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HOUSE CALL WITH DR. SANJAY GUPTA

Staying Healthy Despite Flu Shot Shortage; Finding Safe Alternatives to Vioxx

Aired October 9, 2004 - 08:00   ET

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


DR. SANJAY GUPTA, HOST: Good morning. And welcome to HOUSE CALL.
Checking the headlines. The government is urging most healthy adults to delay or skip getting a flu shot this year. That's because of a predicted shortage of the vaccine. We'll be talking to infectious disease chief Dr. Anthony Fauci in just a few minutes.

Also, the federal trade commission is suing the marketers of the diet supplement CortiSlim, saying the claims made in their advertisements, quote, "fly in the face of reality." The ads say by using their products to reduce the stress hormone cortisol, you can lose four to 10 pounds a week.

And the fallout from the Vioxx recall continues. A report out this week finds the arthritis drug could be linked to thousands of heart attacks. And a class action lawsuit involving about 300,000 people was filed in Illinois against Vioxx's maker, Merck.

The head of the Arthritis Foundation will be taking your questions later in the show.

But first, our top story.

Just weeks after the government advised us to get our flu vaccines, a major problem. Almost half of this year's doses won't make it to the U.S.

Elizabeth Cohen has the latest on what this means for you.

(BEGIN VIDEOTAPE)

ELIZABETH COHEN, CNN CORRESPONDENT (voice-over): It couldn't have happened at a worse time. Nearly half of the nation's supply of flu shots will now not be available, because of fears the vaccine might have been contaminated during the production process at the Chiron Corporation. And this just as the flu shot season was getting under way.

HOWARD PIEN, CEO, CHIRON CORPORATION: We profoundly, and I cannot overemphasize how profoundly, we profoundly regret that we will be unable to meet public health needs this season.

COHEN: The timing is especially bad, because many expected last year's severe flu season would mean even more people lining up for shots this year. TOMMY THOMPSON, HHS SECRETARY: This is very disappointing news that creates a serious challenge to our vaccine supply for the upcoming flu season.

COHEN: The government strategy now: get flu shots only to those who really need it.

THOMPSON: Our immediate focus will be on making sure that the supply of vaccine we do have reaches those who are the most vulnerable.

COHEN: The CDC says among those who should get shots first: children ages 6 to 23 months, adults over age 65, adults and children with chronic illnesses, pregnant women and anyone who could spread the flu to those at high-risk.

And health officials say everyone else should wait until those who really need the shots get them first.

Elizabeth Cohen, CNN, Atlanta.

(END VIDEOTAPE)

GUPTA: Thanks, Elizabeth.

This latest massive shortage has caused many to question our system for making and supplying vaccines.

Here to talk with us about that and answer your questions on where to go from here is Dr. Anthony Fauci. He's director of the National Institutes of Health, Allergy and Infectious Disease Division.

First of all, Dr. Fauci, I know you're very busy. Thanks for taking some time for us.

DR. ANTHONY FAUCI, DIRECTOR, NATIONAL INSTITUTES OF HEALTH, ALLERGY AND INFECTIOUS DISEASE DIVISION: It's good to be here, Sanjay.

GUPTA: What's being done now to make up for the shortfall?

FAUCI: Well, first of all, the prioritization that you just mentioned. Clearly, we have to be very strong in our encouragement of the general public to get the vaccine to those who are most susceptible to the complications, the high-risk group as well as for stalling the vaccination of people who are otherwise healthy adults.

With regard to getting more doses, we're pursuing, the Department of Health and Human Services, is pursuing with Aventis Pasteur and with Medimmune the possibility that there may be a couple of million extra doses one way or another that they have designated for someplace else that we could, perhaps, add to our own material (ph).

As you know, we started expecting 100 million doses, and now we'll have about 54 million from Aventis Pasteur, the other company. An additional two million from Medimmune, which is the flu mist.

So I doubt, and in fact more than doubt that anyone will be able to produce more this late in the game of the vaccine production. So it's merely going to be a matter of redistributing it and finding out if there are some doses that we can swing over to our stockpile, as opposed to just going with the 54 that we have.

GUPTA: OK. Well, as you can imagine, Dr. Fauci, viewers are a little concerned about this latest news. Let's try and get to a few questions.

James in New Jersey asks, "Why is something this important left to foreign manufacturers of dubious quality control?"

And Dr. Fauci, I know that you would maybe argue, by the way, about the term dubious quality control. What about that? How does this whole process work? Why in Britain?

FAUCI: Well, that's a good question, Sanjay. And it's an issue that the -- the incentive for vaccine companies -- pharmaceutical companies to get involved in vaccine is very low.

First of all, there's very little profit margin; and secondly, there a lot risk taking. Just look at what happened to Chiron just this past 24 to 48 hours.

So we would love to have more companies, and companies in the United States, but they just are not stepping forward for understandable reasons.

The solution to that is to try and develop some incentives for these countries -- for these companies to get involved in vaccine research. If we had our way, we'd have many companies. They're just not there.

GUPTA: Another question being raised is really about how we go about making vaccines. And you've talked about this. I've been listening over the past several days, using chicken eggs and sometimes taking months to brew.

In a case like this, the slow process can be a major problem. Is there a faster way to make these vaccines, Dr. Fauci?

FAUCI: We're trying right now to implement a more modernized way.

The chicken egg way of making the virus for the vaccine is time honored, and it's good. It just is something that doesn't have much flexibility.

There's a new approach called a cell culture-based approach, where instead of relying on injecting the virus into chicken eggs and letting it grow there, you actually put it into a cell culture that you can maintain continuously and that you could have much more of a direct control over. Hopefully, over the next few years, the vaccine industry will be moving from the chicken egg-based culture system into the cell-based system.

GUPTA: And how much faster would that cell-based system be?

FAUCI: Well, it would be less a situation of being faster, but a situation where you could scale up or scale down with much greater flexibility.

So you could anticipate that you need a certain number of doses, and then if something happens, some quality control issue, where you had an unanticipated need, you could ratchet up the system with much greater flexibility than if had you to rely completely on the eggs.

GUPTA: OK. We've got time for one more e-mail. I think Abner from North Carolina writing, "I am scheduled for a flu shot in a couple of weeks. In view of recent events, should I cancel the appointment?"

I think Dr. Fauci, this sort of speaks to the options that healthy adults have and should people like Abner cancel their appointments now?

FAUCI: If -- if Abner is a healthy adult below the age of 65, he should not go ahead and get a vaccine. He should forestall it for the time being, and perhaps indefinitely this season, because we're really squeezed with regard to getting the vaccine to those people who are truly within the high risk, the ones that you mentioned just a moment ago.

GUPTA: Right. And you know, you and I both spend so much time telling people to go get this flu shot. It's going be quite a different message this year, educating some people not to do it.

What can she do or any of the other people do instead?

FAUCI: Well, what -- what you can do is to practice common sense public health measurers: good hand hygiene, washing your hands, staying away from places where there's a lot of sneezing and coughing going on. Just good common sense 19th Century type of hygiene can go a very long way in the absence of a vaccine.

GUPTA: And some of that still works very well even hundreds of years later.

FAUCI: Indeed.

GUPTA: We've run out of time on this topic. Dr. Anthony Fauci, thank you so much for your time.

Coming up on HOUSE CALL another big story this week. The FDA is under fire for keeping Vioxx on the shelves. Stay tuned.

(BEGIN VIDEO CLIP) ANNOUNCER: Looking for options after Vioxx? An expert answers your questions on how safe your arthritis drugs are, and what can you take now?

But first, take today's "Daily Dose Quiz." Can getting injured increase your risk of arthritis? The answer when we come back.

(END VIDEO CLIP)

(COMMERCIAL BREAK)

(BEGIN VIDEO CLIP)

ANNOUNCER: Checking the "Daily Dose Quiz." We asked, can getting injured increase your risk of arthritis? The answer is, yes. Both overuse and injury to your joints can put you at risk of developing arthritis.

(END VIDEO CLIP)

GUPTA: And one-third of everyone watching this show either has or will develop arthritis. Millions of those struggling with this disease use the anti-inflammatory drug Vioxx to relieve their pain and their swelling and their stiffness.

(BEGIN VIDEOTAPE)

GUPTA (voice-over): For Dolores O'Brien, every day brings constant reminders of her fight against arthritis.

DOLORES O'BRIEN, ARTHRITIS SUFFERER: When I try to get something off the floor, or get underneath the bed to pull things out, I get down there and take about 10 or 15 minutes to get up.

GUPTA: For millions of arthritis sufferers, Vioxx was the drug of choice, said to kill pain and reduce swelling all without causing the ulcers and stomach problems of other anti-inflammatories.

But there was a catch, reports starting in 2000 that Vioxx increased your heart attack and stroke risk. And just last week, its maker, Merck, pulled it from the shelves.

RAYMOND GILMARTIN, CEO, MERCK & CO.: The risk of a cardiovascular event did increase among those on Vioxx. Accordingly, we are voluntarily withdrawing Vioxx, effective today.

GUPTA: This cardiovascular risk was found in a study of Vioxx as a prevention for recurring colon polyps.

The number of heart attacks and strokes during the trial was small, the equivalent of 15 per 1,000 patients after three years, but still that was twice the rate of those taking a placebo in the study, and now the FDA is taking a closer look at similar drugs.

DR. STEVEN GALSON, FDA ACTING DIRECTOR, CENTER FOR DRUG EVALUATION AND RESEARCH: They may be totally OK. There's no indication with those other drugs, that there's going to be this same problem. But we'll be meeting with the companies to talk about the need for longer-term data.

GUPTA: As the government continues its research, patients and some doctors, like rheumatologist Alex Limmani...

ALEX LIMMANI, RHEUMATOLOGIST: I will be quitting cold turkey, yes.

GUPTA: ... are looking for what to do next.

LIMMANI: Everybody has a number of options available. So the loss of this drug isn't going to mean that people are going to be going without -- with unmet pain needs or without good alternatives.

(END VIDEOTAPE)

GUPTA: And alternatives and their safety is what we're going to be talking about today.

But first, the "Wall Street Journal" reported this week that a yet to be released study by the FDA and HMO Kaiser Permanente raised a major red flag about Vioxx.

The study looked at data from thousands of patients taking Celebrex and Vioxx and compared the number of heart attack deaths in both groups. Broadening those numbers out to the entire population, the searchers concluded that nearly 28,000 more heart attacks would have been avoided if patients had taken Celebrex instead of Vioxx. Again, these are not exact numbers but they certainly accentuate the cardiac risks of Vioxx.

Here to talk with us about Vioxx and alternative treatments is Dr. John Klippel. He's head of the Arthritis Foundation and a visiting professor at John Hopkins University. Thanks for your time.

DR. JOHN KLIPPEL, ARTHRITIS FOUNDATION: My pleasure.

GUPTA: What do you make of this study? You think this is -- the numbers seem pretty alarming.

KLIPPEL: Well, it's been an interesting week. The -- we've learned a lot about the risks of taking drugs, but we shouldn't lose sight of the fact that millions of people actually benefited from this drug.

And so for those people, this is a real challenge. The withdrawal was the right thing to do. But those people are now faced with a choice. Where do they go from here for their arthritis treatment?

GUPTA: And we're going to talk about the withdrawal, that whole process, whether it was done timely. With Vioxx being pulled, people are wondering about the safety of our drugs.

Here's what else is out there. In the same class of Vioxx are the drugs Celebrex and Bextra. They're both called Cox-2 inhibitors. Then there are other non-steroidal anti-inflammatory drugs. You've heard of these. They're known as inceds (ph), like ibuprofen, naproxen, sold as Aleve, and as well as acetaminophen, or Tylenol.

So what's safe and what's a good alternative to Vioxx?

Carol from the Virgin Islands asked this question: "Does Celebrex have the same side effects as Vioxx?"

You know, Dr. Klippel, they both have the same mechanism. So is the side effects going to be the same?

KLIPPEL: Well, it's interesting. That's an important question to ask.

But what we need to bear in mind, that this has been looked at. Once we first came aware of that fact that this problem was associated with Vioxx, it's been looked at extensively, particularly with Celebrex.

And I think that it's -- it's reassuring that I'm not aware of any clinical evidence this is a complication associated with other Cox-2 inhibitors.

That's not to say we shouldn't be vigilant, but I think that at this point, this has been looked at and it's rather reassuring.

GUPTA: Another question that comes up, is there any reason why someone would take a Cox-2 like Celebrex and Bextra when they could taking over the counter drugs, which are, of course, less expensive? Is that something that you tell your patients or you think about?

KLIPPEL: Well, the real advantage of Cox-2 inhibitors and the reason they were developed is, of course, reduce a serious side effect of other non-steroidal drugs, and that is their affect on the G.I. system. And that can include serious bleeding and ulcers.

So Cox-2 inhibition is an important advance in our ability to treat people with arthritis more safely.

GUPTA: Let's keep on topic here. We've got another e-mail now coming in, this from Faith in Tennessee, who writes, "I've been taking Vioxx about two years and would like to know what harm it may have down me already?"

So, doctor, we've been talking about the side effects, the cardiac risks, the stroke risks. What about someone who's been on it but hasn't had those problems? Do they need to worry?

KLIPPEL: Well, I think as best we understand the mechanism by which this might occur, once the drug is stopped, the actual risk associated with the drug actually goes away and diminishes. So I would tell Faith that at this point she doesn't face any other greater risk than anyone else.

GUPTA: And is it OK to stop this drug cold turkey, right? I mean, just stop it?

KLIPPEL: Well, it's OK. But the problem is that the signs and symptoms of arthritis, the pain and stiffness that was being relieved by the drug are going to return within 24 to 48 hours. So people are faced with a real problem once the drug is stopped.

GUPTA: And we're going to talk about some alternatives, some more of what people should do.

Probably our most common question we got asked was what to do now that Vioxx is off the shelf? Mary in Missouri writes, "I've been taking Vioxx since it came out and had no ill effects. The stuff worked like a charm. But I stopped taking it, and I'm already hurting. What do we do now?"

And that's what you just said, 24 to 48 hours, not surprising that she' already got some pain back. What do you tell her?

KLIPPEL: Well, for Mary this is an opportunity to begin to work with her doctor. And we would encourage people to really look at all the drug options and all the treatment options.

She's going to have to think about a drug to replace Vioxx. And you mentioned some of them. Acetaminophen or Tylenol is a pain reliever. Non-steroidal drugs, over-the-counter or prescription drugs.

But people shouldn't lose sight of the importance of things like exercise, diet. And for some people who really are impaired by arthritis, this might be the time to even begin to think about surgery.

So for many people this is an opportunity to reexplore, how can they best treat their arthritis?

GUPTA: That's a good point and for some people, Vioxx was sort of a last-resort drug. They did try a lot of these other drugs and then got to the Vioxx. And we'll talk more about that, as well.

When HOUSE CALL returns, our guest tells us what's on the horizon for treating arthritis? Stay tuned.

(BEGIN VIDEOTAPE)

ANNOUNCER: New options and better tools for treating a painful disease.

Plus, losing weight and eating healthy? Good for the heart, great for the bones. Surprising stats coming up.

But first, here's a tip from our health-conscience "Bod Squad."

CHERYL STRAHM, LIPOSUCTION STUDY PARTICIPANT: Oh!

COHEN (voice-over): About a year and a half ago Cheryl Strahm had 20 pounds of fat sucked out of her stomach. She did it to look better, and...

STRAHM: To lower my blood sugar, lower my cholesterol and lower my blood pressure. That's what I was hoping for.

COHEN: But it didn't turn out that way. Strahm's part of a new stud that found that having liposuction, even having lost of fat removed, like she did, does not help lower blood sugar, lower cholesterol or lower blood pressure.

DR. SAMUEL KLEIN, WASHINGTON UNIVERSITY IN ST. LOUIS: It's not just how much fat you lose, but how you lose the fat that's important.

COHEN: Doctor Klein says only diet and exercise actually reduce the fat in the liver and in the muscles which are important for health benefits. Liposuction doesn't touch that kind of fat.

Strahm says she's still glad she got the quick weigh loss with lipo. Now she's not looking for that quick fix but for a slow and steady weight-loss that will make her slimmer and healthier.

Elizabeth Cohen, CNN, Atlanta.

(END VIDEOTAPE)

(COMMERCIAL BREAK)

GUPTA: Welcome back to HOUSE CALL.

Weight-loss is just one of several ways you can help prevent or lessen the pain of arthritis. Others include working out. Regular exercise protects joints by strengthening muscles. Also, maintain a healthy diet.

Talking with us about all of these things, Arthritis Foundation head Dr. John Klippel.

Doctor, we've received lots of e-mails on this topic, as you know. You hear all these questions all the time.

A.J. in Connecticut asking, "What is your opinion on the treatment of R.A. with antibiotics?"

That's A.J., asking about R.A. What about that? Antibiotics in the use of rheumatoid arthritis?

KLIPPEL: Well, it's interesting. There are intriguing studies with minicycline (ph), which a tetracycline, not only in rheumatoid arthritis but recent studies in osteoarthritis that actually suggest it can relieve signs and symptoms, that has nothing to did with its effect on antibiotics. It's not part of the standard care of someone with arthritis but intriguing.

GUPTA: What is on the sort of horizon for the treatment of arthritis? We've obviously talked about Vioxx. That's sort of a last-line sort of drug. Are there new drugs that are coming out there? KLIPPEL: Well, I think particularly if we focus on a disease like rheumatoid arthritis, one of the more common and serious forms of arthritis, we're sort of in the beginning phases of a biologic revolution.

We're seeing -- we're seeing drugs developed through biotechnology that have had a profound impact on that disease. I think if we look ahead over the next 10 years we're going to continue to see biotechnology come to the forefront.

And, of course, developments are really dependent on our understanding of the arthritis. And that's why a continued investment in research so that we can understand arthritis better is really critical.

GUPTA: And we talk about prevention. The ultimate prevention might be a vaccine for arthritis. Is that a possibility? Is that something that could be developed in the future?

KLIPPEL: Yes. I think things like vaccines or gene therapy or tissue engineering are all things that are -- that people are actively working on right now. And I hope in our lifetime we actually see those things actually come to the clinic.

GUPTA: The next couple of decades, maybe?

KLIPPEL: I would hope in the next decade.

GUPTA: Well, all right. Our lifetime for sure.

We've got to take a quick break. More HOUSE CALL coming up.

(BEGIN VIDEO CLIP)

ANNOUNCER: From checking your risk factors to checking out your options, we'll show you where to click for arthritis help.

Plus, medical hot topics, like brother like sister. Could your sibling's heart history predict your heart health? Stay tuned for more HOUSE CALL.

(END VIDEO CLIP)

(COMMERCIAL BREAK)

(BEGIN VIDEO CLIP)

CHRISTY FEIG, CNN CORRESPONDENT: Having a family history of heart disease increases your risk for developing it. But a new study says that if your brother or sister has premature heart disease, that's a better predictor of your future risk than if your parents have it.

The study, released by the American Heart Organization, found that brothers and sister of heart disease patients were twice as likely to have calcium buildups in their arteries than those who only had a parent with the disease.

And women on hormone therapy may have double the risk of blood clots, says a new study in the "Journal of the American Medical Association."

Researchers found that in addition to increasing your blood clot risk in general, using the combined estrogen and progesterone hormone treatments also makes old age and obesity even more serious risk factors for future clots.

Christy Feig, CNN.

(END VIDEO CLIP)

GUPTA: Christy, thanks.

For more information on your options after Vioxx, go to www.arthritis.org. You're going to find the latest Vioxx news as well as treatment options.

Plus, click on "conditions and treatments" and take a quiz to check out your joint health.

We're out of time for today. I want to thank Dr. John Klippel.

Thank you very much for your time. I know you're busy. Appreciate it.

KLIPPEL: My pleasure, Sanjay. Thanks.

GUPTA: And thank you as well, all of you at home for all of your e-mails.

If you're looking to kick start an unhealthy lifestyle we're here to help. Apply to be a part of CNN's "New You Revolution" by going to "AMERICAN MORNING" show page on CNN.com. Scroll down to the bottom and click for more details.

Thanks for watching. I'm Dr. Sanjay Gupta. Stay tuned now for more news on CNN.

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