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Concerns Raised About Celebrex Safety; FDA's Safety Screening Questioned

Dec 17, 2004 | LOU DOBBS TONIGHT

LOU DOBBS, Host: Tonight, another blockbuster drug bombshell. First it was Vioxx, now Celebrex. Researchers say Celebrex may sharply increase the risk of a heart attack.

UNIDENTIFIED MALE: If you're an individual with high risk for heart problems, that you should shy away from this class of agents.

DOBBS: Senator Chuck Grassley is investigating the pharmaceutical industry. He says it's time for a review of drug safety. He's our guest.

I'll also be talking with Dr. John Abramson, a Harvard Medical School professor who says Celebrex is not a wonder drug. It's simply the product of wonder marketing.

DOBBS: Good evening.

Tonight, a shocking new scare about the health risks of one of this country's most popular painkillers. The drug company Pfizer says a study of its Celebrex drug found that patients taking high doses have a much higher risk of heart attacks.

Celebrex is the same type of drug as Vioxx. Vioxx was withdrawn ten weeks ago because it may cause heart attacks and strokes.

We have three reports tonight. Christine Romans reports on the dangers of Celebrex. Lisa Sylvester reports on the FDA's failure to protect the American people. And Peter Viles reports on a drug industry in crisis.

We begin here in New York with Christine Romans.

CHRISTINE ROMANS, CNN CORRESPONDENT: Lou, Celebrex is America's most prescribed arthritis medicine. Twenty-seven million Americans, one in ten people at one time or another, have taken this drug.

ROMANS: Celebrex is prescribed for arthritis, aches and pains, and menstrual cramps. And it may be deadly.

A National Cancer Institute study found people taking 480 and 480-miligram daily doses were 2.5 times more likely to have a heart attack or stroke.

Pfizer called the news unexpected and inconsistent with other studies and said it will not pull this drug from the market.

HANK MCKINNELL, CEO, PFIZER: Arthritis patients don't use these drugs at anything more than 100 to 200 milligrams, and they don't take them every day for three years.

ROMANS: Pfizer has taken advantage of Merck's recall of Vioxx, touting the safety of Celebrex.

In late November, the company said, "There are no significant cardiovascular concerns. November 4, "The safety profile of Celebrex is well established." September 30, "Pfizer is confident in the long-term, cardiovascular safety of Celebrex.

Now the safety of the whole class of drugs is being questioned.

DR. SIDNEY WOLFE, PUBLIC CITIZEN GROUP: People should not be using Vioxx, which they can't use anymore, because it's off the market, or Celebrex or Bextra. And the sooner that action is taken, the better.

ROMANS: Bextra is another painkiller, also from Pfizer. The "New England Journal of Medicine" today issued a rare warning on Bextra, declaring it a public health concern.

ROMANS: At about $2 a pill, Celebrex will deliver almost $3.5 billion in sales to Pfizer this year. Bextra, more than $1 billion. But many doctors, Lou, say aspirin works just as well. It costs pennies, and its side effect is an upset stomach. DOBBS: Christine, thank you very much.

Less than three months ago, another widely popular drug, Vioxx, was recalled. Merck pulled Vioxx from the market after it found the drug doubled a patient's risk of heart attack or stroke if used over the long term.

More than 100 million prescriptions were written for Vioxx since it went on the market in 1999.

Last month, FDA whistleblower Dr. David Graham testified on Capitol Hill that the FDA does not do enough to protect the public from dangerous drugs.

He also listed five other widely used drugs he said should be withdrawn or restricted. Those drugs are Crestor, Meridia, Accutane, Serevent and Bextra. And as we just reported, the "New England Journal of Medicine" today recommended doctors stop prescribing Bextra because of increased heart risk.

The Food and Drug Administration is facing massive criticism for its failure to stop drugs like Celebrex and Vioxx before they're sold to the American people.

The FDA today said it has great concerns about Celebrex, but the FDA said it has taken no decision yet on whether to withdraw Celebrex from the market.

LISA SYLVESTER, CNN CORRESPONDENT: In 1992, Congress passed a law that allowed the Food and Drug Administration to accept money from the pharmaceutical industry to help speed up the approval of new drugs. At the time, the concern was AIDS drugs were not getting to the market quickly enough.

But the law gave the drug industry a lot more power. Critics say the Office of Drug Safety is now beholden to the industry.

LARRY SASICH, PUBLIC CITIZEN STAFF PHARMACIST: They don't have the independent authority, for example, to require a safety labeling change on a drug or to recommend or institute procedures for withdrawal of a drug that is clearly dangerous.

SYLVESTER: Since 1990, 14 drugs approved by the FDA have been pulled from the market.

A survey by the Department of Health and Human Services Office of Inspector General found that two out of three FDA scientists believe the agency does not adequately monitor the safety of prescription drugs on the market. And nearly one in five scientists felt pressure to approve or recommend approval, despite reservations about the safety or quality of a drug. LARRY NOBLE, CENTER FOR RESPONSIVE POLITICS: I think there are probably a lot of American citizens out there who are very worried about this right now and who are wondering, well, what does it really mean if I'm told that the FDA has approved this drug for this use?

LESTER CRAWFORD, FDA ACTING COMMISSIONER: We can never be fail- safe, though, because we're dealing with products that are very difficult to evaluate. But we have to continue to refine and improve, based on the science that we have at hand.

We're far better at it than we used to be, but we need to be better in the future.

SYLVESTER: Congress has only recently started looking into the FDA's approval process. But even on Capitol Hill, the pharmaceutical companies carry clout.

REP. SHERROD BROWN (D-OH), HEALTH SUBCOMMITTEE: It's pretty clear the drug industry has way too much influence in the White House, way too much influence in Congress. And now we see way too much influence in the Food and Drug Administration.

SYLVESTER: The FDA is considering a proposal to make the office of drug safety more independent.

And as for the drug, Celebrex, as you mentioned, Lou, the FDA says it will review the new data before determining if the drug should be pulled from the market, Lou.

DOBBS: Lisa, thank you.

The Celebrex scandal is another huge blow to an industry that already faces a number of challenges. Those challenges include a declining public image, the threat of generic drugs, and foreign competition, and now massive lawsuits.

PETER VILES, CNN CORRESPONDENT (voice-over): High prices, high profits, a failure to meet crucial needs such as the flu vaccine.

Even before the Celebrex scandal the drug industry's new lobbyist, Louisiana dealmaker Billy Tauzin admitted, quote, "This industry understands it's got a problem. It has to earn the trust and confidence of consumers again."

But when we asked a drug industry spokesman today, the day the Celebrex news broke, incredibly, he said the problem is one of perception, not reality.

DR. PAUL ANTONY, PHRMA: The problem is really a perception problem, and people need to realize that we have the best drug development system in the world.

JANELL DUNCAN, CONSUMERS UNION: There is a perception problem and it's quite likely based on reality. When you have the drugs and the safety of drugs that have been called into question after they're already marketed and are being taken by millions of people.

So yes, millions of people are concerned when they find out the drug that they are taking maybe could cause them harm.

VILES: On Wall Street, perception is reality, and it's very ugly for drug stocks. Eli Lilly has lost $60 billion in market value from its five-year peak. Merck has lost $134 billion, and Pfizer has lost $182 billion in market value.

For years, the industry did what investors wanted, consolidated, maximized profits through aggressive marketing of blockbuster drugs, and "me, too," versions of existing drugs, leading to what "The Wall Street Journal" now calls an industry crisis over lack of research and development productivity.

The industry faces pressures now from generic drugs, overseas competition, angry consumers, and politicians fed up by those high prices, and now, a growing scandal over whether those heavily advertised, billion-dollar drugs are even safe in the first place.

VILES: Now, back for a second to this issue of perception versus reality. Whatever the drug lobby would have us believe, this safety issue is a real issue. And it is a very real issue tonight for 27 million Americans whose doctors put them on Celebre, Lou.

DOBBS: And Pete, we thank you.

And we should point out to our viewers that Billy Tauzin, representing the industry, has declined our invitation to discuss all of these issues.

That brings us to the subject of our poll tonight: "How would you rate the Food and Drug Administration's ability to protect you from dangerous drugs? Good? Satisfactory? Or poor?" Please cast your vote at We'll be bringing you the results later in the broadcast.

More on the Celebrex scandal ahead. I'll be talking with Senator Chuck Grassley. His committee is investigating the FDA. He says it's time for a major reform.

I'll be talking with Harvard medical school professor Dr. John Abramson who says Celebrex is nothing more than a marketing miracle.

DOBBS: My guest says the system that oversees drug safety in this country is simply broken. Dr. John Abramson says there isn't enough separation between the FDA and drug companies. The disturbing result is the doctors aren't receiving critically important information about the drugs they're prescribing. Dr. Abramson is a Harvard Medical School professor joining us tonight from Boston. Doctor, good to have you with us.

DR. JOHN ABRAMSON, AUTHOR, "OVERDOSED AMERICA": Pleasure to be with you, Lou.

DOBBS: The idea that Celebrex is not being withdrawn, but a warning, a significant warning today. You're not surprised, though, are you?

ABRAMSON: Well, actually, I must say, I am surprised, Lou, because the issue of cardiovascular risk hadn't come up with Celebrex before. It certainly had come up with Vioxx. And when the Vioxx story broke in September, there was a trail of suggestion. With Celebrex, we hadn't seen a cardiovascular risk. It's a possible situation because the Cox 2 inhibitors of which Celebrex is one can increase the clotting of the blood.

DOBBS: It can increase the clotting of the blood, raising the risk of heart attack?

ABRAMSON: That's exactly right. That's what we saw in one of the studies that came out today.

DOBBS: Well, amongst the studies that are being conducted by the FDA by the profession itself, what in the world is going on? We have an entire class of what are called Cox 2 inhibitors, pain relievers, that are apparently a significant health risk. We've had the withdrawal of Vioxx. What is going on?

ABRAMSON: Really, Lou, we're not connecting the dots. The reviewers within the FDA did a beautiful job of analyzing the data from what was called the class study back in 2000. The manufacturer of Celebrex looked at 8,000 people treated with Celebrex or older antiinflammatory drugs for osteoarthritis. That study showed that Celebrex is no safer than the older drugs, it provides no better relief, and it costs ten to 15 times more. So the real issue with Celebrex is why the docs didn't know that it really didn't add very much clinical value for their patients. The docs were misled by the medical journals. That's where the real problem is.

DOBBS: Well, the "New England Journal of Medicine," as you know, has taken the unusual step of coming out on Bextra with a warning saying that it poses some considerable concern as well, a week before its publication date because they're so concerned that people are using Bextra. That's remarkable.

ABRAMSON: That's and that's an excellent trend. The article that published the original research for Celebrex was the "Journal of the American Medical Association" back in 2000. That article concluded that Celebrex, when taken for six months, produces fewer G.I. complications. The problem is, it wasn't a six-month study, it was a 12-month study. And the FDA and the manufacturer had all 12 months when that article was published.

The full 12 months show that Celebrex is no safer than the other drugs. So the real issue here, Lou, is that the docs the docs who are reading the best medical journals are not getting the full view of the information, the scientific evidence, that's available. That's our problem. And until we straighten out what kind of information real doctors take into the examining room with them to see real patients, we're going to keep having these drug debacles one after the other.

DOBBS: And we're out of time, Doctor but is it also important to push back the relationship between our practitioners, our physicians in this country, push back the drug companies in that relationship? Because they are immersed in the offices of those doctors all around the country?

ABRAMSON: Absolutely. It's critically important. The job of the drug companies is to sell more drugs, not to improve our health. We need to be getting impartial information, and the docs need access to good information. That's the basic problem.

DOBBS: Dr. John Abramson, we thank you for being here.

ABRAMSON: Pleasure to be with you, Lou.

DOBBS: Well, one of the people trying to do something about what is beginning to look very much like a crisis in this country is Senator Chuck Grassley. He's chairman of the Senate finance committee and has held public hearings on dangerous prescription drugs. Senator Grassley has called for major changes in the FDA in order to ensure drug safety is that agency's priority.

Chairman Grassley joins us tonight from Cedar Rapids, Iowa. Senator, good to have you here.

SEN. CHUCK GRASSLEY, (R) IOWA: Glad to be with you, Lou.

DOBBS: This new study, you've just heard Dr. John Abramson, one of the most respected voices on this issue. You've been holding hearings. What in the world are we going to do? Because it looks like an entire class of drugs is, at best, problematic. And some of them apparently dangerous to the public health.

GRASSLEY: Well, ten days ago, when you interviewed me, I wouldn't have said this, but we've had another shoe drop. And I think we're going to have to have very great scrutiny of the process within the government of the review of drugs. So I'm calling for a 9/11-type commission of scientific experts to review the drug safety issues and how the government supervises it and what's wrong and come up with some recommendations so that we can get on top of this.

Now, this wouldn't be a permanent organization. It would just be a short-term one to look at it. But scientific experts to tell us what needs to be done so what the FDA and the drug companies are not doing to ensure safety, we can have a better grasp of the safety.

DOBBS: One of the complications in what is a very complicated situation, it seems to me, senator, is that we have the finest doctors in the world. They're busy. And interposed with those doctors is both the source of information as well as bringing new products to their attention in terms of marketing are the pharmaceutical companies. The educational role has, by default, if you will, a continuing education of doctors, as by default, been relegated to the pharmaceutical companies themselves, giving them extraordinary influence in our medical care system. Is there anything we can do about that?

GRASSLEY: Well, yes. And this is another thing I suggested on your previous interview with me. And that is legislation I'm going to put into have full transparency of all of the tests that are done, the clinical tests, clinical trial registries so we have full transparency of programs so that I mean of the drugs and the safety of the drugs.

DOBBS: Right.

GRASSLEY: So that when doctors want to get more information, they'll have access to all the information.

Now, I don't think that solves your question to me about doctors being busy and having to rely upon drug companies and maybe having too close of a relationship. But at least for doctors that are interested, there will be more out there.

DOBBS: Senator Chuck Grassley, thank you.

GARSSLEY: Thank you.

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