Safe To Whom?

The notion of a drug being simply "safe" or "effective" is entirely fallacious. There are degrees of safety and degrees of effectiveness. One major drawback of monopolistic drug regulation among many is that only one version of "safe" and "effective" can exist. Life is not so simple. Most decisions we make involve evaluating the benefit of an action weighed against the risk, whether it be crossing the street, working in a factory, playing a sport, or investing in the market. Why should the use of medications be any different?

An article in the USA Today points to people who are no longer allowed to make this choice as a result of the recent recall of the painkiller Vioxx.

The pain reminds her of the time before she began taking Vioxx five years ago, when some mornings her body hurt so badly that her husband helped her dress. She often arrived at work exhausted.

Sales of the drug were halted worldwide on Sept. 30, after a study showed it doubled the risk of heart attack and stroke. But, for Rubinstein, relief trumps risk.

Vioxx "was the best pain drug I had been on in 27 years," says the 47-year-old Manhattan resident, who has fibromyalgia, a chronic condition that causes pain in muscles and joints. "I felt good enough to do some exercise. Getting to work was not such a difficult thing.

"I would go back on it in a heartbeat," says Rubinstein, who now takes Celebrex.

Lori Rubinstein is stating that she would take Vioxx despite the increased risk of heart attack and stroke. She knows the risks and perceives the benefits of pain relief to be greater by her own lights.

There are millions of people out there who similarly are deprived of the unique, subjective choice of weighing the risks and benefits of drugs. Though Vioxx was pulled voluntarily by Merck, the the US government bans drugs outright which do not meet its single standard of "safe". This is the "Not Seen" side of pharmaceutical regulation, the white collar Drug War of our time. How many millions suffer from pain daily because medications are deemed simply "unsafe"? How many millions are prevented from obtaining relief and repose as they try to live a tolerable existence against illness? How many die each year waiting for the FDA to declare a drug "effective" by its standards?

The choice to intake a chemical in one's body is as fundamental as the ability to express our views in public, the power to form voluntary relationships with others on our own terms, and the choice of which god, if any, to worship. Taking away this choice robs us of our autonomy to pursue our own personal paths in life. It demeans our very existence by depriving us of the dignity to make decisions for ourselves and take reponsibility for the consequences that follow. It is paternalism of the highest degree.

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Around the horn with

Around the horn with prescription drug posts
Over at Catallarchy, Jonathan Wilde asks Safe to whom? Over at Truck and Barter, Ian has two posts on the Canadian situation....

COX-2 Update: "Heart Attack

COX-2 Update: "Heart Attack for an Ulcer"
We like to use the shorthand that a drug "causes" side effects. But in reality, the most that can typically be said is that a drug may increase the likelihood of a side effect. ...Here's an anecdotal update from Catallarchy.

Hmm. Looks like next Grand

Hmm. Looks like next Grand Rounds material to me, Jonathan.

-Diana

My sister is another person

My sister is another person who would gladly continue to take Vioxx despite the risk, if given the choice. We are quietly very angry at Merck.

I agree wholeheartedly...all

I agree wholeheartedly...all the more so in the case of Celebrex, where the "increased risk" is dubious for the therapeutic dose.

(Sorry for hawking my page, but it's quicker than reiterating the whole post.)

Doesn't the FDA approve all

Doesn't the FDA approve all drugs?

If the FDA then turns around and disapproves the drug,
or the drug just turns out to be 'bad news', what does that
say about their regulation?

What a bunch of perverts they are.

[...] the pizza industry).

[...] the pizza industry). Meanwhile, Michael Moore’s on drgus. And Catallarchy questions the notion of safety. Trent gets riled by medical gatekeeping again. Dr. Charles a [...]

All very good if you are

All very good if you are aware of the risks. But what about those cases where potential risks are not disclosed in some meaningful way?

I've heard that Chiron's flue vaccine "Fluad" now being imported from Europe into the US, has adjuvant "squalene."

Anybody know about this?

I've heard "squalene" is what's kicking up the fuss in the DOD's anthrax vaccine?

Anybody have info on this?