Here We Go Again: Court documents Allege Big Pharma Used Ghostwriting Program to Promote Antidepressant

Here is a shocker. More documents indicate that Big Pharma engaging in nefarious conduct to peddle drugs. Who is the FDA protecting, us or Big Pharma. I realize there is a revolving door at the FDA, but at some point, someone has to say enough is enough.

The AP (8/19, Perrone) reported that, "according to court documents obtained by the Associated Press," pharmaceutical maker "GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil [paroxetine], allowing doctors to take credit for medical journal articles mainly written by company consultants." In fact, "an internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the" medication. "Known as the CASPPER program, the paper explains how the company can help physicians with everything from 'developing a topic,' to 'submitting the manuscript for publication.'" The AP notes that "the document was uncovered by the Baum Hedlund PC law firm of Los Angeles, which is representing hundreds of former Paxil users in personal injury and wrongful death suits against GlaxoSmithKline," alleging that "the company downplayed several risks connected with" the medicine, "including increased suicidal behavior and birth defects."

Read more on this issue:

http://http//www.nytimes.com/aponline/2009/08/19/us/politics/AP-US-GlaxoSmithKline-Ghostwriting.html?_r=1&scp=2&sq=+%22wrongful+death%22&st=nyt

Chris Hellums may be reached at Chrish@PDKHlaw.com

UAB Report: Tort Reform Provides No Savings

I was recently watching CNBC and they were debating health care costs. Former Tennessee Senator Bill Frist was on and was asked about tort reform as part of the health care debate. He remarked that what he considered it an issue, it was not a significant piece of the solution. I was shocked by this remark.

For years, this has been the battle cry of groups like Citizens for Lawsuit Abuse. Hatched in Texas by Karl Rove and others and perfected in Alabama and Mississippi, these groups convinced virtually everyone that "tort hells" and "greedy trial lawyers" were the cause virtually everything evil in society. All lawsuits are frivolous, everyone who sues wants something for nothing, and juries of average people (who can determine whether someone lives or dies in a criminal context) are too stupid to determine whether or not corporations engaged in fraudulent conduct and if so, the level to which they should be punished.

Guess What----It Worked---But for Who??????????????

The success of this endeavor, financed by insurance companies, tobacco and large corporations has been extremely successful. Many states have passed tort reform statutes. Juries view all plaintiffs with distrust, and are much less willing to award damages---"for fear that my insurance rates will go up" as many interviewed jurors will openly tell you. A trial judge recently told me that about 50% of rear end accident cases tried in his court result in a verdict for the defendant. That's right, 50% of the time, when someone admits the were not paying attention and hit someone from behind, the jury refuses to hold them responsible for their conduct. While at a restaurant recently, I spoke with a lawyer who previously worked for a large insurance company trying car wreck cases. He said that he was fired by one insurance company because he recommended that they pay twice the medical bills.

One must then ask the question, who benefits when this occurs. I would submit that it is insurance companies who benefit. See also, "Ironic Twist of Fate--Tort Reform Champion loses his own Medical Malpractice case."

On to the subject of medical malpractice. Frequently, I talk to my friends who are physicians about medical malpractice. Few have been sued. All know of situations where they think physicians should have been sued, and all are scared to death that they will get sued, lose their practice, their homes, and everything they have worked for so long to accumulate.

I ask them where they get their information from and of course, it is their insurance company. They know about the huge verdict here and there, but not the ultimate outcome. They know their rates are going up and assume it is because of huge settlements and verdicts. They never compare the premiums written to the verdicts in Alabama. Their response to that inquiry is that the insurance companies settle out of court. They seem unaware that largest insurance carrier for doctors in Alabama tries virtually all case filed, so that hypothesis is invalid.

I ask them if they have ever driven by the home of the recently retired CEO of the insurance company which writes most doctors in the state. I ask if they ever considered how it is that he could afford a house that published reports indicate the property taxes alone are in excess of $100,000 per year?

I guess I digressed from where I started, which was with the reading of two articles I found ver interesting. One from the Kentucky Lexington Herald-Leader, "Tort Reform does not cut health costs" and the second from from the New Yorker, authored by Ault Gawande titled "The Cost Conundrum, What a Texas town can teach us about health care" .

According to the Lexington Herald-Leader, States that enacted limits on malpractice claims have seen no cost savings. To the contrary, Texas capped malpractice damages in 2003 only to experience a steep rise in health insurance premiums and medical costs.

Boston surgeon Ault Gawande wrote in The New Yorker about his visit to Texas (see full New Yorker article hyperlinked above). While at dinner with several physicians, he asked about lawsuits. He was told that they had dropped "practically to zero." Well, he wondered, what happened to the claim that doctors were practicing defensive medicine---the basis for tort reform. He learned that doctors have an incentive to order lots of tests---they profit from them!!!!!!!!

These results are not unique.

In 2008, researchers at the University of Alabama at Birmingham published reports of their study which surveyed 27 states with non-economic caps. The principle findings state:

"Using a variety of empirical specifications, there was no statistically significant evidence that noneconomic damage caps exerted any meaningful influence on the cost of employer-sponsored health insurance."

The study concluded:

"The findings suggest that tort reforms have not translated into insurance savings."

(read abstract to study here)

Unfortunately, I think too many to may physicians have been misled by the insurance industry that the evil lurking is a lawyer who trying to take everything they have work tirelessly to attain. Perhaps if they formed their own mutual company and insured their own risk, they could see what the real cost of malpractice coverage.

Court Documents Show Wyeth Paid Writers of Hormone Therapy Articles

In a front-page story last week on August 5th, the New York Times reported that "Newly unveiled court documents show that ghostwriters paid by [Wyeth] played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known."

The articles were uncovered by lawyers suing Wyeth over the hormone therapy written about.

The articles were drafted by a medical communications firm paid by Wyeth, and were "published in 18 medical journals including The American Journal of Obstetrics and Gynecology and The International Journal of Cardiology. between 1998 and 2005." The articles did not disclose Wyeth’s role in initiating and paying for the work.

The articles "emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia."

The "supposed medical consensus" created by the papers is said to have helped sales of Wyeth's hormone drugs Premarin (conjugated estrogens) and Prempro (conjugated estrogens/medroxyprogesterone acetate) rise "to nearly $2 billion in 2001."

That "consensus fell apart in 2002 when a huge federal study on hormone therapy was stopped after researchers found that menopausal women who took certain hormones had an increased risk of invasive breast cancer, heart disease, and stroke."

Corporate Bonuses: The bubble that it seems will never burst

According to a report issued by New York Attorney General Andrew Cuomo Citigroup, Inc., Merrill Lynch, and seven other banks who received more than $175 Billion (yes, that is billion with a "B") in taxpayer, aka OUR MONEY, paid out more than $32 Billion in bonuses to executives. According to Bloomberg, more than 5,000 of those bonuses were more than $1,000,000.

Cuomo's study, called “No Rhyme or Reason: The ‘Heads I Win, Tails You Lose’ Bank Bonus Culture,” comes as Congress and the Securities and Exchange Commission examine whether to limit the compensation paid to top corporate executives.

Citigroup and Merrill Lynch suffered losses of more than $27 billion at each firm, the report said. Yet Citigroup paid out $5.33 billion and Merrill $3.6 billion in bonuses.

Industry talking heads say that pay is tied to performance and that government should not get involved. The problem is that this type of structure led to the taking of huge amounts of leveraged risk, and when that blew up in their faces, they fired employees, eliminated 401(k) contributions, ruined the economy and left us (the taxpayers) to pick up the tab.

Take as an example the case of Andrew Hall, who runs Philbo, Citi's oil-trading subsidiary. He is on track to collect $100 million, which is his cut from profits from a year of extremely aggressive bets on the oil market. Citi says his trading resulted in $2 billion for Citi over the past five years and they are contractually obligated to pay him. The problem is that this type speculation was not used to lock in supply or steer capital where it was needed, but rather by outsmarting other investors. That bodes the question---what happens when he bets wrong and loses 2 billion, and 10 of his collegues do the same? Well, we know how that story ends.

On main street, if you bet the farm and lose, you lose the farm. On Wall Street, if you bet the farm and lose, the rest of us have to buy you a new farm.

The problem remains that these executives continue to suffer the what I call the "Marie Antoinette Syndrome." They don't get it. They continue to fly around in corporate jets, promote their children, pay themselves (and their buddies whose boards they sit on) huge bonuses while the rest of the country suffers under immense economic stress.

Despite their political power across both parties, I would submit that this simply cannot continue. The industry has had the chance to police itself. That time is past. Just as small businesses cannot put lazy family members on the payroll and pay them to hang out at the country club, neither can banks.

One day the government free cheese program will be over. Banks will have to compete in a new environment. I submit that when that day comes, many good bankers will have gone to community banks and they will become a real force in the industry. In the meantime, we will continue to read about such bonuses at the same pace we read about major league baseball players and steroids.