Kudos to a Couple of Pharmaceutical Whistleblowers!

Two private citizens, employees of Physiotherapy Associates, Inc., will receive almost $3 million dollars for blowing the whistle on Physiotherapy and Kalamazoo, Mich. based Stryker Corporation. (Physiotherapy is the former outpatient therapy division of Stryker.)

Stryker and Physiotherapy will pay the United States a $16.6 million settlement to resolve allegations that Memphis based Physiotherapy submitted false claims for services to Medicare, Tennessee Medicaid programs, and the DoD's TRICARE program which they falsely billed as one-on-one services and which they additionally double-billed for.

The Physiotherapy whistleblowers, Kerry Deering and Wendy Whitcomb, filed two successful qui tam suits. Under the whistleblower provisions of the False Claims Act, the whistleblowers receive a portion of the proceeds of a settlement or judgement awarded against a defendant.

Chalk one up for a couple of Good Guys!

Read more here.

I'll Take Zits, and a Loud Blow with a Big Whistle

There's nothing remotely funny about the findings of Dr. Sarah Bailey at the University of Bath regarding Roche pharmaceutical's acne medication Roaccutane, but "I'll take zits" does come to mind.

Dr. Bailey's research shows how Roaccutane, (Accutane in the US) an acne drug, which is similar structurally to vitamin A, could disrupt seotonin levels in the brain leading to feelings of severe despair in an already vulnerable population of teenagers and young adults. Despair that could turn deadly.

From Dr. Bailey: "In the brain, it [serotonin] is thought to play an important role in the regulation of a range of behaviours, such as aggression, anger and sleep. Low levels of serotonin have been linked to depression, as well as bipolar and anxiety disorders. Many medications aimed at treating depression seek to increase levels of serotonin to help overcome these problems. Our findings suggest that Roaccutane might disrupt the way serotonin is produced and made available to the cells."

What do the folks at Roche have to say? They prefer to talk about a glass they consider to be well over half full, rather than dwell on the negative and even deadly side effects they KNOW are associated with their drug. According to a Roche spokesman, over 13 million patients worldwide have been treated with Roaccutane, a drug which "...has revolutionised the management of severe acne."

Indeed. Roaccutane (Accutane) has been linked to over 200 deaths in the US and at least 15 in the UK, prompting parents who've lost their children to demand that the drug be taken off the market.

Back to Roche's eloquent spokesperson:
"Unfortunately, severe acne can cause some sufferers to become depressed and can also affect their mood and self esteem. This is why the information provided with Roaccutane carries a warning that some patients may experience mood changes, including an increase in depression."

In other words..."don't say we didn't warn you." Thanks. I'll take the zits. And hope I hear a whistle blowing, 'cuz this just ain't right...being a teenager is tough enough without worrying that your zit meds might be killing you.

You can read more here.

UCLA blows the whistle on pharmaceutical ads in medical

Check out the Feb. 15 issue of the Canadian Medical Association Journal for a UCLA study reviewing pharmaceutical advertising validity and funding. They found that almost ONE THIRD of the drug ads contained NO references for the medical claims they made. Researchers also examined the funding sources of the research cited in the ads and concluded that most of the "original research" used to support the ads claims was in fact sponsored by pharmaceutical companies.

According to the study, the FDA does "screen" drug ads, but because of the huge volume of ads they are not able to "check" many of the ads. (In 2002, for example, the FDA "screened" more than 34,000 ads for drugs.)

The investigators looked at 438 ads from 10 American medical journals, along with a random sample of 400 references in journal articles from the same publications.

Here's what they found.
Out of 438 ads, 126 included NO references to support the medical claims they made. In the ads that did include a reference, over half cited other journal articles, and 19 percent cited "data-on-file" which is simply an unpublished company document.

When the researchers dug a little deeper, to see if they could actually get their hands on the referenced documents, they could only obtain 20 percent of the "data-on-file" documents. Repeated requests to the pharmaceutical companies yielded 37 out of 88 requests for the data-on-file, however over half of these responses were that "...due to 'company policy' or the proprietary nature of the data, the information requested would not be provided."

"We found that almost one-third of the pharmaceutical ads offered no references at all to support medical claims. In addition, most of the data-on-file documents in support of the medical claims were not available from the drug companies," said Dr. David Schriger, study author and professor of Emergency Medicine at UCLA.

Journal articles fared better--99 percent of the referenced documents were available to the researchers.

What about the funding of these pharmacuetical ads?
Out of 294 ads that claimed to rely on original research, 58 percent were sponsored by a pharmaceutical company or its authors were affiliated with the funding pharmaceutical company. Nineteen percent were government or charity funded, and 23 percent INCLUDED NO FUNDING STATEMENT WHATSOEVER.

Go here to read more.

Whistleblowers awarded $177 million in 2007. Pharmaceutical Whistleblowers blew the hardest and strongest!

Of the $2 billion recovered by the Justice Department for fraud in 2007, $1.45 billion was associated with suits initiated by whistleblowers under the False Claims Act’s qui tam provisions.

These whistleblower provisions authorize individuals, known as "relators" to file suit on behalf of the United States against those who have falsely or fraudulently claimed federal funds. Such cases run the gamut of federally funded programs from Medicare and Medicaid to defense procurement contracts, disaster assistance loans, and agricultural subsidies. Persons who knowingly make false claims for federal funds are liable for three times the government’s loss plus a civil penalty of $5,500 to $11,000 for each claim. Relators recover 15 to 25 percent of the proceeds of a successful suit if the United States intervenes in the qui tam action, and up to 30 percent if the United States declines and the relator pursues the action alone. In fiscal year 2007, whistleblowers were awarded $177 million. (This figure does not include relator shares for fiscal year 2007 which have not yet been awarded or were awarded after September 30, 2007.)
The largest health care recoveries came from pharmaceutical companies and related entities. Settlements with Bristol-Myers Squibb Co., Aventis Pharmaceuticals, Inc., Medco Health Solutions, Inc., Purdue Pharma L.P. and Purdue Frederick Co., and InterMune, Inc. accounted for more than $800 million of the $1.5 billion. In addition to federal recoveries, pharmaceutical fraud cases returned $264 million to state Medicaid programs.

Among the Department’s most significant settlements and judgments in fiscal year 2007 were these five against Pharmaceutical Companies:

$328 million from Bristol-Myers Squibb Company (BMS) and its generic division, Apothecon, to resolve a broad array of allegations involving illegal drug pricing and marketing activities. BMS and Apothecon paid an additional $187 million to state Medicaid programs based on the same allegations. The civil settlement arises from seven qui tam actions and resolves allegations that (1) BMS and Apothecon set and maintained inflated prices knowing that federal health care programs used these prices for reimbursement, and then marketed the “spread”–the difference between the reported price and cost–to induce sales by increasing providers’ profits; (2) BMS paid kickbacks to doctors in the form of bogus consulting fees to induce them to purchase BMS’s drugs; (3) BMS paid kickbacks to wholesalers and retail pharmacies to induce purchases of generic products; (4) BMS promoted its atypical antipsychotic drug, Abilify, for juvenile use and to treat dementia related psychosis–uses that were not approved by the Food and Drug Administration; and (5) BMS violated the Medicaid Drug Rebate Act, 42 U.S.C. § 1396r-8, by reporting false "best prices" to the government for its drug Serzone, which resulted in BMS underpaying quarterly rebates owed to the Medicaid program. The six relators will share a $52 million award plus additional amounts from the states.
Read the original press release here.

$180 million from Aventis Pharmaceuticals, Inc. to resolve allegations that the company engaged in a scheme (1) to set and maintain fraudulent and inflated prices for its drug, Anzemet, knowing that federal health care programs established reimbursement rates based on those prices, and (2) to use the difference between the inflated prices reported and the actual prices charged to its customers to market, promote, and sell the drug. In addition, Aventis paid $10 million to several state governments based on the same allegations. The relators shared a $33 million award.
Read the original press release.

$155 million from Medco Health Solutions, Inc. to settle allegations that Medco submitted false claims in connection with the mail order prescription drug benefit offered under the Federal Employee Health Benefits Program. The government alleged that Medco cancelled prescriptions it could not fill timely to avoid late penalties, shorted pills, and billed for pharmacy services it didn’t provide. The government also alleged that Medco solicited kickbacks from pharmaceutical manufacturers to favor their drugs on Medco’s formulary, and paid kickbacks to health plans to obtain business. The settlement resolved two qui tam lawsuits and a separate federal investigation prompted by Medco’s disclosure to the government concerning billing problems for diabetic supplies. The relators received $23.9 million as their award. Medco also entered into a corporate compliance agreement with the Department of Health and Human Services and the Office of Personnel Management.
Read the original press release here.

$100.6 million ($109 million including interest) from Purdue Pharma L.P. and Purdue Frederick Company, Inc. to settle allegations of fraud against Medicaid and other federal health care programs. The government alleged that Purdue fraudulently misbranded OxyContin as being less addictive and less subject to abuse and diversion than other pain medications. The civil settlement resolved allegations that, based on these misleading marketing claims, Purdue knowingly caused the submission of false claims for OxyContin that were not eligible for federal reimbursement. In addition, Purdue paid $60 million to state Medicaid programs, forfeited $276 million to the United States, set aside $130 million to resolve private civil claims (with unclaimed amounts to revert to the United States), paid $5.3 million to the Virginia Attorney General’s Medicaid Fraud Control Unit to fund future health care fraud investigations, and paid $20 million to fund the Virginia Prescription Monitoring Program. Finally, Purdue paid $500,000 in criminal fines–the maximum allowed under the statute.
Read the original press release here.

$30.2 million from InterMune, Inc. to resolve allegations that InterMune marketed its drug, Actimmune, for uses not approved by the Food and Drug Administration resulting in federal health program losses. The government alleged that InterMune marketed Actimmune for idiopathic pulmonary fibrosis (IPF), a fatal disease that causes scarring of lung tissue. Although the company had failed to demonstrate Actimmune’s efficacy for IPF, it nevertheless misled physicians and the public to believe that the drug trial had been successful. The relator received $5.7 million as her share of the recovery. InterMune paid an additional $6.7 million to state Medicaid programs.
Read the original press release here.

Smoke, Mirrors and Advertising

Pharmaceutical companies spend huge amounts of money on advertising. "Scent" is the latest sense it looks like they'll use--KFC is already pumping That Chicken Smell into workplaces and seeing the lines at the counter increase around lunchtime.

The Pharmaceutical executives won't be far behind. They have this advertising thing figured out. According to the journal Pharmaceutical Executive, one of their favorite techniques is to go 3D.

"Interaction is the next step. Once the door has been kicked open and you have a target's attention, you must generate interaction ("Who is it from?" "How does it work?" "I get a free...what?"). If interaction is achieved, then a connection is born. Dimensional pieces invite interaction through unfolding, touching, investigating, inviting a response to key messaging, and prompting the recipient to wonder, "How did they do that?" Lights, sound, puzzles, games, and clever charts that lead the recipient through complex information in a fun and interesting way also achieve interaction—but it can't stop here."

Before you touch that nifty ad gimmick, read the rest of "From 3-D to Pop-ups: Go Dimensional".

Read the rest here.

Private Sector Whistleblower Protection Streamlining Act of 2007

On Nov. 1, Rep. Lynn Woolsey (D-CA) and 13 co-sponsors introduced H.R. 4047, the "Private Sector Whistleblower Protection Streamlining Act of 2007".
“This is a ‘Good Housekeeping,’ good government measure more than 30 years overdue,” said GAP Legal Director Tom Devine. “Whistleblowers are the life blood for the government to enforce consumer protection laws. But the legal system is hopelessly dysfunctional. For too long, whistleblower law at the non-federal government and corporate levels has been a crazy quilt of contradictory, hit or – usually – miss protections tucked into specific public health and safety laws.”

“It will benefit labor, management and the public to streamline the 32 disparate federal whistleblower statutes, while filling arbitrary coverage gaps,” GAP Legislative Representative Adam Miles explained. “Currently almost everyone is flying blind about whistleblower rights. Nobody knows what the rules are without a legal specialist.”

To illustrate, an employee at a meat packing plant has whistleblower rights when challenging the release of fecal-contaminated water flowing into a river. But the same employee has no rights when disclosing the shipment of fecal-contaminated meat and poultry to a supermarket’s butcher case. A truck driver is protected for challenging bad tires, but not illegal cargo in his haul. An employee of a pharmaceutical company has protection for disclosing false statements in financial reports to shareholders. But there is no protection for challenging false statements to the government or the public about potentially lethal drug safety hazards.

The list of 13 original co-sponsors includes Rep. George Miller (D-CA), Chairman of the Education and Labor Committee, Rep. Robert Andrews (D-NJ), Rep. Tim Bishop (D-NY), Rep. Raul Grijalva (D-AZ), Rep. Phil Hare (D-IL), Rep. Dale Kildee (D-MI), Rep. Dennis Kucinich (D-OH), Rep. Ed Markey (D-MA), Rep. Carolyn McCarthy (D-NY), Rep. Don Payne (D-NJ), Rep. Linda Sanchez (D-CA), Rep. Carol Shea-Porter (D-NH), and Rep. John Tierney (D-MA).

http://www.commondreams.org/news2007/1102-02.htm

2007 a "good year" for health fraud whistleblowers

In fiscal year 2007, (ending Sept. 30) the US Justice Department received $2 billion in fraud settlements, with most of the recoveries coming form whistleblower lawsuits.
Individuals who filed whistleblower suits were awarded $177 million in 2007, with most of that coming from health care fraud lawsuits.
The Justice Department is cracking down on illegal and unethical pharmaceutical company practices such as inflating the price of drugs that are reimbursed by federal programs, and paying kickbaks to physicains and pharmacists who push drugs for uses that have not even been FDA approved, also known as "off-label" marketing.

Read the rest of the story here:
http://www.chron.com/disp/story.mpl/ap/fn/5265264.html

Medifraud: Available at a Pharmacy Near You
By Art Levine, The American ProspectPosted on November 2, 2007, Printed on November 4, 2007http://www.alternet.org/story/66653/

We're hearing those phrases again," declared Law and Order district attorney, former Republican senator, and presidential candidate Fred Thompson in a July 26 ABC podcast. "National health care, universal health care, socialized medicine. We're being told that government bureaucrats can take over our entire medical industry -- which, by the way, is the best and most complex in the world -- and make it better."
Ah yes, the bureaucrats. As if the problem with our current medical system is too much oversight by meddling government agents. In truth, while conservatives rail against government-run health care, our limited versions of that -- Medicaid and Medicare -- have been exploited as boondoggles by the same drug companies that have, since 2000, spent nearly $1 billion on federal and state lobbying drives as well as campaign donations given overwhelmingly to Republicans, according to the Center for Public Integrity. In return, the corporate drug dealers have gotten their money's worth: unbridled profits and lax regulation of both corporate fraud and drug safety.

A recent study in The New England Journal of Medicine found that 94 percent of physicians had some type of explicit relationship with the pharmaceutical industry. In fact, a government report done in Vermont found that in 2006 drug companies gave the average psychiatrist with high drug-company earnings a bit more than $45,000 in assorted honoraria and travel expenses. The report also found that physicians who took the most payments tended, more often than other doctors, to prescribe to children "atypical antipsychotics" -- a new class of powerful medications -- although none of these drugs have FDA approval for use with kids.