TCS Daily


Crazy Lawyering, Crazy Journalism

By Henry I. Miller - January 22, 2007 12:00 AM

Would you try to review a 700-page book after reading a single paragraph? Of course not - but major newspapers have done the equivalent, by publishing sensational and censorious articles about defendants in civil litigation that are based on selective leaks from lawyers. Unethical lawyering combined with shoddy journalism threatens many sectors of the economy, especially those that commonly face costly lawsuits alleging torts -- the drug, chemical, automobile and financial sectors, among others.

An egregious example occurred recently when a lawyer who represents mentally ill patients violated a gag order by leaking to various news outlets documents related to litigation over damages allegedly caused by Eli Lilly Company's anti-psychotic drug, Zyprexa. Based on information that was obviously incomplete and out of context, the New York Times made outrageous - and often misleading - allegations in news articles and editorials.

Lawyers owe their clients zealous representation, to be sure, but that is not the same as conducting an ideological vendetta in the media or attempting to poison the jury pool by trying a case in the newspapers and on National Public Radio. James B. Gottstein, the lawyer who leaked selected documents concerning the Zyprexa litigation to the New York Times and other media outlets, certainly appears to fall into the former category. He admits to conducting a "campaign against forced (court ordered) psychiatric drugging and electroshock around the country," because "the massive amounts of forced drugging in this country, amounting to probably at least a million cases a year, is resulting in decreased, rather than increased, public safety; causing an almost unimaginable amount of physical harm, including death; [sic] turning many patients into drooling zombies." The culprits? "In large part, this state of affairs has been created by the lies told by the manufacturers of psychiatric drugs . . ."

Mr. Gottstein appears to think he qualifies as a mental health expert because he has experienced psychotic episodes intermittently for a quarter-century. (See his autobiographical information at http://akmhcweb.org/recovery/jgrec.htm.) I think he needs to have his medications adjusted.

Within the past month, two federal judges independently have harshly condemned both the underhanded manner of Mr. Gottstein's obtaining of the documents and his dissemination of them, which violated a court-issued gag order. Another jurist, Judge Jack B. Weinstein, who is presiding over the consolidated federal cases in the Zyprexa litigation, wrote this about the need to prevent unauthorized leaks: "First, the cost and time to explain a single document taken out of context by a plaintiff's lawyer creates an incentive not to prepare memoranda. Second, what appears damning may, in context after difficult proof, be shown to be neutral or even favorable to the defendant." My own experience as an expert witness (in other litigation) corroborates Judge Weinstein's observations.

Access only to documents that argue one side of the case has not deterred the Times from repeated, vicious attacks on Lilly and Zyprexa, a drug widely prescribed and highly regarded by psychiatrists. In spite of relatively frequent side effects - the most common of which are sleepiness, weight gain and dry mouth - the drug has been administered to almost 20 million seriously ill patients in 84 countries. Many psychiatrists consider it a wonder drug for two of the most debilitating mental illnesses: schizophrenia and bipolar disorder.

The Times (and other papers that subscribe to its news service) accuses Lilly of promoting Zyprexa for not yet approved, or "off-label," uses, but the F.D.A. - which carefully monitors and takes a dim view of such violations of federal regulations - has never issued a warning to the company about this.

Without access to the complete database related to the litigation, I cannot judge the merits of the other accusations against Lilly and Zyprexa. However, the Times' call for Lilly's protestations of innocence regarding promotion of off-label uses "to be tested in Congressional hearings that should focus on how well the industry complies with existing laws and how effectively the F.D.A. regulates the industry's marketing materials" is clearly disingenuous. The Times knows that House Speaker Nancy Pelosi (D-Calif.) and influential committee chairmen such as Senator Ted Kennedy (D-Mass.), Henry Waxman (D-Calif.) and John Dingell (D-Mich.) have long been antagonistic to the pharmaceutical industry, and that such hearings would be no more than a witch hunt.

Henry I. Miller, a physician and fellow at the Hoover Institution, was an F.D.A. official from 1979 to 1994. Barron's selected his most recent book, "The Frankenfood Myth," one of the 25 Best Books of 2004.


Categories:

136 Comments

Bad reviewers
A lot of reviewers are bloody lazy especially when it comes to long books. This is no shock that is for sure. Then again there are people who critique some books like those of Steyn, Philips & Spencer without even bothering to read the bloody things at all.

Predictable bedfellows
That lawyers would engage in unethical behaviour is not surprising. Especially those who engage in politically motivated attacks on any of the Big evils (Big Oil!, Big Tobacco!, Big Pharm!).

That the NYT would enable such behaviour is equally unsurprising. They long ago lost any ethical foundation. If they ever possessed it in the first place.

Ironic...
that you don't seem to know the topic of the article. Did you read it?

And BTW, there is someone who posts here who believes that all you need to know about a book is in the title.

Unethical...
Many lawyers believe as long as its for the good of the client or interest there is no such thing as unethical. Those are the types that give the entire profession a bad name.

The Power of Capitalism
Many break-through, life-saving drugs have come to market over the past couple of decades in spite of parasitic lawyers, manipulated jury pools, tabloid main-stream journalism and political do gooders. Hopefully dynamic market incentives will continue to trump the above motley group of carpers.

Zyprexa scandal preceeded times articles


At a glance,zyprexa was promoted 'off label' to uses that weren't FDA approved.This opens up a can of worms for patients like myself took it for PTSD for which it was ineffective and moreover gave me diabetes.

True,leaked documents don't convey the 'whole picture' but what is compelling is that zyprexa is the 7th some say 5th largest drug sell in the world and Eli Lilly's #1 drug sale by their own admission.
This is for a drug that won't get you "high" cost $2.50 a pill and only indicated for less than 1% of the population.

Hello! Somebody in Lilly land is pushing zyprexa hard-Daniel Haszard

A Normal Distribution
There is something far more insidious with the litigation against products such as drugs and medical procedures. First it cost a lot of money to produce and then to obtain government approval for a drug. Litigation adds to that cost. Second, something much worse happens. People who are effectively treated by the drug or the medical procedure lose that option. In some cases this may mean losing their lives or at a minimum their quality of life.

What most Americans do not understand or if they understand do not appreciate the full ramifications, is that each drug is based on experiments. Those experiments are assessed by statistical models based on a normal distribution or as some call it a bell shape curve.

What the drug company hope is that those suffering from aa ailment that their drug treats will fall under the broad center of the distribution of curve. In other words the drug will treat them successful and not be offset by undue harm from side effects Yet every distribution has "tails". At one end of the distribution of drug efficacy the drug may not work at all. Under the distribution for side affects some may have dramatic problems, even though the majority of people taking the drug are left unharmed.

Lawyers today play on the "tails". They are demanding perfection from a system both created by humans as well as attempting to solve human problems.

I have known and also supervised people suffering mental illness. Most of the drugs they take have side effects, yet without those drugs they could not function at all. No two suffering from the same diagnosis took exactly the same drug or same dosage.

Of course I love to mention in these discussion one prevailing fact. Who would lawyers sue if medical care was taken over and run by the government?

So drug companies spending hundreds of millions advertising Rx drugs is fine...
But a newspaper publishing a story that casts doubt on drug claims is a threat? Is unethical??

Come on. If the story was inaccurate, the manufacturer can sue for libel. If the drug is harmless, unbiased researchers will vouch for it. This essay's bottom line is "turn off the lights: the public might see something."

But let's all shed a tear for the poor, overregulated, undefended pharmaceutical industry, struggling to bring us life-giving drugs like viagra despite vicious attacks by government make-work bureaucrts and litigation-crazy shark lawyers.

Funny you should ask...
considering your habit for forming an opinion without knowing the full story. Not to mention your aptly demonstrated lack of understanding ethical behaviour.

Tell me again how you can sue for libel when you are under a gag order? Then tell me how it is libel to present one side of an argument. That you, or the NYT, would understand balanced reporting is a joke. The paper has clearly become a part of the story by advocating one side.

Another question, in regards to ethics, does the size and wealth of an organization open it up to ethics violations? What is the wealth/size breakpoint where one no longer has to obey the rule of law or abide by ethical standards?

And once you answer those questions, please tell me that you would have had no problem with the drug company using such unethical behaviours to get their side across. If not then you are merely a class warfare tool that cares nothing about due process or facts.

And some other tidbits:

LeMule: >"If the drug is harmless, unbiased researchers will vouch for it."

Author: >"the drug has been administered to almost 20 million seriously ill patients in 84 countries. Many psychiatrists consider it a wonder drug for two of the most debilitating mental illnesses: schizophrenia and bipolar disorder."

Seems like the drug is pretty popular and useful. No drug is completely harmless. Perhaps this case is about the misuse of the drug? Considering that the FDA has "has never issued a warning to the company" about this it is hard for an intelligent person to come down on one side or the other considering how little is known. Easy for LeMule though cuz the Times done said so.

>"This essay's bottom line is "turn off the lights: the public might see something."

Actually, the bottom line of the essay is "turn on the lights: the NYT's biased reporting is showing." Something everyone should know by now but they are still able to fool some of the more dim-witted ones out there.

>"But let's all shed a tear for the poor, overregulated, undefended pharmaceutical industry, struggling to bring us life-giving drugs like viagra despite vicious attacks by government make-work bureaucrts and litigation-crazy shark lawyers."

Never to afraid to show your stupidity LeMule. Viagra is one of a number of money-making drugs that allows a company to invest in research into other drugs. If you don't like the most state of the art, innovative pharmaceuticals on the planet, as we have in the US, then you can keep trying to bring down the system that supports it.

About the only thing you got right was the descriptions of the bureaucrats and lawyers.

Drug companies and ethics
Sorry, but having spent many years working along side of those in the profession of psychiatry and having watched the "anything for a buck" mentality in the pharmaceuticals industry, I would tend to be a bit leery of promoting either one. I for one feel the a 380,000% markup is a bit much.

On this planet, Lilly is paying $500 million to patients with problems with the drug
And here's the Jan. 6 New York Times story about that settlement, including background on the drug. Maybe you can identify what parts of it are inaccurate.

http://query.nytimes.com/gst/fullpage.html?sec=health&res=9F00E5DB1430F936A35752C0A9619C8B63

It does present information from experts that seems a little at odds with your characterization, viz:

>Author: >"the drug has been administered to almost 20 million seriously ill patients in 84 countries. Many psychiatrists consider it a wonder drug for two of the most debilitating mental illnesses: schizophrenia and bipolar disorder."


The New York Times
"Zyprexa is the brand name for olanzapine, a potent chemical that binds to receptors in the brain to reduce psychotic hallucinations and delusions. Clinical trials show that in many patients, Zyprexa also causes severe weight gain and increases in cholesterol and blood sugar.

Documents provided to The New York Times last month by a lawyer who represents mentally ill patients show that Lilly played down the risks of Zyprexa to doctors as the drug's sales soared after its introduction in 1996. The internal documents show that in Lilly's clinical trials, 16 percent of people taking Zyprexa gained more than 66 pounds after a year on the drug, a far higher figure than the company disclosed to doctors."

Is the idea that these documents are false? If they were, why is Lilly settling instead of fighitng in court to defend its wrongfully challenged reputation??

Lawyers and the MSM
Lawyers Lie? The MSM lie? What a huge suprise. The NY Times has perfected lying to a art form, never mind leaking secrets.

No promotion...
except the promotion of ethics and facts.

The whole story is not known to us except for what one unethical lawyer has presented through a proven ethically-challenged newspaper in an attempt to sway public opinion in their favor.

I for one, will keep an eye out to see how this turns out and what the facts are. Seems quite logical to me.

As for the markup on drugs. I assume you are talking about the cost to make a pill in a factory instead of the cost to research, test, and receive approval to sell a drug since that is what most anti-Big Pharm(!) advocates do.

They put their stock-holder's money at risk to develop these drugs. They are due a profit that covers the entire cost of their ventures.

Who's 'ethically challenged?"
A company that covers up information about real and severe problems with a drug, or a newspaper that prints the information they want concealed?

Weight gain?
That is the "threat" you were screaming about?

Let's see, psychosis or weight gain? Tough call.

Now perhaps the part the lawyer did not leak was that these people, now somewhat free of hallucinations, resumed a normal schedule and lifestyle which includes a normal diet for most. Weight gain. Perhaps 16% of those people went overboard and started to over eat. Weight gain. What is the percentage of sane people who are overweight?

Once again: I don't know the full story but you feel free to run on the word of only one side. If it suits your purposes you really don't need the truth.

>"Is the idea that these documents are false?"

No dummy. The idea is that you are only getting one side of the story from biased sources and that the NYT has no interest in providing any balance.

>"If they were, why is Lilly settling instead of fighitng in court to defend its wrongfully challenged reputation??"

Since when does a settlement prove guilt? The settlement doesn't mean that Zyprexa causes diabetes and doesn't call for Lilly to do so. Perhaps they thought they would settle with the fat ones and tell the others that weight gain is possible? Who knows? With over 11 million pages of documentation I doubt that lawyer provided the NYT with the whole story.

And why defend your reputation when even the most powerful newspaper in the US won't give you a fair shake? I don't know the reasons behind the settlement since I only know the story from the side of the lawyer who represents the psycho lard-asses.

Now let me ask you dummy: Where do you think the bulk of the $700,000,000 goes? Lawyers. Who do you think pays for the settlement that goes to those lawyers? The purchasers of other Lilly drugs. This settlement is a prime reason for those "ridiculous" markups you claim to be against.

And lastly: I see you avoided answering anything about the illegal and unethical disclosure of a small fraction of over 11 million pages of documents in this case. This is probably a good thing since the concept of ethical behaviour is far beyond your ability to understand.

Besides, the NYT has no problem putting our national security at risk. This is small potatoes for them.

The word is evidence...
and you don't have any.

But you do have a dislike for drug companies and that is good enough.

With over 20 million users of this drug world-wide I find it interesting that weight gain would be a "real and severe" problem. Considering the small number of those in the suit I would say the problem is marginal.

But, once again stupid, we don't have all the evidence.

So I would say the lawyer who broke the court order to provide a small portion of a case that generated over 11 million pages of documentation and the newspaper that chose to run this anti-Big Pharm(!) propaganda was the ones who are ethically challenged.

Just as you are intellectual challenged by showing that you cast judgement on an emotional level instead of a logical one.

A nifty experiment...
go to Google and type in "Zyprexa settlement" and see how many ambulance chasers... I mean lawyers, who are trying to make a buck off of it.

No evidence????
Then why did Lilly agree to pay a half billion dollars???

>With over 20 million users of this drug world-wide I find it interesting that weight gain would be a "real and severe" problem.

Sixteen percent of the patients given the drug in the tests experienced huge weight gains, a number covered up by the company. Do you really find 1/6th a trivial or accidental number??

>But, once again stupid, we don't have all the evidence.

But Lilly did, and they agreed to a pay a half-billion in settlements rather than go to trial. Maybe their lawyers don't know what they're doing.

>Just as you are intellectual challenged by showing that you cast judgement on an emotional level instead of a logical one.

Sure: one-sixth of patients in the clinical trial showed severe side effects and the company covered up the result, according to records unearthed in the suit and made public by the NY Times. In your book, that's just pure emotion. Tell me then what counts as facts?

PS - I'm not surprised to learn you know as much about drugs as you do about carbon.

66 pound weight gain
no big deal?? Oh really.

>Since when does a settlement prove guilt?

Since when does a company agreeing to pay one half billion dollars indicate that the drug performed exactly as promised?

>And why defend your reputation when even the most powerful newspaper in the US won't give you a fair shake?

You still haven't said what the Times got wrong. You haven't read those 11 million pages. Why are you so sure they change the story?


>And lastly: I see you avoided answering anything about the illegal and unethical disclosure of a small fraction of over 11 million pages of documents in this case.

If it was illegal and unethical, Lilly has legal recourse against the lawyer and against the Times. Or maybe you think they don't have enough resources to be able to use these resources.

ps - is it really impossible for you to write without namecalling?

an even niftier experiment
Imagine that you're the people at Lilly who arranged to cover up the test results. Is your boss going to blame you or the lawyers for the company's troubles.

Unless it was the boss who covered it up. In which case the stockholderes may have something to say.

Yes. No evidence.
>"Then why did Lilly agree to pay a half billion dollars???"

Because they can and the lawyers know that they can generate bad press if they do go to court. It is the Jesse Jackson school of shakedowns.

>"Sixteen percent of the patients given the drug in the tests experienced huge weight gains, a number covered up by the company. Do you really find 1/6th a trivial or accidental number??"

Where is it proven that this was "covered up"? And where is it proven that this is caused by the drug itself or the relief of psychotic symptoms? Were the patients in the drug trials on the same diets? Were those diets monitored? How was the trial run? What was the methodology?

So yes, I do find it a trivial number since I don't have the evidence to connect the drug to the weight gain. It is no wonder you are a rabid AGW alarmist: you have no grasp of the scientific method and love a good conspiracy theory.

>"But Lilly did, and they agreed to a pay a half-billion in settlements rather than go to trial. Maybe their lawyers don't know what they're doing."

Once again stupid, the courts are an uncertainty. They didn't know how it would play in the courts or the public so they settled. This happens all the time and in no way does it mean the defendant is guilty.

>"Sure: one-sixth of patients in the clinical trial showed severe side effects and the company covered up the result, according to records unearthed in the suit and made public by the NY Times. In your book, that's just pure emotion. Tell me then what counts as facts?"

In your book illegally leaked documents, a few out of millions and provided by the lawyer who has an obvious bias, prove a cover-up of "dangerous" side effect?

The facts are as I stated: illegally obtained documents from a unethical lawyer. That is the only facts we know about the settlement. The rest is conjecture.

>"PS - I'm not surprised to learn you know as much about drugs as you do about carbon."

This isn't about drugs, it's about ethics and truth. Not surprising that your steel-trap mind missed that. Needless to say you did yet another nice job showcasing your lack of understanding of the scientific method.

Better move over to the other thread now. Beatles1 needs to reply to my post over there.

So?
>"no big deal?? Oh really."

Really. Are you having more trouble reading than usual today?

>"Since when does a company agreeing to pay one half billion dollars indicate that the drug performed exactly as promised?"

When they wish to avoid a circus like the one you seem keen on generating. Read the scientific literature on the drug and see how well regarded it is for what it says it does.

>"You still haven't said what the Times got wrong."

Wow. You really don't get it do you? What the NYT got wrong was the ethics. ETHICS. The ethics of publishing illegally obtained documents from a biased source and publishing them while the other side upholds the legally binding gag order not to discuss the settlement.

>"You haven't read those 11 million pages. Why are you so sure they change the story?"

This gets even better. You are arguing that we don't need to know the whole story before handing down judgement? Hard to believe you are not more highly regarded for your well-researched opinions.

Your statement speaks for itself. You are an idiot.

>"If it was illegal and unethical, Lilly has legal recourse against the lawyer and against the Times. Or maybe you think they don't have enough resources to be able to use these resources."

It was illegal and the courts will have their say against the snake... lawyer who broke the law. It is most likely a fine or some such. However, if Lilly takes the lawyer and the NYT to court they might have to release those documents and generate the bad publicity, that they wished to avoid, as part of the trial. As their press release says: they are putting this behind them.

You don't like to think for yourself do you?

>"ps - is it really impossible for you to write without namecalling?"

Your past stupidity and immaturity prevent me from treating you like an adult or in a mature manner. You are beyond redemption and are as unethical and unintellectual as they come.

Other than that I like you. Have a pleasant evening!

Is niftier even a word?
The settlement found no evidence of a cover up. Perhaps that is one of the things we could learn from the whole story that is found in over 11 million pages of documents.

I see LeMule can't answer the ambulance-chasers. The sharks are feeding but LeMule won't see them or admit they are a part of the problem.

don't mean to confuse you with facts, but....
You really don't seem to get it. What about this is unclear

>Eli Lilly agreed yesterday to pay up to $500 million to settle 18,000 lawsuits from people who claimed they had developed diabetes or other diseases after taking Zyprexa, Lilly's drug for schizophrenia and bipolar disorder.

Including earlier settlements over Zyprexa, Lilly has now agreed to pay at least $1.2 billion to 28,500 people who said they were injured by the drug. At least 1,200 suits are still pending, the company said. About 20 million people worldwide have taken Zyprexa since its introduction in 1996.

So we have thousands of people suing (and more likely to) Lilly paying out $1.7 billion, with more on the way -- for people who say they were harmed by taking the drug - but it's the NY Times who's the baddy here??

>Where is it proven that this was "covered up"?

OK, here's the original Times piece:

"The New York Times reports that for at least a year Eli Lilly provided information to doctors about the blood-sugar risks of its schizophrenia drug Zyprexa that contradicts data circulated within the company when it first reviewed its clinical trial results. The original results, according to a February 2000 memo, show that patients on Zyprexa were 3.5x more likely to experience high blood sugar levels as those on a placebo. But doctors were given a very different picture until at least late 2001; that Zyprexa patients were only slightly more likely to suffer high blood sugar. A November 1999 report shows that 16% of patients taking Zyprexa for a year gained more than 66 pounds; Lilly chose instead to focus on data from a different, smaller group of clinical trials that showed 30% of patients gaining 22 pounds."

Do you reeally think the documents don't show this???

>In your book illegally leaked documents, a few out of millions and provided by the lawyer who has an obvious bias, prove a cover-up of "dangerous" side effect?

In anyone's book this is true. The lawyer didn't forget the documets: they came from Lilly. Are you really unable to understand this?

> illegally obtained documents from a unethical lawyer. That is the only facts we know about the settlement. The rest is conjecture.

The contents of the document are not "conjecture." Lilly doesn't say the documents are forged.

>This isn't about drugs, it's about ethics and truth.

Yes, it is. Lilly had one truth that was circulated in house, and another that was sent out to doctors. But you're rooting for Lilly anyway.

The settlement happened because the coverup angle was a slam dunk
Or maybe you think Lilly just settled because they had an extra billion and a half lying around that they were looking to get rid of.

>I see LeMule can't answer the ambulance-chasers. The sharks are feeding but LeMule won't see them or admit they are a part of the problem.

If you don't have irresopnsible drivers, the ambulance chasers dry up and go away. But sure, blame the lawyers suing companies for negligence rather than negligent cmpanies.

blood sugar, diabetes, no big deal???
If you didn't have real people with real problems, the suit never would have begun. You seem to think the whole thing was made up out of accidents. With thousands of plaintiffs, that's really unlikely.

>u really don't get it do you? What the NYT got wrong was the ethics. ETHICS. The ethics of publishing illegally obtained documents from a biased source and publishing them while the other side upholds the legally binding gag order not to discuss the settlement.

The publication preceded the settlement. And the real ethical question was Lilly telling doctors one story about test results while its executives were suppressing another.

>This gets even better. You are arguing that we don't need to know the whole story before handing down judgement? Hard to believe you are not more highly regarded for your well-researched opinions.

What part of the 'real story' are we missing? Please be specific.

> However, if Lilly takes the lawyer and the NYT to court they might have to release those documents and generate the bad publicity, that they wished to avoid, as part of the trial.

But wait: why would this 'generate bad publicity' if they had done nothing wrong???

>You don't like to think for yourself do you?

I like it fine. The problem is, you don't seem able to think at all, for yourself or for anyone else.

>Your past stupidity and immaturity prevent me from treating you like an adult or in a mature manner.

I see you've admitted you don't have any case.

High profit drugs
There are many measuring sticks for measuring greed.
How much do the "officers" of the company make (including stock options)?
What other distributions are there on the "expense" ODB ledger including Billions spent on lobbyists and contributions to "Legislators" including using corporate facilities, assets and personnel?
If their products are so wonderful, why do they have to buy so many people? A good products sells itself, and an outstandingly excellent product will draw more customers than you can handle.
Why do I have such a distaste for most of the conversion of petro-chemicals into "needed" "pharmaceuticals"? Because I pay attention to the damage those drugs do to the people who "must have them". I have also studied the "father" of modern medicine is perhaps another reason my "opinions" are so jaded. My mothers PHD was in the school of pharmacy and was a practitioner in said field. I was a med student until I was pulled into the Korean war and though I was maintaining a 3.87 average, I was about to change fields because I was taking 5 to 8 hours in chemistry every quarter. I also have family in the medical profession, so for the above reasons that is why I am a "right wing knee jerk reactionary" to the petro-chemicals industries practices.

No Subject
This paragraph of Miller's speaks volumes.

"Unethical lawyering combined with shoddy journalism threatens many sectors of the economy, especially those that commonly face costly lawsuits alleging torts -- the drug..."

Isn't it odd, but at one time people used to believe that members of the FDA were paid to protect the public from harmful drugs?

Could I please rephrase Miller's sentence with...

'Unethical FDA members, their protection of "DRUG" "ECONOMY" and shoddy study reviews and approvals threaten many sectors of public health"

Mr Henry Miller appears to have a lot to do with FDA (ie PURPORTEDLY PROTECTING THE PUBLIC) POLICIES for many years:

http://phpab.org/Distinguished%20Fellows/Miller.htm

"...Dr. Miller was at the FDA from 1979-1994, where he served in a number of posts involved with both product review and policymaking. He was the reviewer for the first biopharmaceutical, human insulin (Humulin®, Eli Lilly and Co.), which was approved in record time.

During his government service, Dr. Miller wrote and lectured frequently on regulatory issues and requirements, and participated frequently on various expert and policy panels as a representative of the FDA or the US government.

As the FDA’s contact person for the Securities and Exchange Commission, he reviewed the accuracy of claims made by companies in their prospectuses about the likelihood and timing of drug approvals..."


Just WHO is/was Mr Henry Miller protecting when he was being paid to protect the public? Lets look at the quote from his article again:

"Unethical lawyering combined with shoddy journalism threatens many sectors of the economy, especially those that commonly face costly lawsuits alleging torts -- the drug..."

Cosy relationship between FDA *protecting Drug 'ECONOMY') to blame?
Ask "Dr" Henry Miller, ex member of the FDA, the drug regulators, the people who are supposed to look closely at the drugs trials and safeguard the public.

Despite having made policies in the FDA, despite being paid to protect the public, he's not concerned about the content of those documents.

He's concerned about protecting the ECONOMY, in this case Eli Lilly's ECONOMY.

Wouldn't you expect someone who was in the FDA to want to KNOW about what was IN those documents (as thousands of people across the world now do, they were available for download for days) and WHY there was such a fuss?

Isn't that what you would expect from a PRIMARY doctor, let alone someone who helped make policies for the FDA?

Why isn't "DR" Miller asking... I'd like to see those.
Why is he slamming journalism for reporting it.
Wouldn't you want YOUR doctor (again, let alone your regulators) to be asking questions/

His OWN PRAGRAPH shows why.

"Unethical lawyering combined with shoddy journalism threatens many sectors of the economy, especially those that commonly face costly lawsuits alleging torts -- the drug......sectors"


Something else he needs to look up on.
He has mentioned judges in his article.
He says:

"Another jurist, Judge Jack B. Weinstein, who is presiding over the consolidated federal cases in the Zyprexa litigation, wrote this about the need to prevent unauthorized leaks: "First, the cost and time to explain a single document taken out of context by a plaintiff's lawyer creates an incentive not to prepare memoranda."


Well, Judge Weinstein also wrote a book called:

Individual Justice in Mass Tort Litigation"

(February 2005)

And on Page 70 Judge Weinstein wrote:

"[p]rotective orders may have a legitimate role
when there is no public impact or when true trade secrets are involved.
But we can strike a fairer balance between privacy interests of corporations
and the health and safety of the public.
A publicly maintained legal system
ought not protect those who engage in misconduct,
conceal the cause of injury from the victims,
or render potential victims vulnerable.
Moreover, such secrecy defeats the
deterrent function of the justice system."


We know that money(and Eli Lilly have a great deal of it) often corrupts justice as it clearly does doctors and FDA officials.

However, there are a lot of us around the world, waiting for Judge Weinstein's final course of action, who are hoping that he becomes the rare exception, incorruptable, and that he will abide by what he wrote only 2 years ago.

Mr Henry Miller, I believe you (along with many others, you are not alone in this) have betrayed the hippocratic oath and the public who trusted in you. You have found it more profitable to protect the 'economy' of the drug 'sectors' rather than protect those who trusted the approval of the FDA of drugs.



Predictability
Well I see you side with the lawyers just like you side with the MSM. Has it occured to you that they settled due to the extensive cost of litigation? Trial lawyers innocent? Ha. While I am no huge fan of the drug companies practices in marketing they have done remarkable things to improve and save lives. However, to the trial lawyers they are a target due to deep pockets (just like breast implants, cigarettes and asbestos), to the MSM a target, like all big business, because they are evil capitalist who should give away drugs for free. Face it the MSM distorts the facts every chance they get to push thru the socialist leftist agenda. Read the latest on the study about more women are not living with a spouse in the NYT. Talk about a distortion of facts, all to push same sex benefits. The MSM, lie after lie after lie. I can hardly wait to hear them orgasmically fawning over Hillary while the Republican candidate get roasted as the son of satan.

Tears for life
They have a right to make money. The drugs like Viagra are huge profit centers and I approve heartily. Why? Because those profits fund research for less glamorous drugs like the new anti-biotic that saved my Mom's life 3 years ago. How about new heart and cancer medications? It costs billions to make new drugs and I want them to profit. These profits have made our lives better. As for risks, gee do you suppose drugs have risks? All drugs have risks and some riks have to be mitigated. Sure there are flaws, it is called a human endevour. Safe gaurds need to be in place but it takes years longer in the US to certify a drug than int he EU so I hardly think the FDA is weak. Many drug interactions are person specific and often rare. There is no way every drug can be 100% safe and in fact few are. I suggest that perhaps you be cautious in attacking a industry that has extended human life beyond measure and increased quality of life for perhaps billions. Like all human instituitions they are flawed but I for one admire them for all they do.

PS to FDAbetrayingpublic comments:
I don't know how that happened, but I wrote the 'No Subject' comment before the 'Cosy relationship' one. Reading the 'No subject' first will probably make the 'cosy relationship' comment above it make more sense :)

Question to "Dr" Miller re you comment on Jim Gottstein
You say in your article:

"Mr. Gottstein appears to think he qualifies as a mental health expert because he has experienced psychotic episodes intermittently for a quarter-century... I think he needs to have his medications adjusted."


It would seem that Mr Gottstein is more concerned about the harm done by minimising adverse effects and promoting off-label to the most vulnerable, as evidenced in Eli Lilly's internal documents, than YOU have.

So.. he's mentally ill?


YOU Mr Miller were meant to be protecting the public.
If Mr Gottstein is mentally ill for caring about those documents......


What does it make YOU who, employed for years to regulate those drugs, to check the side effects, to put warnings on the drugs, to CARE for people (as a "doctor" as well as an 'important' FDA official who helped to make the policies) doesn't even ask what those documents contain and does it show harm to the public?

YOU who managed to pass drugs without warning the public?


What DOES it make YOU, Mr Miller?

You didn't need the 'medication' did you.
YOU just needed the perks that came from approving them.

litigation cost: more than $1.7 billion
hello?

> Has it occured to you that they settled due to the extensive cost of litigation?

No, it hasn't. The settlement is $1.7 billion and still climbing. Even at $500/hr, it would take a lt of hours to get there. If Lilly's highly paid defense attroneys thought they had a case, why didn't they tell their bosses, "hang tough, we'll win this?"

>Face it the MSM distorts the facts every chance they get to push thru the socialist leftist agenda.

No, I won't "face it," unless you prove it. With emphasis on the socialist stuff. In this particular instance. is the idea that they didn't line up behind Lilly evidence of "socialist" beliefs? Otherwise, what in the world are you going on about,

>. Read the latest on the study about more women are not living with a spouse in the NYT.

The Times didn't make up the fact: it's from the census. You think it's wrong? Take it up with the people who did the study. You think the Times misinterprets? Show how.

>Talk about a distortion of facts, all to push same sex benefits. T

Please show how.

> The MSM, lie after lie after lie

Lucky we have you, who know the truth. Why not tell us about their facutal errors. Hello??

PS: MR Miller, are not miscontruing what the Honorable Judge Weintein said
Do you really think its wise to preempt what a judge like Judge Weinstein says?

You said:

"Within the past month, two federal judges independently have harshly condemned both the underhanded manner of Mr. Gottstein's obtaining of the documents and his dissemination of them, which violated a court-issued gag order. Another jurist, Judge Jack B. Weinstein, who is presiding over the consolidated federal cases in the Zyprexa litigation, wrote this about the need to prevent unauthorized leaks: "First, the cost and time to explain a single document taken out of context by a plaintiff's lawyer creates an incentive not to prepare memoranda. Second, what appears damning may, in context after difficult proof, be shown to be neutral or even favorable to the defendant." My own experience as an expert witness (in other litigation) corroborates Judge Weinstein's observations."


LETS LOOK AT THAT MORE CLOSELY HUH?


JUDGE WEINSTEIN ACTUALLY SAID - TO ELI LILLY LAWYERS:
(http://www.ssri-uksupport.com/davin.html)

23 THE COURT: I'm not finding that they are
24 affiliated, but I will issue the order as to those three. I
25 do not wish to issue orders as to others besides those three

1 and all I've listed in the draft order and the two people we
2 have added to that because it seems impracticable to do that.
3 The court takes no position on whether and how they
4 can be used by others who received them from other sources.
5 After all, the New York Times has disseminated them. This
6 court is not going to issue an order telling the New York
7 Times to return the documents.
8 So everybody has access to them. It takes no
9 position on whether and how they can be used by others who may
10 have them from other sources or from any sources, and on
11 whether and how Lilly can protect itself against such use.
12 But I don't want to be put in a position, as representative of
13 the court, of issuing futile injunctions. So I'm going to
14 limit the order to those who I've mentioned.
15 Is that clear to everyone?
16 I make no findings of fact with respect to whether
17 any violation of any order of this court has ever been made.
18 I have heard no evidence on the point and I'm not prepared to
19 draw any inferences from any of the materials before me.
20 Is there anything further anybody wishes to be heard
21 on?




You're not a lawyer, Mr Miller. You were a DOCTOR, but sold your hippocratic oath to become a company man/FDA man/industry protector. Maybe you should learn to keep your head down and remain silent, as silent as you have been about adverse events on drugs from companies you were protecting when you helped pass them for approval while you abused public trust as an FDA official?



Your stupidity knows no bounds
>"Do you reeally think the documents don't show this???"

Considering the only source for this story being a small numbers of illegally leaked documents provided by a biased source to a leftist newspaper I can gaurantee that this is not the whole of the story.

But hey, if you like to form informed opinions that is your choice.

Now let us take a look at some other facts:

The courts did not find criminal negligence. A "cover-up" would have been considered criminal endangerment.

In fact, the court considered the change in the warning label, in 2003, to constitute a good faith measure on the part of Lilly to inform doctors and the public.

Since you believe the number of plaintiffs in a case lends a suit validity, let us compare these numbers: 28,500 out of 20 million is 0.14% of the drug's takers seeking compensation and, as my Google experiment shows, this is a litigation with a great number of lawyers trolling for "victims".

You do not, nor does the NYT story, ever indicate that the choosing of one set of clinical trials over another was based on the results or superior methodology. A scientific aspect is hard to come by in the NYT story but that has never stopped you jumping to conclusions. It *must* be a conspiracy!

>"In anyone's book this is true. The lawyer didn't forget the documets: they came from Lilly. Are you really unable to understand this?"

What I understand that these documents were selectively culled to show one person's biased view. I know that you are quite capable of forming an opinion based on the mere title of a memo but I would prefer to know what the other documents show instead of what a lawyer and the NYT wishes me to see.

>"Yes, it is. Lilly had one truth that was circulated in house, and another that was sent out to doctors. But you're rooting for Lilly anyway."

You really don't know that because you don't know the whole story. You don't even understand that I am not "rooting for Lilly" but that I am rooting for a complete story. The unethical disclosure by the lawyer, not to mention the unethical advocacy of the NYT, makes me believe that I am not getting the complete story. If Lilly lied and it actually harmed people in a proven manner then they should be penalized and the liars sent to jail.

This did not happen so I doubt a conspiracy to cover-up actually occurred. But I will hold off judgement until I can read the rest of the documents for myself.

You, on the other hand, need nothing other than the evidence that supports your opinion of drug companies in the first place. Not surprising.

HA!
>"If you didn't have real people with real problems, the suit never would have begun. You seem to think the whole thing was made up out of accidents. With thousands of plaintiffs, that's really unlikely."

0.14%: Some might say this falls within statistical tolerances.

Zyprexa has never been proven to cause diabetes. There is no scientific link that I have found and the settlement does not call on Lilly to declare a conneciton. Please provide a scientific connection between the two if you can.

What is really funny though is the first part of this statement: "If you didn't have real people with real problems, the suit never would have begun".

How about law suits for hot coffee being hot? Or suing a furniture store because you tripped over your own kid? Or suing an auto manufacturer for breaking your hand while attempting to steal hubcaps?

In a class action suit against Cheerios over a food additive—with no evidence of injury to any consumers—lawyers were paid nearly $2 million in fees, which works out to approximately $2,000 per hour. Consumers in the class received coupons for a free box of cereal.

A Florida man sues six bars and liquor stores and the local electric company after he sustains injuries from his drunken climb up an electrical tower. The "victim" climbed over a fence and a locked gate to reach the power lines.

Over hundred people die in a nightclub fire due to unsafe indoor pyrotechnics at a Great White concert. A wrongful death lawsuit is filed, with one of the defendants being a large oil company. What is the connection of this company to the lawsuit? It gave away tickets to the concert as part of a sales promotion.

Yep. No such thing as frivolous lawsuits. Is it any wonder that a company would waste time, money, and lawyers on something so uncertain as the court system? They want to get it out of the way and not generate a public spectacle. Imagine, a publicly traded company trying to protect its image. I smell a conspiracy.

>"The publication preceded the settlement."

Actually the settlement was being worked on long before the settlement. That is a known fact and you even got that part wrong.

>"What part of the 'real story' are we missing? Please be specific."

In other words, you wish me to be specific about the unknown details to be found in 11 million pages of unreleased documents? Think about that for a minute.

>"I see you've admitted you don't have any case."

The case for your stupidity was made long, long ago. It started with your attempts to conceal your identity to avoid being attached to your own opinions.

High cost, high risk, high profits
Interestingly enough, for as much as you claim to know, there is very little fact to respond to in your post.

I have no problem with greed as long as the laws are obeyed and the consumer is not harmed. Drug companies have produced countless wonders that have added to quality of life for millions around the world. What you get in the pages of the NYT are the horror stories or the illusion of horror stories.

In the Lilly case the balance sheets and stockholder shares will take the blow for spending 500-700 million on this frivolous lawsuit. I wonder who really pays for that in the end?

The drug companies spend money on lobbyists because they are under siege by idiots like LeMule who scream Big Pharm(!) without much thought or real analysis to back it up. Everyone has lobbyists including environmental groups and unions. If their cause was so beneficial, why would they have to "buy" people?

In the end it seems like simple class-warfare on an industry. They are hated because they make money.

Interesting...
that the settlement then calls for Lilly to assume no responsibility or make claims of harm done. Or the fact that covering up a health-risk would move the case into criminal proceedings which definitely did NOT happen.

The slam-dunk that has occurred is when your mother dropped you on your head.

dbt3481 did an excellent job answer the rest of your stupidity.

Step in it dummy!
>"The Times didn't make up the fact: it's from the census. You think it's wrong? Take it up with the people who did the study. You think the Times misinterprets? Show how."

If you consider 15-year olds to be single women then the NYT is accurate. They counted them. The census actually says that 60.4% of men and 56.9% of women over 18 years old are married. To fix those numbers you have to consciously lower the age of single women to 15.

Now do you believe that is accurate reporting?

Not that it matters that the left-biased media has been proven time and again. You still keep singing the same tune.

When every thing sell for making money, morality collapse
All book reviewers Journalists are selling their skill only for money, naturally no one care for morality. I know very renowned writers who are recommending books without reading single line of that book,recommendations of all renowned writers used in advertiment and printed on burb of book. This is really cheating but all renowned writers are doing this dirty job.

remember who you are dealing with
eric is famous for taking a phrase, or even an entire sentence from a report, and then declaring that his chosen sentence summarizes the entire report. Context be darned.
No amount of logic or reason is capable of shaking his confidence in his "analysis".

drug safety
How a person responds to any drug depends on that persons dna. Since each persons dna is different, people will respond differently to different drugs.
The only way to test that a drug is completely safe for every person on the planet, is to give the drug to every person on the planet.

The fact that some reactions are not found until after the drug is released to the general population is not proof of ill motives, or a cover up. It's just proof that statistical samples are just that.

this must be why lawyers try cases in the media
because they know that their case is a slam dunk.

In eric's world, wherever that is, (somewhere beneath his mom's basement?) settling a case is proof that you are guilty. In that world, there is no chance that a company makes a business decisiont that even when their case is a slam dunk, it will cost more to defend a case, including the cost of bad publicity, via selective leaks, than the settlement being asked.

they also counted those women
who are seperated from there husbands due to assignment overseas or incarceration as living without husbands.
They also counted elderly women who are widowed.

As usual, the NYT redefines it's terms until it gets the results it's looking for.
Also as usual, eric declares that the NYT is incapable of being wrong.

all renowned writers?
So you've talked personally with everyone you consider a renowned writer and they have confirmed this?

As to the evils of selling your skills for money, can we presume that you spend your entire day volunteering and have never accepted a paycheck in your life?
Or is it just that you are a profound hypocrite, condemning others for the sins you see in your own soul?

Researcher of FDA raw Zyprexa Data: among "the deadliest drugs ever to gain FDA approval"
http://www.onlinejournal.com/health/081905Pringle/081905pringle.html

"...An independent researcher, Dr David Healy, studied FDA raw data on Zyprexa and concluded that it was among “the deadliest drugs ever to gain FDA approval.”

Yet, despite all the warnings of adverse affects and lack of effectiveness, atypicals are being prescribed for patients in record numbers, including children. On April 25, the Ohio Columbus Dispatch reported an investigation of state Medicaid records that found 18 newborn to 3 year-old babies in Ohio had been prescribed antipsychotic drugs in July 2004..."

Any comment, Mr Miller, as to how it could have been passed for approval when an expert independent researcher saw the raw data held by the FDA and came to the conclusion it was among the "deadliest drugs ever..." ?

I gather you'd left the FDA by then, but wouldn't your policies still be in force in 1996?

FDA failing to act on data received by drug companies? Why is that Mr Miller?
You certainly would have been in situ at the FDA when, for instance, Prozac was approved in 1988 would you not?




http://www.socialaudit.org.uk/58096-DH%20to%20WARK.htm

"...Reports on these [CLINICAL] trials list patients who have committed suicide, and list those patients as being of a certain age and as having committed suicide at a certain point during the trial, when the patient in question has a very different age and the event in question happened at a completely different point during the trial".

"Miscoding of suicidal act as emotional lability."

" Lilly have resorted to treatment non-response and a range of other headings to code what happened."

"...records on Prozac, Seroxat/Paxil and Lustral/Zoloft, you will find cases of homicidality coded as nausea for instance."

"Discontinuation of patients from studies for primary adverse effects such as nausea when in fact there has been a suicidal act;"

"But it is also worth adding specifically that this has been a feature of all trials of Zoloft/Lustral, Seroxat/Paxil and Prozac throughout, as far as I can make out... "


Are you a qualified Psychiatrist Mr Miller?
Looking through your bio you don't appear to be.

You diagnose people with specific mental illnesses and comment on medication.

Are you qualified to do so?

In your article which is under discussion you say:

"...Mr. Gottstein appears to think he qualifies as a mental health expert because he has experienced psychotic episodes intermittently for a quarter-century. (See his autobiographical information at http://akmhcweb.org/recovery/jgrec.htm.) I think he needs to have his medications adjusted..."

You are very specific in your diagnosis of Al Gore.

http://www.nationalreview.com/comment/miller200406010833.asp

"...John is not a physician, but he's half right. Al Gore appears to suffer from Narcissistic Personality Disorder, which is not treatable with medications..."

"...Gore's Narcissistic Personality Disorder is one good reason that I wouldn't want him to be president — or to live next door to me..."



I have no idea whether you are right or wrong, whether you are or not is immaterial.

The question is whether you are qualified to make psychiatric diagnoses and recommend medication, or whether it is more a case that you have an inflated opinion of your own superiority?

Two items
500 bucks a hour? Try about 2000 a hour. As to the NYT, http://www.lifesite.net/ldn/2007/jan/07011908.html The NYT is a propaganda rag for the liberal democrats. It is not worthy of bird cage flooring.

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