Posts Tagged ‘Makena’

Week in Review: If you missed this past week’s blogs – catch up!

Sunday, April 10th, 2011

This past week was a busy one for our bloggers. It was also a very busy week in our law practice. Over the last two months, we have also had two new lawyers join us – Sarah Keogh and Jason Penn. Sarah has contributed a number of posts already. Jason , who just started this past Monday, will soon be sharing his contributions, thoughts and comments with you as well. We’re very happy to have both of them. I’m sure you join us in wishing them a very warm welcome.

Last week our writers covered a number of topics related to health, medicine, child safety, medical technology and patient safety. We started the week off with a piece by Brian Nash on some key facts women need to be aware of when having an epidural for labor, delivery and post-partum pain relief.

Epidurals

There can be no doubt that thousands of epidurals are administered to women every day throughout this country. This form of analgesia (pain relief) has become probably the most popular form of anesthetic management and apparently is generally believed to be essentially risk free. As this week’s piece, Having an epidural when you have your baby? 3 questions to ask the doctor, reports, some literature gives the figure of complications from epidurals as high as 23% - ranging in severity from minor inconveniences, to life-long major disabilities and even death.

This particular piece was written as a result of several cases in which we have been involved when women, who had undergone an epidural, became essentially paralyzed from the waist down. We raise some questions for women to ask the doctor and suggest they just might want to ask those questions before they find themselves in the process of labor or when they are going through the recovery phase of having given birth to their baby. We believe it’s an important piece for women – and frankly for all – to read so that they have a much better idea of what they should expect with an epidural and what the risks and benefits are of this wonderful yet potentially life-altering anesthetic technique.

Shaken-Baby-Syndrome

On Wednesday, Jon Stefanuca again brought to the public’s attention a problem that is probably as old as childbirth. Everyone who has had the experience of taking care of a child – particularly a baby – knows that along with the joy of parenting comes the physical and emotional toll on parents and care-givers. The human condition makes us all susceptible to being less than completely tolerant, forgiving and gentle with little ones when we are under stress, frustrated or just plain exhausted. The response to the persistent crying can simply not be “a good shake.”

Medicine and science (and unfortunately the courtroom) have given a name to a syndrome of injury babies can suffer when that “just a good shake” approach is used. While a parent or care-giver may think it unimaginable to strike a child, they may not realize just now much harm they can do with “just a good shake.” Jon brings this information and some expert tips and tricks on how to deal with these difficult times parents and care-givers face in their everyday lives in his piece Shaken Baby Syndrome – What we all should know to prevent child abuse.

Makena: New Anti-Prematurity Drug

Thursday, Sarah Keogh reported on a relatively new drug called Makena, which has been found to help pregnant women, who have previously had a premature infant. I say “relatively” since according to Sarah’s piece, a compounding pharmacy could and was making this medication prior to the FDA giving K-V Pharmaceutical Company the exclusive rights to manufacture this drug for a period of 7 years.

Read Sarah’s piece, Makena: Drug to fight prematurity leads to major firestorm, and see what the controversy is all about. How could people possible be upset with a drug that can fight premature birth? Prematurity is one of the major causes of significant childbirth injuries such as cerebral palsy. Sarah’s blog makes it all too clear why people are upset and why the March of Dimes withdrew its sponsorship for Makena.

Medical Technology and Patient Safety

The week ended with Part II of my series on medical technology and whether all the new toys, bells and whistles of our modern healthcare system are truly advancing safe, efficient and effective delivery of healthcare. The week’s piece focuses on perhaps one of the largest advances in the healthcare industry – electronic medical records (EMR).

The blog, Medical Technology and Patient Safety – Part II – EMR’s (electronic medical records), brings a lawyer’s perspective to this topic. Much has already been written – and frankly will continue to be written – about EMR’s by the medical profession. Controversy has filed the pages of journals and at times probably slowed traffic on the internet (okay – maybe that’s a bit of an exaggeration) since this new marvelous technological advance was rolled-out in our medical institutions.  Those writing and fighting about it have been the end-users themselves – the medical professionals, who have to deal with the issues and flaws that have surfaced with this wonderful new technology. I thought it was about time to tell you how this plays out by another end-user – the lawyer who now deals with EMR’s. This piece is also intended as the foundation for what we as lawyer have seen play-out in terms of patient safety and health as a result of EMR implementation.

Sneak Peak of the Week Ahead

I anticipate that next week we’ll be seeing Jason Penn with his first blog on a recent report about numerous safety violations by hospitals in our practice jurisdictions – Maryland and Washington, D.C. Mike Sanders will be bringing to our readers aN old but back-in-the-news report on super infections, which still seem to be – unfortunately – thriving in our nation’s hospitals. We’ll start off this coming week with a piece by Theresa Neumann, our highly acclaimed in-house physician’s assistant expert, on spinal stroke. We all know about strokes that can damage the brain. Theresa will be sharing her insights on an equally devastating stroke of the spinal cord. I also suspect – shhh – that we’ll be reading more from Sarah Keogh this coming week. If the practice of law doesn’t get too much in the way, I am also hoping to share with you some real life examples – from a lawyer’s perspective – of just how EMR’s may not be advancing the causes of patient safety and health.

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Makena: Drug to fight prematurity leads to major firestorm.

Thursday, April 7th, 2011

Last week, I started following a still emerging story about a drug that I had never heard of before called Makena. The medication is a synthetic form of progesterone that is used for women who have a high risk of prematurely delivering a baby based on having had a premature delivery in the past. The drug must be injected by these women weekly for 18-20 weeks of their pregnancy.

According to the Baltimore Sun, the controversy surrounding this drug began when the “…K-V Pharmaceutical Co. boosted the total cost of the drug during a pregnancy from about $400 to $30,000, igniting a firestorm of objections.” This was possible because originally the medication was created by a compounding pharmacy mixing it together for patient use. Then in February, the FDA granted K-V Pharmaceutical Co. the exclusive rights to manufacture the medication for seven years.

If raising the cost of the medication 75 times its original cost (from $10-20/dose to $1,500/dose) were not enough, the Baltimore Sun reports that the company then went on to “sen[d] letters to pharmacies threatening that the FDA would punish them if they compounded their own versions of the drug.”  However, the FDA, amid a loud outcry of complaints, has “…declared it would do no such thing.  In its statement, the FDA noted that the drug was important and K-V ‘received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug’s effectiveness.’”

What has been so interesting are the implications of this story and the reactions to it. Clearly, the original decision by the pharmaceutical company to raise the cost of the drug 75 times the old cost is an attempt to make money from their exclusive rights. I can hardly imagine that there is any reason other than profit creation for this move given that they did not have costs associated with research and development or any other clearly identifiable costs. So, aside from my initial reaction of disgust that this might make it harder for women who need this medication to protect their children, I also thought about the bigger implications.

First of all, the cost issue is not so simple as it first appears.  As another article from the Baltimore Sun mentioned, “[t]he burden for many will fall on insurance companies, which may have to raise rates. The increase will also affect already strapped Medicaid programs.” The increased costs of drugs impact many Americans directly – those without insurance or those for whom even co-pays are a major budgetary struggle. However, the costs here also reach all of us. If the costs associated with the company’s increased profit are borne by the insurance companies and Medicaid, it also means that the costs are going to be felt by all of us who pay for health insurance or whose companies pay for health insurance and yes, by all of us, who pay taxes.

Secondly, for those women who do not realize that they could still go to a compounding pharmacy for this prescription and for whom it is not covered by insurance, the increased cost may mean that some woman will go without these injections. The Baltimore Sun article reports that:

About 500,000 U.S. infants are born prematurely each year. The March of Dimes estimates that about 10,000 of those premature births could be prevented if eligible women received Makena.

The implications here deal with both the health and safety of the unborn child who is now at risk of premature birth. But, unfortunately, they also have an associated monetary cost. The cost of a baby being born prematurely is also going to weigh on the insurance companies and is, therefore, going to be shared by all in the form of potentially increased premiums.

Given the intense criticism in the news, K-V Pharmaceutical Company moderately changed course in the last few days, according to Medical News Today and said they would bring the cost of Makena down to $690 per dose from the originally announced price of $1,500 per dose. While this is lower, this is hardly a significant adjustment given that the compounded version costs between $10-20 per dose. The March of Dimes, which originally backed FDA approval of the drug and was allowing the pharmaceutical company’s use of its name and logo, is apparently embarrassed by KV Pharmaceutical’s decisions. According to an article on the nonprofitquarterly.org, “…the March of Dimes is backing out of a sponsorship deal with the [pharmaceutical] company that sells [Makena]. Last Friday, the nation’s leading nonprofit focused on the health of pregnant women and babies said it would no longer allow St. Louis-based, KV Pharmaceutical Co. to use its name or logo in any of the drug company’s promotions.”

The response from the March of Dimes is not KV Pharmaceutical Co.’s only trouble as the Wall Street Journal is reporting that after the FDA announcement that it will not take action against pharmacies that compound the drug, and the company subsequently announced that it would cut the cost, the company’s shares fell 5.2%.  Reuter’s is reporting that this represents a drop of more than 20 percent.  Congress is also in an uproar about this issue.  The Reuter’s article says that elected officials are creating pressure for more to do be done on this issue.

What do you think should be done about KV Pharmaceutical Co.? Are they really any different from any of the other pharmaceutical companies? Is it relevant to consider that this is a so-called orphan drug and that the company has exclusive rights because of this? Do you think that allowing compounding pharmacies to create the drug for woman separate from the FDA approved drug is a sufficient solution? What about the bigger question of companies creating inflated prices for their products and having insurance (and all of us) foot the bill?