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New Celebrex Warning Raises Concerns Of FDA's Effectiveness

Dec 17, 2004 | CNN NEWSNIGHT AARON BROWN MILES O'BRIEN, CNN ANCHOR: Good evening. Aaron is off tonight. I'm Miles O'Brien.

Another drug that seemed to be a wonder once again has us wondering. Celebrex, the wildly popular pill that promised relief from chronic pain without serious side effects may, in fact, be a risk doctors and patients don't want to take.

And, while the company that makes the drug, Pfizer, is not pulling it off the market, it is sounding a serious warning, serious as a heart attack. If it sounds familiar, it is. Celebrex is a chemical cousin of Vioxx, withdrawn from the market a few months ago, amid similar concerns.

Some big questions lingering tonight why did Pfizer issue this warning? What does it mean for the future of the drug and for the company for that matter? And what about the 27 million Celebrex users out there what is next for them?

We have several reports. We begin with CNN's Elizabeth Cohen.

ELIZABETH COHEN, CNN MEDICAL CORRESPONDENT: It's been one of the best selling drugs in history but today a bombshell. A government study says people taking Celebrex are two and a half times more likely to have a heart attack or stroke.

The study, which has not been made public, came from the National Cancer Institute. It was investigating whether Celebrex might help prevent cancer. Now, the researchers have stopped using Celebrex in the study.

And, the Food and Drug Administration is telling doctors to consider alternative pain relievers for their patients. And, if a doctor determines the benefits of the drug are worth the risk, the doctor should prescribe the lowest effective dose.

Now many are wondering why did it take nearly five years to notice that this blockbuster drug, which has been used by 27 million Americans, could cause heart attacks? Dr. David Graham is the Food and Drug Administration's safety expert who blew the whistle on a similar drug, Vioxx. He says the system has completely broken down.

DR. DAVID GRAHAM, FDA WHISTLEBLOWER: FDA is incapable of protecting the United States against unsafe medicines.

COHEN: He says the FDA should have been monitoring Celebrex more closely since experts knew even before the drug went on the market it could possibly cause heart problems.

GRAHAM: I think the American people need to ask what's wrong with FDA? Why does it not take seriously the issue of safety?

COHEN: When Vioxx, which is in the same family as Celebrex, was shown to have a similar risk, it was pulled off the market, so does that mean the FDA wants Celebrex off the market too? The agency says no. They want to study the data further and that safety problems are inevitable.

DR. LESTER CRAWFORD, FDA ACTING COMMISSIONER: We can never be failsafe, 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 in hand. We're far better at it than we used to be but we need to be better in the future.

COHEN: But critics of the FDA say drugs aren't so difficult to evaluate and that the agency should require drug companies to study how the drug works in more people for longer periods of time before allowing it on the market. Pfizer defended its drug Friday saying its own study showed no heart or stroke problems.

HANK MCKINNELL, CHAIRMAN, CEO, PFIZER, INC.: We do know from a wealth of other information, some from FDA studies, some from our studies, some from others, that Celebrex when taken as recommended at the doses recommended is safe and effective.

COHEN: The dose patients took in the study, the dose that put them at an increased risk for heart attack and stroke, is a dose recommended by Pfizer, 400mg a day. Now many will be watching Pfizer to see if it takes Celebrex off the market or if perhaps, the FDA pressures it to do so.

O'BRIEN: Celebrex is not the only drug of this type in Pfizer's portfolio. Its sister drug Bextra, which makes millions for the company, is also under fire. Earlier this month, Pfizer added what's called a black box warning to Bextra's label, the most serious type of warning the FDA can demand.

Today, an editorial in the New England Journal of Medicine took an unusual step warning doctors not to prescribe Bextra, saying it's too dangerous. Now the warning on Celebrex had left patients with and their doctors in a terrible bind.

JASON CARROLL, CNN CORRESPONDENT (voice-over): For the past year, Neela Rastogi-Shapiro has had to walk slowly on lunch breaks ever since she hurt her knee from overdoing it in the gym. As recently as Thursday, she took Celebrex, not anymore.

NEELA RASTOGI-SHAPIRO, CELEBREX USER: I'm in my 30s. I shouldn't be worried about heart problems and cardiovascular problems. I'm too young for this. I only have knee problems.

CARROLL: Shapiro started out taking Vioxx but that painkiller upset her stomach so her doctor suggested Celebrex. That was weeks before Vioxx was pulled for its risk of causing heart attacks and strokes. Now there may be risks associated with Celebrex. Shapiro wonders what to do now.


CARROLL: Rheumatologist Gary Meredith is Shapiro's doctor.

MEREDITH: I think people are going to ask is it safe to continue to take it. What we'll probably try to do is see if we can minimize the dose or possibly substitute another medication for those that are at high risk.

CARROLL: Dr. Meredith says as late as Thursday he spoke with representatives from Pfizer, the company that manufactures Celebrex. He says that company rep made no mention of any potential problems.

SHAPIRO: My pain comes and goes.

CARROLL: Now, Shapiro says she's going to look at other options.

SHAPIRO: At this point, I want to experiment on other alternatives, natural remedies, homeopathic remedies, holistic medicine or maybe not take anything.

CARROLL: Medical experts say people taking Celebrex should meet with their doctors and, if there's a history of heart disease, weigh the risks versus the benefits of staying on Celebrex.

O'BRIEN: Vioxx, Celebrex and Bextra belong to one of the most widely marketed and most widely prescribed groups of drugs on the market. The business of killing pain is a very big business indeed. Just Celebrex alone brings in $2.3 billion a year in revenue for Pfizer. The lessons of Merck, which stands accused of withholding damaging data on Vioxx, weigh heavily here.

Here's CNN's Allan Chernoff.

ALLAN CHERNOFF, CNN FINANCIAL CORRESPONDENT: Merck's loss of Vioxx in September appeared to have been Pfizer's gain. As Merck voluntarily pulled its arthritis medicine from drugstore shelves, Pfizer aggressively marketed Celebrex.

CHERNOFF: A chance to gain market share for the number one arthritis pain medication, in the U.S. alone, 27 million prescriptions written, sales this year of better than $3 billion. Some Americans, though, feared Celebrex might also cause heart trouble.

LUISA CONTRERAS, PATIENT: I'm not a person who takes medication easily and so then when you hear something like this then you say "You see I'm right."

CHERNOFF: Pfizer thought it was in the clear until Thursday night.

MCKINNELL: The company received this information about 5:00 p.m. last night. I first heard about it about 8:00 p.m. last night. We advised the Food and Drug Administration immediately and we announced this morning information that we thought was important to prescribing physicians and to patients benefiting from Celebrex.

CHERNOFF: Pfizer says it has no plans to pull the medication. It will keep on selling Celebrex and the company is working with the Food and Drug Administration on a study of arthritis patients taking Celebrex, which is due to begin next year.

The FDA also plans to review data from ongoing Celebrex studies and says "it will determine the appropriate regulatory action."

DR. JOHN ABRAMSON, HARVARD MEDICAL SCHOOL: It's not a wonder drug. We've spent $8 billion on this drug. It's not a wonder drug. It was wonder marketing.

CHERNOFF: It's an especially poor time for Pfizer to have to go into crisis management mode. The industry's new drug pipeline has been drying up as patents are expiring for established drugs opening them to competition from generics. Investors fearing sales of Celebrex will suffer bailed out of Pfizer stock Friday. It lost 11 percent closing at its lowest level in nearly seven years.

O'BRIEN: And NEWSNIGHT has been out front of the drug story, the questions too about regulation and whether that regulation is too lax. We've tried to make it as balanced as we can, recognizing that every drug carries the risk of side effects. Weighing a drug's risk against its benefits is the challenge doctors and their patients face every day. Today, the calculus became more complicated for those who use and prescribe Celebrex.

Joining us from Baltimore, Dr. Roger Blumenthal, director of preventive cardiology at Johns Hopkins, he is also a spokesperson for the American Heart Association. Dr. Blumenthal, good to have you with us.


O'BRIEN: Give us a little perspective here. When it's said that it doubles the risk of a heart attack, Celebrex that is, what does that really mean?

BLUMENTHAL: Well, in the study there was about 2,000 individuals. The absolute incidence of a heart attack or stroke was one percent in the placebo group, two and a half percent in the Celebrex dosage that was 400mg a day, and three and a half percent in the Celebrex dose that was 800mg a day.

O'BRIEN: Are those acceptable percentages?

BLUMENTHAL: Well, all the other prior studies that we had seen with this particular medicine had not shown an increased risk. The totality of evidence would suggest that lower dosages of Celebrex are quite safe and effective.

But one thing that we should stress is that at the two-year mark in the study there was no hint of an increased risk. It was only at nearly the three-year mark that we did see this increased risk.

And I think what we should remember is what the FDA has now put on its website that with these types of medicines we should probably use the lowest dose for pain relief and we shouldn't be using them for a year or two years at a time. They were really meant for short term use for relief of pain in people that had stomachs maybe prone to bleeding.

O'BRIEN: I think a lot of people must be scratching their head wondering what the government is doing, if anything, to vet these drugs before they get to market.

BLUMENTHAL: Well, this particular study, Miles, was based on some very exciting data that Cox-2 inhibitors may decrease the risk of cancer, especially colon cancer. And earlier this month there was a report from M.D. Anderson suggesting that Celebrex may be a potential major breakthrough in the treatment of breast cancer.

So, the science was that these particular drugs, used at higher dosages, may actually decrease cancer but what we see here is a small but statistically significant increase in heart attacks.

We also should keep in mind that there are two other studies of similar size that are going on that didn't show any increased risk of Celebrex at the dosages used in that study.

O'BRIEN: To what extent is this a function of the tremendous marketing associated with these drugs and people going in and requesting them, demanding them? Are physicians kind of rolling over to that pressure and is that creating a potential problem for consumers?

BLUMENTHAL: Well, the American Heart Association always stress that we always want to improve dietary and exercise habits and when we use medications we want to use them for the proper indication.

I think it is true that some people have jumped to using Cox-2 inhibitors long term for pain relief when perhaps maybe short term use would be better and thinking about things such as Tylenol, Ibuprofen, Naprosyn, things of that nature that haven't been associated with an increased risk and they're also a lot less expensive.

O'BRIEN: So, to what extent then should we point the fingers at doctors here? Are doctors not doing their job in prescribing properly?

BLUMENTHAL: I think doctors are doing their job. We have to remember that this was a study using dosages that were two or four times higher than traditional use of Celebrex for pain relief and this was also a long term study.

The drug was really not made for long term use. There's some exciting science data that suggests that it may decrease cancer and that was the purpose of this particular study.

O'BRIEN: Dr. Blumenthal, should it be pulled from the shelves? Should this be off the market?

BLUMENTHAL: No, I don't think so. I think when the drug is used properly in the lowest dose and not used for more than two years but used just for short term use, Miles, I think it can be used very safely and effectively and the totality of evidence would support that conclusion.

O'BRIEN: Dr. Roger Blumenthal with Johns Hopkins thanks very much for your time.

BLUMENTHAL: Thank you, Miles.

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