GlaxoSmithKline intimidation of Bob Fiddaman

Bloggers discussing the intimidation of a patient, Bob Fiddaman, by GlaxoSmithKline

• Does GSK Love Bad Publicity? (Clin Psych Blog)
• Video sets GlaxoSmithKline Hounds to Intimidate British Blogger (AHRP Blog)
• This U.S.A. blog supports Bob Fiddaman (Soulful Sepulcher)
• Glaxo Smith Kline (Bipolar Blast)
• It's Groundhog Day for bullying by GlaxoSmithKline over Seroxat (Scientific Misconduct Blog)
• GSK Lawyers target Seroxat campaigner Bob Fiddaman (Seroxat Secrets)
• Tony Nunn
• Intimidation: a standard tactic? (Matt Holford)
• Glaxo Goes After British Blogger's Video (Furious Seasons)
• GSK Video - The Aftermath
• Pharmagossip
• BLOGSCAN - GSK Lawyers Have Paxil Video Taken Down
• Missisyphus’s Weblog: Bob fiddaman’s video about paxil
• An Angry Blogger And Free Speech (Ed Silverman of Pharmalot and the Star-Ledger of New Jersey)

Two Years Later the Truth Comes Out

1/18/2008
The million or so Americans who've been prescribed Zetia to lower their cholesterol have been duped by the pharmaceutical companies.

Merck and Schering-Plough funded an "independent study" and dragged the trial on for two years, testing 720 patients."This wraps it up," said Dr. Steven E. Nissen, chairman of cardiology at the Cleveland Clinic. "That's all there is. There just isn't any evidence that adding ezetimibe to simvastatin produces any advantage."

Another group questioned why patients should be prescribed more expensive cholesterol-lowering drugs, such as Vytorin, versus cheaper, generic statins such as Zocor."We already know that millions of people who take these brand drugs probably don't need to; they could be taking a less expensive generic instead.

This study lends support to that cost-saving strategy for the health system and for consumers," said Steven Findlay, managing editor of Consumer Reports Best Buy Drugs, a public information and education project of Consumers Union, publisher of Consumer Reports."If there is no apparent clinical benefit, why take a drug that cost three or four times more?" Findlay said in a statement. "Most people do not need that magnitude of cholesterol reduction anyway."

Sales of Zetia and Vytorin totaled $3.7 billion in the nine months ending Sept. 30, up 33 percent from a year ago. Analysts estimate that about 70 percent of Schering-Plough's earnings depend on the drugs, the Times noted.

Read More HERE

Merck and Schering-Plough concealed data in clinical trials

Congressmen John Dingell (D-MI) and Bart Stupak (D-MI) say that Merck and Schering-Plough concealed or manipulated clinical trial data for Vytorin. Trial results showed that Vytorin was no more effective than the cheap, generic versions.“Today’s announcement that the ENHANCE study failed to find any positive benefit from the addition of Zetia to a common, inexpensive, generic therapy raises concerns that attempts were made to mask the minimal value of this new drug. Additionally, Merck and Schering-Plough’s delay in releasing study results, as well as their attempt to manipulate the data is, quite frankly, suspicious,” said Dingell.

The House Energy and Commerce Committee wants more information about the so-called independent panel formed to review the Vytorin trial data, the study’s Data Safety Monitoring Board, stock sales by Schering-Plough execs and the amount of money spent on Vytorin by the Centers for Medicare and Medicaid Services.

Release of the Vytorin data was delayed almost two years and the primary endpoint was briefly changed without the consent of the lead investigator. “In light of today’s results, which were released nearly two years after the ENHANCE trial ended, it is easy to conclude that Merck and Schering-Plough intentionally sought to delay the release of this data,” said Stupak. “It’s currently unclear whether these companies knew that adding a new expensive drug accomplished nothing more than an established, cheaper, generic. But it is clear that our investigation is far from over."

The investigation is also focusing on the heavy advertising for Vytorin.

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: