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2005-02-22

Good Pills, Bad Pills: Dr. Sidney Wolfe Condemns FDA Advisors For Backing the Sale of Vioxx, Celebrex and Bextra Despite Known Dangers

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The FDA panel proposed that the drugs be sold with an FDA "black box" warning. Vioxx is now expected to return to the market even though nearly half the FDA panel voted against it being sold. Its manufacturer Merck voluntarily withdrew the painkiller drug in the fall. Studies have show as many as 55,000 people may have died from taking the drug. [includes rush transcript]

A Food and Drug Administration advisory panel has voted to allow doctors to keep prescribing the popular painkillers Vioxx, Celebrex and Bextra even though the panel overwhelmingly agreed that the drugs significantly increase the risk of cardiovascular problems in patients.

The panel proposed that the drugs be sold with an FDA "black box" warning. Vioxx is now expected to return to the market even though nearly half the FDA panel voted against it being sold. Its manufacturer Merck voluntarily withdrew the painkiller drug in the fall. The FDA panel decided whether a drug should be allowed to be sold on a straight majority vote.

The vote for Vioxx was 17 to 15. For Bextra, 17 panelists vote for the drug and 13 voted to ban it. The panel nearly unanimously recommended Celebrex remaining available.

Last year FDA whistleblower Dr. David Graham publicly estimated that 139,000 Americans who took Vioxx suffered serious side effects. Of these users he estimated that the drug killed between 26,000 and 55,000 people.

The FDA is not required to follow the recommendations of the panel, but generally does so. Minutes after the announcement, Merck stock shot up nearly 12 percent on the New York Stock Exchange. Pfizer shares rose by 5.6 percent.

We are joined in Washington by Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group.

  • Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group.

Transcript

This is a rush transcript. Copy may not be in its final form.

AMY GOODMAN: We’re joined by Dr. Sid Wolfe, Director of Public Citizen’s Health Research Group. He joins us in Washington. Welcome to Democracy Now!

DR. SIDNEY WOLFE: Good morning, again, Amy.

AMY GOODMAN: It’s good to have you with us. Your reaction to — and explain exactly the significance. It’s not the FDA decision, now, but an advisory panel?

DR. SIDNEY WOLFE: Well, the FDA usually pays attention to what its advisory committee says. I actually testified at this hearing last week, and one of the most appalling things was the extent to which the FDA did not adequately inform its advisory committee about the risks. For example, a study published over four years ago showed that Vioxx increased the risk of heart attacks four times above that of Aleve or Naproxen. The FDA presentation of that study at the meeting last week made it sound like: Well, we don’t really understand what this study’s about; it’s not clear that the problem was just Vioxx. So, if I were on that advisory committee, and all I knew was what the FDA presented, I might have voted in the close way (except for Celebrex) that they voted last week. We actually filed a petition on January 24th to ban both Bextra and Celebrex, and we asked for the black box warning that is now being said to be the remedy. We asked for a black box warning over four years ago on both Vioxx and Celebrex. So, there is some serious problem between what the medicine and science shows, and what the FDA is telling its advisory committee, what its advisory committee is then feeding back to it based on inadequate information, and what may well happen. I think the large problem is (and these estimates are probably at the low end), there are a 100,000 people killed every year in the United States from adverse drug reactions, and an additional 2.1 million seriously injured enough so that they have to go to the hospital in most of the instances. And the question is: What’s being done about it? It is estimated between — to be between the fourth and sixth leading cause of death in the United States. A lot of it is preventable. If there are safer alternatives to take and people are instead — because the doctors are telling them to do it because the ads on television are telling them to do it — are taking the more dangerous alternatives, then preventable lives are being lost and serious preventable injuries are going on.

I ask rhetorically, because that’s about all it can be described as: Does it make a difference that this year, 2005, the pharmaceutical industry will give the FDA $150 million in cash directly from the industry to the FDA to run their drug review process. Unless you believe that money doesn’t talk, then this very insidious law that has been in effect for 12 years has really put the FDA in a position of being sort of a handmaiden in many ways of the industry. Decisions — I mean, we were never uncritical of the FDA; but since 1992, when what is called the Prescription Drug User Fee Act passed, the FDA has been much kinder, much gentler, much less vigilant with respect to the pharmaceutical industry; and I think that this case study last week taking a look at these three drugs — Vioxx, off the market, as you said, for a few months, but now very possibly going back on the market, Celebrex and Bextra, which should come off the market — the distorted decision-making and informing that went on last week is terrible. We found that a major study showing a significant increased risk in heart risk for Celebrex was finished five years ago, suppressed by the company, Pfizer, for a number of months, and then sent to the FDA almost four years ago. This study was just sort of mumbled over last week. The FDA disclosed the results of the study for the first time (even though it had it for almost four years) at this meeting last week; and they just sort of spent a few seconds going over the results. So, there is also some possible corruption going on here with respect to Pfizer sitting on this study for a while, the FDA sitting on it for a longer time. Had this study been fully explained and put into context of the other known risks of Celebrex, the vote never would have been 31-1, in favor of Celebrex staying on the market. So, the whole process is corrupt, to say the very least; and the people that suffer are the American public. The drug industry, understandably, is trying to sell drugs, and the FDA doesn’t bother very often to enforce the laws on false and misleading advertising; and so what people see on television, what doctors see in their office, with respect to the risks and benefits of drugs, are wrong. But the FDA is supposed to be representing the public. The FDA, though, getting money from the drug industry, is not putting out accurate information. A few days ago, in the wake of this hearing, the FDA said: 'Oh, from now on, we're going to be telling people right away about the risks.’ They aren’t. The book we have been putting out for a while, the new edition which just came out a few weeks ago, is called Worst Pills, Best Pills; and we’re informing people about the benefits and risks of drugs. We list 181 drugs including Vioxx, Celebrex, Bextra, that we say: Don’t use. We have information that we dig out of FDA files from published studies, and so forth. We don’t take money from the drug industry and, unlike the FDA that does take money from the drug industry, we can say what we want and what is merited on the basis of science. So, the American public is really being misinformed. Physicians are being misinformed. The idea that Vioxx may go back on the market, given that it causes a four to five-fold increased risk of heart attacks and strokes and so forth, is outrageous. It has no unique benefits, and it has unique risks. I mean, our algorithm for looking at all these drugs is: Do they have a unique benefit? If it’s a unique life-saving benefit to cancer or something and it has risks, but the benefit outweighs the risks, that’s a different story.

AMY GOODMAN: Sid Wolfe, we have to break, but we’re going to come back to you. Dr. Sid Wolfe, author of, along with a group of other people at the Health Research Group, Worst Pills, Best Pills: A Consumer’s Guide to Avoiding Drug-Induced Death or Illness.

[break]

AMY GOODMAN: We talk to Dr. Sid Wolfe about the latest news of the advisory panel and let’s just clarify this, saying that Vioxx can go back on the market, Celebrex and Bextra as well, is that right?

DR. SIDNEY WOLFE: Yes. Celebrex and Bextra are on the market now, and they’re saying Celebrex and Bextra are okay to stay on the market, even, as you pointed out a few minutes ago, all three drugs have clear evidence of increased heart attack risk, which is evidence not present for any of these older drugs on the market, if there are older drugs that are just as effective. In some cases the older drugs are more ineffective. Bextra was turned down by the FDA for approval for acute pain, because it didn’t work very well. So that in some sense, the pain relieving properties of these newer drugs may not even be as good as the older ones. They’re more expensive, more dangerous and no more effective. Why would anyone take them? Advertising promotion, the imprimatur of the FDA, its misinformed advisory committee because the FDA sort of loaded the deck of cards at this meeting last week. As we mentioned, a lot of this information is in our book, Worst Pills, Best Pills. We also have a website, worstpills.org, which has the entire contents of the book, and if you sign up for it, you get bulletins every week, two weeks, three weeks, as we find out some new disaster that the FDA should be telling people about, but is not telling people about.

AMY GOODMAN: You have 65 new "do not use" drugs. What are "do not use" drugs, Dr. Wolfe?

DR. SIDNEY WOLFE: Well, most of the drugs in the book are not "do not use" drugs, but of the 538 drugs in the book, 181 of them are "do not use" drugs. In almost all cases these are drugs that have unique risks but are no more effective than existing drugs. They’re often newer drugs. We did a study a few years ago which we published in the Journal of the American Medical Association, showing that in the first seven years after a drug comes on the market, the chances are very high that it will either have to have a new black box warning or be taken off the market. So we advise people, don’t use any new drug, unless it’s a breakthrough drug, which are very few drugs, for the first seven years. Our 181 "do not use" drugs which include, as I mentioned, Vioxx; Celebrex; Bextra; a birth control pill, Yasmin; a very heavily promoted $1 billion promotion campaign, cholesterol lowering drug, Crestor; a largely worthless drug for treating Alzheimer’s Disease, Aricept; Serzone, an antidepressant; a weight reduction drug, Meridia. So most of these 181 drugs, safer alternatives that are just as effective or more effective and often the safer alternatives are much less expensive. On any page in the book where it says "do not use," for instance, Crestor, the cholesterol lowering drug, it says, "do not use," it says, see page 180 for the preferable alternative, which are other cholesterol lowering drugs in addition to diet and exercise. So, we are not anti-drug, we’re just anti-dangerous drug. Unlike the FDA and the industry, we’re actually warning people with evidence on why these drugs are so dangerous.

AMY GOODMAN: Dr. Wolfe, this is a test. It’s actually at the beginning of the introduction. It says a 40-year-old woman who dies from a heart arrhythmia. A 58-year-old man who has just developed Parkinson’s. A 68-year-old woman with a hip fracture. A 63-year-old woman with memory and ability to think clearly slipping, according to her daughter. A 62-year-old man with recent onset of extreme dizziness and occasional fainting when he first gets up. A 52-year-old woman who dies while having some dental work done. What do all of these people have in common?

DR. SIDNEY WOLFE: The point of these examples, and these are all actual examples that were brought to my attention, and fortunately, in most cases, other than the ones where the people died, these are reversible, if you pick them up early enough. These are adverse drug reactions. A lot of people think that when they have a disease, and they take a drug, and something new develops, that it’s the course of their disease. We list in this book 160 drugs that can cause depression, 130 drugs that can cause sexual dysfunction. A lot of men were taking Viagra and Cialis actually have adverse drug reactions to other drugs that are making them impotent. It would seem to be more sensible to try and adjust these other drugs rather than layering on a second drug to treat what is an adverse drug reaction. I remember when we first started working on this issue, a woman came to me who had a low thyroid level and she was put on thyroid medicine. A good idea. The problem is her dose was too high and she was taking it right before she went to bed. What was happening is she couldn’t go to sleep because thyroid has sort of upper qualities. So instead of figuring out what had happened to her that she couldn’t go to sleep, they prescribed a sleeping pill. The sleeping pill helped her to go to sleep, but it made her depressed, because sleeping pills are one of our 160 drugs that cause depression. Instead of figuring out that the depression had started after the sleeping pill, they prescribed an anti-depressant. So here was a woman who had a cascade of drugs being used to treat adverse drug reactions. I talked with her and arranged to lower the dose with her doctor, of course, of the thyroid medicine, to take it early in the morning and she stopped having trouble going to sleep. So she stopped needing to take a sleeping pill, and therefore, she stopped being depressed, and therefore, she stopped needing an anti-depressant. This is not an uncommon story. The falls and hip fractures that account for one out of every seven hip fractures in older adults are caused often by prescription drugs that lower the blood pressure so far that someone falls. There are dozens of drugs that can cause Parkinson’s Disease. A 65-year-old man goes to his doctor and says, I have a little tremor, and the doctor said, well, you know, you’re 65, it looks like you’re getting Parkinson’s Disease, let’s prescribe a drug for treating Parkinson’s Disease. Later on, someone puts two and two together and figures that this guy’s Parkinson’s Disease started right after he starting using a drug for his gastrointestinal tract called Reglan. And so, instead of treating what is a drug induced disease, Parkinson’s in this case, they removed the other drug that was causing it. So aside from everything else in this book, the 181 "do not use" drugs, we have a whole chapter devoted to drug induced disease. In consultation with doctors when the patient and doctor realizes that the start of this disease really started after they started a drug, a lot of this can be reversed. Memory loss in older adults is very, very often related to the use of tranquilizers, sleeping pills and other drugs. And it’s a tragedy to sort of write it off, to say, well, this person looks like they’re getting early Alzheimer’s Disease when that particular problem can be completely reversed if someone stumbles on it. So we’re talking, as I said before, of 100,000 deaths a year, and 2.1 million serious injuries from adverse drug reactions. It’s a leading cause of death and disease in this country. The FDA and the drug industry are only telling you the good news about drugs. Let us be very clear. Prescription drugs can make a huge difference in people’s lives, improve their health and everything. That can happen without all of the death and injury that’s caused by unnecessary prescriptions of unnecessarily dangerous drugs.

AMY GOODMAN: We’re talking to Dr. Sid Wolfe. He’s with Health Research Group. He is head of it, also one of the authors of Worst Pills, Best Pills: A Consumer’s Guide to Avoiding Drug-Induced Death and Illness. I was shocked to read that 100,000 people die a year of wrongly prescribed drugs. Now, that is — is that — tell me how many people that is a day?

DR. SIDNEY WOLFE: Well, the 100,000 is all adverse drug reactions, and a large proportion, not necessarily all, but a large proportion of them are drugs that could have been substituted for a safer drug, or in some cases for no drug. Let’s just say a safer drug. As I say in our book, every time we say, don’t use this drug, there’s a safer drug going on. I mean, if we had —

AMY GOODMAN: It is shocking, though, 273 about, almost 300 people a day die in this country?

DR. SIDNEY WOLFE: Right. No. That’s absolutely right. A lot of these are preventable. And a lot of these are younger people. Not that older people dying unnecessarily is not an equal tragedy, but a lot of younger people are getting seriously ill, being hospitalized. I mean, this weight reduction drug, Meridia, has caused the deaths of people in their 20s, 30s, and 40s. It’s a drug that has amphetamine-like properties. The doctor at the FDA who reviewed this drug in the 1990s said it’s too dangerous, it shouldn’t be approved. The advisory committee in this case properly informed voted against approving this drug, Meridia. The FDA, under pressure from the drug industry, approved it, and since it’s come on the market, there have been dozens of deaths and a much larger number of people with non-fatal heart attacks, strokes and so forth from this drug. So here is an example of a problem over being overweight, which really can only be dealt with seriously in a long term basis by eating a little bit less and exercising a little bit more. But drugs are put out that have no evidence of any long term benefit, and have clear evidence, even before they’re approved, of short term risks. There are wonderful people, scientists, physicians, Dr. Graham is one of dozens, who are trying to do their job in the FDA, but they’re getting sort of run over by the forces at the top of the FDA that are financed by the drug industry, but 100,000 deaths a year. You think of this as way more by factor of two-and-a-half than the people dying in automobile accidents. It’s way more than the people dying a year for AIDS. It’s one of the leading causes of death. Tragically, it could be prevented, and it is not. It affects people of all ages.

AMY GOODMAN: Dr. Sid Wolfe, last week, responding to widespread criticism of the government’s handling of drug safety problems, the FDA announced it was creating a board to advise it on drug complications and to warn patients about unsafe drugs. Lester Crawford, the acting commissioner, said the board would be made up of scientists drawn from throughout the federal government. The board, which is to make its conclusions public on a webpage, will not have independent power to force the withdrawal of drugs but will simply advise the FDA. He also said, Dr. Crawford, in addition, the agency will soon tap into large databases, including those at the Medicare agency, to uncover dangerous side effects in drugs already on the market. The agency said it would increase the number of fact sheets that patients receive with prescriptions. Your response?

DR. SIDNEY WOLFE: Well, a couple of responses. There are over 100 people in the FDA whose job it is to look at what happens to drugs after they come on the market. It’s called the Office of Drug Safety. This office has been rendered impotent because a much larger number of people funded by the industry, are there to say, we made the right decision when we put this drug on the market, and you’re not going to tell us that this drug is too dangerous. There is absolutely no plan to alter the serious and dangerous imbalance of power between those who look at drugs after they come on the market, the Office of Drug Safety, and the much larger part of the FDA and the leaders of the drug division of the FDA. So instead of making a fundamental change in the power relationship between the Office of Drug Safety and the rest of the drug division, they’re putting up this smokescreen outside advisory committee that’s going to report to the same people that are suppressing decisions from the Office of Drug Safety. It is not going to have any independent authority to do anything, and it’s going to provide some patina for an FDA that says the same. I have been following these issues for 34 years. The Office of Drug Safety has had three or four different names while I have been there, because whenever a crisis comes up, instead of actually doing something, they change the name. This time, they’re leaving the name the same, but putting in place an outside group that’s going to be dependent on the FDA for information, and they’re certainly not going to do anything bolder than what the bosses at the FDA, funded by the drug industry, want them to do. Dr. Crawford who has been nominated for commissioner cannot do a good job. He has worked for the drug industry. He is beholden in many other respects to industries such as the food industry. He had a miserable record because much of last four years, he was the acting commissioner. He was the acting commissioner when FDA decided not to put a black box warning on Bextra and Vioxx and Celebrex four years ago. He was the FDA commissioner during most of the time when the FDA let the death toll mount and mount on Ephedra, this dangerous dietary supplement. So his record as acting commissioner is terrible. There’s no reason to think his record as commissioner is going to be any better.

AMY GOODMAN: When you go into the drugstore and you get a prescription filled, and you ask the pharmacist for the insert, because you cannot see it, it comes — you get your little pill box, you know, the little plastic container, but that goes — that comes in the actual container. There’s a couple of things they can give you. They can give you the insert, or they can pull something off of their own computer. Can you explain the difference?

DR. SIDNEY WOLFE: Ninety-nine percent of the time, when a patient goes into the drugstore and gets a prescriptios filled, they get something called a patient information leaflet. These have been studied by the FDA and found to have extraordinarily incomplete, inaccurate, and dangerous information in them. The FDA has no control over the content of these leaflets. What the FDA does have control over is the actual, as you said, package insert that goes with the drug, or is in what many people know as the Physician’s Desk Reference, the P.D.R. We have been pushing the FDA, I think for 22 years to start taking control of the kind of information that is in these leaflets. For about a dozen drugs, right now, the FDA does dictate what’s in the leaflets, and maybe what is being said by Dr. Crawford is that it will go up to two or three dozen. For the other thousands of drugs, the same kind of inaccurate information is going to keep going up. The kind of information that we have in our book, Worst Pills, Best Pills, and it’s on our website, worstpills.org, is an attempt to fill in the gaps that are missing in the information in these patient information leaflets, in the information that is put out in drug ads, and in the information that the FDA makes public. The FDA is talking in a desperate situation because they’re beginning to get congressional oversight, which they haven’t had for fifteen years. They’re beginning to talk about doing all kinds of good things. I don’t believe it, because as long as they are taking $150 million a year from the drug industry to review drugs, they’re going to be giving the drug industry their money’s worth. So that, by and large, what people get when they get their prescriptions filled is information that is inaccurate enough that it may cost their lives. We actually on behalf of a now dead nine-year-old child named Corey Christian, on — with his parents, we asked the FDA to start putting out a much larger number of accurate leaflets. That was a few years ago, and the FDA are still sort of siding with the medical profession and with the pharmaceutical industry and pharmacists, and not putting their imprimatur on this otherwise misleading information that is going out there.

AMY GOODMAN: Finally, Dr. Wolfe, what is the number one recommendation you have to people who are in the hospital, or go to their doctor? What should they say? What should they be aware of? People have just an implicit faith in their doctors, and they trust that they’re doing the best for them.

DR. SIDNEY WOLFE: I don’t think doctors maliciously do things. I think that doctors become very misinformed about prescription drugs. A very tiny amount of time is devoted in medical school or residency to train doctors to be suspicious about any new drug, unless it’s a breakthrough drug. So, I think the number one piece of advice which we discuss in detail our website, worstpills.org and the book Worst Pills, Best Pills: Don’t use any new drug. If someone is prescribing a drug for you, ask when it came on the market. If it is not a breakthrough drug say you’d rather have an older drug, because the older drugs have passed the hurdle of the first seven years. They’re still on the market and they have not yet presumably had a black box warning, or if they have at least we know something about them that we didn’t know in the first seven years. People need to be very cautious. The FDA is not functioning as it should be to protect the public from the pharmaceutical industries excesses. It seems to be acting more as a health agency to protect the financial interests of the pharmaceutical industry and they’re misinforming doctors. So, just be very cautious about any new drug that comes on the market; and when you take a new drug, if some course — some change occurs in your illness, the first suspicion should be: It’s an adverse drug reaction, until proven otherwise, and call your doctor. Because too many cases — in too many instances, that’s exactly what it is, and instead of thinking: Well, your disease isn’t responding, we should increase the dose of the drug, it may be that the drug that’s causing this new symptom, whether it is falling down or your blood pressure falling out, or Parkinson’s Disease, or other kinds of serious problems. Loss of memory. So, be very, very cautious.

AMY GOODMAN: Dr. Sid Wolfe. On that note, I want to thank you very much for being with us. Your book, Worst Pills, Best Pills: A Consumer’s Guide to Avoiding Drug Induced Death or Illness. Dr. Sid Wolfe is the head of Public Citizen’s Health Research Group.

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