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Boycott Makena

This month KV Pharmaceuticals gained FDA approval for their drug Makena, or 17 Hydroxyprogesterone Caproate, for use in prevention of preterm birth.  This drug has been shown in randomized studies to moderately decrease the rate of preterm birth in women with previous preterm deliveries. 

While this is the first FDA approved product for this indication, this very compound has been available on the market for many years, generated by compounding pharmacies nationwide for as little as $9 a dose.  One major supplier, Wedgewood Pharmaceuticals, provides the product in vials every bit as professional looking as anything you would get from a major Pharma manufacturer.

The big problem, as most already know, is that KV Pharmaceuticals has decided to price their drug at approximately $1500 a week.  Furthermore, they are extending legal power to prevent compounding pharmacies from creating any more of the drug.

This is outrageous.  This is a well studied drug, already having gained acceptance in the community based on the landmark 17-OHP trial published in 2003.  Millions of doses have been given nationwide without adverse effect.   The fact that it has become FDA approved has done nothing for women or infants.  The only effect has been that KV now has legal protection to price the drug at 200 times the previous price and block out competitors who previously had been providing the same drug at a tiny fraction of the cost. 

An article was recently written in the New England Journal decrying this usurious pricing scheme.  In their analysis, they write “For every dollar spent for compounded 17OHP, $8 to $12 in health care costs related to pematurity are saved.. by contrast,  Makena will require $8 to $12 in drug spending for every dollar in such prematurity costs avoided.”  Further editorials have been published in both print and digital media, such as this, this, and this.  My friend @drjengunter weighs in here

KV has responded to the criticism, pointing out that they have a patient assistance program.  To be fair, they are willing to give the drug for free to uninsured women making less than 60,000 a year, and at a small copay for women making less than 100,000.  But to be fair to women and the world, this isn’t nearly enough.  No matter what individuals are paying for the drug, the medical system will be paying billions of dollars for something that used to cost a few million a year. 

Positive spin on Makena has promoted it as the first drug to decrease the rate of preterm delivery. This is an agregious mistruth. The drug has been on the market for over 50 years, and has been used for the indication for almost a decade in the United States.

At the core, KV Pharmacueticals is a leech on the blood of our society.  They are providing nothing of value, but through our bureacratic process have been guaranteed that they can extract billions of dollars a year from our healthcare system – all to get a benefit we already had.  They didn’t even have to do the research; it was done for them and published in 2003 (with compounded drug.)  The idea that their particular FDA approved product is somehow better or safer than the compounded product is completely theoretical, cannot be justified by any data.  Furthermore, the underlying efficacy of the drug KV claims has immeasurable benefit is worthy of some skepticim despite the 2003 trial, as since it went into widespread use the preterm birth rate has risen from 12.3% to 12.7%.

So what are we to do about this.   I am doing this.

I will not write a single dose of Makena, and I call for you to do the same.

If I can, I will continue to use compounded 17-OHP.  If I can’t, I will recommend daily vaginal prometrium, which very likely will have the same effect as 17-OHP.  Its off label, but so was 17-OHP before KV got ahold of it.  If a patient asks, I will politely explain that I refuse to give in to KV Pharmaceuticals and their piracy.  The cost of healthcare is destroying this country, and this is an area in which we cannot afford to give in.  Patients need to understand that these are the kinds of decisions that drive the cost of healthcare, and that we are all responsible for protecting our country’s healthcare future.

I encourage everyone over which I have any influence to refuse to write Makena for any reason, and to pass this message on to anyone who will listen.

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  1. March 17, 2011 at 6:38 am

    I agree. I am completely disgusted with this company’s marketing/pricing plan. This company and its product should be made the “poster child” of obscene gouging by pharma. Considering that there have been Congressional hearings in the past on “high” gas prices I would like to see some hearings on this much more important matter.

    The company’s saying that they have a “patient assistance program” is nonsense and beside the point. NO ONE, not even the hated health insurance companies, and especially not our financiall-strapped medicaid programs should have to pay these extortionate price to this company for this medication.

    I would love to hear of other ideas for coming down on these unethical and malevolent pieces of absolute human garbage who came up with and are pursuing this money-grubbing rip-off scheme. And, yes, I attribute malice to them because they know full well that their scheme *will* keep many women who and their babies who could benefit from 17-OH-P from getting it. A boycott is not enough – this is far FAR worse than “chicken of the sea” killing some turtles and dolphins in their nets intended to catch tuna!

  2. S. Marsh
    March 17, 2011 at 2:05 pm

    Good on you, Dr Fogelson! I wonder what the status of this drug is in Australia. I follow the work of Dr RH Lustig, too, on fructose consumption. Big Food and Big Pharma have a lot to answer for in the health system. Thank you for standing up the common woman (in the sense of the common man) and doing the decent thing. All power to your arm.

  3. March 17, 2011 at 2:30 pm

    You articulated my thoughts very well. Now for action: In Oklahoma, we have taken a graduated approach to tighten the noose around KV Pharmaceuticals/Ther-Rx. We sent protest e-mails to the company in St. Louis and, as expected, received well-rehearsed form letters defending their policy. We then called their brand-new local rep, who drove all the way up from Dallas to explain their pricing policy and patient assistance policy. I politely explained our plan to disallow any Makena rep in our offices and that we were going to campaign statewide for every OB/GYN to do the same. I then heard from her district manager, responsible for Texas, Oklahoma, and New Mexico. He did not provide any new information but passed it along to the Makena national marketing director in St. Louis. She explained to me Ther-Rx’s policy but, upon hearing what we have done so far, practically begged me not to proceed with our campaign until they had a chance to talk with ACOG. What she heard from me was that we have contacted ACOG’s executive director, who emphasized that they are actively involved in efforts to convince Congress and the FDA to come down hard on KV Pharmaceuticals. I later spoke with Dr. Fleischmann, the national director of March of Dimes, who explained that his organization had nothing to do with this egregious pricing policy even though they actively supported approving 17OHP Caproate as an orphan drug with the FDA.

    Bottom line- if we in Oklahoma do not hear back from KV Pharmaceuticals about drastic steps to reduce the cost of Makena by Monday 3/21/11, we will start a statewide campaign to boycott Makena and support using compounded 17OHP-C (a slight change in the formulation, including simply adding Vitamin D, may make it possible to distribute it). The Makena rep called me yesterday and complained that she was not allowed admission to several physician offices in Oklahoma City. That is happening even though we have not even started campaigning. I encourage all of you from other states to do the same.

    Several years ago, during a temporary gasoline shortage, the gas station across from my hospital hiked up their prices drastically. Within a month, they were out of business, victim of television exposure and public boycott. KV Pharmaceuticals is a company on the financial brink. I suspect it will go the way of that gas station..

  4. March 17, 2011 at 2:38 pm

    I was just going to post and ask you to blog about this. I have been tweeting alot about this. I encourage all to join this facebook page also.

    http://www.facebook.com/pages/Shame-on-you-KV-Pharmaceutical-and-CEO-Greg-Divis/205462536133171

    I did not start it but I think it is a great idea.

    The one question I have not been able to find out is whether or not I will still be able to buy 17 OH P from a compounding pharmacy like I have been for the past few years. I am happy to buy the non FDA approved version just like we always have.

  5. March 18, 2011 at 4:12 pm

    Thank you for taking this issue to the public. I hope your colleagues will follow suit.

  6. Angus Goldberg
    March 18, 2011 at 6:52 pm

    Well spoken! The actions of KV Pharmaceuticals are an affront to the best values of our society. I have contacted my congressman about the issue, which seemed the least that I could do.

  7. Dr C Thompson
    March 19, 2011 at 3:07 am

    Wow, when will you focus on the 60-80 billion a year in public insurance fraud? Sounds like you are ready to use a compounded product off label/avoid the FDA product. I hope you have all your bases covered legally with private and public insurances. Maybe you would enjoy practicing medicine in Cuba where the drug costs are very low, just don’t speak out against the government!

  8. March 19, 2011 at 4:23 am

    Dr C Thompson just doesn’t “get it.” Either he has not read the post with all the comments or he is a plant by KV Pharmaceuticals. In fact, what KV is doing is ***exactly*** what Castro has been doing ever since he took over that country: enjoyed wealth for himself at the expense of everyone else through force and fraud.

    • Rick Swensen
      September 4, 2013 at 9:35 pm

      Thank you Dr. C Thompson for revealing your obvious financial interest in this drug….typical.

      • Timothy Gorski MD
        September 5, 2013 at 2:26 am

        So where are we at now? What does KV charge for this drug now – for inscos and medicaid and for cash-paying patients?

  9. Dr C Thompson
    March 19, 2011 at 7:20 am

    Tim, I get it and no I’m not a plant. I have done my homework on the costs of what it took to get the approval by the FDA. I am not happy with the initial cost, but I want to see if my patients have more access. One last thought, are you calling for investigations into the cost of gas and food today? The price today is higher in my community than back during “the greedy oil companies witch hunt.”. Maybe it doesn’t bother you as much based on who is in the White House.

    Comparing what KV is doing vs Castro and his government is laughable. KV didn’t have thugs rounding up people who disagree with them. My point was a simple one if you want fixed costs on goods, equal access to healthcare (no mention of quality), and you have to give up your freedom. Pack your bags and let us know how it’s working out for you!!

  10. Dr C Thompson
    March 19, 2011 at 9:10 am

    Eli, Which gas station should we boycott and drive out of business? Seeing how you are comfortable being the judge, jury, and executioner let us know.

    • March 19, 2011 at 11:01 am

      A boycott is only as strong as its members. Obviously if its only a few people it will have no effect. If its big enough to bring down a company, then obviously the people have spoken.

      >> Sounds like you are ready to use a compounded product off label/avoid the FDA product. I hope you have all your bases covered legally with private and public insurances.

      Well, we’ve been using a compounded product for almost a decade, and the original NIH funded research that underpins Makena’s FDA approval was with a compounded product, so I think our bases are pretty well covered there.

      >> I am not happy with the initial cost, but I want to see if my patients have more access

      How could they have more access? They can get 17OHP right now for $10 a dose, and its already covered by all insurers. Jacking up the price is only going to decrease access, and line the pockets of KV to the tune of billions of dollars a year.

      >> I have done my homework on the costs of what it took to get the approval by the FDA.

      Who cares? It certainly wasn’t billions of dollars. They didn’t even need to do the trials – they were already done for them. In the end, KV has done nothing that benefits women. They are only siphoning cash with no return benefit from the siphoned.

      There’s nothing wrong with KV creating an FDA approved product. More power to them. If the market will support that price because it values the FDA stamp, then great. But that’s not what they are doing. They aren’t even letting the market decide. They are muscling the compounders out and cornering the market.

      KV – “Hmmm.. that 17-OHP made by those evil compounding pharmacists must be pretty dangerous… not mixed well… impurities….. how about I make a pure version?”

      Women of America – “OK. sounds good”

      KV – “Here’s the new version. BTW its 300 times more expensive that what you were already using. Oh… one more thing… if you ever try to use what you were using before we’ll sue you…”

      Sounds like a protection racket to me. Right out of the Sopranos.

  11. March 19, 2011 at 11:13 am

    Show me the gas station that sets the price of gas at 150 times what it has been while suing the competition that are willing to sell for less. That’s the gas station that needs to be shut down and its owners shamed and driven into some other line of business. What will be dealing with next, some company pays the FDA some money and brands its version of water as the only FDA-approved drug to treat dehyration at $1000 a liter and sues everybody else selling the same thing?

  12. Dr C Thompson
    March 19, 2011 at 11:48 am

    Tim, I’m not the one who gave the example of the gas prices back during those terrible Bush years. Granted congress went after the oil companies based on their record profits. Yet no Democrats are up in arms about gas prices. If you really believe government will provide your protection, freedom from want, and always be just. You have not only not studied your history, but a person who Lenin coined a “useful idiot.” In the sense of by depending on gov’t to provide for you……they can also restrict you be it in a polite manner at first.

  13. March 19, 2011 at 12:04 pm

    I never attributed that to you, Thompson. Meanwhile, YOU are on the wrong side of the question of whether the gobbermint is a great thing can be relied upon to do the one thing it is entitled to do, which is to protect the natural rights (not the entitlements) of its citicens. In this case the gobbermint is colluding with KV to enrich it wrongfully, even if legally. It’s not even about the price of drugs. There are lots of expensive drugs. But not any others whose makers seek to supplant far cheaper medications that are already in use without there being sufficient additional clinical benefit. So, again, you just don’t get it – it’s nothing to do with Lenin or any of that.

  14. March 20, 2011 at 4:05 am

    Thompson- I’m glad I met ya! Here are some facts and figures regarding Makena: KVP did not pay for R&D. The studies on 17OHPC were performed by NICHD. A conservative estimate is that KVP would pay $210 million to purchase the rights to distribute the drug (via Ther-Rx)and conduct a follow-up study, as requested by the FDA. If KVP’s pricing policy stands, the company will make an estimated $2.4 BILLION annually at the expense of my patients, me, and ,yes, you, Thompson! KVP was a very good company at the time. Victor Hermelin (the “V” in KV) created it in 1942 and was responsible for multiple innovations, including the time-release capsule. His son Marc is now under indictment for drug misbranding and purportedly is going to jail. Victor went to court to have his own son removed as president because of multiple improprieties. KVP has been in financial trouble in the past few years. Most of its products were withdrawn from the market (remember Niferex, Chromagen, Premesis, Primacare, Clindesse, Gynazole?) Its stock rose drastically in February at the heels of the FDA approval but is now in downwards spiral. A congressional investigation has been requested by 2 congressmen. Nuff said?

  15. March 21, 2011 at 1:45 am

    @ Nicholas and all:

    I’m curious about a couple of things:

    1. If this (relatively) same compound has been used for years already in the moderate prevention of pre-term birth, why is our national rate still hovering around 12%? (http://www.usatoday.com/news/health/2010-05-12-preterm12_ST_N.htm)

    2. How widely advertised is KV’s “patience assistance program?” If no one knows about the program–if women being prescribed this med (by those providers not-yet getting on board with the above-discussed boycott) don’t know to ask for the assistance, does KV plan to go out of its way to let patients/providers know about this supposed philanthropic program? Sounds like PR smoke and mirrors to me.

    3. Less an accusational, than an educational question: What are the risks of exposing a fetus to week after week of a sex hormone? When the causes of pre-term birth still remain a mystery in many cases (aside from nosocomial pre-term birth), how does a provider know when the potential risks are worth initiating the treatment? (A reference to a long-term study looking at children who were exposed to 17 alpha-hydroxyprogesterone caproate in utero would be much appreciated.)

    Thanks ~

    • March 21, 2011 at 3:01 am

      These are very good questions.

      1) We have no idea. The 2003 NIH study did demonstrate that 17-OHP significantly reduced the rate of recurrent preterm delivery in women who had previously experienced a preterm birth. It went into widespread use after that, yet the preterm birth rate did not decrease. One theory is that because a large part of preterm birth is primary preterm birth (first time preterm birth), the effect of 17-OHP, which is only for prevention of recurrent preterm birth, is muted. 17-OHP is not used in every pregnancy that is eligble for it, as well. It also may be that 17-OHP is not as effective as we thought.

      2) patient assistance programs are not typically advertised widely, though they are easily found if searched for. I don’t know what KV plans to do. In my opinion the assistance program isn’t the issue. Saying that it is to say that it doesn’t matter if one charges $30,000 a pregnancy to an insurance company. All of this is the cost of health care. In the end we still pay for it.

      3) Every pregnancy is awash with multiple sex hormones, so we can’t really accuse 17-OHP on that alone. While 17-OHP is made synthetically, it is a naturally occurring metabolite of progesterone, and is present in low levels in normal pregnancy. It is not androgenic, so we would not expect it to have any effect on sex organ development. The 2003 did not find a significant attributable risk for for birth defects with 17-OHP. The drug isn’t started until 16 weeks, after all major organogenesis is complete, so it would be hard for it to be substantially teratogenic.

      There is a nice summary of the teratogen studies on 17-OHP here: http://www.hydroxyprogesterone.com/hydroxyprogesterone-safety.html

    • Roger Sortie
      March 29, 2011 at 7:51 am

      Those statistics on preterm birth are a bit misleading. They include multiple gestation pregancies. The rate of preterm birth among women with a singleton birth has actually been on the decline. Women having children at an older age and multiple births are the real reason for the continued increase.

  16. March 21, 2011 at 2:58 am

    1) This has not been studied, but it is easy to speculate. Increasing use of assisted reproductive technology with multiple gestation, and 17-OH-P seems to not work in mutliples. Women at highest risk probably don’t start prenatal care early enough – this is contributed to, IMHO, by the difficulty in getting approved for medicaid quickly. Remember, too, that preterm birth rates in the USA include all the women delivering prematurely that come in from Canada.

    2) Yes, it’s PR smoke and mirrors intended to deflect criticism of their scheme to make the reasonably-priced medication unavailable.

    3) See http://www.healthline.com/blogs/pregnancy_childbirth/labels/preterm%20delivery.html – last para is most pertinent: “more reassuring is another recent study (Northen, et al., Obstet Gynecol 2007;110:865-72) that did follow-up evaluations of the babies born in the original 2003 17P trial of Meis and colleagues. At a mean age of follow-up in 194 children exposed to 17P and 84 placebo controls, “no significant differences were seen in health status or physical examination , including genital anomalies” between the 17P and the placebo children. Testing scores for “gender-specific roles” were also normal and comparable between the two groups. Since this is the only randomized, controlled study of substance published to date, it must be considered the most reliable information available as well and it would appear that 17P, as used in this trial, beginning at 16-18 weeks gestation, has a minimal risk for the fetus and newborn, at least from the standpoints of birth defects and development.”

  17. March 21, 2011 at 4:40 am

    Please read Ohio Senator Sherrod Brown’s editorial in today’s USA Today titled “Sherrod Brown: Drug firm fleecing pregnant women”

    http://www.usatoday.com/news/opinion/forum/2011-03-21-column21_ST1_N.htm

  18. March 21, 2011 at 10:38 am

    Contact Senator Brown – author of the USA Today piece – and urge him to introduce legislation to block any effort to prohibit (by the courts and/or FDA) continued compounding by pharmacists of 17-hydroxyprogesterone caproate. KV Pharmaceuticals won’t be able to rape Americans and kill premie babies as long as the fairly-priced alternative remains available. Contact Senator Brown here:

    http://brown.senate.gov/contact/

  19. March 21, 2011 at 5:50 pm

    Thanks to both Gorski and Fogelson for references to pertinent articles.

    We will be covering this general issue on Science & Sensibility as well, with some additional discussion on other approaches to preventing pre-term birth.

  20. March 22, 2011 at 1:41 am

    The Oklahoma opening salvo in the fight against price-gauging:

    http://www.news9.com/Global/story.asp?S=14294858

  21. Marcy Bliss
    March 23, 2011 at 3:16 am

    Here is a useful link we put together with the 17P NEJM editorial, joint letter to Ther-Rx corporation from AAP, ACOG and SMFM, Senators’ letter to FTC, AHIP’s letter to FDA, and more. We will update daily as we have more info.

    http://www.wedgewoodrx.com/learningcenter/17p-information-resources.html

  22. March 31, 2011 at 5:04 am

    A copy of letter distributed to all OB/GYNs in Oklahoma on behalf of ACOG- I wrote the letter and ACOG “watered it down” a bit, removing the call to Boycott Ther-Rx. We sent a more “assertive” version calling for boycott but without ACOGs monniker (double whammy)

    The following information has been compiled by a group of concerned Oklahoma ACOG members.

    Dear Colleague,
    The Food and Drug Administration (FDA) recently approved 17-hydroxyprogesterone Caproate (17OHPC) for prevention of prematurity. The approval route was through an accelerated orphan-drug process. The rights to distribute the drug, now known as Makena, were purchased by KV Pharmaceutical (KVP) from St. Louis via its subsidiary, Ther-Rx. KVP did not spend any money on research and development. As you may have heard, KVP intends to market the drug for $1500 per injection. A weekly injection for 20 weeks of treatment will therefore cost $30,000!
    A conservative estimate reveals that KVP would pay $210 million for the rights to distribute the drug and for follow-up studies, but will make $2.4 billion annually for 7 years if its pricing policy holds. It would take the company 4-5 weeks to recoup the entire cost of purchasing the rights to distribute the drug! Who will pay this exorbitant cost? KVP announced a patient assistance program (“no patient left behind…”). It will therefore be the responsibility of all of us (with higher insurance premiums and Medicaid costs) to incur an outrageous financial burden.
    The College, along with the American Academy of Pediatrics and the Society for Maternal-Fetal Medicine, is urging Ther-Rx Corporation to reconsider its pricing of Makena. The College is concerned that the extremely high cost of Makena™ will hinder access and affordability to this treatment for both insured and uninsured patients. The following is a link to the College’s press release on this issue: http://www.acog.org/from_home/misc/20110311GoedekeLtr.pdf

    Thus, in addition to the College’s advocacy activities, this is what we recommend that you, as a caring physician do:
    Review the College’s Committee Opinion 419, October 2008, Reaffirmed in 2010, Use of Progesterone to Reduce Preterm Birth that can be found at http://www.acog.org/publications/committee_opinions/co419.cfm. You should also be aware that compounded 17OHPC may still be available being made by some Oklahoma compounding pharmacies at low cost.
    Write a letter to your Senator (Coburn, Inhofe) or Representative (Boren, Sullivan, Lankford, Lucas, Cole) demanding a congressional investigation of KVP for price-gouging and ask your patients to write a letter. CLICK HERE FOR A SAMPLE LETTER
    There is already a Facebook page entitled “Shame on you, KV Pharmaceutical” that is worth visiting.

  23. Timothy Gorski MD
    April 1, 2011 at 10:20 am

    Just received this from ACOG:

    >> Since the announcement about the availability of FDA-approved Makena(TM), we have received numerous calls and emails from ob-gyns across the country expressing outrage over the cost of this critical therapy. We want you to know that The American College of Obstetricians and Gynecologists shares your concerns and we’ve taken a variety of steps demanding action, including having met this week with key representatives from K-V Pharmaceutical Company and other concerned medical groups. With respect to the recent Makena(TM) ad in the April issue of Obstetrics & Gynecology, The College has been advised that the journal will no longer accept advertising for Makena(TM)

    In response, K-V Pharmaceutical Company has agreed to reduce the cost of its drug from $1,500 per dose to $690 per dose. The American College of Obstetricians and Gynecologists strongly believes that K-V’s subsequent price reduction is inadequate

    In addition, we applaud the FDA for its position not to take enforcement action against compounding pharmacies that continue to produce valid prescriptions for hydroxyprogesterone caproate or 17P.

    Be assured that we will continue to address this important issue on behalf of our members and their patients and will work to ensure that this medication is accessible and affordable to every pregnant woman who needs it. <<

    To my mind, KV ought to be able to make and sell its product for less than the compounded material and still make a profit through economies of scale. There is simply no reason to spend more per dose than we do with the current preparations and any effort to have it otherwise is ill-intentioned, particularly considering the need to economize on all things medical (and on everything else!) as the US economy continues to slide into a long stagflation-depression.

    • April 3, 2011 at 2:34 pm

      Thanks for the commet Dr Gorski.

      Even at the reduced price, I see no reason to prescribe Makena. Compounded 17-OHP has been working fine, and was the substrate of the original 2003 study. Its true that compounding pharmacies have the potential to mix imprecise dosages of drugs, but KV’s track record on drug production hasn’t been so great in the past either. There’s also little reason that 17-OHP couldn’t be produced accurately, given that there are some large commercial compounders that make it (Wedgewood being the biggest.) Furthermore, there’s no reason to believe that a small variation in dosage would have an impact on the efficacy of the drug. 250 mg was pulled out of the air. 230 or 270 is probably just as good (or not good, depending on how you interpret the 2003 data).

  24. none
    April 15, 2011 at 8:23 pm

    Dear all:
    The cost of this drug to KV is 300 M. However, you forget the fact that many other researched/tested drugs do not come to the market. The real cost of a drug to a company is not how much it spent developing it, it is the sum of money the company invested in multiple compounds so that it can bring one to the market. Pharma is 19th profitable industry and biotech as a whole has never made a dime. Yes, some companies like Alexion ( which markets $450,000 a year Soliris, to kids with PNH, and yes, it is a 9 Billion dollar company and sells its drugs to a handful of patients ) are profitable, but many others are bankrupt. It is plain stupid to expect that a company will sell a new drug at its cost. Instead of writing this propaganda to advance your agenda, you should be supporting the health care industry that has saved lives. KV went to FDA, simply asked if they invest in this compound and do the work after marketing ($60M to confirm its safety), they would let them sell the drug if approved and got a “yes” answer. Now that years passed, and it is approved, you ask them to sell it at cost, actually less than the cost. What you are doing will not benefit patients, it will harm them. It will harm them, because the post marketing studies will never get done, and other companies will shy away from developing such medicines.

    The above commenter writes; “230 or 270 is probably as good” I am shocked by this comment. How can a physician prescribe anything, stating “probably good”. You guys are dangerous and play with people’s babies lives. When you write a prescription, please state your patient that you are not writing an approved drug, but a compound that is “probably just as good”.

  25. rt
    April 15, 2011 at 9:30 pm

    When writing a prescription for this indication the “standard of care” calls for a prescription of Makena.
    A competent doctor who truly values the life of his patient and her fetus over his monetary concerns will prescribe an FDA approved drug manufactured in a CGMP facility vs having drugs compounded in some backroom lab which lacks FDA oversight.
    Only a quack would prescribe using a compounder when an approved product is readily available.
    The standard of care for this indication is MAKENA and prescribing a Makena knock off made in a non compliant facility is unnecessarily putting the patient and fetus at grave risk.
    SHAME ON YOU QUACKS for putting your patients lives at risk.

  26. April 16, 2011 at 2:13 am

    Thanks for the two comments. I suspect that both of you are either shills for KV or investors who foolishly went long on KV-A and are now hoping for some miraculous recovery. But in case you’re just completely misguided souls –

    17-OHP has been available for over 50 years. The 2003 NIH study was published with compounded material, just as we have been using before Makena. There is no reason whatsoever to believe that KV’s FDA approved product will have any greater efficacy than the compounded product.

    17-OHP is made in great quantity in very large compounding pharmacies such as Wedgewood. Their technology is very similar to what would be used in a major pharmaceutical drug factory. Unlike KV, however, they have not been fined tens of millions of dollars by the FDA for prior shoddy manufacturing processes, nor was their former CEO fined for industry violations.

    Given that Makena is hardly even on the market yet, it is hardly the standard of care. Standard of care is defined as what other reasonably practicing OB/GYNs would prescribe in a similar situation, and given that a huge proportion of the physicians in this country will continue to prescribe compounded product, compounded product is still firmly within that standard.

    The comment that the use of compounded 17-OHP puts patients lives at risk is ludicrous and ridiculous. The converse is quite true, however, as the use of Makena would redirect tens of thousands of dollars of funds from areas where it could be truly useful.

    Given that ACOG, SMFM, members of congress, and the FDA have expressed great concern over Makena and KV, physicians are in good stead in their outrage over this drug.

    The specific dosage of 17-OHP studied in the 2003 NIH study (not funded by KV) was an arbitrary number – 250 mg of drug. Given the pharmacokinetics of steroid hormones, there is no reason to believe that this is a magic number. A little more or a little less would make litle difference. The FDA allows a 10% variation in their drugs as well (KV could produce Makena at 225 – 275 mg and still be in compliance with FDA rules)

    KV has attempted to rape our healthcare system by pulling profit while providing no benefit whatsoever, all while attempting to muscle out their competition through legal loopholes. Fortunately, the FDA has informed them that their muscle will be ineffective. What they charge now is irrelevant. Physicians are not going to write their drug, and they will likely be bankrupt for it.

    You make some strong statements for a couple of anonymous posters.

    Nicholas Fogelson, MD
    American Board of Obstetrics and Gynecology Certified
    Fellow of the American College of Obstetricians and Gynecologists

    Maybe you should post your credentials as well.

  27. S. Marsh
    April 16, 2011 at 2:36 am

    Good on you, Dr Fogelson. I haven’t heard of this drug but your argument makes good sense to an outsider and consumer, non-professional, in another country. The people who commented did not even put their names to their opinions, which is pretty gutless. They also seem ignorant. Thanks for taking on some pretty big shifts in conventional thinking, Dr F. Regards from Australia.

  28. April 16, 2011 at 3:54 am

    Well Dr. Fogelson,

    I think you regulated fine enough on your own. The only two option as I see it are:

    1. The two posters are woefully misinformed and believe what they are saying (doubtful).
    2. Are morally bankrupt shills for KV.

    Quote: Only a quack would prescribe using a compounder when an approved product is readily available.

    No, Only an informed doctor who has compassion and real-world knowledge of the economics of medicine, costs to patients, and the safety of the compounded product would.

  29. rt
    April 16, 2011 at 5:53 am

    Fogelson,

    Better make sure your malpractice insurance is in full force because you will be easy pickins by any malpractice attorney seeking an easy buck when you have to explain to the jury why you used a compounded product over an FDA approved product manufactured in a CGMP facility after one of your patients experience a less than desirable outcome.
    Any good malpractice attorney will paint you as a second rate hack who would put his patients at risk to save a few bucks.
    I’m sure that’s not your intention but that’s how it will play out in the public forum.
    All it takes is one bad outcome and your career is……… kaput.

    • April 16, 2011 at 11:12 am

      No doubt any good malpractice attorney will try to paint any defendant as a second rate hack for any reason they possibly can. That’s their job. It would be my defense attorney’s job to show the jury that this is not true. Just the way it goes.

    • Timothy Gorski MD
      April 24, 2011 at 12:53 pm

      Nice try. And while defensive medicine is common, if the only way Makena can succeed is by such scare-tactics – “you’ll be sued if you don;’t use it” – then it just shows the utter poverty of the argument for using this over-priced product being marketed by this rapist-pharm company. The vast majority of pharm companies are doing what they should, but not this one. If they *can’t* make a product that is as good as what we’ve had at less cost then their product is not any kind of real innovation (as opposed to a simple effort to buy a license to steal through monopoly from the FDA) and is not needed.

      Sorry if you folks lost money investing in this company. Next time make sure the company’s business plan makes sense.

  30. April 16, 2011 at 5:57 am

    Mmmmmmm… The good old “anonymous” chicken act…I guess millions of consumers, numerous good doctors, scores of congressmen, and plain common sense must take second seat to some cowardly, nonsensical, and insensitive comments…NOT!

    “Is KV Pharmaceutical A Flat-Out Evil Company?”(David Whelan, Forbes, 3/11/11)

    “Most companies agree that they have some level of corporate responsibility to make the world better, not worse. Pure free-market thinkers argue that a company’s only responsibility is to maximize shareholder value, i.e. profits, through any means necessary.

    That would presumably include a strategy like gaming the regulatory system to secure a monopoly on a drug that patients desperately need and then jacking up the price. If that’s what your company does, does that make you an evil company?”

    Well, not only evil, but the worst kind- unintelligent evil!

    We are continuing our effort in Oklahoma to educate the public and physicians about alternatives to Makena. Let these two fools above try to unload their KVa stock- it is spiraling down to 4.16 from a high of over 13 1-2 months ago…

  31. rt
    April 16, 2011 at 6:11 am

    Fogelson,

    All your posts have been archieved and will likely be used against you in a court of law when one of your patients delivers a premee and decides to sue you for malpractice becaue you failed to prescribe the only FDA approved drug for this indication.

  32. rt
    April 16, 2011 at 6:20 am

    FDA’s Public Health Concerns Regarding Compounding
    The public health threat posed by inappropriate drug compounding is the object of FDA concern and enforcement. Improper compounding has caused patient harm and death. Although many pharmacists are well-trained and well-equipped to compound certain medications safely, not all pharmacists have the same level of skills and equipment, and some products may be inappropriate for compounding. In some cases, compounders may lack sufficient controls (equipment, training, testing, or facilities) to ensure product quality or to compound complex products such as sterile or modified release drugs. The quality of the drugs that these pharmacists compound is uncertain and these drugs pose potential risks to the patients who take them.

    Moreover, when compounding occurs on a large scale and it is not performed properly, compounders can expose many patients to health risks associated with unsafe or ineffective drugs. This is especially the case when patients take these compounded drugs in lieu of FDA-approved products.

    FDA is also troubled by pharmacists that compound large volumes of drugs that are copies of FDA-approved drugs. This practice circumvents important public health requirements, including the FDC Act’s drug approval provisions. By definition, pharmacy compounding involves making a new drug whose safety and efficacy have not been demonstrated with the kind of data that FDA requires to approve a new drug. Consumers and health professionals rely on this evidence-based drug approval process to ensure that drugs are safe and effective.

  33. none
    April 16, 2011 at 9:16 am

    I am not here to support a drug company or else. I believe that every patient should have access to medical care regardless of the cost. I firmly believe that the only thing is life that counts is happy, healthy and long life. I am not defending KV, I am defending a principle.

    Everybody, including doctors complain about the cost of drugs to patients. In my view, those who complain about prices have never been to a lab, have never done countless experiments just to throw away them because they do not work. What you do not understand is the true cost of a drug that makes to the market.

    KV said that they will make sure that everyone that needs the drug will get it. Period. How much it costs is irrelevant. Money goes from one pocket to the other. If KV makes money, it will eventually spend it on developing other drugs. KV has been around for a long time. It has never paid a dividend, and it is just a 200M company. If you had invested in KV 70 years ago, you would have not made a penny. All that came, went to the workers’ salaries, and that is it. Not to shareholders! What KV charges is not a rip off, it is what makes newer drugs come to life. When you take that away from them or other drug companies, you stop development of the ultimate need in life: Drugs development for the advancement of life.

    The college wrote that KV would make $4.2 B per year. Multiply that with 7 years of exclusivity, you get about $30 B. This is incorrect. A company with that prospect would not worth $200 M today. If college is that involved with this issues, it should gather 200 OBs with a M each and buy KV. Than you could do anything with Makena. Why not that?

    As I wrote earlier, biotech that made millions live longer never made a dime as a whole. And Big Pharma is not the most profitable industry. Tiffany’s that sell 20x inflated diamonds is making more money than Big Pharma, and yes than KV. Big Pharma is not even one of the top 15 profitable industry. Instead of calling them names, we should thank them. When a patient comes in for help, and when there is a drug to help them, Big Pharma is to thank. If you do not support them, one day, you will end up saying “I am sorry, but there is nothing I can do”

    The issue here is not KV, but a principle.

    When I see a physician that is blinded by anger of the cost of a drug, and even say that they would rather use a compounded drug, or a vaginal get that will “probably” do the same thing, it saddens me. A mentality like that is dangerous to the degree that they should not be allowed to practice. I hope that they are not serious about what they say!

    As a caring doctor, your job is to make that everyone gets the drug, regardless of the cost and KV will give it free to those in need. If you succeed in bringing down KV, the post marketing studies will never get done, and we will never know what this drug is truly about. And if you succeed to bring down pharmaceuticals, by calling them “Big Pharma” and create a hatred feeling among people, we will never develop the drugs, etc.. to improve lives including our own. Anybody stating that pharma companies charge us a lot, steal from us, or that they make big bucks is a liar! If they know that pharma makes big bucks, they I advise them to put their retirement money into them!

    I think you are wrong. I do not believe that you do this negative propaganda just to be seen that you are on the side of the people that you consider ill and helpless… the patients. To show that you care… I believe that you are angered that something that used to cost less is now costing a lot. It has to cost more with all that regulations to ensure quality, to make post marketing studies possible, and to create the seed money to make new possibilities come to life.

    I wrote without giving my name. I am not affiliated with KV, I never met a soul from this company in my whole life. I ran into this issue while following the news about the market that I invest in. As a person, who has seen many promising companies fail, many drugs disappear before getting a chance to get a name, who has seen the frustration, and fear in the eyes of a patient, when I say it is time to stop active treatment, whose heart raced as high as those of a patient looking at me for help that I no longer have, and who just have been on the other side and know how costly and difficult to bring a drug to market is, I know I have to support the drug companies as a caring person. In my book, anybody that argues that the drugs are expensive are either cheap, or do not have clue about the facts of economics of pharmaceuticals. In my book, they have never looked in the eye of a woman and felt the sadness and fear losing a baby. If I were you, I would make sure that every woman had access to Makena, held KV responsible for loss of a life if that does not happen. But only then, you can prove that those at KV are heartless, and greedy, not now.

    Again, I do not have any relationship with KV at all. I said, all I have to say, and I am not gonna write again. Best to you.

  34. April 16, 2011 at 10:52 am

    I appreciate your thoughtful comment, though I disagree.

    I have no problem with Pharma in general, and am quite aware of the cost to bring a drug to market. That is, most drugs, but not Makena. The cost of bringing Makena to market is tiny compared to the massive price they are asking.

    KV’s explanation of the ‘cost’ of their drug and their patient assistance program is an absolute lie, or at least a twisting of the truth. The cost of a drug is not just what a patient pays, its also what the insurer pays. If the copay is only $20 and the insurer has to pay $500, that’s still $520 being paid from a cash strapped medical system for a product that provides no real benefit over what we already had. KV’s claim that they are saving the healthcare system money is a complete lie, given that we were using the same drug for far less before they came around.

    Regarding the potential legal liability of writing a non-FDA approved product. This just isn’t something I worry about. I could pull my hair out trying to do every little thing that I perceived made for less legal risk, but I don’t. Doing so would make me an inferior doctor, and drive up my slice of the cost of healthcare massively. If I have a patient who is a good 17-OHP candidate, I’ll explain the situation and offer her a choice. If she chooses Makena I’ll write for it. I really doubt that is going to happen though.

    The truth is, at this point I don’t really care if Makena is on the market nor what price it is at. The FDA has made it clear that compounders will not be prosecuted for continuing to compound 17-OHP. If physicians or their patients believe that the FDA regulation of the production of Makena makes it 69 times more valuable than a compounded product, then they will write for it. I think most physicians will not write for it, and that KV will fail.

    I’m certainly not alone in my feeling about this issue. The entirely negative article about Makena graces the cover of OB/GYN News in today’s issue. Not available online yet unfortunately.

  35. April 16, 2011 at 11:06 am

    In regards to your comments about pharma –

    I think at a fundamental level we disagree about what humanity really needs.

    Individuals within pharma are most likely operating on an altruistic level to create new drugs, and to satisfy their own curiosity and passion. On a large scale level, pharma exists like all other businesses to make profit.

    While some new drugs benefit patients, a huge number of them, like Makena, provide no real benefit over what we already have. Birth control pills are another great example. Bayer and Warner Chilcott come out with new formulations of birth control pills every 4-5 years, and every time they do they come out claiming why the new one is so much better and we should stop using the old one. Fast forward five years and now the drug they were pushing is garbage we shouldn’t use anymore. This isn’t benefiting patients in any way, its a pure and simple shell game meant to keep patients in relatively expensive patented drugs rather than far less expensive but equivalent generics.

    The same goes for antihypertensives. Unlike antibiotics, old hypertensives work just as well as they used to. It is entirely possible to control a patient’s hypertension without using a single drug patented in the last 10 years, yet drug companies continue to produce new ones. This is not altruistic, it is just business.

    In the end, we don’t really need so many new drugs. What we need is for people to be more healthy. Eat less. Exercise. Don’t smoke. Without those things, all the new drugs in the world aren’t going to mean much, but they will still destroy our nation with crushing healthcare costs (along with all kinds of other fancy and expensive new interventions)

  36. none
    April 16, 2011 at 12:06 pm

    I was not gonna write as this topic only involves me peripherally, but I could not stop.

    I agree with you on most issues but one.
    I will give two examples.

    I wrote my PhD thesis 20 years ago on a Windows 3.1 using a program called AmiPro. That program and that computer would do everything I do today just as good as my top line computer today. And as fast as my current one. I have changed computers not because of my needs, but because I was forced to do so by some not needed requirement. Several computers I have had only served to pollution, and personally to me, gave nothing more than I already had, a word processor and internet.

    But, the money I spent created iPhone, iPad, touch screens and so forth. That is progress that this system has created. This is what made this country what it is today. I wasted money on buying new computers, but I am thankful for my cell phone.

    You are right in antihypertensives. An ACE inhibitor does a lot good, and nothing topped them for years. But the money we paid for lisinopril created ACE receptor blockers that some patients who cannot tolerate lisinopril can now take. Now that these blockers are going out of patent, we have Aliskiren, a direct renin inhibitor. My mother did not tolerate lisinopril nor valsartan. Now she has the option of Aliskiren to control her hypertension, and all the cardioprotective properties that come with blocking renin-angiotensin system. I am thankful for the companies that may give me the gift of having my mother for as long as it possible. I am thankful that I will have the option of having drugs for myself when I need them.

    Who can say that by blocking KV from making a profit on a deal that it made 10 years ago to bring this to market, will not prevent it from developing a new one? A better one that our daughters will need? Who can say that paying for a new birth control pill now will not help one to be developed with really less side effects? Docs do not write prescriptions because they want to punish or reward companies, they write it to help their patients. In doing so, our personal feelings and price should come last.

    Yes, they probably overpriced it, and they decreased the price. But going on TV and showing them as the enemy is not right. After all, the 70 years old company is just $200 M now. You have to reward the investors to come out and keep the business of pharma viable.

    With regards to the issue that women who need the drug will not be able to get it if they are poor is a joke. All these years, I can remember only one case that I tried to get financial help and failed, only one case. And it was because the patient was not interested in anyway. Give KV a chance to do it right, you will see that who are needy, including illegal immigrants, will have access to the drug if needed. As I said earlier, I know nobody from KV, but I do not believe that they will deny medicine to the needy if it comes to that one day. Let’s say that they are greedy and selfish and do not care about human life. Even then, they will do the right thing in order to keep their seat in the office.

    You wrote that we do not need new drugs. We need people to eat healthy and do the right things for themselves, but we need drugs too. We eat less healthy today then we did 100 years ago, but we live twice longer. Why?

    There is a price for everything. If it is going to help me better and longer, I would give all my wealth in a heart beat.

    I read the letter in NEJM, and college’s letter.

    To the insurance company that wrote to NEJM, I would remind that insurance industry is more profitable than pharma. That is why Warren Buffet has insurance companies but not pharmaceuticals.

    To the college, the numbers they quoted are misleading and if they did it on purpose to gain popularity, shame on them, they should resign. KV will never make 4 billion a year on this drug, even at the initial price. Thousands will get it free, or at a significant discount. KV is extremely lucky if they make a billion over 7 years even if they sold it at the initial price. That is why the market value of the company never came close to a billion before all these boycotting started.

    Well, forgive me if I were blunt, and again best to all. Hopefully, one day, you will understand. No matter what, right is right, wrong is wrong.

    • April 16, 2011 at 1:33 pm

      Its an interesting logic that you present here.. that it is society’s job to pay for unhelpful advances in pharmaceuticals so they can fund the occasional one that actually is helpful.

      I often get detailed on all kinds of new surgical technologies that seem to offer no real advantage over much less expensive traditional methods. For a while there I saw a rash of expensive devices for preventing surgeons from sticking themselves with needles, even as far as creating a big gun that drives a needle through fascia without exposing my tender fingers to the needle. These things are gimmicks. They are not advances. They are answers to a question I never asked, and solutions to a problem I never had.

      The cost of healthcare is crippling our nation. Anyone watching the news in the last week could not help but agree. We cannot continue to believe that any incremental benefit in healthcare is worth an unlimited amount of money. Even more, we cannot tolerate a company that manipulates a legal system to jack up the price of a drug we already have. Its not where our dollars should go.

      But each patient will ultimately vote with their wallets, and each doctor with their prescription pad. If enough people agree with you, KV will survive.

      >> In doing so, our personal feelings and price should come last.

      I really disagree. Price should not come last. As a society we need to keep the cost of healthcare in our mind, and divorce ourselves of the notion that we are not personally responsible for a that cost. Prescribing Aliskeren is great when someone is truly unable to take a generic ARB or ACE. But pharma would like you to prescribe Aliskeren first, and that is a choice we should not make.

    • April 17, 2011 at 3:40 pm

      I was re-reading this, and can’t see how you can connect your purchase of a defunct word processor with the rise of Apple. The product you supported was not a great product in the long run, but penetrated the business world through strong business practices. Apple, on the other hand, rose under the leadership of a genius designer and marketer, fell under the leadership of a soulless businessperson, and then was reborn from its ashes under the banner of great design once again.

      Great drugs will be profitable, just as Apple is profitable. We do not need to support crap to continue to reward true ingenuity and passion.

  37. none
    April 16, 2011 at 3:25 pm

    I guess we have a disagreement.
    I wish well to those whose intention and interest in this issues is the well being of patients, and nothing else.
    Goodbye.

  38. April 16, 2011 at 4:36 pm

    If I thought that Makena were even one iota better than what we have been using for the last decade, there would be a choice to make between cost and benefit. But as there is no difference, there is no conflict.

    Ultimately its up to the patient to decide. If it were their own money they were spending, 100 out of 100 would choose compounded product. Fortunately the FDA has chosen to continue to give patients the choice, and ultimately it will be up to the market to decide who is right.

    • rtt
      April 17, 2011 at 5:05 am

      The FDA and malpractice lawyers will disagree with you on this issue but who cares it’s only a patients life that your needlessly putting at risk just so you can make your point……SO SAD!

      FDA’s Public Health Concerns Regarding Compounding
      The public health threat posed by inappropriate drug compounding is the object of FDA concern and enforcement. Improper compounding has caused patient harm and death. Although many pharmacists are well-trained and well-equipped to compound certain medications safely, not all pharmacists have the same level of skills and equipment, and some products may be inappropriate for compounding. In some cases, compounders may lack sufficient controls (equipment, training, testing, or facilities) to ensure product quality or to compound complex products such as sterile or modified release drugs. The quality of the drugs that these pharmacists compound is uncertain and these drugs pose potential risks to the patients who take them.

      Moreover, when compounding occurs on a large scale and it is not performed properly, compounders can expose many patients to health risks associated with unsafe or ineffective drugs. This is especially the case when patients take these compounded drugs in lieu of FDA-approved products.

      FDA is also troubled by pharmacists that compound large volumes of drugs that are copies of FDA-approved drugs. This practice circumvents important public health requirements, including the FDC Act’s drug approval provisions. By definition, pharmacy compounding involves making a new drug whose safety and efficacy have not been demonstrated with the kind of data that FDA requires to approve a new drug. Consumers and health professionals rely on this evidence-based drug approval process to ensure that drugs are safe and effective.

  39. Darby
    April 17, 2011 at 2:30 am

    It looks like we have some sour comments from a couple investors that bought KV stock and are now taking out frustrations on everyone they run into.

    To me, one of the most interesting observations (a comment from above) is that the compounded products provided much of the basis of getting the KV product approved. I am sure the investors are all happy about that. However, they turn around and talk about all the doom and gloom of these same products once the brand product comes to the market.

    If there was some significant benefit to the patient and, then perhaps the cost difference could be justified. However, when a $15-$25 product works just as well as something that costs 30x-40x more, then the answer is quite simple.

  40. rtt
    April 17, 2011 at 5:06 am

    QUACK QUACK QUACK

  41. Darby
    April 17, 2011 at 10:46 am

    RT,

    When you earn a medical degree, then perhaps you can provide your critical analysis on the practice of medicine. I am sorry if you lose money on your stock position, but that does not justify the use of a product that adds greater burden to an already stressed medical system.

    • DVM
      May 28, 2011 at 4:00 am

      Everything rtt said was correct.

      I have a veterinary degree, and I deal with the issue of cheaper compounded medications constantly. Bottom line: if there is an FDA-approved medication available, that’s what veterinarians are supposed to prescribe, even if an (illegally) compounded medication is available, and cheaper. That is the law. We’re also told our malpractice insurance will not cover adverse outcomes when we’ve prescribed an illegally compounded medication. Those of you who are physicians should look into that.

      Don’t believe me? There’s a position statement on compounding on the AVMA website. Maybe the laws governing veterinary medicine are more strict than those for human medicine, but I don’t think so.

      I think pharmaceutical companies are vultures, overall. Nothing they do surprises me.

  42. May 2, 2011 at 7:29 am

    Great post and excellent comments. I work with doctors for their medical equipment needs. I had seen small articles about this in the news but had no idea what was really going on. Thank you for the insight.

  43. Timothy Gorski MD
    May 28, 2011 at 1:48 pm

    Compounded meds are not illegal. Period. But it just shows how pathetic this company is being now reduced to scare tactics, threatening doctors with lawsuits if doctors use what they’ve been using for years instead of this “new” overpriced stuff that the company planned to make an easy killing from on the backs of the medical system.

  44. DVM
    June 3, 2011 at 8:45 am

    No, compounded meds are not illegal, but their use is more highly restricted than some of you appear to believe. Quotes below from the FDA website re: compounding of veterinary medications (which, as I said, may be subject to more strict regulation than human medications… but I doubt it). FDA may consider enforcement action when:

    9.Compounding of drugs for use in animals where an approved new animal drug or approved new human drug used as labeled or in conformity with 21 CFR Part 530 will, in the available dosage form and concentration, appropriately treat the condition diagnosed.

    (Like it or not, Makena is an approved medication.)

    You may not like the price. I don’t like the price. The company is of course using scare tactics, but the law is on the side of the licensed product.

    If you think the QC for compounded meds is at the standard of that for licensed products, I suggest you Google Franck’s Pharmacy, polo pony. Keep in mind Franck’s compounds human meds, too, though I found their QC quite lax on the one occasion I ordered medications from them, years before the pony fiasco.

    Physicians who don’t want to look foolish should spend some time educating themselves about compounded medications. Information is available on the FDA website (Compliance Manuals/Human Drugs/Pharmacy Issues/Pharmacy Compounding). Personally, I avoid using compounded meds on my patients unless it’s absolutely necessary, even when the price is much higher. First of all, it’s the law. Second, I don’t feel like being sued. You should ask your malpractice provider if you’re covered when prescribing a compounded product. I asked mine: I’m not.

    I learned about compounded medications in veterinary school. Apparently, this is not a topic adequately covered in medical school.

    • June 3, 2011 at 8:58 am

      Thanks for the comment, but I respectfully disagree, and quite specifically address that compounded drugs are in no way illegal (which you say at the beginning of your comment, making it strange that you then say they are illegal later). As for malpractice carriers, I think yours is advising you of a course. No malpractice carrier is going to be able to ‘not cover you’ if you use a non-FDA approved product.

      I’m not the only one that feels this way – in fact its the predominant thought right now. Check out the recent article in Obstetrics and Gynecology –

      Obstet Gynecol. 2011 Jun;117(6):1263-5.
      Deus ex Makena?
      Silver RM, Cunningham FG.

      • DVM
        June 5, 2011 at 3:38 am

        >>compounded drugs are in no way illegal

        When used according to FDA regulations, compounded drugs are not illegal. As I said: visit the FDA website and read what it actually says, vs. what you wish it said.

        This pharmaceutical company may be profiteering and sleazy (this is hardly the only example of a scummy pharma company) but that doesn’t mean they’re not in the right here, legally if definitely not morally.

        Like you, I have prescribed products from Wedgewood. Unlike you, I don’t trust their products to be equal in safety and quality to FDA-approved products simply because the packaging is professional-looking. Then again, you probably don’t receive sleazy faxes from Wedgewood advertising a number of improperly compounded veterinary products. Wedgewood may be one of the more “reputable” compounding pharmacies, but so was Franck’s, at least until all those polo ponies died as a result of their poor quality control. FYI, the insurer and owners of the horses are suing Franck’s for value and future earnings: $4 million.

        >>No malpractice carrier is going to be able to ‘not cover you’ if you use a non-FDA approved product.>>

        My malpractice carrier, AVMA-PLIT, specifically informs veterinarians we are not covered if an adverse event occurs after we use a compounded drug when an FDA-approved generic or brand-name product is available. Perhaps veterinary regulations are more strict than those governing physicians.

        I suggest you call yours and inquire, then request an answer, in writing.

        >>I’m not the only one that feels this way – in fact its the predominant thought right now.>>

        FDA regulations are not based on the “feelings” of physicians or veterinarians.

  45. June 6, 2011 at 6:41 am

    First off DVM and MD’s need to stay out of the world of manufacturing. Stay within your medical field. To the person that states compounding is illegal is half right. If a Prescriber writes a scrip that is NOT an approved drug the patient is allowed to take the scrip to a Compounding Pharmacy and have it provided.

    To the person that brings Wedgewood into a very good discussion, really? You do know that they have been warning letters issued and court cases filed because of the “above the law” mentality? A recent FDA field survey demonstrated that Ten (34%) of the 29 sampled products failed one or more standard quality tests performed. Nine of the ten products with failing analytical results failed assay or potency testing.

    Don’t confuse me with defending KV, I’m not. The product at the producer would go through a Process Validation process, Analytical Validation, Sterile Validation etc., Of which, a compounder would never be subjected to. DO NOT MAKE THE MISTAKE OF SAYING THE TWO PRODUCTS ARE THE SAME THEY ARE NOT!

    • June 6, 2011 at 6:43 am

      I mean that statement from a Quality view of the GMP’s and the requirements for Pharmaceuticals and Compounding Pharmacies.

      • June 6, 2011 at 7:06 am

        One other item. Understand the drug approval process in the US before you act like you know what your talking about. User Fee, extablishment fee, product fee, Phase IV requirements, REMS etc.

    • October 9, 2012 at 6:30 am

      John – feel free to detail said process and make an argument why you think that KV is justified in charging $1600 a dose for something that previously was produced for less than $20 a dose.

      There is no question that GMP for the FDA does hold the producers of Makena to a higher standard than what would be required of a compounding pharmacy. There is question, however, of what value was brought to women and infants through the FDA-approved commercialization of a drug that was already being used safely and efficaciously, to the best of our knowledge, with a compounded product.

      If KV had priced their drug at some kind of reasonable level, based on the actual cost of acquisition of the drug and FDA approval, I would have had no complaint and would have used their drug. But they didn’t do this. They priced the drug based on what they believed the market value of preventing a preterm birth was, and naively thought that doctors would not find that absurd.

  46. July 18, 2011 at 1:04 pm

    I want to add that the patient assistance program takes a while to process, and from my understanding, the savings are not retroactively applied to the doses before the paperwork clears. Health plans would still pay the full price until the PAP begins.

  47. Poornnounc
    June 21, 2012 at 1:57 am

    delete this topic 0

    • Timothy Gorski MD
      June 21, 2012 at 2:44 am

      Why delete? Just would benefit from an update. For example, is this ripoff company making a profit on this thing now? We cannot get commercial ins to approve almost any of our pts at risk for PTL since this company came out with their bank-busting product even though we are happy to use the compounded product instead.

      • Jeff
        October 8, 2012 at 9:26 am

        Because its for preterm birth, wow, hope your not a doc? Lerner the indications genius.

      • Timothy Gorski MD
        October 8, 2012 at 10:26 am

        “Jeff” is probably a troll for the company.

  48. Concerned Preemie Father
    June 23, 2012 at 4:03 am

    Anyone else victim to a bait and switch by Makena sales rep? Stating full coverage by insurance when in fact it’s not?

  49. Jeff
    October 8, 2012 at 9:23 am

    Sure, just get your “safe effective compound version” it’s all the same, ask the folks that got tainted steroids from “legitimate compounders”. Pay for the best, and if you HCP’s are so worried lower or waive all copays and only bill 15-20.00 for your 5 minute visit with your patient that waited 25-60 mins to see you.

    Unreal you all believe HCP’s are not billing too much and product and company should suffer and you blame them when the unborn child or mom still may have another per- term birth with the garbage made at a compound pharmacy.

    You know what, your pedigree from that great medical school is the same if you got it online, you just paid more to attend the Ivy League school right, but its all the same, tight?

  50. Jeff
    October 8, 2012 at 9:46 am

    So will insurance costs go up for the docs that used a compound pharmacy product that ends up killing a patient? Or is that somehow not an issue docs should worry about? Google search meningitis outbreak related deaths and compounding pharmacies. You see, batched garbage is cheaper at compounding pharmacies and its NOT FDA approved.

    Thus, it’s a ride at your own risk type of deal. So keep complaining about price with Makena. This is a dumb argument especially if this stuff coming out of compounding pharmacies ends up killing people. But wait that hasn’t happened right?? I know, this hasn’t happened with C17P, so there’s no argument in the world that can validate using makena over c17p currently right?

    Well, when a compounding pharmacies makes cheap versions of products when an FDA approved product is available and has got the FDA stamp of approval, why take the risk? Use FDA version. Cost? Well ask the dead people if they would have paid more if they knew they’d be alive today. They would pay 1000 times more if they knew what a contaminated compound pharmacy version of a product would do?

    Nicholas Fogelson :
    Thanks for the comment, but I respectfully disagree, and quite specifically address that compounded drugs are in no way illegal (which you say at the beginning of your comment, making it strange that you then say they are illegal later). As for malpractice carriers, I think yours is advising you of a course. No malpractice carrier is going to be able to ‘not cover you’ if you use a non-FDA approved product.
    I’m not the only one that feels this way – in fact its the predominant thought right now. Check out the recent article in Obstetrics and Gynecology –
    Obstet Gynecol. 2011 Jun;117(6):1263-5.
    Deus ex Makena?
    Silver RM, Cunningham FG.

    • October 9, 2012 at 6:29 am

      Jeff – thanks for your comment, which is pretty trollish.

      So here’s a non-trollish version of what you wrote.

      “I think the recent outbreak of meningitis associated with a lot of compounded methylprednisolone provides evidence to suggest that the use of compounded 17-OHP is an unacceptable risk, and therefore you should recant your previous opinion and support the use of Makena.”

      And my non-trollish answer:

      Its a concerning issue, and its certainly tragic what is going on with the meningitis outbreak. I’m not sure that it is directly applicable, though. FDA approved drugs occasionally have problems with contamination as well, despite appropriate precautions. I’m sure we will come to know more as time goes on. Given the decades of experience with compounded 17-OHP, I don’t think its reasonable to think there is some kind of demon in the freezer here.

      The argument that efficacy is necessarily better with Makena than a compounded product is entirely spurious. The trials that documented the effectiveness of the drug were done with compounded product, presumably as affected by potential differences in potency that would currently exist in the marketed products. Furthermore, steroid medications in general are much less dose-dependent than an non-steroid molecule. Ultimately there is no data to suggest that Makena has better efficacy than the previously available compounded products, and I doubt such a trial would ever be undertaken, as KV would have far too much to risk to put such a trial into action. The wouldn’t want to know the answer.

      This is a pretty old topic at this point. Makena remains on the market, at a level of success less than anticipated by KV I suspect. The last I heard, which was about a year ago, our local home health agency that provided 17-OHP continues to use compounded product.

      • Timothy Gorski MD
        September 5, 2013 at 2:28 am

        So where are we at now? What does KV charge for this drug now – for inscos and medicaid and for cash-paying patients?

      • September 22, 2013 at 10:24 am

        A lot of people still use compounded product, though I imagine there is some penetration of Makena. They have created a fairly aggressive program for discounted and free product for people of moderate and low incomes, though this program still demands high payment from insurers when possible. It looks good to the public but still creates significant medical cost with no clear benefit over what was previously available.

  51. Christy Pena
    August 10, 2013 at 8:46 am

    The price if this medication is ridiculous..I’m on Medicaid because if my low income but I was horrified to see that monthly this prescription cost the state almost 4,000.00 a month. I guess because of the nature if the diagnosis the state is required to pay for it or risk lawsuits if they deny it and the baby doesn’t survive a premature birth. I have had 2 premature births prior to this pregnancy in which I was not on this medication and both survived thank god. But it just doesn’t seem right for the drug manufacturer to be allowed to profit off such situation s. what about the middle class that can’t afford it but make to much to qualify for Medicaid. Who has 4,000.00 a month extra for medication even to save their child’s life. Especially if they have existing children to feed and support. Something should be done.

  1. March 27, 2011 at 5:26 am
  2. March 28, 2011 at 9:10 am
  3. April 1, 2011 at 11:18 pm
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