Vioxx

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.)

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

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

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

ALSO NOTED: Demand for health IT pros to soar; Pharmas lobbying hard in DC; and much more...

Mon, 21 Apr 2008 06:59:50 -0400

> Industry researchers are predicting that it will take a huge increase in the volume of professionals available (more than 40,000) to meet the near-term demand for skilled health IT pros. FierceHealthIT

> Pharmaceutical companies are lobbying hard for their position in Washington in the wake of the black eye they've taken with the Vytorin and Vioxx marketing scandals. FiercePharma

> Concerned by the potential for an outbreak, Japan has begun inoculating health care workers with a pre-pandemic bird flu vaccine. FierceVaccines

> Drugmakers Wyeth and Elan have suspended testing on their Alzheimer's vaccine study after one of the patients in the study developed skin lesions. FierceBiotech

And Finally... What's more interesting than man bites dog? Citizen tickets cop, of course! Article

Reports suggest that Merck downplayed Vioxx risks

Wed, 16 Apr 2008 06:59:57 -0400

Another day, another report suggesting that a pharmaceutical company tried to bury data impugning the safety of one of its products. This time, a study has been published in The Journal of the American Medical Association suggesting that Merck & Co. downplayed evidence that Vioxx tripled the risk of death in Alzheimer's-prone patients. What's more, a separate analysis of court documents in the Vioxx lawsuits suggests that many studies on the drug were written by Merck employees or paid consultants, rather than the physicians named as lead authors, researchers said. Apparently, in two company-sponsored trials attempting to find out whether Vioxx could slow the progression of Alzheimer's, the results suggested instead that patients were three times more likely to die of any cause than patients taking a placebo.

To learn more about this research:
- read this USA Today piece
- read this Modern Healthcare article (reg. req.)

Related Articles:
Congress says drugmakers held back Vytorin data
Vytorin defenders funded by drug makers
FDA says Glaxo didn't report Avandia data

WellPoint, FDA collaborate on tracking drug safety

Tue, 15 Apr 2008 06:59:57 -0400

Now here's an interesting partnership--one that likely will generate some valuable results. WellPoint and the FDA have agreed to work together to create a real-time drug-surveillance system to look for hidden problems that may be related to medications or combinations of drugs, and report them as they happen. Under the terms of the agreement, WellPoint will scan medical data on more than half of its 35 million members. The FDA hopes to strike similar deals with other insurers in the future.

The deal could prove to be something of a turning point for the FDA, which hasn't been doing a great job of detecting problems in drugs once it approves them (think Vioxx, Avandia and Zyprexa for starters). In fact, according to the Government Accountability Office, it detects less than 10 percent of bad drug reactions.

To get a detailed picture of the program:
- read this Wall Street Journal article (free content)

Related Articles:
GAO to study FDA's post-approval review process
Report faults FDA's postmarketing vigilance
FDA streamlining drug approval process

ALSO NOTED: AIDS vaccine back at square one; What's behind the FDA's low drug approval rating?; and much more...

Thu, 27 Mar 2008 07:59:50 -0400

> After trying and failing repeatedly to develop an AIDS vaccine, federal officials say they're going back to the drawing board to come up with some new ideas. Report

> Could hip and knee doctors be receiving kickbacks from orthopedic device companies? According to the New York Times, a federal investigation on kickbacks in the orthopedic industry is pointing in the direction of doctors who "receive money as the [orthopedic device] companies' paid consultants." Report

> Although current executives at Emerson Hospital deny any wrongdoing, it certainly looks as if two former executives at the Concord, MA facility were found to have created misleading financial documents. Report

> Is a rising tide of risk aversion at a post-Vioxx FDA behind the agency's anemic approval record? No way, say the FDA's Janet Woodcock. Report

> A hospital looking for a new home doesn't seem to be offering enough compensation to people for theirs. Report

> If you're looking to get high, why not go for a run? Article

And Finally... Dr. Andrew Wakefield and two colleagues will begin their defense today against charges they violated ethics guidelines in the U.K. while developing a 1998 paper that linked autism to vaccines. That study raised a hue and cry around the world that has yet to completely die down, even after a raft of studies now conclude that there is no link. Report

ALSO NOTED: TN Medicaid to test e-prescribing program; NIH alerts patients of stolen personal information; and much more...

Tue, 25 Mar 2008 07:59:50 -0400

> Tennessee's Medicaid program and one of its Medicaid managed care providers have announced that they plan to kick off an e-prescribing pilot program in 13 of the state's rural counties. Report

> New calls for old drug data in the U.K. have experts second-guessing big drug-safety scandals. If scientists and regulators had had access to every bit of data on Vioxx from the get-go, for instance, would heart attacks and strokes have been averted? Report

> After waiting for nearly a month, officials at the NIH alerted some 2,500 people that their names, addresses and detailed personal health information gathered from heart scans in a clinical trial were purloined when an unknown person stole a government laptop with the data on it. Report

And Finally... Looks like breakfast really is the most important meal of the day. Article

Merck agrees to pay$650M+ to settle suits

Fri, 08 Feb 2008 06:59:58 -0500

Merck has agreed to pay more than $650 million to settle two whistleblower suits, the U.S. Justice Department has announced. One of the suits claimed that the pharma paid providers to use its products, disguising kickbacks as compensation for training, consulting and market research. The other suit claimed that Merck gave hospitals volume discounts on Zocor, Vioxx and Pepcid while failing to offer Medicaid the same discounts. (Nevada, for example, concluded that Merck was charging hospitals less than 8 percent of its reported price on Zocor, while failing to give the state's Medicaid program the same price.) Former Merck sales manager H. Dean Steinke will get about $68.2 million for his role in the suits, while the other whistleblower, New Orleans physician William LaCorte, will receive $24.1 million.

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

Related Articles:
Providers settle whistle-blower suits. Report
Merck posts $1.6 billion loss. Report
Merck settling Vioxx claims for $4.85B. Report