Let public decide on drug risks

Denver Post ^ | April 11, 2005 | David Harsanyi

[aynrandy]

Does anyone read warning labels anymore?

Did you know, for instance, that the Prozac warning label cautions a "risk of suicidal thinking and behavior"?

And you thought Prozac was merely an anti-depressant.

Prozac, states its warning, also may induce "nausea, nervousness, weakness, loss of appetite, tremors, dry mouth, sweating, decreased sex drive, impotence, or yawning."

Obviously millions of patients accept those hazards because the benefits outweigh the risks.

Impotence? What about erectile dysfunction drugs?

You've heard the warning: Sometimes the stuff works exceedingly well - for four straight hours, even.

The patient is then left with an uncomfortable decision of either placing an alarming call to his doctor or taking a cold shower. Yet tens of millions of the drug's users are willing to risk it.

Sure, some warnings are ridiculous.

Did you know that certain condom brands have a warning that reads: "Use for sex only - not to be eaten."

There's a scooter with the alert: "This product moves when used." A digital thermometer with a caution that reads: "Once used rectally, the thermometer should not be used orally."

But, while treating us like a bunch of confused dolts might be funny when it comes to scooters and condoms, it can have serious implications when treating people who are seriously ill.

Last week, at the request of the Food and Drug Administration, pharmaceutical giant Pfizer pulled its pain reliever Bextra off the market. It also has pulled back marketing of the pain medication Celebrex.

Not a new warning label. No drug.

The Arthritis Foundation's Rocky Mountain chapter estimates that there are more than 1.3 million people in the Rocky Mountain region who suffer from some form of arthritis. Many of the more serious cases use these drugs to live a normal life.

Yet Dr. John H. Klippel, president and chief executive of the Arthritis Foundation, believes "the FDA decision helps to better inform people with arthritis about the potential risks associated with these drugs."

Well, what about the many arthritis sufferers who now are better informed about the potential risks and still have decided they want Bextra?

Perhaps they've decided that instead of living in excruciating pain, or sitting in a wheelchair, they are ready to face a possible heart attack or stroke.

When I take my anti-inflammatory drug of choice, Excedrin, I read the warning. Then I decide whether I want a splitting headache or the chance of "hives, shock, facial swelling and nervousness."

Since I suffer from most of those symptoms already, I take the pills.

Adults can walk to thousands of shops and buy a pack of cigarettes (for now). The product has a warning label reading: "May cause death."

May cause death!

Nevertheless, adult consumers can buy it. They can buy cartons of it. Online. Without a prescription.

So why should a potentially dangerous choice that can essentially give someone their life back be banned?

Bextra has been prescribed to millions of patients since its approval in 2001. It is now snatched away, as is another painkiller, Vioxx.

The FDA banned Bextra despite the recommendations of a 32-member panel of expert advisers, who after a three-day public hearing about all non-narcotic painkillers recommended that the drug be allowed to remain available.

The panel also recommended that Vioxx be allowed back on the market.

The FDA didn't agree.

So I ask: What is the purpose of a warning label? Or a prescription?

What is the point of possessing the crucial information we need to make educated decisions, often with a doctor, when in the end we're not actually allowed to make a decision?

David Harsanyi's column appears Monday and Thursday. He can be reached at 303-820-1255 or dharsanyi@denverpost.com. Let public decide on drug risks

[RockinRight]

My dad once said (in response to the Levitra commercial) "if I have a 4 hour erection, I'm not seeing my doctor, I'm seeing every woman I know..."

[cinives]

What is the point of possessing the crucial information we need to make educated decisions, often with a doctor, when in the end we're not actually allowed to make a decision?

The article makes an interesting assumption - that doctors correctly point out warnings on labels. They often don't, so the patient is not informed of certain risks and thus cannot and does not make an informed decision. Since over 40% of the US population can't read well enough to decipher a label themselves, they won't get the information on their own, either.

All that said, as an inteligent person, I'd want to be able to make the choice if I know the risks and understand the statistics.

[The Great RJ]

Aspirin has as many potential risks as many of the drugs the FDA is banning. What I want to know is that since these drugs have been on the market for years and given in millions of doses, how many people have experienced these side effects now only being seen in single clinical trials? To believe the alarmists, there should be millions of people suffering these side effects, but where is the real world data?

[festus]

A digital thermometer with a caution that reads: "Once used rectally, the thermometer should not be used orally."

Seriously. Does anyone know how to tell the difference between an oral and a rectal thermometer ?




They taste different..... ;-)


or so I'm told.....

[secretagent]

Abolish the FDA. Separation of risk assessment and State.