Who would dare prey on the anxieties of pregnant women? Big Pharma, of course

Hostage situation

Imagine the tension, the worry, and the dread that must fill any young couple when they’re informed that their unborn child is at high risk of premature birth.

Now imagine drug company executives who are willing to hold hostage the health of at-risk unborn fetuses in return for an exorbitant ransom.

Seriously — it’s THAT bad. And worse!

But there’s a simple way to avoid the drug company ransom.

Greed, greed, and more greed

For many years, doctors have relied on a hormone therapy — a type of progesterone called 17P — to help prevent preterm births. It’s given by injection once a week for about 20 weeks in women who are considered at high risk of delivering their babies prematurely.

This treatment costs only $20 per dose. But there’s a catch: It’s only available through compounding pharmacies.

As I’ve mentioned before, compounding pharmacists can formulate unique treatments, such as 17P, that aren’t otherwise available.

But many conventional doctors aren’t comfortable writing prescriptions for compounding, and not everyone has access to a compounding pharmacist. That’s why many doctors were happy to learn that the FDA recently approved a drug version of 17P.

They were happy, that is, until they heard the price.

KV Pharmaceutical is the maker of the new drug, called Makena. And as you might expect, KV is charging a higher price than the $20-per-dose of 17K.

The KV price? You may want to make sure there are no children in the room: $1,500.

Per DOSE!

I believe that markup — 75 times — may set a new record for hideous gouging of vulnerable patients.

And it didn’t go unnoticed.

Mainstream organizations such as the March of Dimes and the American Academy of Pediatrics openly protested the pricing. Members of Congress even got involved, asking the FTC and the Centers for Medicare and Medicaid Services to investigate.

Not so fast

Of course, you know as well as I that Big Pharma execs aren’t stupid. KV executives realize that women won’t pay $1,500 per dose while compounders are practically giving the stuff away. So immediately after the FDA approval, KV sent letters to compounding pharmacies, instructing them to stop offering 17P.

The letters warned that the compounded product would be subject to strict FDA enforcement for violating provisions of the Food, Drug and Cosmetic Act.

As low and miserable as that is, it’s a predicable business move. KV has to cut off the inexpensive supply of 17P, in order to force women to make the excruciating choice between risking their baby’s health or paying out an exorbitant fee.

But then…something astonishing happened.

The FDA said, “No.”

FDA officials released a statement flatly calling the KV letter “not correct,” adding that the agency will not take “enforcement actions” against compounders who continue to supply doctors and patients with 17P.

I can hardly believe I’m writing this, but for once, patients win!

And I definitely can’t believe I’m writing THIS, but: Well done, FDA. (Yes, even a blind squirrel finds a nut now and then.)

A few days after the media explosion, KV backed down and lowered Makena’s per-dose price to $690. Well, that’s better, but it’s still shamefully high.

And there’s still that little detail about the $20 dose that remains available through compounders.

But KV’s got that covered with an age-old strategy: fear.

In the price-reduction announcement, a KV spokesperson pointed out that Makena is “an FDA-approved sterile, injectable medication, manufactured under mandatory strict quality controls.”

Riiight…as if compounding pharmacists do their work in dirty basements with no concern for quality, somehow beyond the reach of the FDA.

So in order for patients to win this one, women at risk of preterm birth need to be aware of their options.

If you or someone you know is at risk of a preterm pregnancy and your obstetrician can’t or won’t work with a compounding pharmacy, you’ll need to find a doctor who will. Many mainstream doctors simply don’t bother with compounders. If you need to locate a new doctor who’s more open-minded, use the Find a Doc feature on the HSI website.

Sources:
“Critics slam cost of FDA-approved drug to prevent preterm births” Rob Stein, Washington Post, 3/28/11, washingtonpost.com

“FDA Won’t Pursue Compounders Making KV Drug” Ed Silverman, Pharmalot, 3/30/11, pharmalot.com

“KV Pharma Lowers Price of Preemie Drug” Ed Silverman, Pharmalot, 4/1/11, pharmalot.com