4 ms·

Where was the FDA? Were the doctors all innocent? Is stupidity a good criminal defense? They should be all in the same cell.

Retric 2y ago
FDA has some culpability, but the fraud was so effective Medical Schools where teaching students to prescribe more opioids. Perdue Pharma effectively hacked the medical system. I think the real takeaway is there’s likely more of this going on than we realize. The common decongestant phenylephrine being no more effective than placebo comes to mind. Without the mass deaths there’s apparently little to stop modern snake oil salesman. Perhaps the FDA needs to conduct direct hands on oversight of medical trials? I mean if there’s billions to be made and little chance of prison the incentives get crazy.
- rallison 2y ago
  There is a phenomenal article in Scientific American talking about the phenylephrine/pseudoephedrine debacle: https://www.scientificamerican.com/article/how-two-pharmacists-figured-out-that-decongestants-dont-work/ https://www.scientificamerican.com/article/how-two-pharmacis... It's sort of a different class of failure than with opioids, but it is a notable area of weakness. Basically, for OTC drugs that were initially approved before 1962, many are still on the market despite sometimes having weak efficacy data. While the FDA has been making some progress in reevaluating these older drugs, we're still far from where we should be. A few quotes from the conclusion of the article (but the entire piece I linked in SA is worth a read!): > In 2023, 16 external experts on the second Nonprescription Drug Advisory Committee looked at all the evidence compiled by FDA staff, heard manufacturers' arguments in favor of oral phenylephrine's efficacy, and heard from experts like me who argued that oral phenylephrine is ineffective. In the end, they concluded that oral phenylephrine is not GRASE. A final ruling on whether decongestants containing the drug can still be sold will take time. We hope science will prevail. > From this experience we've learned that the monograph process for OTC drugs approved before 1962 needs to be reexamined. Systematic reviews of the available evidence indicate that other nonprescription drugs such as guaifenesin (sold in Mucinex and Robitussin), dextromethorphan (sold in Robitussin DM) and antihistamines marketed for colds (for instance, chlorpheniramine) probably don't help with coughs and colds. They are usually not dangerous, but their effects are likely to be the result of a placebo response; more modern research is needed. > The outcome for oral phenylephrine shows that the FDA needs more funding to look at old drugs. We need public funds to support independent researchers who want to examine these products objectively. The government should be able to spend millions to save consumers billions on ineffective products. Companies that market these products have no incentive to prove they don't work. Nonprescription drugs must be effective, not just safe.
  - harimau777 2y ago
    I'm surprised there aren't lots of PhD students doing modern trials on these. "I was the person disproved a widely available drug" seems like it would be a great thing to have on an academic resume. From the outside, it also seems like this would be relatively easy research since the drugs are widely available, safe, and treat common symptoms.
- wyldfire 2y ago
  > FDA has some culpability They appear to have left the oversight up to two individuals - ones with whom there was an obvious quid-pro-quo [1]. It's a stain on the agency and they should take responsibility and make changes. [1] https://journalofethics.ama-assn.org/article/how-fda-failures-contributed-opioid-crisis/2020-08 https://journalofethics.ama-assn.org/article/how-fda-failure...
datadeft 2y ago
>Were the doctors all innocent? Some medical professional went from healers to corporate shills for big pharma in 50 years. My favorite video about this subject: Dr. Aseem Malhotra - 'Evidence Based Medicine Has Been Hijacked' https://www.youtube.com/watch?v=qwovXFzUvfg https://www.youtube.com/watch?v=qwovXFzUvfg

Retric 2y ago

FDA has some culpability, but the fraud was so effective Medical Schools where teaching students to prescribe more opioids. Perdue Pharma effectively hacked the medical system. I think the real takeaway is there’s likely more of this going on than we realize. The common decongestant phenylephrine being no more effective than placebo comes to mind. Without the mass deaths there’s apparently little to stop modern snake oil salesman. Perhaps the FDA needs to conduct direct hands on oversight of medical trials? I mean if there’s billions to be made and little chance of prison the incentives get crazy.

rallison 2y ago
There is a phenomenal article in Scientific American talking about the phenylephrine/pseudoephedrine debacle: https://www.scientificamerican.com/article/how-two-pharmacists-figured-out-that-decongestants-dont-work/ https://www.scientificamerican.com/article/how-two-pharmacis... It's sort of a different class of failure than with opioids, but it is a notable area of weakness. Basically, for OTC drugs that were initially approved before 1962, many are still on the market despite sometimes having weak efficacy data. While the FDA has been making some progress in reevaluating these older drugs, we're still far from where we should be. A few quotes from the conclusion of the article (but the entire piece I linked in SA is worth a read!): > In 2023, 16 external experts on the second Nonprescription Drug Advisory Committee looked at all the evidence compiled by FDA staff, heard manufacturers' arguments in favor of oral phenylephrine's efficacy, and heard from experts like me who argued that oral phenylephrine is ineffective. In the end, they concluded that oral phenylephrine is not GRASE. A final ruling on whether decongestants containing the drug can still be sold will take time. We hope science will prevail. > From this experience we've learned that the monograph process for OTC drugs approved before 1962 needs to be reexamined. Systematic reviews of the available evidence indicate that other nonprescription drugs such as guaifenesin (sold in Mucinex and Robitussin), dextromethorphan (sold in Robitussin DM) and antihistamines marketed for colds (for instance, chlorpheniramine) probably don't help with coughs and colds. They are usually not dangerous, but their effects are likely to be the result of a placebo response; more modern research is needed. > The outcome for oral phenylephrine shows that the FDA needs more funding to look at old drugs. We need public funds to support independent researchers who want to examine these products objectively. The government should be able to spend millions to save consumers billions on ineffective products. Companies that market these products have no incentive to prove they don't work. Nonprescription drugs must be effective, not just safe.
- harimau777 2y ago
  I'm surprised there aren't lots of PhD students doing modern trials on these. "I was the person disproved a widely available drug" seems like it would be a great thing to have on an academic resume. From the outside, it also seems like this would be relatively easy research since the drugs are widely available, safe, and treat common symptoms.
wyldfire 2y ago
> FDA has some culpability They appear to have left the oversight up to two individuals - ones with whom there was an obvious quid-pro-quo [1]. It's a stain on the agency and they should take responsibility and make changes. [1] https://journalofethics.ama-assn.org/article/how-fda-failures-contributed-opioid-crisis/2020-08 https://journalofethics.ama-assn.org/article/how-fda-failure...

datadeft 2y ago

>Were the doctors all innocent? Some medical professional went from healers to corporate shills for big pharma in 50 years. My favorite video about this subject: Dr. Aseem Malhotra - 'Evidence Based Medicine Has Been Hijacked' https://www.youtube.com/watch?v=qwovXFzUvfg https://www.youtube.com/watch?v=qwovXFzUvfg