According To Pfizer, A Clinical Trial Is A 'Marketing Strategy'

from the our-regional-sales-rep-will-help-you-gather-your-data dept

Wed, Jul 6th 2011 9:21am — Tim Cushing

It seems like only yesterday (but it wasn't -- it was actually June 28th) that we were discussing the pharmaceutical industry and its general abuse of numbers to keep itself afloat. (In a pool full of money.)

Some more drug company ugliness has surfaced in a report published in the Archives of Internal Medicine. Examining documents uncovered during the Franklin v. Pfizer case, researchers came across details of a marketing ploy disguised as a Phase IV trial of gabapentin, a drug used for treatment of seizures and neurological pain:

"The Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS)" study was a so-called seeding trial, in which the stated objective was to assess the safety and efficacy of gabapentin, but the actual aim was to increase prescribing of the drug by duping the very physicians recruited to conduct the "trial," according to three medicolegal consultants involved in litigation against the drug's manufacturer.

In the STEPS trial, Parke-Davis recruited 772 physicians to prescribe Neurontin (gabapentin) and titrate the dose upward in patients whose partial seizures were not completely controlled by other drugs. The drug company purposefully recruited "site investigators with little or no clinical trial experience [and] provided insufficient training," and limited enrollment to about four patients per investigator.

The study design was uncontrolled and unblinded, and its rigid titration protocol led to the exclusion of 87% of the study subjects. One institutional review board that twice rejected the STEPS application to be conducted at their medical center stated that "the entry criteria and outcome measures are too vague to allow any scientific conclusions to be reach[ed]." Parke-Davis sales representatives collected and recorded individual subject data. In a clear example of data tampering, they not only attended epilepsy patients' office visits (under the guise of "shadowing" the clinician), but also actively promoted the use of Neurontin and blocked the use of competing medications, particularly lamotrigine (Lamictal), at those visits. They also rewarded participating investigators with free lunches and dinners.

In addition(!) to the data tampering, exclusionary tactics, unethical recruitment practices and low-level bribery, the researchers also found that Parke-Davis' (a subsidiary of Pfizer) own internal documents referred to STEPS as "a marketing strategy" and that the trial's findings were secondary to "increasing market share in new prescriptions":

"Mr. Krumholz and his coauthors clearly demonstrate that the true intent of seeding trials is to introduce a new product and induce clinicians to use it," according to Dr. G. Caleb Alexander. As others have noted, "Deception is not just an incidental part of a seeding trial, but rather the very success of the trial depends on such deception, since few institutional review boards, investigators, clinicians, or patients would willfully participate in a study with marketing objectives and little or no scientific value," Dr. Alexander wrote in commentary accompanying the report.

When contacted about its ethics breach (an understatement along the lines of the "Titanic's hull breach"), Pfizer spokesman Christopher Loder responded with a canned response that he quite possibly copied right off Neurontin's (gabapentin) promotional pamphlet:

"Neurontin is an important FDA-approved medicine that physicians have prescribed to treat millions of patients safely and effectively. Neurontin has been widely studied for more than 2 decades and there is an extensive body of publicly available literature on its safety and its use."

True that, I suppose. But at this point you can add "as well as a growing body of publicly available literature on its unethical testing procedures and another in a long series of black eyes for the pharmaceutical industry" to the end of that little blurb any time you want, Chris. "Now" would be good.

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Filed Under: clinical trial, marketing, pharmaceuticals
Companies: pfizer

30 Comments

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Anonymous Coward, 6 Jul 2011 @ 9:36am

medicine like software, shouldn't be pantentable.

you can't own ideas, man!
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John Nemesh, 6 Jul 2011 @ 10:37am

It really makes you wonder how much our health care system will improve once greed is removed from the equation!
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Overcast (profile), 6 Jul 2011 @ 10:41am

"When contacted about its ethics breach"

Ethics... lol
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Overcast (profile), 6 Jul 2011 @ 10:42am

It really makes you wonder how much our health care system will improve once greed is removed from the equation!

Once greed is removed? How will that ever happen? lol
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Anonymous Coward, 6 Jul 2011 @ 10:43am

Holy old news batman - this happened more than a decade ago! This happened back when Parke-Davis was a subsidiary of Warner-Lambert, before it was bought by Pfizer in 2000. I didn't even know Pfizer kept the Parke-Davis name alive.

And they did get their wee-wees whacked pretty hard for this stunt. Granted, they still wound up in the green after all was said an done.
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Anonymous Coward, 6 Jul 2011 @ 10:45am

Re:
Who will invest the time and money to develop and test these drugs if there isn't money to be made? Sorry, but in the real world things don't get done unless there's money to be made.
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weneedhelp (profile), 6 Jul 2011 @ 10:51am

Re: Re:
"things don't get done unless there's money to be made" That is a sad view of the world, and totally untrue.
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weneedhelp (profile), 6 Jul 2011 @ 10:53am

Re: "When contacted about its ethics breach"
Caller replied: Eth-ics? I am sorry sir, we are unfamiliar with that term.
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weneedhelp (profile), 6 Jul 2011 @ 10:54am

Re:
Holy insult fail Batman - if I have not heard it, it is new to me.
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Anonymous Coward, 6 Jul 2011 @ 10:54am

Re: Re: Re:
And that's a naive and childish view of the world that goes totally against human nature.
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Anonymous Coward, 6 Jul 2011 @ 10:57am

Re: Re: Re: Re:
I guess that explains why people keep having kids, for the money...oh, wait...
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Anonymous Coward, 6 Jul 2011 @ 11:03am

Re: Re:
Most of the drugs that the "Big Pharma" sell are based on government supported research. So, I doesn't matter if Pharma makes money off of something, because its the government doing most of the work for them.

So, basically what I am saying is that drug research should be socialized. Oh , I bet you hate that word, dont you?
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weneedhelp (profile), 6 Jul 2011 @ 11:11am

Re: Re: Re: Re:
People dont do things for fun, fame, or just plain gratification of helping others?

Again you have a sad view of the world and of others that live here with you.
"And that's a naive and childish view of the world that goes totally against human nature." - In your sad world, maybe.
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RoadWreckRob (profile), 6 Jul 2011 @ 11:12am

"IGNORE THE LITTLE MAN BEHIND THE CURTAIN......."
Attention sheeple - pharmaceutical companies have only your best interests at heart and are only using testing such as the above stated to further their research and provide better drugs to treat all of your ailments. You may resume your normal life now.........

I hate pharmaceutical companies!!! There is a SMALL need for SOME pharmaceuticals that actually treat the problem and not the symptoms. Pharmaceutical companies are now making drugs to treat the SYMPTOMS that have shown up in patients from taking other drugs that will only treat symptoms due to the overprecribing medical community handing out prescriptions rather than telling patients the truth - - - "Get off your lazy ass and excercise! Eat right! Stop overindulging in drugs and alcohol! Stop putting carcinogens into your body (smoking anything)! Follow this prescriiption and I guarantee you won't need most of the pills that you are taking."

Why is it that doctors precribe so many pharmaceuticals instead of just providing the truth? Because they get tired of listening to people whine about how they can't handle anything. Not the best way to handle things but they are looking to stay employed and major medical care is now run by crooked health care giants that make being a doctor damn near impossible any more.

Agggghhhhhh!!!! Someone get me down off this soap box!!!

Sorry.
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tracker1 (profile), 6 Jul 2011 @ 11:24am

Re: Re: Re:
I personally don't have much issue with Pharma patents, I do think they, along with software patents should probably be limited to 3-5 years. I also think that copyright should probably be limited to 15-20 years, maybe a 15/15 15 years original, with 15 year extension filing, original must be filed within a year of the work's production, and the extension more than 1 year before expiration.

I'm not against the commercialization, but there should be fair limits to monopolies, and encouragement of competition. Beyond this, it's not like the U.S. is the only government in the world, more sharing of publicly funded research can only lead to faster improvement of what's available.
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Anonymous Coward, 6 Jul 2011 @ 11:36am

Re: Re:
Dont universities using government funding develop medicines all the time? Why cant medicines be crated for the common good, instead of profit? This way, we get cures, instead of the shareholder profit favored ongojng tratments...
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garm (profile), 6 Jul 2011 @ 12:10pm

Why cure if you can medicate
Removing pharma patents is the only way to go. These patents only empower a system where the goal isn't to get people healthy, it's only to get them well enough to not die.

Why cure someone if you can sell him a lifetime supply of expensotron (TM).

If medical research was free and there where no drug patents the only way a company could make big money was if THEY CREATE A BETTER DRUG THAN EVERY ONE ELSE!.
And this will be easy if there are no software patents.

And even if patents didn't exist there are laws to stop people for stealing your product and passing it off as their own. The only way they can "steal" your work is if they also improve it.
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out_of_the_blue, 6 Jul 2011 @ 12:12pm

So? It's capitalism! MONEY is the ONLY object.
I wonder how one can go on day after day relating the corrupt money chase and not become a trifle less enthused about the premise that corporations solely pursuing profits is rational basis for society. -- The solution is easy: absolute upper limit on incomes. I set it at $10M a year, not likely to affect anyone here: ZERO income taxes below, 100% above. Simple and fair. The IRS would only have to watch the 1% or so Filthy Rich, and that's as it should be.
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garm (profile), 6 Jul 2011 @ 12:13pm

Re: Why cure if you can medicate
Woops, that should have read "pharma patents" and not "software patents" >
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Darin (profile), 6 Jul 2011 @ 12:22pm

Why highlight this now?
These sleazy tactics took place in the early 1990s. The regulatory environment has changed significantly since then, which makes such abuse of the clinical trial process much harder today. Parke-Davis was destroyed by the fallout from STEPS, which led directly to their acquisition by Pfizer.

What next from the time-delayed outrage of Techdirt? Perhaps you could attack Mother Theresa for her support of slavery (since she is affiliated with the Roman Catholic Church, which inherited Latin and many resources from the Roman Empire, which supported slavery). The logic is a bit twisted, but no more than Tim's attempt to resurrect illegal activities from two decades ago as a current "scam".
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Capitalist Lion Tamer (profile), 6 Jul 2011 @ 1:23pm

Re: Why highlight this now?
Why now?

Because this study that's being quoted was published on June 27th of this year:

http://archinte.ama-assn.org/cgi/content/abstract/171/12/1100

From the abstract: "as well as depositions elicited in legal proceedings of Harden Manufacturing vs Pfizer and Franklin vs Warner-Lambert, most which were created between 1990 and 2009"

It's not all old news.
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Prisoner 201, 6 Jul 2011 @ 1:55pm

Re: Why cure if you can medicate
I'll take two boxes of expensotron. With a name like that I simply must have some.
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Reality called, 6 Jul 2011 @ 2:44pm

RoadWreckRob
Come on roadwreck, why dont you tell us what "eat right" means
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RoadWreckRob (profile), 6 Jul 2011 @ 3:20pm

Re: RoadWreckRob
Properly portioned meals. Less sugar. Try to stay away from foods that have preservatives if possible. No fried foods. Less carbohydrates and more of the balanced food groups we should be eating. More fruits and vegetables but DO NOT cut out meat. Meat is an important part of a healthy diet when eaten in the proper proportions. Most of all drink lots of water. So many of us do not drink enough water. I know you say there is water in what I drink but most sodas and other drinks have ingredients that are diuretic and actually pull more water out of our system than we are putting in.
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Nicedoggy, 6 Jul 2011 @ 5:37pm

Re: Re:
Open initiatives just like in the past and present?
http://www.iowh.org/

According to some recent studies the drug companies are responsible for 15% of discoveries and papers all the rest is done by public funding in universities, where it is transferred after to private institutions.

You see the money to develop those things comes from society not from sales, that money from sales is not available to research apparently since drug companies are more interested in promotion than in R&D.

Want to see those people get scared, lets pass a law mandating that any public research becomes public and everyone can produce it, they will go ballistic over such a bill since they depend on public funding to develop what they sell.
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Nicedoggy, 6 Jul 2011 @ 5:38pm

Re: Re:
I even think that if public funding was used any company that used that should pay the people for having fund their research is not that how companies work they must repay their stakeholders?

But somehow when it is public taxes people don't get a dime out of the deal.
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Nicedoggy, 6 Jul 2011 @ 6:05pm

Re: Re: RoadWreckRob
Here is an idea.

Weight yourself before going to bed and after your 8 hours sleep, you will noticed that you have lost weight and that is your metabolic rate, so if you lost 500g multiply that by 3 and you have the total weigh in food you can consume for each day. If you want to loose weight eat less, if you want to gain some eat more and if you to stay the same just eat that much or more or less 1.5 Kg/per day.

List of things you need to observe as you age:

- Blood pressure, if it is high you need blood thinning food like onions, blueberries etc that will complement your medicine, unfortunately rarely just food will help you with that.

- Cholesterol check to see if you need to cut on the grease food.

- HbA1c check this, it will tell you if you are going to get diabetes type II and since it has a constant rate of accumulation of glucose it can tell you if your sugar control is good or not, if you happen to have diabetes. In non diabetic people this never passes 4.8%~5.9%, if it does pass it means that glucose is not being metabolized, if it is bellow maybe you should go to a psychiatrist to treat you for eating disorder.

Focusing on that you can eat anything you like as long as you pay attention to your weigh(BMI), blood pressure and glucose levels, there is not much else one can do.

And of course you can go nuts on the weekends once or twice a month so if you plan right you will miss on nothing and stay healthy.
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Nicedoggy, 6 Jul 2011 @ 6:11pm

Re: Re: Re: RoadWreckRob
ps: The weighing thing works best with digital balances, the analogue ones are hard to read.
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Anonymous Coward, 7 Jul 2011 @ 9:24am

Re: Re:
Patents aren't necessary for profits to be made.
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Jose_X, 8 Jul 2011 @ 4:28pm

Re: Re: Re: Re:
There are a great many motivations for enriching yourself and for becoming the "creator" of something and participating in a society where you get to use all other creations as well.

For example, it is a pleasure to grow up in a world where we don't have to pay to speak English and socialize with others. In this world, it is a pleasure to contribute back interesting conversation.

You are most importantly missing the fact that there is much money to be made by experts and many others in a world without IP monopolies.

Are you aware of all the high quality open source software that has been created by people getting paid and by those not getting paid directly, none of whom rely on IP?

But the real problem is in the details of the law, and patent law (along with copyright law) is very broken. You don't want to give a monopoly to someone that hardly contributed to something as happens almost all the time (patents are so broad or through inheritance of these monopolies). You don't want to give a very long monopoly. You don't want to stifle progress. Etc.
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