Friday, November 20, 2009
Pfizer - Prempro: Kris Hundley writes
Is Prempro, the hormone drug known to increase the risk of breast cancer, a public hazard?
If a judge in Pinellas County determines that it is, hundreds of thousands of documents now under seal in lawsuits against the drug's manufacturer nationwide could be released for the public to inspect.
The key to the confidential company records has ended up in Pinellas-Pasco Circuit Judge Anthony Rondolino's hands because of a clerical misstep and a unique Florida statute.
A hearing on the matter is scheduled for Monday, though attorneys were negotiating a possible resolution late Thursday.
More than 9,000 women have sued Pfizer's Wyeth unit, the maker of Prempro and Premarin, claiming its bestselling hormone drugs caused breast cancer and stroke. The vast majority of those lawsuits have been consolidated in federal courts in Arkansas, Pennsylvania and Nevada.
But the case of Loretta Esposito, a 63-year-old Clearwater resident who died of breast cancer in 2006, slipped through the cracks, making it the only Wyeth case in a Florida court. That could subject it to the state's Sunshine in Litigation Law, which prohibits the court from keeping papers secret if they concern a public hazard.
Citing this statute, Esposito's attorneys have refused to agree to the confidentiality order Wyeth has required other plaintiffs' attorneys to sign before giving them access to an estimated 16 million discovery documents.
During a hearing in the spring, James Clark, the Tampa lawyer who represents the deceased woman's husband, Peter Esposito, said the agreement would "be asking us and enticing us and luring our client through us — and the court — to violate Florida law … because it's our position that the product isn't okay."
How to report a possible medicine related adverse event to the FDA
1. Click on this link:
https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
2. Click on "BEGIN" - it's on the right of the page
https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
2. Click on "BEGIN" - it's on the right of the page
Click the BEGIN button to report serious adverse events for human medical products, including potential and actual product use errors and product quality problems associated with the use of:
- FDA-regulated drugs,
- biologics (including human cells, tissues, and cellular and tissue-based products)
- medical devices (including in vitro diagnostics)
- special nutritional products and cosmetics
Justice Department Recovers $1.6 Billion in Healthcare False Claims Cases in 2009
Justice Department Recovers $2.4 Billion in False Claims Cases in Fiscal Year 2009; More Than $24 Billion Since 1986
FY09 Recovery is Second Largest in History
WASHINGTON, Nov. 19 /PRNewswire-USNewswire/ -- The United States secured $2.4 billion in settlements and judgments in cases involving fraud against the government in the fiscal year ending Sept. 30, 2009, the Justice Department announced today. This represents the second largest annual recovery of civil fraud claims in history, and brings total recoveries since 1986, when Congress substantially strengthened the civil False Claims Act, to more than $24 billion.
A top priority for this administration is fighting health care fraud. On May 20, 2009, the Attorney General and the Secretary of the Department of Health and Human Services (HHS) announced the creation of a new interagency task force, the Health Care Fraud Prevention and Enforcement Team (HEAT), to increase coordination and optimize criminal and civil enforcement. These efforts not only protect the Medicare Trust Fund for seniors and the Medicaid program for the country's neediest citizens, they result in higher quality health care at a more reasonable price.
In fiscal year 2009, health care fraud recoveries reached $1.6 billion, two-thirds of the year's total. The Department of Health and Human Services reaped the biggest recoveries, largely attributable to its Medicare and Medicaid programs. Recoveries were also made by the Office of Personnel Management, which administers the Federal Employees Health Benefits Program, the Department of Defense for its TRICARE insurance program and the Department of Veterans Affairs, among others.
The largest health care recoveries came from the pharmaceutical and medical device industries, which accounted for $866.7 million in settlements, including Aventis Pharmaceuticals Inc., Bayer HealthCare LLC, Eli Lilly & Company and Quest Diagnostics Inc. and its subsidiary, Nichols Institute Diagnostics Inc. In addition to federal recoveries, these pharmaceutical and medical device fraud cases returned $402 million to state Medicaid programs.
The Civil Division's investigation of the pharmaceutical industry is part of a department-wide effort. The Civil Division is pursuing allegations of a variety of schemes, including "off-label" marketing, which is the illegal promotion of drugs or devices that are billed to Medicare and other federal health care programs for uses that were neither found safe and effective by the Food and Drug Administration (FDA) nor supported by the medical literature; paying kickbacks to physicians, wholesalers and pharmacies to induce drug or device purchases; establishing inflated drug prices knowing that federal health care programs use these prices to reimburse providers, then marketing the "spread" between the federal reimbursement and the provider's lower cost to induce drug purchases; and knowingly failing to report the company's true "best price" for a drug in order to reduce rebates owed to the Medicaid program.
SOURCE U.S. Department of Justice
via prnewswire.com
Thursday, November 19, 2009
"Grease the skids" for whistleblowing!
A federal appeals court has ruled that Cell Therapeutics can pursue a claim for nearly $23 million against a former consultant that advised it to market a drug off-label, adding a whole new wrinkle to whistleblower lawsuits. Report
Free lunches for doctors in Oz - "big down under"
Helen Jaques is a British science journalist and an active presence on Twitter.
She points to an Australian study published this month in PLoS Medicine. Australian doctors, the researchers found, are courted by the drug industry to the tune of $900,000 per week. The primary means of influence are “education events” for health professionals, often held in luxurious restaurants or hotels.
More at Seed
Helen's Blog: http://www.helenjaques.co.uk/blog/
Attention USA - you are being milked by Big Pharma contd.
Reuters: 'I want to know if there's a back-door move underway by the drugmakers to recover some of the concessions they've promised for health care reform,' said Senator Bill Nelson, who represents many older Americans in the state of Florida.
AHA News - generic simvastatin rocks!
Cholesterol pills Vytorin from Merck & Co. and Lipitor from Pfizer Inc. worked no better than simvastatin, a cheaper generic medicine, at keeping patients out of the hospital for heart attacks or stroke, a study found.
Researchers with UnitedHealth Group Inc.’s pharmacy benefits unit Prescription Solutions analyzed medical claims of 30,000 patients taking one of the three drugs. They found no difference in rates of heart attacks or stroke among the three groups, according to data presented today at the American Heart Association meeting in Orlando, Florida.
The analysis suggests that heart patients may fare just as well by taking the least-expensive cholesterol-lowering pill. Simvastatin costs 84 cents for a 40 milligram dose, compared with $3.91 for the same dosage of Lipitor and $3.74 for Vytorin. A study last year showed that Vytorin worked no better than simvastatin at reopening arteries and a separate study reported this week found that Abbott Laboratories’ Niaspan may be superior to Vytorin in certain patients.
AstraZeneca - Seroquel: bring it on!
Nov. 19 (Bloomberg) -- AstraZeneca Plc may face as many 6,000 trials of lawsuits claiming its antipsychotic drug Seroquel causes diabetes after a judge said she will recommend sending the cases back to their home courts.
U.S. District Judge Anne Conway in Orlando, Florida, who is overseeing pre-trial proceedings in federal Seroquel litigation, said yesterday she’ll urge a panel of judges to return all of the cases to courts across the U.S. for possible trials.
AstraZeneca, the U.K.’s second-largest drugmaker, wanted Conway to send as many as 60 suits back to their home courts for trial as test cases. Lawyers for former users contended they were ready to press forward on their claims that the London- based company downplayed Seroquel’s diabetes risk.
Conway’s ruling “will get the litigation moving,” Paul Pennock, a lawyer for former Seroquel users, said in an interview. “The decision will help get a huge group of cases to a state of trial-worthiness.”
Introducing Evidence in Medicine Blog
http://www.evidenceinmedicine.org/
Well written by Dr David Rind, an academic primary care physician in Boston.
Well written by Dr David Rind, an academic primary care physician in Boston.
ScriptSwitch sold
ScriptSwitch, the provider of drug comparison software, has been acquired by UnitedHealth UK, for a reported sum of £50m.
The company supplies more than six out of 10 of the UK’s primary care trusts, which use its software to provide doctors with information about cheaper generic drug alternatives, as well as data on patient safety and dosage levels.
ScriptSwitch says that annualised savings to the NHS as a result of decisions made by GPs supported by is software are set to exceed £20m.
The Coventry-based firm currently has about £10m of annual revenues and increased staff from 18 to 45 in the past year. ScriptSwitch was founded by two students and a pharmacist at the University of Warwick in 2001.
In April 2009 the business was awarded a Queens Award for Enterprise in the Innovation category. More recently, Mike Washburn, CEO, was announced as the 'Venture Capital Backed CEO of the Year'.
UnitedHealth UK confirmed the acquisition to E-Health Insider. The company is the UK arm of giant US parent firm, UnitedHealthcare, which describes itself as “a diversified health and well–being company dedicated to making the health care system work better."
In the UK the company focuses on four main areas: improving the commissioning of care; delivering new models of primary care; improving the care of patients with long term conditions; and information tools and services.
In 2008, UnitedHealthcare reported revenues up 8% to £12.9 billion ($21.7 billion).
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