As an OB/GYN physician, I know intimately the dangers of preterm labor. I’ve held in my arms the mother who lost her preemie daughter after her uterus inexplicably began contracting and spewed out her 24 week old baby before she was fully cooked. I’ve watched the preemies in the nursery get stuck with tubes in every orifice while incubators try to mimic the womb and ventilators push air into their undeveloped lungs. I’ve seen the children, years later, get wheeled into my exam room after enduring countless surgeries to deal with the disabilities prematurity can cause. And I’ve attended the pregnant women we imprison in the hospital for weeks on end as we try to prevent this deadly pregnancy complication.
We don’t know what causes preterm labor. If we did, we might be able to prevent it. It’s still one of the great mysteries of obstetrics. While technological advances like gene therapy and transplant surgery revolutionize health care, we still don’t understand the most basic things about how pregnancy works. In fact, at the University of Chicago, there’s an empty plaque, awaiting the name of the person who discovers what causes labor, so we can learn to prevent preterm birth.
So far, we’re still clueless.
But we’ve made progress in the past decade. When a New England Journal of Medicine article suggested that the hormone 17-hydroxyprogesterone (17-P) would reduce the risk of preterm birth, OB/GYNs listened. However, this old drug, which used to be used to treat preterm birth, had fallen out of favor, and no manufacturers made it anymore.
So practitioners got resourceful and started getting 17-P from compounding pharmacies, where it could be manufactured from scratch for about $20 per dose.
Because the quality of compounding pharmacies vary, and because what drug a woman gets during pregnancy matters, docs were happy when the FDA approved a new drug Makena which would standardize 17-P and make it readily available at hospitals and pharmacies.
The FDA reviewed data of a study that showed that, among women with a prior preterm birth, women given Makena in a subsequent pregnancy had a preterm birth rate of 37%, compared to 55% in the control group. Good news, eh?
You’d think. So KV Pharmaceutical, who won seven years worth of exclusive rights on this drug that has been around since the 1950s, then started firing off letters to compounding pharmacies, announcing that they could no longer make 17-P available to the public without facing possible legal action.
Which means that women at high risk of preterm birth must now buy Makena, instead of relying upon their friendly neighborhood compounding pharmacist to
make it up.
So how much does the new (old) drug Makena cost?
$1500 per dose.
Yes, you heard me right. This $20 drug now costs $1500 per dose. That’s about $30,000 per at-risk pregnancy. And insurances get to decide individually whether or not they will cover it -- but even if they do, that’ll mean big co-pays and deductibles.
Can I just say it like it is? BULLSHIT. F you, Big Pharma.
Are you telling me that women who are at risk of preterm birth (lower socio-economic women are at the highest risk) will have to pony up 30 grand if they want
to prevent losing a pregnancy or raising a disabled child because insurance won’t cover it? Are you telling me our health care industry is so broken that, instead of making this ancient drug available at an affordable price and preventing preterm births, they’d prefer to pay millions to care for that preemie in the NICU or treat that disabled child?
Why? Why? Why?
Why is this legal? According to the Washington Post, “FDA officials said that they had no idea how much the company planned to charge for the drug and were surprised by the cost but that the agency has no power over pricing.”
How did our health care industry become so broken that this kind of thing can happen? Where is the heart in medicine these days? When did patient care start taking a backseat to the bottom line?
No wonder patients and health care providers alike feel so frustrated, demoralized, and disempowered.
Something’s gotta change.
According to the same FDA official, “If requested, the agency could approve a lower-priced generic version of the drug for another use that doctors could prescribe 'off label.'” The official also said that the agency would not prevent compounding pharmacies from continuing to provide 17-P unless patient safety is thought to be at risk. “We have our hands full pursuing our enforcement priorities,” the official said to the Washington Post. “And it’s not illegal for a physician to write a prescription for a compounded drug or for a patient to take a compounded drug. We certainly are concerned about access of patients to medication.”
So if you or anyone you know had a previous preterm baby, tell them to ask their doctor about prescribing 17-P. If the doctor thinks they are a good candidate for 17-P, suggest getting it from a compounding pharmacy, rather than supporting a Big Pharma company that’s trying to screw us all.
I still have my issues with Big Pharma, but I do understand that pharmaceutical industries pay big bucks to support research programs that help us all. I do understand that it’s a business and that they need to make their money in the first seven years, while their drug is still under patent. I get that their business model supports innovation and the creation of drugs that move us forward, and that without them, we might lag in our pharmaceutical options.
But this drug has been around forever. And it’s a natural hormone. I mean seriously people! Get a heart. These are pregnant women we’re talking about. These are preemie babies we’re trying to save. This is an old, natural hormone that you didn’t just invent, KV. Do something right for a change. Put the health of people above the bottom line. Or at least back off the compounding pharmacies and let people seek this potentially life-saving hormone elsewhere. It’s the right thing to do.
What do you think of this? Is your blood boiling like mine is? How did this happen? When did we lose the heart of medicine?
Speaking up on behalf of mothers and babies everywhere,
PS: Woah, check out this Washington Post article from this morning -- "FDA to allow cheaper preterm baby drug". Looks like the FDA is stepping in -- but still, how do you feel about this whole controversy? I'm glad the FDA is stepping up to the plate and laying off of compounding pharmacies, but still outraged that KV even tried something like this in our health care system.. On that note, I’m hard at work on a manifesto about this very topic (not so much Big Pharma, but reclaiming the heart of healing). So stay tuned…
Lissa Rankin, MD: Founder of OwningPink.com, Pink Medicine Woman coach, motivational speaker, and author of What’s Up Down There? Questions You’d Only Ask Your Gynecologist If She Was Your Best Friend and Encaustic Art: The Complete Guide To Creating Fine Art With Wax.
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