Makena controversy makin’ me think twice

The March of Dimes saved my son’s life. There is no debate about that. If it weren’t for decadron, surfactant, and other medications, therapies and treatments whose development was supported and championed by the March of Dimes, The Kid would be buried next to Benjamin.

Ever since The Kid was born and I discovered the role that March of Dimes had played, I have been a big supporter of the organization. After a few years of just donating to the organization through SEFA, the State Employees Federated Appeal (the NY state worker United Way program), I decided to get off of my butt and help some more. Over the last five years, between my personal donations and the money raised through my participation in the WalkAmerica/March for Babies event (the name changed a few years ago) I have put around $20,000 into the organization’s coffers. It’s something that I feel very proud of, and I have been a staunch supporter this whole time.

That’s what makes this blog post especially hard to write. The last week has injected quite a few misgivings about the direction of the organization. You may have heard about the controversy surrounding the “new” drug, Makena. Previously available through compounding pharmacies (pharmacies that mix “custom” drugs that are not manufactured by large drug-makers) and known then as 17P, this synthetic progesterone has helped to prevent one in five women who had previously gone into premature labor from doing so again, allowing them to carry subsequent babies to full term. The drug carried a cost of $10-$20 per shot, which—at the standard course of 18-20 weekly injections—cost up to $400 per pregnancy. March of Dimes championed the use of this drug, and helped to save many babies over the years that it has been used.

On February 4 of this year, the U.S. Food & Drug Administration (FDA) approved the manufacture of the synthetic progesterone as an “orphan drug,” a designation for medications targeted at a smaller population in order to give a drug company exclusive rights to manufacture the drug for 7 years, aimed at allowing them to recoup their research and development costs before generic pharmacies can start creating their own versions. The FDA granted approval to a company called Hologic, Inc. Hologic’s pursuit of the approval was funded by K-V Pharmaceutical Corporation and its Ther-Rx Corporation affiliate, who had an agreement to acquire the rights to produce the drug from Hologic.

Greg Divis, head of K-V and Ther-Rx, trumpeted the approval as “a significant step forward for the thousands of women whose families have been impacted by preterm birth.” The March of Dimes, which receives hundreds of thousands of dollars a year from the company, was also prominent in the press release. The organization’s medical director, Dr. Alan Fleischman, noted that “The approval of this new treatment is a breakthrough in our fight against preterm birth.” Great news, right? The wonder drug will now be mass-produced and therefore consistently and widely available.

Fast-forward a month. On March 8, K-V issues a press release about a “Comprehensive Patient Assistance Program for Makena,” which talks about the financial assistance that will be made available for women meeting certain criteria “to ensure that all eligible women have access to FDA-approved Makena.” Not apparent from the press release, and only leaking out through other sources, was the fact that K-V planned to charge a whopping $1,500 per shot, or as much as $30,000 for a single pregnancy, and had warned all compounding pharmacies that they would face legal action if the attempted to continue making the drug themselves. To justify the price of the drug, the company didn’t even try to invoke any costs incurred by them, but rather compared it to the cost of bringing home a premature baby.

Now, K-V did not spend money to develop the drug. They didn’t even spend money to conduct clinical trials of the drug. That was done through a study by the National Institutes of Health released in 2003, that was supported by the March of Dimes! All K-V did was to buy the rights to produce it from Hologic and help to get it approved. But the company, in financial trouble after a number of problems, “including the criminal conviction of a subsidiary for shipping oversize painkillers, a two-year manufacturing shutdown and mass layoffs,” needed the huge profits from the astounding cost to try to dig themselves out of a hole.

Many maternity and prematurity advocates were busy pointing out that, the high prices might keep low-income women from getting the drug, and that the cost to health insurers and government programs might lead them to shy away from paying for it, both of which would lead to fewer women getting the treatment and more babies being born prematurely.

Meanwhile, the March of Dimes said practically nothing. A post on the @marchofdimes Twitter account on Thursday avowed that “The March of Dimes plays no role in the pricing of products.” and claimed that the patient assistance program from Ther-Rx would make sure that everyone who needed the treatment would get it. A further series of posts on Friday (concatenated here) noted:

Thank you to everyone who has shared their concerns about the cost of Makena. We agree that the price of Makena is too high. We’ve shared our concerns about the price with Ther-Rx in the past and will do so again today. Ther-Rx has promised that every eligible woman will get care regardless of their ability to pay and we will hold them to that promise. We will also work with insurance companies and Medicaid to be sure that there is coverage. The needs of moms and babies are our only priority and your voices will be heard.

To many of us, it still sounded like “we don’t like it, but we don’t want to do anything that will jeopardize our donations from them.” The organization that was the unflinching advocate for doing anything to prevent prematurity was still dancing around the issue, rather than baring its teeth and digging in to fight. And they want us to join them in lobbying lawmakers on prematurity issues later this spring? In what kind of fight?

Finally, under continuing pressure, on Tuesday the March of Dimes released a letter sent late the previous day from March of Dimes President Dr. Jennifer Howse and SVP/Medical Director Fleischman to Divis and Ther-Rx making it sound as if they were caught off-guard by the pricing and noting that “we respectfully request that you reconsider the market price of Makena and commit your company to the promise that every eligible woman who is offered the drug will receive it without regard to ability to pay.” A related Twitter post stated that “We want you to know that MOD is committed to ensuring that all women who are prescribed the drug are able to get it.”

Still not huge teeth, but at least a direct request to K-V/Ther-Rx instead of a “we’ll trust that they’re going to do the right thing.” But this letter should have been written (and publicized) last Thursday when the pricing became apparent and all news media were still hot with the story, and should have been followed up with stronger wording when Ther-Rx showed no concern that the price was an unfair burden.

Boy, I’ve written about 1200 words, and I still haven’t gotten to the point. OK, here’s the bottom line. The March of Dimes is an advocacy organization. When a company that provides a significant chunk of money to the organization via donations decided to save it’s financial butt on the backs of at-risk patients who don’t have the power to fight back, the March of Dimes gave a limp response and didn’t make a big deal about the astounding increase in cost that would likely reduce access to the  medication.

In fact, I just read an account from a woman who was informed by her insurance company that due to the cost to them for Makena, it counted as a medical benefit and not as a pharmaceutical; therefore, she’s responsible for a 20 percent co-payment, making her cost of Makena $385 per week. (Which brings up the point that $385/week is 20 percent of $1,925 per week, not $1,500 per week.) And since she’s insured, she doesn’t qualify for the assistance plan. I don’t think that’s an acceptable compromise on price.

Why did the organization wait to take the strong stance, especially as supporter concerns were rising on Thursday and Friday? Why did it wait nearly five days, well past the peak of the news cycle on the story, before sending that letter? Are the donations from K-V/Ther-Rx enough to silence advocacy? Did they really not believe that the high price might cause resistance? With their connections to the company, did they really not have a clue that K-V/Ther-Rx would price the drug so outrageously? Or do they blindly trust a company in financial trouble to provide sufficient financial assistance to all?

If this is what the March of Dimes’ advocacy is going to be like in the future, I seriously have to consider how (or whether) I’m going to continue to support it. This pains me to no end to even have to think about this. My support of the March of Dimes has been unwavering, because I want to help prevent others from going through what we had to go through with Benjamin and with The Kid. I don’t like that I’m now considering dropping my support, especially because there is no other group that has done as much to help expecting and new parents and premature children.

But for now, I’m holding off sending out emails for donations and campaigning at my office for the March for Babies because of this. I will continue running the requests for donations in the MousePlanet WDW Update and on the MouseStation podcast for consistency’s sake and because it’s a pain to pull it out and put it back in, but will not yet ask for donations on this blog, via email, or via standard interpersonal communication for a while yet. I’m going to wait another week or two to see how much further the March of Dimes will go to protect the access to the medication for those who have the least say (and most need) in the matter.

It pains me to do so, but this whole situation has me wondering about the organization’s principles and ability to do strategic thinking when it comes to the motives and plans of partnering pharmaceutical and other companies. I’m not closing the door, just pausing to re-evaluate. Let’s see what develops.

What do you think? Am I off-base? Am I over-reacting? Let me know in the comments below.

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13 Responses to Makena controversy makin’ me think twice

  1. M.B. says:

    I have the same concerns about the March of Dimes. I’m certain we’re not fundraising for them this year. I’m not angry just because they failed to take a strong stance on the price-gouging when it became widely publicized. I’m angry because the March of Dimes actually SUPPORTED KV’s application to the FDA to give the drug company market exclusivity over 17P, an established and widely available drug. The March of Dimes has never provided any evidence to substantiate its theoretical concerns about the compounded 17P, and whatever evidence there may be certainly doesn’t outweigh the negative effects that will stem from KV’s monopoly (inaccessibility due to cost, rising health care costs for all, more premature births and losses). These negative effects were foreseeable (as price-gouging has happened in the past with other drugs that received orphan drug status), and it’s shocking that March of Dimes did not take a stand against it from the very beginning. Instead, they supported KV and sold out the families of preemies for whom they were supposed to advocate. I appreciate their past work, but something is very wrong at the March of Dimes right now. How could they screw up such an important advancement that could actually prevent prematurity in many cases? They’re incompetent.

  2. Max Kennerly says:

    It’s worse than you think: March of Dimes was closely involved with KV throughout the Orphan Drug Act application process. While lobbying to get the FDA approval — and thus the lucrative guaranteed monopoly for KV — March of Dimes did nothing more than get a weak promise that “eligible” women (whatever that means; it’s a standard weasel word used by insurers) would get “assistance” to pay for it. Then they put their considerable clout into the initial marketing of Makena, including allowing KV to use the March of Dimes logo on the Makena website, up to and until everything hit the fan, when March of Dimes went silent and then “respectfully requested” that KV “reconsider” the price.

    Like you, I’m a preemie parent, and I also started putting a lot of work into supporting the March of Dimes. For what? So an organization with an administrative budget over $20m could either (a) collude with a greedy pharmaceutical company to restrict access to the biggest preemie development in over 20 years or (b) be so profoundly inept and incompetent that they didn’t even recognize, much less advocate against, what shady pharmaceutical companies do with Orphan Drug approval?

    The whole situation is a disgrace. I will not have any confidence in the March of Dimes until they publicly account for, and apologize for, their role in lobbying and marketing for Makena without ensuring any safeguards for preemie parents, and until the primary people involved take responsibility and are fired or resign.

  3. Mark says:

    M.B. and Max, you both make good points. I am trying to believe that there was a strategic reason why March of Dimes wanted Makena approved. Was 17P an FDA-approved treatment for potential prematurity, or was it considered an unapproved secondary use? Could the drive to get Makena approved be so that there was actually a prematurity-prevention treatment that had the stamp of approval from the FDA? What happened is a high price to pay (literally), but at this point I’m still trying to give March of Dimes the benefit of the doubt in that area until I hear something more definitive from inside the organization.

    Of course, if this is pure greed, then I’ll have to reluctantly conclude that I am done with the March of Dimes until they clean up their ethical house. As I noted above, the only four possibilities that I see are:

    Greed: The donations from K-V/Ther-Rx are enough to silence advocacy.
    Incompetence and lack of concern: They really didn’t believe that the high price might cause resistance.
    Poor strategic insight: They really didn’t have a clue that K-V/Ther-Rx would price the drug so outrageously
    Naivete: They blindly trusted a company in financial trouble to provide sufficient financial assistance to all.

    I’m really hoping that there’s a fifth possibility, because remedying any of those four reasons will probably be a long and painful process. I’m looking for March of Dimes to make a grand statement in some way, perhaps refusing to take any more support from K-V, returning what they got this year (or setting it aside in a fund to act as a safety net for those who don’t qualify for the Ther-Rx assistance program), and taking a more public advocacy position against the pricing of Makena.

    I think that the FDA is probably extremely unhappy about what happened as well, but will probably not rescind their decision. I don’t know that they have any recourse at this time, though it may make them think twice before their next “orphan drug” approval.

    I’m waiting to hear more from the March of Dimes in the next week or two. If I don’t hear anything that gives me hope, I may cut off the part of the financial spigot that flows through me, much as it pains me to do so. I may even try to get some movement among other top walkers or top teams to withdraw support until we find out what happens.

    I’m not happy either with what apparently happened with the March of Dimes or with the fact that it may cause me to withdraw support, so I’m really hoping that there’s something behind this that will change my mind. I just can’t help the feeling that there’s something gone wrong at the core of the organization.

  4. A.K. says:

    I’m not totally convinced. Blame it on me being too close to the pharmaceutical industry (my husband is a methods development chemist for a pharmaceutical company. Mark knows which one. 😉 ) Blame it on me listening to his stories over the past almost 14 years. But I just have too many questions in defense of the pharmaceutical company and the March of Dimes motivation.

    From what I’ve read, Mark’s comment here, hits the nail on the head:

    “Was 17P an FDA-approved treatment for potential prematurity, or was it considered an unapproved secondary use? Could the drive to get Makena approved be so that there was actually a prematurity-prevention treatment that had the stamp of approval from the FDA? What happened is a high price to pay (literally), but at this point I’m still trying to give March of Dimes the benefit of the doubt in that area until I hear something more definitive from inside the organization.”

    It was NOT approved for use in prematurity.

    The way that the FDA and prescription pharmaceuticals works is this: Once a pharmaceutical has been approved, a doctor can prescribe it for any.reason.whatsoever. Even if the safety and efficacy of that using it for a particular condition has never been proven.

    I have two words for you: Phen Fen. (Or was it Fen Phen?) This is exactly what happened in that case. The two products, individually, were approved for use by the FDA. Doctors figured out that if they prescribed them in combination, they were “effective” as a weight loss treatment.

    The result? People lost weight! And then they found out they had caused extreme heart damage and even deaths because the combination of the two products was hazardous to their health.

    So compounding pharmacies that would produce this product off-label, may have been putting themselves at grave risk. What would happen if long term, they found out that the result of this treatment caused unforeseen complications?

    The FDA in this country, is in place to oversee the safety and efficacy of pharmaceuticals. (I’m not here to debate the efficiency and success with which it achieves this goal, but it does drive the industry.) Companies actually take a risk by putting products on the market. The makers of Fen and Phen were sued when the complications of the combined prescription came to light.

    My husband’s company makes several pharmaceuticals but one in particular is very well known. It has been approved by the FDA for something like 36 indications, although one of it’s more frivolous indications is the one for which it’s probably most known. (And, btw, it is very frequently prescribed in helping conditions associated with prematurity and birth defects.) But the reality is that before it was approved for that indication, doctors all over this country were prescribing it and using it, off-label, for a number of indications. On the one hand, pharmaceutical companies like his have been criticized (They only go after these frivolous approvals so they can market them and make more money off of them!) On the other hand, they pretty much have to pursue these investigations because of the lessons learned from Fen Phen: If they do not pursue the studies, and there is a tragic result, they’re going to be held liable, even though the physicians were using these products off-label.

    (BTW, I’m not totally against off-label indications, I’m just describing the process. One of the indications of the aforementioned product came about because doctors prescribing it off-label for the well-publicized indication, saw a side-effect/benefit to patients suffering from a second indication. That second indication has also now been approved by the FDA.)

    Ok, so this company was not at risk of being sued for off-label use. But they took the risk and liability to get this pharmaceutical approved by the FDA for this use. Ultimately, this has the potential to protect patients. And I can tell you, first hand, that these companies have to do extensive testing for FDA approval, not just clinical studies. My husband develops the methods his company uses to defend its products to the FDA. They are expected to perform a large number of chemical tests involving stability of not just the products but the containers in which they are packaged and the methods by which they’re distributed. When you see a time-released capsule, I see methods development headaches. (Phew, he got out of the capsule project!) Every single aspect of a product must be validated to the FDA, even the ink and the glue in the labels on the packaging.

    He has personally been audited by the FDA. When I hear claims that the pharmaceutical companies have the FDA in the palms of their hands, I’d LOVE to see those FDA departments to come oversee some of his projects. It would make my life a heckuvalot more serene at times.

    And, by the way, this is not just the FDA, either. For a product to be available abroad, there are other agencies which must be appeased. My husband has also had to defend products to agencies in Europe. Is this company also considering making its product available for parents internationally?

    Ok, One More Thing: Disclaimer: I do not know anything about any of the doctors involved with any of the media stories. That Said: I’m intimately associated with two pediatricians as well. Two hard core pro-vaccination pediatricians. And yet, there are doctors out there in the media who will say that their opinions are hooey and that vaccines are bad. Just because a doctor disagrees with something, doesn’t make it valid. (Don’t get my relative started about celebrity doctors speaking outside their specialty who don’t know what they’re talking about. Her patients then come to her and say well “Dr. SO AND OS — oops I mean SO, said so.” Well, Dr. SO AND SO is not a pediatrician and doesn’t know what he’s talking about…

    My point is that I’m going to take the media with a grain of salt because they’re not always in the business of giving facts but of getting attention to their stories.

    Before pharmaceuticals, my husband worked for the petroleum industry so we’re sort of used to being involved with “necessary evil” or “hated” companies. 😉 I hope I’m not sounding too defensive. I do think that it is important to ask questions. But when I watch the news reports, I do see that they all seem to be one sided: This company is evil! Look what they’ve done! This product used to cost $20 and now it costs over a thousand! Clearly, they are greedy. Doctors are very upset at the pharmaceutical company so clearly, the company is in the wrong wrong wrong.

    There’s more to this story that isn’t being told. I don’t know what it is. They may still be overcharging when it all comes out — I don’t know. But I strongly strongly suspect that it’s not as grossly out of line as the media is building it up to be.

    Thanks for letting me express my opinion, Mark. 🙂

  5. Mark says:

    Thanks for adding some perspective from the other side, A! I’m figuring that there’s got to be a strategic reason for getting this FDA-approved, I just think that the price may have been too high. Couldn’t it have gotten approval as a generic, without going through the “orphan drug” stage first?

    And the thing that makes me think that the pricing is pure greed, aside from the financial situation of K-V, is that fact that, when answering criticism of the pricing, there was no mention of the costs to K-V/Ther-Rx in getting the drug to market or through FDA approval, no mention of any costs whatsover. It was just “it’s cheaper than getting a preemie home from the hospital.” That’s not a justification, that’s an excuse.

    If March of Dimes had a strategic reason for pushing Makena through, let them make it public. If K-V/Ther-Rx has a good reason for the pricing, let’s hear it. Otherwise, I continue to have concerns about how the March of Dimes is accomplishing their mission. The price is too high, in more ways than one.

    A, if K can provide more perspective from the “inside,” as it were, I’d welcome it.

  6. A.K. says:

    I asked. He talked. I typed:

    “Generic applications go through what’s called Abbreviated New Drug Application (ANDA) pointing to the original drug and all the clinical data that supported it and the laboratory data to establish its equivalence. All orphan drug means is that it doesn’t have a large market indication but it has to go through the same NDA (New Drug Application process that all drugs have to go through for safety, efficacy and quality. So nothing can become a generic without having the predicate drug approved. ”
    So, no, it can’t just go straight to generic without having its indication approved first.

    K hasn’t been following this story. It sounds to me like K-V/Ther-Rx, at the very least, should hire a new PR firm.

    I think we also discussed in private, wasn’t K-V under consent decree? I will absolutely grant you that this leads me to suspicions based on our experience dealing with a company (NOT MY HUSBAND’S EMPLOYER) who has been under consent decree before. That doesn’t help their case, except that, I do have to say, if they were under consent decree, that does mean that the FDA will be watching them even more closely than they would a company that has not been under consent decree. (And if they’re still under consent decree, they’re paying the FDA to have someone from the FDA on-site to monitor their manufacturing.)

    My biggest fear in all of this is that the greed stigma being assigned to this company will bleed over to other pharmaceutical companies. My husband’s most recent project to go to market does cost thousands of dollars a dose. It’s a ground-breaking pharmaceutical in numerous ways both in the indication it treats and the delivery system it uses. And we lived through only a portion of the drug approval. At the time it began, I was pregnant with our youngest child and the product was already through the development process. He picked it up as a project just before the clinical trials, the stability testing and the NDA process. And just from that phase alone to the point that it was put on the market was almost 7 years. During that time, another project which had been under development for some time was abandoned when the FDA requirements to get it approved would have cost the company tens of millions of dollars in more testing (I think the actual number was $42M in ADDITIONAL testing.) The company could not recoup that loss before so they abandoned the project. And yet another product was abandoned because it was found to be highly carcinogenic during a development phase.

    Really. Pharmaceutical companies DO invest in research. They DO employ highly trained (incredible) scientists. And they’re not just making money hand over fist out of pure greed. In this country, we throw thousands of dollars at theme parks and ball parks for entertainment and pay our athletes millions of dollars to hit a ball 30% of the time and run around in a circle (fine, a diamond.) And we do all this without blinking. So when I know scientists who work their tails off, I do get defensive about the word “greed”. While I was home pregnant, my husband was on the road working on that project. After that son was born, he had to make two business trips to Ireland working on that project while I stayed home taking care of the boys. (He’s a very involved father and, really, the business trip to Ireland – not as romantic as a vacation to Ireland sounds. I promise.) And that doesn’t count all the hours in his office and lab in between. 😉

    Ok. I rambled and ranted. I apologize. I took your soapbox opportunity and got on my own. 😉 If you have more questions K can try to answer, let me know.

  7. Mark says:

    Thanks again, A!

    See, the big problem I have here is that 17P has been used for this purpose for quite some time, and that the studies here were done by the NIH in 2003. There has been no information forthcoming AT ALL indicating that K-V/Ther-RX or Hologic did any additional research.

    Something here doesn’t add up. I have the feeling that there’s some information that’s missing from this whole picture, and nobody seems to want to make it public. With the available information so one-sided and the parties under fire making no effort to clear it up, I find myself asking “why?” I can’t come up with a single possibility yet. Why would they not bring to light anything that would help to clear up this public relations nightmare? As time goes by, more and more of the maternity and preemie communities are turning against them. Don’t they have anything to defend themselves with? Is it really that they don’t have anything valid to counter the arguments?

    I appreciate you and K spending the time to share some insight from the other side. (And I’m assuming that the other company you mentioned under consent decree was K’s “almost-company”?)

  8. tl says:

    I have been in the drug approval business for 10 years. I know this company, and this product. This author doesn’t know anything. I started to go through line by line and comment on the inaccuracies, but there were just too many. Just jump on the bandwagon of public outrage, and please don’t think for yourselves. Hundreds of millions were spent by KV alone not including Hologic’s cost, including ongoing clinical trials. KV’s programs will help cover the co-pays for INSURED people too. This whole argument is stemmed from pure ignorance.
    Did you know that some pharmacists were compounding 17P with sesames oil? That’s never been tested and is very dangerous. You are taking a huge risk using these “bargain” drugs.

  9. Doug says:

    Welcome to the real world!!! Big pharma plays with big government brings in big nonprofit and we have a nice racket ripping off consumers directly and in collusion with big insurance and of course big medicine. Wake up America!!!

  10. Mark says:

    Hi “tl”, thanks for posting. I welcome all viewpoints, and appreciate factual corrections. I have no doubt that you have been in the drug approval business for 10 years, since it says so on your resume. Of course, your resume also says that you’ve been working for KV Pharmaceutical since 2007, and are responsible for publishing regulatory submissions, NDAs, ANDAs, INDs, and so forth. What I’d like to know is whether you are posting this on your own, or is this attack approved by corporate management?

    And while I would very much appreciate a line by line refutation of my post to help me to understand what I may have misinterpreted, it may perhaps be best for me to wait for your company’s official response to Rep. Henry Waxman’s request for more information on exactly how much KV did spend on research and clinical trials for Makena.

    Oh, and yes, I do take exception to you calling my argument “pure ignorance.” I freely admit that I do not have all of the facts at my disposal, but I am making the most sense that I can from what I can discover through my research. If you read my subsequent blog posts, I continue to refine my viewpoint based upon what information I can find and the facts that are presented to me. Please, present me with facts. I would love to share the KV viewpoint with the world. If you would provide an official response, I promise to post it verbatim, in its entirety. I do not promise to agree with it, nor do I promise not to attempt to refute it, but I do promise to present it forthrightly.

    If you were interested in engaging in an open dialogue, it would have been more transparent to reveal your identity rather than making an attempt to conceal your vested interest in this matter.

  11. A.K. says:

    “This author doesn’t know anything. I started to go through line by line and comment on the inaccuracies, but there were just too many. Just jump on the bandwagon of public outrage, and please don’t think for yourselves.”

    I totally get feeling defensive, tl. We feel it around here rather regularly. But I do think that Mark has really tried hard to understand what’s going on and has wanted to give KV the benefit of the doubt. I quoted the above because, frankly, attacking people isn’t going to help promote discussion or move the debate forward. In fact, I’ll bet that your identity wouldn’t be an issue if you’d approached your comment with a more cooperative tone.

    You have the potential to support the arguments I’ve been trying to suggest on your company’s behalf: “Hundreds of millions were spent by KV alone not including Hologic’s cost, including ongoing clinical trials. KV’s programs will help cover the co-pays for INSURED people too. This whole argument is stemmed from pure ignorance.
    Did you know that some pharmacists were compounding 17P with sesames oil? That’s never been tested and is very dangerous. You are taking a huge risk using these “bargain” drugs.”

    But the “pure ignorance” is not the author’s fault. Mark is ASKING for this information. I’d love to hear it, too. This information has the power to help not only your cause but to increase the public’s understanding about how all pharmaceutical companies must work with the FDA to get approval for their products and why this is important.

    Just my 2 cents.

  12. John Friedman says:

    Not to jump on the TL-bashing bandwagon, but I find someone who positions themselves as concerned about accuracy has used the word ‘ignorance’ when the original author has ASKED for opinions, information and perspective, and has engaged in open, transparent dialogue to further understanding. That’s not ignorance. That’s someone who is concerned about the issue, describing his concerns and questions and asking for help. That is the true strength of social media and the internet – crowdsourcing is the ultimate Socratic debate, where orators present their arguments and the decision of what is right and true emerges from the chaos of constructive dialogue.

    In the interst of further transparency, Mark is a friend of mine for more than 30 years, has ALWAYS had an open mind and keen intellect, comes to this discussion because of his own personal experiences and is passionately committed to helping others and particular in the area of premature births. He’s not out to ‘get’ anyone, any company or not-for-profit organization. His agenda is pure.

    Make sure yours is, before you hit ‘post comment.’

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