Once the Food and Drug Administration approves drugs, doctors can prescribe them off-label for any use, but makers can't market them for anything other than approved uses. Pfizer subsidiary Pharmacia & Upjohn pleaded guilty to a felony violation for promoting off-label uses of Bextra. At the FDA's request, Pfizer pulled Bextra off the market in April 2005 because of its risks.In a statement, Pfizer senior vice president and general counsel Amy Schulman 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."
Pfizer, the world’s largest drugmaker, has just been slapped with the largest health care fraud settlement in history. The company must pay $2.3 billion for illegally promoting uses of four of its drugs, including Bextra, a painkiller that was linked to an increased risk of heart attacks and stroke.
Well, $2.3 billion is a hefty fine, but certainly one Pfizer will be able to absorb. The company reported profits of over $2.7 billion in the first quarter of 2009 alone, along with revenue of close to $11 billion.
The allegations, meanwhile, may have never come to light if it hadn’t been for Gulf War veteran and former Pfizer sales rep John Kopchinski, who filed the whistleblower lawsuit against Pfizer some six years ago. The lawsuit prompted federal and state officials to investigate, and what they found was a felony violation for promoting drugs for off-label uses.
Among the allegations, Kopchinski told USA Today that Pfizer told him to distribute 20-milligram samples to rheumatologists and orthopedists, even though the FDA had approved only 10-milligram doses for arthritis. Kopchinski said in a statement:
"In the Army I was expected to protect people at all costs. At Pfizer I was expected to increase profits at all costs, even when sales meant endangering lives.”
The truth of the matter is this: drug companies will stop at nothing to sell their products when billions of dollars are at stake.
They are out to make a profit so enticing doctors to prescribe their drugs for as many uses as possible, regardless of whether or not they have scientific evidence to back them up, will only allow them to sell more drugs and make more money.
Pfizer is certainly not alone in this process. Off-label drug promotion and use is commonplace.
How Many are Suffering From Taking Off-Label Drugs?
While doctors can legally prescribe FDA-approved medications off-label for any use, drugmakers are not allowed to market them for anything other than approved uses.
Many physicians, however, rely on drug reps to educate them about the indications for drugs and what other leading physicians are using them for. Drug companies are not shy about suggesting off-label uses. Further, for many drugs it can be difficult for physicians to determine whether medications were not approved based on the Summary of Product Characteristics (SPC) -- the information given to physicians about drugs.
In fact, according to one recent study, it was impossible for physicians to determine the licensing status for one in five drugs … which means it’s even more likely they’ll rely on drug reps opinions and suggestions.
Again, off-label drug use is extremely common. According to studies conducted in Britain, when a "suitable alternative" did not exist, doctors used unlicensed or "off label" medicine in:
90 percent of babies in neonatal intensive care units
70 percent of children in pediatric intensive care units
Two-thirds of children on general medical and surgical pediatric wards in the UK
Two studies suggest that children taking these medicines face a higher risk of side effects, with one estimate suggesting they suffer up to three times more side effects as a result.
Drug Companies Commonly Use Deceptive Marketing Practices
Several years ago, Pfizer paid another settlement, this one for $430 million, related to a 1996 whistleblower lawsuit involving their epilepsy drug Neurontin (which was formerly owned by Parke-Davis). It was this debacle that reportedly inspired Kopchinski to come forward in the current Bextra lawsuit.
Neurontin was only approved to control seizures at the time, but was promoted for unapproved uses such as treating bipolar disorder.
Among the tactics used to "sell" Neurontin:
Parke-Davis paying 14 doctors with honoraria and research grants anywhere from $10,250 to $158,250 from 1993-97 to peddle their influence to promote Neurontin to their peers.
Medical education and communications committees (MECC) running continuing medical education courses funded by drug companies that are held in conjunction with other meetings.
Through MECC scams, those influential doctors or assistants conducting conference calls with other doctors, and drug company representatives monitoring those conversations.
Drug companies funding small trials of their own drugs that would be published only if the news was good.
The drug company cartel spends an obscene amount of cash -- an estimated $30,000 annually -- to promote their worthless drugs to every doctor in this country, amounting to some $18.5 billion. Unfortunately, let me assure you the mega-drug companies aren't throwing their money away, as they get a far better return on their marketing investments than you'd think.
The people who stand to lose in this equation, are unfortunately those who unknowingly take a prescription drug for a use that has never been thoroughly tested. Most would not agree to become guinea pigs for the drug companies just to increase their profits, but that is essentially what happens when you take a drug for off-label uses.
Fortunately, you can avoid becoming Pfizer’s, or any other drug companies, next victim by taking control of your health. Leading a healthy lifestyle and staying educated about drug-free and non-invasive treatment options are the keys to your well-being.
Most are not aware of the pervasive corruption that exists in the corporate drug world. You need to understand that any corporation's primary and essential responsibility is to their shareholders -- NOT to you.
Drug companies have accumulated so much wealth, power and government influence that so far they have been able to largely escape any consequences linking them to profitting from permanently disabling, crippling or even killing consumers.
However, what they hadn't anticipated or planned for was the freedom and liberation that the Internet provides in exposing their corrupt plans. So please keep staying informed and opening your mind to the real routes to health and happiness.