A retired pharmacist discusses the Rx "Risk/Benefit" Ratio
From John Curry, September 12, 2009
"In the last 10 years, over $11,000,000,000 including the cost of the Bextra episode have been paid in fines by the pharmaceutical manufacturers for violating a number of regulatory rules, such as violating good manufacturing practices and selling drugs for unapproved uses, even though the FDA told the manufacturer they could not sell the drug for the unapproved medical condition."
A pharmacist's view of the world. — Confessions of a Drug Pusher —
HEALTHCARE ROULETTE
Risk/Benefit Ratio drives Big Pharma Marketing Decisions
By Tom Braun, RPh.
A bout now, most of us are all aware that inflated medical insurance costs, excessive end of life procedures, and fraud in the Medicare System and physicians defensive medicine practices all contribute to the vastly inflated cost of healthcare in the US.
One that has not been in the spotlight till now is the policy of the pharmaceutical companies to employ aggressive marketing practices to convince the physicians of this country to use drugs for unapproved medical conditions.
They are betting that by the time the federal regulators catch up to their illegal marketing practices that they will have sold enough of their high priced prescription drugs to more than pay for the future fines they know they will have to pay.
The report this week that Pfizer has agreed to a $2,300,000,000 fine for marketing their anti-arthritic drug Bextra for unapproved medical conditions is the crowning blow to a FDA regulatory system that needs to be fixed. Go to: http://www.usdoj.gov to read the shocking whole story.
Bextra was Pfizer’s answer to the seriously flawed drug called Vioxx by Merck. Five years ago, both Vioxx and Bextra were removed from the market. Merck received all the publicity at the time because it was estimated that over 100,000 people died from taking Vioxx. Most of the civil lawsuits resulting from the Vioxx were settled for over 4 billion dollars.
In the last 10 years, over $11,000,000,000 including the cost of the Bextra episode have been paid in fines by the pharmaceutical manufacturers for violating a number of regulatory rules, such as violating good manufacturing practices and selling drugs for unapproved uses, even though the FDA told the manufacturer they could not sell the drug for the unapproved medical condition.
In my opinion, this is only the tip of the iceberg. We have a voluntary adverse drug reporting system that under reports on an untimely basis the harm that drugs are doing to patients.
The fact that becoming aware of drugs that create adverse reactions in patients is not recognized on a timely basis drives up the hospitalizations and cost of healthcare unnecessarily.This is in addition to the added healthcare costs caused by doctors induced to prescribe drugs for unapproved uses, for which Pfizer was fined 2.3 billion dollars five years after it was taken off the market.
Currently, the adverse drug reporting system used by hospitals is a voluntary system. Consequently, it is not used properly and the FDA does not have a timely and quick way of knowing what drugs should be removed from the market. This does not address the fact that drugs are not always properly tested to avoid the after effect scenario. In addition, the regulatory process for removing a drug is drawn out and slow and many additional patients are harmed or die in the process. All of this contributes to the healthcare crisis we have in the US.
Isn’t it time that the FDA becomes an active advocate for all Americans and is given the authority to prevent the abuses that are driving up the cost of healthcare because of having drugs improperly marketed and prescribed?
Isn’t time we all support positive regulatory changes to our healthcare system that will drive down the inflated costs?
posted by Kathie Bracy at 7:59 PM
<< Home