In our documentary segment about the Fen Phen disaster, we met Dr. Stuart Rich, a respected cardiologist and pulmonologist from the Rush Heart Institute in Chicago. During the mid-1990s, Rich played a central role in conducting the International Primary Pulmonary Hypertension study -- a large study of European men and women who were taking diet drugs, including Pondimin, which was on the market in the United states, and a closely-related "sister drug," Redux, which was not yet on the American market.
One of the main goals of the study was to evaluate the connection between these drugs and pulmonary hypertension, a devastating side effect that reduces the lung's ability to absorb oxygen, leading to constant shortness of breath and ultimately death. While a few cases had been reported around the world, drug manufacturers had long claimed that Pondimin and Redux only rarely caused pulmonary hypertension. Furthermore, they said, the benefit of losing weight was far more significant than the risk of developing the side effect.
In their three-year study, Dr. Rich and his colleagues found that Pondimin and Redux posed a "significant risk of dying from pulmonary hypertension," according to Rich. "And the risk went up the longer you took the drugs." Those results, and the fact that on average most people only lost a small amount of weight when they took these medicines, made Rich an opponent of FDA approval for Redux -- particularly for long-term use.
While Rich was appalled by the drug company's determination to put its drug on the American market, he was even more upset when the FDA acquiesced and approved the drug in the summer of 1996. "My reaction was despair," he told us. "Why despair? My specialty is I treat patients with pulmonary hypertension. These are the sickest cardiovascular patients that exist. They're young people. They're tragic stories. We have some treatments … but it's a death sentence. And it's a slow death, drowning, months to years."
Rich's only comfort was knowing that the European study would soon be published in The New England Journal of Medicine -- one of the most prestigious medical journals in the world. The drug company may have pushed this controversial product onto the market, thought Rich, and the FDA may have gone along with the idea, but doctors would soon read the study's findings about Redux when the Journal came out. Then, he hoped, doctors would stop prescribing the drug so often.
But getting out a clear message to consumers and the medical community about the risks posed by these diet drugs proved to be more difficult than Rich imagined.
• • •
The day before his article officially came out, Rich got a phone call from a newspaper reporter who had received an advance copy of the Journal and wanted Rich's reaction to an accompanying editorial -ã which Rich hadn't seen yet. (As was the custom at The New England Journal of Medicine, the magazine's editors had invited two prominent scientists to write an editorial about the European study to put it into perspective and help doctors determine whether and when the risk of using the diet drugs would be justified by the benefits.) Much to Dr. Rich's dismay, the editorial claimed that the benefits of using Pondimin and Redux far outweighed any risks and compared the risk of taking the diet drugs to taking penicillin for an infection. In effect, the editorial advised the medical community not to pay too much attention to Rich's study, and not to stop prescribing the drugs.
When Rich heard who the authors of the editorial were -- Dr. JoAnn Manson and Dr. Gerald Faich -- he realized immediately that both had financial ties to the drug companies that were making and/or selling Redux. And both had done work with those companies specifically in connection with Redux. "This was one of the greatest scandals that ever hit The New England Journal of Medicine," says Rich.
To guard against such potential conflicts of interest, it had been the Journal's policy to always ask editorial writers whether they had any "ongoing financial associations" with the company producing the product. In this case, the two scientists who authored the diet drug study editorial had told the magazine's editors -- in writing -- that they had "no financial interest or equity in any pharmaceutical company producing anti-obesity agents."
As word of the editorial controversy spread, the Journal's editors asked the two scientists to explain their written statement that they didn't have any financial interest in the company. In their defense, both authors downplayed their financial connections to the companies, and pointed out that the Journal had defined "ongoing financial associations" as "equity interest, regular consultancies, or major research support" and that their associations were neither "regular" nor "ongoing" but more occasional and not relevant to their editorial.
Despite the authors' explanations, a few weeks after publishing the pulmonary hypertension study the Journal's editors, Dr. Marcia Angell and Dr. Jerome Kassirer, ran a new editorial acknowledging that the authors may have misinterpreted the Journal's definition of "financial associations," but the editors also cast doubt on the credibility of any editorial written by someone with the kinds of financial ties that the authors had. (You can read the original Journal article [free registration required to read the full text] on the study and the accompanying editorial on the New England Journal's Web site. And you can also read the editors' follow-up editorial.)
But by that time, the damage may have been done. Thanks to the editorial that had run with the study article, many doctors around the world may well have dismissed the study's results and decided not to worry about prescribing Pondimin and Redux.
• • •
The Journal affair wasn't the only development that interfered with getting the story out about the European diet drug study, says Rich. The drug manufacturer, he says, tried to stop him from talking to the general public.
The news that popular diet drugs carried significant risks prompted NBC's Today show to invite Rich to appear on their morning program to talk about the study. Host Bryant Gumbel asked him to tell the country about the study and put it in perspective. "What I said," Rich recalls, "was nothing that was not mentioned in the paper: that the drug carried a very high risk of developing this fatal disease, that it should not be prescribed lightly."
A couple of hours after the live broadcast, Rich returned to his office where, he says, he received a phone call from a senior executive at Wyeth Pharmaceuticals.
"He told me he saw my interview on the Today show and warned me that it was very dangerous for me to talk to the press about that, that if I had any issues regarding their product that I wanted to publish in a scientific journal, so be it. But if I spoke to the media about their drug, bad things would happen. 'Bad things would happen' was the exact phrase he used. ... And I never talked to the press again. Because I didn't know what they had in mind. ... They are a very big, a very powerful company."
Rich has told his story under oath in several legal depositions as part of lawsuits brought by Fen Phen victims against the company.
For his part, the senior Wyeth executive has testified under oath in at least one deposition and denied having ever threatened Rich.
We will never know whose version of the facts is correct -- because none of the parties can prove one way or the other that they are being truthful. One thing is certain, however. Dr. Rich didn't speak to the popular press about Redux and Pondimin for many years after that appearance on the Today show -- and until now, he never told anybody in the media the details about that phone call.
No comments:
Post a Comment