Archive for the ‘Pharmaceutical’ Category

Skin Cancer: Types, Causes and How to Protect Yourself

Tuesday, June 28th, 2011

Image from psvresort.com

From the (guest) editor:  Although today’s weather forecast is for thunderstorms, we should keep in mind that the summer season is upon us.  It is time to protect one of our largest organs — our skin!

–Jason

The news last week about the new FDA regulations on sunscreen had me prepared to write a blog article this week about the changes. I wanted to clarify what the new rules will mean for consumers – how to choose the correct product, what the various claims actually mean about protection, whether safety has been considered. However, as I delved deeper into the topic, I realized that the first concern has to be sun exposure and cancer in general. There is too much information – medical and legal – out there for one post. So, I am going to write a brief series. The first topic – today – will be about the startling statistics about various skin cancers. I will discuss various types of skin cancers, their prevalence and the survival and death rates from these cancers. In future posts, I plan to examine the original issue – whether the new regulations will help consumers choose a product that will help protect from some of these risks and how these legal steps may fall short of the final goal. Finally, I will look at the issue of tanning beds. Should children or teens be allows to use them? What about parental consent? There are medical and legal ramifications surrounding the use of tanning beds – I will look at a few of those. Along the way, please comment and let me know your thoughts. Or, if you are just daydreaming about enjoying summer…you can let us know that too (for my own personal idea of a great summer vacation see today’s photo).

Not All Skin Cancer is Created Equal

Personally, I tend to lump all skin cancer together in my mind. Unfortunately, whether you are putting yourself at risk for or are diagnosed with squamous cell, basilar cell or malignant melanoma makes a big difference. The rates of these diseases and the survival statistics are dramatically different.

So, first, what are these diseases?

Image from www.cancer.org

 

The National Cancer Institute at NIH explains the different types of skin cancers:

Skin cancer that forms in melanocytes (skin cells that make pigment) is called melanoma. Skin cancer that forms in the lower part of the epidermis (the outer layer of the skin) is called basal cell carcinoma. Skin cancer that forms in squamous cells (flat cells that form the surface of the skin) is called squamous cell carcinoma. Skin cancer that forms in neuroendocrine cells (cells that release hormones in response to signals from the nervous system) is called neuroendocrine carcinoma of the skin.

How Common are these Cancers?

According to the Skin Cancer Foundation, skin cancer is the most common form of cancer in the United States. Of the various types of skin cancer, basal cell carcinoma is the most common (2.8 million/year the US), followed by squamous cell carcinoma (700,000/year), and finally melanoma (115,000). However, the death rates caused by melanoma are much higher than the other types of cancer. The statistics on the Skin Cancer Foundation website are shocking (just a sampling):

  • One person dies of melanoma every hour (every 62 minutes).
  • One in 55 people will be diagnosed with melanoma during their lifetime.
  • Melanoma is the most common form of cancer for young adults 25-29 years old and the second most common form of cancer for young people 15-29 years old.
  • The incidence of many common cancers is falling, but the incidence of melanoma continues to rise at a rate faster than that of any of the seven most common cancers. Between 1992 and 2004, melanoma incidence increased 45 percent, or 3.1 percent annually.
  • An estimated 114,900 new cases of melanoma were diagnosed in the US in 2010 – 46,770 noninvasive (in situ) and 68,l30 invasive, with nearly 8,700 resulting in death.
  • Melanoma accounts for less than five percent of skin cancer cases, but it causes more than 75 percent of skin cancer deaths.

I was particularly taken by this last fact – while accounting for “less than five percent of skin cancer cases, [melanoma] causes more than 75 percent of skin cancer deaths.” This is startling because “[t]he survival rate for patients whose melanoma is detected early, before the tumor has penetrated the skin, is about 99 percent.” However, ‘”[t]he survival rate falls to 15 percent for those with advanced disease.” So the key here is clearly prevention and early detection.

Unfortunately, the melanoma incidence rate is rising annually. Melanoma is responsible for approximately 8,700 deaths a year in the US, as compared to rare deaths from basal cell carcinoma and approximately 2,500 deaths a year from squamous cell carcinoma.  And this is not just a problem for those with light skin – the Skin Cancer Foundation explains that “[w]hile melanoma is uncommon in African Americans, Latinos, and Asians, it is frequently fatal for these populations.”

Given the high incidence rate and the high survival rate for early-diagnosed melanomas, it seems key that people should know the risks factors and causes for melanoma. The better the prevention, the less likely that you should develop this type of cancer. Secondly, if you are in a high-risk category, you should be seeing a dermatologist regularly since the key to survival is early detection.

Causes of Melanoma

The CDC provides confirmation that “[s]kin cancer is the most common form of cancer in the United States” and that the incidence of melanoma of the skin has “increased significantly by 3.1% per year from 1986 to 2006 among men” and 3% among woman from 1993 to 2006.Yet, we know many of the risk factors for melanoma.

The CDC reports that “[a]bout 65%-90% of melanomas are caused by exposure to ultraviolet (UV) light.” This is the kind of radiation that come from the sun – and tanning beds (more on that in a later post). There are three different types of ultraviolet light and two of them have a role to play in changing and damaging skin cells.

The three types of UV rays are ultraviolet A (UVA), ultraviolet B (UVB), and ultraviolet C (UVC)-

  • UVA is the most common kind of sunlight at the earth’s surface, and reaches beyond the top layer of human skin. Scientists believe that UVA rays can damage connective tissue and increase a person’s risk of skin cancer.
  • Most UVB rays are absorbed by the ozone layer, so they are less common at the earth’s surface than UVA rays. UVB rays don’t reach as far into the skin as UVA rays, but they can still be damaging.
  • UVC rays are very dangerous, but they are absorbed by the ozone layer and do not reach the ground.

Too much exposure to UV rays can change skin texture, cause the skin to age prematurely, and can lead to skin cancer. UV rays also have been linked to eye conditions such as cataracts.

From the CDC website

In addition to sun exposure, there also additional risk factors to consider:

  • A lighter natural skin color.
  • Family history of skin cancer.
  • A personal history of skin cancer.
  • Exposure to the sun through work and play.
  • A history of sunburns early in life.
  • A history of indoor tanning.
  • Skin that burns, freckles, reddens easily, or becomes painful in the sun.
  • Blue or green eyes.
  • Blond or red hair.
  • Certain types and a large number of moles.

From the CDC website

Children and Adults are Not Doing Enough to Protect Themselves

Certainly, some of these risk factors are immutable, but others, like sun exposure and tanning are risks that can be avoided or at least minimized. The CDC says they have supported surveys that show that “U.S. youth and adults are being exposed to ultraviolet radiation and can do more to protect themselves. More than one-third of the U.S. population reported a sunburn in the previous year, with rates higher among men and the non-Hispanic white population.”

I found the CDC statistics troubling given how long it has been known that sun exposure and damage lead to skin cancer:

In 2005, only 56% of adults said they usually practice at least one of the three sun-protective behaviors (use sunscreen, wear sun-protective clothing, or seek shade).

  • 30% reported usually applying sunscreen (27% applied sunscreen with an SPF of 15 or higher).
  • 18% reported usually wearing some type of fully sun-protective clothing.
  • 33% usually sought shade.
  • Only 43% of young adults aged 18-24 used one or more sun protective methods, whereas 58% of those 25 years of age and older reported using one or more methods. Among men 18 and older, only 47% reported usually using one or more methods of sun protection, in contrast to 65% of women 18 and older.

Among high school students, when they were outside for more than an hour on a sunny day-

  • 11.7% of girls and 6.3% of boys reported they routinely used a sunscreen with an SPF of 15 or higher.
  • 15.9% of girls and 20.5% of boys reported they routinely stayed in the shade, wore long pants, wore a long-sleeved shirt, or wore a hat that shaded their face, ears, and neck.

Nearly 9% of teens aged 14-17 years used indoor tanning devices. Girls aged 14-17 years were seven times more likely than boys in the same age group to use these devices.

From the CDC – internal resources omitted.

The recommendations are clearly not being followed. To best protect yourself from sun damage, there are 3 simple steps:

  • Use Sunscreen
  • Wear Protective Clothing (including hats and sunglasses)
  • Find Shade

Do not forget that these tips are important whether you are at the beach or just around town and on both cloudy and sunny days. It is especially important to be careful during the peak times of 10 am to 4 pm.

Of course, “use sunscreen” is oversimplifying how to protect oneself. It is within this context that I will look into the various legal and marketing changes coming soon to sunscreens in my next post.

Did you know all of these facts about skin cancer? Did you know that melanoma was so common and so deadly, despite being very survivable when detected early?

Children’s Medications: Coming Changes and Tips to Avoid Overdose

Tuesday, May 24th, 2011

We all know that a little over-the-counter (OTC) pain medication can be just what the doctor ordered for minor aches, pains or to help combat the symptoms of a nasty flu. Most adults, however, also realize that medications can be dangerous. No, I am not talking about the blast from the past news stories about medications that have been tampered with (…though it is weird that the Unabomber, Ted Kaczynski, is back in the news as one possible suspect in the Tylenol poisonings that killed people in the Chicago area in 1982). My focus today is on the danger involved with overdoses of commonly used pain medication. In particular, the risk of accidentally overdosing children on OTC pain relievers such as Tylenol.

Image from www.tylenol.com

There has been quite a bit of focus recently on the possible changes to Tylenol and other acetaminophen containing drugs for children. These are not formula changes and they have nothing to do with the myriad of Tylenol recalls over the past couple of years. Currently, the basic concern is that overdoses of this common medication accounts for a fairly sizeable number of poisoning cases, which can be very serious since overdose can cause liver damage to children. An AP article reports that:

Dosing errors with children’s acetaminophen products accounted for 2.8 percent, or 7,500, of the 270,165 emergencies reported to poison centers last year, according to the American Association of Poison Control Centers.

Overdoses can be caused by parents not reading the label, misinterpreting the dosing instructions or using a spoon or other container instead of the cup included with the product.

These overdose situations most often occur in children under 2 years old.

Chart provided on www.tylenol.com

When I read this, I was not surprised. Currently acetaminophen for children, Tylenol and other brands, come in two different concentrations.  Most commonly one is labeled “Children’s” and the other “Infant’s.” Each of these medications include on the outside packaging a confusing little matrix that details the correct dosage for a child of a particular age or weight range. The correct dosing for your child’s age and weight may not be the same if you have a child that is particularly large or small for their age. Additionally, if you have both children’s and infant’s acetaminophen products in your home, you must be careful to provide the correct dosing for the correct concentration. This does not even get into the differences in dosing between the liquid medicine and the tablets. Finally, the box does not provide dosing information for children less than two years of age. The dosing instruction for children under 24 months is “ask your doctor.” So, how many of you are going to make that phone call?

The harsh realities of parenting and sick kids

My children are both young; the youngest is now a little past her second birthday. In the last few years, we have had both infant and children medication in the house, liquid and tablets, and I have been very careful to make sure to double-check myself if I ever have to medicate either child to make sure that I am reading the correct dosing matrix for the correct concentration and for the correct child. More often than not, I have found that children need medication when their parents are tired. As parents know – children frequently get sick in the middle of the night and when children in the house are sick nobody in the household sleeps well. I always try to take this into account to avoid dosing errors. However, this can be confusing particularly when children are little.

When my children were very little, I used to ask the doctor at each appointment what would be the correct Tylenol dose for their current weight. I did not foresee having to use that information, but I wanted to make sure that I knew the correct amount in case I was caught with a sick child in the middle of the night. If it had been a while since my child was weighed, I would sometimes have to call for dosing information. Additionally, I found that it was nearly impossible to dose a child properly using the little cups included with the medication. However, the medicine packaging clearly states that you are only to dose using the enclosed cup. I found that my ability to dose the correct amount of medication was much improved when I used a syringe style dropper.

The FDA steps in – finally!

Well, apparently, I have not been alone in my concerns. The FDA panel that met last week, has made some recommendations that may improve some of these problems in the future and lessen the chances that children will receive too much medication. According to the AP article, the following recommendations have been voted on and will be recommended to the FDA:

  • Dosing instructions should be added for children younger than 2 years old
  • Dosing instructions should be provided based on a child’s weight (rather than the focus being on a child’s age)
  • Limiting cup measurements to milliliters  (rather than both teaspoons and milliliters…one of many things that make the current measurement cups confusing)
  • Mandating a single dosage for children’s solid acetaminophen tablets

Infant Tylenol (and other acetaminophen products) a thing of the past

Relatedly, the article mentioned that the Consumer Healthcare Products Association, which includes the makers of Tylenol and many other acetaminophen producers, agreed to voluntarily stop producing infant drops. This decision means that a day may be coming soon when there would only be one concentration available of children’s acetaminophen.

Some tips and tricks to avoid overdosing your child

If infant acetaminophen is eliminated and children’s acetaminophen is sold with the changed dosing instructions, I think that parents and other caregivers will find it much easier to provide children with the correct amount of medication. However, I would still recommend taking the following steps to protect your children:

  • Keep all medications, including children’s acetaminophen, in a locked closet or other locked secure location away from children.
  • Do not forget to re-secure medication, even when children are sick, so that children are not accidentally able to overdose (when using medicine frequently the temptation to leave it accessible should not overcome the safety element of keeping it away from little hands).
  • Keep a list of the current weight of each child in the house available with the medications so that a caregiver (or tired parent) knows the weight of each child to be able to refer to the dosing chart when needed.
  • Use a clearly marked cup or syringe that is specifically for medicine to dose your child – do not use a household spoon or other imprecise measuring tool.
  • If in doubt on dosing, call the pediatrician to be sure – do not guess!
  • When multiple people will be caring for a sick child (or if you are tired), make sure that you note down the time of each dose of medication to ensure proper timing between doses to avoid accidental overdose.
  • Read the ingredients on any medication carefully to ensure that you do not give your child multiple medications containing the same ingredient – acetaminophen is sometimes added to other medications in combination drugs.

The best advice

Obviously, since I am not a doctor, you should check with your pediatrician if you have any questions about what the correct method is for providing medication to your child, but these tips will hopefully help eliminate some of the more common medication errors in your home.

Your take?

Do you have other tips to share? What about the recommended changes, do you think that additional changes are needed? Do you use fever-reducing medications in your child if your child is not displaying other symptoms, or do you allow the fever to do its work its way out?

Meningitis & Your Baby: Three Things To Think About

Tuesday, April 26th, 2011

A quick story.  I remember opening the piece of mail. It was a quick note from a school official informing the student population that there was a suspected incidence of meningitis at another local university. The long and short of it was that if, as a residential student, I didnt want to move back home with my parents, I wanted to continue to live on campus, I would need to sign a waiver or be vaccinated.

Too many years have gone by, and  I can no longer remember what I chose, but the thought of meningitis made me think very carefully about whether I wanted to be vaccinated. At the time I didn’t know much about meningitis, but with the stern warning I received in the form of that letter, I researched and learned that the effects of bacterial meningitis (commonly caused by Neisseria meningitides) can be devastating. My choice notwithstanding, the choice of “to vaccinate or not” has recently been extended to that parents of infants and toddlers.

1. The signs of meningitis

The classic symptoms of meningitis are a high fever, headache and stiff neck. Detection of these symptoms, particularly headache and stiff neck are certainly difficult to detect in infants and toddlers. According to the Centers for Disease Control and Prevention, infants with meningitis may appear slow or inactive, have vomiting, be irritable, or be feeding poorly. Seizures are also a possibility.

2. An Ounce of Prevention: A vaccine is available

I was fortunate; I had the choice. I was a young adult, and I had access to a vaccine. Until recently, however, parents could not make a similar choice for their small children. The Food and Drug Administration (FDA) has recently approved a vaccine to prevent meningitis in babies and toddlers. Specifically, the FDA has approved the vaccine Menactra for usage in babies and toddlers. Menactra has been frequently used to vaccinate non-toddlers and non-elderly (ages 2 to 55). For now, the FDA has approved the usage of Menactra in babies as young as 9 months.

3. Is it safe to give to your child?

The FDA has ushered Menactra into the great debate of “to vaccinate or not to vaccinate.” I’ve read the literature and opinions of others on the topic. Each position has its passionate advocates. Putting the debate aside, the potential harm created by meningitis is well documented. Even though rates of meningitis are low in the United States, infants and toddlers are particularly vulnerable.  Meningitis can develop rapidly; in a matter of hours or days.  Even with proper care, the FDA says up to 15% of people who develop meningitis die from the infection. Of the people that contract meningitis, one in four will suffer complications such as brain damage or hearing loss. A scary number for any parent to consider. So, no matter what side of the debate you stand on, at least you now have a choice for your baby.

It doesn’t say “leave a response” down below for nothing. Feel free to let us know…

QUESTION:  What choice will you make?  Is vaccinating with Menactra a choice you will make?

 

Deadly Super Bugs on the rise.

Wednesday, April 13th, 2011

Health scares are common and are many times overblown. However, the evolution of bacteria that are resistant to antibiotics (dubbed Super Bugs) is a very real and growing danger. Yahoo Health is reporting that two especially dangerous bacteria – MRSA and CRKP – are becoming resistant to all but the most advanced antibiotics, which is posing a major health threat.

Klebsiella is a common type of gram-negative bacteria that are found in our intestines (where the bugs don’t cause disease). MRSA (methacillin-resistant staphylococcus aureus) is a type of bacteria that live on the skin and can burrow deep into the body if someone has cuts or wounds, including those from surgery.

The reason for this new resistance is likely over-use (which includes mis-use) of antibiotics by health care providers (with likely some contribution from use of antibiotics in animals). For a few years now, there has been a growing recognition that doctors are over-prescribing antibiotics, i.e., routinely prescribing antibiotics when they are not necessary. For example, in 2005, U.S. News reported a Harvard study that revealed that doctors routinely prescribed antibiotics for sore throats in children when they were not indicated. A 2007 study indicated that Dutch doctors (whom are generally considered more careful in their use of antibiotics) routinely prescribed antibiotics for respiratory tract infections when they were not indicated.

The Problem with “Overuse”

The danger this poses is that antibiotics – even effective ones – typically leave some bacteria alive. These tend to be the stronger or more resistant bacteria, which then leads to the development of more and more resistance. This occurs in a single individual body in which a patient may have less response to an antibiotic after earlier use of that same antibiotic, but because of the easy spread of bacteria in our world, it also occurs on a global scale. For certain strains of bacteria, doctors are becoming hard-pressed to treat these infections.

CRKP – worse than MRSA?

Thankfully, MRSA is still responsive to several antibiotics so it is still considered a treatable infection. CRKP, however, is of more concern because it is only responsive to Colistin, which can be toxic to the kidneys. Therefore, doctors have no good options when treating CRKP. While so far, the risk of healthy people dying from MRSA and CRKP remains very low, the most vulnerable of us (the elderly and the chronically ill) remain at risk because of their lowered immune system and because the elderly are in nursing homes or other long-term care facilities where infections tend to spread more easily than in the general community.

CRKP has now been reported in 36 US states—and health officials suspect that it may also be triggering infections in the other 14 states where reporting isn’t required. High rates have been found in long-term care facilities in Los Angeles County, where the superbug was previously believed to be rare, according to a study presented earlier this month.

It is essential that we rein in the casual use of antibiotics before we are left with infections that have no cure. Doctors must be better trained to know when antibiotics are necessary and when they are not. For example, antibiotics are useless against viruses (such as the common cold), but how many of you have been given an antibiotic by a doctor “just in case” or because your symptoms have gone on slightly longer than a typical cold would last? It is unfortunately a more common occurrence than we realize. The past success of antibiotics has naturally led doctors to want to give them to patients to relieve suffering. No one wants to turn down a patient who is seeking relief.  However, it makes no sense to give antibiotics to a patient who has no bacterial infection or whose illness will clear up on its own.

Patient Awareness is key

The problem, however, is more than just educating doctors. Patients share some blame too. We – the public – need to learn that antibiotics are not always needed, which can be a difficult lesson to learn when we’re sick. Everyone knows that antibiotics are a quick and effective remedy against common bacterial infections. Antibiotics have saved countless lives over the years and have relieved untold human suffering. So naturally, when we are sick (or our child is sick) and we go to the doctor, we want to see results. We want something that will alleviate the pain and symptoms, not simply be told to wait for the illness to run its course. Sometimes, however, that is the best course when you consider the side-effects of antibiotics and the dangers of over-use. That being said, who wants to hear that when you’re in pain and want relief? It is very easy to demand of doctors that they use all available means to treat a sick child. Doctors need to be able to stand-up to patients and educate them on why antibiotics are not necessarily the best course of treatment in a specific situation.

Don’t kill the good ones!

Doctors also have to teach patients that antibiotics are not targeted killers.  The body contains a lot of good bacteria that are vital to our body’s functioning.  Antibiotics kill those bacteria as well, which some researchers believe can adversely affect health by allowing harmful bacteria to proliferate.  (If you have seen “probiotocs” advertised on certain food products – like yogurt – that is an attempt to introduce good bacteria back into your body.).

Some basic steps to take

In order to protect yourself (or a loved one), good hygiene remains the most effective method of remaining infection-free.  Thankfully, neither MRSA or CRKP are transmitted through the air.  They are typically transmitted through person-to-person contact, or else through hospital equipment such as IV lines, catheters, or ventilators.  If you have a loved one in a hospital or nursing home, be vigilant with your hand-washing and those of the healthcare providers caring for your loved one.

Also, if you are a patient who has been prescribed antibiotics, follow your pharmacist’s orders scrupulously and take the medication in the proper dosage and for the proper amount of time.  Stopping antibiotics too soon can leave bacteria alive, which contributes to the evolution of more resistant bacteria.  You may feel better and want to stop the medication, but it is important to take the full dose.

So – now that you know the risks of over-using antibiotics, are you willing to forego antibiotics when you are sick in order to do your part for the greater good?

UPDATE: (Editor – Brian Nash) Within an hour of posting Mike Sander’s blog on MRSA (and CRKP), I came across a tweet about Manuka Honey is being used for dressings to fight the spread of Super Bugs – particularly MRSA.

Researchers now believe that it can also put a stop to the rates at which superbugs are becoming resistant to antibiotics.

Anyone know of this practice being used in your area hospital or clinics? Does anyone know if this really works? If so, most interesting and useful. Here to spread the word – how about you spreading it too?

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?