4 ms·

Ever heard of Vioxx? It was a new drug to treat a condition which was already treatable with other drugs. Vioxx caused tens of thousands of deaths (~50,000?). T

by calebm 5y ago

Ever heard of Vioxx? It was a new drug to treat a condition which was already treatable with other drugs. Vioxx caused tens of thousands of deaths (~50,000?). Transparency is paramount with new medical interventions.

nradov 5y ago
Transparency is necessary but there's no evidence that Merck hid Vioxx clinical trials data from the FDA. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/vioxx-rofecoxib-questions-and-answers https://www.fda.gov/drugs/postmarket-drug-safety-information...
colpabar 5y ago
Also, are people unaware that pfizer had to pay a $2.3b settlement in 2009 for fraud? It was the largest health care fraud settlement ever at the time. https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history https://www.justice.gov/opa/pr/justice-department-announces-... It's so odd to me that the whole "trust the science" mantra of this entire pandemic is thrown out the window when we ask to actually see the science for ourselves.
- dntrkv 5y ago
  Lex asks the Pfizer CEO that question in his interview: https://youtu.be/Z_LhPMhkEdw?t=1369 https://youtu.be/Z_LhPMhkEdw?t=1369
ludamad 5y ago
"increased risk of heart attack and stroke associated with long-term, high-dosage use" with benefit of the doubt, I'd imagine that people are quite interested in arthritis treatment alternatives, and it seems hard to determine the problems with trials? Apparently the drug did find a niche for "hemophilic arthropathy" per wikipedia post recall, so it seems far from an unmitigated disaster
ceejayoz 5y ago
Vioxx gets complicated; other NSAIDs, including non-selective ones, turn out to have a pretty nasty cardiac risk profile too, and the withdrawal harmed a lot of patients who relied on it. https://pharmaceutical-journal.com/article/feature/still-feeling-the-vioxx-pain https://pharmaceutical-journal.com/article/feature/still-fee... > After Vioxx was withdrawn, there were numerous papers and discussion on the increased risk of cardiovascular events with all NSAIDS and labelling changes were made. However, Silman argues that it has still not been proven in observational studies that Vioxx’s cardiovascular events were any higher than, for instance, diclofenac, a popular non-selective NSAID. > It proved to be complex: not all COX-2 inhibitors have the same cardiovascular risks and not all non-selective NSAIDs have the same cardiovascular risks. “If the VIGOR study had been comparing Vioxx against diclofenac, it is entirely plausible that it would have shown no difference in cardiovascular events,” Silman points out. > ... > If MSD had not withdrawn the drug, perhaps regulators would have deemed that it not be used in patients with pre-existing heart conditions and the elderly, Silman ponders. “It was not necessarily a given that Vioxx should have been withdrawn completely. For instance, diclofenac has not been withdrawn and is still on the market but with advice to use with caution,” he says. > Neither does Silman think Vioxx should have been withdrawn, since it proved to be a very effective anti-inflammatory drug. “The joke at the time of its withdrawal was that every rheumatologist was stockpiling Vioxx because of its efficacy.” The Vioxx story is not so simple and it was not about “Vioxx being the bad guy”, he says.
TeeMassive 5y ago
And accountability. I understand the need for urgency and the use of emergency orders, but once these are gone these companies will still be unaccountable and will still be getting paid even if their promise of efficacy are not held.

by calebm 5y ago

nradov 5y ago

Transparency is necessary but there's no evidence that Merck hid Vioxx clinical trials data from the FDA. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/vioxx-rofecoxib-questions-and-answers https://www.fda.gov/drugs/postmarket-drug-safety-information...

colpabar 5y ago

Also, are people unaware that pfizer had to pay a $2.3b settlement in 2009 for fraud? It was the largest health care fraud settlement ever at the time. https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history https://www.justice.gov/opa/pr/justice-department-announces-... It's so odd to me that the whole "trust the science" mantra of this entire pandemic is thrown out the window when we ask to actually see the science for ourselves.

dntrkv 5y ago
Lex asks the Pfizer CEO that question in his interview: https://youtu.be/Z_LhPMhkEdw?t=1369 https://youtu.be/Z_LhPMhkEdw?t=1369

ludamad 5y ago

"increased risk of heart attack and stroke associated with long-term, high-dosage use" with benefit of the doubt, I'd imagine that people are quite interested in arthritis treatment alternatives, and it seems hard to determine the problems with trials? Apparently the drug did find a niche for "hemophilic arthropathy" per wikipedia post recall, so it seems far from an unmitigated disaster

ceejayoz 5y ago

Vioxx gets complicated; other NSAIDs, including non-selective ones, turn out to have a pretty nasty cardiac risk profile too, and the withdrawal harmed a lot of patients who relied on it. https://pharmaceutical-journal.com/article/feature/still-feeling-the-vioxx-pain https://pharmaceutical-journal.com/article/feature/still-fee... > After Vioxx was withdrawn, there were numerous papers and discussion on the increased risk of cardiovascular events with all NSAIDS and labelling changes were made. However, Silman argues that it has still not been proven in observational studies that Vioxx’s cardiovascular events were any higher than, for instance, diclofenac, a popular non-selective NSAID. > It proved to be complex: not all COX-2 inhibitors have the same cardiovascular risks and not all non-selective NSAIDs have the same cardiovascular risks. “If the VIGOR study had been comparing Vioxx against diclofenac, it is entirely plausible that it would have shown no difference in cardiovascular events,” Silman points out. > ... > If MSD had not withdrawn the drug, perhaps regulators would have deemed that it not be used in patients with pre-existing heart conditions and the elderly, Silman ponders. “It was not necessarily a given that Vioxx should have been withdrawn completely. For instance, diclofenac has not been withdrawn and is still on the market but with advice to use with caution,” he says. > Neither does Silman think Vioxx should have been withdrawn, since it proved to be a very effective anti-inflammatory drug. “The joke at the time of its withdrawal was that every rheumatologist was stockpiling Vioxx because of its efficacy.” The Vioxx story is not so simple and it was not about “Vioxx being the bad guy”, he says.

TeeMassive 5y ago

And accountability. I understand the need for urgency and the use of emergency orders, but once these are gone these companies will still be unaccountable and will still be getting paid even if their promise of efficacy are not held.