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Red Pill or Blue Pill? First, take off those 3D glasses.
September 22, 2012 1:48 AM   Subscribe

The drugs don't work : a modern medical scandal - "The doctors prescribing the drugs don't know they don't do what they're meant to. Nor do their patients. The manufacturers know full well, but they're not telling."
posted by Gyan (76 comments total) 46 users marked this as a favorite

 
This is a MAJOR factor for so many people losing trust in Science in general. If the "business" is distorting the facts about medicine that so many of us use to function or even survive, then what can we believe from any field of Science? We'll never eliminate the quacks of "Alternative Medicine" if there are equally dishonest players controlling "Conventional Medicine".

This also explains why it is so easy to distrust studies on such vital scientific issues as Climate Change. But ironically, the richest and most powerful interests that could be distorting the data are the same people who deny that there is any problem. So it becomes disturbingly likely that the scary forecasts we are seeing are actually too optimistic.

So our economic system of Corporatism (NOT Capitalism) will at least neutralize the efforts of Scientific Progress to protect and improve Humanity, if not outright destroy us. And not even Bill Nye can save us.
posted by oneswellfoop at 2:34 AM on September 22, 2012 [12 favorites]


It's all about keeping the doctors prescribing patented medication. Nuke the patent system. Fully fund the full drug development cycle using taxes, presumably with universities and hospitals doing the work.

In fact, you might start by killing only the privately held patent system. Assign all patents on drugs developed with national funding to a pool that only companies entirely located inside the nation can exploit, but nevertheless permit any generic drug company inside that country to produce the drug. In short, national funding pays for the development, but free market competition amongst producers works out the price.
posted by jeffburdges at 2:52 AM on September 22, 2012 [15 favorites]


So our economic system of Corporatism (NOT Capitalism)

The definition of capitalism is not "a perfectly free system, run correctly, and which does not wear underwear under its kilt".
posted by Pope Guilty at 2:53 AM on September 22, 2012 [17 favorites]


The definition of capitalism is not "a perfectly free system, run correctly, and which does not wear underwear under its kilt".

Sure, but I would argue that it is apt to call what we have corporatism.

I would say that the fundamental aspect of capitilism is the dynamics of supply and demand. In order for this to work, there needs to be a diversity of corporations trying to provide supply, so that competition renders the supply effecient. In capitalism, profit is considered a sign of inneficiency, because it is money that should be used in the very least to reduce prices.

Instead what we have is a lack of diversity in many supplies, where monopolies use their position to extract as much profit as possible. This is practically anti capitalist in the strict sense, and I would rather call it corporatist.
posted by Alex404 at 3:40 AM on September 22, 2012 [5 favorites]


"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."

Isn't it wonderful how we now live in a world where the only stuff that gets done is stuff that someone somewhere can make a profit off? But hey, gotta cut that government spending...
posted by Dysk at 3:55 AM on September 22, 2012 [9 favorites]


Important to note that, as it says at the foot of the article, this is an excerpt from a book that is going to become available for purchase next week.
posted by XMLicious at 3:59 AM on September 22, 2012 [3 favorites]


One thing I really admire about Ben Goldacre is that he is just as sceptical about the pharmaceutical industry as he is about alternative medicine.
posted by Azara at 4:02 AM on September 22, 2012 [8 favorites]


After suffering some very frightening and potentially life-threatening side effects (SLEEP DRIVING WHAT THE FUCK MAN?) when trying to find meds that manage the worst symptoms of my bipolarity, I just want to smoke a fatty whose dangerous side effecting include enhancing creativity (and orgasms!), allowing me to sleep restfully for 8 hours uninterrupted, and helps me keep a healthy weight.
posted by PapaLobo at 4:05 AM on September 22, 2012 [19 favorites]


Well, at the very least, there should be much stricter oversight on trials design, plus full disclosure of a) all results, with "stopped trials" included (including the reason for stopping), b) commercial affiliations of everyone who touched the data before publication, and c) all the funding streams for the project.

I suspect this won't have any real effect until testing is completely removed from the corporations. They pay fees for tests, the testing is done at blind locations, and the company gets the results at the same time as everyone else. Sure, this will reduce profits, but we are talking about lives....
posted by GenjiandProust at 4:09 AM on September 22, 2012 [3 favorites]


Very often the relevant trials aren't conducted in the first place. Tylenol is prescribed to pregnant women all the time (I am one) apparently on the basis that "pregnant women have been taking it for a long time; we'd probably have noticed by now if it were causing major problems." There are ethical issues for trials on that population for sure, but prescribing medications without any trials has some ethical issues too. And my daughter has a condition that's sufficiently rare that hardly any studies have been done on it at all, and those are small and sometimes contradictory.

I'm a scientist (in another field) and a big fan of science-based medicine. But often I am very disappointed in how little science there is to support a doctor's decisions one way or the other.

And if so many of the studies that there are, are flawed, it makes you wonder how medicine has been able to progress this far in the first place.
posted by OnceUponATime at 4:35 AM on September 22, 2012 [4 favorites]


Sure, this will reduce profits, but we are talking about lives....

This claim doesn't fit in a world market where human trafficking is one of the largest industries.
posted by Reasonably Everything Happens at 4:49 AM on September 22, 2012 [2 favorites]


We should make a note to distinguish science or evidence based medicine from profit based medicine, the latter being a subset of alternative medicine.
posted by Pyrogenesis at 4:49 AM on September 22, 2012 [10 favorites]


This is not news, of course. The problem has been pointed out many times. The key issue is that drug companies don't have to publish all their data. They do five tests, and one shows results, that's the one they publish.

There are changes that would help. 1) Make the drug companies submit all data from all tests when getting government approval. 2) Make the doctors who prescribe new drugs submit patient results for follow-up studies.

Of course, this is "move gov't regulation", which has been radically out of favor for the past decade or so.
posted by CheeseDigestsAll at 5:10 AM on September 22, 2012 [4 favorites]


Quacks concern me. I mean SERIOUSLY concern me. The Law of Attraction, the Secret, Byron Katie, Landmark forums, James Ray, weird guru cultures, homeopathy, a nutraceutical industry and "pop nutraceutical" "research" that is frighteningly badly done. It also frightens me that whole fields such as social work and psychology-- classes I've been taking a lot of--- teach scientifically false information to students because many teachers got education 20-30 years ago and are seriously behind on the relevent science in their field. Psychology and Sociology are "soft sciences" where a lot of subjective reasoning gets applied to a small amount of data. And then you look at how "data" can subsist of a chart that someone made up about "stages of development" which gets taughts as fact and you're in lala land.

"I can prove that this persons problem is their mother because freud, and also that they have not attained self actualization because of maslows hierarchy of needs"

And you pass the test because you used the words, but so many of my friends who have masters level social work degrees do NOT even pretend or try to read actual science that could change how they do their work. And if they do it comes through the pop science filter which is again problematic. And even more, peer reviewed itself is useful but STILL doesn't mean conclusions about the data are accurate, simply that they aren't outrageously or noticeably inaccurate to those who evaluated it.

When alternative medicine means "anything solution that is not a pharmacetical drug" it makes you wonder whether what we fear about alternative medicine is actually quacks--or facing that our own doctors are quacks and there might be some benefits to systems that see health as a multifactorial issue of environmental/social/familial/financial/job security/housing stability/air quality/food quality/self determiniation/healthy work environments---- and other factors that can be maintained in populations and individuals by many different means.

There is tons of science based evidence that we could be using to ensure people have access to a healthy envionment. actvities, and way of life. I'm not opposed to pharmaceuticals existance, but it is funny to me that we tend to believe being manufactured in a lab is inherently a sign of being better designed for the human body. And that pills made in labs are the only SCIENCE BASED methods of maintaining health. I like research, but we don't seem to be applying the research that leads to solutions that might work better than meds for many problems because it's not as neat and tidy and it doesn't generate an immediate profit.

Many very nice people can believe very false things about how to heal, maintain wellness and live fulfilling lives. And their nice but wrong ideas can cause a lot of real harm. As in disease, death, worsened emotional or mental health, and worse life outcomes. I want evidence based medicine, but I want an evidence based social system and policies for creating access to healthy lives for human beings. When peoples bodies are falling apart and they just keep working and working and working, there are some solutions that you won't see suggested by a doctor. Reduce the amount of physically demanding or stressful work.

Which, in our culture, for many people is not an option. And no pill will fix that we're missing many critical pathways to disease-requiring people subsist in conditions that are problematic for human health and that pills are the only way to fix the diseases that result.
posted by xarnop at 6:13 AM on September 22, 2012 [14 favorites]


1) Make the drug companies submit all data from all tests when getting government approval.

And if that doesn't work, require them to give notice of each test before they start it then refuse to accept data from tests that weren't notified. There is no sane reason not to do this, or at least no sane non-monetary reason.
posted by A Thousand Baited Hooks at 6:14 AM on September 22, 2012 [12 favorites]


I sometimes enjoy toying with the question of what would happen if the government were to force a (probably modified) nationalization of the pharmaceutical industry. This is the kind of story that leads to those thoughts.
posted by mr. digits at 6:16 AM on September 22, 2012 [1 favorite]


Market-based solutions hurt "consumers" because they systematically favour the interests of marketers. This is as true in medicine as anything that is subjected to the "discipline of the market." The results of "market forces" are malignity, corruption, and human misery.
posted by Sonny Jim at 6:32 AM on September 22, 2012 [7 favorites]


I have participated in many clinical trials for various drugs, as a subject; I've seen the kind of measures the echnicians take in order to get the results within the ranges required by their bosses- including making people do jumping jacks because their BP had fallen below the acceptable (desired) range, as required by the company that contracted the research. It's scary.

I also know a massage therapist who used to be a research chemist. He described to me the methods that his company trained him to use in order to massage the data. One technique he mentioned involved graphs; if a graph's data showed results that were mostly out of range, but there was one small area within range, he basically had to cut-and-paste only the good section into a new graph. He had a special name for it. He said its why he left his profession.
posted by windykites at 6:47 AM on September 22, 2012 [6 favorites]


I am an MD in reseach at one of the largest pharmaceutical companies in the world. Now, let me admit that I didn't read the entire piece -- I skimmed the last 1/3 or so looking for some key issues.

The tl;dr version": Pharma most definitely shit its own bed and put itself in the position it's in. There is systematic bias from journals for rejecting many negative studies. The placebo response is robust and demonstrable. Pharma is making strides in publishing all data in a timely manner. This whole issue is not as simple as it's made out to be.

The tl version:

With respect to Pharma-sponsored publications, I think the author leaves out a key issue: It can be damn near impossible sometimes to get a negative trial published. Why? Because journal editors don't want to give precious journal space to negative studies, particularly "uninteresting" negative studies sponsored by Pharma. I've read enough journal editorials and seen enough lectures at scientific meetings to know that journal editors are some of the most self-serving, hypocritical, sanctimonious assholes when it comes to publication bias. I'm here to tell you from experience, much of the bias is on their side, not ours. To that point, just how many submissions should we attempt? 2? 5?

A story: my colleagues and I wrote a completely novel secondary analysis regarding hypertension and cardiovascular outcomes with NSAIDs using data from the largest randomized NSAID cardiovascular outcomes trial ever conducted (N=34,000). (I guess there goes my thinly-veiled anonymity.) We initially submitted it to Annals of Internal Medicine, one of the highest-rated journals in the world. We received a single -- 1!-- reviewer comment: "I wanted to hate this study from the outset, but I could not find anything wrong with it." The reviewer noted the novelty and rigorusness of the study and suggested it be published. The editor, however, said it would not be of enought interest to the readership for publication.

Firstly, given the furor over NSAIDs and CV risk, the editor's comment is patently and demonstrably false, as these types of results continue to be of interest. Secondly, those of you who publish know that when you get essentially no reviewer comments, that study gets published. Period. In total, it took us 7 attempts before we finally got it published. THAT is what our commitment was to get this information out.

In many of my papers, reviewers often expressed their suspicions about the veracity of our results because there were Pharma employees. As MDs, PhDs, et al., on these papers, we find that extremely insulting. We've spent our careers in the pursuit of furthering science, and we sure as shit did not check our ethics at the door. I can't speak for the entire industry, but I can say unequivocally that my colleagues and I are as ethical as they come.

Not only that, we encounter other accusations about changing endpoints and other scientific fraud, both from reviewers and in letters to the editor that are completely baseless. It is one of the reasons I think peer review should be unblinded. Studies have shown a significant bias in blinded vs. unblinded review.

THIS is the kind of bullshit we encounter.

Moreover, while Pharma studies tend to be rigorously designed, you will find some of the most poorly designed non-Pharma studies published all over the place. I note, too, the assumed, implicit trust journals give independent studies. One look at Retraction Watch and scientific fraud will tell you that this occurs in academic circles, not with Pharma.

With respect to placebo-controlled trials, much has been written about both the strength of placebo response, as well as the increased response over time (see this Wired article. Without going into all of the literature (I don't have time to cite all of it), it was orignally estimated that the placebo effect is approximately 35%. That is to say, approximately 35% of patients will have a significant response with placebo. Other studies have shown that approximately 20% of the response to active drug is attributable to placebo response. Studies in asthma have consistently shown demonstrable physiologic response (e.g., changes in FEV1) with placebo. Interestingly they can induce it by telling patients they are inhaling known allergens. That is, there is a percentage of the population that are "suggestable" to such effects.

Given this, there is a move to conduct trials specifically in true responders. At first blush, this seems to stack the deck for Pharma. But if you think about it, if you know that there will always be a significant portion of nonresponders, it makes no sense to include them. What you really want to know is how well a drug works in responders. Enter the enriched enrollment, randomized withdrawal trial. You have a run-in period with active drug, those who do not respond are excluded. Those who do respond are then randomized to either: 1) continue active drug; or 2) taper off active drug. This is, perhaps, a truer test of efficacy.

Now, back to the article. A good move on Pharma's part -- part voluntary, part mandated -- was to publish all results. This is a very good move to publish all results in a timely fashion. This not only helps solve the problem of hiding negative studies, but also to avoid the problem of getting negative studies published.

Summary (a reiteration of the tl;dr): Pharma has shit its own bed and put itself in the position it's in. There is systematic bias from journals for rejecting many negative studies. The placebo response is robust and demonstrable. Pharma is making strides in publishing all data in a timely manner. This whole issue is not as simple as it's made out to be.
posted by ssmug at 6:51 AM on September 22, 2012 [71 favorites]


oneswellfoop : This is a MAJOR factor for so many people losing trust in Science in general.

You don't need to "trust" science - Science speaks for itself.

What TFA describes, however, does not count as science; rather, I would call it nothing more than marketing and regulatory compliance - With "compliance" taken in the same sense that the Devil always honors his bargains.

But look at the bright side - The FDA now allows pharmaceutical companies to patent long-existing ("orphan") drugs proven effective over years of in-situ human trials (aka "use"), Allowing Phizer to charge us a fortune this year to use something that cost pennies per month last year. So some drugs really work...
posted by pla at 7:26 AM on September 22, 2012


You don't need to "trust" science - Science speaks for itself.

You do, though. I don't know much about pharmaceutical chemistry, and I probably never will, and I have to trust that doctors and scientists are doing their jobs properly. The science might speak for itself to an expert, but I can't tell a good from a bad study except by listening to scientists. So if I can't trust them, what the hell do I do, other than get my own PhD?
posted by vogon_poet at 7:39 AM on September 22, 2012 [4 favorites]


Just wanted to add a link to Ben's wicked blog: Bad Science
posted by Monkeymoo at 7:41 AM on September 22, 2012 [2 favorites]


I dont think ill have a phd or even an AA.

I read the studies, I find doctors I can talk to & who will talk to me without going over board & doc shopping.

& I try stuff & see what works. Some of the side effects might kill me, but in the meantime theyre keeping things somewhat tolerable. When it doesn't, I'll move to cannibas county & start baking brownies.
posted by tilde at 7:44 AM on September 22, 2012 [1 favorite]


Sorry - I read the studies & message boards. Yay Internet. I never would have hit upon what's going on pos & neg on me in some ways without the Internet.
posted by tilde at 7:46 AM on September 22, 2012


I heard an "On The Media" once where the guest talked about drug trials and said that here in the US, legally, drug companies can hide failed drug trials by classifying the results or deaths as trade secrets. I'll try to find it.
posted by discopolo at 7:56 AM on September 22, 2012 [1 favorite]


The definition of capitalism is not "a perfectly free system, run correctly, and which does not wear underwear under its kilt".

The "No True Scotsman" thing is only relevant when someone is defending their political philosophy.

If someone's trying to reform their political philosophy, it's more effective to say, "We need Real Capitalism, not this lousy Corporatism we've got" than to say, "We need to abolish this lousy Capitalism and replace it with this better thing I've thought of called Whateverism."
posted by straight at 8:01 AM on September 22, 2012 [1 favorite]


It's worth mentioning that reboxitine, the anti-depressant Goldacre leads with, is not approved for use in the United States.
posted by escabeche at 8:06 AM on September 22, 2012 [2 favorites]


I'm sure all the evidence about illegal, recreational drugs is rock solid. The numerous, life-threatening side effects of LSD, for instance, are well-documented as compared to the complete safety of legal pharmaceuticals...really, the evidence is there. People try to fly off of buildings and stuff...
posted by Chuffy at 8:15 AM on September 22, 2012 [1 favorite]


Hey, it all balances out. In my practice, few people can afford patent protected medications anyway, so I rarely prescribe a medication that doesn't have 10+ years of widespread use in the general population. And guess what? Our outcomes data (NCQI certification for diabetes, CHF, cancer screening, immunization rates) are among the best in the nation. By the time you're using a fourth line $300 a month diabetes drug that doesn't work very well and confers extra hazard to control your patients, you'd be way better off using good old fashioned insulin or referring for gastric bypass. So much of pharma's success depends on convincing doctors to spend lots of money for very marginal benefits, based on incomplete data. Tragically, this undermines the public's confidence when we recommend things that have real benefits, for instance statins or inhaled steroids. I spend so much time convincing people that yeah, drug companies are evil and they lie, but the data for *this* drug really *is* good and it really will benefit you. The number of people forgoing recommended potentially life saving treatment because of well placed but incorrectly applied mistrust of the pharmaceutical industry is not trivial.

But the big take home message I try to impart to the students and residents I teach is that it pays big dividends to be extremely conservative when prescribing. Wait five or ten years on that new miracle drug that just came out. The chance that your are withholding a life saving treatment from your patients is infinitesimal.
posted by Slarty Bartfast at 8:32 AM on September 22, 2012 [12 favorites]


ssmug, thanks for the link to that NSAID study. That's useful information for me and I'll pass it to my doctors.

Wait five or ten years on that new miracle drug that just came out.

This is my philosophy as a patient. Kept me off Vioxx, which worked for me.
posted by immlass at 8:39 AM on September 22, 2012 [1 favorite]


Folks, apologies in advance, but this is the kind of stuff that makes people... um... not put a lot of trust in the current (very profitable) vaccine regimen...
posted by emmet at 8:44 AM on September 22, 2012


Sometimes I feel like we'd be better off in the US if we had a moratorium on all medical research for 20 years and put that money into improving access to medical care. I have a suspicion we'd see much better health outcomes.
posted by vitabellosi at 9:01 AM on September 22, 2012 [5 favorites]


Sometimes I feel like we'd be better off in the US if we had a moratorium on all medical research for 20 years and put that money into improving access to medical care. I have a suspicion we'd see much better health outcomes.

It would only take 6 months, but bravo, his eyes uncovered!
posted by Slarty Bartfast at 9:06 AM on September 22, 2012 [2 favorites]


Melody Peterson, author of Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs, was interviewed on Bill Moyers Journal about her book (Video & transript).

The statements "Science works" and "Big Pharma is corrupt and run by venal greed-heads who make decisions based on marketing and corporate shareholder profits over people's health, and fuck what the science (to whatever extent it's even understood) really says" are in no way incompatible.

The docs keep offering me a prescription pill for my migraines. Not a chance in Hell.

Luckily, I live in Oakland, Ca and have a note from my doctor.
posted by Pirate-Bartender-Zombie-Monkey at 10:07 AM on September 22, 2012 [1 favorite]


This is not news, of course.

It is to a lot of people. It should be, to the media. It should be shouted from rooftops.
posted by JHarris at 10:13 AM on September 22, 2012


It can be damn near impossible sometimes to get a negative trial published.

This. This is the problem. It was just discussed in a recent cancer research thread. I don't know the solution; should there be negative trial journals? Or maybe a database all negative trials go into? Should we compell researcher publish all trails, regardless of outcome?
posted by [insert clever name here] at 10:15 AM on September 22, 2012


emmet: no. Sorry. This kind of stuff isn't the the reason that the anti-vax movement is strong. This is far too nuanced a topic for that crowd. The reason the anti-vax movements strong is that some individuals have a default mistrust of 'unnatural' treatments that has been gleefully exploited by quacks and charlatans and Pyschic Extra-Dimensional Angel Mothers for profit and fame by citing the same debunked study from over a decade ago and encouraging people to misunderstand the nature and scope of vaccinations. Pharma / Science / Evidence-Based Medicine didn't shit the anti-vax movement in their own bed.
posted by lazaruslong at 10:16 AM on September 22, 2012 [7 favorites]


This is practically anti capitalist in the strict sense, and I would rather call it corporatist.

Most scholars do. The study of neo-corporatism was a veritable cottage industry in the 1980's. This trend began in the early to mid seventies, but really solidified as a consensus (that neo-corporatism is the dominating paradigm of all western liberal democracies) in the 1980's.

The fact that people act all confused and surprised when we have disastrous outcomes like we have had in education and healthcare is darkly comedic.
posted by AElfwine Evenstar at 10:33 AM on September 22, 2012 [1 favorite]


gleefully exploited by quacks...


Wow, slow down there! Now, I personally believe that vaccinations are good. But I know alternative health practitioners who disagree and advise against them. These people aren't trying to rip anyone off; they do what they do in good faith. They believe they are right. I know that metafilter loves to hate on homeopaths and psychics, and to be honest I think a lot of it is nonsense myself. But it's not fair to assume that all of these folks are deliberately trying to take advantage of the gullible. And many of these "quacks" do something that other practitioners, due to a lack of time and resources, fail to accomplish: they make the patient feel heard, validated, cared for, hopeful. That's not nothing. And sometimes it does help people. At least, it usually doesn't actively hurt them, unlike some of these medications.

I wanted to mention something else about clinical trials: if you're part of a clinical study as a healthy volunteer, you're probably there because you desperately need the cash. If you exhibit serious negative side effects, you are removed from the study. Everyone participating in the study is well aware of this. So what do you think happens? That's right: people make every effort to hide their side effects. Often successfully. There's a lot of "don't ask, don't tell" that goes on.
posted by windykites at 10:56 AM on September 22, 2012 [2 favorites]


With all due respect ssmug, your comment reads like a big "not our fault." Lots of issues are complex, yes, but that doesn't mean there's no culpability. And I have no idea how you can claim "the whole issue is as simple as it is made out to be" when you haven't even read the whole thing. It's not that long.

With respect to Pharma-sponsored publications, I think the author leaves out a key issue: It can be damn near impossible sometimes to get a negative trial published. Why? Because journal editors don't want to give precious journal space to negative studies, particularly "uninteresting" negative studies sponsored by Pharma.

Total outsider to the field here, but... isn't there some repository that studies that are not published into journals goes into? Not published shouldn't mean the same thing as secret.

Pharma most definitely shit its own bed and put itself in the position it's in.

This is part of the summary, but I don't get that implication from the content of your comment.

Studies have shown a significant bias in blinded vs. unblinded review.

But on the other hand... and again, speaking as an outsider to your field but I presume you're prepared for that given the audience here... I get the impression that there are corporate interests who push ahead studies that benefit them and hide studies that don't, and the example given in the article you didn't read lists the unfortunate result of that. And the article states early on: "They found that industry-funded trials were 20 times more likely to give results favouring the test drug." You skipped that part of the article, would you mind responding to it?

Moreover, while Pharma studies tend to be rigorously designed, you will find some of the most poorly designed non-Pharma studies published all over the place.

We're great! Everyone else sucks! What?

This is from the Guardian article:
In fact, the opposite is true: it is entirely normal for researchers and academics conducting industry-funded trials to sign contracts subjecting them to gagging clauses that forbid them to publish, discuss or analyse data from their trials without the permission of the funder.

Your statement:
A good move on Pharma's part -- part voluntary, part mandated -- was to publish all results.
directly contradicts this, but your supplied link, presumably intended to be support, seems to just be a general government site.

I don't know. Your comment seems strange, like it kind of misses the point off the article, and that makes it difficult to engage with. Honestly, it kind of looks like a blatant whitewash. You bring some random link and spend most of your comment responding to that. Could you please elaborate on what that has to do with the Guardian article?
posted by JHarris at 11:00 AM on September 22, 2012 [5 favorites]


windykites: "Wow, slow down there! Now, I personally believe that vaccinations are good. But I know alternative health practitioners who disagree and advise against them. These people aren't trying to rip anyone off; they do what they do in good faith. They believe they are right. I know that metafilter loves to hate on homeopaths and psychics, and to be honest I think a lot of it is nonsense myself. But it's not fair to assume that all of these folks are deliberately trying to take advantage of the gullible. And many of these "quacks" do something that other practitioners, due to a lack of time and resources, fail to accomplish: they make the patient feel heard, validated, cared for, hopeful. That's not nothing. And sometimes it does help people. At least, it usually doesn't actively hurt them, unlike some of these medications. "

1. It's cool that you believe that vaccinations are "good".

2. Alternative health practicioners that both advise against vaccinations AND do not have malicious intent do, of course, exist. There are true believers out there that believe they are doing good. That does not make them any less wrong. But the success of the movement is not on the credit of true believers, it is to the credit of quacks and charlatans who are perfectly aware they are peddling nonsense but do it anyway for profit, and encourage the true believers to continue true believing without thinking critically about the morality and efficacy of their "treatments".

3. Your impressions of MetaFilter notwithstanding, homeopaths and psychics, whether they be self-aware and intentionally duping people, or true believers that think they are helping, are nonsense. Pure and simple. I didn't mean to imply that ALL practicioners of pseudoscience are intentionally ripping people off. Of course not all of them are. There are two distinct groups there, certainly.

And many of these "quacks" do something that other practitioners, due to a lack of time and resources, fail to accomplish: they make the patient feel heard, validated, cared for, hopeful. That's not nothing. And sometimes it does help people. At least, it usually doesn't actively hurt them, unlike some of these medications.

There are many ways to get the benefits of attention, care, validation etc that you mention. The idea that 'alternative medicine' practioners should be lauded for providing this service, and that it doesn't actively hurt their patients, is nonsense. There are all SORTS of ways in which these practices harm their patients. Just a couple include financial hardship (paying outrageous fees for placebic care), false hope, wasted time, delayed treatment from evidence based medicine, and so on and so on. The idea that alternative medicine treatments are harmless good times is pernicious and false.
posted by lazaruslong at 11:41 AM on September 22, 2012 [7 favorites]


"Alternative medicine, by definition, has either not been shown to work, or been shown not to work. Do you know what they call alternative medicine that has been shown to work? Medicine." - Tim Minchin

What's The Harm? has some good info on the real harm caused by alternative medicine practitioners, quack or true-believer alike.
posted by lazaruslong at 11:43 AM on September 22, 2012 [8 favorites]


Hey lazaruslong, I'm not really interested in debating whether or not alternative practises have validity. Especially when the larger conversation here is about a failure of allopathic practises/standards/applications, and how the very "proofs" in favour of some medicines are suspect.

My issue was that the comment I was responding to seemed to be painting all alternative practitioners with the same brush- the implication was that all homeopaths (or whoever) are deliberately malicious or self-serving people out to take advantage of others. I didn't find that implication fair, and that's the only thing I wanted to respond to or engage with by my comment.
posted by windykites at 12:36 PM on September 22, 2012 [1 favorite]


And with all due respect, JHarris, I started off by capitulating that Pharma shit the bed and, thus I'm not trying to whitewash anything. And that bed would still be shitty unless journals really put a spotlight on it.

I can't respond to all of your comments. However, about the part about the positive trials. As I wrote, journals tend to publish positive trials more than negative ones. They are part of the problem of publication bias but rarely admit to their role. Has Pharma buried results? Yep. And again, I stated that.

Yes, I covered more ground than the Guardian article. Why? Because the issues are intimately related and were completely ignored. If anyone was doing the whitewashing, it was the Guardian.

I was very hesitant to link to my own work, not only because it identified me, but also my company. I consider that paper to be one of the most important papers I or my colleagues have written. We spent nearly a year developing the analyses--making sure we did it right. I think other Pharma people can tell you--that paper has almost no marketing upside. It was an analysis done for purely scientific purposes. And if you look at my other work, I've written many purely scientific publications. Analyses on placebo response. Identifying factors predicting response. Developing responder analyses. Why? Because it's important. And you know what? Journal editors and my academic colleagues respect us for that. That we're willing to use our own time, money, and data to satisfy intellectual and scientific curiosity.

You admit that you are an outsider. You responded to personal experience and knowledge with some snark and derision. You can choose to interpret what I wrote in any way you like. I'm not trying to assert truth by authority but, the fact is, with nearly a decade of work in clinical trials, I'm pretty comfortable saying that I know what I'm talking about. I'm not a cheerleader; rather than I'm passionate about what I do. I'm sorry if you can't distinguish the two.

My bottom line is that I never said everyone else was wrong. They're just not entirely right. Or blameless.
posted by ssmug at 12:45 PM on September 22, 2012 [3 favorites]


windykites: "Hey lazaruslong, I'm not really interested in debating whether or not alternative practises have validity. Especially when the larger conversation here is about a failure of allopathic practises/standards/applications, and how the very "proofs" in favour of some medicines are suspect.

My issue was that the comment I was responding to seemed to be painting all alternative practitioners with the same brush- the implication was that all homeopaths (or whoever) are deliberately malicious or self-serving people out to take advantage of others. I didn't find that implication fair, and that's the only thing I wanted to respond to or engage with by my comment.
"

Fair enough. I hope my clarification helped in addressing that. I did not mean to imply that all alternative medicine practitioners are quacks and charlatans. There are many true believers as well, I am aware. I'm sorry that my intention was unclear.
posted by lazaruslong at 12:59 PM on September 22, 2012 [1 favorite]


We lost a good point windykites made in the arc-up over whether homeopaths are delusional or deceptive. There is a financial motive for people to act as test subjects and there is a further financial motive for them to distort the data to downplay side effects, in effect in collusion with the researchers.
posted by aeschenkarnos at 1:54 PM on September 22, 2012 [1 favorite]


That's ok. I've done the same thing about other subjects. You've obviously put a lot of thought into the topic, and I'll check out the resource you suggested!
posted by windykites at 1:58 PM on September 22, 2012 [1 favorite]


It can be damn near impossible sometimes to get a negative trial published. Why? Because journal editors don't want to give precious journal space to negative studies, particularly "uninteresting" negative studies sponsored by Pharma.

It's too bad we live in a time in which journals must be published on paper for distribution and hence can only contain a limited number of papers. Perhaps, in a few more centuries, mankind will one day figure out a way around this problem.
posted by LastOfHisKind at 2:10 PM on September 22, 2012 [3 favorites]


Given this, there is a move to conduct trials specifically in true responders. At first blush, this seems to stack the deck for Pharma. But if you think about it, if you know that there will always be a significant portion of nonresponders, it makes no sense to include them. What you really want to know is how well a drug works in responders. Enter the enriched enrollment, randomized withdrawal trial. You have a run-in period with active drug, those who do not respond are excluded. Those who do respond are then randomized to either: 1) continue active drug; or 2) taper off active drug. This is, perhaps, a truer test of efficacy.

Holy shit, I had no idea! I mean.. Of course I knew the concept. In particular, I know about Amgen's favourite hyper responder. I never made the connection to scientific studies though. That is pretty cool!
posted by Chuckles at 2:22 PM on September 22, 2012


You admit that you are an outsider. You responded to personal experience and knowledge with some snark and derision.

Well, I wasn't trying to snark, at least not much, and I'm sorry if it came across that way. It just seemed difficult to connect what you said to the article, and that worried me.

I think we can both agree that it's a complicated problem and Big Drugs' isn't completely to blame, but the Guardian article points a thicker and sharper finger, I think, than can be deflected easily, at least to my outsider's-eye. Not to mention, you might happen to work for a relatively enlightened company that does try to publish negative trials.

Aside: I don't think you have to worry so much about making over-long comments here. If you know your stuff, I think you'll find people will read, and respond, to them happily.
posted by JHarris at 2:53 PM on September 22, 2012


It can be damn near impossible sometimes to get a negative trial published.

I don't know the solution; should there be negative trial journals? Or maybe a database all negative trials go into?


And maybe we could access it online?

(on preview: right on)
posted by hat_eater at 3:04 PM on September 22, 2012


Studies have shown that no matter how cynical you get, it is impossible to keep up.
posted by homunculus at 3:08 PM on September 22, 2012


This kind of renders Tom Cruise as having been right after all
How awkward.
posted by Fupped Duck at 5:59 PM on September 22, 2012 [1 favorite]


The FDA now allows pharmaceutical companies to patent long-existing ("orphan") drugs...

I didn't know the FDA controlled patents.
posted by Mental Wimp at 9:22 PM on September 22, 2012


...it can be damn near impossible sometimes to get a negative trial published.

I don't know. NEJM sucked this negative study up in a hurry.
posted by Mental Wimp at 9:30 PM on September 22, 2012


The FDA now allows pharmaceutical companies to patent long-existing ("orphan") drugs...

I didn't know the FDA controlled patents.


I read about this a while back. They may not be passing out actual patents, but they're granting patent-like exclusive distribution (for patent-like amounts of time, if I remember right) as a reward/incentive for drug companies to do trials for old drugs that got grandfathered into the current system without trials having been done for them in the first place.

It seems that some people saw the benefits of this (proper scientific tests of medicine, yay), without the thought occurring to them that the drug companies would leverage their exclusive distribution rights by charging ridiculous amounts of money for what was, until that moment, widely available.

I read about it on an awesome organic chemistry blog, In the Pipeline. I'd get a link but my computer is hurting super bad right now. Some Google might help. (I don't understand the politics, economics, or chemistry. I just read it for the entertaining descriptions of chemicals that explode on contact with anything, poison in two different ways, or render wet sand and asbestos flammable.)
posted by reprise the theme song and roll the credits at 9:47 PM on September 22, 2012


In the Pipeline article about a particular case of the whole "orphan drug" thing and how it went wrong.

Stuff that explodes when you look at it funny.
Heavy gas that poisons twice.
Super-oxidizer that burns wet sand.

posted by reprise the theme song and roll the credits at 10:05 PM on September 22, 2012 [4 favorites]


patent-like exclusive distribution (for patent-like amounts of time, if I remember right)

You remember wrong. The longest term for exclusivity is 7 years, for orphan drugs. Patents have a term of 20 years from the filing date, which is often extended by a few months to a few years to make up for delays on the part of the Patent Office (called patent term adjustment).

And by the by, the exclusivity term in Europe is much longer than in the US [pdf]: 10 years for orphan drugs (12 for pediatric orphan drugs), and up to 11 years for new drugs. If the drug is patented then the patent holder can get a 5 year extension on the patent term, much longer than the typical patent term adjustment in the US.
posted by jedicus at 10:26 PM on September 22, 2012 [1 favorite]


You remember wrong.

Yes, I see that now. I should have done my research before I commented.
posted by reprise the theme song and roll the credits at 10:33 PM on September 22, 2012


But I know alternative health practitioners who disagree and advise against them. These people aren't trying to rip anyone off; they do what they do in good faith. They believe they are right.

Up to a point. The real test is whether such practitioners recommend their treatments for serious illnesses like cancer or whether they stick to helping out with vague discomforts and the like.

One of the reasons alternative therapies are popular I've long suspected is that they offer the possibility of having treatment without all the side effects, whereas proper medicine is often painful and difficult and nasty even when successfull.
posted by MartinWisse at 3:58 AM on September 23, 2012


...it can be damn near impossible sometimes to get a negative trial published.

I don't know. NEJM* (ed- added *) sucked this negative study up in a hurry.

I think we're talking about 2 different definitions of negative trial. When I was referring to negative, I meant a drug trial that missed it's primary endpoint for which there was an expected outcome. E.g., Drug A will be better than Drug B for Disease X.

However, the article you cited evaluated the effect of prostate cancer screening on mortality does not appear to have a specific directional outcome. That is, they don't state, "The primary hypothesis was that prostate CA screening would result in lower mortality rates." So when they found no effect of screening on mortality, it isn't "negative" in the sense that your typical negative drug trial is. If they said, "We hypothesize that annual screening will result in lower mortality," then yes, I would consider that negative.

To your larger point about a negative study being published in NEJM and the like, I would point out that, not only was this a large observational trial funded by the NCI, it also had serious implications on public health. Those types of trials will get published in major journals even if they are truly "negative" and/or sponsored by Pharma. On the other hand, negative drug studies that have little-to-no impact on public health will end up in a pretty low-tier journal**, if you can even accomplish that.

*You may be referring more to the controversy about this paper and prostate CA screening in general, and implying that "negative" is "wrong." If this is the case, I don't have an informed opinion; CA is not part of my field and I haven't kept up with the literature.

**Pharma has been accused of "burying" negative results in low-tier journals. Listen, we'd all love to have all of our papers in NEJM, JAMA, Lancet, etc. Sadly, this is not the case. If the lower-tier journals are the only ones who will publish them, we can't really do much about it. Again, this is the type of overall hypocrisy about publication bias and hiding results that was one of my main gripes about the original article.
posted by ssmug at 5:17 AM on September 23, 2012


lazarouslong emmet: no. Sorry. This kind of stuff isn't the the reason that the anti-vax movement is strong. This is far too nuanced a topic for that crowd.

really? Oh, that's certainly convincing! And thanks for throwing me in with your generalizing, but I'll politely decline. This does, in fact, demonstrate pretty much exactly why it's entirely reasonable to distrust the vaccine industry.

I'm sure they're grateful for the witch hunt though. Nothing like viral marketing, as it were.
posted by emmet at 9:47 AM on September 23, 2012


emmet: "lazarouslong emmet: no. Sorry. This kind of stuff isn't the the reason that the anti-vax movement is strong. This is far too nuanced a topic for that crowd.

really? Oh, that's certainly convincing! And thanks for throwing me in with your generalizing, but I'll politely decline. This does, in fact, demonstrate pretty much exactly why it's entirely reasonable to distrust the vaccine industry.

I'm sure they're grateful for the witch hunt though. Nothing like viral marketing, as it were.
"

I'm not particularly interested in persuading you, which is why my tone was less than rhetorically-gentle. I have a lot of patience for some fights. The anti-vax movement isn't one of them.

It's possible to recognize that all evidence-based medical interventions and industries are less-than-perfect, in need of improvement, and susceptible to the same corruption that any human institution inevitably must fight against, and at the same time be educated enough about the mechanisms and science behind vaccines to reject the despicable fear-mongering pseudoscience (with a direct mortality cost, most of which is among the poor) that is the anti-vax movements. I am aware of the corruption present in human governments, but that doesn't mean I think they are all secretly lizards. Conflating the distrust of a human institution due to problematic instances with a complete denial, rejection, ignorance, or cocktail mixture of them all of the science behind vaccines is par for the course. And unfortunately has a direct human life cost associated with it, usually amongst the very young and poor.

So I'll say it again: the entire reason the anti-vax movement is strong is because of the gleeful exploitation of ignorance by quacks, charlatans, and Pyschic Extra-Dimensional Angel Mothers for profit and fame by citing the same debunked study from over a decade ago and encouraging people to misunderstand the nature and scope of vaccinations. This movement is very easily traceable, just takes a little bit of digging.
posted by lazaruslong at 10:44 AM on September 23, 2012 [2 favorites]


Just a little bit.
posted by lazaruslong at 10:48 AM on September 23, 2012


emmet: "I'm sure they're grateful for the witch hunt though. Nothing like viral marketing, as it were."

This doesn't even make sense on a meta-meta level.
posted by meehawl at 11:23 AM on September 23, 2012


Azara: "One thing I really admire about Ben Goldacre is that he is just as sceptical about the pharmaceutical industry as he is about alternative medicine."

I'm kind of partial to the inversion of that, really. Too many people who are skeptical of big pharma buy into the alternative medicine new age antivax etc etc etc bullshit. Good to know that some people do understand that there's a middle ground.
posted by symbioid at 2:59 PM on September 23, 2012


Studies in asthma have consistently shown demonstrable physiologic response (e.g., changes "in FEV1) with placebo. Interestingly they can induce it by telling patients they are inhaling known allergens."

Isn't that the "nocebo" effect? That placebos can induce side effects, in this case, a decrement in FEV1?
posted by etherist at 8:36 AM on September 24, 2012


I think we're talking about 2 different definitions of negative trial.

So you don't think that millions of men and their urologists and primary care physicians who sopped up PSA screening since 1996 expected the outcome to be superiority of PSA? Huh.

As far as I know, all superiority drug trials have two-sided hypotheses, so the PLCO did not differ in that respect at all. You have to really bend the definition of a negative trial to say that the PLCO prostate result wasn't one. Ditto the lung cancer and ovarian result. The only positive result was the colorectal cancer result, but all four outcomes landed in top journals. The difference is that drug trials are usually focused on the earliest possible endpoint the company can convince the FDA to accept, whereas studies like the PLCO focus on clinically relevant outcomes like, oh, say, death.
posted by Mental Wimp at 9:46 AM on September 24, 2012


"...expected the outcome to be superiorityinferiority of PSA?"
posted by Mental Wimp at 9:47 AM on September 24, 2012


As the topic was raised, we can guess why big pharma might want to manipulate trial reporting but who profits from the anti-vaccine movement?

It is clear that someone has identified a sub-population of paranoid, suggestible individuals and is successfully exploiting them. Has nobody tried to follow the money?
posted by epo at 11:11 AM on September 24, 2012


Has nobody tried to follow the money?

It may be collateral damage. The originator of the hoax, Dr. Andrew Wakefield, had an economic agreement with some lawyers who planned to sue the vaccine makers and wanted to create supporting literature for it. To do so, he confabulated the data and drew some colleagues who trusted him into the study. He threw a tantrum to get his shoddy research published in the Lancet, which eventually retracted it. He seemed to give no more thought to the repercussions of his despicable behavior than he gave to random passersby on the street. He probably had no inkling that the Jenny McCarthy's of the world would lap up his junk science, looking for answers to the question, why my child?
posted by Mental Wimp at 5:33 PM on September 24, 2012 [5 favorites]


Sometimes I feel like we'd be better off in the US if we had a moratorium on all medical research for 20 years and put that money into improving access to medical care. I have a suspicion we'd see much better health outcomes.

----------------

It would only take 6 months, but bravo, his eyes uncovered!

Need time to retrain all those extra specialists to be primary care docs.
posted by vitabellosi at 6:24 PM on September 26, 2012


Ben Goldacre @ TED: What doctors don't know about the drugs they prescribe
posted by Pirate-Bartender-Zombie-Monkey at 10:37 AM on September 27, 2012


Psychiatrist Contends the Field Is ‘Committing Professional Suicide’: Psychiatry — and medicine in general — has a dangerously close relationship with the pharmaceutical industry
posted by homunculus at 2:30 PM on October 8, 2012 [1 favorite]


From homunculus's link: The conflicts throughout medicine — not just in psychiatry — are clear. In 2004 alone, pharmaceutical companies spent about $58 billion on marketing, 87% of which was aimed squarely at the roughly 800,000 Americans with the power to prescribe drugs.

That's $63,075 per prescriber, but I bet it's not equally distributed. A lot of money sloshing around there.
posted by Mental Wimp at 2:45 PM on October 8, 2012


I attended a seminar by this guy the other day about this particularly egregious incident at my institution. It seems a couple of professors and a drug company were playing fast and loose with entry criteria and ignoring the wishes of a severely ill patient's next of kin and it ended badly. The seminar covered a lot of discovered memoranda within the company detailing how it used the various studies and manipulated the results to make it appear their expensive new drug was more effective than available generics. It also revealed the intertwined nature of the relationship between the ostensible guardians of patient well-being and the economic interests of the pharmaceutical companies. I have no idea if this is the norm or something that only happens occasionally, but the openness with which it was discussed internally makes me think the former is closer to the truth.
posted by Mental Wimp at 2:27 PM on October 9, 2012


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