble if I keep taking one of these more modern drugs?

GOTTLIEB: Well, Brit, I urge you to discuss that with your doctor. You look pretty healthy to me right now.

HUME: No. I’m just talking about as a category of people.

GOTTLIEB: Right. No. I understand.

HUME: I don’t have any heart disease trouble. I never have. My family doesn’t have a history of it. Well, what should think? There’s got to be a lot of people like me out there.

GOTTLIEB: Right. And I think there are people who are concerned about the news that they’re hearing. The risk is associated with people who are at higher risk for cardiovascular events. So people might already be at higher risk for heart attack or stroke are clearly at higher risk when they take a drug, like Vioxx where there’s evidence that it does increase a person’s risk for a heart attack.

But these drugs — all of the risks they found so far associated with long-term use of these drugs. And Vioxx, for example, was approved for the acute treatment of migraine headaches, where people would take the drug only for a few days just to relieve the migraine. Certainly we don’t have any evidence that the drug causes an increased risk of cardio events when used on short-term basis.

HUME: But now it’s off the market. Right?

GOTTLIEB: Well, now it’s off the market. I think these drugs are important and they’re going to continue to serve a niche indication. And so I think it’s unfortunate that Vioxx is off the market. I think it’s unfortunate that people are calling for Celebrex to be taken off the market.

HUME: And you think that because your belief is that if you don’t take it over a long period of time, and you’re not already identified as someone at risk for heart problems, that you’re probably OK with it? Is that your thinking?

GOTTLIEB: That’s probably the case. I mean people should discuss their risk factors with their doctors. I don’t want to make generalizations. But all the evidence we have so far points to the fact that the risk really is associated with the long-term use; people who use it chronically for more than a year.

And a lot of people were using these drugs for temporary pain relief. Like I said it’s approved for the treatment of migraine headaches. And in that market, you think most of the people who are going to be taking the drug tend to be younger patients, who really don’t have a lot of cardiovascular risk factors. So they really should be OK on the medication over a short period of time.

HUME: So what are we dealing with here? The FDA — I mean took the Merck (search) down for Vioxx, then the FDA chimed in. You sensed that the FDA may be about to move over the other two. Is this an over reaction?

GOTTLIEB: Well, I certainly hope the FDA doesn’t move against the other two. I think the new evidence that we have certainly calls for some changes in labeling to increase the warnings on the labels, to give physicians and consumers more information.

But this is clearly an over reaction. Every three or four years, you have one of these high profile product withdrawals and it triggers calls on Capitol Hill and all around to tighten up the safety requirements on new drugs. And it triggers lawsuits, of course. But we’re never going have 100 percent safety. And I’m very fearful that we’re going to spend a lot of money and do a lot of damage trying to get ourselves there.

HUME: Well, this guy, Dr. Graham who you heard from earlier who was on Sunday television yesterday, said that there are 100,000 people who had heart attacks. I believe that is what he said, 100,000 people had heart attacks because of Vioxx. Is that a documented fact?

GOTTLIEB: That’s not a documented fact. Dr. Graham was using a theoretical model, where he predicted how many people might have had heart attacks related to the drug. We, in fact, don’t know if anyone had a heart attack related to Vioxx. There’s been no case where we can’t prove what we call causality, that the drug actually cause the event.

Dr. Graham — I was at FDA and worked — I knew of him when I was at the FDA. And I’m not sure that there are drugs that Dr. Graham ever thought were safe. I think he felt every drug had safety problems. So he was right this time

HUME: Dr. Scott Gottlieb. Pleasure to have you. Thank you very much.

GOTTLIEB: Thank you.

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