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Nearly 400 medical devices, procedures and practices found ineffective in study

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Re: Nearly 400 medical devices, procedures and practices found ineffective in study

#81

Post by lekanwang »

dannykwells wrote: post #18

Everyone yelling about how the FDA is corrupt or should only screen for safety are completely ignorant of history and basic facts. Medicine is not like trying out a new coding framework - in some cases, like cancer: i) There is no ability to "try it out for your self" - you are either all in or not ii) There are extreme risks to taking the drug (most cancer drugs are actually somewhat to extreme toxic...just less tox…

Having worked closely with FDA, I've been very impressed by the people there and how thoughtful they are despite the pressure they're under and the almost complete lack of good software tooling due to the sensitivity, regulatory requirements, and complexity and specialization of the data. Most of the medical officers there could easily be a very successful (and much higher paid) private physician or a pharma researcher somewhere but choose to remain at FDA.

On one point people are making specifically -- unlinking safety with efficacy is really tough -- an immunooncology product that causes serious AEs/hospitalizations in a quarter of the population and costs $250k and only extends life by 6 months may be approved because the alternative is almost certain mortality; whereas another drug may not be approved simply because it increases bleeding risk in a small percentage of people because there are good alternatives already.

Re: Nearly 400 medical devices, procedures and practices found ineffective in study

#82

Post by geggam »

gumby wrote: post #66
geggam wrote: post #44

Earlier quoted context omitted.

When employees at the FDA leave and take positions at one of the companies they had a hand in approving something for, at an increased salary. The appearance of impropriety is blatant. Regardless of it actually happening or not it looks terrible. This should never happen

> Regardless of it actually happening or not it looks terrible. This should never happen I understand the problem you're describing, but consider what you're asking for: people with competence and experience should be barred from taking jobs that require competence and experience? Non-competes have the same problem.

Think of it like a judge. You should be recusing yourself of anything that looks improper.

Public servants have a higher standard they need to adhere to and they simply aren't, it is endemic in the public space.

Re: Nearly 400 medical devices, procedures and practices found ineffective in study

#83

Post by kolbe »

addicted wrote: post #70
geggam wrote: post #58

Earlier quoted context omitted.

Of course I did. After watching the govt and the FDA in action for 5 decades, detassling corn for Monsanto, watching Monsanto sue farmers into submission, seeing increased rates of cancer autism and other issues. Being told everything is ok. Then I travel the world eating food in other countries and notice the difference in my health. I see the cancer rates in Africa. You say I am uneducated and stupid. I say I have…

No one has said everything is ok. Just by claiming we are being told “everything is ok” you are showing the absolute lies and false straw men and disingenuousness that is at the centre of the anti vax movement. Somehow you don’t apply even close to the same standards to the anti vax side, where the only evidence is proven to have been falsified. Also, Anti vaxxers claim they are sick of experts, yet are unwilling to…

I have more empathy for people who are intellectually stunted and now buy into conspiracy theories. They really never had a choice. If the US or their parents had provided them with sufficient education, maybe it would have been different, but it's hard for me to get as mad at them as you are.

On the other hand, the doctor who knows better, but chooses his own pocket book over the well being of millions is far less empathetic in my mind.

Both people suck in their own way, but I'm less inclined to get worked up about the former.

Re: Nearly 400 medical devices, procedures and practices found ineffective in study

#84

Post by jjwhitaker »

geggam wrote: post #35
criley2 wrote: post #33

Earlier quoted context omitted.

Anti-vax comes from anti-intellectualism, just like your opinion does. Two sides of the same coin. It has nothing to do with "trust in agencies" and everything to do with intellectualism. We live in a society where academics, data, evidence, etc are all maligned. How can you trust in an agency if you aren't willing to trust anyone at all? The cancer is not trust in agencies, it's your culture of anti-intellectualism…

Good way to convince people... Call them stupid ;)

They are actively resisting scientific data, analysis, and research that overwhelmingly supports vaccines. They may not be stupid, but they are acting like it by putting their beliefs and bias over fact.

I'll stick with actively malicious over stupid as anti-vax is actually crippling and killing people by increasing the spread of diseases that were prevented or eradicated.

Re: Nearly 400 medical devices, procedures and practices found ineffective in study

#85

Post by geggam »

evandijk70 wrote: post #68
geggam wrote: post #44

Earlier quoted context omitted.

When employees at the FDA leave and take positions at one of the companies they had a hand in approving something for, at an increased salary. The appearance of impropriety is blatant. Regardless of it actually happening or not it looks terrible. This should never happen

I am not in this field, but I guess that as an employee at the FDA you approve drugs for all the big pharma companies, which aside from the FDA are the major employers that value their skillset. It may be that if you prohibit FDA employees to transition to one of the big pharma companies, you're telling them that they can either work at the FDA forever or have to leave their field

Yes, there is a price to pay for being a public servant.

Re: Nearly 400 medical devices, procedures and practices found ineffective in study

#86

Post by geggam »

addicted wrote: post #67
mola wrote: post #59

Earlier quoted context omitted.

That's not true. Trust is a major issue and is directly responsible for anti vaxxer movement. Major corporations and media outlet have made bending the truth (PR spins etc) a legitimate common place practice. Any talking head you see on television /other media is not genuinely trying to convince you. They are all hired hands which will say whatever it takes to produce the results their employers demand. The amount of…

This is nonsense. The anti vaxxers place far more trust on someone who is known to have falsified data, and committed egregious malpractice. The anti vaxxers lack of trust in the media has almost nothing to do with what the media may or may not have done to lose trust. The actual difference is that one side does not have a good explanation for what causes autism, and as a result admits that they don’t have the answer…

You dont need that falsified data to come to the conclusion vaccinations in the US are a problem. Remove it from the picture.

Compare the US vaccination schedule to any other develop country. Compare our infant mortality rate.

Aside from the differences in the vaccination schedules what is the US doing different from other developed nations. Keeping in mind infants do little but eat food, sleep and see a doctor.

So it's food or healthcare causing the difference. With WIC and the fact poor people qualify for free medical care it's arguable economics dont play much into this.

so explain why the US is so bad at this ?

Re: Nearly 400 medical devices, procedures and practices found ineffective in study

#87

Post by EvanAnderson »

I found this one from the table of reversals to be interesting:

Article: Efficacy of infant simulator programmes to prevent teenage pregnancy: a school-based cluster randomised controlled trial in Western Australia

Summary: The infant simulator is an example of persuasion technology or captology, where the use is intended to prevent teenage pregnancy.26 Their use is widespread in developed countries27 and is expanding into low-income and middle-income countries.28 However, in this study done in Australia, the infant simulator-based VIP program did not reduce teenage pregnancy. In fact, girls in the intervention group (n=1,267) were more likely to experience a birth (8% vs. 4%; HR=1.35; 95% CI=1.06-1.73; p=0.016) or an induced abortion (9% vs. 6%; HR=1.33 (1.00-1.78; p=0.049) than those in the control group (n=1,567) before they reached 20 years of age. This is a reversal of the practice of infant simulator programs to prevent teenage pregnancy.

A school district I contract with purchased some of these "infant simulators" a few years ago. I shared spooky photos of them entombed in foam in their storage cases (evoking visions of racks of "hibernating" astronauts from sci-fi) with my wife. She made a general observation that she thought some fraction of teenage girls would feel encouraged to have a baby after time w/ the infant simulator. Guess there was some truth to that intuition after all.

Re: Nearly 400 medical devices, procedures and practices found ineffective in study

#88

Post by geggam »

ehnto wrote: post #77
geggam wrote: post #58

Earlier quoted context omitted.

Of course I did. After watching the govt and the FDA in action for 5 decades, detassling corn for Monsanto, watching Monsanto sue farmers into submission, seeing increased rates of cancer autism and other issues. Being told everything is ok. Then I travel the world eating food in other countries and notice the difference in my health. I see the cancer rates in Africa. You say I am uneducated and stupid. I say I have…

My argument would be to look into the studies made by numerous universities from all around the world, not just American ones. I have no business telling you whether or not you should trust American government entities, it's not my country. But the world has had medicines and universities for longer than the United States has existed.

You do realize the EU has banned many many things allowed by the FDA because of their studies ?

Re: Nearly 400 medical devices, procedures and practices found ineffective in study

#89

Post by chimeracoder »

skybrian wrote: post #40
dannykwells wrote: post #18

Everyone yelling about how the FDA is corrupt or should only screen for safety are completely ignorant of history and basic facts. Medicine is not like trying out a new coding framework - in some cases, like cancer: i) There is no ability to "try it out for your self" - you are either all in or not ii) There are extreme risks to taking the drug (most cancer drugs are actually somewhat to extreme toxic...just less tox…

This is true, but there may be moderate reforms that would work. Could drugs approved by European regulators be allowed without FDA approval? Which regulators do a better job?

> Could drugs approved by European regulators be allowed without FDA approval?

Why should they be? It's not like European regulators have a better track record than the FDA here.

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