It has been a pretty hectic and busy couple of weeks, with travel, meetings, work, and a short vacation.
While I have been otherwise occupied, a lot has been happening. Unfortunately, much of it hasn’t had to do with advancing the treatment and science of cancer. Instead, we have learned more than we should need to know about the inner workings of our profession and how research and practice are being supported in the new millenium.
My last comments on this blog had to do with erythropoiesis stimulating agents, or ESAs. These are the drugs which stimulate the production of red blood cells in patients receiving cancer treatment. Recent evidence, as outlined on several occasions in this blog, suggests that they may be harmful as well as helpful.
The FDA hearings a couple of weeks ago led to a lot of press, but at the end of the day there may be some more restrictions put onto the use of these drugs. However, they will continue to be appropriately available for patients who need them while receiving chemotherapy.
The FDA panel did suggest that these drugs not be used in patients who are being treated with curative intent, such as women receiving adjuvant chemotherapy for breast cancer. The reason for this is that the drugs increase the risk of deep vein thrombophlebitis and pulmonary emboli (blood clots to the lungs), which can be fatal. The panel concluded that the risk of harm outweighed the benefits for patients where the treatment could lead to cure of the patient’s cancer.
One of the more bizarre moments in the hearing was the occasion where one of the physicians on the FDA panel asked repeatedly whether the drug companies had been giving financial rebates to doctors to prescribe these drugs.
Now, this was not new information. The topic had been previously reported in the New York Times back in May.
Despite that public knowledge, including verification of one modestly sized practice having received a couple of millions of dollars as part of these rebate programs, the pharmaceutical representative did everything he could not to answer the question.
Instead, there were long winded and obviously pre-planned responses which were designed to deflect an answer. Comments such as there is no evidence that these rebates influenced practice, and so on.
The doctor had to reask the same question several times before getting a simple, “Yes.”
It was very demoralizing to watch this in person and realize that if you need to work so hard to hide something then you must realize that it doesn’t look particularly good in the light of day. If that’s the case, then why do it at all, especially when Medicare beneficiaries are forking over their money (and the government is forking over our money) to pay for these so-called rebates? Why not just reduce the price of the drug so everyone can benefit?
The behavior I saw at that hearing makes me wonder whether more “rebate” programs are out there, and how much is being paid to doctors to prescribe these expensive drugs. I hope the answer is “none” and “zero,” but after what I saw at those hearings I am no longer so certain.
And, from my perspective, it was difficult to watch the hearing avoid the entire question of the off-label use of these drugs in treating the anemia of cancer patients not receiving active treatment. Since that is not an approved use, the FDA has no jurisdiction over their use and could not address that question as part of this hearing.
Yet, who knows how many patients are receiving these drugs at what cost in a circumstance where there is no scientific evidence of benefit and where there may be substantial risk?
I guess silence is supposed to be preferable to sunlight, but that is difficult for me to accept.
The other distracting event of the past couple of weeks was the publication of a front page story in the New York Times on March 26 which revealed that the physician who has been the leader of research into the effectiveness of CT scanning for the early detection of lung cancer in fact headed a foundation that had received $3.6 million from one of the tobacco companies from 2000 to 2003.
That money, in turn, has helped fund a major international lung cancer screening trial that, in the opinion of the investigators, demonstrated remarkable survival in patients who had their lung cancers detected by CT scans.
As noted in the Times’ article, the American Cancer Society has also made grants in excess of $100,000 to the same study, some to support part of the research program and part to support the meetings held regularly by the investigators to update the results of the research. We did not know that tobacco money was involved in this project.
This same researcher was recently called to task because she and her colleagues have patents that are related to her research program, yet she had failed to disclose that information on the articles she had authored which appeared in leading medical journals and in lectures she has given in multiple venues.
Now the hordes are swarming, claiming that the research she has performed may be tainted. Although I personally hope that is not the case, it has raised a cloud over what up until now has been a vigorous discussion among experts about the effectiveness of lung cancer screening.
The conflict was uncovered because a footnote appeared in a study that was published in the New England Journal in October 2006. An enterprising reporter followed up on the notation that the research project had been supported by Foundation for Lung Cancer: Early Detection, Prevention and Treatment. That’s when they found out about the tobacco connection.
In our world, any connection to tobacco money is as taboo as it gets.
I guess you might say that I am a bit despondent that we are now spending more of our time dealing with peripheral issues than promoting a common agenda against cancer, either through improving access to care or advancing cancer research and treatment.
Conflicts are all around us. Even I have become more aware of my own conflicts, and realize that I need to pay more attention to how my various activities may in fact raise conflicts with one another.
But I am concerned that many otherwise well meaning and well intentioned researchers and scientists don’t perceive their activities as creating conflicts, and that we are dealing with may be the tip of the iceberg.
Taking large amounts of money from tobacco companies then doing research on lung cancer is a conflict. Taking large amounts of money from drug companies then touting their drugs is a conflict.
I could go on and on about these types of situations. They are ubiquitous, and are far more serious that taking a doctor taking a pen from a drug company at a medical meeting. My friends, the conflicts that I am talking about are insidious, ubiquitous and becoming an integral part of our professional and research landscape.
I certainly don’t have an answer as to how we get ourselves back on track. Exposes such as those in the New York Times and the Cancer Letter are unavoidable if we behave the way we do.
What will it take for us to regain the high ground?
It is infinitely better for us to straighten our own house as opposed to have others do it for us. But if we don’t get busy, we will have only ourselves to blame.