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Drug Companies Cherry-Pick Data to Get Approval for Useless Drugs

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- 2058 days ago -
It goes without saying that the drugs you take for a headache, or high blood pressure, or even depression should work better than a Tic-Tac. That's what drug trials are for:

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Kit B (276)
Monday October 1, 2012, 1:55 pm
(Image courtesy of Candy / Wikimedia Commons)

It goes without saying that the drugs you take for a headache, or high blood pressure, or even depression should work better than a Tic-Tac. That’s what drug trials are for: researchers give a group of subjects either the drug under investigation or a placebo to check that the medicine is significantly more effective than a sugar pill. Plus, the trials can reveal any potentially harmful side effects. In theory, this is a great way to weed out useless or actively harmful drugs. But it fails when drug manufacturers cherry-pick their data, publishing papers on the positive trials and sweeping the unsuccessful ones under the rug. And this behavior is completely legal.

Science writer and medical doctor Ben Goldacre wrote a book, with a long excerpt published at the Guardian, about how this process leads to approval for drugs that don’t actually work. And as he explains, when widely used drugs—such as the diabetes medication rosiglitazone—have harmful side effects, they sometimes remain in common use.

In 2003 the Uppsala drug monitoring group of the World Health Organisation contacted [pharmaceutical company GlaxoSmithKline] about an unusually large number of spontaneous reports associating rosiglitazone with heart problems. GSK conducted two internal meta-analyses of its own data on this, in 2005 and 2006. These showed that the risk was real, but although both GSK and the FDA had these results, neither made any public statement about them, and they were not published until 2008.

During this delay, vast numbers of patients were exposed to the drug, but doctors and patients learned about this serious problem only in 2007, when cardiologist Professor Steve Nissen and colleagues published a landmark meta-analysis. This showed a 43% increase in the risk of heart problems in patients on rosiglitazone. Since people with diabetes are already at increased risk of heart problems, and the whole point of treating diabetes is to reduce this risk, that finding was big potatoes. Nissen’s findings were confirmed in later work, and in 2010 the drug was either taken off the market or restricted, all around the world.

In both published papers and results presented at conferences, trials sponsored by the drug industry are far, far more likely to yield positive results. Goldacre lists more examples where selectively chosen data and inadequate regulations let doctors treat their patients with useless or harmful drugs. Read about them in the longer excerpt at the Guardian.

by Sophie Bushwick in Health & Medicine | Discover Magazine |

JL A (281)
Monday October 1, 2012, 3:11 pm
Other parallel histories include the Tardive Dyskenesia from psychotropic medications and, more recently, the increased risks of diabetes from many ;psychotropic medications. In fairness, one of the women's medication trials was stopped early when way too many were experiencing significant side effects.

One reason, perhaps, has been how little pharmacology is required in most medical schools for those becoming doctors.
At least now there are more limits on doctors getting free samples, etc., to promote drugs for their patients than there used to be and it is easier for them to get such information, when reported.
Many electronic medical record systems (yes, a piece of ObamaCare) also include flags regarding issues to watch for on the patients' records relevant to any given drug.
And the system to report side effects to the FDA is easier for health professionals to use to get it on file.
So, a little progress, but not near as much as the expectations most have from the Hippocratic Oath.

Kit B (276)
Monday October 1, 2012, 3:18 pm

Thanks J L, that's good information. I had a problem with Pharmaceutical sales people telling doctors what to prescribe and for what problems, I glad that has slowed down. I do not think that giving people who have a temporary pain issue anti-depressants helps any one but the drug companies. I have one pharmacist, and he will call the doctor should something be prescribed that I can not or should not take, at least the pharmacists usually do know the medications.

Ernst A. (0)
Monday October 1, 2012, 3:52 pm
I can't believe how much corruption exists in some of the big pharmaceutical companies.

JL A (281)
Monday October 1, 2012, 3:55 pm
You are right, Kit. Laws in my state require a consult with the pharmacist be recommended for any new prescription--at my pharmacy, it also happens whenever it is a different manufacturer or supplier where the pill could even look different.
I've found them Very helpful and knowledgeable about side effects, recommended lab monitoring, etc. Electronic records also put drug allergies or intolerance in a prominent position for the doctor to see before/concurrent with prescribing to minimize the risk of those types of medical errors.

pam w (139)
Monday October 1, 2012, 4:16 pm
And what about the ads? Patients are encouraged to DEMAND certain drugs, even though 75% of the ad is spoken in a quiet voice which explains dozens of possible side effects!

Past Member (0)
Monday October 1, 2012, 5:12 pm
Noted. Thanks.

Kamila A (141)
Monday October 1, 2012, 5:37 pm
The state of healthcare is deplorable when drug companies run by the Mitts of the world can push their poison like its medicine, and take advantage of the people who believe they might help. They make us sick, then they harvest our money to "heal" us while maximizing their profits. The ones who run the companies, all who work for them, have blood on their hands if they know what is going on and allow it to go on. It is up to each citizen to pull back and ask what are we doing?! Then do something to change direction.

Kit B (276)
Monday October 1, 2012, 5:53 pm

I have wondered many times why a cigarette company can not advertise their product, as it can cause harm but it's okay for Pharmaceutical companies to advertise, what ever they are currently peddling. If one side effect is death should that drug really be sold on TV? How much does advertising increase the price of drugs?

Kenneth L (314)
Monday October 1, 2012, 6:30 pm
"And of course all these (psychiatric) 'diseases' require pharmaceutical treatment---this is big, big business". Dr. Pamela Popper, Ph.D
"This is not science (regarding psychiatric drugs). This is incredibly effective marketing. It has nothing to do with science". Kathleen Slattery-Moschkau, former pharmaceutical sales rep.
"They're learning every trick in the book. They're evolving into efficicient marketing machines" Dr. David Stein, professor of Psychology
"There's definitely an unholy alliance between Psychiatry and pharmaceutical sales. It's a match made in heaven". Gwen Olsen, former pharmaceutical sales rep
"They're like conjoined twins, they're joined at the wallet (regarding Psychiatry and pharmaceutical companies)" Kay Carlson, former pharmaceutical sales rep
"In clinical trials psychiatrists are engaged to do the research, and we can bank on the fact that these psychiatrists are tied to the pharmaceutical companies" Arlene Tessitore, former manager of a pharmaceutical marketing comapany
"They use what I call 'statisical contorionism', basically just skew the numbers, make everything look fantastic, you hide the bad numbers". Shane Ellison, former drug research chemist, Eli Lilly
"If you can come up with a (psychiatric) label, a diagnostic label for a drug, then you can sell it like hotcakes" Andy Vickery, trial lawyer
"Psychiatrists specifically are just sort of working as sales agents for pharmaceutical companies" Dr. James Chappell, Clinician
"The drug companies really have Psychiatry in their pocket" Dr. Colin Ross, Psychiatrist
"In terms of (psychiatric) medication, the evidence that's claimed is the medications are highlty effective and not very toxic---but actually in fact the data in Psychiatry are very clear that that's not true. What is true is the medications are barely, if at all, more effective than placebo (sugar pill)" Dr. Colin Ross, Psychiatrist

Kenneth L (314)
Monday October 1, 2012, 6:42 pm
"I find it pretty outrageous that we can base a multi-billion dollar industry on a few 6 or 8 week clinical trials where anti-depressant medication has beaten a sugar pill by a few percentage points" Andy Vickery, trial lawyer.
"We don't really know what they're doing (regarding psychiatric drugs). That's what scares me. It's all made-up theory. There are no facts about what these drugs really do." Ana Koenig, former pharmaceutical sales rep
."With psychiatric medications, you can invent diseases all day long. You're selling drugs to people under false premises, about a disease that's been invented. So how do you measure efficacy among a disease that doesn't even exist?." Shane Ellison, former drug research chemist, Eli Lilly
"The American public is being treated as a mass medical experiment, we are all being treated like guinea pigs by the pharmaceutical companies, the psychiatric industry, and the FDA" Mike Adams, Consumer Health Advocate
"The issue of serotonin in depression is utterly unproven and is one of the greatest examples of misinformation in medicine over the past 100 years.
And the question arises, why would this be? Perhaps it has something to do with the enormous financial gain that's involved in the whole treatment business of mental health" Dr. Terry Lynch, M.D., psychotherapist
"The theory of 'biochemical imbalance'---"was actually made up by the brilliant minds at the drug company Eli-Lilly. Even before the approval for Prozac by the FDA (1988), Lilly was sending it's minions, it's paid physicians and consultants out into the world to say that 'depression' was caused by a 'biochemical imbalance'. So from the beginning it was a flim-flam. It was a PR (public relations) claim that you've got biochemical imbalances and Prozac is going to fix it." Dr. Peter Breggin, Psychiatrist


Sheryl G (363)
Monday October 1, 2012, 7:30 pm
Shame on them.

Victoria P (113)
Monday October 1, 2012, 8:46 pm
Noted with thanks Kit

Patricia H. (440)
Tuesday October 2, 2012, 2:08 am
noted and shared

Marcillane Basso (18)
Tuesday October 2, 2012, 5:13 am
This is not new, the pills I am on for my heart have the same side effects they are supposed to stop. Either I take them and die later or stop and die sooner, either way my heart is getting someone rich!!!

SuSanne P (193)
Tuesday October 2, 2012, 9:27 am
So sad...So very, very sad!
""Shame on them.""

Paul Carter Block (28)
Tuesday October 2, 2012, 12:39 pm
As Marcillane Basso (Oct 02, 05.13) observes, the side effects of medication are often identical with the condition they are touted to treat. One wonders if they are designed to counter the infirmity or to enhance it - and that is a serious question in the light of the billions that the drugs manufacturers make from stuffing their products down our throats. And our general practitioners (that's UK-speak for family doctors) are rewarded handsomely by Big Pharma for prescribing this or that latest magic bullet, whether or not its use is appropriate. In the UK, the third greatest killer is prescribed medication, behind coronary disease and stroke, but this fact appears on no official statistics. Rocking the lucrative boat is not permitted.

Past Member (0)
Tuesday October 2, 2012, 1:15 pm
Big Pharma and Big Insurance have officially taken over this country and it's law makers. Turn on the TV, any channel, any time of day and just count their ads.

Sandra M Z (114)
Tuesday October 2, 2012, 9:46 pm
I mute almost all commercials now. There are so many cancer commercials, why would a person want to hear the words and stories over and over? I'm thinking that is not healthy, oh yeah, that makes sense now........

Plus we have all the political ads, now, so keep that remote handy.

Noted, Thank you Kit.

Lois Jordan (63)
Wednesday October 3, 2012, 4:46 pm
Noted & thanks for posting, Kit. There are many "alternative" methods for various diseases and symptoms. Dr. Andrew Weil has an Integrative Medicine Clinic here in Tucson. Various herbs, acupuncture, massage therapy, and other alternative treatments are used to help patients. Big Pharma isn't all bad, but when they began to advertise on TV, and put profit over peoples' health as their main dictate, we all lost.

Past Member (0)
Wednesday October 3, 2012, 5:30 pm
Noted. Thanks.

Jessie D (42)
Sunday October 14, 2012, 10:57 am
Noted and shared.
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