State sues Merck for deceptive marketing of Vioxx

South Florida Business Journal- Wednesday, October 1, 2008 - 11:49 AM EDT

Florida Attorney General Bill McCollum has filed suit again Merck & Co. for alleged deceptive marketing and promotion of the prescription drug Vioxx.

The lawsuit claims that Merck repeatedly failed to disclose the drug’s adverse effects while offering it to the state’s Medicaid program as a safe painkiller, in direct violation of Florida’s Deceptive and Unfair Trade Practices Act.

Vioxx was used to treat joint pain until it was removed from the market in 2004 after studies suggested those taking it had an increased risk of heart attack and stroke associated with long-term use.

The lawsuit follows a three-year investigation of Merck’s promotional practices and alleges that, due to the company’s marketing practices, numerous state agencies approved the inclusion of Vioxx as a covered or approved drug, and agreed to pay for the prescription or reimburse its expense.

In a prepared statement, Merck said it acted responsibly and intends to defend the complaint, which is similar to those filed by eight other states and pending in federal and state courts.

“The medicine was labeled appropriately under the direction of the FDA according to evolving science available at the time it was on the market,” the company stated in a news release.

Vioxx purchases by the Florida Medicaid program alone exceeded $80 million between 1999 and 2004.

The suit also alleges that Merck tried to intimidate physicians and researchers who questioned the safety of Vioxx, and may have misrepresented or concealed published evidence, including its own, showing possible harmful effects.

The lawsuit demands restitution to the state plus interest, for all state program payments – including Medicaid reimbursements – made for Vioxx prescriptions. It also seeks civil penalties of up to $10,000 per violation.

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Well, Don't say I didn't tell you so!

In one of my recent newsletters from September 21, 2008, Top-Selling Prescription Drug Mismarketed to Women?, I wrote , "I hope I am wrong, but this article from the Journal of Empirical Legal Studies may be a trial balloon for legal trouble for the pharmaceutical industry. We may soon see health insurers, Medicare and State Medicaid filing lawsuits worth billions of dollars to recover money spent on alleged false claims for Lipitor."

Fortunately or unfortunately it seems that the state of Florida is making my prediction ring true by filing suit against Merck Pharmaceuticals Vioxx medication. Vioxx is in a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). Vioxx worked by reducing substances that cause inflammation, pain, and fever in the body. The manufacturer of Vioxx, in 2004, announced a voluntary withdrawal of the drug from the U.S. and worldwide market. This withdrawal was due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking Vioxx.

What the true risks of Vioxx were will probably never be known. In my practice, Vioxx worked very well and caused very few and minor side effects. It was removed from the market not due to lack of efficacy, but due to the economic potential of future lawsuits. It was a sad day for the 99%+ of patients who used the drug safely and effectively. But it was a sadder day for the patients who were potentially injured by the drug.

This all could have been avoided if Merck marketed the medication properly and did not allegedly attempt to hide data that showed possible complications from using the drug. If Merck had been prudent and shared this knowledge beforehand, Vioxx would still be on the market, helping millions of patients with Arthritis and other inflammatory conditions. It would have a big black-box warning attached to it warning of the dangers in a select population, but it would still be in use today.

Motto of the story: Big Pharma needs to work on their business and marketing practices and once again put patients health and well being ahead of profits. Until that time, do not expect the pharmaceutical industry to be trusted or respected as it had in the past.

If you have any questions on your medical care and the medications you take, call the office, make an appointment and discuss your options. My motto has always been to use the least amount of medication possible and only when necessary.

Steven Horvitz, D.O.

Board Certified Family Medicine

Founder of The Institute for Medical Wellness

Top-Selling Prescription Drug Mismarketed to Women?

From the PharmaLive.com News Archive - Sep. 17, 2008

ITHACA, N.Y. – September 17, 2008 – Lipitor has been the top-selling drug in the world and has accounted for over $12 billion in annual sales. It has been prescribed to both men and women to lower cholesterol and reduce the risk of heart attack and stroke in patients with common risk factors for heart disease. However, a new study appearing in the Journal of Empirical Legal Studies was unable to find high quality clinical evidence documenting reduced heart attack risk for women in a primary prevention context. Furthermore, advertising omits label information relevant to women.

Theodore Eisenberg of Cornell Law School and Martin T. Wells of Cornell University assembled studies for a meta analysis of drugs’ effects on cardiovascular risk, taking into account all relevant studies reporting risks for both men and women.

Not one of the studies that included women with a mixture of risk factors for heart attacks provided statistically significant support for prescribing Lipitor or other statins to protect against cardiovascular problems. Pfizer’s claims of clinical proof that Lipitor reduces risk of heart attack in patients with multiple risk factors for heart disease does not appear to be scientifically supported for large segments of the female population.

In addition, Lipitor’s advertising repeatedly fails to report that clinical trials were statistically significant for men but not for women. Unqualified advertising claims of protection against heart attacks may therefore be misleading. Pfizer’s advertising also does not disclose critical portions of the Lipitor FDA-approved label, which acknowledges the absence of evidence with respect to women.

“Our findings indicate that each year, reasonably healthy women spend billions of dollars on drugs in the hope of preventing heart attacks but that scientific evidence supporting their hope does not exist,” the authors conclude.

This study is published in the September 2008 issue of the Journal of Empirical Legal Studies.

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This article shows the increased scrutiny of the pharmaceutical industries medical studies, medical claims and marketing practices.

As many of you already know, I am not a big fan of Lipitor or other statins, such as Crestor, Pravachol, Zocor, Mevacor and Lescol. Their use in prevention of heart disease leaves a lot to be desired. While not being a fan of statin drugs, I still am a fan of the pharmaceutical industry, just as I am a fan of the vitamin and neutraceutical industries, as long as their claims are valid and marketed truthfully.

I hope I am wrong, but this article from the Journal of Empirical Legal Studies may be a trial balloon for legal trouble for the pharmaceutical industry. We may soon see health insurers, Medicare and State Medicaid filing lawsuits worth billions of dollars to recover money spent on alleged false claims for Lipitor.

There are other methods of reducing heart disease risk, that do not rely on drugs. Eating and exercising properly. quitting tobacco, and reducing alcohol intake are just a few. The goal is not to lower your cholesterol number to the lowest it can go, but to increase your age to the highest it can go, but in a safe, effective and healthy manner that increases your quality of life. That is the goal of my practice, and I hope it is yours as well.

Steven Horvitz, D.O.

Board Certified Family Medicine

Founder of The Institute for Medical Wellness

Pharmaceutical Advertising- Good or Bad?

Pfizer Resuming Ads for Lipitor After Controversy

From The Associated Press WorldStream - Sep. 02, 2008

TRENTON, N.J._Television ads for the world's top-selling drug, cholesterol fighter Lipitor, are back, six months after Pfizer Inc. pulled them amid charges its use of a celebrity doctor endorser who's never practiced medicine misled the public.

This time, Pfizer is leaving out the celebrity.

In the new ads, the endorser is a talent agent from the San Francisco Bay area who tells viewers he started taking Pfizer's Lipitor after surviving a heart attack last year.

The ads began running Tuesday and will be part of an open-ended national campaign that also includes print ads in newspapers and magazines, said John Sage, head of Pfizer's marketing team for Lipitor.

Lipitor generates more than $12 billion a year in revenue for New York-based Pfizer.

Pfizer had run frequent TV ads from late 2006 until then in which artificial heart inventor Dr. Robert Jarvik endorsed Lipitor, appearing to be giving medical advice. While he holds a medical degree, Jarvik never completed licensing requirements to practice medicine.

Pfizer, the world's biggest drugmaker, pulled the ads in February as members of Congress were investigating and media outlets were reporting on that conflict and Pfizer's use of a stunt double in an ad that showed Jarvik rowing.

"Although it wasn't clearly our intent, the ads created misimpressions and distractions around what we were trying to do," Sage said late last week.

He said the man in the new ad, John Erlendson, is "a real Lipitor patient, who is very representative of people with" cholesterol problems.

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Growing up in my father's family practice office, I saw the interaction between doctors and pharmaceutical sales reps. I have seen the interaction change very little over the past 20 years, but what has changed is the public perception of Big Pharma.

Big Pharma used to be adored by patients and by Wall Street.

But No Longer!

Why???

Just look at the a few items.

1) Direct to Consumer Advertising for medications that may cost the same as a car payment with very little if any benefit over much more affordable generic medications.

2) Putting profits ahead of patient care. I have analyzed many of the big medical studies that are marketed to doctors, and much of the statistics are achieved with smoke and mirrors. Profits to improve their stock prices has more influence than patient health and safety.

3) The most telling point comes from my discussions with many of the pharma reps. Ten years ago, the reps were usually 10-20 year veterans in their fields and hoped to remain until retirement. Today , many of the reps are much younger, and are keeping their eyes and ears open for other employment. They see the future of their industry and at present it does not look so good.

Pearl of the day.

Never believe the pharmaceutical marketing and propaganda on television or print advertisements. Their goal is to sell you something that most likely you do not need.

If you have any questions on your medical care and the medications you take, call the office, make an appointment and discuss your options. My motto has always been to use the least amount of medication possible and only when necessary.

Steven Horvitz, D.O.

Board Certified Family Medicine

Founder of The Institute for Medical Wellness

For past issues of the newsletter please click here.
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Addendum: 9-9-2008 taken from a pharmaceutical website:

Published on FiercePharma (http://www.fiercepharma.com)

Pharma drops again in public opinion

By tracy

Created Jun 30 2008 - 10:01am

It's not pleasant company at the bottom of this list. According to a new Harris Interactive poll, only 26 percent of Americans have a favorable view of the drug industry--a record that's even worse than Big Oil, and better only than tobacco companies. It's a low point, following a slow-but-steady decline in consumer opinion.

Fair? That's not the point. The question is, do drugmakers intend to do whatever it takes to reverse the trend? Or should they just accept the dubious honor? Given the challenges pharma faces these days, improving public opinion may not be number one on the priority list.
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Published on FiercePharma (http://www.fiercepharma.com)

Survey: Pharma not a good info source

By tracy

Created May 29 2008 - 10:35am

Remember last month when Merck CEO Dick Clark remarked on Big Pharma's "trust deficit [0]?" Well, here's quantitative evidence of it. A European Commission study found that healthcare professionals and payers are "mostly suspicious" of drugmakers as sources of information about drugs. Nearly half of the responders said pharma has too many conflicts of interest to be appropriate sources of general information on medications.

Some of the responses, however, indicated that if drug companies provided a clear distinction between ads and information, they could be valuable repositories because of their intimate knowledge of their products.

The opinions will be factored into decisions about a proposed code of conduct governing the release of info about pharmaceuticals in the E.U.
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Pharma CEOs mull industry "trust deficit'

By admin

Created Apr 24 2008 - 6:59am

We love it when pharma CEOs depart from their usual talking points about financial results and restructurings and pipelines, to wax philosophical on their place in the word. This week, we heard an entire trio musing on the state of the industry: Merck chief Richard Clark, GlaxoSmithKline's putative chief Andrew Witty (photo [1]), and Pfizer's Jeff Kindler (photo [2]). Some choice bits:

• Pharma's equilibrium is "shattered," Witty told the Academy of Medical Sciences this week. To fix it, drug makers need to listen more--and talk more--particularly with drug buyers (about the true value of new meds) and with government. Pharma and regulators are "like two ships missing in the night," he said.
  
• "There is a trust deficit we have to fix," Merck's Clark told The Star Ledger, when asked about lessons learned from the Vytorin controversy. "I think everyone has a lesson to be learned from this. Drug makers "may have to become more transparent" about their spending and their relationships with docs, he said.
  
• "There's a lot of public concern about the pharmaceutical industry," Kindler told the Wall Street Journal. "But...everybody recognizes that you can't solve the healthcare reform problem without an innovative, healthy pharmaceutical industry. We have to be a part of the solution." He went on to talk about truth-telling: "It's important for the industry to communicate with integrity and to do everything it can do to insure the integrity of the data and the science."

Sounds like these guys are all picking up on the same vibe: communication, transparency, telling the truth. And that they recognize that the "shattered equilibrium" and "truth deficit" need to be fixed. What will they do to make that happen, that's the question.
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Published on FierceBiotech (http://www.fiercebiotech.com)

10 reforms for drug advertising

By maureen

Created Aug 2 2007 - 2:06pm

At BrandweekRx, Jim Edwards outlines 10 direct-to-consumer advertising reforms he says are urgently needed to protect consumers from unscrupulous drug advertising. Edwards' recommendations include banning product-placement ads and forcing drug companies to disclose to the SEC how much money they're spending on advertising (companies don't have to say how much is spent promoting a drug, but it's about double the cost of R&D). He also recommends an FDA requirement for head-to-head studies between competing drugs so that doctors can make educated decisions when prescribing medications. Finally, Edwards argues in favor of total transparency of the amount and usage of drug company dollars spent on Continuing Medical Education, along with full disclosure of payments and gifts to doctors.