A recent study says negative news coverage of statin drugs makes some patients discontinue their use, subsequently producing more heart attacks (and death) as a result. But, one of the authors was paid by the drug maker as a consultant. Does this automatically nullify the study? Or, is there something else going on?
1- Does this cause any harm?
2- Can the results be trusted, since the companies selling the drugs gave money to one of the study authors (although he did not hide it)?
The latter is part of a much larger, ongoing issue about the validity of company-funded science and trials, and it's been a very prominent news item lately.
The answer to the first question appears to be "yes," however, if the answer to the second question is "no," then the first question becomes irrelevant.
Let's assume yes for now.
Drs. Sune Fallgaard Nielsen and BÃ¸rge GrÃ¸nne Nordestgaard of the University of Copenhagen, Denmark published the results of a study in the December 2 issue of the European Heart Journal. They concluded that when there was significant negative news about statins, people who were taking the drugs were nine percent less likely to refill their prescriptions than during other times.
In addition they said, "Early statin discontinuation was also associated with increased risk of myocardial infarction and death from cardiovascular disease." The increased risks of heart attacks and cardiovascular deaths were 26 and 18 percent, respectively.
In terms of retrospective studies, this one wasn't bad. The study group was huge 674,000 Danes who were followed over a 15-year time period.
But, can we believe it?
The apparent conflict of interest was either a big deal, or not, depending on who was being quoted. Here is the disclaimer at the end of the paper:
"Conflict of interest: There are no financial or other conflicts of interest for S.F.N [Nielsen]. B.G.N. [Nordestgaard] has received consultancy fees and/or lecture honoraries
from Astra Zeneca, Pfizer, Merck, Amgen, Sanofi, Regeneron, Omthera, Dezima, ISIS Pharmaceuticals, Aegerion, Fresenius, B. Braun, Kaneka, Lilly, Kowa, and Denka Seiden."
You can put Dr. Kailash Chand, who is the deputy chairman of the British Medical Association, in the skeptic column: "We need doctors to concentrate on research that matters to patients, not their careers or the advance of drug companies."
And, "Medical research is fraught with incompetence, careerism and fraud. Conflict of interest ... is a cancer eating at the core of medical research." This is a rather sweeping statement, especially because the European Heart Journal is very well-respected, and the study itself was independently funded.
Perhaps Dr. Chand has biases of his own. He is known as an outspoken critic of what he calls "industry-driven hype surrounding statins."
On the other side of the pill is, Dr. Thomas Whayne Jr., of the Gill Heart Institute at the University of Kentucky.
Statins can, of course, have side effects, and some patients can t tolerate them," he said, "[but the benefits] far outweigh the potential risks for people at high risk of heart disease."
Ironically, the biggest story here may be neither the results, nor the veracity of the study. In stead, it could be the media. News organizations are notorious for using misleading or factually incorrect headlines, either due to carelessness, or to drive circulation. It happens all the time.
Dr. Stephen Evans of the London School of Hygiene and Tropical Medicine addresses this. "Being certain that it is the media stories that cause discontinuation requires some assumptions,though they are reasonable," he said. "The message from the paper should be listened to by journalists and the media as well as by patients. The media need to be responsible in their use of scare stories they may affect patients' health."
In the end, would not be the least bit surprised if people stopped taking statins not because of negative headlines, but, rather, because of inaccurate headlines.
Things are rarely as simple as they seem, and there is nothing even remotely simple about this issue.