Thank you for the clarification on the difference between approved versus medical procedure classification. Do you know whether the risks of infection with FMT are similar or worse than the infection risk associated with Remicade, Stelara, etc.? I’m not a conspiracy theorist “literally blaming” big pharma for lack of FMT options (proced…
Thank you for the clarification on the difference between approved versus medical procedure classification. Do you know whether the risks of infection with FMT are similar or worse than the infection risk associated with Remicade, Stelara, etc.? I’m not a conspiracy theorist “literally blaming” big pharma for lack of FMT options (procedure or capsule). My concern is not even having the option as a patient to discuss it with my GI doctor. It seems unreasonable in light of the infection risks with various monoclonal t-cell inhibitors, which are on the table. Has FMT proved to be that much more risky in trials or is it solely due to the risk of the antibiotic resistant e. coli strains?
I don't know how the risks of infection as a result of FMT compare to those of mabs like Remicade and Stelara. Mainly because there is so little data on FMT. I'm not too familiar with the topic, but there were at least two US reports of E. coli infections, both involving multiple patients. One was antibiotic-resistant strain which resulted in death, another was enteropathogenic strain. Both were from clinical studies, in which donors were prescreened for the presence of pathogens. And now with Covid pretty much all legitimate FMT were put to a halt while people are trying to develop procedures to minimize the risk of Covid infection due to FMT. The virus can be detected in the GI tract, it's just not known whether it can be transmitted or not.
And I perfectly understand your position. Personally, I'm very much in favor of opening up experimental treatments through "compassionate use" not only to terminal cancer patients, but also to sufferers of debilitating chronic conditions, like UC. With all appropriate disclosures and risk warnings. The current US model is awfully restrictive
But I'm afraid there are too many players who prefer the status quo. Like insurance companies who are interested in maximizing their profits as much as the greediest big pharma exec. And who have more influence over treatment options than the FDA. And malpractice lawyers, against whom no disclosure is ever safe.
No, the industry has faults. I’ve worked in big law and have seen a pharma company “Martin Skrlei” a neonatal medication that treats a condition primarily associated with premature babies born to women on medicare. The potential liability was assessed at $25m because they had raised the cost of that drug 1300%. However, that company was being bought in a multi billion dollar deal so the larger well known acquirer swallowed the risk or deducted in part from the purchase price. DOJ investigated but I never learned what penalty came down, if any.
Thank you for the clarification on the difference between approved versus medical procedure classification. Do you know whether the risks of infection with FMT are similar or worse than the infection risk associated with Remicade, Stelara, etc.? I’m not a conspiracy theorist “literally blaming” big pharma for lack of FMT options (procedure or capsule). My concern is not even having the option as a patient to discuss it with my GI doctor. It seems unreasonable in light of the infection risks with various monoclonal t-cell inhibitors, which are on the table. Has FMT proved to be that much more risky in trials or is it solely due to the risk of the antibiotic resistant e. coli strains?
I don't know how the risks of infection as a result of FMT compare to those of mabs like Remicade and Stelara. Mainly because there is so little data on FMT. I'm not too familiar with the topic, but there were at least two US reports of E. coli infections, both involving multiple patients. One was antibiotic-resistant strain which resulted in death, another was enteropathogenic strain. Both were from clinical studies, in which donors were prescreened for the presence of pathogens. And now with Covid pretty much all legitimate FMT were put to a halt while people are trying to develop procedures to minimize the risk of Covid infection due to FMT. The virus can be detected in the GI tract, it's just not known whether it can be transmitted or not.
And I perfectly understand your position. Personally, I'm very much in favor of opening up experimental treatments through "compassionate use" not only to terminal cancer patients, but also to sufferers of debilitating chronic conditions, like UC. With all appropriate disclosures and risk warnings. The current US model is awfully restrictive
But I'm afraid there are too many players who prefer the status quo. Like insurance companies who are interested in maximizing their profits as much as the greediest big pharma exec. And who have more influence over treatment options than the FDA. And malpractice lawyers, against whom no disclosure is ever safe.
Would it be so bad to blame big pharma for something? I guess so. It seems we all know who the 800 pound gorilla is these days.
No, the industry has faults. I’ve worked in big law and have seen a pharma company “Martin Skrlei” a neonatal medication that treats a condition primarily associated with premature babies born to women on medicare. The potential liability was assessed at $25m because they had raised the cost of that drug 1300%. However, that company was being bought in a multi billion dollar deal so the larger well known acquirer swallowed the risk or deducted in part from the purchase price. DOJ investigated but I never learned what penalty came down, if any.