Good Satire Video on YouTube

Vytorin Scientific Fraud and Parody Cholesterol Ad on YouTube, by "The Health Ranger"

Click HERE to see the video!

World Net Daily "Killing Consumers for the Almighty Dollar"

See the article by Joel Hesch
World Net Daily

Check out this excellent commentary on the fraud perpetrated by Purdue Frederick Company Inc, the makers of Oxycontin. Hesch writes about how Purdue Frederick’s sales team lied to increase sales, telling doctors the drug was safe and effective, instead of addictive. The company’s researchers used misleading graphs to publish bogus articles in medical journals.

Oxycontin was first marketed in 1995. Billions of dollars of profit later, there was a trail of bodies and a huge group of addicts.

Last year, the government finally got a criminal conviction for fraud, tho no one went to jail and Purdue Frederick Company, Inc., paid a total of $635 million—nothing when you figure they got to keep $1 billion a year profits for over 10 years.

Enter a whistleblower! He got a monetary reward and more than that he’s responsible for saving countless lives. God Bless the Whistleblowers.

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 The unpublished trials were at least a year long.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The discovery of these unpublished data raises questions about the accuracy of information on Zetia.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.