Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Celgene to Pay $280 Million to Settle Fraud Suit Over Illegal Marketing of Cancer Drugs

Celgene to Pay $280 Million to Settle Fraud Suit Over Illegal Marketing of Cancer Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The pharmaceutical company Celgene has agreed to pay $280 million to settle claims that it marketed the cancer drugs Thalomid and Revlimid for unapproved uses, the company said on Tuesday.

 

Under the terms of the settlement, which resulted from a lawsuit filed by a whistle-blower — a former sales representative at Celgene — the company will pay $259.3 million to the United States and $20.7 million to 28 states and the District of Columbia.

 

The Celgene settlement is the latest in a string of multimillion-dollar fines that pharmaceutical companies have paid to settle charges that they inappropriately marketed certain drugs in recent years, but this case is one of the largest settlements to involve a cancer drug, said Reuben A. Guttman, who represented the whistle-blower, Beverly Brown.

 

Cancer drugs are seen as more difficult to pursue in so-called off-label marketing cases in part because oncologists often prescribe drugs for unapproved uses in an effort to combat a deadly and still mysterious disease.

 

“The company got the idea that it could be fast and loose with what it was saying about its drug because it was selling to cancer patients who might be in need,” Mr. Guttman said. “At the end of the day, what this is about is that even when you’re on life’s edge,” he added, a company “can’t break the law by off-label marketing a drug.”

 

Brian Gill, a spokesman for Celgene, which is based in New Jersey, said in a statement on Tuesday that the company denied any wrongdoing and said it was “settling to avoid the uncertainty, distraction, and expense of protracted litigation.”

 

For background, read:

  • “A Pharma Marketing "Bait-and-Switch" Scheme: Sales Reps Disguised as Medical Science Liaisons”; http://bit.ly/Mxr9I3
  • “Thalidomide Offsprings Yield Blockbuster Profits for Celgene Aided by Off-Label Promotion”; http://sco.lt/5kJeZV

Pharma Guy's insight:

The CEO of Celgene looks like Bruce Willis! :) But he's no "good guy"!

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Frances Kelsey Was No Hero, Says @DrBobGoldberg, the Donald Trump of #Pharma Bloggers

Frances Kelsey Was No Hero, Says @DrBobGoldberg, the Donald Trump of #Pharma Bloggers | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Frances Kelsey,  a medical officer with the Food and Drug Administration in the 1960s died last week at the age of 101.  She has been celebrated as the FDA official who kept thalidomide from being marketed in the United States.  


Thalidomide was never approved in the US.  In fact, as noted in Regulating New Drugs: The application was delayed for reasons having nothing to do with potential risks and was moving towards approval when the company itself reported the horrible side effects.  It took four months for the FDA to realize that people were at risk and in fact Helen Taussig, a cardiologist at Johns Hopkins University had been sounding the alarm about thalidomide for years.  The FDA finally acted after John F. Kennedy insisted on it.  


The current FDA approach -- a product of the 1962 amendments to the Food and Drug Cosmetic Act -- and dependency on the randomized controlled trial is a legacy of the political reaction to a problem.  Efforts to increase regulatory flexibility at the FDA are opposed, the critics always invoke "another thalidomide."  Most people stop the story there. It’s an open and shut case, they say, thalidomide was a horribly dangerous and deforming drug allowed to get onto and stay on the market due to grossly inadequate safety testing and monitoring and the callous actions of companies interested in profits over patients. This, they believe, is why we cannot be too careful about any drug that might be risky. But the tale of thalidomide doesn’t end with its withdrawal – and millions have lived better, longer lives because of it. 

Pharma Guy's insight:

Really? The lady is not even cold in her grave.

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Thalidomide Offsprings Yield Blockbuster Profits for Celgene Aided by Off-Label Promotion

Thalidomide Offsprings Yield Blockbuster Profits for Celgene Aided by Off-Label Promotion | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The modern drug-regulation system traces back to a once-popular morning-sickness pill whose linkage to babies born with flipper-like limbs in the 1960s led the U.S. to tighten oversight for approving medications.

 

That makes it all the more amazing that Celgene Corp. has built itself into a biotech powerhouse, rebranding the drug thalidomide using a slightly different name: Thalomid. Recently unsealed documents in a lawsuit by a company saleswoman-turned-whistleblower allege that its success is due to an aggressive campaign to encourage doctors to prescribe it and successor drugs to treat maladies beyond those the FDA authorized.

 

After some studies suggested thalidomide could treat blood cancer but long before it was authorized for it, Celgene created a thriving market by hiring doctors to tout uses beyond what the product was approved for and ghostwriters to promote the drug in medical journals, according to the suit (read "A Pharma Marketing 'Bait-and-Switch' Scheme: Sales Reps Disguised as Medical Science Liaisons”). Though doctors have broad latitude in prescribing drugs, even for uses that aren’t approved, drugmakers can’t push “off-label” uses.

 

Manufacturers including Pfizer Inc. and Johnson & Johnson have paid billions of dollars to settle such claims.

 

Even after the Food and Drug Administration approved Thalomid for multiple myeloma, a blood cancer, in the mid-2000s, Celgene continued to promote it for other forms of cancer, including cervix, thyroid and brain, whistleblower Beverly Brown alleges in the suit, filed in 2010.

 

Celgene vigorously disputes the allegations.

 

Although the U.S. Justice Department declined to join Brown’s suit, which claims Celgene defrauded government insurance programs by marketing its drugs for off-label uses, a California judge cleared her case for trial.

 

“These allegations, which date as far back as 15 years, are baseless,” Celgene spokesman Brian Gill said in a statement. “Celgene is committed to patient safety, and its products have improved and extended the lives of many thousands of cancer patients

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Dr. Frances Kelsey, Who Protected Americans from Thalidomide, Turns 100

Dr. Frances Kelsey, Who Protected Americans from Thalidomide, Turns 100 | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Today marks the 100th birthday of one of America’s most celebrated public servants. Frances Oldham Kelsey, Ph.D., M.D., was born in Cobble Hill, Vancouver Island, British Columbia, and earned her Ph.D. in pharmacology and her M.D. at the University of Chicago. She was on the faculty of the University of South Dakota and practicing medicine when, in 1960, she accepted the offer to become a medical officer at FDA.


A month after assuming her position she was assigned the review of a new drug application for thalidomide, a sedative that had been used by expectant mothers and many others in dozens of countries since the late 1950s. U.S. law at the time required a firm to provide evidence of a drug’s safety as a requirement for sale. Despite the global popularity of this drug, and despite a constant and increasing pressure from the firm to approve the application, Dr. Kelsey refused to do that without adequate evidence that the drug was safe, a decision that was supported by her colleagues and superiors.


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