3 ms·

> The other thing I learned is that Big Pharma/FDA does a horrible job of listing medication side effects. I say that because "causes sleep apnea" was not on th

by gumby 4y ago

> The other thing I learned is that Big Pharma/FDA does a horrible job of listing medication side effects. I say that because "causes sleep apnea" was not on the list of side effects for carbamazeine Having designed and run clinical trials, I think your assertion based on a single experience is unreasonable. Companies are very interested in unexpected events, particularly bad ones (called “adverse events” in the jargon). Viagra was “discovered” because of an unanticipated side effect of a drug being tested for a heart disorder. That long list of side effect warnings? The companies love that list because it reduces legal risk (and marketing risk: doctors will tell patients what to look for and/or will avoid giving it to patients at risk of effect X). While it seems plausible to me that sleep apnea could be a side effect of a drug like carbamazepine (though it’s not a benzo) it was not reported to any statistically significant extent. since you have to report all AEs, the FDA will, in some cases, zero in on one that was reported at a minor level for additional study, because someone in the review panel thought worthy of investigation due to some scientific issue in their specialty. Drug companies hate that of course, but that’s one reason why there’s a review panel rather than a single reviewer.

clsec 4y ago
While I respect your expertise in the field, I disagree. >Companies are very interested in unexpected events, particularly bad ones (called “adverse events” in the jargon). Viagra was “discovered” because of an unanticipated side effect of a drug being tested for a heart disorder. Tell that to Moderna and Pfizer. They, nor the FDA, have shown any interest in adverse events reported by both patients and doctors to VAERS [1], unless whatever hypothetical minimum number of people report it. I've had, as well as Dr. Greg Poland [2], a pretty severe adverse reaction to the mRNA vaccines but our problems remain unaddressed because not enough people have reported it, science knows little about our reaction, or it doesn't monetarily benefit anyone (liability or profit). As for the Viagra discovery, it was a monetary benefit. Scientists and researchers in the medical field need to realize everyone is different and we have different reactions to various drugs. I guarantee you that carbamazepine was causing my apnea problems. It also caused two other adverse reactions that are not listed as side effects. Now that I think about it, your entire comment screams pharmaceutical marketing to me. [1] https://vaers.hhs.gov/ https://vaers.hhs.gov/ [2] https://www.mayo.edu/research/faculty/poland-gregory-a-m-d/bio-00078220 https://www.mayo.edu/research/faculty/poland-gregory-a-m-d/b... edit: mRNA
- gumby 4y ago
  > Scientists and researchers in the medical field need to realize everyone is different and we have different reactions to various drugs. You really think that they do not realize this? The whole reason for phase 3 trials is to have a candidate drug tested on a sufficiently large and diverse population that represents the treatment population in order to look for these very variations. If there is anyone who doesn’t want to recognize this, it would be the actuaries at the insurance companies. > I guarantee you that carbamazepine was causing my apnea problems. I never suggested otherwise. I merely said that a statistically significant number of such cases did not show up in trials so it wasn’t listed as a side effect for doctors to look out for. Your comment about vaers doesn’t make much sense either. Vaccines have absolute insurance coverage provided by the government so that companies will make them at all. Vaers is a postmarket surveillance system for the government. Both Moderna and Pfizer’s Covid vaccines have been through the full phase 1,2,3->NDA process (i.e. no longer under emergency use authorization) including ae surveillance.

by gumby 4y ago

clsec 4y ago

While I respect your expertise in the field, I disagree. >Companies are very interested in unexpected events, particularly bad ones (called “adverse events” in the jargon). Viagra was “discovered” because of an unanticipated side effect of a drug being tested for a heart disorder. Tell that to Moderna and Pfizer. They, nor the FDA, have shown any interest in adverse events reported by both patients and doctors to VAERS [1], unless whatever hypothetical minimum number of people report it. I've had, as well as Dr. Greg Poland [2], a pretty severe adverse reaction to the mRNA vaccines but our problems remain unaddressed because not enough people have reported it, science knows little about our reaction, or it doesn't monetarily benefit anyone (liability or profit). As for the Viagra discovery, it was a monetary benefit. Scientists and researchers in the medical field need to realize everyone is different and we have different reactions to various drugs. I guarantee you that carbamazepine was causing my apnea problems. It also caused two other adverse reactions that are not listed as side effects. Now that I think about it, your entire comment screams pharmaceutical marketing to me. [1] https://vaers.hhs.gov/ https://vaers.hhs.gov/ [2] https://www.mayo.edu/research/faculty/poland-gregory-a-m-d/bio-00078220 https://www.mayo.edu/research/faculty/poland-gregory-a-m-d/b... edit: mRNA

gumby 4y ago
> Scientists and researchers in the medical field need to realize everyone is different and we have different reactions to various drugs. You really think that they do not realize this? The whole reason for phase 3 trials is to have a candidate drug tested on a sufficiently large and diverse population that represents the treatment population in order to look for these very variations. If there is anyone who doesn’t want to recognize this, it would be the actuaries at the insurance companies. > I guarantee you that carbamazepine was causing my apnea problems. I never suggested otherwise. I merely said that a statistically significant number of such cases did not show up in trials so it wasn’t listed as a side effect for doctors to look out for. Your comment about vaers doesn’t make much sense either. Vaccines have absolute insurance coverage provided by the government so that companies will make them at all. Vaers is a postmarket surveillance system for the government. Both Moderna and Pfizer’s Covid vaccines have been through the full phase 1,2,3->NDA process (i.e. no longer under emergency use authorization) including ae surveillance.