Tuesday, September 02, 2008

Back To The Drugs. You May Think The FDA Makes Big Pharma Prove Their Medicines Help Disease Or Suffering Before They Are Sold. You Would Be Wrong.

"Drugmonkey you've lost it" I can hear some of you saying. "Last night some cockamamie story about reporters getting arrested at the Republican National Convention, and now this. I know damn well the FDA requires a company to prove a new drug is effective!"

Well, several reporters have been arrested during the Republican convention:

There was a photographer right next to me who was also taken down pretty violently. He was screaming he was press, as well. He had credentials. He kept saying he was a photographer for the New York Post. And quite funnily, he said, “For Christ’s sake, it’s a Republican paper!” But that didn’t seem to matter.


And while the FDA indeed requires evidence of effectiveness for a new drug to be approved, there are times when it requires zero proof of effectiveness against an actual disease.

Meet our friend Mr. Surrogate Marker. He makes this possible. I think the best illustration of Mr. Surrogate Marker and how he can lead you off the path of the scientific method can be done with the help of a little time travel. So climb with me into the wayback machine to 16th century London, ground zero for culture and cutting edge medicine of the time:



The scene, The Academy of Smart Fellow Medicine, London's finest hospital:

Doctor wearing a wig: Zodooks and other curses! Another case of ill humored corpsucular spirits! It has been the leading cause of death in our fair city for a score of year now! Assistant! knock that rat off the table and prepare the leeches to suck a pint of blood from the patient immediately!

A scantily clad wench enters through the office door, carrying an armful of boxed lunches: My good doctor! I bring you tidings and wonderful news! A breakthrough in the treatment of ill humored corpsucular sririts (IHCS) from my superiors at the general meydicyne and surgical company!

Doctor Wig (staring at the wenches breasts): Tell me more of this breakthrough young lass!

Wench: We call it Warfarene. And it decreases the amount of time needed to bleed a pint of blood from an IHCS patient by over 50%! Here are many studies to prove this from the Royal Leeching Society. And many quill feathers you may use as pens.

Doctor Wig: Huzzah! Everyone knows decreasing the amount of time necessary to bleed a pint of blood helps in the treatment of IHCS!

Wench: It is a glorious day! Soon the future of IHCS patients will be long and prosperous!

As you can probably guess. The future of IHCS patients was in fact short and wracked with misery. That is because the good Dr. Wig fell into the trap of the surrogate marker. Surrogate markers are easy to identify. If you can fill in x and y in the following sentence:

"Everyone knows x helps in the treatment of y"

You've got yourself a surrogate marker. Let's try a few:

"Everyone knows lowering LDL cholesterol helps in the treatment of heart disease"

Vytorin and Zetia undeniably have been proven to lower LDL cholesterol. Six years after they came to market however, there is no proof that either lowers the risk of heart attack or helps heart patients live longer. In January, a study designed to show the drugs shrink arterial plaque was a failure.

"Everyone knows lowering a patients blood sugar helps in the treatment of diabetes"

Avandia unquestionably lowers a diabetic's blood sugar. It also might increase the risk for a heart attack. If your diabetes improves and your heart explodes, you're just as dead.

Surrogate markers aren't always bad. When other evidence is thin and not many options are on the table, knowing that a med has been proven to shrink your tumor (but not necessary lengthen your life) is a way better option than a bottle of shark cartilage. For diseases such as hypertension, high cholesterol, and diabetes though, where there are many proven disease-modifying treatments already available, approval based solely on surrogate marker evidence makes no sense. Let's see what happened when the FDA grew a pair and stood up to Big Pharma's surrogate marker play:

"Everyone knows raising HDL cholesterol helps in the treatment of heart disease, and our drug raises HDL, so it must be very helpful" said Pfizer.

"Prove it" said the FDA.

So Pfizer reluctantly did a large scale study measuring actual outcomes in actual patients, and found that its drug, torcetrapib, which did indeed raise HDL, also increased the risk of death by 60% Remember that the next time someone tells you about the evils of government regulation and the virtues of the free market.

Be careful out there friends. Don't stop taking anything without talking to your doctor first, but be careful.

Go here for the New York Times article I used as source info for this post.

9 comments:

Anonymous said...

Dear DM,

Thank you for helping me to keep my sanity for so long. Tomorrow is my last day as a corporate mushroom and pill pusher. I work for one of the big chains that starts with a "K". 14 years and I've had it. Retail is an insane way to make a living. I admire your ability to resist using tall buildings along with a high-powered rifle as your hobby. There are days I'm tempted.
I'm off to see the world. Check my url if you're curious.
Meanwhile, you really must listen to this:

http://www.sciencefriday.com/program/archives/200808013

Live long and prosper and I'll be back for visits often.

Go O!

Lucid1

Anonymous said...

Yay, guess who's back :)

It's the scantily clad wench, equipped with boxed lunches and peacock feathers.

Anonymous said...

Just wanted to say thanks. Appreciate the humour that makes your point and the link to the article that has all the quotes and facts to back it up.


By the way--did you know there is another drug monkey?
http://scienceblogs.com/drugmonkey/

Anonymous said...

Good post, as always. Just thought I would post a comment saying I read your blog constantly, and I'm in my first year of pharmacy school. One day I hope to be one of the good guys as well.

Anonymous said...

"I read your blog constantly...." Is this like the most bored person on the planet? wink

All kidding aside, enjoyed the post. And yes, I only take aspirin and herbals. My mother swears by aspirin, BC Powder, Creomulsion Children's Cough Syrup and Mentholatum. She has lived to be seventy. Who am I to argue?

Best,

Tammy

Anonymous said...

OMG Just went over all these studies in my drug lit. evaluation course. Talk about Deja Vu! You aren't a Steelers fan are you? I don't know what I would do if you turned out to be my prof.

DrugMonkey, Master of Pharmacy said...

anonymous #2

You're safe. I'm way too straight to be a football fan, and I don't work in academia.

If I were slightly homosexual and followed the football though, I think I would hate the Steelers. Mostly because Terry Bradshaw comes across as so damn stupid. Even in the world of football, he's really stupid.

Anne said...

If my biostats lecturer could explain things like surrogate markers with your humor (and memorability) I wouldn't get that feeling of slow death every time I went to his talks. Also, I would actually understand biostatistics. Wanna go into teaching?

Jen said...

warfarene. classic.