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Drug Company Disguised Advertising As Science
ananyo writes "A former pharmaceutical company employee has blown the whistle on drug promotion disguised as science. Drug companies occasionally conduct post-marketing studies to collect data on the safety and efficacy of drugs in the real world, after they've been approved by the U.S. Food and Drug Administration. 'However,' writes the anonymous author in an editorial in the British Medical Journal (subscription required), 'some of the [post-marketing] studies I worked on were not designed to determine the overall risk:benefit balance of the drug in the general population. They were designed to support and disseminate a marketing message.' According to the whistleblower, the results of these studies were often dubious. 'We occasionally resorted to "playing" with the data that had originally failed to show the expected result,' he says. 'This was done by altering the statistical method until any statistical significance was found.' He adds that the company sometimes omitted negative results and played down harmful side effects. Nature says it was unable to work out who the writer was but they likely worked on diabetes and the studies criticized were from the Denmark-based pharmaceutical company Novo Nordisk."
Perhaps if big Pharma was actually honest that would merit a story.
SOP.
Pharmacutical companies, especially in the US, are constantly making dubious claims, and marketing products that, occasionally, provide more suffering in the form of side-effects, than the disease they are designed to treat. It's generally accepted that these companies are genuinely apathetic to the medical issues, and simply do anything they can to maximize profit. Next, you'll be telling me that the firearms industry deliberately pressures governments into military action.
This was done by altering the statistical method until any statistical significance was found
I'm convinced that backing into a conclusion by playing with analysis is the raison d'être of most white collar work in the Western world. Using 'risk' models to rationalize market positions enables arbitrary use of capital by so-called banks. Economic and climate analysis pretty much boil down to teasing out curves that fit the preconceived policies of various statists.
Not surprising that multi-billion dollar drug companies.leverage the same tools. Monkey see monkey do.
I work in drug marketing, (software dev at an ad agency) and all I can say is that my pot dealer is more ethical than a typical multinational drug company.
If it's not illegal, they will do it. If you don't want drug companies to do something, make it illegal. Libertarian nonsense won't fix this problem any more than it helps deal with other problems.
Drug companies have lawyers, and always seek to obey the law (and sometimes fail). They don't care about ethics. They care about the law, and perception. Their purpose is to maximize shareholder value, not do good for the world.
As for me... yes I sold out.. no I don't care. It's a cold world.
Huh?
When someone says, "Any fool can see
So, some international drug companies are lying about science just to make a profit while callously risking millions of people's heath as a consequence? What's that to me?
Do you really expect me get upset about this when Apple's new MacBook Pro is expensive and impossible to repair? It's APPLE, for cryin' out loud.
I think /. needs to get some perspective!
Although it's nice to have this backing it up. I'm a med student and 10% of our course is dedicated to analysis of clinical trials, and the statistical tricks drug reps use to dupe you into prescribing their new drugs.
Because if I did, my doctor would run the tests and tell me, you've got whatchamacolis and hyperwheesis, I'm dialing up for you drugs X, Y, and Z. Don't worry, your plan should cover almost all of it.
Then I'll go home and google and doc would be the featured speaker at Big Pharma's progress against hyperwhesis conference.
despite knowing that pharmaceuticals companies falsify the "benifits" of their "medicine" by putting it in studies with 'active' placebos. 'active' placebos are not placebos, are produced by the pharmafia with no regulation, and administered to their sample set these 'placebos' make them sicker so their pills theyre testing against look like they're benificial.
despite 90% of prescriptions for depression being unecessary.
Despite being expensive and the cause of chronic illness, people still buy this bullshit.
Stop blaming these companies and stop taking their drugs.
The medical system is nothing but a bunch of drug pushers for our fascist system.
now, wake the fuck up.
Scientists 'alter the statistical method until any statistical significance is found'. Full story at 11.
Is there anyone who knows much about science and scientists who didn't realise that this was common practice these days?
This is what happens in for-profit research. And for that matter, if you need results to get the next grant, then you're effectively doing for-profit research. The whole practice of science, private and public is essentially profit driven. Until we start rewarding scientists for negative results as well as we do positive results, we're going to see a lot of faulty positive data published. This is why most major published results in cancer science can't be replicated, for instance.
Give me Classic Slashdot or give me death!
They marketed a drug called Victoza before recieving authorization to market it several times, and "making claims and comparisons that were misleading, disguising promotional material and failing to provide information which reflected available evidence".
SHOCKED I say!
The whole point of the field of statistics is to keep changing your models until you find one that shows the result you want. Why else do you think there are more than a dozen different normalization tests?
http://en.wikipedia.org/wiki/Kevin_Trudeau
'We occasionally resorted to "playing" with the data that had originally failed to show the expected result,' he says.
So, what you're saying is you're from the marketing division?
What do I know, I'm just an idiot, right?
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Sounds exactly like what climate scientists do in order to find a signal for man-made global warming in the vast pool of noise that is natural climate variability.
Every week, we'd get news stories based on "studies": coffee is good for you, bananas are good for you, aspirin is good for, etc.
The coffee study was invariably done by retailers or growers of coffee, the same for bananas, aspirin, etc. The problem about medicine and pharmacology (or science in general, for that matter) is that you almost never get a zero-one phenomenon, and correlation does not necessarily equal causation. These ambiguities present a very large 'gray area' for the people doing these studies, unfortunately.
Add to that the fact the groups comissioning the research are going to censor out anything negative about their products, and you get an extremely unreliable information product. Trust me when I say that the husk of what remains of modern traditional journalism has neither the time, the resources, nor the inclination.
The only solution I see to this problem is for users to keep the same jaded cynicism that they should probably have for any media product, or to advocate better government regulation to separate real research from junk science.
This is the same Diabetes drug company that employs Paula Deen as spokesperson.
Is there a reason that this should be considered more bad then other practices?
Is there some government limit on advertisement that is being circumvented?
5 out of 5 advertising execs will tell you that a great deal of advertising is disguised as some sort of research.
I work in drug marketing, (software dev at an ad agency) and all I can say is that my pot dealer is more ethical than a typical multinational drug company.
Well let's take a look at the relationships you propose here. Your drug dealer is a single entity, probably not making a ton of money. I mean, he's making money but he in turn pays it to the supplier and then X middle men back to whoever is growing it. It's probably not as much as a software developer. Even if he is making a lot of money, he depends on you to not rat him out to the cops. So if he starts busting your balls or raising prices and you feel like he's unfair you can just turn him over to the cops and face little or no repercussions. So he will probably be friendly, courteous and -- assuming he doesn't mix business with pleasure -- have his shit together enough to accommodate your emergency needs. He/She is the interface to your whole pot experience and has reason to make sure personally that you are a very happy camper.
... when someone wants to license a patented drug in India and Pfizer wants $200 per dosage and that means that Indian patients can't get the super expensive research compounds, people die. And when an Indian firm just makes a generic version of it, they've basically painted a target on their back for international IP laws. When something does go wrong that they are indeed liable for, you are clumped into a class action lawsuit with no voice ... you have the option to opt out of the class action lawsuit (which I think are opt in by default) but to do so would mean going toe to toe with your personal resources and lawyers against their infinite sums of both. Tell me, what incentive do they have to even give a shit about you? And you, Anonymous Coward, you are doubly F'd in the A because you work for one, so that's just more leverage they hold over your head.
Let's look at a multinational drug company. They have infinite resources, they have infinite lawyers, they will sue you on a whim, they will sue you if voice concern. They are faceless, they never meet you, they actually abuse a broken system to interface with you (HMOs and prescriptions). They operate "within the law" (like you said if it isn't illegal they'll do it) so you have no leverage on them if your relationship goes sour. In fact, if your relationship goes sour your goose is pretty much cooked. Oh, and if you manage to threaten their infinite capital, they have ways of generating more of it. When they fight amongst themselves, people die. That's how powerful they are
And I'm supposed to be surprised that your pot dealer is more ethical and humane than big pharma? He'd have to develop some pretty complicated drugs and then go on a rampage of carnage and bloodshed and looting to come close.
As for me... yes I sold out.. no I don't care. It's a cold world.
Listen, from various points of view, everyone has sold out. You live in a capitalistic society and in your employment respect you cannot hold yourself to higher standards than that unless you're okay with living on the street. And nobody should blame you for putting good food in your mouth and living in the best place you can afford. Capitalism's the name of the game and if you don't play it right, you get screwed over. So just suck it up and embrace it, I have. Might make us hypocrites but it doesn't invalidate our logic.
My work here is dung.
If you want, and can stomache, a real insiders view of the completely FUBAR pharmaceutical industry I highly recommend this book: "Blood Feud". All about Procrit and Epogen and a few of their variants, the woeful tale of the whistleblowers, and much more. A mind blower.
They're all the same.
Look no farther than the dearth of actual, fucking, take once and done *CURES*. Oh, but plenty of life-long maintenance drugs for profit lock-in, yessiree bob.
unable to work out who the writer was but they likely worked on diabetes
I realize that insulin is a huge cash cow for Big Pharma in the US, but hopefully they are not so brazen as to actively lobby the FDA to attempt to prevent the cure (discovered 6 years ago) from reaching the millions suffering from this disease. Suspiciously, I haven't seen any major US news outlets reporting on this interesting and insanely good news for those that suffer from the disease.
The Admin and the Engineer
Coercion, by Douglas Rushkoff
http://www.rushkoff.com/coercion/
Trust Us, We're Experts, by Sheldon Rampton and John Stauber
http://www.prwatch.org/books/experts.html
insensitive clod overlords obligatory xkcd car analogy russian reversals whoosh pedant fanbois ftfy in 3...2...1..PROFIT
It's APPLE, for cryin' out loud
Apples keep doctors and their evil medicine away!
Ponder about Apple, and your medical problems will solve themselves! /s
I am an ACCA student. Got a query on Accountancy/Finance? Maybe I can help!
Post-marketing observational studies: my experience in the drug industry
BMJ 2012; 344 doi: 10.1136/bmj.e3990 (Published 12 June 2012)
Cite this as: BMJ 2012;344:e3990
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I was an employee of a major drug company for more than seven years. During most of that time I was part of the medical department, which was responsible for designing, conducting, and publishing clinical research. I was mainly involved in post-marketing observational studies. These studies are challenging because of their observational nature, very different from the controlled settings of phase II and III clinical trials. In theory, post-marketing studies are primarily used to answer an important clinical question: “Is this drug effective and safe in a non-controlled, real life setting?” However, some of the studies I worked on were not designed to determine the overall risk:benefit balance of the drug in the general population. They were designed to support and disseminate a marketing message.
Whether it was to highlight a questionable advantage over a “me-too” competitor drug or to increase disease awareness among the medical community (particularly in so called invented diseases) and in turn increase product penetration in the market, the truth is that these studies had more marketing than science behind them.
Since marketing claims needed to be backed-up scientifically, we occasionally resorted to “playing” with the data that had originally failed to show the expected result. This was done by altering the statistical method until any statistical significance was found. Such a result might not have supported the marketing claim, but it was always worth giving it a go to see what results you could produce. And it was possible because the protocols of post-marketing studies were lax, and it was not a requirement to specify any statistical methodology in detail. On the other hand, the studies were hypothesis testing (such as cohort studies, case-control studies) rather than hypothesis generating (such as case reports or adverse events reports), so playing with the data felt uncomfortable.
Other practices to ensure the marketing message was clear in the final publication included omission of negative results, usually in secondary outcome measures that had not been specified in the protocol, or inflating the importance of secondary outcome measures if they were positive when the primary measure was not.
Although the medical department developed the publication plans, designed the study, performed the statistical analysis, and wrote the final paper (which when published was passed on to marketing and sales to be used as marketing material), the marketing team responsible for that product were directly involved in all stages. They also closely supervised the content of other educational “scientific” materials produced in the medical department and intended for potential prescribers. Instructions from marketing to the medical staff involved were clear: to ensure that the benefits of the drug were emphasised and the disadvantages were minimised where possible.
Carrying out large post-marketing studies was also a great opportunity to increase product name recognition by recruiting lots of patients via prescribers. A small group of these investigators would also act as so called key opinion leaders and would become part of the company’s advisory boards. These were clinicians, usually experts in the subject of study, and key prescribers and influencers. Every big international observational study had a large advisory board. This was critical since the success of a newly launched drug in the market would depend on how many key opinion leaders were part of the study. Not only would they add credibility to the results, but they would also be key in influencing decision makers and other prescribers. In regional studies with thousands of patients, the study’s advisory board was form
I was at a big medical society meeting, where they gave free silver-platter dinners to people who attended "scientific" talks by drug companies about their product. (Of course, everyone knew it was just propaganda BS; they were just there for the free meal.) The speaker gave glowing reviews to sibutramine, which the FDA had just withdrawn from the market that day. I pointed this out during the Q&A session, and the speaker was not aware of this and made quite a fool of herself.
Surely the markets aren't so sensitive to a little $3billion marketing effort that messing with data would interfere with the natural ability to self-correct?
Say it ain't so.
"Nature says it was unable to work out who the writer was but they likely worked on diabetes and the studies criticized were from the Denmark-based pharmaceutical company Novo Nordisk."
Why does Nature want to figure out who the whistleblower is, and then announce it to the world? Seems to me that would make a future whistleblower NOT want to expose wrong-doings they discover.
Why don't you tell us in advance which pharmacy company owns you.
It seems to me that you're only interested in treating the symptoms of the problem, which really isn't that surprising since you work in the pharmaceutical industry.
Apparently diabetes only affects millions of canadians. Just move to another country and you're cured!
Japanese companies disguise whaling ships as research ships.
In one of the new stories up the front page a bit, there's a posted comment by someone who claims hearing aids are so very expensive because of all those damn pesky and unreasonable regulations his company has to follow.
$DEITY forbid the drug industry in the US ever gets deregulated. It's bad enough already with all the ads on television and radio for new pills everyone should "ask your doctor" about.
FTFY: "Drug companies disguise advertising as science."
Just four posts before this one we read: "VMware's Serengeti Brings Hadoop To Virtual, Cloud Environments"
If that's not disguising ad as news, I don't know what is.
Having been in the belly of the beast (a different specimen than Novo Nordisk) i agree with some of this guy's findings.
First of all, pharmaceuticals are definitely all about profit margin. They're in a risky business; every new drug application is a gamble and one failure late in the game will easily bankrupt even a medium size company; so they must be big. Even then, a couple or a few failures in a row will bring down the brontosaurus. So, financial theory requires that they be compensated for the risk; if they only paid as much as a savings account, who would invest in such a risky business? So, 20% is like a minimum nowadays, and they would rather have 25%. And to get that profit, they need to pull every lever there is; that's why the same drug costs ten times as much in the US as in Canada, for instance. The price is not based on what it costs to make the pill; it's based on how much money they need to keep the company afloat.
Secondly, the drug research pipeline has been dry for a while and isn't improving any time in the near future, despite any progress in basic research. At this point, generating new and interesting molecules is easy enough, but the bottleneck is in clinical testing; most of them are either useless or toxic. If you're lucky, you find that out in your first bunch of rats. If you're not lucky, you find it out in stage III clinical trials, after you've spent billions. See paragraph above. So: firstly, you emphasize any drug that makes it through trials as a great breakthrough, even if it isn't any real improvement over what's already out there. Secondly, you wring the last nickel out of all the drugs you have, by putting more money into patent lawyers and marketing than into basic research. Every time you can find a new use for your old drug, you push the day it goes generic back; so you develop time release variants. And IV variants. And pediatric variants. And you discover that your antidepressant is good for PMS. and so on and so on.
Thirdly, and finally to the point, of course 'some of the [post-marketing] studies ... not designed to determine the overall risk:benefit balance of the drug in the general population. They were designed to support and disseminate a marketing message.' The whole idea behind the post marketing study is that they will find a wonderful risk/benefit profile to market with; what company is going to pay big money (and I mean big money) for a study to prove that its drug sucks? However, the folks on the scientific side of a drug company, which includes the scientific writers, statisticians, etc. are usually pretty honest, at least compared to marketing folks. At least that was the case in the company I was in; it was honest enough to voluntarily pull a drug that looked a bit iffy, and instead of being rewarded got smacked for it in the media and ended up laying off lots of people, me included (as in normal with layoffs, I had nothing to do with the drug or the study in question, I should mention, just the usual collateral damage). Ironically, the competition which shows similar side effects, stays on the market.
Anyway, there is nothing wrong with 'altering the statistical method until any statistical significance was found'. That's not the same as altering the data, or some such; in fact, drug companies have to be pretty conservative in their statistical methods, so that stuff like Monte Carlo simulations which are generally recognized as acceptable but are not mathematically proved to never give a wrong result can't be used. Some statistical methods are more sensitive than others; as long as they are mathematically provable, they aren't wrong, they are in fact, better. If you look at the population in general and find that annual mammograms don't provide any health benefit, of course you are allowed to adjust for risk factors, etc.; and then if you find that annual mammograms do have a benefit, that's not wrong, that's in fact a better answer.
But, "he adds that the company sometimes omitted negative results and played down harmful side effects"; that is unethical.
So, like I said, some of his complaints I think are valid, some I don't.