The drugs don't work

POSTED BY: canttakesky
UPDATED: Sunday, October 26, 2025 11:22
VIEWED: 2880
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CANTTAKESKY

Sunday, September 23, 2012 11:44 AM

Quote:
Originally posted by FREMDFIRMA:
Quote:
EXPERIMENTAL:
This drug has not been sufficiently tested for safety and effectiveness, any use should be considered "off-label" and physicians should refrain from prescribing save at patient request.

Yep, I can live with that.

Quote:
As for budget/personnel expansion, simple logistics - the FDA flat out does not have, at this time, the resources or personnel to do it's job effectively... I mean it, they really don't.
OK. If we're going to have an FDA, or any federal agency, we should fund it correctly and not half-assed. I'm ok with that.

I would prefer to have truth in labeling monitored by an NGO. But life is full of compromises.

MAGONSDAUGHTER

Sunday, September 23, 2012 10:16 PM

I sometimes feel like the doctors in the US have no ethics whatsoever. If a drug is still at clinical trial stage, not only should they let you know ethically, you should not be required to pay for it.

The drugs can and do work, but there needs to be some cleaning up of practises around prescribing and how these drugs are clincally trialled.

CANTTAKESKY

Monday, September 24, 2012 1:27 AM

Quote:
Originally posted by Magonsdaughter:
I sometimes feel like the doctors in the US have no ethics whatsoever. If a drug is still at clinical trial stage, not only should they let you know ethically, you should not be required to pay for it.

The article was written by a physician in the UK. And Reboxetine was not in clinical trials. They were already approved by the UK version of the FDA.

CHRISISALL

Monday, September 24, 2012 3:34 AM

Quote:
Originally posted by Magonsdaughter:
I sometimes feel like the doctors in the US have no ethics whatsoever.

1KIKI

Monday, September 24, 2012 4:14 AM

I would really like to see a thoughtful discussion of this ...

I recommend these articles, which are what scientists say to each other, about each others' work, about the process of drug testing, about what is the nature of the science, and about what they think it means:

http://the-scientist.com/2012/05/01/data-diving/
Data Diving
What lies untapped beneath the surface of published clinical trial analyses could rock the world of independent review.
"There’s been an understanding for some time that publication bias is a real occurrence, and that it often favors the drug. Trials that show no efficacy are less likely to get into print than trials that demonstrate a positive effect. So when Lisa Bero at the University of California, San Francisco, decided to redo 42 published meta-analyses of drugs and include unpublished, but available, data, she suspected the drugs would fare poorly. “But that’s not what we found,” she says."

http://the-scientist.com/2012/05/14/opinion-misleading-drug-trials/
Opinion: Misleading Drug Trials
Amgen’s incomplete report on an early major trial of epoetin misled the medical community about the anemia drug’s risks and benefits—and helped make Amgen rich.
"The academic authors of the 1998 publication state there was no intent to mislead, claiming the NEJM editors removed from drafts all the adverse results that I reported in 2012. They also state the 1998 publication clearly discouraged targeting hematocrit to 42 percent. What the 1998 publication did not do, however, was make clear, as my report does, that higher epoetin doses carry great risks, while the only benefit was a meager reduction in transfusion risk at great monetary cost."

http://the-scientist.com/2012/05/23/overhauling-industry-sponsored-stu
dies/
Overhauling Industry-Sponsored Studies
Major pharmaceutical companies have agreed to a handful of recommendations aimed at increasing the transparency of clinical trials they fund.
"All clinical trial findings—even negative ones—will be made public, author contributions to manuscripts will be made clear, and study authors will have full access to all trial data in industry-funded clinical trials if a list of recommendations hashed out by editors at top medical journals and eight major pharmaceutical companies are actually implemented."

MAGONSDAUGHTER

Monday, September 24, 2012 4:14 AM

Quote:
Originally posted by canttakesky:
Quote:
Originally posted by Magonsdaughter:
I sometimes feel like the doctors in the US have no ethics whatsoever. If a drug is still at clinical trial stage, not only should they let you know ethically, you should not be required to pay for it.

The article was written by a physician in the UK. And Reboxetine was not in clinical trials. They were already approved by the UK version of the FDA.

I beg your pardon.

I trust Ben Goldacre, not merely because he is a relative by marriage, but because I find him a clear thinking,critical scientist.

He says it all:

"Nobody broke any law in that situation, reboxetine is still on the market and the system that allowed all this to happen is still in play, for all drugs, in all countries in the world. Negative data goes missing, for all treatments, in all areas of science. The regulators and professional bodies we would reasonably expect to stamp out such practices have failed us. These problems have been protected from public scrutiny because they're too complex to capture in a soundbite. This is why they've gone unfixed by politicians, at least to some extent; but it's also why it takes detail to explain. The people you should have been able to trust to fix these problems have failed you, and because you have to understand a problem properly in order to fix it, there are some things you need to know.

Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don't like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug's true effects. Regulators see most of the trial data, but only from early on in a drug's life, and even then they don't give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion.

In their 40 years of practice after leaving medical school, doctors hear about what works ad hoc, from sales reps, colleagues and journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are, too. And so are the patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are owned outright by one drug company. Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it's not in anyone's financial interest to conduct any trials at all."

Really the issue is about the quality of research and who researches it and why.

1KIKI

Monday, September 24, 2012 6:50 AM

Hi Magonsdaughter

I wonder if there are significant differences between UK and US processes, and therefore significant differences in positive v negative results from manufacturers. I would like to have seen the data teased out rather than lumped together. Perhaps it's that way in the book, which isn't available online.

From the various reading that I've done over the years, there are OBVIOUS cases of positive manufacturer bias, but in the US on statistical review (using detailed data not contained in the original report) it is literally 50/ 50 as to whether more detailed, more inclusive review downgrades the product (which one would expect) or upgrades it (which one would not).

My belief is that this testing should be done by government, after all, why would you WANT to have a vested interest conducting the testing? On the face of it, that's a ridiculous proposition.

But there are other more difficult questions about testing that haven't been resolved that have to do with the statistical nature of biological testing, with placebo and nocebo effects, with standards against which you judge the medicine or therapy (placebo or standard treatment), and with placing a value on risk v benefit. And also where the rubber meets the road - in the practice of medicine as either a statistical intervention or an individual one.

And also, just to address the title of the thread, it's pretty obvious drugs do work, the question is on whom do they work, and when.

I'll probably order the book, but I suspect it'll be years and more data before I make my mind up about the best way to test drugs to get the most useful answers (with the exception I think it should be in the hands of government or universities paid by government).

1KIKI

Monday, September 24, 2012 7:04 AM

This is a similar conundrum, except it's about exercise, not medication. In this case the endpoint are measures THOUGHT to be meaningful to future heart risk (excerpts):

For Some, Exercise May Increase Heart Risk
http://well.blogs.nytimes.com/2012/05/30/can-exercise-be-bad-for-you/

By analyzing data from six rigorous exercise studies involving 1,687 people, the group found that about 10 percent actually got worse on at least one of the measures related to heart disease: blood pressure and levels of insulin, HDL cholesterol or triglycerides. About 7 percent got worse on at least two measures. And the researchers say they do not know why.

But counterbalancing the 10 percent who got worse were about the same proportion who had an exaggeratedly good response on at least one measure. Others had responses ranging from little or no change up to big changes, seen in about 10 percent, where risk factor measurements improved anywhere from 20 percent to 50 percent.

The problem with studies of exercise and health, researchers point out, is that while they often measure things like blood pressure or insulin levels, they do not follow people long enough to see if improvements translate into fewer heart attacks or longer lives. Instead, researchers infer that such changes lead to better outcomes — something that may or may not be true.

... In all the studies, a proportion of people, about 10 percent, had at least one measurement of heart disease risk that went in the wrong direction.

Then the researchers asked if there was some way of predicting who would have an adverse effect.

They found it was not related to how fit the people were at the start of the study, nor to how much their fitness improved with exercise. Age had nothing to do with it, nor did race or gender. In some studies subjects were allowed to take medications to control their blood pressure or cholesterol levels. In others they were not.

Medication use did not matter. The study subjects exercised at a range of intensities from very moderate to fairly intense. But intensity of effort was not related to the likelihood of an untoward effect. Nothing predicted who would have an adverse response.

FREMDFIRMA

Monday, September 24, 2012 4:06 PM

Worth a note to that, in regards to rigging clinical trials...
Gardasil...

Not only was the sample size too damn small, and did not include their intended market anyways, they also front-loaded the results by using a "placebo" laced with an adjuvant known to cause adverse reactions.
What pissed me off was that in spite of this no one would friggin listen till the bodies started piling up.

Doctors are like auto mechanics for the human body, they're not infallible, and not always trustworthy either, that whole doctor-as-diety perception needs to go, and quick-like.

-Frem

ETA: I totally forgot to include WHICH drug, d'oh!
My brain ain't workin too well right now due to severe cat deprivation.

RIONAEIRE

Thursday, September 27, 2012 5:30 AM

Well all I know is that after my stint of getting off regular medicine for my mental health differences and trying naturopathic options, from Oct. to Aug. of this year, I was really glad to get back to taking the regular stuff that helps my mood component, because I feel sooooooooooooooo much more like me again instead of feeling like the evil hagbeast of death and doom. I had very little success in the naturopathic experiment, though we tried several things and several different avenues. I do think that everyone should give it a go if they can, in case it will work for them, since it does for some, but I'm glad I've gotten back to taking my stuff. Now if we could find something that helps with my other components I'd be doing good, but those components are a lot harder to treat for me it seems. Multi pronged mental illness sucks sometimes.

"A completely coherant River means writers don't deliver" KatTaya

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