< link rel="DCTERMS.isreplacedby" href="http://caltechgirlsworld.mu.nu/" /> Not Exactly Rocket Science: FDA Approved doesn't mean safe

Monday, December 27, 2004

FDA Approved doesn't mean safe

Here's a rant I posted in the comments of this post at Dean's World.
"Oh for Christ's sake. Dean is right. The REAL problem is that people think drugs are candy. You take two pills, you don't feel sick, and in fact, maybe you feel better, or at least feel normal, so you think that there's nothing to worry about.
Wrong.
Drugs are not candy. They're drugs. Aspirin, Alleve, Tylenol, etc. All drugs. Just because they're available in the store whenever you want to buy them doesn't mean they're harmless. In fact, they're ANYTHING BUT HARMLESS, that's why they come with DIRECTIONS for use. If they were candy, instead of saying "Directions: Take two pills" they would say "serving Size: two pills".

FDA approved doesn't mean safe all the time. It doesn't even mean safe most of the time. What it really means is "This will kill your disease before it kills you".

There are any numer of drugs on the market that are not at all safe. One example, the incredibly popular anti-acne medication, Accutane. Accutane is L-Retinoic Acid, a TERATOGEN. This means that if you're taking accutane and get pregnant, your baby could have serious deformities, including craniofacial malformations, a deformed heart, and deformities of the limbs and digits (I used to work in a lab where we studied RA). Not to mention that accutane can destroy your liver if levels become toxic. Another example is a drug that I take for my Rheumatoid Arthritis, Methotrexate. MTX is a chemothereputic agent that is given in low doses to auto-immune patients, but attacks newly dividing cells (including cancer) and can destroy the liver and has also been included in some formations of RU-486 type drugs. This is a bad bad drug, but it looks like a tic-tac.

My point is this. We're all gonna die. Prescription drugs make us live that much longer and that much better. Shouldn't we leave the decision of whether or not to make drugs available up to the doctors? Rather than the media or the drug company attorneys? First do no harm, the oath says. As long as drugs are helping patients more than hurting them, I don't understand why you would want to wage a war without all of the weapons at your disposal."
My point is this. We're all gonna die. Prescription drugs make us live that much longer and that much better. Shouldn't we leave the decision of whether or not to make drugs available up to the doctors? Rather than the media or the drug company attorneys? First do no harm, the oath says. As long as drugs are helping patients more than hurting them, I don't understand why you would want to wage a war without all of the weapons at your disposal."

Here's my thing. Disease is like a nasty enemy. We have lots of weapons to fight it. But we need to use those weapons judiciously. For example, we can't just prescribe automatically. Antibiotics aren't going to help the Flu or a cold. Doctors shouldn't give pills just because a patient asks for them. And at the same time, doctors have a responsibility to ensure that their patients understand the risks and benefits associated with the drugs they're taking. By this same token, patients have a responsibility to take these drugs appropriately and discuss side effects and other medications (possible interactions) seriously with their doctors.

If it says "take with food" don't blame the doctor for your ulcer. If it says "do not operate heavy machinery" don't blame the pharmacist for your car accident. If it says "don't take while pregnant", then for God's sake don't shit on the FDA to ban a perfectly good drug just because you can't read and now your baby looks like somebody squashed his face and he's gonna grow up to be schizophrenic.

Is this what we've come to? That we can't even take responsibility for taking medication properly? Are we so sensitzed (yes, I mean sensitized not de-sensitized, sensitized is correct, go look up the relevant behavioral literature) to taking pills that we forget what we're really doing when we swallow those babies?

So now what? The FDA plays Mary Poppins and ties the hands of thousands of American physicians even more? All because some morons can't read directions or discuss the risks with their doctor beforehand. Or maybe because some shitheads (not sha-theeds) are so sue happy they think that 80 year old Granny's heart attack was due to her Celebrex or Vioxx rather than the fact that she has an 80 year old heart?????? (the average age in the Vioxx increased risk study was >60)

As an arthritis patient, I can tell you that there are millions of people in this country who are terrifed right now at the prospect of losing the only relief that they've been able to get because the COX-2 drugs were much more effective in treating advanced arthritis than anything else out there in the NSAID group. Alleve didn't work for me either, but I know tons of people who are better off because of it. I say put the risks in the black box (on the patient information sheet, the outlined area that lists risks and contraindications for eaxh medicine) and let the patient and the doctor decide. If Granny has heart disease, then no Vioxx. If 35 year old Jim is healthy except for his arthritic knee, put him on the Vioxx and do an EKG once a year.

As with everything else, the media in this country are the LEAST qualified to decide which medications a person should or should not take.

5 Comments:

At Tuesday, December 28, 2004 3:53:00 AM, Blogger Ben said...

Amen and amen. And I think you mean over-sensitive.

 
At Monday, January 03, 2005 10:21:00 PM, Anonymous Anonymous said...

As a physician, I agree that having more tools available is generally a good thing. I disagree strongly with those who criticize the FDA for not pulling Vioxx before the company's attorneys did. I believe that, provided current info is clearly and honestly presented, physicians and pts are perfectly capable of making these choices.

 
At Saturday, October 01, 2005 1:02:00 AM, Anonymous Anonymous said...

Vioxx health - Merck Earns Fall After Vioxx Withdrawal NEW YORK (Reuters) -

Merck Earns Fall After Vioxx Withdrawal
NEW YORK (Reuters) - Merck & Co. MRK.N on Thursday said first-quarter profit fell 15 percent following the withdrawal of its arthritis drug Vioxx last year. Link to original article
recall vioxx

 
At Sunday, October 02, 2005 1:11:00 AM, Blogger musica said...

Your Blog. It's nice . I'm sure you'd be interested in acne cure Stop acne cure

 
At Sunday, October 02, 2005 2:13:00 AM, Blogger musica said...

This is an excelent blog. if you want really found a cure click here nature cure acne treatment Get here nature cure acne treatment

 

Post a Comment

<< Home