Proscar and other drugs not FDA approved for hair loss.

[swim]

http://www.washingtontimes.com...ord-23-billion-fine/

 

"Federal prosecutors hit Pfizer Inc. with a record $2.3 billion in fines yesterday and called the world's largest drugmaker a repeating corporate cheat for illegal drug promotions that plied doctors with free golf, massages, and resort junkets.

 

Pfizer and a subsidiary, Pharmacia & Upjohn, agreed to the settlement after pleading guilty to a single felony charge that accused the firm of marketing its anti-inflammatory drug Bextra for broader uses and for higher dosages than those approved by the Food and Drug Administration.

Announcing the penalty as a warning to all drug manufacturers, Justice Department officials said the overall settlement is the largest paid by a drug company for alleged violations of federal drug rules, and the $1.2 billion criminal fine is the largest ever in any U.S. criminal case. The total includes $1 billion in civil penalties and a $100 million criminal forfeiture.

 

Authorities called Pfizer a repeat offender, noting it is the firm's fourth such settlement of government charges in the last decade. The allegations surround the marketing of 13 drugs,including big sellers such as Viagra, Zoloft, and Lipitor.

 

As part of its illegal marketing, Pfizer invited doctors to consultant meetings at resort locations, paying their expenses and providing perks, prosecutors said.

 

"They were entertained with golf, massages, and other activities," said Mike Loucks, the U.S. attorney in Massachusetts.

He said that even as Pfizer was negotiating deals on past misconduct, they were continuing to violate the same laws with other drugs.

 

 

To prevent backsliding this time, Pfizer's conduct will be monitored by the Health and Human Service Department inspector general for five years.

 

In an unusual twist, the head of the Justice Department, Attorney General Eric Holder, did not participate in the record settlement, because he had represented Pfizer on these issues while he was in private practice.

 

Associate Attorney General Thomas Perrelli announced the settlement at a news conference with federal prosecutors, FBI officials, and Health and Human Services Department officials.

 

The settlement ends an inquiry that also resulted in guilty pleas from two former Pfizer sales managers.

 

One consumer advocate voiced hope that yesterday's penalty was so big it would curb the abuses.

 

"There's so much money in selling pills, that there's a tremendous temptation to cheat," Bill Vaughan, an analyst at Consumers Union, the nonprofit publisher of Consumer Reports, said.

 

"There's a kind of mentality in this sector that [settlements] are the cost of doing business and we can cheat. This penalty is so huge I think consumers can have some hope that maybe these guys will tighten up and run a better ship."

 

The government said the firm promoted four prescription drugs, including the painkiller Bextra, as treatments for medical conditions other than those the drugs had been approved for by federal regulators. Authorities said Pfizer's sales staff created phony doctor requests for medical information in order to send unsolicited information to doctors about unapproved uses and dosages.

 

Use of drugs for so-called "off-label" medical conditions is not uncommon, but drug manufacturers are prohibited from marketing drugs for uses that have not been approved by the Food and Drug Administration. They said the junkets and other perks were designed to promote Bextra and other drugs to doctors for unapproved uses and dosages, backed by false and misleading claims about safety and effectiveness.

 

Bextra, for instance, was approved for arthritis, but Pfizer promoted it for acute pain and surgical pain, and in dosages above the approved maximum. In 2005, Bextra, one of a class of painkillers known as

Cox-2 inhibitors, was pulled from the U.S. market amid mounting evidence it raised the risk of heart attack, stroke, and death.

 

A Pfizer subsidiary, Pharmacia and Upjohn Inc., which was acquired in 2003, has entered an agreement to plead guilty to one count of felony misbranding. The criminal case applied only to Bextra. The $1 billion in civil penalties was related to Bextra and a number of other medicines.

 

A portion of the civil penalty will be distributed to 49 states and the District of Columbia, according to agreements with each state's Medicaid program.

 

Ohio Attorney General Richard Cordray said yesterday that his state's share of the settlement will be $32 million. Michigan Attorney General Mike Cox said his state would get $15 million.

 

Pfizer's top attorney, Amy Schulman, said the settlements "bring final closure to significant legal matters and help to enhance our focus on what we do best - discovering, developing, and delivering innovative medicines."

 

In her statement, she said: "We regret certain actions taken in the past, but are proud of the action we've taken to strengthen our internal controls and pioneer new procedures."

 

Five Pfizer employees and a Pennsylvania doctor revealed the allegations. They will share $102 million of the settlement money.

 

Yesterday's announcement was made amid the escalating political debate on health-care reform, which hinges in part on concerns over the ballooning costs of medical care and prescription drugs.

 

Mr. Perrelli, the associate attorney general, called the Pfizer case "an example of the department's ongoing and intensive efforts to protect the American public" from fraud and abuse, which costs the Treasury billions of dollars a year. The bulk of the probe was conducted under the Bush administration, which also began negotiating with the firm on a settlement."

 

 

I am very ignorant, so I seek guidance, from all you promoters of Proscar, Avodart, Dutasteride ,etc, to treat hair loss.

 

Will you still promote them?

 

Is it safe?

 

Thanks

Swim

[HairHope]

You text is irrelevant, it was for a completely different class of drug.

 

Propecia=Proscar/5...

[swim]

This are words,that i think are relevant,

a single felony charge that accused the ... of marketing broader uses and for higher dosages than those approved by the Food and Drug Administration.

 

 

Proscar is not approved by FDA for hair loss.

 

Proscar is promoted, by some, here, for hair loss, in dosages higher than those that the approved drug, Propecia have (1mg finasteride).

That is done ,by some, advising to cut the Proscar pill,containing 5 mg finasteride, in 4 peaces, which amounts to 1.25 mg finasteride.

 

But, I would like to hear what the site administrator thinks, not you. You call it irrelevant if you want.

[HairHope]

K, but I stand by proscar/5=propecia.

[Bill - Seemiller]

Use of drugs for so-called "off-label" medical conditions is not uncommon, but drug manufacturers are prohibited from marketing drugs for uses that have not been approved by the Food and Drug Administration.

 

Swim,

 

I think this is a valid question worth discussing. Thanks for posting it.

 

In my opinion, the above quote says it all.

 

There is no law against consumers using medication for other conditions and/or dosages of medication higher or lower than what's FDA approved. It's only illegal for drug companies to promote medication for conditions other than what's been FDA approved.

 

Thus, since Proscar and Avodart aren't promoted or marketed as hair loss treatments, nobody is in violation of any law. However, consumers should always be very careful and learn all there is to know about any and all medications whether they're FDA approved or not for an intended use. All medication comes with the possibility of side effects and it's crucial to consult with a physician before taking any medication.

 

Bill

[swim]

Yes Bill, correct. The actus reus is in the "marketing/promoting".

 

I don't think that only the manufacturer of the drug is capable of the violation.

[riodon]

Hello,

I just started using propecia. My question is I know to expect shedding so during the shedding phase will this make you look more bald than you were before you started using propecia?

[Maxxy]

Hey Riodon,

 

I guess it will all depends on your level of loss and how much you shed. Some people shed a lot, some a little and others not at all.

[Dr. William Lindsey]

I would not get too bogged down in the off label use of proscar. Off label can be significant or meaningless, it all depends on the drug and use.

 

For example, botox was only FDA approved for cosmetic use a few years ago, and then only for the wrinkles between the eyes...Prior to that it was used for spasms and twitches(medical terms not used) and doctors saw that it decreased wrinkling and therefore we started using it cosmetically. I personally have used botox on my wife and me since '94 in the frown and crows feet region as I know botox is completely safe if administered by someone with adequate training. Same with propecia and proscar. And, I was a huge fan of bextra which is discussed above and I still like celebrex, a non narcotic pain reliever from the same class. Many folks argue that ibuprofen has a nearly identical risk for heart problems...so please keep in mind that everything has potential risks and benefits that must be weighed by the patient and doctor.

 

As a long time prescriber of propecia, who does NOT sell it, and who used it for about 11 months (giving up due to the side effect..) just discuss the pros and cons with your doctor and make an informed decision.

 

Dr. Lindsey McLean VA

[blowdry]

Read the entire article and expand your knowledge of what is really happening..enjoy!!

 

http://search.lef.org/cgi-src-...ry=FDA&hiword=FDA%20

[blowdry]

Here is another one.Generic Drug Rip Off

 

http://www.lef.org/magazine/ma...-Drug-Rip-Off_01.htm

 

Who is looking out for you??