Pharmaceutical Companies

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Pharmaceutical Companies

Postby HarryZ » Mon Jun 28, 2004 5:27 am

There has often been talk on this forum about the actions of pharmaceutical companies and how influential they can be. Some readers may refuse to believe that companies that produce medications can act in the manner that they do. I think after reading this long article from the NY Times, your views may be changed.

Harry


As Doctors Write Prescriptions, Drug Company Writes a Check

June 27, 2004
By GARDINER HARRIS


The check for $10,000 arrived in the mail unsolicited. The
doctor who received it from the drug maker Schering-Plough
said it was made out to him personally in exchange for an
attached "consulting" agreement that required nothing other
than his commitment to prescribe the company's medicines.
Two other physicians said in separate interviews that they,
too, received checks unbidden from Schering-Plough, one of
the world's biggest drug companies.

"I threw mine away," said the first doctor, who spoke on
the condition of anonymity because of concern about being
drawn into a federal inquiry into the matter.

Those checks and others, some of them said to be for
six-figure sums, are under investigation by federal
prosecutors in Boston as part of a broad government
crackdown on the drug industry's marketing tactics. Just
about every big global drug company - including Johnson &
Johnson, Wyeth and Bristol-Myers Squibb - has disclosed in
securities filings that it has received a federal subpoena,
and most are juggling subpoenas stemming from several
investigations.

The details of the Schering-Plough tactics, gleaned from
interviews with 20 doctors, as well as industry executives
and people close to the investigation, shed light on the
shadowy system of financial lures that pharmaceutical
companies have used to persuade physicians to favor their
drugs.

Schering-Plough's tactics, these people said, included
paying doctors large sums to prescribe its drug for
hepatitis C and to take part in company-sponsored clinical
trials that were little more than thinly disguised
marketing efforts that required little effort on the
doctors' part. Doctors who demonstrated disloyalty by
testing other company's drugs, or even talking favorably
about them, risked being barred from the Schering-Plough
money stream.

Schering-Plough says that the activities under
investigation occurred before its new chief executive, Fred
Hassan, arrived in April 2003, and that it has overhauled
its marketing to eliminate inducements.

At the heart of the various investigations into drug
industry marketing is the question of whether drug
companies are persuading doctors - often through payoffs -
to prescribe drugs that patients do not need or should not
use or for which there may be cheaper alternatives.
Investigators are also seeking to determine whether the
companies are manipulating prices to cheat the federal
Medicaid and Medicare health programs. Most of the big drug
companies, meanwhile, are also grappling with a welter of
suits filed by state attorneys general, industry
whistle-blowers and patient-rights groups over similar
accusations.

In many ways, the investigations are a response to the
evolution of the pharmaceutical business, which has grown
in the last quarter-century from a small group of companies
peddling a few antibiotics and antianxiety remedies to a
$400 billion bemoth that is among the most profitable
industries on earth.

Offering treatments for almost any affliction and facing
competition in which each percentage point of market share
can represent tens of millions of dollars, most drug makers
now spend twice as much marketing medicines as they do
researching them. Their sales teams have changed from a
scattering of semiretired pharmacists to armies of young
women and men who shower physicians with attention, food
and - until the drug industry recently agreed to end the
practice - expensive gifts, just to get two to three
minutes to pitch their wares. A code of conduct adopted in
1990 by the American Medical Association suggests that
doctors should not accept any gift worth more than $100,
but the guidelines are widely ignored.

A quarter-century ago, the Food and Drug Administration was
the lone cop on the drug industry beat. But the F.D.A.'s
enforcement powers over drug marketing have been severely
curbed since 1976 by a series of court rulings based mainly
on the companies' free-speech rights. That left a vacuum
that many companies decided to exploit, said William Vodra,
a former F.D.A. lawyer.

"A lot of people decided there was no check on what they
were allowed to do," Mr. Vodra said. Using fraud, kickback
and antitrust statutes, federal prosecutors, state
attorneys general and plaintiffs lawyers stepped into the
void, asserting that the companies' sales pitches have cost
the government billions of dollars in payments for drug
benefits.

This legal scrutiny can be expected to intensify. Once the
new Medicare drug benefit takes full effect in 2006, the
government will pay for almost half of all medicines sold
in the nation. So the marketing programs will cost the
government even more money and, if they are uncovered and
determined to be illegal, will probably result in even
larger fines.

Last month, Pfizer agreed to pay $430 million and pleaded
guilty to criminal charges involving the marketing of the
pain drug Nuerontin by the company's Warner-Lambert unit.
AstraZeneca paid $355 million last year and TAP
Pharmaceuticals paid $875 million in 2001; each pleaded
guilty to criminal charges of fraud for inducing physicians
to bill the government for some drugs that the company gave
the doctors free.

Over the last two years, Schering-Plough, which had sales
of $8.33 billion last year, has set aside a total of $500
million to cover its legal problems - mainly for expected
fines from the Boston investigation and from a separate
inquiry by federal prosecutors in Philadelphia who are
investigating whether Schering-Plough overcharged Medicaid.


Besides looking into whether Schering-Plough paid doctors
large sums to prescribe the company's drug for hepatitis C,
prosecutors are investigating whether many
company-sponsored clinical trials for the drug were simply
another way to funnel money to doctors.

Dr. Chris Pappas, director of clinical research for St.
Luke's Texas Liver Institute in Houston, said that
Schering-Plough "flooded the market with pseudo-trials."

Dr. Pappas and eight other liver specialists who were
interviewed say the system worked like this:
Schering-Plough paid physicians $1,000 to $1,500 per
patient for prescribing Intron A, the company's hepatitis C
treatment. In conventional clinical trials, participants
are given drugs free, but the doctors said that in these
cases the patients or insurers paid for their medication.
Because patients usually undergo Intron A treatment for
nearly a year and the therapy costs thousands of dollars,
Schering-Plough's payments to physicians left plenty of
room for the company to profit handsomely, the doctors
said.

In return for the fees, physicians were supposed to collect
data on their patients' progress and pass it along to
Schering-Plough, the doctors said. But many physicians were
not diligent about their recordkeeping, and the company did
little to insist on accurate data, according to Dr. Pappas
and the others.

One of the nation's most prominent liver disease
specialists, who spoke on condition of anonymity for fear
of angering big drug makers, called the trials "purely
marketing gimmicks."

"Science and marketing should not be mixed like that," the
doctor said.

Schering-Plough did more than encourage physicians to place
patients on Intron A, many of the physicians said. They
said the company would remove any doctor from its clinical
program - and shut off the money spigot - if he or she
wrote prescriptions for competing drugs, participated in
clinical trials of alternatives to Intron A or even spoke
favorably about treatments besides Intron A.

The main competitor to Intron A, which Schering-Plough now
sells as Peg-Intron, is Roche's comparably priced drug
Pegasys.

Dr. Donald Jensen, the hepatology director at Rush
University Medical Center in Chicago, said he wanted to
perform clinical trials using drugs from both
Schering-Plough and Roche. "I was told by Schering-Plough
that I couldn't do both - that I had to sign an exclusive
agreement with them," Dr. Jensen said. "That was the
juncture when Schering and I parted ways."

Six specialists in liver disease said Schering-Plough also
paid what it called consulting fees to doctors to keep them
loyal to the company's products. The letter accompanying a
check for $10,000 explained that the money was for
consulting services that were detailed on an accompanying
"Schedule A," said a doctor who insisted on anonymity. But
when the doctor turned to the attached sheet, he said,
"Schedule A" were the only words printed on an otherwise
blank sheet of paper.

Dr. Pappas, who in the past has consulted for
Schering-Plough and worked for Roche, said that stories
about the enormous sums that Schering-Plough paid its
consultants were common among liver specialists. "These
were very high-value consulting agreements with selected
opinion leaders that looked like payments of money with no
clear agreements on what was supposed to be executed," Dr.
Pappas said.

In an interview, Mr. Hassan and other top executives
declined to discuss past marketing practices. Richard
Kogan, the company's previous chairman and chief executive,
declined to be interviewed.

Schering-Plough's current management says that much has
changed at the company since Mr. Hassan took over. The
company no longer allows sales representatives or marketing
executives to have any say over its clinical trials,
physician education or medical consulting, they said. And
in all clinical trials begun in the last year, they said,
drugs have been provided free to the enrolled patients,
rather than being billed to them or their insurers.

"The temptation to give clinical grants to high prescribers
and consulting agreements to high prescribers is why we
pulled those decisions out of the hands of the sales
representatives," said Brent Saunders, who was named senior
vice president for compliance and business practices last
year. "Sales representatives had an input into that process
before, which I think is still fairly normal in the
industry."

In the separate Philadelphia investigation, Schering-Plough
is expected to plead guilty soon to charges that it failed
to provide Medicaid with its lowest drug prices, as is
required by law, and to pay a fine. Investigators are
examining whether Schering-Plough, to gain sales with some
private insurers, offered premiums, such as free patient
consulting arrangements, with its drugs. Prosecutors are
arguing that such incentives had a market value and meant
that Schering-Plough was offering drugs to private payers
at prices well below those offered to Medicaid. Many other
drug companies are the targets of similar inquiries.

The Boston inquiry into suspected kickbacks and improper
marketing by Schering-Plough could take months more to
resolve, people close to the investigation say.
Schering-Plough may also be charged with obstruction of
justice and document destruction as part of the Boston
inquiry, according to the company's filings with securities
regulators.

Industry experts say the federal inquiries into
Schering-Plough and the other drug giants have led some
companies to adopt significant changes in the way they
peddle drugs to doctors. Other companies have been slower
to react. "These investigations came out of left field, and
no one saw them coming," said Peter Barton Hutt, a former
F.D.A. general counsel who now advises drug companies. "The
industry has since had to reshape entirely what they are
doing, but it was too late to redo what they'd been doing
for years."

Tony Farino, leader of the pharmaceutical consulting
service at PricewaterhouseCoopers, said that as a result of
the investigations many companies in the drug industry were
hiring executives to police marketing and sales practices.

"Reputational risk is something they're all trying to
manage," Mr. Farino said, "because the damages from failure
can be significant."
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Postby OddDuck » Mon Jun 28, 2004 6:51 am

Harry,

That article was GREAT! Glad you posted it! I worked on the inside of a medical corporation, although not pharmaceutical, for a while, and now I'm on the other side again (union), so I won't or can't say much, but I personally witness(ed) daily all manner of corporate strategies, so I can't say I'm surprised at all.

My curiosity now is whether and/or how the NMSS will respond, if at all.

Not to say that they are involved in any wrong-doing at all - I have no knowledge or opinion whatsoever on that due to lack of any facts at my disposal - I'm just speculating that this WILL be something of a backlash on probably all medical/disease/research non-profit organizations to some extent. I would think many people will now be wondering where particular "loyalties" lie, i.e. with corporations or with patients?

I DID "hint" one time, though, to the NMSS that I wondered how much valid research and/or possible beneficial medical therapies were being ignored or overlooked purely for the sake of the mighty dollar (well, ok, I was pretty blunt actually). Think of it this way, how much valid and unswayed research is even the NMSS themselves getting back from "some" (not all) researchers due to possible influence or involvement with pharmaceutical companies? I'm not saying everybody is "on the take". I certainly don't believe that. But this sounds fairly large in scale and a more common practice than originally known, perhaps; not just isolated incidences.

(You know, I hate to say it, but one time I did get a little ticked off at my old neuro, after he reviewed my research, said it looked valid, could find no flaws, but then wouldn't proceed on it - who also does quite a few simultaneous pharmaceutical clinical trials at a time - and I said to him without really even thinking because I was frustrated - I said, "You know what? Your hands might be "tied", but mine are not! They can't get to me! You watch me go!" Then of course, though, he wrote in my chart that day that basically, I might be a little "psycho". ROFL!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Yea, right. Well, I'm probably in very good company then. HAH! LOVE it!

Interesting!! Thought provoking! Thanks, Harry. I feel vindicated! (I'm weird, huh?) :wink:

Deb
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Postby HarryZ » Mon Jun 28, 2004 7:33 am

Deb,

You asked if the NMSS is perhaps involved in this kind of situation with the CRAB drug companies.

I am in a tricky situation here because what I have been told is being held in confidence to protect those who have devulged the information. I know some people may comment that this kind of information isn't reliable and should be taken "with a grain of salt" because the "proof" that it is accurate is not being given. Fair enough, then.... I can understand that concern but I can only say that I have no reason to believe that what I was told was anything but the truth. Each reader will have to decide for him/herself whether to believe what I have to say...that is solely up to them...

There is no reason to believe that the NMSS is acting any differently in obtaining pharmaceutical "money" than what was mentioned as taking place in the NY Times article. Many MS docs and clinics are in exactly the same boat.

That's all I can say for the time being.



Harry
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Postby OddDuck » Mon Jun 28, 2004 7:57 am

You asked if the NMSS is perhaps involved in this kind of situation with the CRAB drug companies.

Harry, well no, not exactly. I wondered if the NMSS might respond to that article, precisely because they don't want their reputation to be sullied at all or for anyone to think they have any connection whatsoever in nor do they condone that type of behavior (kickbacks and/or "being on the take"). I didn't inquire (nor was I trying to imply) as to whether they themselves might be involved directly. I just figured people might ask them out of curiosity.

I am in a tricky situation here because what I have been told is being held in confidence to protect those who have devulged the information.

Again, I don't believe I had joined this forum at the time some previous comments (that you refer to above) must have been made or something, because I'm unaware of what you mean exactly.

My main comment was:
Think of it this way, how much valid and unswayed research is even the NMSS themselves getting back from "some" (not all) researchers due to possible influence or involvement with pharmaceutical companies?
meaning that I wonder if the NMSS itself might be in the same boat as we patients are, because THEY might be getting "snowed" a bit, also, by "influenced" researchers and the researchers' possible involvement with pharmaceutical companies, not the NMSS's involvement with the companies. It was just a thought.

Sorry..........I guess I wasn't very clear with my comments. I do that sometimes. :)

Deb
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Postby HarryZ » Mon Jun 28, 2004 9:25 am

Deb,

>>Sorry..........I guess I wasn't very clear with my comments. I do that sometimes<<

Perhaps it was more of me "assuming" that's what you meant and not reading closely enough. That happens a lot on the internet when you can't speak to someone face to face and really get the full meaning of what was said.

I don't think the NMSS will reply to that article unless a number of people specifically ask them to.

The huge amount of money that floats around in the drug industry makes organizations, companies and people do things they sometimes may not want to do. If a drug company comes up to you and says..."we have a few hundred thousand dollars to "donate" to you in exchange for a few "favors", it becomes mighty tempting.

What irritates me is the secret and under the table manner in which it is done, is always denied and then when discovered, the company pleads guilty and pays the fine....only to do it again and again.

Money always has a way of getting almost anything done!

Harry
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Postby willysnout1 » Mon Jun 28, 2004 11:13 am

OddDuck wrote:That article was GREAT! ... My curiosity now is whether and/or how the NMSS will respond, if at all.

Why should the NMSS feel compelled to respond to an article that said nothing about MS or the companies that make MS drugs? :?

OddDuck wrote:I DID "hint" one time, though, to the NMSS that I wondered how much valid research and/or possible beneficial medical therapies were being ignored or overlooked purely for the sake of the mighty dollar (well, ok, I was pretty blunt actually).

Your suspicions are nothing other than that.

OddDuck wrote:You know, I hate to say it, but one time I did get a little ticked off at my old neuro, after he reviewed my research, said it looked valid, could find no flaws, but then wouldn't proceed on it

What was he supposed to do? Do you have a sense of what your neuro's options were?

HarryZ wrote:I am in a tricky situation here because what I have been told is being held in confidence to protect those who have devulged the information. ... There is no reason to believe that the NMSS is acting any differently in obtaining pharmaceutical "money" than what was mentioned as taking place in the NY Times article. Many MS docs and clinics are in exactly the same boat.

That's all I can say for the time being.

Harry met some guy at an MS conference who told him what he wanted to hear. Harry has inflated this conversation into a body of secret knowledge that can only be hinted at but never really disclosed. As for the practices discussed in the NYT story, they have no direct bearing on the NMSS because it isn't in the medical care delivery business and therefore wouldn't be involved in such a scheme.

There could be other schemes involving the NMSS for all we know, but to imply that it's involved in what the NYT described is simply ludicrous. Frankly, the degree to which anyone buys into this notion says more about the ability of the "buyee" to think rationally and critically than it does about ethics on the part of the NMSS or drug companies. :(
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Postby OddDuck » Mon Jun 28, 2004 12:05 pm

Willy wrote:
Why should the NMSS feel compelled to respond to an article that said nothing about MS or the companies that make MS drugs?

Exactly my point. I didn't say they would feel compelled. That's what I'll be curious about. To see if they will feel compelled or not.

Willy wrote:
Your suspicions are nothing other than that.

Ah, yes, but there would never be any searches for truth or facts without "suspicions", would there? And then where would we be?

Willy wrote:
What was he supposed to do? Do you have a sense of what your neuro's options were?

Yes, because we had discussed them. There is just no need to discuss them here, is all. Here is where trust in my integrity and honesty comes in. Sometimes you just can't break confidentialities.

Willy wrote
Frankly, the degree to which anyone buys into this notion says more about the ability of the "buyee" to think rationally and critically than it does about ethics on the part of the NMSS or drug companies.

That's your opinion, and I, for one, respect that. On the other hand, I also have worked in, researched, and personally seen the "not so ethical" side of corporations, so I can only say that from my factual experience, it's not only possible, but it happens more often than a person would like to think. Unfortunate, but often true. So, even though I have faith in the NMSS, I can't say for certain one way or the other, since I don't have all the facts at hand to back up my faith in the NMSS. So in all fairness, I won't throw stones at the opposite viewpoint, based on the same lack of factual information.

I readily admit that my opinion and support of the NMSS is based more on faith and intuition than it is on anything factual.

Bottom line: I guess I'm back on the fence. I know, I guess I should just be quiet, then, huh? :wink:

Oh! I almost forgot. Who was it who said to me: "All decisions are made under conditions of uncertainty, Deb." I think it was a very wise man, myself.

Deb
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Postby HarryZ » Mon Jun 28, 2004 12:34 pm

Willy,

>>Harry met some guy at an MS conference who told him what he wanted to hear. Harry has inflated this conversation into a body of secret knowledge that can only be hinted at but never really disclosed. As for the practices discussed <<

Sorry to disappoint you on this one but that old line you continue to use again and again has nothing to do with this thread. My information comes from a former volunteer with the NMSS who worked in this capacity for a number of years. Like I explained in my thread, Willy, either believe me or not on this but please don't continue to confuse your threads like you have a habit of doing.

If you think the NMSS is immune from what the NY Times article is saying, then that is your prerogative. But others closer to the situation know differently.

Harry
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Postby willysnout1 » Mon Jun 28, 2004 1:10 pm

HarryZ wrote:My information comes from a former volunteer with the NMSS who worked in this capacity for a number of years. Like I explained in my thread, Willy, either believe me or not on this but please don't continue to confuse your threads like you have a habit of doing.

So is this source someone different than the one you cited in the other thread?
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Postby willysnout1 » Mon Jun 28, 2004 1:19 pm

OddDuck wrote:I didn't say they would feel compelled. That's what I'll be curious about. To see if they will feel compelled or not.

Compelled was the wrong word. So let me try again. What possible reason would the NMSS have to respond to an article that doesn't mention them; that has nothing to do with MS; and never mentions charities or charity-funded research? The NMSS isn't in the business of reforming the medical system or the drug companies, particular as it concerns issues in which they have no involvement. The word here is irrelevant.

Odd Duck wrote:Ah, yes, but there would never be any searches for truth or facts without "suspicions", would there?

There is also the concept of the "wild goose chase."

Odd Duck wrote:On the other hand, I also have worked in, researched, and personally seen the "not so ethical" side of corporations, so I can only say that from my factual experience, it's not only possible, but it happens more often than a person would like to think.

I think if we knew each other better, I'd probably be the last person you'd ever view as a corporate toady. I am well aware of the nasty behavior of many corporations. I'm not making a pro-corporate argument here. Nor, by the way, am I giving anything to the NMSS "on faith." I'm using cold-hearted logic, and am saying that the NYT story doesn't point toward any misdeeds involving the NMSS.

Odd Duck wrote:I guess I should just be quiet, then, huh?

Caution: Martyrdom Ahead?
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Postby OddDuck » Mon Jun 28, 2004 1:27 pm

(Willy, you crack me up!)

Willy wrote:
What possible reason would the NMSS have to respond to an article that doesn't mention them; that has nothing to do with MS; and never mentions charities or charity-funded research?

I don't know. We'll have to ask them if they do respond, huh?

Willy wrote:
There is also the concept of the "wild goose chase."

Depends on how long you chase the goose.

Willy wrote:
I think if we knew each other better, I'd probably be the last person you'd ever view as a corporate toady.

You're right. It's hard for me to think of you that way, because....well, just what is a "corporate toady"?

Willy wrote:
I'm using cold-hearted logic, and am saying that the NYT story doesn't point toward any misdeeds involving the NMSS.

Number one, I'd never refer to you as "cold hearted". Hard headed, maybe, but NEVER cold hearted! And besides, I didn't say there was a direct correlation between the NYT story and the NMSS. I said:
I'm just speculating that this WILL be something of a backlash on probably all medical/disease/research non-profit organizations to some extent. I would think many people will now be wondering where particular "loyalties" lie, i.e. with corporations or with patients?

And is that not possibly proving itself to be true already? Of course, only time will tell for sure. Apparently, there's been an ongoing debate regarding this very subject for some time now. (Of course, that's only my impression.)

Willy wrote:
Caution: Martyrdom Ahead?

Naw, just trying to beat ya to the punch, is all. :wink:

Deb
Last edited by OddDuck on Mon Jun 28, 2004 1:41 pm, edited 2 times in total.
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Postby OddDuck » Mon Jun 28, 2004 1:33 pm

Oh, and Harry?

I still thank you for posting the article. It was still interesting to me and very thought provoking!

Deb
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Sheesh...

Postby JoyceF » Mon Jun 28, 2004 2:38 pm

Oh for pete's sakes......we all know what is going on here and I'm sure that most of us can tell when a spade is a spade no? Good going Harry and Willy....quit being such a horse's ass.
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Postby Arron » Mon Jun 28, 2004 2:58 pm

hey hey hey

hey HEY hey :)

you know i love you all, but let's keep it civilized. :oops: I don't like editing or deleting posts of any kind, and I don't yet feel I have to, but no name calling please, and (from earlier posts), no questioning other people's character's. Things have been said, apologies have been exchanged; the board grows.

MS is the enemy.
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Postby willysnout1 » Mon Jun 28, 2004 5:40 pm

OddDuck wrote:I don't know. We'll have to ask them if they do respond, huh?

Well, while we're at it let's see if the NMSS will take a stand on the troops in Iraq being given Lariam to prevent malaria. One side effect is that it causes psychotic behavior in some people who take it. I wonder what the NMSS has to say about this, and about the military's procurement policies and testing procedures for Lariam.

And, for that matter, I wonder what the NMSS has to say about homelessness, AIDS, prayer in school, the heartbreak of psoriasis, the occupation of Tibet by the Chinese, the federal highway program and the fact that my dog isn't getting enough cheese. If they're going to be expected to comment on an unrelated story about Schering-Plough in last Sunday's newspaper, then surely we want to know their position on every other problem in the universe, right?

OddDuck wrote:You're right. It's hard for me to think of you that way, because....well, just what is a "corporate toady"?

A Republi ... oops, someone who always believes whatever a corporation's p.r. people say, especially if it's a really big company. :)

Odd Duck wrote:And besides, I didn't say there was a direct correlation between the NYT story and the NMSS. I said:
I'm just speculating that this WILL be something of a backlash on probably all medical/disease/research non-profit organizations to some extent. I would think many people will now be wondering where particular "loyalties" lie, i.e. with corporations or with patients?

But there was nothing in the story about research or non-profit organizations. This was about drug companies pressuring individual doctors. By the way, I'm not in favor of that. I think someone ought to go to jail for it. But it doesn't even have a tangential relationship to anything the NMSS does, yet here we have you and Harry acting as if the NMSS somehow ought to say something. I really don't get it.
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