What do we know about Vytorin?

It looks like Merck and Schering-Plough failed to publish several nasty studies that raise questions about the safety of their new cholesterol drug, Vytorin. Zetia, one component of Vytorin, causes liver damage, according to a New York Times report.

The drug makers are already under scrutiny for delays in publicizing the results of an important trial called Enhance of Vytorin, a combination of the cholesterol-fighters Zetia and Zocor.

The safety data at issue now were from trials conducted between 2000 and 2003 that were designed to assess Zetia’s long term safety. Most of the published studies on Zetia have been 12 weeks long, probably too short for liver toxicity to show up. The unpublished trials were at least a year long.

Data from the Enhance study of Vytorin show that at least some patients dropped out because of elevated liver enzymes, but the full results won’t be revealed until March.

There have been questions by the FDA and in case reports in medical journals, about whether the combination of Zetia with statins heightens the risk of liver damage.

The discovery of these unpublished data raises questions about the accuracy of information on Zetia. Schering-Plough didn’t consider these data “scientifically important enough” to publish, a company executive told the NYT.

“We keep telling people we want to practice evidence-based medicine, and what we keep finding out is that much of the evidence is obscured,” said Harlan Krumholz, a cardiologist at Yale, told the NYT.

New: FDA Watch

We've added feature to our website at www.PharmaceuticalWhistlblowers.com that's worth watching. We'll be adding the status of FDA Warning Letters sent to pharmaceutical companies...and there's plenty to keep up on! We'll also be adding The Forum soon, a confidential, anonymous discussion area. Keep watching!

FDA Tells GSK to stop sending out misleading info to health professionals

Read the FDA WARNING LETTER TO GSK.



According to the FDA, GlaxoSmithKline has sent out letters promoting Tykerb, which "...omit and minimize the most serious risk information" and "...selectively present efficacy information for Tykerb, thereby overstating the efficacy of the drug. Most important, the letters minimize the important risk of decreased left ventricular ejection fraction," which is a measurement of the amount of blood pumped out of one section of the heart.



Tykerb (generic name lapatinib) was approved by the FDA last March as a once-a-day pill for certain patients with advanced breast cancer.


The FDA's six-page warning letter to GSK also says that they failed to warn patients about liver problems and pregnancy. Glaxo was asked to STOP sending the letters, and to stop sending out any information like it, AND to send corrected information to every health professional who received the original, misleading letter.
GSK says they're taking the FDA's letter seriously and they'll work with them to address their concerns. Wow, big of them.
Hopefully someone on the inside will blow the whistle on this one. Will GSK send out corrected information before it's too late?

This is Your Brain on Drug Industry Money

Read the whole story here. Dr. Carlat tells all, or at least most.

D'you think the devil made him do it? Or the money?

Dr. Daniel Carlat made $30,000 spinning Wyeth's Effexor XR to other doctors. Wyeth gave him slides, info, and paid for him to go to a speaker's seminar. Carlat made $500 for every "Lunch and Learn" talk he gave around town...$750 if he had to drive an hour to do it. Wyeth flew him around to other places, wined and dined him, and basically pimped him out. Now he says he maybe oughtn't have done it. But he kept the $30,000. His story is worth reading. Wyeth says they follow "guidelines"...those of "the industry" and their own, when it comes to compensating docs for spinning, er, speaking fees.

Any Whistleblowers know more?

FDA Probing Safety of Advair and Serevent for Children

Read more HERE.

There seem to be an alarming number of opportunities for GlaxoSmithKline pharmaceutical whistleblowers. Today the concern is all about potential fatal side effects of Advair and Serevent in children who take the drugs to treat asthma.

Five deaths, and four cases of "adverse events" were reported in children under 16 since March 2006, when GSK was granted pediatric exclusivity. Just five months earlier, in March of 2005, the FDA issued a warning that drugs containing long-acting beta agonists (such as Advair) can trigger severe asthma attacks and even possibly death.

GSK isn't worried. They said they've provided clinical data that "proves" the products are safe, and they're confident that the benefits outweigh the risk. Advair is a huge seller for GSK, with sales of $6.8M worldwide.

Whistleblower Seeks Her Fair Share

Read more HERE.

CANTON – Antoinette Menapace helped the federal government uncover millions of dollars in health-care fraud.

She isn’t a doctor, a lawyer or a cop. She’s a grandmother and former medical coder who didn’t think the numbers added up.

Almost two years ago, she filed a lawsuit against her former employer, Dr. Mohammed Aiti, claiming he and other doctors at Premier Medical Group were billing government and private insurance companies for unnecessary heart-related tests.

The FBI and federal prosecutors took up the case, which led to Aiti’s conviction, the end of his medical career and the forfeiture of close to $1.9 million. Aiti is to be sentenced Jan. 10. He faces up to five years in prison and a $250,000 fine.

Psychchiatric Warnings on Flu Drugs Tamiflu and Relenza?

An FDA panel is reviewing recommendations that psychiatric warnings be added to the labels of two flu drugs, Roche's Tamiflu and GlaxoSmithKline's Relenza.

The label warnings on Tamiflu would include "in some cases, these behaviors resulted in serious injuries, including death, in adult and pediatric patients." The Relenxa box label would be updated to include: "reports of hallucinations, delirium and abnormal behavior" seen in some patients taking the drug.

The adverse events have occurred. The FDA isn't sure whether the drugs are the cause, or a disease, or a combination of the two. Roche and GSK say it's not the drugs.
Wonder if any whistles will blow on this one?

The summary document for advisory meeting can be found right here:

Pharmaceutical Industry's "free speech" trumps public safety.

We know that street drug pushers are dangerous to society...but we need to look out for the the Professional Drug Dealers as well--Pharmaceutical Companies that peddle poison to patients and get away with it.

Don't look at the Senate or the House to keep you safe, they're getting lobbied by the pharmaceutical corporation big time--and just passed an FDA reauthorization bill that ignores public safety and instead catering to the marketing interests of drug manufacturers.

Drug manufacturers now spend more money on Direct-to-Consumer (DTC) advertising than they do marketing to physicians. People may laugh at the "erections lasting more than 4 hours" warnings and the long lists of side effects included on these ads, but while they're laughing, they're also ignoring. DTC advertising sells more drugs. Patients ask their doctors for the purple pill or the blue pill, and doctors sign 'em up.

Since drugs entering the market have been tested only on a small number of people in clinical trials (using extremely limited demographics and making wild generalizations of efficacy and safety) the American TV Viewing public becomes the real guinea pigs.

Sure, the FDA may pull a drug off the market after thousands of people are adversely affected by it (fen-phen and Vioxx immediately come to mind) but is that good enough?

What about informed consent? People who believe the DTC propaganda don't consider themselves part of a "clinical trial" but they are. Where are the whistleblowers?

Reformers asked Congress to enact a three-year bar on ads for new prescription drugs, limiting the numbers of people put at risk. Unfortunately, Congress sided with lobbyists, taking cover behind the drug-maker's claimed free speech rights to justify their inaction.
Read more here.

FDA and BigPharma: Too Close for Comfort?

According to the Pharmaceutical Research and Manufacturers of America, the US drug safety system is "the best in the world." Of course, as one of the most powerful lobbies around, they're paid well to say that.

The fen-phen diet-drug fiasco was ten years ago--thousands of cases of severe heart and lung damage and several deaths after it was approved by the FDA and widely prescribed, it was withdrawn from the market. 8 million prescriptions were written for fen-phen between 1994 and 1997.

Since then Baycol (cholesterol drug) Vioxx and Bextra (pain relievers) and the Guidant heart defibrillator have been recalled, after initial FDA approval. Last month an FDA panel admitted that there's not enough proof that over-the-counter cough and cold medications work, or are even safe for young children.

In other words, the FDA and the drug companies are slow to react even when faced with evidence of drug dangers. The FDA and drug-industry critics blame the too cozy relationship between medical researchers and pharmaceutical companies, and they alledge that the industry has turned medical education seminars into drug pushing campaigns.

Dr. Bruce Psaty (University of Washington cardiologist) and Dr. David Graham of the FDA say that things are no better than 10 years ago when it comes to the FDA and their oversight of the pharmaceutical industry.

In 2005, Psaty was asked to join the Institute of Medicine's review of the FDA on drug safety. The institute, part of the National Institutes of Health, issued a scathing report in September 2006, calling the FDA dysfunctional.

In 2004, Dr. Graham sought whistleblower protection from Sen. Chuck Grassley (R-Iowa) after the FDA began an investigation to find out who had leaked information about potential links between antidepressants and teenage suicides.

Read the latest story here.

Arkansas files suit against J&J and two subsidiaries

Risperdal is being prescribed to treat illnesses it isn't approved for. This one isn't a Whistleblower suit, but it could have been.
Arkansas Attorney General Dustin McDaniel filed suit Tuesday against health-care product manufacturer Johnson & Johnson Inc. and two of its subsidiaries, accusing the drug makers of illegally promoting a popular antipsychotic medication.
The lawsuit, filed in Pulaski County Circuit Court, says the drug, Risperdal, is being prescribed to treat illnesses it isn’t approved for and the manufacturers have been misrepresenting its risks to patients.
Risperdal is the most widely used antipsychotic medication of its kind in the world, sales in 2005 amounting to $ 3. 5 billion, the lawsuit states.
The 35-page filing before Circuit Judge Timothy Fox comes about two months after McDaniel told the Legislative Council he planned to sue three major pharmaceutical manufacturers over what he said was a “marketing scheme” for antipsychotic drugs paid for by the state Medicaid program. The other two companies are Eli Lilly & Co. of Indianapolis and a European company, Astra Zeneca.
The lawsuit seeks to recover state money paid out on behalf of clients of Medicaid, patients of the Arkansas Department of Human Services and state employees and retirees through the Arkansas Department of Finance and Administration’s employee benefits division.
The lawsuit claims the companies took advantage of state programs to promote the drug for nonmedically approved purposes and have also misled users about how well it works.
“Defendants have engaged in a direct illegal nationwide program of promotion of the use of Risperdal for non-medically necessary uses,” according to the lawsuit. “Defendants have conducted this program of promotion knowing that prescriptions for Risperdal are generally reimbursed by the state... programs even though such prescriptions may be written for non-medically necessary uses of Risperdal.
“ Defendants have falsely represented to the state, and to the public in general, that Risperdal is safer and more effective than less expensive, first-generation anti-psychotics.”
The medication is federally approved to treat schizophrenia and some symptoms of bipolar disorder. But the companies have pushed it as a treatment for such conditions as attention deficithyperactivity disorder, depression, anxiety, mood disorder and aggression associated with late-onset dementia, according to the lawsuit.
The companies also failed to adequately warn users that Risperdal’s side effects include diabetes, pancreatitis, hyperglycemia and cardiovascular complications, the lawsuit says. Further, the lawsuit says, the defendants have paid “key opinion leaders” to support the companies’ market claims for the drug.
The suit lists eight claims of action against the drug makers, including negligence, recovery of the cost of treatment for injuries caused by the drug and violations of the Arkansas Medicaid Fraud False Claims Act and the Arkansas Deceptive Trade Practices Act.
The lawsuit doesn’t say how much the state is seeking from the companies but notes that Arkansas has spent “millions” on the drug since its introduction in 1993.
The lawsuit is being handled by Bailey Perrin Bailey LLP of Houston, Texas. The firm, which is handling similar suits in six other states, will bear all the expenses in exchange for 15 percent of any award.

On the side of Pharmaceutical Whistleblowers

Senator Charles Grassley, the ranking Republican member of the Senate Finance Committee, loudly and clearly told the pharmaceutical industry that he would not tolerate their attacks on medical researchers any longer. Grassley told scientists and researchers to contact his office directly if a pharmaceutical company makes any threats or attacks on their reputation when they raise an alarm about possibly dangerous drugs in the public domain.

A November 2007 report on an investigation showed that executives at GlaxoSmithKline intimidated Dr. John Buse, a medical researcher from the University of North Carolina, when he blew the whistle about increased cardiovascular risks associated with Avandia, a popular diabetes drug.

In early 1999, the same year that Avandia was FDA approved for use in the US, Dr Buse spoke out about, suggesting that Avandia (rosiglitazone), a thiazolidinedione used to control blood sugar in patients with type 2 diabetes, may increase cardiovascular risks.

The Finance Committee, which oversees Medicaid and Medicare, initiated an investigation last spring after the New England Journal of Medicine published a study on May 21, 2007, by Cleveland Clinic Cardiologist Dr Steven Nissen and Kathy Wolski, which found that Avandia was associated with a 43% increased risk of heart attacks and potentially a 64% increase in the risk of cardiovascular death.

US doctors wrote 13 million prescriptions for Avandia last year, worth more than $2 billion in sales for GSK.

In a June 5, 2007, editorial in the New England Journal of Medicine, entitled, "The Record on Rosiglitazone and the Risk of Myocardial Infarction," Dr Bruce Psaty of the University of Washington and Dr Curt Furberg of Wake Forest University placed some of the blame for the Avandia debacle on the FDA itself.

"The primary measure of regulatory success is the timeliness of information, warnings, and withdrawals," they wrote. "With rosiglitazone, the FDA failed to warn or inform in a timely fashion."

They point out that in August 2006, GSK provided the FDA and the European Medicines Agency with the results of several studies, including a meta-analysis on Avandia, with results similar to Dr Nissen's and that the product labels in Europe included the information by October 2006.

They also report studies that show Avandia is associated with "significant weight gain, an adverse effect on low-density lipoprotein cholesterol, an increased risk of heart failure, an increased risk of fractures in women, and an apparent increase in the risk of myocardial infarction."

In February 2003, the World Health Organization issued a warning of the potential cardiac risks associated with drugs like Avandia.

The Subcommittee of the House Committee on Oversight and Government Reform, which oversees the FDA, also held hearings on Avandia. In an opening statement at a June 6, 2007, hearing, Committee Chairman Henry Waxman (D-CA) stated: "Although Avandia has been on the market for eight years and has been used by millions of Americans, the post-market studies have not been done to say conclusively whether Avandia increases or decreases the risk of heart attacks."

"That's a major failure of our system," he stated.
"As a member of Congress," he said, "I'm not qualified to judge whether the risks of Avandia outweigh its benefits."
"But I do know," he added, "that the millions of diabetics who have taken Avandia have not been well served by our regulatory system."

"The FDA is on notice that we have reached the end of our rope on their stonewalling of investigations into their failures to keep Americans safe from dangerous drugs," Rep Bart Stupak (D-MI) said in a May 21, 2007 written statement.

Lawmakers on both side of the isle also called on FDA Commissioner Andrew von Eschenbach to explain the agency's conflict-of-interest policies regarding employees hired from companies which are regulated by the FDA, after it became known that on May 24, 2007, FDA spokesman Doug Arbesfeld, who worked for numerous drug companies prior to being hired, sent an email to journalists with derogatory comments about Dr Nissen, implying that he published bogus research on Avandia because GSK does not conduct research at the Cleveland Clinic.

On May 30, 2007, Dr Nissen told ABC News, "I'm a pretty tough guy, but I'll tell you, having this kind of an e-mail that questions my motives, broadcast to the major journalists with whom I work and have established a reputation, is -- it's an outrage."

A letter was sent to the FDA Commissioner on June 7, 2007, requesting more information about Mr Arbesfeld's e-mail to journalists, which was signed by Senators Grassley, Baucus and Sherrod Brown, as well as Representatives John Dingell and Bart Stupak.

The letter noted that Mr Arbesfeld sent the message using his Government e-mail, which carried his FDA signature line and work-related contact information and that in several news articles on other matters, Mr Arbesfeld was listed as spokesman for the FDA.

The letter stated, in part, "this e-mail may have given journalists the impression that the United States Government actively encourages smear campaigns against independent scientists."
"If so," it said, "this is a completely unacceptable use of Government time and equipment."
In a press release announcing the letter, Senator Grassley stated, "it's discouraging and alarming to see another situation where you can't tell the difference between the actions of the FDA and those that might come from a drug maker it's regulating."

"The opinions of independent scientists must be valued by the FDA," Senator Baucus stated.
"I have some serious questions about Mr. Arbesfeld's use of government resources, but I am even more concerned about whether his drug company connections led him, in any way, to seek to unjustly discredit Dr. Nissen," he said.

"The FDA's ultimate duty" he pointed out, "is to ensure the safety of the products it regulates, which includes sharing credible, potentially life-saving information from any trustworthy source."

"The FDA should thank doctors who identify potential health risks, not demonize them. Congress is working on legislation to clean up FDA's act, and none too soon," Senator Brown said in the press release.

Staffers of the Finance Committee also came across a February 22, 2006, internal FDA memorandum, which showed that safety official Dr David Ross recommended that GSK add a black box warning about congestive heart failure to the Avandia label a year earlier.
In addition, the memo recommended that macular edema, a condition that causes swelling of the retina and can lead to blindness, be listed as a serious adverse event and shows that, although the recommendations were approved by Dr Rosemary Johann-Liang, the Deputy Director of the FDA's Division of Drug Risk Evaluation, they were never added to label.
Instead of forcing GSK to post warnings, the Committee reports, top FDA officials basically demoted Dr Johann-Liang for approving the warnings to begin with.

In a July 26, 2007 speech on the Senate floor, Senator Grassley said, "Not only did the FDA disregard the concerns and recommendations from the office responsible for post-marketing surveillance, but I have found that it also attempted to suppress scientific dissent."
In the past two months, he said, "I've had to write to the FDA regarding the suppression of dissent from not one but two FDA officials involved in the review of Avandia."
In a July 25, 2007 press release announcing the company's 2007 second quarter earnings, GSK reported that sales of Avandia fell 22% worldwide and 31% in the US, following the publication of the May 2007 analysis in the NEJM.

The press release also reported the filing of Avandia related lawsuits. "Following publication of the NEJM article," it stated, "the Group has been named in product liability lawsuits on behalf of individuals and purported class action cases asserting consumer fraud and/or personal injury claims on behalf of purchasers and users of Avandia."

Read the original here.

NYT tells Cynthia Fitzgerald's Whistleblower Story

Cynthia Fitzgerald's dream job with Novation (an Irving, TX company that negotiates medical supply contracts for its 7,000 member hospitals) turned into a nightmare.

In 1998, a few months into the job, she became aware of improper sales practices and erroneous accounting that were draining millions of dollars out of public programs like Medicare through overcharges or unauthorized uses. She confronted her bosses, because she believed that if she told the people who could put a stop to it, it would stop. It didn't. Instead, Ms. Fitzgerald was fired. She decided to blow the whistle, and she's blowing it loud and clear.

Johnson & Johnson and Merck are two of the companies she included in her 2003 suit filed in federal court in Dallas. State and federal authorities in Texas are investigating Ms. Fitzgerald's allegations. The companies named in the suit claim that they didn't knowingly do anything illegal.

A 2005 audit by Daniel R. Livinson, the inspector general of the federal Department of Health and Human Services appear to bear out what Ms. Fitzgerald is saying. After studying the finances of three unnamed purchasing consortiums in response to repeated questions from Congress, federal agencies and the news media about their business practices, Mr. Levinson reported that their member hospitals “did not fully account” for such flows of money. In just five years, the discrepancies ran into the hundreds of millions of dollars.

Novation claims that any "underreporting was unintentional" and whined about the complexity of hospital cost reporting.

After Novation fired her, she was contractually forbidden from disclosing information about the company or filing lawsuits against it for three years, she says. Once that period lapsed, she gradually became aware she was eligible to file a suit under the False Claims Act. That led her to Phillips & Cohen, a law firm involved in whistle-blower cases.

The False Claims Act is a federal law that allows private individuals to sue on behalf of the United States if they believe that they have inside knowledge of a fraud. Their lawsuits stay under court seal at first, to give federal and state investigators time to look into the accusations quietly and to decide whether to join the case. If the government recovers money, the whistle-blower gets 15 to 30 percent of the amount.

Of the 20 largest False Claims Act recoveries listed on the Web site of Taxpayers Against Fraud, a group that supports whistle-blowers and their lawyers, 19 involved health care companies. (The other involved municipal bonds.)

The size of recoveries has soared in recent years. All told, the government has recovered more than $20 billion since 1986, when the False Claims Act was last amended, with $5 billion of it in the last two years.

The biggest single whistle-blower settlement to date was the $900 million that Tenet Healthcare, a hospital company, paid last year to settle accusations of overbilling the Medicare program. That settlement is dwarfed by the $1.7 billion that HCA, another big hospital chain, paid between 2000 and 2003 to settle a number of fraud suits.

Ms. Fitzgerald wasn't able to get another job in her field after Novation fired her. She did form her own company, Dimension Medical Supply.

Read this excellent account here.

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.