Paul
07-16-2004, 01:33 AM
Dear Lisa,
I hear ya! Your second post provides more context. I like the "do your homework" message as well as the fight, fight, fight motto in your most recent post. I think many read into your prior post that you were critical of those that seek herceptin off-label. I think you meant that the inability of obtain herceptin off-label is not the "end of the game." In fact, many women who have used herceptin in Stage IV are experiencing sustained NED.
The issue that your post raised involves many of the issues confronting oncologists today.
1. Many years ago, bone marrow transplants were "in vogue" as part of breast cancer treatment. Many doctors used this treatment early on, only to discover later through long-term studies that bone marrow transplants were on par or slightly below treatment with normal chemo. When it comes to new or novel treatments, many oncologists are "once burned, twice shy" with respect to new ideas or novel approaches.
2. The Hippocratic Oath taken by doctors requires them to "do no harm." In an adjuvant setting, where the patient is asymptomatic, it is (from a doctor's perspective)impossible to make the patient any better without the possibility of doing more harm. Herceptin has been shown in up to 7% of the cases to cause cardiac related problems. It also appears true that when the drug use is properly monitored, and discontinued when a cardiac related problem arises, the problem resolves itself. The possibiltity of death with the use of herceptin is small in the hands of a skilled oncologists. The "do no harm" requirement makes most doctors extremely conservative in an adjuvant setting where the patient is asymptomatic.
3. Joe raised the point of potential litigation and it is a valid point in today's society. It should be noted that off-label use of a drug is not illegal or unethical if a doctor can demonstrate that the patient is benefited without undue risk. It is true that the vast majority (if not all) of research and teaching hospitals will not treat a patient with herceptin off-label. As long as lawyers exist, drug companies and doctors will get sued -- regardless of the studies available, etc.
I suppose that all of these issues are relevant. But, a woman should approach "the fight" by looking at the technology front as a whole. Stated differently, several levels of defense are available today. If one fails, you move to the next level. Herceptin is one such level of defense. The M.D. Anderson results suggest that sooner may be better than later in terms of herceptin use. I'm hoping the M.D. Anderson study results will prompt some reporting (even mid-term results) by the larger adjuvant herceptin clinical trials. It seems that M.D. Anderson's step of making neoadjuvant use of herceptin + chemo its standard of care is a courageous and gutsy move in an otherwise lemming-like healthcare environment. It certainly sends out a sort of "wake-up call" to all the major adjuvant herceptin trials that have not reported any information (including early or mid-trial results) yet.
I hear ya! Your second post provides more context. I like the "do your homework" message as well as the fight, fight, fight motto in your most recent post. I think many read into your prior post that you were critical of those that seek herceptin off-label. I think you meant that the inability of obtain herceptin off-label is not the "end of the game." In fact, many women who have used herceptin in Stage IV are experiencing sustained NED.
The issue that your post raised involves many of the issues confronting oncologists today.
1. Many years ago, bone marrow transplants were "in vogue" as part of breast cancer treatment. Many doctors used this treatment early on, only to discover later through long-term studies that bone marrow transplants were on par or slightly below treatment with normal chemo. When it comes to new or novel treatments, many oncologists are "once burned, twice shy" with respect to new ideas or novel approaches.
2. The Hippocratic Oath taken by doctors requires them to "do no harm." In an adjuvant setting, where the patient is asymptomatic, it is (from a doctor's perspective)impossible to make the patient any better without the possibility of doing more harm. Herceptin has been shown in up to 7% of the cases to cause cardiac related problems. It also appears true that when the drug use is properly monitored, and discontinued when a cardiac related problem arises, the problem resolves itself. The possibiltity of death with the use of herceptin is small in the hands of a skilled oncologists. The "do no harm" requirement makes most doctors extremely conservative in an adjuvant setting where the patient is asymptomatic.
3. Joe raised the point of potential litigation and it is a valid point in today's society. It should be noted that off-label use of a drug is not illegal or unethical if a doctor can demonstrate that the patient is benefited without undue risk. It is true that the vast majority (if not all) of research and teaching hospitals will not treat a patient with herceptin off-label. As long as lawyers exist, drug companies and doctors will get sued -- regardless of the studies available, etc.
I suppose that all of these issues are relevant. But, a woman should approach "the fight" by looking at the technology front as a whole. Stated differently, several levels of defense are available today. If one fails, you move to the next level. Herceptin is one such level of defense. The M.D. Anderson results suggest that sooner may be better than later in terms of herceptin use. I'm hoping the M.D. Anderson study results will prompt some reporting (even mid-term results) by the larger adjuvant herceptin clinical trials. It seems that M.D. Anderson's step of making neoadjuvant use of herceptin + chemo its standard of care is a courageous and gutsy move in an otherwise lemming-like healthcare environment. It certainly sends out a sort of "wake-up call" to all the major adjuvant herceptin trials that have not reported any information (including early or mid-trial results) yet.