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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline

« More On Homemade Street Drugs | Main | Has Luc Montagnier Lost It? »

January 10, 2011

Ahem: "Sell Gobs of Dope"?

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Posted by Derek

Thanks to Jim Edwards at Bnet, we have an example of some of the worst pharma sales techniques imaginable. A lawsuit alleging that Gilead Pharmaceuticals had been illegally pushing off-label indications for their angina medication Ranexa (ranolizine) was dropped recently, which brought a lot of court papers into view. According to the whistle-blower who filed the suit, a director of sales force training at the company said that their mission to, and nothing will do except a direct quote, "sell gobs of dope" and "get those pills into people's mouths any way you can."

The drug's supposed to be used only for refractory angina, but the suit alleges that Gilead's sales people were targeting the larger cardiovascular market. "I do not care what you do to sell the drug," a sales manager is quoted as saying. "I don't see anything and I don't hear anything. Just get those scripts."

Now, I realize that these are papers from only one side of this case. And as it turns out the Department of Justice actually did not get involved in the suit, which is probably why it's been dropped (for now). Furthermore, even if these allegations are true, they may well reflect the culture of CV Therapeutics, the company selling Renexa when Gilead bought them in 2009.

But this should really be an alarm bell for the management at Gilead. If they have people in their sales organization with this worldview, then it's only a matter of time before some of them do enough, say enough, present enough, and write down enough evidence to allow a successful whistle-blower case. And if that's what's going on, then such a suit would be richly deserved. This sort of stuff is idiotic, and it's wrong, and it's a big reason why the public opinion of our industry has been relentlessly sliding down over the years.

Comments (15) + TrackBacks (0) | Category: Business and Markets | Regulatory Affairs | Why Everyone Loves Us


COMMENTS

1. AttorneyatRaw on January 10, 2011 11:16 AM writes...

Derek, I think you were right to point out that this is only one side of a case and perhaps I would emphasize that point even more strongly. This is a party who is hoping to make boatloads of money by a successful whistleblower suit. The fact that the DOJ did not pursue the case would make me even more cautious. People allege things all the time and where they have a monetary interest in the outcome, well....Without emails, recorded conversations, etc, something like this is pretty much meaningless in my opinion.

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2. Hap on January 10, 2011 11:21 AM writes...

Maybe this should also be filed under "How Not To Do It: Sales".

Something that stupid and juicy is not likely to stay buried long enough to help your company, and considering the pressures and job insecurities for sales reps, well, that seems to be asking for trouble. Alternatively, this could be part of a whistleblower's scorched-earth policy - even if it isn't true, lots of people that see it won't really care, and others will forget out about it by the time someone figures out it didn't happen.

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3. PharmaHeretic on January 10, 2011 11:51 AM writes...

And your last post was on the "dangers" of Homemade Street Drugs? At least those people do not use authority and suits to CON people.

http://pipeline.corante.com/archives/2011/01/07/more_on_homemade_street_drugs.php

This is how low the legal pharma industry has sunk.. I am not saying that things were prefect in the past, but this level of CON was the exception, not the norm.

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4. Zigzag on January 10, 2011 12:00 PM writes...

While not every company is caught pushing 'gobs of dope' on the gullible patients/greedy physicians, pretty much every Pharma company's top-level executive secret evening (or morning, whatever) prayer seems to be to find a new quasi-legal way to 'push gobs of dope'. Note the *quasi* modifier - just like the famous Quasi Turtle Soup, the corporate definition of legal often does not withstand close scrutiny.

The modus operandi of this business is as follows: we might not outright lie to you (although on occasion we might, if we feel frisky) but we will engage every other possible mode of misdirection and persuasion - up to and including indirectly peddling sexual gratification - to sell as many units of our highest-priced medicines as humanly possible.

To be fair, this is nothing new or unlike pretty much any other industry that has to sell something to someone. Just look at what morticians get up to.

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5. AttorneyatRaw on January 10, 2011 12:19 PM writes...

I find it odd to consider how quick we industry folks are to criticize our own industry marketing practices when we are probably the most regulated of all industries. Look, our industry is caving in with attacks from all sides (patients wanting cheaper drugs,governements and insurers wanting cheaper drugs, government looking to fill its coffers by suing pharma companies for any number of putative infractions, whistleblowers looking to fill their coffers, generic companies looking to invalidate our patents, plaintiff attornies looking to sue us for any possible harm our products could have (think autism and vaccines), regulatory authorities looking for reasons not to approve our drugs,etc). As we ponder our own dwindling fate and cast our eyes out to our many colleagues who have been laid off and will never work in this industry again, please understand that it is largely due to these reasons. As much as we seem all too willing to blame our plight on the industry itself in a kind of Stockholm syndrome manner, we need also to look out to the context of the very messed up, litigous society that we live in. Everything is a fineable and punishable offense and making money is the worst offense of all.

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6. Hap on January 10, 2011 1:11 PM writes...

But these reasons all existed before - there weren't as many generics companies, nor probably as many litigious lawyers, but there were plenty of these before. People wanted drugs cheaper, but there was enough money for people to afford them, so the system was stable. (The buyers have aggregated now, giving them more leverage, which is different.)

What was different was that people trusted pharma, and that there were actual products for it to sell. When those were true, generics companies were marginalized (because there was a trust in the brand and not in the generic) and companies didn't have to oversell the products they did have because there were enough other products in the pipeline that the cost to one's reputation wasn't worth the extra money. The lawsuits have effects because pharma decided the goodwill of its reputation was worth less than the money that could be gotten in its absence, and once you have no goodwill, people are willing to believe the worst of you. In the absence of goodwill, even the good products you sell will be used against you because they cost a lot (even if they're worth it). If we knew why there aren't products, someone would be making money - all we know is trials are really expensive and really unpredictable and take a long time. Lawyers didn't do any of those things (the safety margins - some, but there's an awful lot of efficacy failures in P3 for that to be sufficient).

Making money is a crime? Ask the bankers about that.

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7. Barry on January 10, 2011 1:38 PM writes...

Maybe it's actually progress that more big Pharma companies are naming lawyers rather than marketers as their CEOs. In their own glacial trying-to-turn-a-warship-around way, this may be the belated response to an industry unmoored from the science.

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8. AttorneyatRaw on January 10, 2011 1:43 PM writes...

Not really Hap.

Hatch Waxman changed the game for generics significantly - Generic companies are actually rewarded for invalidating innovator patents.

The regulatory burden before the FDA has increased substantially, to argue otherwise is to ignore the tremendous size and costs of clinical trials currently compared to previously.

"Lawyers didn't do anything" - I reckon those who worked for any number of companies that lost billions and billions of dollars to mostly senseless tort actions would disagree, especially the many thousands of folks who were laid off as a result. If you think lawsuits are solely the product of the actions of an industry then you don't know much about which leads which. Plaintiff lawsuits bring bad press, which brings more lawsuits which eventually cave an industry in.

I am not sure what you mean by "overselling" - I can't think of many other industry whose marketing is regulated to the extent that pharmaceuticals except maybe alcohol or tobacco (isn't it ironic that companies who spend gazillions of dollars to discover drugs to make people healthier have their marketing restricted together with those that make them sick!!). The reality is that we are the the most regulated industry and the pharma sales/marketing people who we seem so quick to blame the woes of our industry on have the least leeway to sell the product of essentially anything on the market. Have you ever watched a pharma commercial on tv - the warnings are longer than the explanation of benefits. Then watch a beer commercial, lots of pretty girls and fun...but hey, what about the cirrhosis of the liver, family destruction, esophogeal cancer, drunk driving, etc.

Like it or not, the drugs we sell generate the profit for the research we do. I believe in this industry and believe in its value but understand it is a business too. Cut marketing means cut sales means cut budgets and so on. While all other industries can market their stuff to their heart's contents, we shouldn't I guess.

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9. Hap on January 10, 2011 2:04 PM writes...

When you market things for what they aren't permitted to be sold for and what they don't work for (or what you don't know if they work for - see first clause), no. That's pretty simple.

Lawsuits don't have traction unless they're reported and unless people have a reason to believe that the people suing have anything other than self-interest and lack of responsibility on their side. Media plays on people's sympathies, but without reason to trust Random Dumb Guy's claim that "Viagra gave him AIDS", well, then no one cares. Only when something gives people reason to distrust you do the lawsuits generate the press necessary to damage you. And Merck, etc., gave it to them in spades.

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10. Hap on January 10, 2011 2:10 PM writes...

Clinical trial costs also relate not just to the possibility of lawsuits, but to that belief that pharma's word is not good anymore. If you tell your parents that you cleaned your room and they haven't reason not to trust you, they probably won't check, but if you lie to them once, and they find out, you can be sure they'll check from then on, and you'll have to spend lots more time to make sure nothing is out of place. The added costs are in part a self-inflicted wound.

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11. AttorneyatRaw on January 10, 2011 2:26 PM writes...

Hap, I love your blue sky belief in what it takes to file a lawsuit in our country! Are you at all familiar with the tremendous amount of fraud that goes into plaintiff lawsuits against any number of industries? Do you really believe that vaccines cause autism? do you know how much money is spent and lost in lawsuits like this every year? Hap, there is very few if any industries so regulated as Pharma. have you ever reeally studied what it takes to get any drug on the market? You wish to use the Merck example for some odd reason but I am not sure why. I assume you are talking about Vioxx? This drug was extensively studied in numerous clinical studies and reviewed by the fda and approved. What did Merck fraudelently do? When they ran another study to look at expanding the label, the observed increased heart risks and pulled the drug...this was even after an advisory committee reconvened and voted by majority to allow the drug to stay on the market!

Can you explain to me how if somebody's word is not good anymore that a larger study will fix that? When was the size of a clinical study determined by "how good somebody's word was?" I always thought it related to statistical power but maybe you remember back to the good old days when a Man's handshake was good enough. I don't know what to say so I won't even try anymore....

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12. Zigzag on January 10, 2011 4:45 PM writes...

Excessive and frivolous litigation is a fact and there's no escape until necessary reforms are passed. Funny contest - between large numbers of lawyers and associated trades who benefit from frivolous tort, and equally large numbers of other lawyers who are paid to defend against frivolous tort. On the surface of things it seems that industry may be able to win since the lawsuits cost it a lot of money -- but this is an illusion since the people who are doing all the work (i.e. arguing the case for tort reform) more or less directly benefit from things staying the way they are (i.e. themselves and their colleagues being employed to defend against frivolous lawsuits). True tort reform results in loss of revenue and jobs for legal firms and departments therefore it's highly unlikely that it happens. It's like expecting that convicts who run an underground meth lab in a prison suddenly see the light and shut their business down 'pro bono publico'. Not likely.

The existence of large numbers of frivolous lawsuits does NOT negate the existence of a (medium but growing) collection of tried-and-true legitimate cases where Pharma was caught with its hand in a cookie jar. Or a shovel in a lard pit, etc. And having witnessed the motivation behind pharma executives first hand, I for one have quit the business. No more pharmaceutical chemistry for me - not until I can find a 'real' nonprofit or other similar organization that does not daily prostitute the 'values and standards' that all pharma companies so readily espouse and flaunt.

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13. sepisp on January 11, 2011 3:24 AM writes...

You should use the full term "angina pectoris", since in other than American usage, "angina", Latin for throat infection, means just that: tonsillitis.

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14. processchemist on January 11, 2011 8:01 AM writes...

@8

"The reality is that we are the the most regulated industry "

Sure. The problem is application of these rules, and I think about the generics field.
Ask everyone at FDA or EMEA, and they will not be able to negate that controls and inspections are based not on necessity, but on proximity.
While innovators are burdened with the heaviest weight of requirements about clinical trials, genericists are adequately controlled only in theory - in reality only if they're easy to be controlled. And FDA stated that they lack the resources to control every asian API manufacturer whose products are allowed in the US market.
In Europe we're only at the beginning of an action to contrast fake GMP products. And we're starting to see the first unexpected effects (some generic APIs are vanished from the market).

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15. Hap on January 11, 2011 9:56 AM writes...

Let's try this again...

#11: see this post. There are more pieces of drug company shenanigans there, as well, if you want to know why people might mistrust "the most regulated industry on the planet" - after all the FDA doesn't run trials, but relies on companies' data - their word, as it were.

One other post on that thread quotes, "Only a moron would want to live in a society where people are ashamed to work for drug companies." If you think selling drugs to the same standards as 8-Hour Boost or Bud Lite is likely to make that position easier to hold, then have at it.

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