In Ontario, Canada, Big Tobacco is currently under attack. Ontario claims that, among other things, Big Tobacco misrepresented the dangers of smoking and the addictiveness of nicotine to the public for decades. Ontario also claims that Big Tobacco caused or contributed to an additional $50 billion in health care costs.

Sounding familiar? No one should be surprised that Big Tobacco has felt at liberty to conduct themselves in other countries as they have in the United States. In fact, the findings in Ontario sound very much like the findings by courts and juries across Florida and in other parts of this country:

• Manufacturing, selling and promoting the sale of cigarettes while knowing that cigarettes are addictive, cause serious diseases and that second hand smoke also causes diseases;
• Manipulating the level of nicotine in cigarettes;
• Suppressing information, scientific information and medical data about the risks of smoking and of second hand smoke;
• Misrepresenting to the public and government that filters reduce the risks of smoking and that “light” cigarettes were safer than other cigarettes;
• Misrepresenting that the defendants were aware of no credible research establishing a link between smoking or exposure to second-hand smoke to disease;
• Failing to adequately warn the public that cigarettes are addictive and cause disease;
• Promotional activities with the primary intent to neutralize the effectiveness of the warnings on cigarette packaging;
• Targeting children and adolescents in advertising, promotional and marketing activities for the purpose of inducing them to start or continue to smoke.
• Orchestrate public relations programs with the objects of promoting cigarettes, protecting cigarettes from attack based on health risks and reassuring the public that smoking was not hazardous.

My guess is that the tone of arguments will become increasingly severe as our brethren to the north continue their review of the documents generated by the tobacco industry in previous litigation.

In the United States, one judge who has been perhaps the most exposed to the tobacco documents is United States District Court Judge Gladys Kessler. Judge Kessler has issued a few scathing findings against the tobacco companies and disclosed startling information she found in her review of evidence presented to her.

Her findings and comments have included:

“The evidence spelled out above is simply overwhelming that Defendants knew that smoking is addictive and knew that nicotine is the agent creating and sustaining that addiction. There is also overwhelming evidence that even though Defendants have known internally about addiction for decades, they have endeavored to keep the extensive research and data they had accumulated out of the public domain and out of the hands of the public health community by denying that such data existed, by refusing to disclose it, and by shutting down or censoring laboratories and research projects which were investigating the mechanisms of nicotine.

If, in fact, “everybody knew” that smoking and nicotine were addictive, then why were Defendants publicly, vehemently, and repeatedly denying it?

In short, after reassuring the smoker that smoking was not bad for her health, and was not addictive, Defendants then blamed her for being unable to stop using the product they had so successfully marketed with false information.

Based on the extensive individual Findings of Fact set forth in this Section, the Court finds that Defendants have known for decades that cigarette smoking was addictive, and that nicotine is the addicting element in smoking behavior. Defendants’ false and misleading statements relating to addiction continue even today.

Moreover, Defendants deliberately and intentionally hid this information from the public and closed down research laboratories and on-going projects in order to ensure secrecy. Time and time again, Defendants falsely denied these facts to smokers and potential smokers, to government regulatory authorities, to the public health community and to the American public.”

Our own Florida Supreme Court has found:

• That cigarettes cause a whole bunch of diseases, including: aortic aneurysm, bladder cancer, cerebrovascular disease, cervical cancer, chronic obstructive pulmonary disease, coronary heart disease, esophageal cancer, kidney cancer, laryngeal cancer, lung cancer (specifically, adenocarinoma, large cell carcinoma, small cell carcinoma, and squamous cell carcinoma), complications of pregnancy, oral cavity/tongue cancer, pancreatic cancer, peripheral vascular disease, pharyngeal cancer, and stomach cancer).
• That cigarettes are addictive.
• That the Tobacco Companies knowingly marketed cigarettes that were defective and unreasonably dangerous.
• That the Tobacco Companies concealed or failed to disclose important information about cigarettes that was not able to be known by the public.
• That Tobacco Companies misled the public about the dangers of smoking cigarettes.
• That the Tobacco Companies, acting together, concealed information regarding the negative health effects of cigarettes.
• That the Tobacco Companies, acting together, concealed the addictive nature of nicotine in cigarettes.
• That the Cigarette Companies sold products that were defective.
• That all the Tobacco Companies were negligent.

Nine different judges. Three different parts of North America. It seems time to believe that the tobacco industry has been lying and deceiving people all over the world about the dangers of cigarettes. The deception started in the early 20^th century while Big Tobacco was literally handing out cigarettes on street corners.

Of course, when tobacco needs to defend itself in court, they like to argue that “everybody” knew about how addictive and dangerous cigarettes were by the 1930’s and 1940’s.

Yet, as late as 1994, the CEO’s of all the Big Tobacco companies swore under oath that cigarettes were not dangerous and nicotine was not addictive:

http://www.youtube.com/watch?v=jQUNk5meJHs

A lawsuit is filed…and that is often when the real work begins for all the parties involved.

In some cases, neither the plaintiff nor the defendant has all the proof; documents, data and other types of evidence; they need to fully prove their respective cases. So, each party is allowed to ask questions and request documents (data) from each other.

This is a journey called “discovery”. Once it involved going to filing cabinets and boxing up sometimes hundreds of boxes of paper. In our digital world, the discovery process can be a frightening experience for those unprepared and an experience fraught with error for those not sufficiently informed.

Let’s take a look at what is faced in the digital discovery world today.

Many in the United States are convinced that we manage more email than anywhere else and that is simply untrue. We only represent around 14% of the world’s total email volume; with Asia and Europe beating us by two and three times our volume.

Last year the average number of business emails received and sent daily by a single worker averaged 105. If you are involved in a lawsuit with a company in which a single department has   25 workers, you may be dealing with as many as 958,125 email documents generated in a single year. If (3) of the company’s departments have relevant documents and data, you are now   trying to sift through nearly two million emails or an average of 3 million pages (not including attachments).

(more…)

Do cigarette manufacturers know their customers, or do cigarette manufacturers know their customers?

A recent article in the New York Times found that “low-income smokers in New York spend 25% of their income on cigarettes.”

While statistics like this might come as a surprise to regular folks like you and me (and seem far-fetched), the notion that an addicted smoker will continue to buy cigarettes to feed his addiction – no matter what the cost – is old news to cigarette makers (http://legacy.library.ucsf.edu/action/document/page?tid=leq11b00).  As one Philip Morris research scientist so matter-of-factly put it in 1969, during a presentation to the Philip Morris Board of Directors:

The cigarette will even preempt food in times of scarcity on the smoker’s priority list.

Cigarette makers have been studying smokers for years.  And they have used this research to design their products.  But don’t take my word for that – all one must do is look at the previously confidential internal business records of the major cigarette makers to find out about the lengths they went to study their customers.  And why they did it.

Of all the previously confidential cigarette business records, one of the documents that sums up this aspect of cigarette/smoker research the best, in my opinion, is a Philip Morris business record from 1977.  The document’s title alone is simple, yet informative – SMOKER PSYCHOLOGY PROGRAM REVIEW – and can’t help but conjure up images as cigarette researchers as evil puppet masters who have taken it upon themselves to learn more about smokers than even smokers know about themselves.  And if the title alone doesn’t bring the puppet-master visual to mind, let me highlight some things that the author – who wrote this believing it would never see the light of day – states:

I’ve taken this as an occasion to review our basic premises – to ask

myself why are we doing the things we’re doing.

First, every undertaking has to have some mission.  I would state

our charter from Philip Morris in this fashion:

Study the psychology of the smoker in search

of information that can increase corporate

profits.

Our charter is unique in that we are given the smoker to study.

Meanwhile, back in the lab, we continue to ask what it is that the

smoker derives from smoking.

I’ll try to explain the conceptual model that we are using.

We sell a product that is bought often and used from 10 to 60

times a day, day in and day out.

You are all familiar with Pavlov’s dog.  Present a dog food,

he salivates.  Ring a bell each time you present food, and in

due time you can ring the bell without the food and he will

salivate.  This is classical conditioning.

Operant conditioning is quite different.  Consider the classical

operant experiment.  Put a hungry rat in a cage.  Put a lever in

a cage.  Make it so that a push on the lever delivers a pellet of

food.  In its random movements the rat will push the lever.

He’ll get the pellet.  The rat will soon associate lever pushing

with food.

Consider the smoker.  Smoking the cigarette is the lever press.

The effect of that smoking act upon his person is the reward.

That effect reinforces the smoking act.  He comes to push the

lever 10 to 60 times per day.

This, then, is how we have translated our corporate charter

into a scientific model.

So if you read the above article and are left shaking your head how, in this extremely difficult and sometimes desperate economic climate, a smoker can spend one quarter of their income on cigarettes, somewhere, cigarette executives and researchers read the same article; and that after they did, they congratulated each other on a job well done, and saying to one another “I told you so … just like rats in a cage.”

Having been in the legal and insurance industry for 30 years now, I have reasonably good insight on what really does go on, but I can simply not help being surprised and disturbed by how far corporate America is willing to go.

Even when dealing with the health, life and death of human beings, it seems corporations and, in this case also doctors are willing to do almost anything to increase the profit line. According to the story in the Palm Beach Post we have a graphic example right here in our backyard; HCA Lawnwood allegedly performing unwarranted surgical procedures by its physicians to insert cardiac stents into patients who never needed them!

Motive? Profit driven.

Shocked? Well you shouldn’t be.

Frightened? Maybe we all should be.

Sadly, the only way we even know about these occurrences is because a Registered nurse, C.T. Tomlinson, had the courage to do the right thing and told the truth. What did he get for his courage when he told the management at HCA? You guessed it, he got his contract terminated and through HCA’s own internal documents we know that Mr. Tomlinson was retaliated against. I wish I could tell this is the only dirty little secret hidden by “the white code” in medicine. You would shudder to know how many people have died or were unnecessarily injured by bad medicine and no one was told the truth.

The medical community and insurance companies are fond of claiming that unnecessary tests and procedures are ordered because doctors fear lawsuits. The fact is they get paid for every test or procedure they order. Justifying it by claiming they are protecting themselves is simply a convenient route to the bottom line and increased profits.

Medical mistakes occurring because profit is an overriding motivation is much more common than people realize.  And realistically, the patient seldom has possession of their own medical records; so lost, misplaced and “amended” medical records also happen more than most people realize.

There is an unfortunate public mindset that medical errors happen to other people, but will never happen to us. It is when you or a loved one is harmed at the hands of bad, or profit driven medicine that it hits home.

In fact it was only 6 or 7 years ago that the Tenet Healthcare Corporation paid over $350 million for doing unnecessary heart surgeries in its Redding, California hospital.

So, we should be careful to not marginalize whistleblowers or medical practice lawyers who, at best are simply able to level the playing field by a mere fraction and then only for some victims.

As they say, absolute power corrupts absolutely. Thank goodness for brave nurses like C.T. Tomlinson and the majority of medical providers who are honest and use their amazing talents to save lives day in and day out. There is no doubt we need more of the type courage displayed by Nurse Tomlinson who has now helped saved lives, who knows, maybe yours or mine.

Kids continue to be targets of tobacco manufacturers. They have been from the very beginning and as tobacco company sales fall, the tobacco industry has demonstrated a willingness to pull out all the stops to maintain their beginner smoking programs.

In 2009, as part of President Obama’s comprehensive Family Smoking Prevention and Control Act, candy and fruit-flavored cigarettes were banned.

Lucky Strikes Uses Santa Claus as a Role Model

Anyone who has even the most basic knowledge of the history of cigarette manufacturers like Philip Morris and R.J. Reynolds and their targeting of the youth market can appreciate why cigarette makers would manufacture candy and fruit flavored cigarettes.  Almost 90 percent of adult smokers start smoking as teens and over 440,000 die each year from cigarette-related deaths, the goal of such a ban is just as obvious. In fact, tobacco companies spent millions conducting studies of youth smoking trends long after the Surgeon general’s report in the 1960’s. A 1974 study comparing the effect of menthol cigarettes on youthful smokers set forth:

”More than 50% of men smokers start smoking fairly regularly before the age of 18 and virtually all start by the age of 25.”

“If a person is going to smoke cigarettes, he generally starts during his teens…”

“Most of the young men spoken to indicated very early initial experiences with cigarettes. Many talked about first trying a cigarette before the age of ten.”

So it should come as no surprise that while the new federal law called for merely the ban of candy-flavored cigarettes, flavored tobacco products such as chewing tobacco and flavored cigars are not against the law.  And who then is surprised by the fact that these products are rising in popularity, especially among the grade-school aged crowd.

This trend is troubling.  Any tobacco product that a child uses, whether it is a cigarette, cigar or chew, contains nicotine.  Nicotine is a drug, a powerful drug.  In 1988, the Surgeon General determined that the addictive properties of nicotine are similar to that of heroin and cocaine.  One need not be a specialist in addiction to know the dangers of a child exposing their still maturing brain to any addictive drug, much less one as powerful as heroin.

This trend is also disturbing.  Why?  Because among other things, it highlights exactly the type of opponent that anti-tobacco advocates (and those hundreds of millions of Americans who actually do value our children’s lives) are up against – an industry who preys on our kids and, who short of federal regulation, have shown no willingness to stop preying on our kids, simply because it is obviously the right thing to do.

Kudos then, to Miami-Dade County, for attempting to join only New York City, Providence, R.I., and Santa Clara, CA, as the only municipalities that have banned flavored cigars and chewing tobacco.

It is all about research and publishing. That is the pressure supposedly exerted on academics, scientists and some physicians – “publish or perish”.

Scientific research is no different than any other form of research from the perspective of “garbage in garbage out”. These days most of us do some form of research on the internet. It may be simply trying to find the very best camera or the very best doctor for a tragic illness. The internet is crammed full of valuable information and…garbage. Separating the wheat from the chaff can sometimes be difficult.

Scientific research can not have the same margin of error that we may be able to live with when we are shopping for a camera, for example. Scientific and medical research has a far broader and potentially more injurious result if it is, well…garbage.

The New York Times published an article discussing the recent increase in retractions that seems to be permeating scientific and medical research. The Times interviewed two noted editors of the Journal of Infection and Immunity. They have recently discovered dozens and dozens of retractions that have had to be issued by very noted scientific journals.

One of editors told the Times that “he feared that science had turned into a winner-take-all game with perverse incentives that lead scientists to cut corners and, in some cases, commit acts of misconduct.”

A Harvard Medical School professor stated that “there are problems all through the system.”

To be certain, this is a very scary epiphany for the scientific community to have and perhaps it really is a revelation to some of them. Sadly, it is not new to many people who have been victims of bad or skewed medical or scientific research. We have been writing about at least a portion of the problem for some time:

“Ghostwriting Mysteries of the Medical Device Industry” (2009)

“Ghosts Writing About Science and the Public Health” (2009)

“The Drug Business, Broadway, and Casper the Friendly Ghost” (2009)

“Pain Pumps and a Lack of “Reliable” Scientific Evidence” (2010)

“Scientific Research or Corporate Marketing?” (2010)

“Pride & Prejudice About Product Safety” (2010)

“Dietary Supplements — Litigating Unregulated “Drugs” (2010)

In the New York Times article the various experts offer explanations such as:

“What people do is they count papers, and they look at the prestige of the journal in which the research is published, and they see how may grant dollars scientists have, and if they don’t have funding, they don’t get promoted,” Dr. Fang said. “It’s not about the quality of the research.”

Dr. Ness likens scientists today to small-business owners, rather than people trying to satisfy their curiosity about how the world works. “You’re marketing and selling to other scientists,” she said. “To the degree you can market and sell your products better, you’re creating the revenue stream to fund your enterprise.”

Putting aside the very real danger to the lives of patients of promoting untrue, invalid or fabricated scientific research, there are also very practical, but just as damaging repercussions of this invalid research.

The medical and scientific industry has complained and whined for decades about lawyers bringing “junk science” into courtrooms in an effort to substantiate negligence cases in drug, medical device and medical negligence cases. The courts have gone so far as to impose standards, referred to in federal court as the Daubert Rule. The failure of a party to be able to have their science withstand the scrutiny of the Daubert principles can and will result in dismissal of claims. The problem is that much of the evaluation and analysis exacted in the Daubert rule is based upon research published in noted journals. Experts evaluating the science in those cases rely on research in those same scientific journals.

The ultimate damage can caused by judges who, at least in some cases, have been encouraged to dismiss cases based solely on one side or another arguing that the available research does not support the science being used by a particular party in a case. Tragically injured people have lawsuits dismissed by judges simply because the “scientific research” that the court decides to acknowledge as “authoritative” does not seem to support the claims.

We increasingly are discovering that the research used in courts to dismiss claims may be simply the result of paid “ghostwriting” by manufacturers; the greed for grant dollars; you are being a “small business owner” instead of a scientist; or the desire for career advancement.

The result? Tragically injured people, with very legitimate claims, are barred from having their “day in court”.

Our law firm has tried eight trials in a row to successful plaintiffs’ verdicts; involving what has become known as the “Engle Progeny Cases”. These cases arise from the “Engle” case tried two decades ago in which juries heard 12 months of evidence and made a series of findings about cigarettes. Subsequently, the Florida Supreme Court found the following facts about the conduct of tobacco companies including:

• Cigarettes are addictive.
• Tobacco companies concealed important information about the dangerous health effects and the addictive nature of cigarettes from the public.
• Smoking cigarettes cause over 20 different diseases.
• Cigarettes are a defective product placed in the market by tobacco companies.
• Cigarettes are unreasonably dangerous as manufactured by tobacco companies.
• Tobacco companies conspired to conceal from the public important information about cigarettes and the dangers of smoking.
• Tobacco companies were negligent.

Those of us in this law firm who have worked on cases against the tobacco companies have read the documents used in the Engle case and other cases, including the Minnesota Attorney General’s case. Once you read and review those documents it could not be clearer that all of the findings by the Florida Supreme Court set forth above are absolutely, crystal clear. In fact, because so much evidence and so many documents exist, most of it is never exhibited at the trials of cases against tobacco companies by tobacco company victims – most jurors never see but a small fraction of all of the evidence available .

We have seen the evidence of an industry that has made a science out of hiding, lying and manipulating. We have seen the documents summarizing plans by the tobacco companies to manipulate the nicotine in cigarettes; to create marketing plans that target teenagers; and to create “scientific” data in order to support the message that smoking cigarettes is actually good for you. Tobacco’s marketing plans for doctors to tell the public that smoking is good for you; athletes talking about smoking cigarettes improving their “wind”; and movie stars glamorizing the entire smoking genre – all are diabolically brilliant.

So, quite frankly, members of our firm were not at all surprised that we received two verdicts in favor of our clients and against the tobacco companies; in two different trials; tried in two different parts of Florida. The fact is that when anyone involved in the trial of tobacco cases hears about a verdict in favor of the tobacco companies, we are, well, shocked.

It is inspiring that two juries; in two different geographic locations; with two different sets of lawyers, can reach the same conclusion: the tobacco industry addicted people to a drug they knew was one of the single most addictive drugs in existence and then further manipulated that drug to increase its desperate hold on smokers. Then this industry literally invented the art of propaganda marketing and threw billions of dollars to make it successful.

We are pleased that our clients received their opportunity for justice in receiving verdicts of $3.5 million in one case and $2.7 million in another case. We would also like to recognize the talented attorneys who tried these cases: James Gustafson, Matthew Schultz (Levin, Papantomio law firm), Brian Denney, and Hardee Bass.

These were truly victories for “the good guys”.

Big Tobacco has recently agreed to pay over $6 million to settle claims with the US Department of Justice.

A summary of the conduct causing the $6 million payment?

US district Court Judge Gladys Kessler, after hearing mountains of evidence, says this about the tobacco corporations:

• They lied.
• They misrepresented the truth.
• They deceived.
• They concealed.
• They destroyed documents.
• They distorted the truth.
• They abused the legal system.

They conspired to keep away from the public scrutiny documents that demonstrate “smoking’s negative health effects, nicotine addiction, and altered cigarette design to increase addiction, light- and low-tar cigarettes and marketing to young consumers”.

Judge Kessler went on to say:

“In short, defendants have marketed and sold their lethal product with zeal, with deception, with a single-minded focus on their financial success, and without regard for the human tragedy or social costs that success exacted”.

But, Big Tobacco did not act alone. Judge Kessler also had comments about Tobacco’s lawyers: they “played an absolutely central role in the creation and perpetuation of the enterprise and the implementation of its fraudulent schemes”.

These findings and Big Tobacco’s willingness to pay millions in order to avoid an airing of the evidence in a court of law come as no surprise to attorneys who have had to litigate against them. Simply reviewing the tobacco documents that have not been destroyed or hidden by Big Tobacco leads to only one conclusion. The tobacco industry has spent a hundred years perfecting a talent for hiding the truth and spinning facts to a point that fact becomes fiction.

Big Tobacco wrote the playbook for all other corporations who have held “shredding parties” and data dumping get-togethers in order to hide their wrongdoing.

It is a part of the Florida Constitution.

It seemed fair to patients. With hospitals and doctors claiming the medical negligence problem was over blown, Florida Section 25, “Patients’ right to know about adverse medical incidents”, seemed like a common sense and fair law.

Read it. It is not very complicated.

But, since 2004, hospitals have been spending a great deal of time and money trying to circumvent, dodge and slip under the law. Sadly, hospitals have had reasonable success in throwing up legal roadblocks to the constitutional “requirement”.

What does Section 25 set forth? It seems pretty straightforward:

1. Patients have the right to have access to any records made or received in the course of business by a health care facility or a health care provider that relate to any adverse medical incident.
2. The health care provider is required to redact the personal information of any patient records released in complying with the law.
3. A patient is intended to mean: an individual who has sought, is seeking, is undergoing, or has undergone care or treatment in a health care facility or by a health care provider.
4. The law was intended to encompass: “adverse medical incident” means medical negligence, intentional misconduct, and any other act, neglect, or default of a health care facility or health care provider that caused or could have caused injury to or death of a patient.

A Coral Springs man, Harlan Ginsberg, has run headlong into a huge roadblock constructed by Northwest Medical Center, owned by HCA (Hospital Corporation of America), in Margate, Florida.

Mr. Ginsburg suffered a kidney stone attack. In the scheme of medical problems – not exactly a four alarm emergency. Certainly a medical condition that should allow health care providers to be deliberate and careful about their treatment, right?

Before leaving Northwest Medical, however, health care providers had been successful in cutting Mr. Ginsburg’s ureter (a tube that delivers urine to the bladder) and removing a completely healthy kidney, according to testimony of a physician.

Mr. Ginsburg was, understandably, upset. I would be if you removed a perfectly good, properly working organ from my body without even, well, asking me first.

He wanted to know how many other similar incidents occurred at the hospital and what the details were of those other incidents. He asked for the records under Section 25 of the constitution. Northwest Medical refused to provide him with the records. Later, probably after getting some good legal advice, the hospital relented and agreed to search its records for Mr. Ginsburg’s requested data. First, though, the hospital wanted $77,550 up front. I think we can look at $77,550 as a pretty big roadblock.

Section 25 of the Florida Constitution does not set forth anywhere that the hospital is permitted to charge to do a search that will produce the information. In fact, one might argue that if a law requires the provision of certain information, a corporation is intentionally violating the law by not maintaining record keeping in a way that allows compliance. But, that is one of the favored excuses from hospitals – “we do not maintain our records in a way that allows us to easily locate that information”.

Let’s think about that a minute. You run a hospital. I mean let’s pretend you are the CEO of a major hospital corporation. You are sitting in your office trying to determine the types of reports you want to regularly look at to accomplish your job responsibly. Wouldn’t a report that tells you how many medical incidents of negligence or mistake occurred in your hospital be one of the top five reports you would want to see? So, how can that data not be readily available to anyone?

How long will health care facilities and malpractice insurance companies be permitted to simply ignore or to dodge a part of the Florida Constitution? When will our lawmakers start requiring corporate compliance? When will someone stand up for individual citizens rights?

So far, citizens are not seeing any standing up from the executive branch or the legislature.

Corporate America needs protection from trial lawyers!?

So goes the tort reform mantra. Trial lawyers are victimizing corporations; which is causing job loss; which is ruining the economy; which is leading to higher prices; which is causing Wall Street uncertainty; which is leading to all around chaos.

I have worked for Corporate America and I have worked for lawyers. All the lawyer jokes aside, I am happy to no longer be working in the moral ambiguity of Corporate America.

Let’s take today’s Corporate citizenship example. Pfizer, Inc.

Recently, Pfizer agreed to pay fines of a record amount, $2.3 billion, for hiding off-label drug marketing practices. That would be the practice of selling drugs for uses that the FDA has not approved them for or, in some cases, uses that the FDA has specifically prohibited. Now, Pfizer investors are suing Pfizer saying that the Corporate Pharma “promised” it would stop its off-label marketing practices, but $2.3 billion later proves otherwise.

Also, just unsealed yesterday, is a complaint filed against Pfizer for the marketing of its drug, “Vfend” (voriconazole); an antifungal medication approved for the treatment of invasive aspergillosis and candidemia. Pfizer requested FDA approval to market the drug as “empiric therapy” as well. Empiric therapy is the medical practice of initiating treatment before an actual diagnosis can be made based upon laboratory or other objective studies. Antibiotics and some antifungals are often prescribed, quite correctly, by physicians based only upon their judgment of a patient’s symptoms. Pfizer wanted the ability to market Vfend on this broad basis so that physicians would prescribe it more often and, thus, increase Pfizer’s profits proportionally.

The FDA refused to allow Pfizer to market Vfend as an empiric therapy. So, what did Pfizer do? You guessed it, they marketed Vfend for broad use anyway. Why would a corporation specifically violate FDA regulation?

Vfend was approved for the limited use of treating diagnosed fungal infections in 2002. Certainly, the fact that Pfizer made $825 million in 2010; $798 million in 2009; and $743 million in 2008 off the drug may have played into their decision. Also, Vfend was designed to replace an antifungal, Diflucan, for which Pfizer was losing its US patent. Diflucan had been generating annual sales for Pfizer averaging $1.1 billion per year – an amount they stood to lose if they could not replace Diflucan with a substitute.

The current lawsuit brought by the US government was the result of company “whistleblowers”; former employees of Pfizer who have provided information to the US government suggesting that Pfizer’s off-label marketing resulted in much higher sales and this resulted in a fraud upon Medicare and Medicaid.

Sour grapes from some disgruntled employees? Let’s take a look at those employees; both of whom reportedly resigned from Pfizer:

Catherine Brown was Senior Marketing Manager at Pfizer and had been employed by them from 1996 to 2005. She holds multiple degrees in science and business and she was, in fact, “Representative of the Year” in 1998. She resigned from Pfizer in 2005

Bernard Vezeau was a Senior Product Manager on the “Vfend Marketing Team”. Mr. Vezeau went to West Point, was a Captain in the US Army and held a Master’s degree in Business Administration. He worked for Pfizer between 1989 and 1992; and was rehired by them in 2003.

The complaint brought by the US government gives insight into what allegedly occurred. Apparently, Pfizer was using a study, “the 608 Study” to substantiate its claims that Vfend was effective in treating broad categories of fungal infections. Notably, Pfizer claimed that Vfend was effective in treating a very aggressive and potentially lethal fungal pathogen, C. glabrata. The problem explained in the complaint in detail is that the 608 study results were, first, of a small patient population and, second, the results were substantially manipulated by Pfizer in an effort to cause the study to demonstrate an effectiveness in treating broad categories of fungal infection when it, in fact, was not effective.

While Pfizer marketed Vfend as having an “extended spectrum” and recommending physicians use Vfend “at the earliest clinical suspicion of a fungal infection”, respected medical journals condemned these assertions. The New England Journal reviewers stated that the 608 study “significantly obfuscate the presentation of results” and found the study “a bit deceptive”. The Lancet published comments by a noted and respected expert in fungal infections as finding the results of the 608 study to be “most perplexing” and seeming “seriously flawed”. In English, they did not believe Pfizer’s study and, if the allegations prove to be true, these experts had good reason.

What did Brown and Vezeau do wrong? Well, from Pfizer’s perspective, they insisted on clarification of the study results and asked for substantiation for claims that Vfend was effective in treating broad categories of fungal infections, most notable a life threatening fungal like, C. glabrata. Pfizer’s medical director, Dr. Dr. Schlamm, allegedly complained that Mr. Vezeau, was asking too many questions about the 608 study.

Now, Pfizer stands accused, yet again, of marketing drugs for uses NOT approved by the FDA. In addition, they are accused of manipulating scientific studies and opinion – for what? To maximize profits.

So, ask yourself: who needs protection from whom?