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Is the $10 Preterm Labor Drug Really Worth $1,500?--Editorial

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Inflation exists, as we all know. But how does a drug that has been repeatedly used for high-risk pregnant women go from just $10-$20 per injection to $1,500 a dose? That’s what has happened in the case of Makena, a medicine used to prevent preterm labor.

Medical professionals have exclaimed everything from shock and outrage to utter disbelief. But it’s not like they didn’t hear of KV Pharmaceutical winning governmental approval to exclusively sell this drug. Even the March of Dimes celebrated this approval in their own press release, reported MSNBC.com. Then again, the March of Dimes does receive a large amount of funding from Ther-Rx Corp, a KV Pharmaceutical subsidiary, which will be responsible for marketing Makena. So although they knew about this move, doctors and medical professionals did not expect the gigantic hike in cost.

It is important to note that this drug, a synthetic form of progesterone, has been around 50 years so development and research had already been done. Why then the exorbitant price? MSNBC.com even quoted Dr. Roger Snow, deputy director for Massachusetts Medicaid program, who stated that this increase was huge for a drug that was not all that expensive to make in the first place. How does KV justify the costs? Maybe they feel like the classic credit card commercial: Makena: $1,500 a dose; the chance to possibly erase the risks of mental and physical disabilities that preterm births may bring: priceless. But the real question is - should it be? Especially when many of the mothers who experience this type of pregnancy are mothers who are uninsured and low-income.

To solve this problem, Ther-Rx announced a patient-assistance program to help these individuals. While that sounds good in theory, the working class all know that somewhere along the line, someone will have to pay. The first to feel the brunt will be the insurance companies. As a result, they will more than likely have to raise insurance premiums and other fees to their clients. And lastly, a measure will be laid on the already cash-poor state Medicaid programs.

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EmpowHER Guest

I hate to be the one to throw some facts in here but to get FDA approval, the company is spending hundreds of millions of dollars in additional research, including an international study involving 1,700 women, Divis said. The FDA last month signed off and gave Makena orphan drug status. That designation ensures Ther-Rx will be the sole source of the drug for seven years."

Looking up: http://en.wikipedia.org/wiki/Orphan_drug
"The Orphan Drug Act (ODA) of January 1983, passed in the United States, with lobbying from the National Organization for Rare Disorders,[1] is meant to encourage pharmaceutical companies to develop drugs for diseases that have a small market. Under the law, companies that develop such a drug (a drug for a disorder affecting fewer than 200,000 people in the United States) may sell it without competition for seven years,[2] and may get clinical trial tax incentives."
So the company spent a ton of money getting this drug FDA-approved and gets to make a profit off it during a 7 year window. At the end of the 7 year window the drug is cheaply available to everyone.
If you look past the rhetoric, this seems like a win-win. Look at the information in the article: Aetna covers the drug for 1,000 women a year. Is any company going to spend hundreds of millions on FDA approval to sell maybe $100k of drugs a year?

March 14, 2011 - 2:12pm
EmpowHER Guest
Anonymous (reply to Anonymous)

Your "facts" sound like KV Pharmaceutical propaganda to me.

KV Pharmaceutical did not CREATE 17P, nor did they spend a "ton" of money to get it approved by the FDA. (They are dangerously close to bankruptcy http://www.bizjournals.com/stlouis/stories/2009/07/20/daily80.html, but I'm sure they have our babies' best interest at heart.) The medicine has been around since the 1950s and has previously cost $200 per pregnancy. So, they'll be making a $29,800 profit on every woman that requires the injections.
Aetna is ONE insurance company of several, but sure, I'll go with your math. If 1,000 Aetna customers require 17P in one year, KV Pharmaceutical just made $29,800,000. Add in Blue Cross/Blue Shield, United Healthcare, Humana and others, that's over $100 million in ONE year. And of course, don't forget all the uninsured women who will need the shots, so that's several million dollars more that Medicaid will be spending...and we all know that the government is just rolling around in extra money right now.

So let's review: KV Pharmaceutical did not develop the drug (they merely pushed the paperwork on a drug that already existed and had been researched by the National Institute of Health-funded by TAX dollars), nor does the drug help less than 200,000 people a year. Therefore, it does not qualify for "orphan drug" status.

The "orphan drug" status is meant to help people with RARE disorders, not prey on women and babies for a obscene profit.

If those aren't enough facts for you, hear what Dr. Dombrowski has to say: http://www.youtube.com/watch?v=55J4VFnuhGU

March 14, 2011 - 3:12pm
EmpowHER Guest

I'm a little sad by the assumption that "many of the mothers who experience this type of pregnancy are mothers who are uninsured and low-income." There are MANY, MANY women--regardless of socioeconomic status or prenatal care--that suffer from pre-term labor, due to uterine abnormalities, pre-eclampsia, PROM, etc. To imply otherwise simply adds more guilt to those of us who had excellent prenatal care and still gave birth too early.

Also, there IS something that your readers can DO to make a difference. We are urging all Americans upset by this price gouging to speak up and let their voices be heard by their Senators and U.S. Representatives. THEY have the power to introduce legislation to revoke KV Pharmaceutical's "orphan drug" status, as it really doesn't apply to this situation anyway. ("17P does not meet the requirements for “orphan drug” status by virtue of the fact that (1) over 200,000 women may benefit from 17P injections each year and (2) the costs of research and development of the drug for the indication can be easily recovered by sales of the drug in the United States." http://gallipot.wordpress.com/2011/03/11/a-letter-to-my-congressperson/)

For more information, this article is clear and concise: http://bit.ly/h1zPbu

Legislators can be found here: https://writerep.house.gov/writerep/welcome.shtml

Thank you so much for speaking out on this issue!
Mom to a 1 lb., 8 oz. miracle AND 12 weeks pregnant with our 2nd
(This issue really affects our family!)

March 14, 2011 - 11:38am
(reply to Anonymous)

I am so glad you commented. This information is not meant to make anyone feel guilty - only to inform. There are many mothers who experienced preterm labor who are uninsured and low-income. But you are right, then there are many others who for other reasons have experienced this type of pregnancy as well. I'm excited that you have become an advocate and are encouraging others to be as well. It is ridiculous to be bullied into paying such an exorbitant price for such an inexpensive drug. Good for you!

March 14, 2011 - 12:10pm
(reply to Dita Faulkner)

Oh, and congrats on your bundle of joy!!

March 14, 2011 - 12:16pm
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We value and respect our HERWriters' experiences, but everyone is different. Many of our writers are speaking from personal experience, and what's worked for them may not work for you. Their articles are not a substitute for medical advice, although we hope you can gain knowledge from their insight.

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