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HOUSE CALL WITH DR. SANJAY GUPTA

A Look at the Drug Celebrex and it's Side Effects

Aired December 18, 2004 - 08:30   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.


BETTY NGUYEN, CNN ANCHOR: Well, good morning. I'm Betty Nguyen at the CNN center here in Atlanta. Here's a check of the stories now in the news. We now know the identity of an American man taken hostage in Iraq. The U.S. embassy confirms that 56-year-old Roy Hallums was kidnapped six weeks ago in Baghdad. Hallums worked for a Saudi company that caters for the Iraqi army.
A 36-year old Kansas woman has confessed to kidnapping a baby and killing the baby's mother. Lisa Montgomery told Missouri police she strangled Bobbie Jo Stinnett and took her eight month old child from the womb. The baby girl was found alive and is now with her father.

The Justice Department has asked an immigration judge to deport a man who the government says once served as a Nazi guard in a concentration camp - in fact, two concentration camps. 84-year old John Demjanjuk is a retired Ohio auto worker. Demjanjuk son-in-law says the family will challenge the government's request. We'll have more on that story.

In the meantime, I'm Betty Nguyen. HOUSE CALL with Elizabeth Cohen starts right now.

ELIZABETH COHEN: Good morning, and welcome to HOUSE CALL. I'm Elizabeth Cohen in for Dr. Sanjay Gupta. Checking medical headlines, months after announcing a flu vaccine shortage, the government now fears that tens of thousands of doses may go to waste. A federal panel is recommending the CDC ease restrictions so more people can get their flu shots.

According to a new study, more Americans die from heart attacks and other natural causes during the holidays than at other times of the year. Researchers say one reason may be that people delay seeking medical treatment for symptoms over the holidays.

And just 24 hours ago, news that another popular drug may increase the risk of heart problems. This time, it's the painkiller Celebrex. The news about Celebrex comes about three months after similar concerns about Vioxx. That drug was pulled from the shelf. This latest scare is our top story.

It's another blow to millions of Americans who suffer from arthritis. The drug company Pfizer is warning of a possible link between Celebrex and heart problems. It's raising all sorts of questions about the safety of what's in your medicine cabinet.

(BEGIN VIDEOTAPE)

ANNOUNCER: These are just a few of the 23 million people who have discovered Celebrex.

COHEN, (voice-over): It's been one of the bestselling 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 a 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 effected 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 safety expert who blew the whistle on a similar drug, Vioxx. He says the system has completely broken down.

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

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.

LESTER CRAWFORD, DR., FDA ACTING COMMISSIONER: We can never be fail safe, though, because we're dealing with products that are very difficult to evaluate.

COHEN: Pfizer defended its drug Friday, saying its own study showed no heart or stroke problems.

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

(END VIDEOTAPE)

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

Now this could affect millions of people around the world. Celebrex is used to treat common ailments like arthritis, menstrual pain, as well as intestinal polyps. We want to hear your questions about Celebrex. E-mail us now at housecall@cnn.com. We'll try to get to as many e-mails as we can.

Joining us now to help us answer those questions is Dr. Marie Griffin. She's a professor of preventative medicine at Vanderbilt University and an expert on drug safety. Welcome, Dr. Griffin.

MARIE GRIFFIN, DR., VANDERBILT UNIV. MEDICAL CTR.: Thank you.

COHEN: Now doctor, should people stop taking their Celebrex?

GRIFFIN: Well, we believe that people at high risk of heart disease, this poses a threat. And so they should definitely talk to their doctor sooner rather than later.

There's no danger of immediately stopping this type of drug. I think the danger is that people get worried about all their drugs and say, you know, these are bad things. And they shouldn't be afraid of their other drugs. But there's no danger with stopping these types of pain relievers.

COHEN: Now the dosage in the study was 400 milligrams. That's what put -- gave people that two and a half times increased risk of having a heart attack or a stroke. Is this the dosage that's commonly taken?

GRIFFIN: It is a dosage that's commonly taken, although if you read the recommended dose, it's not the dose that's recommended for many people. But many people do take this dose. It really is only recommended for short-term use or for people with rheumatoid arthritis, but many people take this dose. Yes.

COHEN: Now you co-authored a letter to The New England Journal of Medicine this week, advising against he use of another Cox II inhibitor. That's the class of drugs we're talking about here, that this one's called Bextra, the one that you wrote about. What's dangerous about this class of drugs?

GRIFFIN: Well, we now have -- I think we've learned something since the Vioxx episode. There was concern that all three of these drugs, these new Cox II inhibitors, might cause heart attacks and strokes. And we got the first signal from Vioxx. Now we have a signal from both Bextra and Celebrex. And I think it makes it more clear that the basic science was probably correct in suggesting that all these drugs could increase the risk of heart attack and stroke. So it's very concerning.

COHEN: And that basic science was known, as I understand it, pretty early on in the game, the basic science said that there could be an increased risk of heart attack.

GRIFFIN: Exactly. But what the real proof is when -- if you see this in patients. So a lot of times the basic science, it may not pan out in patients. So -- but when you start seeing what the basic science predicts, that's a very strong signal. And now when we're seeing it in both of the other drugs, I think that we have to be very cautious about using these drugs. COHEN: Well, we have a question now, an e-mail question from Glenn in Florida. And Glenn says, "I was prescribed both Celebrex and Vioxx for two years. I haven't taken either for a couple of years, but is there any long-term risk after discontinued use?"

Dr. Griffin, I know a lot of people are wondering this. If you took Celebrex, Vioxx or Bextra and stopped, are you still at an increased risk for heart attack or stroke?

GRIFFIN: We don't think so. From what we know about these drugs, the effects should be just while you're taking the drugs. So people should not worry about past use.

COHEN: Well, good. I know that will make a lot of people breathe easier. We've got to take a break now. When we come back, we'll talk about options. From arthritis to painful injuries, what should you do for pain relief? We'll discuss alternatives right after the break.

(COMMERCIAL BREAK)

COHEN: Welcome back to HOUSE CALL. We're taking your questions on the latest concerns about Celebrex. Talking with us this morning is Dr. Marie Griffin, a drug safety expert and professor of preventative medicine at Vanderbilt University. Welcome, doctor.

GRIFFIN: Hey.

COHEN: Vioxx is off the market, as everybody knows. And you've advised doctors to stop prescribing Bextra. And now we have this latest Celebrex study. Well, we have a question from a viewer. Lori from Connecticut writes, "Celebrex doesn't work and Bextra is marginal. I am very concerned about what I can use instead."

Any recommendations for Lori, doctor?

GRIFFIN: Sure. Well, it depends on what she's taking the drugs for. And her experience is not unlike many people. The drugs work really great for about 20 percent of people. And for the rest, they may provide a little bit of relief.

So first of all, there are a lot of other things for joint pain, such as trying to strengthen your muscles and your joints, doing exercises, heat and cold. And then over-the-counter medicines like Tylenol are really safer than these drugs. And if you're at the point where you -- these drugs really help, then the older drugs that we've had around for a long time like Ibuprofen and Naprosyn are certainly alternatives.

COHEN: Now sometimes doctors prescribe Celebrex for, let's say a sports injury or some kind of short-term problem. So that you're not taking it for very long. Is that a safer use of Celebrex because it's for a short period of time?

GRIFFIN: Well, obviously if you take it for shorter, you limit your risk. But it's really no more effective than the older drugs for that type of injury. And so, at this point, I don't really see that there's any benefit to using this drug where we're questioning the safety, as far as cardiovascular risk, as far as heart attacks or strokes.

COHEN: Well, thank you, Dr. Griffin.

Coming up on HOUSE CALL, is the FDA doing enough to keep you safe?

We'll hear from one family who paid a high price before one prescription drug was pulled from the market. But first, more of this week's medical headlines in "The Pulse".

(BEGIN VIDEO CLIP)

COHEN (voice-over): Three years after 9/11, the U.S. is not as ready as it should be for a bioterrorism attack. That's according to a new report from an independent non-profit organization, called Trust for America's Health. On a scale of 10, more than two-thirds of the states scored six or below. Better bioterrorism plans, more laboratory staffing, and practice drills are among the group's suggestions from proved readiness.

Elizabeth Cohen, CNN.

(END VIDEO CLIP)

(COMMERCIAL BREAK)

COHEN: Prescription drugs are a huge business in this country, but should some of the drugs now on the shelves even be there? Is the government doing its job getting drugs on the market to possibly save lives, but also keeping the dangerous ones off the shelves?

Vioxx, the pain medication pulled by Merck because of increased risk of heart attack, is what some critics of he FDA consider the tip of the iceberg.

(BEGIN VIDEOTAPE)

COHEN: Tilllman and Mary Harris were married for 47 years, raised a daughter, had grandchildren.

MARY HARRIS: I miss him terribly. I wish he were there.

COHEN: Tillman Harris isn't here because after taking a cholesterol lowering drug called Baycol, he developed an unusual muscle wasting condition called rhabdomyolysis. He became so weak, his wife and daughter rushed him to the hospital where he died 10 days later.

Six months after his death, Bayer called Bay off the market. AT that point, 31 people taking the drug had died of rhabdomyolysis. And now the question is, could Bayer have prevented those deaths?

Tillman Harris died in February 2001. In March 2000, nearly a year earlier, an internal Bayer memo that was quoted in The Journal of the American Medical Association this month stated, "[Baycol] substantially elevates the risk for rhabdomyolysis compared with other [cholesterol-lowering] drugs."

Dr. Jerry Avorn is a professor at Harvard Medical School and author of the book, "Powerful Medicines."

JERRY AVORN, DR., HARVARD MEDICAL SCHOOL: Baycol is one of several drugs that we are asking ourselves how in the world did this drug stay on the market as long as it did?

COHEN: The answer, he and others say, is complicated. When drug companies hear of serious side effects, they have to, by law, report them to the Food and Drug Administration. But connecting the dots and analyzing the data is time consuming.

UNIDENTIFIED MALE: They haven't had the person power to receive and deal with all of these thousands and thousands of spontaneous reports that the companies send in.

COHEN: If a drug company finds a side effect before a drug goes on the market, it legally has to show that study to the FDA. But the law prevents the FDA from making those studies public. Drug companies say the studies contain trade secrets. Pharmaceutical companies say they reliably report side effects, both before and after a drug is put on the market.

ALAN GOLDHAMMER, PHD, ASSOC. VP FOR REG. AFFAIRS PHRM.: These are significant reporting requirements that the companies engage on, on an ongoing base.

COHEN: Concerning Baycol, Bayer says it kept the FDA fully informed about all pertinent safety information, including adverse event reports. When Bayer became aware of an increased rate of reports of rhabdomyolysis, it took appropriate action.

But the Harris family is left wondering, what if Bayer, what if the FDA had taken quicker action before there were 31 deaths?

ROSE OGBURN, DAUGHTER: Somewhere between the one and the 31, there were probably people who wouldn't have passed away.

(END VIDEOTAPE)

COHEN: A survey of FDA scientists found that two-thirds are less than fully confident in the safety of drugs on the market. Nearly 20 percent said they felt pressured to approve drugs that they felt might be unsafe.

Here to help us understand how sometimes dangerous drugs get approved is Dr. Brian Strom. He's the chairman and director of the Center for Epidemiology and Biostatistics at the University of Pennsylvania.

Welcome, doctor.

BRIAN STROM, UNIVERSITY OF PENNSYLVANIA: Well, thank you very much.

COHEN: What do you think of that survey that says that there are some pressures that FDA scientists feel pressure to approve unsafe drugs?

STROM: Well, I think people may be misunderstanding the interpretation of it. All drugs have side effects. All drugs have safety problems. Not just one drug or five drugs or 10 drugs or any given drug.

And so, it's important to recognize whether you talk about a prescription drug or an over the counter drug or an herbal drug. Those drugs are approved because the toxicities are felt to be worth it and worth the beneficial effects of the drug.

That's a value judgment. Different people can disagree about those value judgments. That's part of the nature of science. And there will always be disagreements of that kind. It's not a surprise that there are some people at FDA who disagree with some of the judgments. I would be, in fact, extremely surprised if it was to the contrary.

COHEN: Now doctor, explain the process of how a drug gets approved? I think some people think that the FDA studies the drug, that the FDA actually does the studies.

STROM: The FDA does not do the studies. There are pre-marketing or pre-clinical animal studies done by manufacturers. And then there are a series of different human studies, increasing numbers of humans used in different studies.

In total, drugs are exposed -- people are exposed to between usually between 500 and 3,000 patients prior to a drug's being marketed. At that point, that means we know reliably about adverse reactions that occur 1 in 100 patients. Adverse reactions that occur in 1 in 1,000 patients like unfortunately the Baycol situation or the Vioxx situation or the Celebrex situation are not normally detected prior to marketing. We understand that. It's unfortunate. It's part of the risk of using a new drug. And it's why patients should not want to use a new drug when an older drug is available.

COHEN: So why doesn't the FDA just require drug companies to try it out in more than 500 or 3,000 people? I mean, for Celebrex, 26 million ended up using it. Why didn't they tell them, you know what, try that on a couple more thousand people before you market it?

STROM: One option clearly would be to use it in more individuals. You would need 10,000, 20,000, 30,000 people in order to gain substantial additional information.

And the trouble is that will take a few years. In the meantime, you're denying access to good drugs, to people who could benefit from those good drugs.

And so, the drugs are put on the market, understanding there's a one -- we know 1 in 100 risks. 1 in 1,000 risks remain to be detected after drugs are marketed.

And it's critically important that the public understand and that physicians understand that new drugs have these yet unknown side effects. The fact that there's a rare serious side effect detected doesn't necessarily mean that somebody did something wrong. It may be that somebody did something wrong, but the fact that there's a rare side effect detected afterwards doesn't mean that there was something done incorrectly.

COHEN: Well, similar drugs, similar problems. Two popular painkillers making headlines. Should you be thinking twice about what's in your medicine cabinet? We'll address your prescription fears when we come back.

(COMMERCIAL BREAK)

COHEN: Welcome back to HOUSE CALL. As we've said, drugs, we're talking about the legal kind, are big business in this country. One study shows that for every dollar spent on drug advertising, pharmaceutical companies cash in more than $4 in sales. But could these ads cause a backlash?

Mary Snow takes a look.

(BEGIN VIDEOTAPE)

ANNOUNCER: Ask your doctor about Celebrex. Take control of your joint pain with the proven strength of Celebrex.

MARY SNOW, CNN CORRESPONDENT (voice-over): Ads like this help make Celebrex popular. Analysts project sales of the drug will generate roughly $3.4 billion worldwide this year. While announcements like the one about Celebrex are worrisome, doctors say drug companies are not to blame.

JOHN ABRAMSON, DR., HARVARD MEDICAL SCHOOL: The drug companies are no more responsible for our health than the fast food industry is for the quality of our diet.

SNOW: John Abramson, author of "Overdose Nation," says the real responsibility pharmaceutical companies have is to generate profits. And the industry is growing.

Last year, Americans spent an estimated $216 billion on prescriptions, an estimated 11.5 percent increase over a year. Critics say with profits driving the marketing, health takes a back seat.

SIDNEY WOLFE, DR., CHAIRMAN, PUBLIC CITIZEN: The FDA is not doing a good job protecting people from dangerous drugs. Part of the reason is that the FDA gets funded directly from the drug industry and is much kinder to the drug industry than it is protective of the public health.

SNOW: Public Citizen lists 180 drugs it believes are not safe. It wants to see more congressional oversight of the drug industry, an industry that some doctors say is having an effect in their offices.

UNIDENTIFIED MALE: There has been a trend to patients distrusting both the pharmaceutical industry, the FDA, sometimes their physician.

SNOW: Some patients are thinking twice about what's in their medicine cabinets.

UNIDENTIFIED FEMALE: 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.

SNOW: But doctors say the danger of a possible backlash against the pharmaceutical industry is that people might not take the medicine they need.

UNIDENTIFIED MALE: It think it's very important for people not to stop medicines, not to stop prescription medicines without talking to the doctors.

SNOW: Mary Snow, CNN, New York.

(END VIDEOTAPE)

COHEN: And of course, we do want you to talk to your doctor about concerns that you might have about any medication you're taking. And we've been talking with Dr. Brian Strom. He's the chairman and director of the Center for Epidemiology and Biostatistics at the University of Pennsylvania.

Now doctor, you've heard in this story and I'm sure elsewhere that some people think that the FDA bowed down to pressure from pharmaceutical companies. What do you think?

STROM: Personally, I don't buy that. I've had a lot of experience with the FDA. I've had experience with industry. My sense of the two is the two of them are antagonists. And they see each other as antagonists, which is as it should be.

I think the system can use a lot of changes and could be improved in many ways, but I don't believe that the FDA is bowing to the desires of the industry.

COHEN: Well, Dr. Strom, thank you for joining us this morning.

STROM: Thank you.

COHEN: Well, we're out of time today. Thanks to everyone for getting up bright and early. Make sure to watch next week when we'll be profiling people living a life beyond limits, from climbing the world's highest peaks, to diving deeper than light. Take an inside look as people challenge their minds and their bodies to the limit.

Thanks for watching. I'm Elizabeth Cohen. Stay tuned for more news on CNN.

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