Off-label prescribing

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Cold medicine scam finally exposed after decades of harming children Mike Adams, the Health Ranger See article keywords and concepts

The scam of off-label prescribing Speaking of applications of prescription drugs, here's the big kicker that just blows the whole "scientific" medicine idea right out of the water: off-label prescribing. This is when a drug has been approved for one thing -- such as foot fungus -- but is prescribed by a doctor for something entirely different, for which it has never been tested: Such as asthma. It's an extremely common practice, and it's entirely unregulated. What is the FDA's view of this issue, where doctors are prescribing drugs for health conditions that they've never been tested for?

Comfortably Numb: How Psychiatry Is Medicating a Nation Charles Barber See book keywords and concepts

Many patients have no idea that this goes on and just assume that the physician is writing a prescription for their indication."20 off-label prescribing for drugs in general has soared, nearly doubling in the period between 1997 and 2003.21 One of the taglines used in the ads for Zoloft tacitly acknowledges the never-ending applicability of its formulary—"Zoloft—#1 for Millions of Reasons." So, if not for a serious mental illness, what exactly is Julie taking the antidepressants for? There are a couple of alternatives. First, there is the catchall term depression.

Pharmaceutical television advertising is a grand hoax Mike Adams, the Health Ranger See article keywords and concepts

And then there's the fraudulent practice of off-label prescribing, too, which means that a drug approved for ANY condition can be legally prescribed for ALL conditions, regardless of whether it has undergone a single test for those conditions. Example: A drug approved for migraine headaches can be legally prescribed for heart disease, even if it hasn't undergone a single clinical trial for heart disease. So much for the grand claims of "evidence-based medicine.

Too Profitable to Cure Brent Hoadley, Ph.D. See book keywords and concepts

Doctors can recommend FDA-approved drugs for any purpose, an act called off-label prescribing. However, a pharmaceutical company cannot promote an approved drug for a use that has not received approval. How can doctors be "educated" about this new use for Drug X? Enter Madison Avenue research firms. Their pseudo-research shows that Drug X is wonderful for the treatment of some disease or condition for which it has not received FDA approval. Madison Avenue —not the pharmaceutical that financed the research — issues a press release. Voila!

The ADHD Fraud: How Psychiatry Makes "Patients" of Normal Children Fred A. Baughman, Jr., M.D. and Craig Hovey See book keywords and concepts

The practice is called off-label prescribing. Doctors can prescribe a drug for children after it has been approved for use in adults, the assumption being that they will administer it responsibly. As proven by the exponentially swelling ranks of normal children being forced to ingest drugs for unproven disorders, that assumption is no longer warranted. One of the most incredible things about the ADHD epidemic is that over the years of its evolution all proffered "proofs" have been found false. Not a single benefit of diagnosis or drugging has been found.

Prescribing drugs approved for adults but never tested in children, or approved for use in that population, is the off-label prescribing Pfizer got in trouble for with for Neurontin. It seems that pharmaceutical companies can promote the practice without leaving behind the kind of trail that lands them in court. So, if a child has mood swings from the Adderall (which isn't surprising with an amphetamine cocktail) he is on, why not add the adult diagnosis of bipolar disorder and treat it with adult drugs like Depakote (primarily an anticonvulsant drug)?

Generation Rx: How Prescription Drugs are Altering American Lives, Minds, and Bodies Greg Critser See book keywords and concepts

Often, this type of advertising involves the distribution of medical journal articles that discuss such uses — Paxil for shyness, for example — with the intent of subtly encouraging physicians to, let's just say it, experiment. off-label prescribing, particularly in the last-ditch treatment of acute diseases, like cancer, can often hold tremendous promise, but when it comes to chronic diseases, it often causes more pain than relief.

After all, how different was self-prescription from what was happening at physicians' offices, where off-label prescribing was rampant? Was it really so surprising that "what works now" should become the dominant force in prescribing drugs, rather than "what is proven safe and effective"? Whatever the answer, one thing was clear for Gen-Rx2: a new prescription culture — expanded, self-justifying, increasingly outside the domain of the physician — was exploding inside and outside their own office doors.

Putting aside all of the off-label prescribing and the taking of supplements, seniors were using more pills than ever before. Over-the-counter medication use was also at an all-time high. Among seniors and, for that matter, the general population, polypharmacy was no longer seen as a problem. It was an opportunity. And it was, when one backed up and looked at it all — away from the political Sturm und Drang of Medicare drug benefits and HMOs — a strange and wonderful thing to behold.

Consider off-label prescribing, which has skyrocketed since the court rulings that established pharma's right to distribute off-label data — studies, say, paid for by GlaxoSmithKline to show how great Paxil is for twelve-year-olds. "Incentivization" of physicians also works. That is what marketing executives at Schering-Plough discovered not long ago, when they simply began mailing out unsolicited $10,000 checks to leading liver specialists. The checks were consulting fees that required nothing other than that the physician agree to prescribe Intron A, Schering's drug for hepatitis C.

The same goes for off-label prescribing of chronic disease meds in general. Today the FDA says that at least 8,000 people a year become seriously ill because of it. Since physicians report only about one in ten such instances to the agency, the figure is in reality more like 80,000. Less dramatic but far more extensive is the harm to the tradition of patient-physician independence. In a review of sixteen studies of drug company-physician interactions, Dr. A.

Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill Kelly Patricia O'Meara See book keywords and concepts

There is little doubt that each of the mental-health experts that sat on the FDA committee was well aware of the off-label prescribing long before their participation in the February 2004 hearing and, therefore, the fact that a number of families felt compelled to share the intimate and often gruesome details of young children lost to the alleged adverse effects of the antidepressants could be of little surprise. A 2003 survey by Express Scripts Inc.

This mention is about off-label prescribing of antidepressant drugs - currently the only antidepressant approved by the FDA for ADHD is Eli Lilly's Strattera, which carries with it its own set of potentially life-threatening problems that will be explored later in this and other chapters. As has been well-demonstrated in Chapter Three of this book, the pharmaceutical manufacturers of the most popular antidepressants, the NIMH and the FDA don't "completely" understand how the mind-altering antidepressants work on other targeted mental illnesses.

Bitter Pills: Inside the Hazardous World of Legal Drugs Stephen Fried See book keywords and concepts

Or he could have become a zealot for off-label drug use; he might have championed the free speech issues surrounding the dissemination of off-label prescribing information and lobbied for changes in FDA promotion rules. Instead, Dreyfus became obsessed with Dilantin itself. He recommended it to his housekeeper and then his tennis partner in Miami, both of whom believed it cured their depression. Eventually he went on a mission to turn on the entire world. Over the years Dreyfus became convinced that Dilantin had more uses than aspirin.

It surrendered much of the agency's ability to control the dissemination of journal articles about off-label uses for drugs—like the one that set off the fen-phen craze—and some were already predicting that even more rampant abuses in off-label prescribing would be the next growing problem in drug safety. It also loosened agency control over several aspects of medical device regulation, and put into law several previous rule changes, like the one that allowed some drugs to be approved with only one well-controlled study.

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