Vioxx Spinistics
July 30, 2005
Exactly my take, here, but so much better stated.
spinistics: purposeful twisting and creation of inferences from a subset of statistical data; see red fire engines.
Failure of Care
July 26, 2005
U.S. Attorney’s Office Reaches Agreement with Hospital to Resolve Failure of Care Allegations Stemming from Improper Use of Patient Restraints | US Attorney’s Office E.D. Pa. | 7.25.05
July 25, 2005- PHILADELPHIA – United States Attorney Patrick L. Meehan today announced the first of its kind civil settlement with Central Montgomery Medical Center (CMMC), a hospital located in Lansdale, PA, and the hospital’s management company, UHS of Delaware, Inc. The settlement agreement, which is the first of its kind in the nation, addresses failure of care claims based upon alleged violations of regulatory requirements pertaining to physical and chemical restraints at the medical center that ended with the death of a restrained elderly patient in 2002. CMMC has agreed to pay the government $200,000 and to hire a consultant to review restraint usage at the hospital as part of the agreement.
CMMC has denied any wrongdoing in agreeing to the settlement.
In August 1999, CMS implemented federal regulations that addressed the ordering and use of physical and chemical restraints for medical/surgical purposes and for behavioral health management. Among other requirements, these regulations mandate less restrictive alternatives must be offered prior to the use of restraints and the procedures that must be followed when implementing a physician’s order for restraints. These requirements are contained in the patients’ rights section of the Medicare conditions of participation for hospitals.
The government alleged that from February, 2002 through August, 2002, CMMC knowingly billed the government for numerous patients that were improperly physically and/or chemically restrained in violation of federal law and regulation in violation of the federal False Claims Act.
“This case and 20 years of research show that restraints can lead to tragedy and we want to make sure providers use them as a last resort. Patients and their families deserve every precaution,” said Meehan. “CMMC has taken significant steps in reducing restraint usage at the medical center. We hope that other hospitals will review carefully the procedures followed prior to as well as after the decision is made to place a patient in a physical restraint or to administer a chemical restraint.”
The case was investigated by the HHS-Office of Inspector General and has been assigned to Assistant United States Attorney David R. Hoffman.
False Claims Act, chemical/physical restraints, and failure of care—first ever! This is very serious, especially for a specialty like Emergency Medicine where restraints (both chemical and physical) are often part of the initial evaluation and stabilization.
Happy 21st!
July 25, 2005
Happy Birthday Seann!
Today my oldest son is 21.
Defense Score
July 22, 2005
Merck Witness Challenges ER Doctor in Vioxx Trial | WSJ | 7.21.05
ANGLETON, Texas — Merck & Co.’s top epidemiologist testified Thursday that an emergency room doctor was too quick to blame a heart attack for the sudden death of a Texas man at the center of the nation’s first Vioxx-related lawsuit to go to trial.
There is absolutely no way an ER doctor can make a diagnosis of sudden death by Vioxx—this is either an inaccurate recollection of the plaintiff or the ER doctor was engaged in sheer hyperbole and deserves to be shredded in the witness stand.
“The ultimate diagnosis comes from an autopsy,” Dr. Santanello told Merck attorney Gerry Lowry in her fourth day on the witness stand.
Absolutely!
Mr. Ernst’s autopsy said he died of arrhythmia, or irregular heartbeat, secondary to plaque buildup in two major arteries. He took Vioxx for eight months before he died to relieve pain in his hands.
Conclusion and association—surely the plaintiff has got more than this? With this the first of 4,200 state and federal Vioxx suits, there are going to be lots of associations, but with well in excess of 90% of cardiac deaths associated [dys]ryhthmias—how will mere expected association show causality?
Can’t change the laws of physics…
July 21, 2005
Tommy Chipped
July 20, 2005
He’s ready to be a human guinea pig, if only… | Philadelphia Inquirer | 7.18.05
Tommy Thompson, the former secretary of health and human services, is ready for his implants.
The Wisconsin native has joined the board of directors for VeriChip Corp., a Florida firm that sells microchips. Each chip contains a 16-digit identification code that can be scanned and then linked to a database carrying the person’s medical information.…
So far, about 7,000 chips for people have been sold, with about 2,000 implanted worldwide, said Scott R. Silverman, chairman and chief executive of Applied Digital, which owns VeriChip.…
Dodge Ball
July 20, 2005
Lawyer Grills Merck Executive on Tactics to ‘Neutralize’ Doctors | WSJ | 7.19.05
ANGLETON, Texas — Merck & Co.’s marketing team targeted doctors viewed as unfriendly toward Vioxx to bring them into the fold, neutralize or discredit them, the plaintiff’s lawyer in the nation’s first Vioxx-related lawsuit to go to trial alleged Tuesday.
Houston litigator Mark Lanier questioned Nancy Santanello, head of Merck’s epidemiology department, about an internal list of 36 doctors identified as “physicians to neutralize” in an email circulated two months after the popular painkiller went on the market in 1999.…
On Monday Dr. Santanello testified that an in-house training game for Vioxx sales representatives dubbed “Dodge Ball” wasn’t about learning to dodge questions from doctors about the drug’s safety. Mr. Lanier presented an internal memo laying out the “Dodge Ball” training and asked Dr. Santanello why trainees could only move on to the next round of the card game if they gave Merck-approved answers to possible doctors’ questions about Vioxx safety or dodged such questions altogether.…
Lawyer comes out swinging in Vioxx trial | Houston Chronicle | 7.18.05
Among those was a letter (FDA) Merck received in September 2001 — two years after Vioxx was introduced to the market with much fanfare — about Vioxx marketing in the aftermath of a 2000 study dubbed VIGOR. The study found some Vioxx users suffered five times as many heart attacks as people who used the older pain reliever naproxen, sold under the brand name Aleve.
Neutralize? Dodge ball? I’ll bet many physicians have suspected as much.
Profession Pandering
July 19, 2005
Agree! It is a real shame that professional societies take great leeway with their memberships when they confuse the political agendas of a few with the professional aspirations of the many.
Critical Push
July 19, 2005
Critical Care, the Insurance Industry’s Latest Push | WSJ | 7.18.05
As Health Costs Rise,
Companies Market Policies
Tied to Specific IllnessesThe insurance industry is rolling out a new breed of products designed to lessen the financial blow of serious or life-threatening illnesses.
A growing number of insurers, including MetLife Inc., American International Group Inc. and UnumProvident Corp., have recently introduced new or expanded policies that pay a lump sum that you can use however you want if you’re diagnosed with a covered health condition — such as cancer, heart attack or stroke.…
The policies provide lump-sum payments that can be used to cover many costs related to illness — including copayments, travel expenses, experimental treatments or wages of a family member leaving work to help — that often aren’t covered by health or disability insurance.
Insurers say payouts for their critical-illness policies typically average about $25,000, which can cost about $300 to $500 a year, depending on the health, gender, age and location of the insured. Some insurers are now offering higher-end versions, such as AIG’s new “CriticalCare MVP” insurance, that pay benefits of more than $100,000. (A policy with a $100,000 benefit might cost about $1,500 to $2,000 a year.)…
It would be interesting to know not just the average payout, but what the enrollment is and likelihood of use by the individual. This smells like a very lucrative boutique type of policy.
Big Juicy Apple
July 19, 2005
New York Medicaid Fraud May Reach Into Billions | NYT | 7.18.05
It was created 40 years ago to provide health care for the poorest New Yorkers, offering a lifeline to those who could not afford to have a baby or a heart attack. But in the decades since, New York State’s Medicaid program has also become a $44.5 billion target for the unscrupulous and the opportunistic.
It has drawn dentists like Dr. Dolly Rosen, who within 12 months somehow built the state’s biggest Medicaid dental practice out of a Brooklyn storefront, where she claimed to have performed as many as 991 procedures a day in 2003. After The New York Times discovered her extraordinary billings through a computer analysis and questioned the state about them, Dr. Rosen and two associates were indicted on charges of stealing more than $1 million from the program.…
New York’s Medicaid program is by far the most expensive and most generous in the nation. It spends far more - now $44.5 billion annually - than that of any other state, even California, whose Medicaid program covers about 55 percent more people. New York’s Medicaid budget is larger than most states’ entire budgets, and it spends nearly twice the national average - roughly $10,600, more than any other state - on each of its 4.2 million recipients, one in every five New Yorkers.…
The Executives
Among the biggest beneficiaries of the Medicaid program have been executives of the state’s nursing homes and clinics, many of whom earn substantial salaries and profits from the program.
According to records obtained from the Health Department under the Freedom of Information Law, 70 executives of nursing homes and clinics personally made more than $500,000 in 2002, the last year for which figures are available. Twenty-five executives made more than $1 million.…
Kudos Dr. Dolly 29, seconds per procedure…
Healthcare fraud, got some? Rampant, pervasive, and just the beginning…