Slouching To Primary Day: More Bender Demagoguery

The latest study showed that Avastin was not efficacious (4.00 / 1)

Physicians are not 100% objective, although we all strive to meet that goal.

We need experts in their fields to determine whether a drug should be available, free from politics and free from 'outside influences.'

Anecdotal evidence is just that - it is not hard scientific fact.

Bender should not meddle in a field he knows nothing about, just to score political points.

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by: Putney Swope @ Thu Aug 19, 2010 at 16:09:47 PM CDT

I have to gingerly disagree... (0.00 / 0)

Bender is correct in that in this society, I do NOT want ANY government agency determining what is an appropriate treatment.  I have no problem with testing for efficacy, and testing for safety, but the ultimate decision on treatment should be between the physician and the patient, NOT a government agency.

That drug which is not efficacious for one person may be precidely the right drug for the odd patient...and I offer a relative of mine, whose Thyroid meds are 3 times the recommended maximum dose - - but thats because of complicating conditions found in almost no one else in the country.  Every time she has moved or changed doctors, it has been a nightmare because the 'rules' do NOT work for her.

Hey, I love peanut butter...its safe and nutritious...it also kills those with allergies.  ONE size does NOT fit all, and this is one of the problems with the FDA's approach.

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by: Thomas Simmons @ Thu Aug 19, 2010 at 16:16:28 PM CDT

The physician does not have the time or the expertise to adequately examine ALL the data (0.00 / 0)

I know I don't have the time to read the studies on every new drug.

The FDA has staff to examine these studies in the minutest detail, which I know they do. And like I said 'outside influences' often cloud a physician's judgement.

The FDA does not dictate the maximum doses used for thyroid medications; the label is a recommendation.

I think the culprit in this case are these doctors' fear of lawyers, not the FDA.

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by: Putney Swope @ Thu Aug 19, 2010 at 17:28:23 PM CDT

[ Parent ]

Well, I want government to do the studies (4.00 / 1)

and determine that thalidomide causes birth defects, and take it off the market. Neither the doctor nor the patient can do that research.

The Republican Party is controlled by people who have rejected the scientific method in favor of anecdotes and ideology.

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by: elwood @ Thu Aug 19, 2010 at 18:07:14 PM CDT

[ Parent ]

notice.. (0.00 / 0)

...I never suggested that government shouldnt do the studies, or publish the results.  And I never suggested that doctors should spend their time doing that.

But, once done, it still must be the Doctor-Patient relationship that establishes treatment.

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by: Thomas Simmons @ Thu Aug 19, 2010 at 18:39:49 PM CDT

[ Parent ]

Sometimes the results are definitive. (0.00 / 0)

The treatment does not work, period. There is no statistical difference in results versus a placebo.

In other cases the proven risks far outweigh the claimed benefits. Thalidomide, in the early 1960s, was promoted and prescribed as a sedative.

In those cases I want the government to take the drug off the market.

In other cases a drug may have high risk factors that make it appropriate in only 1% of patients. In those cases I do not want the FDA taking it off the market - I want them ensuring that the risk information is clearly presented.

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by: elwood @ Thu Aug 19, 2010 at 18:51:47 PM CDT

[ Parent ]

well, I think even that logic (0.00 / 0)

can have flaws.  It is always good to measure the placebo effect.  But, as recently showed with antidepressants, a drug may be efficacious when compared with doing nothing but show no statistical difference when compared with placebo.  One key point from the data:

Yes, the drugs are effective, in that they lift depression in most patients. But that benefit is hardly more than what patients get when they, unknowingly and as part of a study, take a dummy pill-a placebo. As more and more scientists who study depression and the drugs that treat it are concluding, that suggests that antidepressants are basically expensive Tic Tacs.

Depression runs in my family, and antidepressants currently help a lot of family members.  I don't want anyone taking away those pills because they're statistically no better than a sugar pill.  We need the government to study these medications, but also the judgment to know when and how to use statistics when recommending certain treatments.

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by: Keene Observer @ Thu Aug 19, 2010 at 21:23:57 PM CDT

[ Parent ]

"Hardly more" > "none" n/t (0.00 / 0)

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by: elwood @ Fri Aug 20, 2010 at 05:41:58 AM CDT

[ Parent ]

You're right (0.00 / 0)

I would also add that "hardly more" is often equal to "no statistical difference".  I'd have to go back to the paper and see what kind of p values they get to see if that's the case with this.  Here's some more food for thought from later in the article

After taking the unknown meds for a while, some volunteers experience side effects. Bingo: a clue they're on the real drug. About 80 percent guess right, and studies show that the worse side effects a patient experiences, the more effective the drug.

And then there's this

That matters because belief in the power of a medical treatment can be self-fulfilling (that's the basis of the placebo effect). The patients who correctly guess that they're getting the real drug therefore experience a stronger placebo effect than those who get the dummy pill, experience no side effects, and are therefore disappointed. That might account for antidepressants' slight edge in effectiveness compared with a placebo, an edge that derives not from the drugs' molecules but from the hopes and expectations that patients in studies feel when they figure out they're receiving the real drug.

My only point would be to never, ever underestimate the ability of the human mind to affect the pathophysiology of any disease.

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by: Keene Observer @ Fri Aug 20, 2010 at 07:00:26 AM CDT

[ Parent ]

Tom, I think we've had this discussion before. (0.00 / 0)

I think it sounds great on paper but I'm worried about the specifics.

The free market may work - but only after drug review journals like the Medical Letter have their say and only if the prescriber actually reads these journals and only if they do not depend solely on the army of drug detail people (with their increasingly illegal perks).

There are a lot of 'ifs' in this equation and I don't think it will be universally applied.

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by: Putney Swope @ Thu Aug 19, 2010 at 20:11:05 PM CDT

The free market always works -- (0.00 / 0)

when all positive and negative effects of the drug are fully known and made publicly available.

when consumers are strictly rational.

when consumers receive all the information available, have sufficiently extensive medical education or knowledge to understand it, and do indeed understand it.

when consumers either receive no false or misleading information (from drug company ads, misled or financially interested physicians, word of mouth or elsewhere) or recognize it as false or misleading and do not take it into account at all.

when consumers' money is what is directly spent.

In 99.3%* of prescription drug cases none of the first four above are true.

*(Data source: wazoo, but accurate nonetheless.)

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by: Tim C. @ Fri Aug 20, 2010 at 10:39:35 AM CDT

[ Parent ]

We haven't done much Yeats here (4.00 / 2)

That must be the most quoted poem in existence.

The Widening Gyre
Things Fall Apart
The Center Cannot Hold
The Ceremony of Innocence
The Blood-Dimmed Tide is Loosed

and oh yes:

The best lack all conviction
While the worst are full of passionate intensity

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by: elwood @ Thu Aug 19, 2010 at 20:51:10 PM CDT

It would make a difference (0.00 / 0)

if the medications they develop didn't cost the patient and the taxpayers so much.  We have higher drug costs than other developed countries whose governments make an effort to control the prices they can charge.  Now I know we don't like price controls, but given that the supposed reason for the high prices is the cost of research and development, and there is evidence that we, the taxpayers, support much of that research, the argument falls a bit short.  

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by: Lucy Edwards @ Fri Aug 20, 2010 at 06:13:34 AM CDT

It's not just demagoguery. It's a non sequitur. (0.00 / 0)

That independent panel didn't decide that the drug isn't worth the money; it decided the drug isn't work the risk.

FDA isn't determining whether or not to buy anybody medicine. Its safety verification functions are not new and complicated Obamacare rationing.  This is just FDA doing the same thing it's been doing since Teddy Roosevelt: protecting the public from dangerous food and drugs whose risks outweigh their benefits.

--
"Act as if ye have faith and faith shall be given to you." -Aaron Sorkin

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by: Douglas E. Lindner @ Sat Aug 21, 2010 at 12:37:58 PM CDT