tag:blogger.com,1999:blog-7323692122514281455.post2002787837544203484..comments2024-03-22T17:05:55.267-04:00Comments on MD Whistleblower: Hepatitis C - Silent Killer or Innocent Bystander?Michael Kirsch, M.D.http://www.blogger.com/profile/07555280388086931097noreply@blogger.comBlogger7125tag:blogger.com,1999:blog-7323692122514281455.post-60827422442206749882018-04-14T10:31:39.619-04:002018-04-14T10:31:39.619-04:00@anonymous, appreciate the comment. Enthusiasts o...@anonymous, appreciate the comment. Enthusiasts of treating everyone defend the practice by stating correctly that we have no surefire way of determining which HCV patient is destined to progress. Therefore, they advocate using a wide net. I have a different philosophy. Michael Kirsch, M.D.https://www.blogger.com/profile/07555280388086931097noreply@blogger.comtag:blogger.com,1999:blog-7323692122514281455.post-39017351296385790262018-04-13T15:48:31.875-04:002018-04-13T15:48:31.875-04:00I work in a corrections environment and we come up...I work in a corrections environment and we come upon the Hep C question all the time. My impression is similar in that I tell my patients that most people with Hep C feel well and will do well for their entire lives, but that about 20% may go on to develop serious liver disease. Currently, our strategy is to treat the ones with identified liver disease beyond a certain point. The rest we watch and wait. The cost of the first few DAAs was quite high, approaching or exceeding $100K per course of treatment. Recently, there has come a regimen which is about a third of the cost, and I suspect this will put a downward pressure on the others. Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-7323692122514281455.post-72877056802295969162018-04-04T17:22:06.324-04:002018-04-04T17:22:06.324-04:00My understanding is that the FDA considers safety ...My understanding is that the FDA considers safety and efficacy, not cost. I do not think that there is consensus on the risks that an asymptomatic individual with HCV will develop complications over time. No one knows which patient will progress, but it is still true that most will not. Because of this uncertainty, it is difficult for me to endorse global treatment.Michael Kirsch, M.D.https://www.blogger.com/profile/07555280388086931097noreply@blogger.comtag:blogger.com,1999:blog-7323692122514281455.post-14246417005938004852018-04-03T19:24:46.732-04:002018-04-03T19:24:46.732-04:00Imagine if you are on the FDA and you are asked to...Imagine if you are on the FDA and you are asked to approve a medicine for cancer that increased yours life expectancy by 5 months. Total treatment costs $50,000. Is this a worthwhile outcome to justify tax payers footing the bill?<br /><br />That is a difficult question and potentially full of controversy. We need drug companies and other institutions (like major academic research centers) to discover new treatments, but they also need to be cost effective. Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-7323692122514281455.post-71209354627057061182018-04-03T19:19:06.983-04:002018-04-03T19:19:06.983-04:00Of course my decision to be treated is influenced ...Of course my decision to be treated is influenced by whether I have to pay for the medicine. <br /><br />There are people out there that are smarter than me and you who can calculate, using statistical models, the cost of treating something like asymptomatic HCV. If your life expectancy is 40 years and there is a 5% chance of contracting debilitating cirrhosis or liver cancer, then there is a price point where it's cheaper to treat everyone now than the cost of treatment for the few who get cirrhosis or liver cancer. I wonder if the FDA considers these costs when approving a medicine. <br /><br /><br />Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-7323692122514281455.post-7239232941012105962018-03-31T12:22:44.627-04:002018-03-31T12:22:44.627-04:00Thanks for your comment. Yes, there were some ser...Thanks for your comment. Yes, there were some serious side effect potential with prior HCV medicines. More commonly, they just made patients feel ill. The rough percentages of what I was taught is that no more than 20% of HCV will progress, although please recognize that experts may disagree on this or favor studies that mirror their own beliefs. My personally belief is that most HCV patients who are treated would likely never have suffered from advanced HCV disease. Keep in mind that HCV is not easily transmitted, so there is not a good argument to treat folks to reduce spreading the illness, such as occurs with influenza. As for your wanting to be treated personally, even if you felt well and faced low risk of progression, I assume your decision is influenced if you are not personally paying for the medicine. Although the cost has come down, a year or so ago, the cost of a standard regimen was $1,000 a pill. I'll leave the math to you for a 12 week course.Michael Kirsch, M.D.https://www.blogger.com/profile/07555280388086931097noreply@blogger.comtag:blogger.com,1999:blog-7323692122514281455.post-28592255519492112792018-03-30T03:07:46.484-04:002018-03-30T03:07:46.484-04:00If you didn't want to treat HC because you fel...If you didn't want to treat HC because you felt the science was poor, that is nothing to be ashamed about. Or to even be defensive over. Or instance, if a Neurologist or ER doc did not want to give tPA for eligible people with an acute ischemic stroke, the science would probably back them up. For some reason that has become the standard of care despite 12 negative trials vs. 2, maybe 3 positive ones. One wonders how tPA passed the FDC approval process!!!?!<br /><br />However if you were a lone wolf in your field, or if HC treatment was recommended in the GI practice guidelines but you simply didn't think it was necessary, then that would be a big problem. About how many active HC patients do you follow? 30? 50?<br /><br />I don't know much about HC. You use words like "most don't progress" instead of percentages. I'll tell ya, as a 42 yo person if I had HC and had even a 5% lifetime chance of developing debilitating cirrhosis or metastatic liver cancer, and there was a treatment out there that was more or less safe and effective, I would want it (unless it was cost prohibitive).<br /><br />If you are elderly and develop atrial fibrillation, your yearly chance of developing an acute stroke is between 2.5 - 5%. Being on warfarin reduces that to 1%. Same with the newer anticoagulstion drugs. They all come with some rather significant potential harms. Were the treatments for HC that you used to eschew also potentially dangerous?<br /><br />Anonymousnoreply@blogger.com