Major risk factors for Type 2 diabetes include a lack of exercise, being overweight and making poor diet choices. Eating a hamburger served between doughnuts; a recipe for which Paula Deen is famous certainly fits into the “poor diet choice category.

Typically, when a celebrity reveals that he or she is battling a disease, the motivation for going public is to create awareness and maybe raise funds for research. Michael J. Fox and Parkinson’s, Magic Johnson and HIV and Lance Armstrong and testicular cancer all come to mind. These people created foundations, took control of their health and inspired others to have hope.

And then there’s celebrity chef Paula Deen. On Jan. 17, the 65-year-old announced that she has been living with Type 2 diabetes for three years. This disorder that usually strikes in adulthood is associated with insulin resistance that causes high glucose levels in the blood. Complications from diabetes include heart disease, stroke, blindness, circulatory problems and early death. According to the American Diabetes Association, 26.9 percent of Americans age 65 and older have diabetes. This is not a disease to be taken lightly and it is sad for anyone to develop this very serious disease.

So did Deen kick off an awareness campaign that might alert other people to their risk for developing the disease? Did she promise to overhaul her sauce filled recipes and the buttered-up message she puts out into the world?

No. On the Today show she dodged questions about her own diet, threw out some vague and worthless advice about practicing moderation, and then bragged about her new gig as spokeswoman for Danish firm Novo Nordisk’s injectable diabetes drug Victoza (Liraglutide).

A day later, under a mound of criticism after the Today interview, Deen announced that she would donate an undisclosed “certain percentage” of her income from Novo Nordisk to the American Diabetes Association.

Celebrity product endorsements are nothing new, but they’re more powerful than ever.

What would Nike Air tennis shoes be without Michael Jordan?

Do you believe that Weight Watchers works after watching Jennifer Hudson drop 80 pounds?

What would we call a George Foreman Grill without, well, George Foreman?

As a celebrity chef on the Food Network, Deen is positioned to make a significant impact, if she cared to do so. She has the ideal platform for inspiring Americans to change their diets, with two hit television shows and a huge audience. Were she to impart education about lifestyle choices and diabetes, she could tell thousands of viewers that in 2010, studies in the New England Journal of Medicine revealed that diabetes drugs don’t help patients avoid heart disease and that lifestyle changes, like diet and exercise, are far more effective in managing—and reversing—Type 2 diabetes.

Yet, where’s the payoff for Deen in that message? Victoza made $784 million for Novo Nordisk in the third quarter of 2011, and now she’ll get a piece of that despite the fact that she’s pushing a drug with a Food and Drug Administration warning about its likelihood to cause thyroid tumors and cancer.

Celebrities, modern-day demigods who wield much influence over the American masses, should be responsible for the products they endorse. Do you recall the 1950s ads with actor/six-pack-a-day smoker/lung cancer patient John Wayne touting the benefits of non-irritating “mild” Camel cigarettes that didn’t harm his voice? Didn’t we learn from that?

One person did. According to the New York Post, Nancy Assuncao quit her post as Deen’s publicist last month, citing her distaste for Deen’s deal with Novo Nordisk.

Before her announcement, Deen brushed aside rumors that she had diabetes for a few years, and said she didn’t go public so she could “figure things out in my own head” and that she wanted to “bring something to the table” when she revealed her condition. But what she brought to the table wasn’t a diabetes-fighting, low-cal, low-sugar, healthier version of her famous doughnut burger. Instead she has decided to hawk a diabetes drug that made its manufacturer, Novo Nordisk, $784 million just in the third quarter last year. Ms. Deen has decided to avoid how diabetes can be prevented and accept a pay check for promoting an answer that is akin to “closing the barn door after the horses have escaped”.

You have to wonder: Did Deen keep her diabetes under wraps to protect her reputation as the queen of fattening comfort food, or did she stay quiet until she inked her deal with Novo Nordisk? Either way, this is an irresponsible, uninspiring, disappointing move that hopefully won’t influence other stars to encourage their fans to hand over their lives to irresponsibility to be solved by drugs and the companies that make them.

When faced with a possible danger, how much of a warning do you need? As far as the Food and Drug Administration is concerned, your tolerance for risk is pretty high. And what about its responsibility for sounding the alarm? Eh, that can wait a while.

When picking up a prescription drug from your pharmacist, you usually receive a few sheets of paper detailing how to use the medication and its possible side effects. Some warnings don’t sound so bad—nausea, loss of appetite, drowsiness. But then there are more extreme warnings…suicidal tendencies, liver failure, heart attack or even death. The text of these stronger warnings is outlined with a black square. Hopefully your doctor or pharmacist will point it out.

Called “black box warnings,” this wording is printing on drug packaging inserts after a drug has shown, through medical studies, to be quite harmful—even deadly—and the FDA deems it worthy of its strictest caution (yet seemingly not serious enough to remove it from pharmacy shelves).

For instance, Seattle Genetics Inc. announced last week that its Hodgkin lymphoma drug, Adcetris (brentuximab), will carry a box warning due to brain infection risk called progressive multifocal leukoencephalopathy (PML). This is a fatal condition that starts with memory loss, clumsiness and aphasia, an inability to communicate using language. There’s no known cure.

The box will also warn that taking Adcetris with cancer drug bleomycin may cause lung toxicity. Since it was approved in August 2011, three people have developed PML and about 2,000 people continue to take the drug.

So why doesn’t the FDA pull Adcetris off the market? According to Bloomberg estimates, Adcetris sales may surpass $275 million in 2014. Even if prescriptions wane between now and then, there’s still plenty for the drug to bring in. Will the FDA stand in the way? Not yet, it appears.

This is just one of many drugs that carries a box warning. In 2007, the FDA issued a black box warning for all antidepressants for users 18 to 24 years old who risk committing suicide when taking drugs like Paxil and Prozac and the other 37 antidepressants on the market. However, millions continue to take antidepressants, even though they’ve also been proven to cause pulmonary hypertension in babies of mothers who took them during pregnancy and triple the risk of potentially fatal falls for people with dementia living in nursing homes.

And there are many other popular drugs with black box warnings … Pfizer has a few you’ve heard of: the anti-inflammatory Celebrex, contraceptive Depo-Provera and smoking cessation drug Chantix. And although they’ve been shown to cause cardiovascular problems, bone loss and suicidal actions (respectively), they remain on the market.

A classic case of prolonging a drug’s availability through a black box warning is Avandia (rosiglitazone), used to increase the body’s sensitivity to insulin in type 2 (adult-onset) diabetes. Its risk? A 43 percent increase chance of having a heart attack. Manufacturer GlaxoSmithKline provided less-than-transparent clinical data that focused on efficacy rather than safety, which the FDA used to fast-track its approval in 1999.

Eight years later, Avandia was making more than $2 billion a year for GSK before it got a black box warning. Some experts estimate that 100,000 heart attacks can be attributed to Avandia. In November 2011, the FDA severely restricted access to the drug, making it no longer available at retail pharmacies (but not pulled from the market completely). But there was still time for GSK to rake in more than $655 million in 2009 and $355 million in 2010 in U.S. sales alone, according to the firm’s annual report. In December 2011, GSK settled an illegal marketing suit related to Avandia and other drugs for $3 billion. The drug maker still came out ahead. Way ahead.

But the bigger point is: Why isn’t the FDA acting faster? You have to wonder who the FDA is truly looking out for. The drug manufacturers? They get to continue business as usual. Americans whose hearts, livers and lives are on the line? Well, at least we get a warning.

You wouldn’t let your toddler play in a busy street. That’s just good common sense that you already know. However, if you’re in a more precarious position—perhaps you’re pregnant and depressed—you need expert guidance you can trust to keep you healthy and your baby out of danger. You should be able to turn to the medical profession to steer you in a safe direction, right?

In your highly vulnerable state, the pharmaceutical and medical industries have assured you that there’s almost no risk in taking medications like antidepressants during pregnancy. But are they using common sense?

The British Medical Journal released a study last week that examined 1.6 million births from 1996 to 2007 and found that women who take selective serotonin reuptake inhibitors (SSRI) antidepressants late in their pregnancy are twice as likely to give birth to a baby with pulmonary hypertension.

This condition occurs when a newborn has high blood pressure in its lung and the lungs do not adequately adapt to breathing on their own after birth. It’s a dangerous disorder that can lead to organ failure, brain damage or even death. About one in every 1,000 babies is born with the condition.

Yet some experts are discounting the severity of the study’s findings. “You’re doubling the risk of extremely low risk to again, an extremely low risk,” Dr. Marjorie Greenfield, division director of obstetrics and gynecology at University Hospitals Case Medical Center in Cleveland, told ABC News.*

Yes, and maybe there’s an extremely low risk that a driver won’t swerve his car in time to avoid hitting your kid.

But there’s a lot at stake in maintaining the “good name” of antidepressants. SSRIs hit the market in the 1980s and ’90s and gave hope to many people battling depression, eating disorders, post-traumatic stress disorder and obsessive-compulsive disorder. Medications like Prozac (fluoxetine), Zoloft (sertraline) and Lexapro (escitalopram) offered a safer, more effective answer to their side effect-plagued predecessors.

Today, antidepressants are the third most widely prescribed drugs in America, with 1 in 10 Americans taking some form of the drug, according to the Centers for Disease Control and Prevention. This translates into $20 billion in annual profits for pharmaceutical giants like Eli Lilly, Pfizer and Forest Pharmaceutical.

SSRIs work by targeting serotonin, a neurotransmitter that sends messages in the brain. The theory is that a serotonin imbalance will lead to mood variations and depression—or, conversely—that depression will cause a serotonin imbalance. It’s not known which comes first or even exactly how SSRIs work in the brain, other than that they seem to wash away the blues.

People who take SSRIs are subject to side effects that range from restlessness to committing suicide. And while depression during pregnancy can also be dangerous, is the risk worth the benefit? This isn’t the first time that question has been asked. To wit:

• In 2009, a Dutch study of 39,000 children found that those who had mothers who took antidepressants were more likely to have respiratory and digestive problems.
• A Denmark study released in 2010 followed 82,000 babies and discovered that those whose mothers took antidepressants had slight delays in reaching developmental milestones like sitting up and walking.
• A small Kaiser Permanente study in 2011 suggested a link between a pregnant woman’s SSRI intake and her baby’s chance of developing autism.

In addition, it is well known that newborns of mothers who take antidepressants like SSRIs are often jittery and cry excessively during their first month of life, likely due to the fact that stopping SSRIs abruptly causes irritability and is highly discouraged due to these withdrawal symptoms. But when you leave the womb laced with SSRIs, you don’t have much of a choice.

Yet antidepressants are still widely prescribed to pregnant women who are battling mood swings, highs and lows and emotion turmoil during their babies’ development. Are the manufacturers of these medications and physicians who dole them out trying to lead you through a healthy pregnancy and offering a variety of feasible treatment options…or are they sending your unborn baby out into oncoming traffic? Where’s the common sense there?

Let’s say you want to form a committee to evaluate the safety of a drug; say for example the drugs Yaz, Ocella and Yasmin.

You begin by looking for people who are “experts” about the drug, the ingredients in the drug and the use of the drug.

You find 26 or so people who fit your criteria.

Do you want to eliminate those people who may, might, could, have a conflict of interest; a “dog in the fight”; a prejudice one way or the other about the drug or its ingredients or its use?

If you are forming this committee as a public safety body, wouldn’t you also want to eliminate those individuals who even have “an appearance of conflict” in being independent about their evaluation of the drug?

I think any objective person would answer “yes” to both these questions. The Food & Drug Administration – well, they apparently do not subscribe to the same tenets for evaluating potential conflicts of interest as most of the rest of us.

On December 8, 2010, the FDA convened a committee to evaluate the safety and continued sale of Bayer’s drug Yaz. Yaz, Yasmin and Ocella and drospirenone as an ingredient. These drugs have been linked to an increased level of stroke, heart attack, pulmonary embolus and a number of other life threatening conditions in women who used them and otherwise had no risk factors for these conditions. It has been fairly established that these birth control drugs caused the life threatening and, in some cases, life ending conditions for thousands of women.

It also seems pretty clear that Bayer was less than forthcoming about the dangers associated with Yaz, Ocella, and Yasmin. In fact, there have been allegations that Bayer actually knew and consciously withheld important data from the Food & Drug Administration.

So, given all this “gray matter” surrounding the drug, you would want your conduct, as a regulator, to be beyond reproach, right? Testimony from a former FDA regulator, David Kessler, about some of the committee members raises concerns; perhaps not actual conflicts, but certainly potential conflicts suggesting that Bayer may have felt “owed” something by these committee members:

• One of the committee members was considered a “Bayer trained speaker” and was involved in promotional programs for Bayer. This same physician was in the Bayer speaker program and helped Bayer by reviewing research materials related to Yaz. This member also participated in video promotions on behalf of Bayer.
• A second committee member was listed as a “Bayer Contraception Expert” and apparently conducted research for a company that Bayer eventually purchased. The research the physician was involved in related to the use of drospirenone, which, of course, is the key ingredient in Yaz, Yasmin and Ocella.
• A third is listed by Bayer as a “key opinion leader” and an “external expert”.
• The fourth committee member apparently performed at least four research projects for Bayer; including one involving, yes, you guessed it, drospirenone. All four research projects seem to relate directly to contraceptive drugs.

In a paper filed with the court, Bayer now seeks to exclude the testimony of Dr. David Kessler; who believes these potential conflicts are important. In their court paper, Bayer does not argue that what Dr. Kessler states is untrue; rather Bayer argues that, for legal reasons, he should not be permitted to testify about his findings.

Does this all mean that the members, and possibly others, in the committee voted in favor of Bayer being allowed to keep its billion dollar money maker drug on the market? Not necessarily. That is not the point.

The point is that we will never know for certain.

No one should sit in judgment of whether a drug is or is not too dangerous to remain on the market if they have even the “appearance of” a conflict of interest. Why risk it? Why risk the potential of exposing the public to unnecessary risk if, in fact, a drug is too dangerous, but remains on the market because someone did have a “dog in the fight”?

The point is that these circumstances fairly raise the question of exactly who is really running the FDA and who does the Food & Drug Administration really work for in safety vs. marketing situations.

Newt Gingrich has, over the years, allowed his mouth to engage before he placed his brain in gear.

“Hypocrisy can afford to be magnificent in its promises, for never intending to go beyond promise, it costs nothing.” Edmund Burke.

His recent comments about hauling judges into congress, arresting judges who refused to respond to the “invite” to appear before congress and refusing to follow Supreme Court rulings with which he disagreed, are all simply a thoughtless extension of his and his supporters’ ideology.

There are rulings by courts and judges everyday that allow for plenty of room for disagreement. In not one of those rulings with which sound people may disagree would it be appropriate to jail the judge or haul her into a tribunal like congress for tongue lashings. That, however, is an ideology born from a group who believes they know best and, as a result, should be above the law and the constitution of this country.

Mr. Gingrich is an historical expert. He is fully schooled about the “separation of powers” included in the constitution. He should be sensitive to the need for the branches of government (executive, legislative and judicial) to maintain a balance of power through checks and balances. He should know that any judge may be removed for misfeasance or malfeasance through the impeachment process. He also knows that he President of the United States does not have the power to jail judges or to haul judges in before congress.

So, how can a man, a leader of his party, an historical expert, a former member of congress, make statements about simply ignoring the constitution?

Mr. Gingrich can make statements like he has because we live in a free country in which that freedom is guarded by the Constitution. The very document allowing Mr. Gingrich to set forth statements he knows to be simply untrue or inaccurate is the document he says he will simply ignore if elected to the office of President.

In a Democracy you can not have it both ways. We can not on one hand hold high a constitution that protects freedoms like free speech and on the other hand ignore those portions of the constitution that may be, well, inconvenient to a particular group.

What does this say about Mr. Gingrich? What does this say about the ideals of those behind Mr. Gingrich?

I have written recently about the “Santa Claus of Bikes”: Jack Hairston.

Our firm and many of our employees were a part of the Jack the Bikeman experience on Sunday. Jack was successful in putting bikes in the hands of nearly 800 kids. By the time we had finished, few bikes were left from the warehouse packed full when we arrived Sunday morning.

To watch the kids file into the warehouse housing the bikes and see their faces light up to be given a bike of their very own was like reliving Christmas morning when I was a kid each time. The joy each child clearly experienced made it all worth the hard work that went into moving bikes from warehouse to child.

The Searcy Denney staff collected bikes, both new and used, for three months before this event. We sent employees out to pick up bikes from people who wanted to donate, but could not get the bikes to Jack. Our employees also contributed new bikes and funds to assist Jack the Bikeman in his quest to make as many kids happy at Christmas time as he could by giving them the responsibility and the freedom a bike provides to a child.

Although we were not able to begin distributing bikes until around 9:00 am, some families were lined up as early as 4:00 am to stake their place in line for a bike.

At the end of a very long day, around 800 kids were just a little happier that they had a bike for Christmas and few bikes went without owners.

Many Searcy Denney employees were involved in the preparations to make sure that Sunday’s bike give away went forward and we are proud to have been involved.

Thank you, Jack the Bikeman!

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.

Florida medical malpractice statutes are a great deal about procedure and less about substance.

As in many states, Florida citizens have suffered the removal of legal rights under Florida’s medical malpractice laws by legislators with specific agendas other than the improvement of citizens’ lives. More often, business and insurance lobbies push for legislation to improve their own financial bottom lines.

In Florida, we have “pre-suit screening procedures” for any medical negligence case before a lawsuit may be filed. These procedures require things like an expert affidavit attesting to the negligence and a 90 day investigation period by all parties. The notion of these things appears to be of value on paper, but in practice – not so much.

The expert affidavit is actually a good idea. Why not require the plaintiff to prove, at least initially, that a good faith basis for a lawsuit exists?

The 90 day pre-suit investigation period would also be a good idea, except for a couple of factors.

Whether it makes any sense or not, medical malpractice insurance companies almost never have any interest in settling a case in the early stages. They want to do a couple of things before they even consider a settlement. First, they want to hold onto their money as long as possible so they can continue to earn investments. Second, they want to see if they can wear down the plaintiff or the plaintiff’s lawyer by spending the plaintiff attorney’s money to litigate the case.

For these and other reasons, for the plaintiff and his lawyer, the 90 day period is filled with a great deal of accumulating documents and responses to questions directed from the insurance company for the physician or hospital. There is almost never any real inquiry of significant substance or discussion of settlement, but mostly an “exercise in exercising” the plaintiff.

I provide this backdrop simply to emphasize the disappointment of a recent case dismissal that was affirmed by the Court of Appeals. The case was filed by another law firm and involved egregious medical malpractice. The basic facts are:

• A man is taken to the emergency room of a local hospital with symptoms of abdominal pain, nausea and vomiting blood.
• The man is found to have elevated blood sugar levels and is in the process of diabetic ketoacidosis.

This is an emergency situation. In fact, from a medical perspective, it should be a four alarm fire. Once the diagnosis of diabetic ketoacidosis was made, the hospital emergency physician knew this man would die without timely treatment by a gastroenterologist.

The decision from the appellate court sets forth that: “Every off-site doctor that [the hospital] contacted refused to come to the hospital to treat” this man. The involved hospital eventually transferred the patient to a hospital in Broward County for treatment, but he died soon after arrival.

The estate for the deceased filed its complaint and apparently alleged that the hospital had violated its duty to provide care and treatment of patients such as the deceased and that care necessarily required providing physicians competent to treat various conditions. So, according to the appellate decision, the plaintiff sued, at least in part, for failures in corporate planning – the failure to provide a framework for properly treating patients. The plaintiff was, in other words, saying that the hospital’s failure, which caused the man’s death, was not medical malpractice, but was corporate negligence. As a result, the plaintiff did not undertake to comply with the pre-suit requirements discussed above.

The appellate court dismissed the lawsuit and set forth that the hospital’s failure did, in fact, constitute medical negligence and the plaintiff’s failure to comply with the pre-suit procedures under the Florida Medical Malpractice statute was fatal to their lawsuit.

So, for largely procedural, administrative, reasons, the death of this young man will go unpunished. No one will be held to account for the gross, reckless conduct of the hospital and its physicians. The family of this poor gentleman will never receive any justice for the callous refusal of the physicians and outrageous failure of the hospital.

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?