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Drug Maker Accused Of Paying Ghostwriters To Pen Journal Articles

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A drug company is accused of paying ghostwriters to write favorable articles about their drugs — even after one drug was shown to raise the risk of cancer.

Drug maker Wyeth paid ghostwriters to write medical journal articles that were favorable to its female hormone replacement therapy drug, according to Congressional letters referenced in an article in the NYT.

The letters, sent electronically Friday by Senator Charles E. Grassley, ask Wyeth and DesignWrite, a medical writing firm, to disclose payments related to the preparation of journal articles and the activities of doctors who were recruited to put their names on them for publication.

The letters are part of a continuing investigation by Mr. Grassley, a member of the Senate Finance Committee, into drug industry influence on doctors.

“Any attempt to manipulate the scientific literature, that can in turn mislead doctors to prescribe drugs that may not work and/or cause harm to their patients, is very troubling,” Mr. Grassley, an Iowa Republican, wrote Friday to Wyeth’s chairman and chief executive, Bernard J. Poussot.

One article in the American Journal of Obstetrics and Gynecology recommended a hormone replacement therapy drug that now carries a cancer risk warning. The article claimed that there was "no definitive evidence" that the drug caused breast cancer.

According to the NYT, the documents show that the drug company executives came up with ideas for the articles, titled them, paid writers to write the manuscripts, "recruited academic authors and identified publications to run the articles — all without disclosing the companies’ roles to journal editors or readers."

At least 10 of the articles seem to have been written before they were submitted to the "author" to review. In all cases, the drug company had final say before the articles were published.

Drug Maker Said to Pay Ghostwriters for Journal Articles [NYT]

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38
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I always thought Wyeth's works had a ghostly quality to them.

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Big Pharma trying to make money at any cost? What has this world come to!?

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Ah, so that's where all the pushy used-car salesmen have gone!

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Anyone remember all of the internal data that leaked out of Purdue regarding how they may have intentionally made OxyContin to be more addictive than it should have been and how they mislead Drs into RXing it for moderate pain in order to create people that were horribly addicted to the drug and boosting their own profits?

A big pharma company? Misleading the public for increased profit? never...

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So really it is on the "authors" head that they approved an article written by someone else...


Those scientists/researchers are the ones who need to pay back their salaries...

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I am not surprised. From shoddy clinical trial data to aggressive and misleading direct to consumer advertising, the government needs a better grip on this industry. Perhaps some criminal charges are in order for the CEO or the executives in the company that are responsible?

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Great, we know the name of the drug company, can we know the names of the "academic authors and identified publications"?

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But if we had Universal Health Care all these companies would no longer be able to fund their desperately needed research.

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But are they taking it "very seriously?"

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This is the same reason people believe that supplements don't work. Big Pharma has manipulated the media and the majority of us have been duped. For instance - do you have osteoporosis? Google "strontium". It has been used extensively in Europe and safely REVERSES osteoporosis. But I betcha no one here has even heard of it. But I'm sure you've heard of FOSOMAX. Not even the Osteoporosis Foundation will tell you about it. Because guess where they get all their money?

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Damn labor unions, it's all THEIR faul...
Oh. Wait.

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Uhhh, they didn't make it more addictive. They were caught lying about it's addictive potential. All opioid analgesics like Oxycontin (oxycodone), hydrocodone (vicodin), MS Contin (Morphine Sulfate), are addictive. I'm not taking their side, but they did not make it MORE addictive.

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This is actually common practice in Journal Article writing. It's important that, as people of the general public, you don't take what you hear on the news about a "scientific study" as being fact. Medical professionals spend a lot of their schooling on learning how to evaluate literature. If you hear about a clinical trial in the news, ask your pharmacist about it before making a judgement, they will help give some insight in to the study. If they have no idea what your talking about, they suck. :)

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@Ailu:

don't. just don't. there's a lot of health professionals in the consumerist reding pool who will rip you apart.

Come back with some actual double blind studies, and you MIGHT be taken seriously.

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@Parapraxis: There ARE studies. Just look harder. At any rate, I had a triple neck fusion and x-rays at 3 weeks showed my fusion was 3/4 complete. My surgeon was blown away. "It's just not possible!" he exclaimed. Well now he's a believer.

There are many sites where people have posted their bone density tests before & after strontium. If a Pharmaceutical had these results, they would shout it as one of the greatest discoveries of the century. But alas, it's too cheap for Big Pharma to bother with. But hey, if you want to swallow Draino (my doctor's definition of Fosomax, not mine) you go right ahead. It's a free world. But I'm posting this for those who are looking for an better & more effective alternative.

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For those interested in learning more about the effectiveness of Strontium:

Strontium and osteoporosis: A treatment not offered to American women
[onlinejournal.com]

Strontium: Breakthrough Against Osteoporosis
[www.worldhealth.net]

Studies:

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in Women with Postmenopausal Osteoporosis
- New England Journal of Medicine
[content.nejm.org]

Strontium Ranelate Reduces the Risk of Nonvertebral Fractures in Postmenopausal Women With Osteoporosis: Treatment of Peripheral Osteoporosis (TROPOS) Study.
[www.obgynsurvey.com]

Strontium ranelate is effective in younger post-menopausal women aged 50 to 65 years with severe osteoporosis
[www.medscape.com]

Strontium ranelate: a new paradigm in the treatment of osteoporosis
[www.expertopin.com]

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This is a common practice in the pharm industry. I worked for a company in the 90's that did this. The docs (or execs) would forward us the data and we would write up the article, which would be reviewed by the lead author before it went out for publication. The docs involved loved it, because they did not have to write anything and they got published.


The practice itself is not inherently evil, although the potential for misrepresentation is always there.

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@TemporaryError: You only need to look at all the drugs with horrible withdrawal symptoms or that the drug companies claim you have to take for life (ie:their drug not a drug) or purposely don't have dose down information. There are tons of classes of drugs that get people literally hooked and they are really difficult to get off of.

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@Parapraxis: Maybe not. A couple of specialists I see put me on supplements and they really help. Doctors not looking to pad their wallet are more open to what is best for their patients.
There are also a number of supplements under trial use at teaching hospitals and many in every day use by doctors and hospitals in Europe.

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@Wonda Land: Having worked and published at a pharmaceutical company, I know it is a REQUIREMENT of all the reputable journals to include "conflicts of interest" when publishing scientific research articles... that is, if a company is paying you to write/research a topic, it must be disclosed in the article.

I find this the fault of the writers, who are probably the ones that lied about their conflicts of interest, saying that they had none.

You really cannot blame pharmaceutical companies for funding the research for their own drug... I mean, if they didn't, who would? The FDA doesn't have time/money to do long term toxicology experiments on every single drug on the market, so the onus is on the companies to fund the research. That, is where it should end, though. No matter who funds the projects, the researchers need to give an accurate assessment of the drug. Do you think Merck didn't help fund Vioxx toxicity research? It still came out negative because the researchers doing the studies were reputable.

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@nsv: Some names are named in the NYT article itself.

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@Apeezee: The articles in question aren't clinical trials, though, they're literature reviews.

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@Apeezee: @Ailu: And the REALLY bad news? Ever take a good look at who manufactures and sells most of the supplements on the market? Go ahead...take a guess.

The same companies that make pharmaceutical drugs. Specifically, I think Abbott Laboratories still has the lions share of the supplements market.

And yes, thanks to some really, really misguided lobbying a few years ago, Abbott may have to prove that a prescription drug is both safe and effective prior to the marketing of that product, in order to prevent marketing of a supplement, FDA would have to be able to prove that it was in fact killing people. Would have to prove that, in fact, without any power whatsoever to compel anyone to study that question. That doesn't mean that no supplements are effective, nor that pharmaceuticals are being effectively regulated (see VIOXX), but it does mean that we know substantially less about the safety and efficacy of supplements than we do about most prescription drugs.

And please -- before anyone goes there. Arsenic is an element -- about as "natural" as you can get. At one dosing concentration it is the primary ingredient in one of the leading blood thinners used in patients with high blood pressure. At another dosing concentration, it is commonly used as rat poison. "Natural" means absolutely bupkiss without adequate and well-controlled clinical trials accurately reported.

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@iamlost26: Actually, that is EXACTLY what Merck did. Having seen suggestions in some of the early studies that suggested a potentially fatal toxicity associated with Vioxx, Merck banked on the fact that those early studies were too small to definitively answer the question. So they scattered their funding of studies around into a bunch of other studies that were too small to answer that question. The question lingered, but nobody could PROVE that Vioxx was harming people, and their marketing people would cite studies that, if accurately reported, might have been said to prove that Vioxx didn't immediately kill 3/4 of the people who took it, but which were interpreted by their sales force to prove that there were no concerns about Vioxx (as I remember it, they paid some big-ass fines for this eventually).

The details of the study that finally evaluated that question are, I admit, a bit hazy in my mind, but if I remember correctly, it was a publicly funded study from the Heart, Lung and Blood Institute with some funding provided by Merck under major pressure from FDA.

In retrospect, Merck's main strategy seems to've been stall, stall, stall, because Vioxx was a blockbuster, and every month it remained on the market, it brought in a whole bunch of money. And as long as they could prevent the question from being answered, everyone involved had deniability and the money kept rolling in. They didn't KNOW they were killing people, even if they were pretty damned comfortable with the possibility.

And Merck is one of the good guys, research-wise. OK, rant finished. Slow curtain. The end.

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@ShanghaiLil: Just realized I hooked this on as a response to the wrong comment. So sorry. Too much indignation, not enough coffee.

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@Ailu: You should take a look at d-chiro-inositol in relation to women with Polycystic Ovarian Syndrome. It's sad that big pharma puts us through all these drugs when a supplement may completely reverse the problem.

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@Ailu: I'm just curious: is there any kind of standardized formulation of this product, with active agent levels sufficiently stable that consistent dosing can be achieved?

And if so, who's the manufacturer?

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@ShanghaiLil: I used Dr's Best brand. Here's their info page on it: [www.drbvitamins.com]

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This is SOP not only in the pharmaceutical industry, but in manufacturing overall. Pay for studies and you can point to "science" saying that your product is safe and you couldn't have known it was unsafe, therefore it's not your fault at all that you hurt or killed people.

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@Wonda Land: Yup, common practice in the industry. The docs have to say if the research was paid for by a pharmaceutical company (which sometimes it is, sometimes it isn't), but they don't have to say that they didn't actually write the article, someone paid by pharma did. They read it, sign off on it, collect their "honorarium."

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@Ailu: Of course I've heard of Fosamax. I have a lot of colleagues who file lawsuits for Fosamax-related injuries.

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@Ailu: I've tried various supplements with varying degrees of success.

The problems I see with supplements:
1) There is no regulation this is a good and bad thing. Good in that it's cheaper to produce and sell...bad in that you don't know what a safe or an effective dose is, or what the appropriate amounts and fillers are in those pills. one company could sell the same thing as another and be completely ineffective.

2) Too many supplements saying too many things in too many ways. If I see some flashy ad in the back of a magazine that looks like it's 30 years out of date claiming to give the youth back to a 90 year old and cure cancer and among the ingredients are a perfectly valid supplement it makes it seem like snake oil.

I won't stop taking them when I can...the best medical results I've ever had have come from acupuncture. I had mono and after a few months my dr wanted to take out my tonsils. 2 months of acupuncture it was gone forever. I didn't have a sore throat for 4 years after that. It's not a cure for everything but it definitely works...and I didn't even believe it would at the time.

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Uhm

...[OLD]?

I seem to recall the makers of Neurontin being out for this very practice back in the early 2000s.

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@snowburnt: Agreed. There is a lot of hype out there. I try to filter the crud out by going directly to the ingredients listed in the supplement, and then seeing if there really is some scientific backing to them - double-blind studies and whatnot. Then if it measures up, I buy generic instead.

And congrats on the mono eradication! :-)