Merck

CVS Caremark accused of violating patient privacy

Anne Zieger — Mon, 17 Nov 2008 11:21:02 -0500

A few weeks ago we told you that the cost of diabetes care had skyrocketed in recent years. Now pharmaceutical benefits manager CVS Caremark is accused of doing their part to make the trend worse.

Labor union group Change to Win (CTW) has accused the PBM of sending letters to doctors encouraging them to prescribe a more expensive diabetes drug, Januvia, to their diabetic patients. CTW is concerned not only about the increased cost to patients, but also the potential violation of patient privacy rights.

CVS Caremark determined which of their patients were likely diabetic based on prescription drug claims that it had handled. Merck apparently paid CVS to send out the letters, but claims that it never saw any personal patient information. CVS, meanwhile, says that they would never force changes to patients' prescriptions, but rather are just making doctors aware of the possible treatments. The final decision lies with the doctors.

To learn more about the accusations:
- read this Kaiser piece

Justice Department recovers $1.12 billion from fraud

Anne Zieger — Tue, 11 Nov 2008 09:16:07 -0500

Every year the Justice Department tries to recover as much as it can from healthcare organizations that have allegedly defrauded them: this year the total it recovered was $1.12 billion dollars.

This is down slightly from last year, when the Justice Department recovered a reported $1.53 billion. However, the year-to-year results are not directly comparable, since some of the settlements made in one year are actually included in the next year's total.

Of the fraud and False Claim Act actions that the department recovered this year, healthcare accounted for 84 percent of the total amount secured.

Some of the biggest cases of the year included Merck & Co's $361.5 million settlement to resolve allegations involving Medicaid rebates and Pepcid discounts for hospitals, Cephalon's $258 million to resolve alleged marketing off-label uses for three of its drugs, and Amerigroup's $225 million to end a case involving allegedly turning away or discouraging enrollment of pregnant women and other high-cost patients in Illinois.

To learn more about the recoveries:
- read this Modern Healthcare piece (reg. req.)

Cervical cancer vaccine used by 25 percent of girls 13 to 17

Anne Zieger — Fri, 10 Oct 2008 14:33:55 -0400

Well, I'd certainly call this a marketing success: It appears that one in four girls ages 13 to 17 have received Merck & Co.'s new vaccine against cervical cancer, Gardasil. This comes after a major direct-to-consumer advertising blitz by Merck, as well as lobbying in several states to make the vaccine mandatory.

The vaccine, which comes in a three-shot series, attacks strains of the HPV virus which causes about 70 percent of cervical cancers. The study covered girls from 13 to 17 only. CDC officials, who sponsored the effort, involved responses from about 3,000 girls.

Since health officials recommend that girls get the vaccine when they are 11 or 12, if possible, the percentage of girls within the whole target population who have gotten the vaccine may actually be larger.

Vaccine supporters had actually been hoping for higher vaccination rates, arguing that the shots could cut down on the almost 4,000 cervical cancer deaths that occur each year in the U.S. But there are some factors holding families back from getting their daughters these shots, including safety fears and high cost ($375, which is often but not always reimbursed by health plans).

To learn more about the progress of Gardasil:
- read this item from The New York Times

Related Articles:
Merck stops lobbying for mandated HPV vaccine
Doctors protest low Gardasil reimbursements
FDA staffers raise Gardasil questions
Merck's Gardasil faces critical new hurdle

FL sues Merck over Vioxx marketing

Anne Zieger — Wed, 01 Oct 2008 13:00:14 -0400

Florida's Attorney General has filed suit against Merck & Co., again, this time for allegedly deceptive marketing and promotion of joint pain drug Vioxx. The suit claims that Merck failed repeatedly to disclose the drug's adverse effects, while offering it to the state's Medicaid program as a safe painkiller, in direct violation of the state's Deceptive and Unfair Practices Act.

Vioxx has been off the market since 2004, when studies suggested that users had a greater risk of heart attack and stroke if they engaged in long-term use of the drug. Attorney General Bill McCollum has been investigating for three of the four years since the market pullout. His research concluded that the Florida Medicaid program spent $80 million on the drug between 1999 and 2004.

In the suit, McCollum contends that Merck tried to bully physicians and researchers who questioned the drug's safety, while possibly misrepresenting or concealing published evidence showing harmful side effects.

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

To learn more about the suit:
- read this South Florida Business Journal piece

Related Articles:
Despite safety issues, Vioxx still in demand
Merck settling Vioxx claims for $4.85B

Drugmakers agree to six-month DTC delay

Anne Zieger — Tue, 17 Jun 2008 11:18:05 -0400

Under fire over direct-to-consumer ads, which some Congressional legislators contend are misleading to consumers, pharmaceutical companies have agreed to voluntarily wait six months after drugs are approved before advertising to the public. The Congressmen pressuring the drug companies--Bart Stupak (D-MI) and John Dingell (D-MI)--aren't pleased, however, given that what they wanted was a two year DTC moratorium. Besides, even the drug companies themselves admit that they generally don't advertise within the first six months after product introductions anyway, given that they usually spend at least that much time educating doctors about drugs before beginning consumer advertising. Meanwhile, the pharmas turned down other requests, including that they only advertise products when studies have shown that they improve clinical outcomes (rather than having used biomarkers). (Looks like they gave up a whole lot of nothing, in other words.) The promise to delay on DTC advertising came as part of a hearing focused on ads for Pfizer's Lipitor, Johnson & Johnson's Procrit, and Merck/Schering-Plough's cholesterol drug Vytorin.

To learn more about the hearing:
- read this Wall Street Journal blog item

Related Articles:
Who will pay for DTC pharma ad oversight?
Drugmakers face direct-to-consumer ad ban
AMA to study the impact of drug advertising

ALSO NOTED: FDA sending fewer warning letters;IL law would limit what hospitals can charge uninsured patients; and much more...

Mon, 09 Jun 2008 06:59:50 -0400

> It looks like the FDA is sending out a lot fewer warning letters to potential violators of late. Officials say they're just changing emphasis, but critics suggest that th agency is slacking off. Blog

> Illinois lawmakers are considering a bill that would set limits on what hospitals would be allowed to charge and collect from eligible uninsured patients. FierceHealthFinance

> Novartis has gotten FDA approval for its bone-building drug Reclast, which used to help patients avoid additional breaks following a hip fracture. FiercePharma

> It looks like there may be another AIDS vaccine trial underway soon, though some skeptics say it may be too soon after a failed Merck program. FierceVaccines

And Finally... Sometimes the power of suggestion is all it takes. Article

Merck agrees to $58M settlement on Vioxx ads

Wed, 21 May 2008 06:59:58 -0400

Merck has agreed to a $58 million settlement with 29 states and the District of Columbia to settle allegations that it downplayed heart risks created by Vioxx in direct-to-consumer advertising. Under the terms of yesterday's agreement, Merck will submit all new TV ads for its drugs to the FDA for seven years, and follow all agency-suggested changes before airing the ads. Merck also agreed to end its practice of "medical ghostwriting," in which paid consultants or employees, rather than physicians listed as lead authors, wrote studies on Vioxx.

The agreement follows a $4.85 billion settlement, which is still pending, that ended most lawsuits resulting from findings that the drug doubled risks of heart attack and stroke. Merck withdrew Vioxx from the market in 2004.

To learn more about the new agreement:
- read this Kaiser Daily Health Policy Report item

Related Articles:
Despite safety issues, Vioxx still in demand
Vioxx defense dealt a blow by new study results
Vioxx lawsuits continue to multiply

ALSO NOTED: Tenet reports $31M loss for quarter; FDA rules against broader Fentora use; and much more...

Wed, 07 May 2008 06:59:50 -0400

> Tenet has reported a $31 million loss for the first quarter of this year. FierceHealthFinance

> An FDA panel has decided against broadening the use of the painkiller Fentora for the time being, though observers predict that the agency will eventually cave. FiercePharma

> In another FDA note, the agency has ordered drugmaker Merck to fix problems with its main vaccine plant in West Point, PA. FierceVaccines

> The National Council for Prescription Drug programs is launching a new database which it says will make claims processing easier and reimbursement faster. Article

And Finally... In this culture, it's normal to drop babies off of buildings. But should we stand by and watch? Article

ALSO NOTED: Group pushing for Medicare e-prescribing requirement; Merck cutting sales force; and much more...

Tue, 06 May 2008 06:59:50 -0400

> If this coalition has its way, Medicare reforms will include a requirement that physicians use e-prescribing technology. FierceHealthIT

> Merck is making some big cuts in its sales force--and apparently, it's not the only drugmakerwho's taking this track. FiercePharma

> New research may offer a shortcut to developing custom flu vaccines. FierceVaccines

> The federal health plan for children, SCHIP, still leaves many children uncovered for a long period due to pre-existing conditions, researchers have concluded. Article

And Finally... I don't know much about wine, but I think I'd notice if it were slippery. Article

Studies show problems with four big-name drugs

Tue, 29 Apr 2008 06:59:56 -0400

It looks like yet another set of popular drugs are facing allegations that they pose safety risks. Drugs named this week in unfavorable studies include Fosamax, which may create heart problems for women who take it for osteoporosis and epilepsy med Dilantin, which may put young women at higher risk of developing osteoporosis. Another study concludes that diabetes drugs Avandia and Actos double or triple the odds of non-spinal fractures, particularly among patients who took the drugs for a year or more. Particularly given other drug safety controversies still very much in the public eye, this can't be giving pharma marketers a warm and fuzzy feeling.

To find out more about the studies:
- read this FiercePharma item

Related Articles:
Merck expects $1.8B hit on Fosamax
Avandia problems erode GSK profits
Takeda touts Actos as heart attack-free
Despite safety issues, Vioxx still in demand