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HOUSE CALL WITH DR. SANJAY GUPTA

Interview with Chris Gharibo

Aired February 19, 2005 - 08:30   ET

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


TONY HARRIS, CNN ANCHOR: Now in the news, it is a working Saturday for Secretary of State Condoleezza Rice and Defense Secretary Donald Rumsfeld. They'll be meeting this morning at the State Department with senior Japanese diplomats. Topping the agenda will be North Korea's claims of possessing nuclear weapons.
In Iraq, at least four insurgency attacks have been reported today, including this suicide car bombing in the city of Baqubah. An Iraqi soldier and a civilian died in the blast. Today's violence coincides with a Shi'ite religious holiday of Ashorah (ph).

The hockey season is already canceled, but negotiations will resume today anyway, according to the players union. The league on Thursday proposed getting back together in New York. Even if they reach an agreement, the commissioner said Wednesday it's too late to have any kind of meaningful season.

I'm Tony Harris. HOUSECALL begins right now.

SANJAY GUPTA, HOST: Good morning. Welcome to HOUSECALL. Checking medical headlines first. A government panel has recommended to the FDA that drugs like Vioxx be allowed to remain on the shelves. That decision comes with plenty of warnings and caveats. We're going to have that full story in just a moment.

A tiny baby receives a new lease on life. Doctors at the Children's Hospital at Stanford perform heart surgery on what is believed to be the smallest baby ever to survive this type of open heart procedure. Born 13 weeks early, the baby weighed just over a pound and a half and had a heart the size of a grape.

And in South Carolina, jurors rejected a teenager's claim that the antidepressant Zoloft contributed to him killing his grandparents when he was 12. Christopher Pittman was convicted of murdering his grandparents and sentenced to 30 years in prison. Last fall, you remember the government warned certain antidepressants can cause children to consider suicide.

And now back to our top story. The FDA has been told by its advisory panels that pain killing drugs, like Vioxx and Celebrex, should remain on the shelves. The panels found the relief provided by these drugs outweighs the risks, but the panels also agree that these drugs needed stronger warnings.

(BEGIN VIDEOTAPE) GUPTA (voice-over): It took three days of hardcore science and gut wrenching emotion for the FDA advisory committee to decide after extremely close votes that the popular painkillers should remain for sale in the U.S. despite known heart risks.

But that decision won't change the minds of some patients who will always believe these medications are too risky and too deadly.

Like Nancy Corran. She says her husband Jack lived an active life. His minor back pain was controlled with Vioxx until at age 64, he died suddenly of a heart attack.

NANCY CORRAN, HUSBAND DIED ON VIOXX: My husband could be alive right now if it wasn't for Merck. And I feel that he was murdered.

GUPTA: We can never know for sure that Vioxx actually caused his heart attack. Although studies have previously shown the increased risk of heart attacks and strokes, Merck didn't take it off the market until September. The research was similar on all three pain killers.

ALASTAIR WOOD, DR., CHAIR, FDA ADVISORY COMMITTEE: We've got data on Vioxx, on Bextra, and on Celebrex from randomized controlled trials that show an increased cardiovascular risk.

GUPTA: But still to some like Betsy Stuart Chaney, sidelined with pain after years of sports, the risks are worth taking.

BETSY STUART CHANEY, TAKES CELEBREGUPTA: I'm here to say would you all pick up your elbow and whack your funnybone and feel that pain that stops you in your tracks from doing what you're doing. All you want to do is say a bad word. Well, I have cracked vertebrates in my neck. And without Celebrex, I start to lose the feeling in my hands. And I can't grasp a paper, I can't hold on to something, I can't do things around my house. I'm willing for my quality of life to take those risks.

GUPTA: The committee says in allowing these drugs to stay on the market the warnings to doctors and patients must be made very clear. They're recommending the strictest warning a drug can have -- a black box on the label. And advertising will be limited as well. So look for fewer commercials.

(END VIDEOTAPE)

GUPTA: And Cox-2 inhibitors were hailed as miracle pills when they first came on the market in 1999. They could treat arthritis and chronic pain, while causing fewer gastrointestinal problems than older painkillers.

Lots of questions about this. Here to help us answer those questions, Dr. Christopher Gharibo. He's the director of the Pain Management Center at NYU Medical Center.

First of all, thanks for your time, doctor.

CHRIS GHARIBO, PAIN MANAGEMENT EXPERT: My pleasure. GUPTA: Listen, lots of questions coming in. These hearings in some ways have raised just as many questions as they've answered with people on both sides of the issue. And we should keep in mind this recommendation still has to be decided on by the FDA. So it's not set in stone yet.

But you have said in the past that you didn't think Vioxx should have been pulled off the shelves in the first place. If the Vioxx ends up coming back, despite all the caveats, will your prescription habits change now?

GHARIBO: Yes, certainly. I will certainly keep in mind FDA's recommendations. And I will have a higher threshold for prescribing Vioxx. But medications like Vioxx and others in its class are special within pain management because they control pain without inhibiting mental function.

GUPTA: And you know, the concerns about the heart risks are certainly there. And I want to sort of hone in on these a little bit. I think it's important.

Just this week, for example, three studies came out in the New England Journal of Medicine, all of them yet giving evidence of increased cardiovascular risk with Vioxx, Celebrex and Bextra.

There was also a scathing editorial, you may have read this, by the head of the Journal in which he says this. "It is reasonable to ask whether the use of the drugs can now be justified." This is the head of one of the biggest medical journals out there. Through the advisory panel, though they - the advisory panel OK'd these drugs, they did so with severe warnings and with very close votes.

Simply put, doctor, is this class of drugs just too dangerous?

GHARIBO: I do think that there is a certain element of cardiovascular and stroke risk with this class of medications. But then again, the same thing can apply to many other different types of pain medications as well as other approved drugs as well.

What needs to happen is that we need to scale back our use of these drugs and more appropriately select which patients they're indicated for.

GUPTA: Is there ever a appropriate situation where it's willing to go ahead and expose someone to the risk of a heart problem to try and take care of their pain?

GHARIBO: Some of the chronic pain patients that I have can simply not function and live the life that they want to live. And what's important to keep in mind is that the heart problems and the stroke problems that we saw were duration related as well as dose related. So in the appropriate patient, they can certainly scale back the dose of the Cox-2 inhibitor such as Vioxx or Celebrex and give it for a shorter duration of time.

GUPTA: So you think.., GHARIBO: So that we can maximize the benefit.

GUPTA: OK. Let's keep on topic here. There was a survey recently done. You may have heard about this, of FDA researchers. And two-thirds of them said they were less than fully confident in the monitoring of drugs on the market. That's pretty startling to a lot of people. Does this surprise you, Dr. Gharibo?

GHARIBO: No, it doesn't. I think what needs to occur is better post marketing surveillance, so that we can pick up such problems. I don't think medication should be incessantly delayed in coming to market.

GUPTA: Big news coming out this past week about these medications. The heat is certainly on the FDA. But critics say there's enough blame to go around. I want to talk about that. Stay tuned for that on HOUSECALL.

(BEGIN VIDEO CLIP)

ANNOUNCER: That's one pill, 24 hours, so you can live your life the way you want.

UNIDENTIFIED FEMALE: How much does advertising affect your doctor's decisions? We'll find out after the break.

And you have tried all the painkillers out there. What you need to know about natural ways to cut the pain.

First, take today's daily dose quiz. How much was spent on drug advertising last year? $1 billion, $3 billion, or $5 billion? That answer coming up.

(COMMERCIAL BREAK)

UNIDENTIFIED FEMALE: Checking the daily dose quiz, we asked, how much was spent on drug advertising last year? $1 billion, $3 billion, or $5 billion? The answer -- $3 billion. That set a new high in 2004.

GUPTA: And that's just for the advertising alone. A lot of money, certainly. As drug companies sink more money into marketing their drugs, the relationship between doctor and patient is changing. So the question is this, is this leading to a more informed patient or to trouble in the doctor's office?

Christine Romans has this report.

(BEGIN VIDEOTAPE)

CHRISTINE ROMANS, CNN CORRESPONDENT (voice-over): When Dr. Jonathan Mohrer started his practice 21 years ago, the idea of a pharmaceutical company pushing pills on his patient was unheard of. Today, he says the drug companies are a third party in his examining room. JONATHAN MOHRER, DR., INTERNAL MEDICAL: Before this became a common practice that the patient would really not know all that much about the medications that they were taking, that they would really rely on my judgment in choosing a prescription drug to give them what I thought was best. And now there's a third party in the room that is exerting influence.

ROMANS: Dr. Mohrer and many doctors like him say money changes everything.

(on camera): The average doctor visit lasts just about 10 minutes. And the drug companies are spending billions to make sure that in that precious time, you're asking your doctor about their prescription drugs and you're getting a free sample to get started right away.

UNIDENTIFIED MALE: The drug companies are marketing their products in the most aggressive way they can to increase their sales volume. That's their business. They make money by selling pills.

ROMANS (voice-over): Dr. Isabel Blumberg says about a third of her patients come in asking about a drug because of an ad, asking for a free sample. But she would never prescribe a medication a patient didn't need.

ISABEL BLUMBERG, DR., OB/GYN: I think most responsible doctors are making decisions based on patients' symptoms and patients requirements and not on free samples.

ROMANS: It's a subject sweeping medical dinners and conferences these days, events often sponsored by the drug companies. Doctors arguing over whether drug companies have too much influence in the doctor's office and whether a real examination of ethics is due.

Christine Romans, CNN, New York.

(END VIDEOTAPE)

GUPTA: And at this point, Cox-2 drugs are not being advertised directly to the consumer. But before all these reports surfaced, those ads helped the sales of Cox-2 inhibitors go through the roof with combined yearly sales of more than $5 billion.

We're talking about this with the Director of the Pain Management Center at New York University Medical Center, Dr. Christopher Gharibo.

Doctor, let's start off by taking a listen to what Dr. David Graham, a drug safety officer at the FDA, had to say specifically about advertising.

(BEGIN VIDEO CLIP)

DAVID GRAHAM, DR., FDA DRUG SAFETY OFFICER: In a world of direct consumer advertising, there's no such thing as informed decision making, or freedom of choice, because you're really sort of a victim now of Madison Avenue.

(END VIDEO CLIP)

GUPTA: And Dr. Gharibo, you're on the front line. I mean, you're the person who a lot of these patients see after they've watched these commercials. Do you think the ads do more harm than good?

GHARIBO: My opinion about the ads is that they certainly do not alter doctor's prescribing patterns. Often, yes, I do get questions from the patients about a particular product. But at the end of the visit , they simply take my advice over that of the ad.

GUPTA: Well, that's good to hear that, you know, the ads aren't overwhelming. Doctor, it's good advice, but you've also said that you didn't think Vioxx was overused by doctors. But a new study shows millions of people were taking the drug who had little risk of gastrointestinal bleeding.

The reason that's important because that was the main selling point for the drug. And when Vioxx was pulled from the shelves, 16 million people were taking it. Do you think all these patients really need to be on this drug? Or are we overselling it?

GHARIBO: I do believe that given the current availability of the data retrospectively speaking, Vioxx probably should not have been used as much as it has. And that use needs to be adjusted to the availability of the current data.

GUPTA: We're talking with Dr. Christopher Gharibo, trying to give you some advice about all of this in terms of Cox-2 inhibitors. And more HOUSECALL is coming up.

(BEGIN VIDEO CLIP)

UNIDENTIFIED FEMALE: I have arthritis of the spine. And it's also compounded by chronic back pain.

(END VIDEO CLIP)

UNIDENTIFIED FEMALE: Find out how this woman found relief without drugs.

But first, more of this week's medical headlines in the pulse.

(BEGIN VIDEOTAPE)

CHRISTY FEIG, CNN CORRESPONDENT (voice-over): Exposure to polluted air can damage the DNA of babies before they are born. That's according to a study published Tuesday. Researchers studied newborns in New York City, concluding that pollutants from vehicles, heating, power generation, and smoking can reach the fetus, causing chromosomal damage. They say the findings may lead to new approaches for the prevention of some cancers.

And a reminder to smokers that it's never too late to quit. Researchers with the Lung/Health Study followed 6,000 middle aged heavy smokers, all with mild lung disease. They found the death rate was cut nearly in half in those participants able to quit smoking for five or more years.

Christy Feig, CNN.

(COMMERCIAL BREAK)

(BEGIN VIDEO CLIP)

UNIDENTIFIED FEMALE: I was on Bextra for about a month when I had a heart attack.

UNIDENTIFIED FEMALE: I'd rather live a short active, quality life, than a long, miserable depressed one.

(END VIDEO CLIP)

GUPTA: And those are just two of the witnesses in the long list of people who testified at the FDA panel hearings this past week. They illustrate the dilemma here. Arthritis is the number one cause of disability in America. It's an incurable painful disease. And here we have many drugs that many of those suffering from chronic pain say help them live a more normal life.

But does that balance out the risks? That's the question. And that's what the FDA still has to decide.

In the meantime, people are left with all sorts of questions of their own. And helping us answer them is Dr. Christopher Gharibo. He's the Director of the Pain Management Center of NYU Medical Center.

Gotten lots of questions from our viewers on this topic. You get these questions all the time, I'm sure. Let's get the one from Carol in Texas.

She writes, "I have arthritis of the hip and have been going to physical therapy, stretching every day, and losing weight. I still do not feel as good as when I was taking Celebrex. The OTC (standing for over the country drugs) just don't cut it for me. Are there any new drugs that are on the horizon for arthritis pain?"

Doctor, so you know, she's saying the Cox-2 inhibitors, they worked. She's concerned. What about the future?

GHARIBO: There are plenty of products in the pipeline for -- in management of her arthritic pain. There's certainly other Cox-2 inhibitors that are in development. They may have a better cardiovascular profile from Merck, from Novartis, as well as from Pfizer.

But there are also other options in treatment of arthritic pain as well. Specifically speaking, Tramadol compounds, as well as potential availability of future long acting Tramadol compounds may certainly be an option for Caroline.

Other medications in the pipeline can include medications such as Bicifadene, which is a centrally acting non Cox-2, non narcotic painkiller, which is currently undergoing Phase 3 trials. And of course, opiate is also an option. And there are a variety of formulations, both sustained release, as well as instant release that can help her regain the function that she has lost.

GUPTA: And what are the Tramadol compounds? And are they available now?

GHARIBO: Yes, they are.

GUPTA: What are they?

GHARIBO: Ultracet and Ultram are the Tramadol compounds.

GUPTA: OK, good for people to know who are taking notes here, because a lot of people sort of left in the lurch here.

Another question now from Carla in Ohio asking, "Does the risk of heart attack go away if you stop taking Vioxx or Celebrex?" A good important question, doctor?

GHARIBO: Sure. Well, for Caroline, I'm sure it does go away at some point after the medication has been stopped. I'm not exactly sure how much time must elapse before the heart attack risk disappears. And it's probably medication specific, but I just don't have a specific timeframe to give you.

GUPTA: OK. And as we hear reports of problems with painkiller, some say it's time to try and turn to other options for pain relief. Like, for example, what you eat.

Christy Feig has the details.

(BEGIN VIDEOTAPE)

FEIG (voice-over): For most of her life, Roberta Hagen has been in pain.

ROBERTA HAGEN, PAIN SUFFERER: I have arthritis of the spine. And it's also compounded by chronic back pain.

FEIG: She took Vioxx, which was recently taken off the market because of heart problems. Now she's on Celebrex. Her physician also told her to exercise and diet.

Pain experts say because of the recent controversy over the Cox-2 inhibitors like Vioxx, Celebrex and Bextra, physicians are moving away from prescribing pills and are putting patients in pain on comprehensive health programs.

LEE ANN RHODES, DR., WASHINGTON HOSPITAL CTR.: Healthier eating, weight loss where indicated, physical therapy for some of the patients where this is appropriate to recondition themselves and regular exercise.

FEIG: Pain is often caused by inflammation and an increase in C reactive protein or CRP. KATHERINE TALLMADGE, AMERICAN DIETETIC ASSOCIATION: A lot of research is showing that certain foods reduce inflammation biomarkers such as CRP and other measures of inflammation.

FEIG: To reduce pain, the American Dietetic Association recommends adding to your diet fruits like strawberries, citrus, and melons, any veggie, nuts, soy and flaxseeds, and the oily fish like salmon.

And limiting caffeine, foods high in animal fat and processed foods, especially those with high amounts of trans fats. And 30 minutes of daily exercise could make the difference in the way your body handles pain.

In Washington, I'm Christy Feig.

(END VIDEOTAPE)

GUPTA: Christy, thanks.

And doctor, your specialty, obviously, is chronic pain. You know, all doctors tell their patients to eat right and exercise. How important is that in terms of relieving pain?

GHARIBO: I'm not sure if there's any evidence on whether if dietary changes make a difference in your pain level, except if the dietary changes result in weight loss. I believe continued activity and continuing to do what you would want to do throughout the day is probably best in terms of maximizing your overall function.

GUPTA: Some people say that motion is lotion. That can certainly help as well.

More alternatives to fight the pain, that's coming up after the break. Stay tuned.

(COMMERCIAL BREAK)

GUPTA: If you're concerned about the safety of any medicine you're taking, click on the FDA Web site at fda.gov/medwatch. There you're going to find the latest news on drug safety and can file a report of your own.

And if you missed anything on today's show, check out our transcript. That's at CNN.com/transcripts. You can usually find them on Monday mornings.

We're talking about painkillers, their safety, and good alternatives as well with Dr. Christopher Gharibo. He's a pain management expert. He's the perfect guy to talk to.

Listen, doc, we mentioned that diet and exercise. But more and more people are looking to supplements to try and treat symptoms as well.

We've a question about that from Connie in Michigan. She writes, "I started taking a daily dose of 1000 mg of Glucosamine for osteoarthritis. After several months, the pain was very manageable. Has it been studied that Glucosamine can be effective and safe?"

I got to tell you, doctor, a lot of my friends take this as well. I don't know that there's the data they see. But what have you been doing with Glucosamine?

Ghaith: I basically do not recommend Glucosamine to my patients because there's no good data to support its use. Nor do I understand the potential mechanism for it.

The hypothesis is that Glucosamine somehow gets into the cartilage and the joints after taking it orally, for example. But there's really no good way for that to happen because there's no blood supply to the cartilage. So therefore, I just cannot imagine sufficient amount of Glucosamine reaching the cartilage in the joints after being taken by mouth.

GUPTA: Well, you know, it's one of those difficult things because for a lot of people it works, I guess. And they're probably going to continue to take it.

Listen, we're out of time for today. It's been a good show. I want to thank Dr. Christopher Gharibo for talking with us, clearing up a lot of stuff. Appreciate your time.

GHARIBO: My pleasure.

GUPTA: Make sure to watch next week when we talk about ancient ways to cure what ails you from dead sea baths to ancient herbs. The science behind these may surprise you.

Remember, this is the place for the answers to your medical questions. Thanks for watching. I'm Dr. Sanjay Gupta. Stay tuned now for more news on CNN.

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