Preventing prematurity: the importance of getting screened for Chlamydia

Chlamydia is a sexually transmitted disease that infects close to 3 million people in the United States each year. For women, chlamydia causes an inflammation of the cervix which often produces no symptoms. Unfortunately, the bacteria can make its way up into the uterus and cause a bigger infection (called pelvic inflammatory disease). Some women get very sick from this infection, and for others it happens silently with no pain, fever, or outward signs. Either way it can scar the fallopian tubes, causing infertility.

Chlamydia is also a factor in premature delivery. A new study from The Netherlands (published in May in the European Journal of Epidemiology) tells us that women who have chlamydia during pregnancy are more than 4 times more likely to delivery before 32 weeks.

Because it is almost always a silent infection, most women have no idea they have chlamydia. Therefore, it is vital to get screened during pregnancy at your first visit. Remember, if you had sex, you are at risk for an STD. If you have concerns about your partner’s fidelity, you have had sex with more than one partner during your pregnancy, or if you are 24 years and younger (women under 25 are three times more likely to have chlamydia than women 25 years and older) ask to be screened again at the end of your second trimester.

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Ther-Rx skips ACOG: the people have spoken. But can we do more?

I just returned from the annual conference of the American Congress of OB/GYN in Washington, DC. The first thing I did when I hit the exhibit hall was look for Ther-Rx and their display booth for Makena. I wanted to see what they were spending on their display and how many docs they were trying to take out for dinner. You know, if they were putting their anticipated profit to good use.

After walking the exhibit hall several times, I couldn’t find it. So, I asked an ACOG official. Apparently, ACOG advised Ther-Rx not to attend the meeting. Wow. I bet that’s a first.

I wonder if that would have happened without all the public pressure? If ACOG, the March of Dimes, and even the FDA would have been prodded into statements and actions without the groundswell of support from outraged parents, providers, and the public in general?

It seems that as far as progesterone is concerned, most providers will continue to prescribe compounded 17-OP and Makena may go the way of the Do Do bird.

But the absence of Ther-Rx at ACOG did give me cause to think. I mean, they are not the only pharmaceutical company to have obscenely priced products. To provide CEOs with hundreds of millions of dollars in salary and stock options while Americans go bankrupt trying to afford much needed medications (and also driving up the cost of health insurance).

If public pressure can impact one medication, why can’t we do the same for others and try to do something other governments seem able to do, but ours, seduced by Big Pharma lobbyists, are unable to accomplish? Insist on reasonable prices for prescription drugs?

We can be heard. We can make change. It just takes outrage and enough public pressure.

I’m open to suggestions for the next target!!!

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What does replacing the word retarded with intellectual disability accomplish?

Another celebrity, this time Lady Gaga, is in trouble for using the word “retarded” out of context.

Retarded is derived from the Latin, retardare and means a delay. This etymology helps to explain the appropriate medical use of the word: mentally retarded referring to an individual with significantly sub average intellectual functioning, typically an I.Q. of less than 70-75, and physical retardation which means a significant delay in physical abilities.

Retarded has also been co-opted as derogatory urban slang for stupid. When it graduated to the derogatory Merriam-Webster English for stupid, it became the R-word. Medical communities have responded in kind, almost universally replacing the word “retarded” with “intellectual disability.” They mean exactly the same thing. A low I.Q.

I find the universal cleansing of retarded from both the English language and medical terminology interesting, because the word retarded was not born out of any offensive intent. There are some medial terms that were born bad. A good example is Mongolism, a term coined by a quite possibly xenophobic Dr. Down for describing what is now known as Down syndrome. But is retarded, a word that has had a valid medical meaning for over a hundred years, and is derived from an inoffensive latin origin, really as bad as words whose sole purpose is to wound and maim. By reducing it to the R-word, aren’t we in fact assigning it the same odious status of the N-word and the C-word?

If changing medical terminology and cleansing our language removes prejudice and intolerance, then our professional societies have a lot of reclassification to organize. Who among us hasn’t heard the word spaz (derogatory for spasticity, the hallmark finding among individuals with cerebral palsy), schizo (short for schizophrenic), psycho (short for psychotic), bipolar, or cretin used pejoratively? Or is it somehow less offensive to co-opt these words?

Language is dynamic. In time, foreign words, slang, and even medical terms will become part of our vernacular and while most will enhance our language, a few will be used offensively. However, removing the word “retarded” from both medicine and what my mother would call polite language does nothing to change attitudes, improve manners, or teach compassion. Those advocates who feel that retarded should be the R-word should ask themselves: Would Lady Gaga’s intent have been any different if she had called her detractors “intellectually disabled”?

Just ask my kids. You can call someone wrong or misinformed, but you should never, ever call them stupid.

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Cigna’s automatic denials: asshattery in action

I’m going to be blunt here. Cigna is on my shit list.

Oliver needed hand occupational therapy. Unfortunately, it wasn’t covered by my primary insurance. Lucky for me, my work provides a secondary insurance that picks up some of the benefits missed by the primary.

Secondary insurances can be tricky, but I know the rules.

As far as my plan is concerned, if it isn’t a covered benefit under the primary, no letter of denial is required. Great, I thought. Hand OT is not a covered benefit, so no problem. So I submitted my $1875 for Oliver’s hand OT, filling out the form exactly right (because they will deny you in a heart beat if you make a typo!).

And guess what I got? I got a nice denial letter.

Two pages of bullshit mumbo jumbo designed to do only one thing – confuse. Somewhere in the back page, in a layout designed to be glossed over, was some info about what to do if I wanted to appeal.

Pissed off as all hell, I got on the phone. I spoke to a nice man. Troy (always ask for their names and write down date and time you talked and everything that was said).

There was hemming and hawing and silence. No, he could not find a reason why the claim was denied. It was an eligible benefit and the form was filled out just right.

“I’ll take care of it,” he said.

So I called back today, because the check, supposedly mailed 5 days ago, has yet to arrive. I thought I’d give it one more whirl.

“No”, the lady I spoke with could find no reason for the denial either.

That’s because automatic denials are common place. Hell, with most insurances they are the norm.

Why? Because many people don’t understand what they are reading. Others think they have no chance, so what’s the point? And to some, an appeal just sounds too daunting. And insurances companies, like my Cigna buddies, know this only too well. Even if 3% of people don’t appeal it’s worth it, because that is probably millions of dollars in prevented claims every year. I’ll bet far more than 3% never appeal their denial.

So always, always, always appeal your claim. You never know. It costs you nothing.

And like me, if you got an automatic denial (a denial that no one can seem to explain)? Send a note to your state’s insurance commissioner. If they get enough e-mails, they might look into it.

And to the politicians? Your 1rst step in reforming heal care should be fixing the obvious, like imposing massive penalties for automatic denials, say $100,000 per occurrence. If I were in charge, that’s what I’d do.

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ACOG’s double standard on Makena: denouncing Ther-Rx but taking advertising dollars

The American Congress of OB/GYN (ACOG) initially supported Ther-Rx’s application to the FDA for Makena. When the astronomical price, a hike from $10 to $1500 a shot, was announced ACOG released this statement:

ACOG is extremely concerned that women’s health may be shortchanged by this high price tag, and we’re asking Ther-Rx to reconsider it’s pricing and to ensure women have full access to this important drug.

Then on April 1, 2011 after Ther-Rx announced the price reduction from $1,500 to $695 a dose, ACOG issued a statement calling the reduction “inadequate” and applauded the “US Food and Drug Administration’s (FDA) statement that it will not prevent compounding pharmacies from continuing to produce valid prescriptions for 17P, a medication that has been safely used for years to help prevent preterm labor in certain high-risk pregnant women.”

So that’s all good. ACOG takes a stand on the price and supports the FDA’s decision to not interfere with compounding.

So imagine my surprise when I received this month’s Obstetrics & Gynecology, ACOG’s monthly journal. It was wrapped with a nice paper announcing the only FDA approved therapy for preterm birth. And inside, a lovely full page glossy add for Makena.

Hey ACOG dudes!

Issuing public statements about the pricing atrocity and how it will burden the already overpriced American system of health care is great and all, but it’s a pretty poor double standard when you are accepting advertising dollars from the very company you accuse of extorting the public.

If your advertising department is so out of touch with, you know, your message can we expect cigarette ads sometime soon?

Just saying. Because it’s stuff like this that makes me wonder if denouncing Makena was more about saving face than important things, like making sure every woman who needs 17 hydroxyprogesterone actually has access to the drug at a reasonable price.

#ACOGfail

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Learning tools for preemies: turning math into music

We have been working on money every night. I posted back in March about how this was posing a particular challenge for Oliver. Each night we spend 15 minutes (that seems like 15 hours) identifying and adding change change. We’re making headway, but Oliver has convinced himself that he can’t do it.

Each time the demon of self-doubt rears its ugly head, I go right back to the Pokémon analogy, that if he can remember Pikachu has iron tail (and every other freakin’ thing about that electric type Pokémon), then he can remember that a nickel is 5 cents.

We discussed his memory again, how he also knows the words and tune to almost every song that he hears. And once again I made my case for his brain being capable.

He argued that music and Pokémon are way more fun than math, that’s why he can remember those things. Math is boring.

“True enough”, was my response, “But we all have to do things we don’t like.”

He eyed me suspiciously. So I listed off a few of the billion or so things that I have to do each day that I don’t like.

And then Victor chimed in. We could make math into music. Maybe that would be more fun?

And so now we are singing this very short song every day, and we’ll see how it sticks.

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Making sense of the mess over Makena. Who wins and who loses?

It started in February. KV Pharmaceuticals submitted an application to the FDA to make Makena (17 hydroxyprogesterone or 17OP) an orphan drug. The application was endorsed by the March of Dimes. The actual quote from the medical director of the March of Dimes, Dr. Alan Fleischman, was “There will be consistency and high quality. This makes it a breakthrough not only that it’s FDA approved and doctors will be comfortable in recommending it, but also there will be high quality and consistency for women as they take it.”

Keep in mind, there were no reports of quality of consistency issues. None at all. And no doctors I know were uncomfortable prescribing it. That is why the March of Dimes whole hearted support of the misadventure is so mind boggling. Oh, well, not really, it turns out they were getting quite a bit of money from KV.

And then, of course the price of Makena was announced. $1500 a shot (more expensive than gold) – a $4.2 billion addition to the already $30 billion or so a year we already spend in this country on prematurity.

The March of Dimes issued a weak statement. Maybe it was hard for Dr. Jennifer Howse, president of the March of Dimes who makes over $600k a year, to understand how people, you know, might now not be able to afford the drug. The same drug that was once a very affordable $10 a shot.

I blogged all along that pharmacies would still be able to compound 17OP. Because Makena was approved under the Orphan Drug Act and not patented (you can’t patent a hormone that has been around for 50 plus years) it would be up to the FDA to police the compounding pharmacies. My two industry insiders assured me the FDA didn’t have the stomach or the resources to wade into that quagmire. Especially as important politicians, like Rep. Waxman were now getting involved.

Public outrage and scrutiny from the medical community as well as politicians was high, so to save face, the FDA formally announced they would take no action against compounding pharmacies. I mean, the FDA already made their money from KV Pharmaceuticals’ application (I’m guessing the FDA does not have a money back guarantee), so they had nothing to lose and everything to gain by stating the obvious. That compounded 17OP is just fine.

The March of Dimes took forever to act. Finally, when the price drop to $690 a shot was announced, the March of Dimes severed ties with KV Pharmaceuticals. Actually, they severed their contract. And now the March if Dimes says it’s OK for women to get the compounded 17OP, you know, the stuff they felt wasn’t high enough in quality on Feb. 4th.

So I’m confused.

The March if Dimes said 17OP compounded wasn’t good enough, but now it’s OK. Is it really OK, or just, “we were getting too much bad PR so now it’s OK”, OK?

And they had a contract with KV Pharmaceuticals? That makes me sick that they would sell their name and endorsement to Big Pharma, especially without considering how the drug might be priced in the first place. Although, then again, they have a lot of corporate salaries to cover before they get around to, you know, helping babies.

So here’s the deal. None of this was needed. And that makes me really angry, because a lot of pregnant moms (and their partners) got really, really worried about cost. A lot of health care professionals got really, really worried about the cost to the system. And a lot of people got really, really worried about their health insurance premiums.

The winners in this are the people. There was enough public outrage that politicians got involved. I mean even  The New England Journal of Medicine promptly issued an editorial decrying Makena’s price. I truly believe the power of the Internet made a difference.

The losers? Well, KV Pharmaceuticals learned a lesson in corporate greed. No one is going to prescribe Makena at $690 a pop when the FDA has ok’d compounding pharmacies to continue mixing it up for less than 1/10th the price.

And The March of Dimes. Taking so long to take a stand told me that you were only interested in your pocket book. You can’t have it both ways. If Makena was as important as you felt back in February, they you should really be committed to fighting for a lower price. But by taking your sweet time in severing ties with KV Pharamceuticals, it seems to me that The March of Dimes is saying one of two things…

  1. Pregnant women should really have Makena over compounded 17OP, but we can’t take the drop in donations and bad PR. We never, ever thought to research the pricing of orphan drugs or even discuss the concept of price with KV pharmaceuticals and KV is just not paying us enough to make it worth our while. We can sure talk about the price of corporate donations!
  2. Makena was never really needed in the 1rst place, and we can’t take the drop in donations and bad PR. KV is just not paying is enough to make it worth our while.

And I don’t know which is worse.

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Magic helps a preemie blossom

Oliver struggles physically, and he knows it. We have discussions about how he is last in sports, even behind the smallest girls (sigh). I tell him about his heart and his lungs and his muscles, but what does that mean to a 7-year-old? He just thinks it is unfair, and it is.

It has taken 18 months to get him anywhere in swimming, and now he can swim the length of the pool, dive to the bottom of the deep end, and is trying to master some semblance of a dive. But there are precious few fast twitch fibers at work…it’s a slow haul to get across the pool and by the 3rd lap he is exhausted while the other kids seem to be just warming up.

The other kids are also shooting hoops after school, playing soccer, softball, of whatever it is the kids with healthy hearts, lungs, and responsive muscles do. Poor Oliver will have nothing to do with competitive sports. And I don’t blame him? Who wants to come in last all the time? Or worse, be picked last for every team.

But he needs to do some kind of activity besides art. And that’s when it hit me.

Magic.

Slight of hand is fine motor. Check, we can always use more of that.

Getting up to give a show. Check, learning to speak in front of a crowd with confidence.

And it’s fun!

And best of all…he loves it!

So David Copperfield, you are on notice. Penn and Teller, run for cover. Chris Angel, face the music.

Boys, Magic Oliver is coming for you!

And here it is, the premiere performance of Magic Oliver

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Rep. Henry Waxman demands answers from Ther-Rx about Makena

Rep. Henry Waxman, Rep. Frank Pallone, Jr., and Rep. Diana DeGette sent a letter on March 24th to Gregory Divis, the CEO of Ther-Rx, regarding the pricing of Makena (see below). Of note, the honorable Mr. Waxman, Mr. Pallone, Jr, and Ms. Degette produced a far more sternly worded letter and asked much better questions than Dr. Howse from the March of Dimes.    

The letter gives an April 1, 2011 time line for a response.

What remains to be seen is whether Ther-Rx will cave and drop the price, or are they going to hunker down and ride out the storm? Personally, I think anything over $100 a shot is ridiculous. That kind of price point still gives them an incredible mark up an a drug that is quite litterally pennies to make and essentially going to be litigation-free (after all, it is recommended by the American Congreess of OB/GYN). However, Ther-Rx was near bankruptcy last year (note to March of Dimes, look into a company’s financial history before you start dating).  I suspect Ther-Rx will drop the price to $1000 a shot. Still egregious, but they can claim 33% is a significant reduction.     

The thing is, compounding pharmacies are still making the drug at a fraction of Makena’s cost (I have heard from many moms who are still getting their 17OP this way).  Because Ther-Rx does not have a patent on Makena, Ther-Rx cannot legally go after any compounding pharmacies. That is the purview of the FDA. And remember, the FDA serves under the direction of the government at the leisure of the people (or so I’d like to think, although, then again I believe in things like love at first sight and the inherent decency of mankind).

Getting key members of the House of Representatives on board is crucial. Personally, I don’t think the FDA will go after compounding pharamcies (detailed in this earlier post), and if the pregnant mothers of America have a few heavy hitters on their team, the chance of the FDA wading into this quagmire should drop even more.

This issue affects us all, whether you are trying to have another baby and desperately trying to not deliver prematurely this time around, a  concerned health care professional, or a taxpayer pissed off about the fact that Ther-Rx is going to line their pockets to a tune of $4.2 billion/yr on the backs of research funded by the NIH.

Tell your Representatives and Senators to get involved. Tell them this kind of extortion is unacceptable. Make it sticky issue, so the FDA decides to turn the other cheek. 

 ——————————————————————————————————–

Letter from Rep. Waxman et. al. to Greg Divis, CEO (Chief Extortion Officer), of Ther-Rx

Click here for full post on the subject on the web site of The Committee on Energy and Commerce 

March 24, 2011 

Mr. Gregory J. Divis
President
Ther-Rx Corporation
Chief Executive Officer
KV Pharmaceutical Company
Corporate Headquarters
One Corporate Woods Drive
Bridgeton, MO 63044

Dear Mr. Divis: 

            We are writing regarding reports of high prices that Ther-Rx Corporation[1] is charging for Makena, a drug recently approved by FDA to reduce the risk of preterm birth in women with a history of spontaneous preterm birth.  News reports indicate that the company will be charging as much as $1,500 per dose, a total cost of as much as $30,000 for women who must take the drug over the course of a pregnancy.[2]

            The high cost of this drug is particularly disturbing because it is not a new drug.  The drug – a synthetic form of the drug progesterone – was originally approved by FDA decades ago, then later withdrawn because of lack of sales.  Prior to Ther-Rx’s marketing an FDA-approved version of Makena, the drug was available from compounding pharmacists for an estimated $20.00 per dose – less than 2% of the price charged by Ther-Rx.  Experts have indicated that Ther-Rx could realize as much as $4.2 billion annually in revenues as a result of its new pricing policy.[3]  Moreover, because Ther-Rx has received an orphan drug designation for Makena, your company will be able to forestall generic competition, maintaining your exclusivity and control of prices for seven years, and potentially beyond, depending on the status of any patents protecting the product.

            Ther-Rx did not invent this drug, or the use of the drug to prevent premature births.  But this has not stopped your company from charging extremely high prices.  The pharmaceutical industry has traditionally justified its high prices by claiming that such prices are necessary to allow companies to recoup their research costs.[4]  In this case, however, Makena was approved under the  “505(b)(2)” pathway, which permits an applicant to rely on studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.[5]  The two studies cited on the FDA-approved label for Makena appear to be funded by public dollars through the National Institutes of Health (NIH).[6]  In addition, Ther-Rx has apparently set its price at the maximum level at which health care plans will still be “motivated to provide coverage” of the drug.[7]  It appears that the price of this drug is not being set on the basis of the cost to produce or research the drug, but at the maximum level that providers are willing to pay.

            There are undoubtedly important advantages to Ther-Rx’s sale of an FDA-approved version of this drug.  But we are concerned about the impact of the high prices for Makena on private insurers as well as Medicare, Medicaid, and other public programs, and we question whether these high prices are justified.  In order for us to evaluate these issues, we ask that you provide us with the following information:

  1. Any fiscal or other contributions made by Ther-Rx to the two NIH studies cited on Makena’s FDA-approved label.6  
  2. Any additional research costs to date incurred by, or studies conducted by Ther-Rx in obtaining FDA approval for Makena, and the expected costs of ongoing research.  Please include all registry numbers listed under www.clinicaltrials.gov for any clinical trials that formed the basis for approval, and for any such trial that was published in a peer-reviewed publication, a copy of the publication.  Please ensure such information includes the five postmarketing requirements as per FDA’s approval letter.[8]
  3. Any research or data on the bioequivalence of Makena to the compounded versions or previously FDA-approved versions of the drug.
  4. Ther-Rx’s promotional expenditures on Makena, and details on how these funds were spent.  Please include information on promotional expenditures to date, and anticipated future expenses.
  5. Ther-Rx’s total cost, and estimated unit costs, to manufacture Makena, and the components of such costs.
  6. Ther-Rx’s expected revenues and profits from sales of Makena.
  7. Ther-Rx’s anticipated revenues and profits from sales of Makena to Medicare, Medicaid, and other federal or state health care programs.

            We ask that you provide us this information no later than April 1, 2011.  Please contact Brian Cohen of the Committee staff or Tiffany Guarascio of Rep. Pallone’s staff if you have any questions about this request.

                                                            Sincerely,

Henry A. Waxman
Ranking Member
Frank Pallone, Jr.
Ranking Member
Subcommittee on Health
Diana DeGette
Ranking Member
Subcommittee on Oversight and Investigations
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The March of Dimes really responds to Ther-Rx and price of Makena, well, sort of…

Today (March 23rd) Dr. Jennifer Howse of the March of Dimes (MOD) finally responded to the egregious price gouging/extortion that is Makena (17 Alpha-hydroxyprogesterone caproate, or 17OP, newly packaged as an orphan drug). As we all know, this travesty was blessed by the March of Dimes. I and others have blogged about our concerns, not only with KV Pharmaceuticals/Ther-Rx and their pricing (and woefully inadequate patient assistance program), but also about the March of Dimes involvement.

The March of Dimes initially issued the blandest of statements about the price. Now, almost two weeks later they are issuing a more strongly worded letter. Although, it is very interesting to me that there has yet to be a press release concerning this letter. I received a copy from Mark Goldhaber, another concerned blogger, who was in contact with a SVP of marketing for the March of Dimes (the SVP was in contact with me as well, but I wanted different answers, so all I have heard in return is crickets).

The letter is posted at the end of this blog. Maybe there is no press release because legal is still working on it, who knows. I mean who knows anymore with the March of Dimes, because the longer they take to really set the record straight the more they sound like a big corporation trying to shore up the bunker and less like a non-profit whose primary mission is to help babies.

And about that letter? Saying you want a significant price reduction means nothing. That’s like saying you want sex more often. Is more often once a week, once a month, or once a year? Not to be flippant, but seriously guys, your failure to commit on this issue (or my guess, even consider the financial ramifications for the pregnant women of America) is one of the things that got you into this mess in the first place. If you actually trusted KV Pharmaceuticals to sell the stuff for, I don’t know, $200 a  pop, then you clearly know nothing about the pharmaceutical business. This is why getting into bed with Big Pharma is never smart.

And asking Ther-Rx to justify their pricing? That’s pretty Junior High of you. They are a business and this is a capitalist society, they don’t have to justify their pricing to you or anyone (see above, why you shouldn’t get into bed with Big Pharma). I don’t agree with the pricing one bit, but private corporations don’t generally have to justify price unless the Federal Trade Commission is willing to do something about it (I’m not holding my breath).

But my major issue with this letter is that it deflects all the “problems with Makena” onto Ther-Rx/KV Pharmaceuticals. We must not forget that the March of Dimes supported this application and clearly did not consider the ramifications. They made a very poor decision, and might I add, they made that decision with the dimes and dollars people have collected one walk at a time.

These are the questions that should have been addressed in the letter:

  1. Why didn’t MOD didn’t think about the price of an orphan drug before colluding with Ther-Rx/KV Pharmaceuticals.
  2. Why MOD thought a drug that has been available since the 1950′s needed to be FDA approved “all of a sudden.”
  3. Why the MOD didn’t just fund a follow-up study of babies whose mothers received 17OP (because the post marketing surveillance was part of the FDA approval).

Until those questions are answered, my money will go to the Perinatal Homeless Project in San Francisco, because at least I know it will be used to buy strollers and other useful things for new mothers who have nothing, not to fund a bunch of corporate big wigs who seem woefully out of touch with the very people they are supposed to be helping.

————————————————————————————————

March 23, 2011

Greg Divis, President
Ther-Rx Corporation
One Corporate Woods
Bridgeton, MO 63044

Dear Mr. Divis:

Thank you for your letter of March 17th. I am pleased to learn that you are ‘listening carefully to stakeholder concerns about list price, patient access, and cost to payers’. Thank you for considering additional steps to ensure that Makena is available to all eligible women, and for convening stakeholders from the March of Dimes, the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, and the Society for Maternal Fetal Medicine next week.

In advance of that meeting, I want to go on record that March of Dimes expects Ther-Rx to come to the table with substantive commitments including:

1)      A significant reduction in the list price of Makena.
2)      Adjustments to the patient assistance program to ensure adequate coverage of all patients, insured, uninsured and underinsured.
3)      A method for reporting on a regular basis to stakeholders on the patient assistance program to ensure that it is meeting needs in a timely and adequate way.
4)      A justification or rationale for your pricing based on your investment in the product, savings to the health care system, or other appropriate methodology, which you are prepared to make public.

Without these elements, I do not believe that Makena can succeed in the current marketplace environment, and as a result, at-risk women will be denied access to a safe and effective treatment to reduce preterm delivery. Therefore if you are unable to make a clear commitment to significantly address the above issues at the meeting, the March of Dimes will need to pursue alternative strategies for ensuring that this proven intervention to prevent preterm birth is made available to all medically eligible pregnant women, and we will step away from our longstanding and productive corporate relationship with Ther-Rx. Thank you for your consideration of this critical matter.

Sincerely,

Jennifer L. Howse, PhD
President

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