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Tuesday, March 5, 2013

"Dr. Drew" and "Competitive Drug Selling" -- Nice Guy Who Takes Big Money To Endorse Drugs?

Let's talk about perceptions -- the trust the public public has for pharmaceutical companies and media medical personalities. Let's have a specific look at  GlaxoSmithKline and golden boy "Dr. Drew" Pinsky. Then, I ask you to question the evidence and discover the truth for yourself about an unholy medical alliance that we, the people, must fight to change.

Many years ago, Glaxo and Pinsky were guilty of a very shady business deal, a business deal that had dangerous consequences for the American public. Here is part of a report by Jeanne Whalen:

"In June 1999,  Dr. Drew Pinsky used the airwaves to extol the virtues of PLC's antidepressant Wellbutrin, telling listeners he prescribes it and other medications to depressed patients because it 'may enhance or at least not suppress sexual arousal' as much as other antidepressants do.
"But one thing listeners didn't know was that, two months before the program aired, Dr. Pinsky—who gained fame as 'Dr. Drew' during years co-hosting a popular radio sex-advice show 'Loveline'—received the second of two payments from Glaxo totaling $275,000 for "services for Wellbutrin."

(Jeanne Whalen, "'Dr. Drew' Was Paid by Glaxo," The Wall Street Journal, July 3 2012)

The payments, made by a communications firm working for Glaxo, are revealed in an attachment to a complaint the U.S. government filed in October 2011 in federal court in the District of Massachusetts.

The documents were disclosed this week as the U.S. Justice Department announced a $3 billion criminal and civil settlement with Glaxo over illegal drug marketing and other matters.

Dr. Pinsky answered the impropriety with the following statement: "In the late '90s I was hired to participate in a two-year initiative discussing intimacy and depression which was funded by an educational grant by Glaxo Wellcome," one of the companies that later merged to form GlaxoSmithKline.

He added that the campaign "included town hall meetings, writings and multimedia activities in conjunction with [a] patient advocacy group." He added, "My comments were consistent with my clinical experience." Yes, he said "consistent with his clinical experience." Would the truth be more like "what Glaxo paid me to say was 'consistent with my clinical experience'"? Dr. Drew... shame, shame.

Doctors are allowed to prescribe drugs as they see fit, but they know it is illegal for companies to promote drugs for uses not approved by the FDA, a practice known as "off-label" marketing.

Wellbutrin's prescribing label doesn't state that the drug is less inhibiting of sexual libido than other antidepressants.

At this point the reader may begin to wonder why Pinsky didn't "man up" and confess to his prior knowledge of the rules for legal drug marketing. He knew he broke the law. He did it for the money.

The U.S. government complaint against Glaxo followed a nine-year investigation of the company's marketing practices, and led to the settlement. It is apparent the company is guilty of many infractions. Pinsky was just one of many doctors charged, yet, to me, his celebrity and homey "honest and confident" media style is all the more reason for taking responsibility.
As part of the deal, Glaxo pled guilty to criminal charges related to illegal drug marketing and failing to report important drug-safety data to the Food and Drug Administration.

Let's look at this case further. Are you satisfied that Glaxo paid the charges and now proceeds with business as usual? True, the $3 billion fine will settle the government's civil claims against Glaxo. But, do you realize this include allegations that the company plied many doctors with cash and lavish trips to resorts to get them to promote Glaxo drugs for uses beyond those specified in the drugs' FDA-approved prescribing labels.

Where is a modicum of justice for the American public that has been conditioned by Big Pharma (and approved by the FDA) to trust medical "talking heads" and transparency of medical advertising? I know the answer to this question. Glaxo made huge profits when "Dr. Drew" extolled the false virtues of Wellbutrin. They settled for a paltry $3 billion, which is inconsistent with the big money they made by illegal means over the last thirteen years.

How does Glaxo apologize to the public? Well, they declined to answer questions about its financial relationship with Dr. Pinsky or other physicians. Listen to their press release for yourself.

The company said...

"The complaint to which you refer concerns events in 1999, 13 years ago. It does not reflect what would be allowed in GSK today." It added: "The government has made many allegations and legal conclusions concerning Wellbutrin that GSK disputes. GSK admits, however, that during the period from January 1999 to December 2003, there were some occasions on which certain GSK sales representatives, speakers, and consultants promoted its antidepressant Wellbutrin to physicians for uses which were not FDA-approved in violation of federal law."

"It does not reflect what will be allowed today"? Nonsense. These criminal practices continue, and they have accelerated to warp speed. If you believe a pharm company has "learned their lesson" and now doesn't conspire to promote their products through shady means, I know a few beautiful, ex-sales representatives you should engage in conversation.

And GSK admits "some occasions"? Just remember that limitation with the word some makes for gross understatement of the offenses. Popular connotation of some is "a few." In my book, any such admittance to this behavior denies common past practice to break the law and to merely admit crimes in which the firm "got caught."

Want to know what Deirdre Connelly, Glaxo's U.S. president, said publicly? She said that the drug industry had "lost its way." She faulted a "competitive selling model" that is fine for cars or candy, but isn't appropriate for prescription medicines. Denial? "The drug industry" and "competitive selling model"? This is not an apology of wrongdoings by the company from the head of operations. It is the old, old "Blame Game."

Deirdre Connelly, Glaxo's U.S. president, said publicly that the drug industry had "lost its way." She faulted a "competitive selling model" that is fine for cars or candy, but isn't appropriate for prescription medicines.

Take a Look at Information Reported in The Whistleblower: Confessions of a Healthcare Hitman by Dr. Peter Rost

Dr. Novella is presently an academic clinical neurologist at Yale University School of Medicine. This book, The Whistleblower: Confessions of a Healthcare Hitman, is a blow by blow description of Dr. Rost's experience as an insider--indeed a high-level pharmaceutical executive turned whistleblower.

Dr. Rost first blew the whistle on Wyeth's global tax evasion scheme in which Wyeth made payments to its foreign employees to escape taxes. He then blew the whistle on Pharmacia's illegal, off-label, marketing of Genotropin, a human growth hormone.

When Pharmacia was swallowed up by Pfizer, his situation dramatically worsened--except for his savvy inroads with the media and politicians. Dr. Rost focused mainly on the lie promoted by Big Pharma about the invented danger of reimportation of prescription drugs.

Although most of the book describes one man's struggle against corporate hard ball tactics and intimidation--despite laws protecting whistleblowers--his chapter, "How Corrupt Is the Drug Industry?" provides the environment in which this industry operates. Giant pharmaceutical corporations that once were held in high esteem, have earned criminal wrap sheets--much like mobsters, not life-savers.

Below is a partial list of pharmaceutical corporate wrongdoing described in Peter Rost's book:

In 1997, Wyeth, after pulling Pondimin and Redux off the market because of heart valve damage, the company was forced to set aside $21.1 billion to settle "fen-phen" liability cases.

In 2000: Wyeth signed an FDA Consent Decree and paid $30 million.
In 2001: "TAP-Astra Zeneca Pay Over a Billion Dollar in Fines"--re: criminal marketing of Lupron.

In 2002: Pfizer paid $49 million to settle state and federal Medicaid fraud charges involving Lipitor.

In 2002: Schering-Plough signed a FDA consent decree and paid a $500 million fine--the biggest in FDA history.

In 2003: Bayer pled guilty to violating the federal Prescription Drug Marketing Act, paying $257 million including a criminal fine for its marketing of Cipro.

In 2003: GlaxoSmithKline shareholders questioned GSK CEO, Jean-Pierre Garnier, about his pay package to which he responded: "I am not Mother Teresa."

GlaxoSmithKline also ran afoul of the IRS--it is facing a demand for $7.8 billion in backdated taxes and interest.

In 2003, GSK signed a corporate integrity agreement and paid $88 million in a civil fine for overcharging Medicaid for the antidepressant, Paxil and nasal-allergy spray, Flonase.
In 2004; Schering-Plough paid $345 million to resolve criminal and civil liabilities for illegal marketing of Calritin.

In 2004 Pfizer admitted criminal marketing of Neurontin, agreeing to pay$420 million.

In 2004 Bristol-Myers Squibb was ordered by the Securities and Exchange Commission to pay $150 million to settle charges of inflating its revenue by $1.5 billion in 2000 and 2001.

In 2004, Merck withdrew its lethal painkiller, Vioxx. Estimates are that it would cost the company $50 billion.

In 2004: The IRS served Merck with a "preliminary notice of deficiency" that could lead to $2.04 billion.

In 2004; New York State Attorney General slapped GSK with fraudulent marketing of Paxil--the company settled and posted its previously concealed pediatric clinical trial data.

In 2005 the Justice Department announced that GSK had paid "over $150
million to resolve allegations of violations to the False Claims Act through
fraudulent drug pricing and marketing."

A separate criminal investigation by the U.S. Attorney General's Office in
NJ resulted in the indictment of two executives for securities fraud--the
company agreed to pay $300 million to shareholders.

In 2005: Serono Laboratories (Switzerland) agreed to pay $704 million to resolve criminal and civil charges in connection with the marketing of Serostim, an AIDS drug. The company also pled guilty to marketing conspiracy.

In 2005: Eli Lilly pled guilty and paid $36 million for its illegal marketing of Evista for off-label uses.

What does Novella contend about the "Dr. Drew" episode? He says...
"What this recent settlement indicates, in my opinion, is that companies will bend the rules to maximize their own profits, and that effective regulation can bring them into line and protect the public. I also think this settlement is a significant piece of evidence against the typical 'Big Pharma' conspiracy theory that government is in the hands of industry. It’s hard to dismiss $3 billion dollars as a slap on the wrist. This was a clear statement.
"But companies are chiefly motivated by profit, and when billions of dollars are at stake there is a huge motivation to bend the rules. We take for granted that companies are going to distort information when marketing their products to the public. Experienced and savvy consumers view all commercial and marketing activity with a skeptical eye and we do need to take some personal responsibility for protecting ourselves (let the buyer beware).

"At the same time the public largely expects that with health care issues the government will play some role in protecting the public from fraud, misinformation, unsafe and ineffective products and services. The stakes are just too high to make every consumer fend for themselves in a completely unregulated wild west of health care. In addition the science behind health care products and services is complex, and it is not reasonable to expect the average citizen to be able to sift through complex technical medical research. That is essentially the reason for the existence of the FDA."
(Dr. Steven Novella, "GSK Pays $3 Billion Fine" Science-Based Medicine, July 4 212)

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