What do these pills do?

[Bleurberry]

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Maybe you think you know...
I've heard the FDA has pretty lax regulation on what exactly needs to be submitted for pharma acceptance, but here's an interesting article that's possibly discussion provoking.

http://www.sciencenews.org/view/generic/id/38881/title/Many_drug_trials_never_see_publication

I often see it mentioned that pharma is evidence based and largely infallible because of it, and that if a drug is proven not to work, it's pulled. Well, this article suggests that it's not so easy to stop a multi-million dollar money train that's already barreling down the tracks.

ex:

" ...The new analysis examined 164 trials for 33 new drugs that were approved by the FDA from January of 2001 to December 2002. By June 2007, 22 percent of the trials were either published only in a partial form — as an abstract, or part of a pooled publication — or were not published at all. The unpublished trials were predominantly those with unfavorable results, the researchers report."

 

[spicedmanna]

This is not at all surprising, I'm sorry to say. What you are witnessing in this article is essentially, "business as usual" for our wounded health care system. When you put profit before the benefit of the patient, this is the sort of thing you are going to get. The article states that "drugs that have favorable results are more likely to be published than drugs that have unfavorable result." In other words, if the results weren't favorable (or neutral), it wasn't as likely to be published. Well, duh, if I were a pharm company, interested primarily in profit, and I wanted to get my drug out in the market and secure funding for further trials, knowing my drug didn't have all favorable results, I might push for something like that. It is demonstrating a so-called "publication bias." That's wrong, of course, and it represents a systemic failure and very bad science.

Drugs are not infallible, but the paradigm of EBM isn't flawed; it is in some cases, the execution that is problematic, owing to the predominate biases in the health care industry/system. The pharmaceutical industry is interested in profit and may play a role in pushing drugs to market that have unfavorable results and unknown side effects. So far, this is all common knowledge. Obviously we need to fix this problem, but to more completely address it, we need to shift the health care system from profit-centered, industry dominated, to one that places the patient first and the control back to the physician and patient. These problems, however, do not at all diminish the utility of drugs that have proven throughout time, with good evidence, to be of benefit. As physicians (or future physicians) it is our responsibility to look out for our patients. We need to do our best to be on the alert for treatments that are problematic and don't have a strong basis to be given as treatment. Drugs aren't special because they are drugs, as any good physician-scientist will tell you. And quite obviously, we need to fix these problems in the system, or better yet, shift the paradigm of profit-dominated health care to a patient-centered one, taking the critical control away from pharm and insurance companies. Don't fault EBM, fault greed.

 

[Bleurberry]

Don't fault EBM, fault greed.

Undoubtedly true. Now compound it with this article, and it gets even more wild:

http://www.sciencenews.org/view/feature/id/39046/title/Imagination_Medicine

ex:

" “The placebo effect is in some way the bane of the pharma industry’s existence because people have this nasty habit of getting better even without a specific drug,” says David Spiegel, a psychiatrist at Stanford University School of Medicine.
It all boils down to expectation. If you expect pain to diminish, the brain releases natural painkillers. If you expect pain to get worse, the brain shuts off the processes that provide pain relief. Somehow, anticipation trips the same neural wires as actual treatment does. "

Fascinating stuff.

 

[Altruist]

ex:
" "The placebo effect is in some way the bane of the pharma industry's existence because people have this nasty habit of getting better even without a specific drug," says David Spiegel, a psychiatrist at Stanford University School of Medicine.
It all boils down to expectation. If you expect pain to diminish, the brain releases natural painkillers. If you expect pain to get worse, the brain shuts off the processes that provide pain relief. Somehow, anticipation trips the same neural wires as actual treatment does. "

What I find most amazing about medications is that, for them to work on the brain, it means that you have receptors for those substances (or similar ones) already in your brain... which means that there are similar chemicals to those medications that already exist in your body, before you ever take them. We just play with the amounts of those substances; that's where the effect that we want comes from. Why do opiates and opiods relieve pain? Because your body already makes substances that are similar to them. That, to me, seems crazy, but helps to explain the placebo effect.

An episode of Radiolab on the placebo effect mentions this point. If you want, you can listen on their website:
http://www.wnyc.org/shows/radiolab/episodes/2007/05/18

One figure I remember is that ~40% of the control group for the study on Propecia (hair-growing drug) reported some degree of hair growth compared to 60-70% of those in the experimental group. That might change your opinion on the effectiveness of Propecia.

About the drug studies, I wonder if some sort of mandate will be required to make drug companies release this kind of information... we always used to say in the chemistry lab that the most useful journal would be a journal of reactions that didn't work... pharmacology is the same way.

 

[Semicolon]

Undoubtedly true. Now compound it with this article, and it gets even more wild:

http://www.sciencenews.org/view/feature/id/39046/title/Imagination_Medicine

ex:

" “The placebo effect is in some way the bane of the pharma industry’s existence because people have this nasty habit of getting better even without a specific drug,” says David Spiegel, a psychiatrist at Stanford University School of Medicine.
It all boils down to expectation. If you expect pain to diminish, the brain releases natural painkillers. If you expect pain to get worse, the brain shuts off the processes that provide pain relief. Somehow, anticipation trips the same neural wires as actual treatment does. "

Fascinating stuff.

Wow, that is really amazing; this is the kind of stuff that leans me towards neurology! 😀

I always did believe that optimism can help recovery; I often use that tactic for myself. From what Altruist said, it seems that drugs simply give us more control over something our mind already has control of (at least under normal circumstances). But I guess that's where drugs come in.

 

[Bleurberry]

About the drug studies, I wonder if some sort of mandate will be required to make drug companies release this kind of information... we always used to say in the chemistry lab that the most useful journal would be a journal of reactions that didn't work... pharmacology is the same way.

As it stands now, they're able to shred any and all trials as they see fit, purely selective, and submit only the trials they wish. I mean it's apparently more insidious than this, because those in the FDA want to be in good with many of the submitting companies so when they leave the public sector, they have a golden parachute of a job lined up, but that's a slightly different topic. This is where private and public interests collide and burn. While the new administration is opening the doors and windows of the FDA and airing it out/bringing in the sunshine (i.e. happening right now, or at least the orders have been issued by the administration for a full top-to-bottom review of the FDA's procedure and practice), what you suggest should be considered, or a form thereof.

 

[Bleurberry]

Wow, that is really amazing; this is the kind of stuff that leans me towards neurology! 😀

I always did believe that optimism can help recovery; I often use that tactic for myself. From what Altruist said, it seems that drugs simply give us more control over something our mind already has control of (at least under normal circumstances). But I guess that's where drugs come in.

I couldn't agree more; even psychiatry, dare I say?! This field of psychoneuroimmunology has some teeth behind it when you see it in this light, but alas, it's a research driven field, and at least right now, I'm a clinical-minded guy. 🙄
But we'll see, it pays to keep up on the literature, I'm sure, and there's definitive value in understanding the biomechanics behind placebo, or whatever we'll call it in the 21st century once the science pans out.

 

[Bleurberry]

If you've got 15 minutes to watch this, I encourage it.
It's really fascinating, he's a clinical professor at UCSF
and founder of the Preventive Medicine Research Institute,
discussing low-cost, high-result techniques for healing in patients.

http://www.ted.com/index.php/talks/dean_ornish_on_healing.html

Best watched with a semi-dry Cabernet.

 

[MossPoh]

They were interviewing some guy on NPR a while back. He was talking about how it is nearly impossible for the FDA to DO all of the testing that is required not only because of the money issues, but because they are simply underfunded and understaffed for all of the things they are charged with doing. Most countries are trying to figure out the best way to do it, so we can't just fault the US, but people get all up in arms about a drug being released that is harmful or ineffective but look at how much crap they have to cover. We keep throwing stuff at them but expect them to do it with the same amount of money. Research is expensive....it is difficult to see what really happens sometimes until a drug is released into the population, after which point it might take a couple of years of waiting to get the numbers back and actually notice a trend. Over all...it doesn't really seem like a surprise to me.

 

[GlobeMedder]

There is a book called overdosed america: the broken promise of american medicine and it basically talks about these issues and even draws on specfic drug classes like statins and antidepressants. Its a really good read and just helps to make sure you look at evrything before jumping to conclusions about a drug

 

[facetguy]

If you've got 15 minutes to watch this, I encourage it.
It's really fascinating, he's a clinical professor at UCSF
and founder of the Preventive Medicine Research Institute,
discussing low-cost, high-result techniques for healing in patients.

http://www.ted.com/index.php/talks/dean_ornish_on_healing.html

Best watched with a semi-dry Cabernet.

Dean Ornish, MD (the guy in the video) is a true pioneer. He's all about lifestyle changes and has done very important research to prove the value of such interventions, including reversing heart disease. His latest book (a book for anyone; not a textbook):
http://www.amazon.com/Spectrum-Scie...bs_sr_1?ie=UTF8&s=books&qid=1234732253&sr=8-1

Unfortunately, our society has been programmed that we just need to take a pill (preferably an expensive blockbuster medication) to stay healthy, which is ruining us both physically and financially. If Dr. Ornish's advice could make a company billions of dollars, we'd surely be hearing a lot more about it.

 

[facetguy]

Here's an article that discusses, in part, the FDA's role in approving various substances, in this case bisphenol-A. It's a fairly long article but it's interesting to see how science is sometimes for sale, and how these bogus research results are used over and over.
http://www.fastcompany.com/magazine/132/the-real-story-on-bpa.html?page=0,0

Just an example from the article:
"...the outside scientist supervising the FDA's latest review [of bisphenol-A, or BPA], Martin Philbert of the University of Michigan Risk Science Center, failed to disclose a $5 million donation from a man named Charles Gelman -- a retired medical-device executive and an opponent of BPA regulation."

It's crap like this that could make one lose faith in 'the process' and begin to question how things really get done.

 

[spicedmanna]

It's crap like this that could make one lose faith in 'the process' and begin to question how things really get done.

I agree with you. I've seen a lot of crap in biomedical research, particularly where it relates to pharmaceuticals and funding. It traumatized me. It certainly can be a dirty business and just being around it as often as I was several years ago, caused me to lose faith in the process for a long while.

 

[facetguy]

Makes it tough for the 'good guys' out there really trying to make a difference.

 

[dozitgetchahi]

Wow, that is really amazing; this is the kind of stuff that leans me towards neurology! 😀

I always did believe that optimism can help recovery; I often use that tactic for myself. From what Altruist said, it seems that drugs simply give us more control over something our mind already has control of (at least under normal circumstances). But I guess that's where drugs come in.

This reminds me of a very interesting study I read a while back. When the H2 receptor antagonist cimetidine (aka Tagamet) came onto the market in the late '70s, it was surrounded with a great deal of (not necessarily unwarranted) hype. After all, it was the first really powerful treatment available for acid reflux/heartburn/etc, so physicians at the time were justifiably pretty excited about it. Consequently, doctors who prescribed the drug tended to talk up how strong and effective it was, and their patients tended to agree - several studies showed that >90% of GERD patients treated with Tagamet reported partial or complete relief of their symptoms.

However, for a drug intended to treat GERD cimetidine had a great deal of undesirable properties. It tended to inhibit a bunch of cytochrome p450 enzymes, leading to a multitude of drug interactions; its half-life was rather short, meaning that it had to be taken frequently; and it was associated with a bunch of goofy and dangerous side effects (including gynecomastia and agranulocytosis). The search for better alternatives continued, culminating in the marketing of ranitidine (aka Zantac) and the early '80s. Ranitidine had almost none of these problems, so yet again gastro docs were justifiably excited and hyped the drug heavily to the patients to whom it was prescribed. Consequently, >90% of the patients who were prescribed Zantac reported that the drug was effective. The kicker, however, is that only about 70% of the patients who were being prescribed Tagamet by the same docs now found it effective - and that percentage dropped steadily in the years following Zantac's introduction. The study's authors concluded that the overall effectiveness of a given drug is largely a function of the doctor's expections about its effectiveness, and that the doctor's expectations tend to be transferred over to his/her patients.

 

[Apterous]

If you've got 15 minutes to watch this, I encourage it.
It's really fascinating, he's a clinical professor at UCSF
and founder of the Preventive Medicine Research Institute,
discussing low-cost, high-result techniques for healing in patients.

http://www.ted.com/index.php/talks/dean_ornish_on_healing.html

Best watched with a semi-dry Cabernet.

This was a great clip to watch. It really brings to heart how powerful our bodies are in healing themselves. I highly recommend this as well