What You Don't Know Could Hurt You
Another disgusting revelation about drug companies and what they do with research that shows their drug might not do much for you. You guessed it: Circular file!
In other words, the data your shrink is going by in prescribing an antidepressant might not be the whole story. Just the part that sells the drug. Even worse, drug companies bury reports of untoward side effects or get the the analysis rejiggered to make them go away (as with Vioxx).
Utterly disgusting details of the antidepressant coverup in this New York Times story by Benedict Carey:
The makers of antidepressants like Prozac and Paxil never published the results of about a third of the drug trials that they conducted to win government approval, misleading doctors and consumers about the drugs’ true effectiveness, a new analysis has found.In published trials, about 60 percent of people taking the drugs report significant relief from depression, compared with roughly 40 percent of those on placebo pills. But when the less positive, unpublished trials are included, the advantage shrinks: the drugs outperform placebos, but by a modest margin, concludes the new report, which appears Thursday in The New England Journal of Medicine.
Previous research had found a similar bias toward reporting positive results for a variety of medications; and many researchers have questioned the reported effectiveness of antidepressants. But the new analysis, reviewing data from 74 trials involving 12 drugs, is the most thorough to date. And it documents a large difference: while 94 percent of the positive studies found their way into print, just 14 percent of those with disappointing or uncertain results did.
The finding is likely to inflame a continuing debate about how drug trial data is reported. In 2004, after revelations that negative findings from antidepressant trials had not been published, a group of leading journals agreed to stop publishing clinical trials that were not registered in a public database. Trade groups representing the world’s largest drug makers announced that members’ companies would begin to release more data from trials more quickly, on their own database, clinicalstudyresults.org.
And last year, Congress passed legislation that expanded the type of trials and the depth of information that must be submitted to clinicaltrials.gov, a public database operated by the National Library of Medicine. The Food and Drug Administration’s Web site provides limited access to recent reviews of drug trials, but critics say it is very hard to navigate.
“This is a very important study for two reasons,” said Dr. Jeffrey M. Drazen, editor in chief of The New England Journal. “One is that when you prescribe drugs, you want to make sure you’re working with best data possible; you wouldn’t buy a stock if you only knew a third of the truth about it.”
Second, Dr. Drazen continued, “we need to show respect for the people who enter a trial.”
“They take some risk to be in the trial, and then the drug company hides the data?” he asked. “That kind of thing gets us pretty passionate about this issue.”
This reminds me of a story of a kid practicing marksmanship in WWII. Some officer came by and asked how he'd managed to shoot a whole row of bullseyes in the wall. The kid said something like, "It's easy. I shoot first, draw the bullseye afterward." Cute, unless you're the one taking the drugs.
This has long been a problem with scientific journals in the experimental sciences (but not with math journals). Journals of experiment simply do no publish negative or marginal results. This leads to all manner of inefficiencies. For example, there is no record of unsuccessful experiments, so scientists the world over end up repeating the same failed experiments over and over. The bias against negative results pervades science education and private research institutions.
I'm appalled but unsurprised to see this problem surface in drug research. To the scientists, it's just an instance of the normal (but incorrect) bias against publishing negative or marginal results. It accords only too well with a drug company's desire for FDA drug approval and sales from prescriptions.
Jeff at January 18, 2008 4:02 AM
Journals of experiment simply do no publish negative or marginal results.
Journals, I don't know about, and I can only speak about what I've seen, but the research associates and scientists in the company I work for are required to keep laboratory notebooks, which I am required to hand out and collect, marking dates of issue and return on all of them, and logging them in a separate notebook. ALL DATA regarding experiments, successful and failed, are recorded in these notebooks, and studied and referred to when conducting other related experiments. Obviously, these are not clinical trials, but the data that goes into the experiments that produce the vaccines that go into clinical trials, are meticulously recorded, studied and verified by the scientists and RAs that perform them. Once the vaccines are manufactured and/or produced for clinical trials, it's out of our hands, and into those of the clinicians who perform the clinical trials. I can assure you, that if the vaccines were produced with faulty information, the clinical trials would definitely be compromised, but this does not prove that "all manner of inefficienies" are not recorded. They are. Whether they are published or not is another matter.
Flynne at January 18, 2008 5:37 AM
Yawn
So, the drugs are a bit less effective than they let on? Big deal. They are not selling poison. You take the pills, if they help, great, keep taking them. If they don't help - don't take them.
Go ahead, join the chorus persecuting big pharma. Throw the CEO's in jail. "Take back" the "excessive profits" and add a couple more layers of regulation. Surely that will fix things.
Except, when you crush the US medical and Pharma industry, don't expect healthcare to fall only to the level of Canada and Europe. They only exist parasitically on US advances. We will fall much further than that if the medical profession isn't freed of state interference.
The FDA should be disbanded as they stifle innovation. They treat life saving scientists as guilty until proven innocent.
newjonny at January 18, 2008 6:27 AM
inefficienies
That should be "inefficiencies" Key-riste, I can't spell in the mornings before I've had my coffee. And sometimes not even after! o_O
Flynne at January 18, 2008 6:29 AM
I totally agree, newjonny.
Flynne at January 18, 2008 6:32 AM
Yawn
So, the drugs are a bit less effective than they let on? Big deal. They are not selling poison. You take the pills, if they help, great, keep taking them. If they don't help - don't take them.
If your Wii didn't work, would you be as blithe about it?
It's serious, for somebody who is seriously depressed, to take a depression-alleviating drug and not have it work. And you should be a little more concerned that this is not just happening with these drugs, but with many others...see Vioxx above.
Amy Alkon at January 18, 2008 6:39 AM
that would be great newjonny except that the antidepressant pills have been found to sometimes cause even worse depression and even cases of suicide.
flighty at January 18, 2008 6:40 AM
Some people who aren't depressed are often prescribed those meds for simple things like not being able to sleep or minor life problems. Most doctors are just too eager to write a prescription than find out the real cause of health issues.
Kendra at January 18, 2008 7:39 AM
Certainly there are people who can benefit from pills, but the majority of sickness could be aliviated by an organic diet. The pill companies are only doing what capitalism does best. If the pill poppers would do a lot more research into their diet instead of what drug to take, this would not be such an issue. Seems more of an issue with the majority of people handing over responsibility to big business hoping for the "miracle cure". It is amazing how people will allow their bodies to be used as a chemical experiment and be so ignorant of the basic and necessary minerals, amino acids, etc needed for a healthy body. The companies would have to actually make pills safe & effective - instead of just effective marketing if there is an informed public.
I saw a billboard advertising "generic prescriptions now just $4". Most would think, "wow that's great - about time health care came down some" but I am very concerned now that it is even cheaper it will keep people drugged up and not seeking what would truly help.
kbling at January 18, 2008 8:10 AM
What really needs to happen is for all these doctors, pharmaceutical company CEOs, manufacturing CEOs, FDA people, everyone needs to take some personal responsibility for themselves, their companies and their products and the efficacy studies and the fallabilities and the dosages and to STOP lying and making it about the almighty dollar. Yeah, like that will happen in this lifetime. o_O
Flynne at January 18, 2008 8:43 AM
> I am very concerned now that it is even cheaper it will keep people drugged up and not seeking what would truly help.
We who live on the frontera have always had access to the many, many pharmacies on the avenidas of Tijuana, with everything available at cut rates and no scrips needed. I don't know that there's any evidence of severe abuse.
Speaking personally, though, I won't be crossing the border for a while. Two major gun battles this week have left senior cops and their families, and assorted bystanders, dead as mutton. Good old TJ, keeping up its reputation!
Stu "El Inglés" Harris at January 18, 2008 8:52 AM
seems like the point missed here is that this isn't just about anti-depressants. It's about the way drug trials are handled, generally. They have found this bias before. Can you say Vioxx? Or even better, my favorite: Seldane. It was an antihistamine from the early 90's, and the prescription immediately gave me a migraine cluster from hades. So I stopped, went back to my doctor who told me it must be unrelated, because there were no studies indicating that as a side effect. I shrugged, and said you'll have to give me something else, I won't take it again. About 6mos. later the FDA pulled it because it had caused some heart attacks.
Er, yeah, do we really want dying to prove/disprove the FDA decisions? The FDA can require much more rigorous studies. They can require testing by independent groups and monitoring by independent groups. So that all data collected gets reported. The question is, will there be a need for a massive failure with many deaths to make it happen?
SwissArmyD at January 18, 2008 9:00 AM
"The FDA should be disbanded as they stifle innovation. " How so? I will agree that it slows things down yes. All you have to do is play by their rules and everything works fine. The regs are there for a reason and I have not had one single issue as far a regulatory that could not be overcome. Not being able to stay within regs means your either doing something wrong or your lazy. The regulatory
The rest of what you said I am in 100% agreement with. Also there are studies that aren't published because there are fundamental flaws in the study (not the drug or device). If the PI screwed the Pooch and missed some obvious factor then the study is invalidated. The FDA knows this and as long as you can explain why this study is flawed then they have no issues with it.
vlad at January 18, 2008 9:16 AM
Exactly, SwissArmyD. Thanks for getting this back on track.
Amy Alkon at January 18, 2008 9:21 AM
"Certainly there are people who can benefit from pills, but the majority of sickness could be aliviated by an organic diet." Utter horse shit. Tried this organic diet crap as advised by my mother faith healer (organic herbalist) for my ADD. 6 moths and NO effect Utterly useless. I do like organic dairy and drink it instead of regular milk.
A BALANCED (not organic) diet does have some effect and doctors will tell you that.
vlad at January 18, 2008 9:23 AM
Here's an other example:
http://www.advicegoddess.com/archives/2007/11/is_your_doctor.html
A commenter there wrote (about the buried finding that Effexor can cause hypertension):
Amy Alkon at January 18, 2008 9:25 AM
Something the drug companies forgot to tell us about acetaminophen (Tylenol).
There is a recommended lifetime maximum dosage of 1000 tablets. Any more than that and you risk liver damage. Last year was the first year that there was more liver damage caused by acetaminophen than by alcohol.
Roger at January 18, 2008 9:55 AM
Here's yet another article about nutrition:
http://health.msn.com/health-topics/cholesterol/articlepage.aspx?cp-documentid=100188262>1=10804
Flynne at January 18, 2008 9:55 AM
I'm not blithe about a drug not working, but that isn't what is happening. It didn't work for some people, but it does for others. Someone said people need to take responsibility, that is true. You should work out with your doctor what to try and see what happens and revise as necessary.
What I see is people attacking scientists and creators of life enhancing drugs. And not too many other industries are treated as guilty until proven innocent. The FDA won't let anything new to the market unless it goes through their 3 to 7+ years of hoops and trials. 17 drugs were approved by the FDA in 2007. How do you like that?
But I can't point to the 100's of drugs that were tabled in the Pharma's R&D because they don't exist. They can only develop and shepherd a certain number through the FDA process because of the high costs. I think the last FLU shot maker in the US stopped because of the attacks (tort law problems), but which ties into the FDA problem as well. We are shackling and attacking our best and brightest and treating them like criminals when they deserve to be left free so they can work on life-enhancing and life-extending drugs.
newjonny at January 18, 2008 11:08 AM
Hot damn, I just switched to Effexor from an SSRI I was on for a year! I like Effexor, though, much more than my SSRI. I will monitor my blood pressure (but the patient info in the sample my doc gave me mentions the drug's blood pressure raising possibilities, so I'm not sure that's being "hidden"... unless this is a fairly new requirement for them).
queenie at January 18, 2008 3:30 PM
Seems like everyone likes to criticize drug companies. Sure, they aren't perfect... However, I think its a pretty safe bet that they have saved more lives than their critics have.
I'm not sure why people are so critical of companies that risk billions of dollars in the research and development of drugs that extend and/or improve our lives. My guess is the demonization of the drug companies is just part of the greasing of the skids for the inevitable disaster of "universal health care".
How many drugs of any import have been developed outside of the US in the past 25 years? The only one I can think of is RU-48. US drug companies make a lot of money, but they take the financial risks. Accordingly they should reap the rewards. Hell, the rewards are the only reason they take the risks in the first place. Eliminate the reward, you eliminate the incentive develop new beneficial drugs.
BDT at January 18, 2008 5:07 PM
Look, Ritalin has changed my life immeasurably, and I'm grateful to people who do research -- honest research -- and to companies who report findings from research honestly.
I recently had a doctor ask me if I had a problem with "Western medicine." (She must have a lot of these asshats who think some lead-containing herbal crap from China is the be all and end all in health care.) I told her I'm for EVIDENCE-BASED medicine, and I preferred that she find out what's wrong with me via tests rather than speculate and give me a drug and see what happens (which was her idea for my care). Took the test, don't need the drug.
But, regarding the stuff in this article, and Vioxx, etc., there are abuses, and they should be criticized -- and corrected. Yes, creating drugs takes enormous financial risk -- and offers enormous financial payouts. But, drug dangers shouldn't be lied about to get to those payouts. I mean, does this really sound uneasonable to you? Do you want to take a drug that really isn't sound or effective, but sounds like it is, because some horribly unethical executives at a pharmaceutical company buried the research that didn't come up dollar signs for them?
FYI, the last thing I want is "universal health care." Why would you equate calling for ethics in research and medical care with that?
Amy Alkon at January 18, 2008 6:07 PM
LOL. I bet you knocked her over. I refused some antibiotics late last year, and my doctor practically fainted.
You've written a giant red herring because my whole point was about published material. By and large, scientists are very responsible at recording their findings. But journaled findings that are negative rarely get published. No one knows about these experimental failures. Scientists who get a similar idea then repeat the same failed experiment, getting the same failed results. It's money and time wasted. It happens because journals are not fulfilling their function as intelligencers. I'm in mathematics, but I know this happens a lot in the physical sciences.
Jeff at January 18, 2008 7:57 PM
Amy - you're from Michigan, right? So am I. I live in Grand Rapids now, but was raised in Center Line - just north of Detroit.
Well, anyway, you can't sue drug manufacturers in Michigan. Seriously.
BDT at January 18, 2008 9:57 PM
"... told her I'm for EVIDENCE-BASED medicine"
I remember reading that in one of your previous blogs and that concept stuck in my head.
I've always questioned my doctor about anything she recommends, and most of the time I politely refuse. I've said to her a few times that she requires my 'informed consent' and frankly, I haven't been given enough information to give her that.
Chrissy at January 19, 2008 9:16 AM
The FDA should be disbanded as they stifle innovation.
No. The FDA should certainly be made more efficient, but I for one, am rather keen on having an agency who's job is to help ensure the safety of food and drugs. The notion that the drug companies can actually be trusted to self regulate, is just as absurd as the notion that they are just a big evil turd, out to kill for profit.
Kbling -
...but the majority of sickness could be aliviated by an organic diet.
Vlad's horseshit is right. While a reasonably balanced diet will do wonders for one's health, it is not going to do a damn thing for the majority of disease, nor does it matter if it's organic.
Evidence based medicine has it's problems, some exacerbated by big pharma. It is by no means even close to perfect. But it is vastly superior to that which has no evidence to support efficacy. Organic diets will not save you. Sugar pills that contain no active ingredients (the "memory" of it's molecular contact, efficacy doth not make), no matter fancy names such as homeopathy, will not save you. "Healing" touches will not save you. Screwing those around you, by refusing to vaccinate your children, will not save you or them, though it can seriously fuck over those who are unable to develope anti-bodies and depend on herd immunity.
If you want to tout the lifesaving benifits of an organic diet, whatever the hell that's supposed to mean, show me the evidence. Show me the double blind studies. Show me the clinical trials. For that matter, explain what the hell a "organic" diet entails. Does it mean that as long as it's all organic, I can eat all the fried junk food I like? Does it being organic imbue it with magical qualities that mean it causes no harm?
DuWayne at January 19, 2008 11:54 AM
So Vioxx and a couple others have been, umm, "soiled". What about Ritalin? It's widely thought to be over-prescribed, especially to the children of parents disturbed that their children don't want to listen to Prairie Home Companion when they do.
Radwaste at January 20, 2008 4:55 AM
Is this the fault of the drug companies? Personally, I'm thrilled with Ritalin, which I'm about to take 10 mg of now so I can concentrate better while I write. Do I have a "disease"? I don't consider ADHD, the symptoms of which I have, a disease, but a different kind of brain function. I'm better at some things than most people, and worse at others.
Amy Alkon at January 20, 2008 6:05 AM
Which illustrates the "works for me" utility of prescriptions. A lot of trouble can be averted by the patient herself, when she's careful about charting what is going on and researches anything having to do with a new prescription, or the alternative to the one she has now. I'll make an assumption: when Joe and Susie go to the doctor, they want to be told what to do so they'll feel better. They don't want to hear - if they even know - that since they are unique individuals, a drug that works perfectly for someone else may not work for them. Can they even take all their pills on time?
This is an interesting aside to the issue of "illegal" drug use in this country. If you advocate that you should be able to use cocaine, marijuana, etc., aren't you also insisting that the user is responsible enough to recognize the deleterious effects of these drugs - an ability the same people apparently don't have with their prescription items?
Radwaste at January 21, 2008 7:00 AM
Radwaste -
First, it is not the fault of the pharmaceutical industry that some drugs get over-prescribed. It is the fault of medical professionals who do the over-prescribing, often at the convincing of pharma reps. The fact that those drugs are being over-prescribed does not mean that they should never be prescribed, nor does it indicate anything about their effectiveness.
Unfortunately, it is true that many people do not or are incapable of effectively investigating things themselves. Even more unfortunate, most people are lucky if they can see one doctor, much less afford to get a second opinion. So it comes down to the luck of the draw, with some folks getting screwed in the process. Again, this is the fault of the system and the populace, not something that can legitimately be put at the feet of big pharma.
I am not trying to say that pharma is blameless, they're sure as hell not. What I would assert, is that it's important to keep in mind that they are corporations, looking for the bottom line. Whether this is a good or bad thing in itself, is rather irrelevant. What it is, is what it is. Unfortunately, the system that regulates it all, is not perfect and comes far from offering a reasonable balance between protecting consumers and allowing new drugs into the market. Compounding that, there is a very pervasive problem with the distribution of pharmaceuticals. Neither is well geared to handle the innumerable problems that a profit driven pharmaceutical industry throws into the mix (please don't take this to mean that I support nationalizing pharma, I most certainly do not).
In effect, many doctors end up with little better understanding of a drug than do the patients they prescribe them to. Or more accurately, they are not likely seeking any more information than the average consumer has access to. The pharma reps provide them with everything they are likely to try to learn about many new drugs. The bottom line, IMHO, is that doctors have an important responsibility to their patients that many of them don't follow through on.
If you advocate that you should be able to use cocaine, marijuana, etc., aren't you also insisting that the user is responsible enough to recognize the deleterious effects of these drugs - an ability the same people apparently don't have with their prescription items?
The answer is an unequivocal yes. And like pharmaceuticals are required to do, all such materials should have bold, unequivocal warnings about said deleterious effects. There is only so much that can be done to make people safe. The fact that people are too fucking stupid to pay attention to the warnings, is not a license to just decide that no one should use a particular substance.
An excellent example, is the tobacco. I buy tobacco regularly, a substance that comes to me with drastic warnings of all the nasty things it can and likely is doing to me. I'm an addict so I buy it and smoke it anyways (due to the wonders of modern pharma, I may defeat it soon). Or, perversely, I also take ibuprofen, in spite of the fact that it can cause heart issues. Strong heart is a part of my genetic heritage, so I take the risk in the interest of defeating pain.
A good doctor will weigh the risk to benefit ratio, when it comes to pharma. Legal recreational drugs would also come with warnings. And making them legal, will make people more comfortable mentioning use t their doctors, so they can at least avoid nasty contraindictions with medications.
DuWayne at January 21, 2008 11:10 PM
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