20 Million is a drop in the bucket in an industry that moves billions.

And this is why software (algorithm) patents are supposed to be illegal.

They obfuscated the risk of addiction throughout the 90’s. Medical literature describes the tolerance to addiction cycle in these drugs as early as the 50’s, it isn’t like it was unknown. When faced with the sharp rise in Opioid deaths post 2000 they convened a panel of experts in 2002, early enough to reign in the off label prescriptions, the panel of 10 experts they brought in had 8 members with significant financial ties to Purdue Pharmaceutical. It wouldn’t be until 2013 before any serious steps were taken, at which point there were enough pills on the market to give every adult in the United States a full bottle.

They were able to prescribe off-label, over produce, and flood both forward facing and black markets for over a decade before any meaningful action was taken. Yes, they absolutely work. They were just way more addictive than the FDA was willing to regulate, and often even recognize.

It's just the good old problem of incentives misalignment. And the article doesn't seem to have any solution that is practical to implement.

Suppose we did form an independent research committee. That committee now has the incentive to test medicines in such a rigorous and harsh ways that nothing would get approved. In a situation of ambiguity, this committee would rather reject a newer medicine based on some vague or ill-founded doubts, rather than approve a medicine that's reasonably effective. They are not paid to get out an effective medicine in public.

I've not experienced that personally, but all I'm saying is that you can't take that from Kuhn or Popper unless they have written stuff subsequent to my study of the subject.

After the prescription opioid crisis, I’m surprised that a comment like this would get upvotes. Are you philosophy guys not following the news or something?

And you sound hopelessly naive.

Is that why true free/hispeed internet isn’t green and available in every house, why they slow down renewable energies and lag on hispeed rail

You said

> Just because there are negative side effects like to a drug (like addiction) does not mean it’s development process was flawed

Either the process is flawed, or killing a ton of people was the intention.

I qualified my statement that I was not familiar with these clinical trials so I don’t know why you think this is some sort of gotcha. I’m not advocating for the current mechanisms we used to fund science and develop new drugs. The entire process socializes the risks and privatizes the profits.

You are shilling for an immoral nexus of pharm $, regulatory capture and corrupt science:

> FDA failure to obtain adequate evidence of effectiveness was not limited to oxycodone. Over the past 25 years, despite mounting evidence that a surge in opioid consumption was resulting in adverse public health consequences, the FDA continued to approve new opioid formulations for chronic pain based on efficacy trials utilizing a controversial methodology called enriched enrollment randomized withdrawal (EERW).26 Since its 2006 approval of oxymorphone, the FDA has relied on EERW as evidence of opioid efficacy for chronic pain.27 EERW trials differ from traditional double-blind, randomized, controlled studies. In an EERW trial, prior to randomization for a double-blind phase, all subjects are made physiologically dependent on the opioid in a 4- to 6-week open-label phase. Then only the patients who tolerated the opioid and found it helpful during the open-label phase are randomized to remain on the opioid or switch to a placebo. Critics of EERW have correctly described this methodology as “cooking the books” for 2 reasons.28 First, because only patients who tolerated the opioid and found it helpful are allowed to proceed to randomization, the study is not representative of the general population, and the results cannot be generalized to clinical practice. Second, because daily use of opioids causes physiological dependence, efficacy results are skewed in favor of the subjects who remain on the opioid. This is because opioid-dependent subjects who are switched to placebo experience opioid withdrawal symptoms, including increased sensitivity to pain. Moreover, switching opioid-dependent subjects to placebo renders the study not truly double-blind. The FDA’s decision to rely on EERW trial methodology is a consequence of the agency’s close ties to industry. In fact, the FDA’s decision to use EERW for analgesics was based on discussions at private meetings between FDA officials and pharmaceutical company executives hosted by an organization called Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT).29 Drug companies paid up to $35 000 each for the opportunity to attend IMMPACT meetings and interact with FDA staff.29 Yet, despite the uproar that followed public disclosure of the IMMPACT meetings, the FDA continues to rely on EERW trials as evidence that opioids are effective for chronic pain.

https://journalofethics.ama-assn.org/article/how-fda-failures-contributed-opioid-crisis/2020-08

Clinical trials assess the safety and tolerability of a drug in the patient population when dosed correctly. I don’t know off the top of my head what follow-up studies are required for the approval of an analgesic. From my understanding OxyContin is safe when used as intended. The marketing campaign to get doctors to over-prescribe it is a completely different process which would not even begin until after the drug is approved (has passed clinical trials). To expand on this a little there are plenty of drugs with addictive potential that are legal to use (I.e dextromethorphan and Xanax). Just because there are negative side effects like to a drug (like addiction) does not mean it’s development process was flawed. All drugs have side effects.

“Through web searches and online services such as LinkedIn, however, Science has discovered that 11 of 16 FDA medical examiners who worked on 28 drug approvals and then left the agency for new jobs are now employed by or consult for the companies they recently regulated. This can create at least the appearance of conflicts of inter

Well the drug in question seems to have qualities that spawned a massive public health emergency, record settlements etc, if there is to be a discussion of a crisis in scientific credibility that seems like a reasonable starting point as OP points out. How does a defender of the pharma establishment explain the variance between trials vs real life outcomes? Gross incompetence seems unlikely?

That counts as R&D and for some reason that's weighed the same as a new vaccine. Do you not think that's little manipulative? What do you have against more nuance?

If you want s source, how about this one?

So you ask for sources, then throw out some juvenile nonsense when presented with them. Yeah, definitely done bothering with you.

I don’t know much about the clinical trials run in OxyContin, but why do you think that the trials were flawed?

Do you consider monster flavored ketchup science?

Self aware wolf of the Mont Pelerin Society.

There’s so much corruption.

It's not hard information to find. From a super cursory Google search pulling up the Funding of Science page on Wikipedia: "According to the Organisation for Economic Co-operation and Development (OECD), more than 60% of research and development in scientific and technical fields is carried out by industry, and 20% and 10% respectively by universities and government."... The International Science Council says that "The private sector’s share of global science and innovation is growing, and is now estimated to represent approximately 70 per cent of global expenditure on science.". Source...

It's really not a disputable fact.

Can you cite that for me?

Just because 14% isn't 50% doesn't mean that bad science isn't passing through the filter. And whataboutism, especially pointing at a social science for replication, certainly doesn't invalidate the points this article is making. Doctors are fire hosed with pharmaceutical propaganda under the guise of impartial science.

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Yes. Unequivocally. The fact that you apparently don't means that you have absolutely no clue what you are talking about and there isn't any point even responding to you anymore.