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Can the FDA Protect the Public? Agency Accused Of Approving Unsafe Drugs Under Pressure From Pharmaceutical Industry

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We take a look at the pharmaceutical industry, the FDA and the corporate influence on the drug approval process with Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group. [includes rush transcript]

The pharmaceutical industry is still reeling from one of its most devastating couple of days in recent history. On Sunday, drug giant Pfizer announced that it was pulling all advertisements for its popular pain reliever Celebrex. This came two days after the company admitted that studies showed high doses of the drug led to an increased risk of heart attacks. But Pfizer said it was keeping the drug on the market and the company says it will continue to market the drug to doctors. In addition to Pfizer’s announcement about Celebrex, drug companies AstraZeneca and Eli Lilly also disclosed serious problems with drugs of their own.

AstraZeneca admitted that tests show that its lung cancer drug, Iressa, did not prolong lives. And Eli Lilly warned doctors that, Strattera, its drug to fight attention deficit disorder drug has caused severe liver injury in at least two patients. The announcements resulted in the three companies losing a total of $30 billion in stock value. Then early this week, the Food and Drug Administration announced that yet another painkiller drug on the market might increase people’s risk of having a heart attack or stroke. The drug is manufactured by Bayer and is known as Aleve when sold over the counter and naproxen when sold by prescription.

Meanwhile, retiring Congressmember Billy Tauzin has announced he has accepted a $2 million post to head the country’s largest pharmaceutical lobbying firm PHRMA. The Center for Responsive Politics reports that the pharmaceutical industry donated more than $200,000 to Tauzin’s campaigns over the past 15 years. We placed a number of calls to both Pfizer and PHRMA asking them to join us on this program. They did not return our calls.

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

AMY GOODMAN: We placed a number of calls to Pfizer and Pharma asking them to join us for the program. They did not return our calls. But Dr. Sidney Wolfe did. He is director of Public Citizens Health Research Group, and joins us in the studio in Washington DC. Welcome to Democracy Now!

DR. SIDNEY WOLFE: Nice to be with you again, Amy.

AMY GOODMAN: It’s good to have you with us. Well, talk about what we are seeing over these last few days. Let’s start with the pain relievers.

DR. SIDNEY WOLFE: Well, the pain reliever story actually goes back about four years, when a study showed that Vioxx, now off the market a couple of months or so, was five times more dangerous than Naproxen, this drug that might cause problems but probably doesn’t anywhere as near as Vioxx. So four years ago, a study showed that the rate of heart attacks in people taking Vioxx was five times higher than people taking Naproxen. We asked the FDA back then to put a black box warning, warning people about this. If they had, the number of people using Vioxx would have gone way down. At the same time, another study caused concern about FDA documents about Celebrex. It didn’t cause a five times increased risk, but there were more blood clots in people using Celebrex. It goes back then and then fast forward to more recently, another study on Vioxx comparing it to a sugar pill, a placebo, shows a doubling of heart attacks and strokes, and another study on Celebrex comparing it to a placebo shows a two to three-fold increase in heart attacks. During the four years, instead of having a box warning deterring most, if not all people from using the drug, the FDA sort of sided with the industry, didn’t do anything, Vioxx is now off the market, Celebrex should be off the market. We are concerned that some nefarious deal has been cut between the FDA and Pfizer who makes Celebrex to say, okay, you ban direct to consumer advertising and we won’t ban your drug. We’re talking about a couple of billions of dollars of sales. A lot of this goes back 12 years when Congress foolishly passed a law called the Prescription Drug User Fee Act which allows or requires direct cash funding from the drug industry to the FDA. Since that law went into effect, something like 700 to 800 million of cash have gone directly from the industry to the FDA, for the drug review process. If people don’t think this affects the attitude that the FDA has toward the industry, they are delusional. And there’s no question that during the same period of time, there’s been a much kinder and gentler FDA towards the industry, but during the same period of time, there have been an unprecedented number of drugs that shouldn’t have come on the market that did, or in the case of Vioxx and Celebrex which looked okay when they came on the market, but a few months later, looked quite dangerous, weren’t taken off the market or weren’t the subject of black box warnings. There’s a whole culture shift at the FDA, and one of the reasons as I mentioned is that the direct funding from the industry. The other is up until the hearing by Senator Grassley a few weeks ago, there’s been almost no congressional oversight. The purpose of having tri-part system of government with the judicial, legislative and the executive is for the branches to oversee each other. And in the 1970’s and 1980’s, not a month went by without a significant Senate or House hearing saying why did you put the drug on the market, why didn’t you take it off the market more quickly. Senator Grassley’s hearing is noteworthy, because it’s the first hearing of that kind in 15 years. Direct cash from the industry and almost no congressional oversight has driven the FDA literally into bed with the industry.

AMY GOODMAN: We’re talking to Dr. Sidney Wolfe, head of Public Health Research Group. Congress member Billy Tauzin, can this also explain some of what we’re seeing, going from being Congress member to getting $2 million to head up the pharmaceutical industry’s lobbying arm?

DR. SIDNEY WOLFE: Well, if the pharmaceutical industry wasn’t already powerful enough, and what we’re talking about is over 600 lobbyists in Washington for the drug industry, way more than the total number of members of Congress. If that wasn’t already a problem and it succeeded in getting a little sentence stuck into the Medicare Drug Reimbursement bill that says you cannot negotiate or control prices, it’s going to be even more ominous for the American public to have a very influential former member of Congress there, heading up the main trade association, able to go back to his former buddies on the Hill and say [snap] “do this,” [snap] “do this,” [snap] “do this.” There’s been enough “do this” already, and I’m just concerned that it will be more. I mean, we are supposed to live in a democracy. When you have an industry so dominating the scene in Washington, both at the level of the congress and then literally at the FDA, where they are funding the majority of the FDA review functions, watch out. What needs to happen is a repeal of this law that has the industry funding the FDA. For the first 86 years of the FDA existence, the appropriations came through Congress as they should. It’s the last 12 years it’s an aberration. The other thing is the restoration of the level of scrutiny that the House and Senate exerted in the 1970’s and 1980’s. We were critical of the FDA in those decades, but make no mistake, the amount of criticism, the number of mistakes has just rocketed up during this period of time of direct funding by the industry to the FDA.

AMY GOODMAN: Last night, Peter Jennings of ABC News report on Aleve was framed by asking “Was this too soon; were they premature in questioning Aleve?” What do you think about this? I think people a lot of people were shocked around the country.

DR. SIDNEY WOLFE: Well, I think everything needs to be put in perspective. There are two clear, unequivocal studies, one on — two on Vioxx actually–and one on Celebrex showing a two-field, three-fold or more risk in huge numbers of people. The study that I mentioned earlier involved 8,000 people. The results are statistically significant and very clear. We don’t even know yet the results on the Aleve study because the government that did the study hasn’t revealed them. All they say is there may be a 50% increase in heart attacks. Contrast that to a doubling of heart attacks, a tripling of heart attacks, and contrast it to the fact that these studies on Celebrex and Vioxx are clear, unequivocal, this one may be, may be not. If you had your druthers, you would stick with the drug that has a lower risk, if any. The government has admitted that the increased risk may not even be a significant one. I think it’s premature to put restrictions or suggest restrictions on Aleve that are actually more severe than the restrictions that have been suggested for Celebrex, a drug that is far more dangerous and for which there is much more evidence of harm. I am — what I am concerned is that much to the delight of Hank McKinnell, the president of Pfizer and Pfizer stockholders, FDA’s action concerning Aleve will take the pressure off of Pfizer, and off of Celebrex, and the FDA may be admitting by virtue of its Aleve announcement and trading off a ban on direct consumer advertising for a ban on the drug, that they’re going to side with the company. It’s interesting that after a number of days of steady falls in the stock of Pfizer, yesterday with the Aleve announcement coming, it started going back up. Well, that may be pleasing for Pfizer and the stockholder, but what about the people that are still using Celebrex, a drug that shouldn’t be on the market? As I said in the introduction, we have a book called, Worst Pills, Best Pills, which will in the next few days be in the bookstores and a website called worstpills.org. We list 181 drugs including Celebrex, Vioxx, a birth control pill called Yasmin, a recently approved cholesterol-lowering drug called Crestor, which should never have been approved. The problem is that the FDA is not doing its job. It is nowhere near as vigilant as it used to be and as it should. Otherwise, what is the purpose of having a government regulatory agency which is just sort of a front for the industry and does more with the industry wants than what the public wants. The FDA is technically part of the public health service; that’s literally what the block diagram shows. The behavior, particularly the last five or ten years, makes it look like the FDA is part of the drug industry protection service.

AMY GOODMAN: Can you explain, Dr. Sid Wolfe, how these drugs work? How does Celebrex work? How does Aleve work? Vioxx?

DR. SIDNEY WOLFE: Yeah. Let’s go back to the promise of these super-aspirins as Vioxx, Celebrex and a newer one, Bextra also made by Pfizer which also causes heart attacks. How they work. The difference — the difference according to all of the hype before these drugs came on the market, was that unlike the older drugs, like Aleve or aspirin or ibuprofen (Motrin), these drugs didn’t harm the gastrointestinal tract, didn’t cause ulcers, perforations and bleeds. It turned out that for Vioxx that was probably true, but a four-fold risk in heart attacks clearly offsets that. It turns out for Celebrex, although that’s how it was hyped, that when the study was done after it came on the market, it didn’t protect the gastrointestinal tract at all, compared with the older drugs. The same was true for Bextra. You have newer drugs that really got hyped and pushed onto the market on the grounds of something that turns out not to be true. For the two that are left, Bextra and Celebrex, there isn’t any evidence that they’re gentler on the gastrointestinal tract. In fact, for some of the pain uses, there isn’t evidence that they are as effective as the older, more traditional, and often available over-the-the counter drugs. So, the promise of these new so-called COX-2 inhibitors was gentler on the gut and at least the two on the market aren’t gentler on the gut. The way they work–they are anti-inflammatory drugs. They fight inflammation and they do cause some relief of pain, including pain from arthritis. But if they aren’t — even as good as for some reasons, pain, and no better than for arthritis, what is the point of having them around? I think the question that we ask over and over again for these or any other drugs, is there clear evidence that the benefits outweigh the risk. Is there some unique property of the drug, other than the unique danger. If there is good evidence that the benefits outweigh the risk, doubling and tripling of heart attacks is good evidence that the risks outweigh the benefits, and if there is no unique benefit, not as good as or certainly no better for pain, why are these drugs on the market? Now, for Vioxx and Celebrex, when they were approved, it looked like they were at least as good as, for many reasons, the older drugs, and is it was thought they were gentler on the stomach. Five months after they came on the market, these studies came out showing a four or five-fold increase in risk of heart attacks for Vioxx. The FDA didn’t put a black box warning on. We advised people in the Worst Pills, Best Pills newsletter, now worstpills.org and in the book, don’t use Celebrex, don’t use Vioxx three-and-a-half years ago. So, there was enough evidence for us, internal FDA documents and so forth, to warn. The question is why isn’t the government using its own evidence to either warn people adequately or when time comes, take a drug off the market. I think it’s too close to the industry is the answer over and over again.

AMY GOODMAN: So, what should people do? How do people, for example, deal with the pain of arthritis?

DR. SIDNEY WOLFE: Well, at a collective level, people should insist from their Senators and Congressmen–and Congresswomen–that there be a reinstitution of oversight over the FDA, so that the mistakes that have been increasingly occurring diminish. At a personal level, people really need to watch out. We published a study two years ago in the journal of the American Medical Association looking at every drug approved during a 25-year period from 1975 to 2000. And the research question of the study was how often are newly approved drugs either taken off the market, or are they subject of a new black box warning for danger that wasn’t known or revealed at the time of approval. It turns out that one out of every five drugs that are approved, within about a 20-year period, either are taken off the market, or more commonly, are the subject of a black box warning. What advice we have from all of this, because most of these drug bans or black box warnings are in the first seven years after a drug comes on the market, is don’t use any new drug unless it’s a breakthrough drug. None of the drugs we’re talking about are really breakthrough drugs. Don’t use any new drug for seven years, because it’s during that period of time that you might unwittingly be a guinea pig for a drug that’s going to be banned or the subject of a black box warning. I think that’s safe advice, except for the breakthrough drugs. The breakthrough drugs, which have been put on a faster track, that’s worked quite well. The US was the first country to approve most, if not all, of the AIDS drugs, and a number of other drugs. The problem is not with the breakthrough drugs, it’s with the 20th painkiller, it’s the 80th drug for treating high blood pressure. Look at the ads and see the frantic efforts to make it appear that a drug that isn’t any better is better.

AMY GOODMAN: Dr. Wolfe, I wanted to ask you about a piece in the Washington Post that came out a few days ago. It said almost one-fifth of the Food and Drug Administration scientists surveyed two years ago as part of an official review said they had been pressured to recommend approval of a new drug despite reservations about its safety, effectiveness or quality. The survey of almost 400 scientists also found a majority had significant doubts about the adequacy of federal programs to monitor prescription drugs once they’re on the market, and more than a third were not particularly confident of the agency’s ability to assess the safety of the drug. The results of the survey conducted by the Department of Health and Human Services inspector general appear to support some portions of the controversial senate testimony last month by FDA safety officer, David Graham, the 20-year agency veteran, who told the senators that the FDA was unable to keep some unsafe drugs off the market, and that scientists who dissented about drug safety and effectiveness were sometimes pressured and intimidated. Graham’s testimony at a hearing into the sudden withdrawal from the market of the arthritis drug Vioxx, put a spotlight on the FDA’s safety and management record. Top FDA officials later criticized Graham’s testimony as inaccurate and unscientific, but the survey results indicate some other agency scientists share similar views. Dr. Wolfe.

DR. SIDNEY WOLFE: The study that was done by the inspector general was in some way a follow-up to a study we did in 1998. We were getting very concerned in 1998, as this law having the industry fund the FDA was being cranked into full force, that a number of drugs that we were told should never have been approved were approved, and then after they killed or injured enough people, they were taken off the market. So we did a survey of FDA physicians, the physicians who review new drug applications. And these are what the findings were in our survey. They identified 27 drugs that they thought were too dangerous to be approved, but which were approved over their objection. They identified 14 instances where they were told not to present information adverse to a drug at a public FDA advisory committee hearing because it might prejudice the advisory committee against the drug. Not to mention that the drug company at the same hearing does everything to prejudice the committee in favor of a drug. So, the climate at the FDA even back in 1998 was silencing criticism, people were leaving the FDA in droves, scientists, physicians and others, and that has continued. The FDA did an internal survey after ours which came pretty much to similar conclusions. And then the third of the survey, the inspector general one in 2002, reached the same conclusion. So Dr. Graham is not alone. There are a large number of people in the FDA, who are there trying to protect the public health as part of the public health service, but being pushed around, I think, because of the influence, the undue influence of the drug industry, to sign off on drugs that they know are too dangerous. An example, fairly recently, is the very popular diet drug, Meridia. It’s an amphetamine-like drug. The physician at the FDA who reviewed it said, it’s too dangerous, it shouldn’t be approved. The advisory committee at the FDA that reviewed the drug said it’s too dangerous, it shouldn’t be approved. What happened? It was approved, and since then, there are dozens of deaths from heart attacks and other cardiac problems, in people often in their 20’s and 30’s and 40’s from this drug. There’s no evidence in the long term this or any other diet drug really prevent people from dying, and there’s evidence in the short term. So here’s a concrete example of a drug that should never have come on the market, but the medical decision of the physician at the FDA and the FDA’s advisory committee were overturned. It’s a drug that we have petitioned FDA to take off the market. It’s another one of the 181 drugs in our book, Worst Pills, Best Pills or the website worstpills.org, that we say do not use. And we explain why it shouldn’t be used. So, the culture at the FDA is really wonderful from the industry’s perspective. The last commissioner, Dr. Mark McClellan was probably the most popular FDA commissioner in the 33 years that I have been doing the work, with the industry. On the other hand, to be popular with the industry is to raise a really red flag as to why the industry likes the FDA so much.

AMY GOODMAN: Dr. Sid Wolfe, I want to thank you very much for being with us. Head of the Public Citizen’s Health Research Group, his book will soon be out, called, Worst Pills, it’s the updated edition.

DR. SIDNEY WOLFE: Worst Pills, Best Pills–it will be in a few days or so.

AMY GOODMAN: The Web site, worstpills.org. This is Democracy Now!

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