Who's regulating the regulators? (Part two) In the last "Dose," I exposed the loosening FDA regulation of drug marketing - and how the government isn't in a hurry to mend its ways, since it's pulling in a hefty chunk of pharmaceutical-industry change. But going easy on drug marketing regulations also creates a "Pandora's box" of potential misuse (and mis-prescription) of these drugs. Here's what I mean:
In order for a drug to be approved by the FDA, it must be designed, formulated, and proven effective for a SPECIFIC CONDITION - or at least a narrow range of related conditions. Broadening the spectrum of maladies a drug is intended to treat would make the approval process slower, more cumbersome, and even less likely. However, sales of a drug radically increase as its "prescribability" widens. Let's imagine a company designs Elixra-B - a drug designed to treat foot fungus. If it can prove itself effective for this specific ailment, FDA approval is relatively simple, fast, and cheap to attain. But what if Elixra-B is also suitable for treating baldness, shingles, eczema, and genital herpes? Proving all of this with trials and scientific studies prior to FDA approval would be enormously expensive and time consuming. However, if the FDA blithely allows a slick TV ad picturing smiling, happy people euphorically applying Elixra-B to their scalp, skin, and you-know-where (as well their feet), the message is clearly sent to the general public that Elixra-B is for more than just foot fungus - all you need to do is ASK YOUR DERMATOLOGIST. Meanwhile, every skin doctor in the country just attended an all-expense-paid conference in sunny Las Vegas sponsored by Cheatham & Steele Pharmaceuticals, the makers of Elixra-B. At this conference, the most renowned dermatologist in the world gives an "unbiased" and "educational" all-day seminar about how Elixra-B cures baldness, eczema, shingles, and herpes as well as foot fungus. Voila - prescriptions of Elixra-B go through the roof. And because these sales are for "unauthorized uses," Cheatham & Steele completely dodges the liability bullet. As scary as it sounds, this kind of indirect, back-door marketing is exactly how the drug biz makes a lot of its money. In fact, in one high-profile case (reported in the New York Times), a drug company spokesperson admitted that 75 percent of one drug's sales were for unauthorized uses. Bottom line: Without stringent and conscientious regulation, advertisements mislead the public - and doctors mislead each other - about a drug's applicability. And drug makers reap the greatest number of sales for the least possible accountability, expense, and approval hassles from the FDA. Modern medicine's "repair rates" leave us stranded…
I hate to give kudos to the rag, but every once in a while, the government's (and the medical establishment's) official apologist newspaper, The Washington Post, runs a good article on mainstream medicine and its foibles. Earlier this summer, the Post published an article that equated conventional medical care with the auto repair business. The basic gist of the piece is that if auto repairs failed at the same rate as conventional medical procedures and recommendations, we would hardly be able to drive anywhere, according to the Institute for Healthcare Improvement. That's right: That guy down at the corner garage who took three appointments to fix your leaking radiator might well be more competent than the doctor who handles your next ER visit… This finding really stuck with me-especially as I read some of the article's other conclusions, which included survey results showing that Americans: - Have nearly a 50 percent chance of receiving sub-optimal care in any given hospital or doctor's office
- Endure a huge variance in quality of care based on their specific condition
- Risk "overtreatment" for many common conditions - like migraines
- Receive recommended medication practices only 69 percent of the time
- Get adequate counseling and teaching only 18 percent of the time
And these aren't the only evidences of glaring inconsistencies rampant in modern conventional medicine, the article reveals. But none of this should surprise you. If you've been a Daily Dose or Real Health reader for any length of time at all, you already know that going to the hospital or doctor's office is all too often one of the most dangerous things you can do. Always driving the truth,
William Campbell Douglass II, MD | 
