|  Today, a friend of mine will be having "experimental" surgery for ovarian cancer.
The surgery itself is not experimental, per se, but rather, the "experiment" involves trying to get enough tumor material to develop a vaccine to develop a vaccine to fight off future metastases. Sounds good in theory. The reality is a little different. First, this experiment is being funded by a drug company, and therefore, they will pay only for the actual removal of tissue, and the processing of the material. Thus, the remaining costs of hospital care, surgery, pre-testing, post-testing, and related care, will be the responsibility of the patient and/or her insurance company. Estimate from the hospital on costs is close to $1,000.000. For one patient. Second, this is a Phase 1 study, so there is no guarantee that it will be possible that the vaccine can be developed, nor that the patient will live long enough to receive it. Finally, the surgery itself is a more invasive form of a surgery which has been studied on advanced ovarian cancer patients and has been shown to increase life expectancy by zero seconds, minutes or hours, with no improvement in quality of life. The only benefit to the surgery is for patients whose first surgery was unsuccessful, and this would be "fix" surgery. Not the case here. The considerations here are two-fold. First, if you are a terminal cancer patient, and all you really have is hope, you might make the decision to try anything, even if the statistical likelihood is that the procedure will not work, will cause you intractable pain, probably decrease your quality of life, and possibly decrease your life expectancy. As a society, one consideration is whether or not spending a million dollars on a terminally ill patient is a worthwhile expenditure of limited dollars. In 2005, there were over 10 million Americans with some form of cancer. For the $34 million dollars that this experiment will cost (there are 34 patients), and not including payments for infections, secondary complications, and other potential issues, there is a lot good that could be done for many, many patients. Am I against research? Certainly not. But this is one example of when health care dollars are being spent to try for profit dollars, and not for "patient good" outcomes. There is an easy way to make this experiment better for patients, and to potentially get far better outcomes, but the costs to the drug company would be higher. This is the way it gets done when profit is involved. Details on the experiment, and the moral question, after the jump. |
Ovarian cancer has the highest kill rate of any of the gynecological cancers. It kills 14,000 American women a year. It is often not discovered until it is in State 3 or 4, because it has no early signs, and so the mortality rate is very high. There is no direct screening test. When someone is diagnosed with ovarian cancer, the initial step is a debulking surgery, where the team goes in and endeavors to reduce the primary tumor to less than 1 cm in size, and to "wash" the peritoneal area of any small tumors that have no imaged. Chemotherapy is then accomplished. Sometimes that puts the patient into remission. Sometimes secondary ovarian tumors appear (metastases) in other parts of the body, and they are sometimes treated with chemo or radiation, or both. Research has shown that if you test the patient's blood after the first chemo set, and she has a T-cell lymphocyte count over a certain number, there is a 65% chance she'll live past 5 years. If the T-cell lymphocyte count is below a certain number, there is a 0% chance of 5-year survival. The theory is that by developing a genetically engineered vaccine from the patient's tumor cells, future metastases can be prevented. A good way to test this hypothesis would be to save all tumor tissue from the initial debulking, freeze some, develop vaccine from some, and then give it to the women who show signs of a low T-cell lymphocyte count after the chemo is accomplished. This would cost the drug company in terms of storage, research, development, and related costs. What they're doing here, though, is taking women whose T-cell lymphocyte count is low, and who have not been successful with the chemo. The surgery is a second debulking, but also including taking small pieces of other organs (like lung, liver, and potentially related needle biopsies of brain and bone) to hopefully get enough tumor material. To get the vaccine, the woman must survive the surgery, go through 3 rounds of new chemo, and reach remission. At that point, the drug company will decide whether or not to give her the vaccine. Remember, this is a Phase 1 trial, and so the company needs a good enough outcome to get FDA permission to move to Phase 2, therefore, the selected patients must meet the "best possible outcome" scenario to increase the chances of the Phase 1 trial being a "success." The reason for doing the trial this way is that it increases the chances of getting good-looking outcomes. This is because the chances of surviving both the surgery and the chemo are not very high, and so only the "strongest" patients will receive the vaccines. There are several questions here: first, should the patient have the surgery and participate in the trial? And the answer is not for any of us to answer unless we are that patient. The risk/reward question is a personal one, and so long as the trial exists, anyone capable of giving informed consent who qualifies should have access to that trial. The second question is: who should determine what clinical trials are acceptable? Since many clinical trials are approved by the FDA (which does not pay for them), and since the FDA and the drug and medical device companies operate like a revolving door peppered with all sorts of coziness, it's pretty easy to get a Phase 1 trial approved if you've got the money. Other trials (and almost all Phase 3 and 4 trials) are accomplished under the auspices of NIH, which lacks the FDA-company relationships. In fact, NIH owns the government clinical trial website, and does not include the initial drug and device company trials. Should the FDA be allowed to sanction trials, or should that be reserved for NIH? Research finds cures: not always, but we certainly need research. But should it be within certain parameters, and how much money are we willing to spend, as a function of health care dollars, on it?
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