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.