THE BLOG
01/28/2008 05:36 pm ET Updated Nov 17, 2011

The Contraindications of Our Pill-Popping Ways

Six different medications in one person's apartment!? It's hardly as scandalous as reporters implied when Heath Ledger's drug inventory was made public. In this pillophile nation of ours -- where four billion prescriptions are dispensed a year and over 51 million people ingest more than three meds daily -- six is hardly outrageous. Certainly not as outrageous as our undiscerning faith in the pharmaceutical powers that be -- the FDA, drug companies, doctors -- when we find ourselves with prescription in hand.

Why, for instance, did the fact of six meds lead so many people to assume suicide, given that unintentional drug-induced deaths are four times more prevalent? Adverse drug reactions are among the top 10 causes of death in the U.S. And (a conservatively estimated) 1.5 million Americans each year are sickened, injured, or killed as a result of errors in prescribing, dispensing, and taking medication. Also, the most recent injury-related death tallies list drug-related suicide as the ninth leading cause, while unintentional poisoning (most often by prescription drugs) ranks second.

These figures shouldn't be surprising. We're confronted daily with media accounts illustrating the fallibility and lack of integrity that pervade the pharmaceutical industry: the drug lobby's unbounded influence, big pharma's big-dollar motives, the FDA's underfunding, understaffing, and overdeliberating when it comes to issuing recalls and warnings. We hear about managed-care doctors who barely have time to conduct an exam and take a history, let alone determine optimal medication and dosage and advise of the necessary precautions -- if, that is, they haven't been swayed or paid by drug reps and their companies to throw precautions to the wind.

Given this awareness, why is it that when our own health is at stake, mantras like, "It's FDA approved," "Drugs undergo years of testing," "My doctor recommended it," are suddenly assurance enough?

It's as if we've been drugged.

(There are, of course, cynics among us who avoid drugs like the plague, and others who take them only with hesitation and out of necessity. But some of us -- actually, many of us -- are responsible for the 60+ percent increase in drug dispensation over the past decade, a period during which the population grew only 11 percent.)

We should be more vigilant. We should be better informed. We should be more attentive to the inherent contradiction between what we know about the pharmaceutical industry and our willingness to trust it.

We can start by considering some realities behind those inordinately sedative phrases:

"It's FDA approved."

• The majority of drugs on the market have met the FDA's rigorous standards for approval.

• Despite those high standards, over 20 (FDA-approved) drugs have been recalled for safety reasons over the past decade.

• More than 600 drug-safety alerts and over 250 black-box warnings were issued during that time.*

• The FDA often approves drugs before safety has been established and then requires the drug company to conduct post-marketing studies.

• Drug companies are notoriously delinquent about doing so.

• The FDA has limited recourse for drug company noncompliance.

• Drug company fees account for more than half of the FDA's drug-evaluation budget.

"Drugs undergo years of testing."

• The clinical-trials phase for most new drugs lasts between six and nine years.

• Drug companies design their own studies and submit the results to the FDA, which bases its approval decisions on the drug companies' data.

• Upon completion of clinical trials only a few thousand people will have taken the drug, none for more than a few years.

• Variables such as how a drug performs when taken with other medications won't become apparent until the drug has gone to market.

• Only an estimated 1 to 5 percent of adverse drug reactions (ADR) are reported to the FDA.

• Numerous reports by government and watchdog agencies have criticized and called for drastic changes to the FDA's handling of post-marketing studies and ADR reports.

• The FDA has been largely unresponsive to their recommendations, as this excerpt from a 2007 (FDA-sponsored) Subcommittee on Science and Technology report indicates:

"There is a long history of excellent reviews of the FDA that have been followed by little to no action taken to achieve the recommendations. Our final recommendation is based in our belief that effective resolution of the issues outlined in this report is urgent. In contrast to previous reports that have issued many of the same warnings, there are now sufficient data proving that failure to act in the past has jeopardized the public's health."

"My doctor recommended it."

• Generally, doctors' training includes between 11 and 16 years of school (counting undergrad) and hospital work.

• While the number of prescription drugs on the market has grown to more than 3,000, the amount of time doctors have to learn about them has decreased.

• Drug companies are the number one source from which doctors receive information about new drugs.

• Half of all continuing medical education courses are underwritten by drug companies.

• Studies show that doctors consistently fail to provide critical information to patients (such as precautions) when prescribing new medication.

• A significant number of ADRs are caused by prescription errors, 40 percent of which are perpetrated by doctors.

• Common prescription errors include improper dosage, misspelling due to similarities between drug names, lack of awareness about new warnings, failure to account for allergies, and failure to account for dangerous interactions with other medications.

* None of Ledger's meds was the subject of a safety alert, not even Ambien -- despite FDA-acknowledged risks of "complex sleep-related behaviors" that include sleep-driving, sleep-eating, and, it wouldn't be such a stretch to imagine, possibly sleep-taking-of-additional-pills.