< Trials and Tribulations

Transcript

Friday, January 18, 2008


BOB GARFIELD:
And I'm Bob Garfield. Those prone to depression have a good reason to feel worse this week. An article in The New England Journal of Medicine revealed that the effectiveness of 12 popular antidepressants like Prozac and Paxil was misreported by their manufacturers in the medical journals doctors rely on. Here’s ABC News.
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MALE COMMENTATOR:
A review of antidepressant studies just out today found that 94 percent of all positive studies are published, but only 33 percent of negative studies ever make it into print.
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BOB GARFIELD:
Congress recognizes that drug manufacturers tend to play up their successful clinical trials and bury their failures, so last year it required drug companies to post announcements of clinical studies in a public database.

But compliance has been – spotty, and anyway, giving notice that a study is being conducted is not the same as posting the results. And, as we learned this week, medical journals offer no antidote to the information deficit.

Jeanne Lenzer is an independent investigative medical reporter. She says there is a federal fine for pharma companies who misreport or don't report, but it’s no cure.
JEANNE LENZER:
Ten thousand dollars, it’s meaningless. Even though some of those fines can accumulate after a certain period of time, they get a 30-day warning period, and at $10,000 a day that’s nothing next to the millions of dollars per day that they pull in. And if the past serves as any kind of information, then what we know is, is that they will ignore these.
BOB GARFIELD:
Now the stakes are high financially, and in many other ways. For example, you have done reporting involving Eli Lilly, which was testing a drug for anti-incontinence applications. But the drug was fundamentally an antidepressant, and people committed suicide while on the drug. You happened upon this information almost by accident. Tell us about that.
JEANNE LENZER:
Yes. There was a research scientist who really had a stricken conscience and called me and said that Congress is looking at whether antidepressants cause suicidality or not. And it’s natural to wonder is it really the drug or is it the underlying depression?

And what this research scientist, who remains anonymous, said to me was because they knew there was a question about suicidality with their pills. What they did in this study was they took healthy test subjects, screened them all to not be depressed and then tested them with this drug that they hoped they would be able to use for urinary incontinence.

And what they found was there was about a doubling of the suicidality among these patients. So that sure seemed like important information to patients who were taking that same drug for depression.
BOB GARFIELD:
But because the drug was not put on the market as an anti-incontinence product, the rules did not require Lilly to disclose the suicide of an otherwise healthy 19-year-old college student in the midst of a trial in its own laboratory.
JEANNE LENZER:
Exactly. And when I filed a Freedom of Information Act request with the FDA for all of the serious adverse events and deaths of patients taking this drug, and when I got that database back, it did not include her death. And it didn't include the deaths of at least four other patients. They weren't even patients. These were healthy volunteers who were taking the drug as part of a clinical trial.

And I asked the FDA why they hadn't released these deaths, and they said, because they are a trade secret. And they were a trade secret because the drug didn't make it onto the market for that particular use, for incontinence. But it was being used by many patients for depression.
BOB GARFIELD:
Now, prescribing physicians basically have two sources of information. One is that which is given to them by the drug companies, which obviously accentuate the positive, and the other is medical journals, which presumably are giving the straight dope on how these various trials turn out. But a lot of that doesn't get published.
JEANNE LENZER:
Journals also have a tendency to publish that which is positive and not to scrutinize the data as carefully as they should. And it’s not hard to imagine why. The lion’s share of their funding comes from the pharmaceutical industry.

And there was an incredible case where Mike Wilkes, a physician, analyzed the ad content of one of the leading medical journals and found that the ad content was not accurate in many, if not most, of the cases. And he reported that in this journal, and the journal was besieged by all the pharmaceutical companies that then got together and boycotted the journal. And they lost the lion’s share of this journal’s income, and they finally had to fire the editors. So that’s how serious the problem is for medical journals.

On the other hand, it’s who’s doing the research. And Marsha Angel, a former editor-in-chief at The New England Journal, told me that they were hard-pressed to find 10 percent that was worthy of publication because the studies are just so bad, and they're bad because by and large they're funded by industry. So they're intended to be biased.
BOB GARFIELD:
It seems to me that, you know, there’s a very good solution for this at hand, and that would be a change in the law that would allow the FDA to demand and post on the Internet not only the existence of all clinical trials but the results, and then let it be sorted out by the medical community. But that’s not possible now, is it?
JEANNE LENZER:
You’re right, because right now, under trade secrecy rules, which is what affected the girl that we discussed earlier who committed suicide, her death was considered a trade secret. We need to change things so that anyone’s clinical outcome on a trial should never be a trade secret, and that should be available for scrutiny - and I'd also add not just the results of these trials but the actual underlying raw data. They need to be available to other scientists for scrutiny.
BOB GARFIELD:
Do you think the press in general has been vigilant on these issues?
JEANNE LENZER:
There is a tendency to go to what are considered to be official sources, and we don't have enough reporting about whether the people being interviewed actually have financial conflicts of interest. There’s a recent article in The New York Times that I read, and I checked. All six of the six people who commented on the use of a drug were all in the employ of the manufacturer.

Journalists are beginning to ask more of these questions now, but we need to do more work to make sure that we have independent sources and also that we put each new study in perspective.

For example, with clot busters for stroke, everybody got on the bandwagon when this NIMS trial came out showing that clot busters, you know, were helpful with stroke, but they didn't mention that there had been five trials before that in which it either had no effect or it killed more people than it helped.

So I think as each new trial comes out, we should always ask ourselves, what has gone before this? And let's put this in perspective.
BOB GARFIELD:
Jeanne, thank you very much.
JEANNE LENZER:
Thank you so much.
BOB GARFIELD:
Jeanne Lenzer is an investigative medical reporter whose work has appeared in The British Medical Journal and Slate.com.