ANNOUNCER: Now from New York's Grand Central Station PBS's David Brancaccio.
DAVID BRANCACCIO: Welcome.
See all those people behind me heading to and from work? If they're a representative sample of the U.S. population, nearly half of those folks are on some kind of prescription drug. And you can bet every darn one of them wants that medicine to be as safe as possible. But deadly things can happen when the agency that's supposed to watch over that medicine works too closely with the big money companies that make the medicine. Bryan Myers prepared our report.
Life changed for 80 million people around the world on September 30th, 2004. That day, they discovered a painkiller they had taken could've killed them. The chairman of one of world's most venerable drug companies, Merck, had stunning news.
RAYMOND GILMARTIN: We are announcing a voluntary worldwide withdrawal of Vioxx.
BRANCACCIO: Merck Chairman Raymond Gilmartin said the company had recently discovered that its popular painkiller Vioxx may cause heart attacks and strokes. Calling those results "unexpected," he said Merck was acting quickly to protect the public. It was the biggest recall of a prescription drug in history.
RAYMOND GILMARTIN: …We are taking this action because we believe that it best serves the interest of patients.
BRANCACCIO: It was less than six years ago that the company introduced Vioxx with great fanfare, hailing it as one of a new generation of remarkably safe and powerful painkillers.
TV AD: "Just one pill, one a day can protect…"
BRANCACCIO: If you owned a television, you couldn't miss the ads. Drug maker Merck was spending over $100 million a year marketing Vioxx, hoping to make it what's known in the trade as a "blockbuster drug"-in other words, a cash cow.
TV AD: Song "It's a beautiful morning!"
BRANCACCIO: Those efforts paid off. It wasn't long before Vioxx became one of the most widely prescribed drugs in the world, ringing up 2 ½ billion dollars a year in sales.
But now, disturbing questions. How could such a well-known drug, produced by one of biggest names in the business, prove so dangerous? And how could the drug maker just be finding out now? In fact, as you'll learn tonight, there were warnings about Vioxx for years warnings that should have prompted the company, and the government regulator who watches over it to say "there's a big problem here"
CAROLINE NEVELS: They lied to the public. They knew these findings on Vioxx was bad.
BRANCACCIO: Caroline Nevels of Lexington, Missouri, says her daughter Shelly never knew of the dangers of Vioxx. Shelly, like millions of Americans, had seen the ads.
NEVELS: Shelly took Vioxx because she had rheumatoid arthritis. She was on Vioxx for two and a half years.
BRANCACCIO: One day, Shelly 34 and a young mother of two suddenly began having chest pains as she was getting ready for a family birthday party. That led to a trip to the emergency room.
NEVELS: And so about an hour later, the phone rung, and it was the hospital telling me to get out there. That she had taken a turn for the worse. And then when I got out there, they said she had a heart attack, and I-I never did get to talk to her anymore after that.
BRANCACCIO: To Caroline, it didn't make any sense. The family had no history of heart disease. And other than arthritis, Shelly was in good health. Even doctors had no clear answers.
NEVELS: They kept telling me she was young. She was going to be okay. And even the day that she passed away, the doctor told me that she was going to be fine.
BRANCACCIO: In fact, scientists believe that Vioxx has contributed to the deaths of tens of thousands of people. But while Merck was busy selling the public on Vioxx, inside the company there were doubts. In March of 2000 less than a year after Vioxx was introduced Merck's chief of research told colleagues that cardiovascular problems with Vioxx are, quote, "…clearly there." And here's a Merck training manual which uses the word "dodge" when instructing salesmen how to handle questions doctors may have about Vioxx and heart attacks.
CAROLINE NEVELS: All Merck cared about was what they were making. They made billions of dollars off of Vioxx. And billions of dollars would never bring my daughter back. They got money for that. And I lost my daughter.
BRANCACCIO: Merck says those company documents have been "taken out of context" and denies it ignored any early warning signs. People like Caroline Nevals aren't buying it. She, and 1000's of others, have filed suit against Merck. According to one estimate those lawsuits could cost the company as much as 38 billion dollars, and may jeopardize the company's very survival. Nevel's attorney, Kenneth McClain, says drug companies are not doing enough testing before they bring drugs to market, and have failed the American public.
KENNETH MCCLAIN, ATTORNEY: We have been disappointed over and over and over again. Companies not correctly reporting the risks of their products. Not carefully assessing the risks of their products, but selling them to the public and essentially, doing a study on the American people to determine the safety of their product. That's not how it's supposed to work. That's not how it should work.
BRANCACCIO: Well, how is it supposed to work? That question gets to the very heart of our story. There is supposed to be a watchdog to make sure companies don't sell snake oil, or unnecessarily harm, or even kill, people who take medicine you've heard of them it's called the Food and Drug Administration. But now, an insider says the FDA has formed an unholy alliance with the very industry it's supposed to regulate.
Doctor David Graham has been working at the FDA for 20 years. He's a senior official in the FDA's Office of Drug Safety the office responsible for monitoring drugs once they've been approved for sale. Even before the recall, he saw the Vioxx disaster coming.
DR. DAVID GRAHAM, FDA OFFICE OF DRUG SAFETY: In the situation of Vioxx, for example, we have 100,000 people in the United States-that's 50 people a day for five years, who had heart attacks. One by one, in the silence, in the loneliness of their homes, their workplaces, wherever it is, it could've been down the street from where you live, it could have been down the street from where I live. And it basically just continued to happened while the FDA continued to say, "This drug is perfectly safe."
BRANCACCIO: We sat down with Doctor Graham for his first extended face-to-face television interview. Before Merck announced its recall, Graham was finishing up his own Vioxx study one that shows the drug has injured and killed ten's of thousands of people. But when Graham told his managers at the FDA he wanted to go public with his results, he says a funny thing happened: they tried to muzzle him.
BRANCACCIO TO GRAHAM: So you do the study. What did you find?
GRAHAM: Both the high dose and low dose of Vioxx increased the risk of heart attack compared to Celebrex, which was the other major drug on the market that people would use to protect their stomachs from bleeding complications.
BRANCACCIO: Now help me with the numbers, that sounds very bad.
GRAHAM: Well, it is very bad, especially if you multiply those risks out by the millions of people who are taking the drug.
BRANCACCIO: Graham wanted to tell the world about the dangers of Vioxx with a preview of his results at a medical conference held last summer in France. But instead of going after Vioxx, the FDA went after him.
GRAHAM: The response of management was just one of negative reaction. And rejection. And criticism.
BRANCACCIO: You really felt that?
GRAHAM: Oh, I felt it but it was present in the e-mails and everything else I received. And the reason why was because as far as they were concerned, there was no regulatory question that needed to be addressed. So I was putting them in a bad position by saying that something more needed to be done.
BRANCACCIO: Graham's bosses tried to tone down his presentation. Internal FDA e-mails, obtained by NOW, called Graham's concerns, "unnecessary," and, "particularly problematic," and warned him about his study's, "strong language."
GRAHAM: So they sent me e-mails in which they said if he's not going to change his result, then we shouldn't let him go to France to present his paper. Or maybe actually, if he won't change his result, then let's make him present a second paper, our paper, in which we say there's no problem.
BRANCACCIO: But nobody told you to change results really?
GRAHAM: No, not change the results, change your conclusion, change how you interpret what it is you found. And they wanted me to change that.
BRANCACCIO: Graham went ahead with his presentation anyway, and the scientific community wanted to see more. But as summer turned into fall, the FDA continued to refuse to release the full text of his study. But the agency did share it with Merck, the maker of Vioxx, asking the company for its, "critical appraisal."
GRAHAM: Even on September 22nd, a week before Vioxx came off the market, senior managers within FDA were saying to me, "Why on earth did you study Vioxx and heart attack anyway?
BRANCACCIO: What does that say to you, that they would make such a statement?
GRAHAM: What it says to me is that you had an agency that was completely oblivious to safety, completely insensitive to safety, that basically was willing to tolerate a 500% increased risk of heart attack with no demonstrable counter balancing benefit for the drug because it suits their client to allow the drug to be marketed in America.
BRANCACCIO: Which raises the question, just who is the FDA working for?
GRAHAM: A former manager of mine from the Office of Drug Safety told me that industry was our client. And when I said to him, "No, the public is my client," he said I was wrong and it was industry. And my response back to him was, "Industry may be your client but it will never be my client."
BRANCACCIO: The battle inside the FDA over his study got so ugly, Graham began fearing for his job. So he got a lawyer through a whistleblower protection group called the Government Accountability Project. But that didn't stop the FDA. Soon his lawyer was getting calls from anonymous FDA officials warning that Graham wasn't to be trusted.
GRAHAM: My understanding is that they were representing themselves as whistleblowers to blow the whistle on me as a whistleblower.
BRANCACCIO: So the whistleblower protection people maybe might not help you or something. That would be the goal.
GRAHAM: If we can knock the Government Accountability Project out so that he doesn't have a lawyer, well, good, then were going to be able to fire him as quickly and as easily as we want.
BRANCACCIO: Eventually, investigators from the office of Senator Charles Grassley got wind of Graham's story. Fed up with the FDA. They called Graham up to Capitol Hill to testify.
GRAHAM: I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless.
BRANCACCIO: The FDA declined to do an interview for this story, but in previous statements, they've called Graham's study "junk science," and dismissed him as "a maverick" who doesn't play by the rules. For a maverick, he sure has a lot of support. This is a survey recently released by the Department of Health and Human Services, the cabinet department that oversees the FDA. It found 2/3's of FDA scientists have concerns about the agency's efforts to monitor the safety of drugs once they're on the market.
GRAHAM: If you were to talk about my Vioxx study to people, researchers outside the FDA they'll tell you that the design of the study is very good, and that this represents one of the best studies that's been done on the subject Vioxx and heart attacks. But not to my managers at FDA. My managers at FDA are trying to get me fired.
BRANCACCIO: How does it feel to be a whistleblower? And would you recommend a whistleblower status to other people?
GRAHAM: No, I don't recommend it to anyone. It's been very difficult. First off, I didn't appreciate that what I was doing was whistleblowing, until almost up to the point of my Senate testimony.
BRANCACCIO: What did you think it was?
GRAHAM: I just thought I was talking to Congress about the truth. And I didn't realize that telling the truth meant that you were a whistleblower.
BRANCACCIO: But even before Graham blew the whistle, others in the FDA had sounded the alarm about Vioxx. Nearly four years ago, another FDA doctor found an increased risk of heart attacks and strokes among patients in a study taking Vioxx. That doctor also rejected Merck's attempt to explain away that increase.
BRANCACCIO: So what did the FDA do? In early 2001, they decided to approach Merck about adding precautionary language that is to say, fine print to the package insert.
GRAHAM: It had zero impact. So every time FDA says we have managed the risk of a drug by labeling, by instituting a labeling change, FDA is being, I think, in my view, cynical and untruthful with the American people.
BRANCACCIO: The FDA had other options. They could have required a stronger warning for patients. Or they could have stopped Vioxx from being advertised on TV. Or they could have even banned Vioxx in high doses. But the FDA didn't do any of that.
BRANCACCIO: I thought that's what the FDA does, is have that kind of leverage.
GRAHAM: I guarantee you that any company faced with the prospect of being brought out into the public as not being in favor of product safety after the FDA thought there was a problem, they would capitulate. You have the bully pulpit. The FDA won't use that bully pulpit because FDA views industry as the client. FDA is there to serve its client industry, and it is not there to serve the public. FDA is an institution that has become a factory for the approval of new drugs and safety is not a consideration.
BRANCACCIO: To understand how the FDA got to where it is today, you need to go back to 1992. That year, the first President Bush, with the support of both Democrats and Republicans, signed into law the "Prescription Drug User Fee Act." The law was passed in response to industry complaints that the FDA wasn't approving drugs fast enough. Part of the deal? The drug companies agreed to start paying the FDA to speed up the approval process.
GRAHAM: It worsened a culture within FDA that was already bad to start with, that said, "We will approve drugs, and we will approve them quickly and we won't pay attention to safety."
BRANCACCIO: Why? Because essentially all this money is coming in from the pharmaceutical companies, therefore, we need to please the pharmaceutical companies?
Graham: Well, that is the mentality that eventually emerged.
BRANCACCIO: In 2003, the drug industry gave $200 million to the FDA. That's changed the whole balance of financial power within the agency. Here's the thing: while the industry has been providing more and more money for approvals, Congress has cut spending for the rest of what the FDA does things like monitoring the safety of drugs already on the market. As a result, almost four out of every five dollars the FDA spends on drug regulation now goes to getting new drugs approved for sale.
GRAHAM: You know, the Roman slave galley, you know, where the guy beats the drum? And each time he beats the drum, the slaves pull the oars. So the slave galley now starts beating the drum faster and faster and faster.
BRANCACCIO: Approve those drugs…
GRAHAM: Approve those drugs, approve those drugs, and safety isn't even on the radar screen.
BRANCACCIO: Given that nearly half of all Americans take at least one prescription drug, Graham says the consequences are obvious.
GRAHAM: It's guaranteed homicide, because you're going to hurt thousands, tens of thousands, of people. It's a mathematical certitude.
BRANCACCIO: You know, I pick up the papers, and I read articles that say that the FDA is slow in approving drugs, that the big problem that you all have over there is bureaucratic foot dragging, keeping important new treatments away from people who need it desperately.
GRAHAM: Right, that is a complaint. I think where that complaint originates from is probably from the pharmaceutical industry.
BRANCACCIO: It's not true though? Even cases of drugs that might be necessary to help someone's cancer from progressing?
GRAHAM: Well, let's put it this way. If you look at most of the drugs that get approved on the marketplace, most of them aren't offering a true therapeutic advance.
BRANCACCIO: You mean you go through this whole rigmarole at the FDA to get a drug approved and you're saying it doesn't offer much over an existing drug?
GRAHAM: No, it usually doesn't offer anything over an existing drug.
BRANCACCIO: Well, like what?
GRAHAM: Let's look at Vioxx. There are other drugs that one can use that don't have a side effect of gastrointestinal bleeding and that don't have a side effect of heart attack.
BRANCACCIO: But here's the thing, the FDA has other people, you, who look at what happens to the drug once they're on the market to be sure when hundreds of thousands of people are taking it the drug, that there aren't other problems that emerge.
BRANCACCIO: So isn't that good enough?
GRAHAM: No, it's not good enough. Part of the problem is, it's fine to look and identify a problem. But what do you do after you've identified that a problem exists.
BRANCACCIO: Case in point, our former friend, Vioxx. It was nearly four years after an FDA medical reviewer first warned of serious problems that Vioxx was pulled from the market. And it was Merck faced with mounting legal claims that made the decision, not the FDA. This, from an organization that calls itself, "the nation's premier consumer protection and health agency."
GRAHAM: The decision that the FDA made is the decision they almost always make, which is to say, "We're on Mount Olympus. We're FDA. What we say is the truth. Trust us. This drug is safe and effective." It's safe and effective because we, the FDA, say it is, and we don't have to produce evidence to justify that.
GRAHAM: And their reaction is predictably, and uniformly the same, which is they deny that there's a problem and they kill the messenger who brought them the bad news.
BRANCACCIO: And lately, there's been a lot of bad news. In his Senate testimony, Graham made headlines nationwide when he named five other drugs he believes the FDA should consider banning or limiting their sale.
BRANCACCIO: And just three weeks ago, it was announced the largest selling prescription arthritis drug in the world, Celebrex, is also linked to heart attacks. There's even been doubts raised about the safety of some of the most common over-the counter drugs, like Naproxen, the ingredient in Aleve. The FDA has called a meeting for early February to reassess several of these drugs.
As for Doctor Graham, he's still working at the FDA, even as he watches his back. But he tells me there may be some good emerging from the sorry tale of Vioxx. Senator Charles Grassley of Iowa, who held the Vioxx hearings, has promised to introduce legislation to strengthen the FDA's Office of Drug Safety.
But Grassley is facing an uphill battle. Sometime this year, the Senate will consider a bill that would let the drug companies off the hook for most legal damages for injuries and deaths resulting from approved drugs that may include Vioxx. Terrific news if -say- you're a shareholder and didn't take Vioxx. And there's more wonderful news for industry. One of the most powerful figures on Capitol Hill, Congressman Billy Tauzin of Louisiana, recently resigned from the House of Representatives and, as of this week, is the pharmaceutical industry's top lobbyist in Washington.