When drugs are FDA approved, doctors and patients have reason to believe that those decisions came as the result of intense scrutiny on both safety and efficacy. But is the FDA’s “accelerated pathway” being misused, possibly harming patients and enriching for-profit industry?
A very important topic to address. Most of us with rare and serious chronic disabling diseases have a love/hate relationship with Big Pharma. As someone with the Progressive form of MS since 1985 (15% of the MS population) I went almost 15 years without being able to get ANY disease modifying drugs as damage accumulated. It was an internist who also had MS (RR form) who lied for me so I could try Copaxone. It wasn't very powerful and made no difference. Then about 6 years ago FDA approved the first DMD that could be used for folks like me with the Progressive form. I had MS for 32 damaging years with no help. For us Ocrevus has a 50% chance of elongating our lives. Which it has done for me as I was in end stages with impact on my diaphragm and autonomic system involving my heart, etc. On the dark side however, the first charge at a 6 month pop was $345,000. For most of my life car commercials dominated the commercials we all saw on network TV. In the last 5 years it is now pharmaceutical commercials. What does that tell you? Now that Big Pharma realized they can still make big $$$$ on us what does that do to the pressure on FDA?? What are the true serious side effects of these drugs that lower your immune system so drastically? How do we determine what diseases and level of disease should be using these drugs, and how does the potential for such exorbitant profit in the for-profit-industry corrupt the process of research and approval?
I will be with my students so hopefully we can see/read later. There is also lots of “noise”on a new variant in France, UK and US. Would appreciate anything you know.
Thank you putting a spotlight on the "accelerated pathway" which could be manipulated by the many players for accelerated profits.
As to "activist judges" there are many litigation tactics that a Physician-ConsumerTeam can deploy in the Courtroom from expert medical testimony for the all important "record" & appeal(s). Note well, a capable litigant does not have to wait for a final judgment to take action.
A very important topic to address. Most of us with rare and serious chronic disabling diseases have a love/hate relationship with Big Pharma. As someone with the Progressive form of MS since 1985 (15% of the MS population) I went almost 15 years without being able to get ANY disease modifying drugs as damage accumulated. It was an internist who also had MS (RR form) who lied for me so I could try Copaxone. It wasn't very powerful and made no difference. Then about 6 years ago FDA approved the first DMD that could be used for folks like me with the Progressive form. I had MS for 32 damaging years with no help. For us Ocrevus has a 50% chance of elongating our lives. Which it has done for me as I was in end stages with impact on my diaphragm and autonomic system involving my heart, etc. On the dark side however, the first charge at a 6 month pop was $345,000. For most of my life car commercials dominated the commercials we all saw on network TV. In the last 5 years it is now pharmaceutical commercials. What does that tell you? Now that Big Pharma realized they can still make big $$$$ on us what does that do to the pressure on FDA?? What are the true serious side effects of these drugs that lower your immune system so drastically? How do we determine what diseases and level of disease should be using these drugs, and how does the potential for such exorbitant profit in the for-profit-industry corrupt the process of research and approval?
I will be with my students so hopefully we can see/read later. There is also lots of “noise”on a new variant in France, UK and US. Would appreciate anything you know.
Thank you putting a spotlight on the "accelerated pathway" which could be manipulated by the many players for accelerated profits.
As to "activist judges" there are many litigation tactics that a Physician-ConsumerTeam can deploy in the Courtroom from expert medical testimony for the all important "record" & appeal(s). Note well, a capable litigant does not have to wait for a final judgment to take action.
Yes, this is a challenging issue. Add the potential problem of active Judges putting a brake on the FDA based on politics, not science.