Posts Tagged ‘FDA’

Skin Cancer Prevention: Will new FDA Rules Help?

Wednesday, June 29th, 2011

In yesterday’s post, I examined the various types of skin cancer and their prevalence in the US. Melanoma is the most deadly form of skin cancer and its incidence is on the rise. In that post, I examined some of the ways to protect yourself from the types of UV radiation that cause skin damage and cancer. One of these protection methods is the use of sunscreen. Sunscreen matters because the data is clear that sun exposure is what is causing deadly skin cancers:

  • About 90 percent of nonmelanoma skin cancers are associated with exposure to ultraviolet (UV) radiation from the sun.
  • The vast majority of mutations found in melanoma are caused by ultraviolet radiation.
  • About 65 percent of melanoma cases can be attributed to ultraviolet (UV) radiation from the sun.
  • One or more blistering sunburns in childhood or adolescence more than double a person’s chances of developing melanoma later in life.
  • A person’s risk for melanoma doubles if he or she has had more than five sunburns at any age.

Statistics from the Skin Cancer Foundation website

However, up until now, there has been very little regulation of the marketing of different sunscreens. It has been very difficult for the American public to know whether the sunscreen they were choosing was going to be effective in protecting them from both UVA and UVB rays.  There was also little way to know how much protection you were really receiving and whether the claims like “waterproof” and “sunblock” were just marketing or really claims with research behind them. Why does this matter? Check out this video from the FDA:

How the New FDA Rules Will Help

Well, some of this is going to change next summer. Last week, the FDA announced new regulations of sunscreen. If sunscreens meet the new legal standards, they can use certain marketing phrases so that consumers know what level of protection will be provided by the product. For example, “[u]nder the new labeling, sunscreens labeled as both Broad Spectrum and SPF 15 (or higher), if used regularly, as directed, and in combination with other sun protection measures will help prevent sunburn, reduce the risk of skin cancer, and reduce the risk of early skin aging.”

Image from FDA.gov

Image from FDA.gov

The FDA explains the impact of the new regulations with the following:

  • Broad Spectrum designation. Sunscreens that pass FDA’s broad spectrum test procedure, which measures a product’s UVA protection relative to its UVB protection, may be labeled as “Broad Spectrum SPF [value]” on the front label. For Broad Spectrum sunscreens, SPF values also indicate the amount or magnitude of overall protection. Broad Spectrum SPF products with SPF values higher than 15 provide greater protection and may claim additional uses, as described in the next bullet.
  • Use claims. Only Broad Spectrum sunscreens with an SPF value of 15 or higher can claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. Non-Broad Spectrum sunscreens and Broad Spectrum sunscreens with an SPF value between 2 and 14 can only claim to help prevent sunburn.
  • “Waterproof, “sweatproof” or “sunblock” claims. Manufacturers cannot label sunscreens as “waterproof” or “sweatproof,” or identify their products as “sunblocks,” because these claims overstate their effectiveness. Sunscreens also cannot claim to provide sun protection for more than 2 hours without reapplication or to provide protection immediately after application (for example– “instant protection”) without submitting data to support these claims and obtaining FDA approval.
  • Water resistance claims. Water resistance claims on the front label must indicate whether the sunscreen remains effective for 40 minutes or 80 minutes while swimming or sweating, based on standard testing. Sunscreens that are not water resistant must include a direction instructing consumers to use a water resistant sunscreen if swimming or sweating.
  • Drug Facts. All sunscreens must include standard “Drug Facts” information on the back and/or side of the container.

Information from the FDA

So what does this all mean? It means that if you want a sunscreen that will provide protection against both UVA and UVB, you need to choose one that says “broad spectrum” AND has a minimum SPF of 15. You also need to look for a time limit on the water resistance of the sunscreen. In the future, other regulations may take effect, including limiting the SPF claims to 50 since there is no evidence that a higher SPF offers greater protection. The impact of the current rules should be an easier way for consumers to know that they are getting the greatest possible protection from the sunscreen they buy.

The New Regulations Do Not Address the Safety of Ingredients

So, while the new sunscreens will make it clearer whether the sunscreen protects against both UVA and UVB rays and how long the sunscreen will remain water resistant, the regulations do not regulate the ingredients that comprise the sunscreens. The ingredients in the sunscreens have not been tested for safety. Dr. Len has written a blog on the American Cancer Society website that touches on this issue:

Many of the ingredients of sunscreens have been used for years, however the FDA acknowledged today that they have not been tested for safety using modern techniques. They did emphasize that the benefits of sunscreens containing these ingredients far outweigh the risks given their longstanding safety profile.

Nanoparticles present in sunscreen-especially those containing zinc and titanium oxides-have been another source of concern.  It is the use of “nanotechnology” that has made these effective sunscreens more acceptable since they don’t leave you with that white, pasty look that inhibited their use in the past.

Although it appeared during a news conference this morning that the FDA is satisfied at this time that products containing nanoparticles such as zinc and titanium oxides are safe when used as directed based on scientific evidence, another representative seemed a bit more cautious in his comments at second briefing held a couple of hours later by stating that nanoparticles are still being evaluated for safety.

The FDA did say they will continue to examine the science and the data regarding sunscreen ingredients, and will advise consumers promptly should they find evidence to the contrary regarding their safety profile.

One interesting outcome of the FDA’s announcement was their statement that they will be seeking further information from manufacturers and others on the safety and effectiveness of aerosol sunscreens.  The FDA apparently is concerned about inhalation risks as well as effectiveness in real-life use.  This is a sunscreen delivery method that many of us (including me) use often because of ease and convenience, and the questions regarding safety and effectiveness are certain to get some notice.

As more and more people are educated and aware of the risks of skin cancer, the use of sunscreens will presumably rise. Does it worry you that the new regulations deal more with marketing issues and confirming that the sunscreens do work effectively to minimize exposure to UVA and UVB rays than with the safety of the ingredients that provide that protection? Do you agree that since the risk of skin cancer outweighs the potential risks caused by the ingredients?

Personally, I use sunscreen and put it on my children daily. However, I also go out of the way to try to use ones that seem to have the “safest” record in terms of the chemicals involved. I also choose to use sun-shirts and other protective clothing as much as possible when at the pool or beach to minimize the amount skin I have to cover with sunscreen. Okay – honestly – it is also to minimize the amount of sunscreen smearing that I have to do every day. In order to work effectively, you are really supposed to use a lot of sunscreen all over exposed skin. As much as possible, we try to spend out time outside during the early morning and late afternoon/evening to minimize the direct exposure.

What steps do you take to protect yourself from sun exposure? What about the idea that a certain amount of sun exposure is good for Vitamin D production? What about the new FDA regulations, do they may sense? Will you shop for sunscreen differently?

Related Posts:

Skin Cancer: Types, Causes and How to Protect Yourself

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?

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.

As with all our blogs, we sincerely invite you to not only read our thoughts and comments but to also share yours with us and our readers. Our latest stats show that around 10,000 pages are viewed by our readers and visitors every month! We sincerely thank all of you, who have taken the time out of your busy lives to read our offerings in The Eye Opener – Views and Opinions from the Nash Community. We invite you to share our posts with your friends and colleagues. Don’t forget to sign-up for easy delivery to your email inbox. Last – but certainly not least – come join our social media communities on Facebook and Twitter.

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?

 

Lap-Band (Weight Loss) Surgery: is it for you? FDA clears new Allergan system and opens door to more patients

Monday, February 21st, 2011

The FDA recently approved Allergan’s Lap-Band weight loss surgery (which is a form of what is known as bariatric surgery). By its 8-2 vote, the FDA cleared the way for patients who are significantly less obese (BMI of 30) than those who would have qualified for weight loss surgery before this recent approval.

Knowing that this controversial clearance vote was on the horizon, major news networks aired stories on the pro’s and con’s of “broadening the base” of patients, who would now qualify. Here’s a report by ABC News’ Diane Sawyer in December 2010. (Sorry about the lead-in ad. If it were not a good report, I would have found something “ad-less” to present the issue!)

With the FDA’s announcement came somewhat of a firestorm of criticism. As reported locally in the Baltimore Sun (actually written by Thomas H. Maugh II of the Los Angeles Times), the approval has raised “concerns” by many in the medical community, who fear that this surgery will now be seen as a “quick fix” to the obesity plague in this country.

“I’m very concerned,” said Dr. Ted Khalili, former director of bariatric surgery at Cedars-Sinai hospital and founder of the Khalili Center for Bariatric Care in Beverly Hills. “You can’t be driving down a street and have a flashbulb go off and think that this will be an easy fix.”

What Dr. Khalili seems to be referring to is a marketing drive that directs patients to clinics that perform the procedure using the Allergan device. Here’s (to the right) a photo that shows exactly what this is all about.

Patient deaths following procedure lead to litigation in California

Maugh reports in his piece in the LA Times that four patients have died following the Allergan lap-band procedure. Lawsuits have followed. In a related article by another Los Angeles Times reporter, some details emerge.

Laura Faitro of Simi Valley died July 26, 2010, five days after surgery at Valley Surgical Center in West Hills. Three other patients have died shortly after surgery at an associated center in Beverly Hills, relatives have alleged in lawsuits and interviews.

Supporters speak out as well

While there are many who have decried the FDA’s approval and the lowering of the qualification standards to undergo this new lap-band procedure, there are certainly those who are in support of its potential therapeutic effects:

For those with Type 2 diabetes, the Lap-Band could be an immediate fix. “This operation takes about an hour, and two days in the hospital, and these people go off their diabetes medication. It’s unbelievable,” Dr. Walter J. Pories, a professor of surgery at East Carolina University and a leading researcher on weight-loss surgery, said in this L.A. Times report.

All surgery – including this new lap-band procedure – has significant risks

Whether one should consider taking advantage of this new procedure is a matter between the patient and his/her surgeon. After advising that not all risks or complications of undergoing this new procedure are listed in its website overview, the product’s manufacturer, Allergan, provides the following information:

Placement of the LAP-BAND® System is major surgery and, as with any surgery, death can occur. Possible complications include the risks associated with the medications and methods used during surgery, the risks associated with any surgical procedure, and the patient’s ability to tolerate a foreign object implanted in the body.

Band slippage, erosion and deflation, obstruction of the stomach, dilation of the esophagus, infection, or nausea and vomiting may occur. Reoperation may be required.

Rapid weight loss may result in complications that may require additional surgery. Deflation of the band may alleviate excessively rapid weight loss or esophageal dilation.

While many people seem to be intrigued by a “quick fix” surgical method of weight loss, some necessary clearance hurdles stand in the way – and should! Allergan is requiring all surgeons who want to order and perform surgery with the manufacturer’s new device “to first complete a comprehensive proctorship and training program, have advanced laparoscopic skills and (we believe this is key) have the staff and resources needed to comply with the long-term follow-up requirements of obesity procedures.”

I would add here that in our experience of handling lawsuits involving catastrophic injuries and death claims following bariatric procedures, issues relating to selection of proper surgical candidates and post-procedure follow-up and compliance have many times been at the core of these cases.

Not a “quick fix” replacement for exercise, diet and possible medication

As anyone who has been involved in any manner with issues relating to bariatric, weight-loss surgery, this is not the first step to be taken toward losing weight. Sure, it sounds enticing to go into a clinic or hospital, have a one hour procedure, and all your weight issues are a thing of the past. First of all, that is not how this works at all. Pre-procedure clearance does and must be taken seriously and not be a mere sham.

There is no doubt that there is a financial benefit for the providers of this procedure; it is reported that it will cost approximately $25,000 for the device, surgeon and operating room costs. It is also said that many insurance policies may cover all or part of this cost. That being said, even Allergan cautions that this is not a drive-by way to achieve weight loss. Read its Lap-Band System Fact Sheet and Lap-Band Labeling and Safety Information if you are interested in knowing more about the indications, alternatives, risks, benefits and advantages of this newly approved system. In addition, make certain that the surgeon you are consulting meets the qualifying standards of the manufacturer. Ask questions – it’s your body, your life.

As a side note, in case you are wondering if your BMI qualifies you for consideration of this procedure, here’s a handy BMI calculator made available online by the National Heart Blood Lung Institute – Calculate your BMI.

Know anyone who has had this or other forms of weight loss surgery?

If you or someone you know has undergone a procedure involving this new device by Allergan, share your story with our readers. If you or someone you know has undergone bariatric surgery, we also invite you to please share your story of how this worked for you or those you may know. Has it changed your or their life? If so – for the better or worse?

FDA warning to healthcare professionals: use sterile prep pads!

Tuesday, February 8th, 2011

Sterile Prep Pads

On February 1, 2011, the FDA issues a News Release about the use of non-sterile alcohol prep pads in certain clinical situations.

“Non-sterile pads are not intended to prep patients prior to procedures requiring strict sterility measures and should not be used on patients with a depressed immune system, to prep patients for catheter insertion, or to prep patients prior to surgery.”

This reminder/warning was issued in the wake of a recall on January 5th of all lots of alcohol prep pads and swabs manufactured by The Triad Group of Hartland, Wisconsin citing concerns about the product’s potential contamination with Bacillus cereus, a bacterium that can be harmful to humans.

While I guess we all need reminders now and then, do healthcare professionals really use non-sterile pads for pre-procedure prep when sterile technique is called for? Isn’t this basic training?

We have heard over and over again about the problems with infection control in medical facilities. Isn’t this a basic way to improve infection control – using sterile prep pads when doing open or penetrating skin procedures? Oh my!

While we in law deal with the end-result of failures to use “sterile techniques” – including the basic concept of using sterile pads - is this really such a problem in the healthcare industry that the FDA needs to remind providers to use the right kind of pad?

A number of our readers are members of the healthcare profession. Tell us – please, is this really a problem in the industry? Are there not basic protocol, stock control, safety measures in place that deal with this apparent problem? The rest of our readers either have been a patient or have a family member who’s been a patient; have you ever encountered a problem with an infection because your provider used the wrong type of prep pad?

Image from dailymed.nlm.nih.gov

DARVON AND DARVOCET WITHDRAWN FROM U.S. MARKET – WHAT SHOULD YOU DO IF YOU ARE TAKING THESE MEDICATIONS?

Tuesday, November 23rd, 2010

Last week, the manufacturer of Darvon and Darvocet, Xanodyne Pharmaceuticals, agreed to withdraw these drugs from the market in response to FDA requests.  The FDA has also requested that generic drug manufacturers also stop marketing propoxyphene-based pain killers like Darvon and Darvocet. These drugs were withdrawn from the U.K. market almost six years ago. About a year and a half ago, the European drug agency also placed a ban on propoxyphene-based pain killers. An estimated 10 million Americans are taking propoxyphene-based drugs.

Although propoxyphene was always associated with a number of complications, the FDA’s request was prompted by new studies revealing the drug’s serious cardiovascular side-effects. The FDA was petitioned on a number of occasions to pull propoxyphene off the market. The latest petition came from the public interest group Public Citizen in 2006.  The FDA submitted the petition to an expert advisory committee that voted in favor of withdrawing the medication in 2009 (14 to 12 ).

The FDA did not request that the medication be removed from  the U.S. market in 2009. Instead, it requested that the manufacturer of the drug, Xanodyne Pharmaceuticals, Inc., conduct research to study the effects of the drug on the heart. This new research revealed that people taking propoxyphene (Darvon, Darvocet and  the like) can develop abnormal or fatal heart rhythm.  These findings prompted the FDA to request the withdrawal of the medication. Propoxyphene is also associated with the following cardiovascular complications:

  • Tachycardia
  • Cardiac/respiratory arrest
  • Congestive heart failure
  • Myocardial infarction
  • Hypotension

Some other side effects include:

  • Drug overdose/toxicity
  • Drug dependence/withdrawal
  • Anxiety
  • Nausea
  • Vomiting
  • Drowsiness/ dizziness
  • Hives
  • Difficulty breathing
  • Chest tightness
  • Swelling of the face, mouth, lips or tongue

The Public Citizen group has claimed that about 2000 people in the U.S. have died as a result of propoxyphene in the last six years. The good news for those taking Darvon, Darvocet or a similar drug is that the cardiovascular side effects of these drugs are not cumulative. Therefore,  the risk of developing cardiovascular problems should go away once the drug is stopped.

If you are taking Darvon or Darvocet, DO NOT stop taking the drug until you talk to your doctor. Sudden interruption of the medication can lead to serious withdrawal symptoms.  If you are taking propoxyphene-based medications, contact your doctor immediately so that you may be transitioned to a safer pain killer.

Photo: pharmer.org

Actavis issues voluntary recall of fentanyl transdermal system C-11 patches.

Monday, October 25th, 2010

Eighteen lots of fentanyl transdermal system C-11 patches have been recalled by Actavis. The fear leading to the recall relates to concerns that the active ingredient could release into the patient’s system at “an accelerated rate,” potentially leading to hypoventilation, respiratory depression and stoppage of breathing.

For more information, you can find the manufacturer’s voluntary recall notification information on the FDA’s website.

A New Blood Thinning Drug is Approved – Pradaxa – better than Coumadin?

Friday, October 22nd, 2010

This week’s press release by the US division of the German based Boehringer Ingelheim pharmaceutical company is certainly a breakthrough for patients. The company announced the FDA approval of their drug Pradaxa (dabigatran etexilate). This is the first new oral anticoagulation drug approved in the US in more than 50 years.The drug was approved for stroke and systemic embolism prevention in people who have atrial fibrillation not caused by a failing/defective heart valve.

The press release touts impressive results. National studies have shown when Pradaxa 150mg was taken twice daily, there was a 35% reduction in stroke and embolism when compared with the traditional drug known to most as Coumadin (Warfarin). In addition, at the same dosing level both types of stroke (embolic/clot and hemorrhagic/bleeding) were greatly reduced when compared to Coumadin. More good news for patients taking the drug…

  • Very few drug interactions,
  • No more dietary restrictions, and
  • No more routine blood testing and dosing changes as required when taking Coumadin.

WHAT IS ATRIAL FIBRILLATION AND WHY DO YOU NEED TO TAKE BLOOD THINNING DRUGS?

Atrial fibrillation is a heart rhythm disorder caused by a malfunctioning electrical conduction system within the heart – see video.  It is usually identified by an irregular rapid heart rate that begins in the upper heart.The smaller 2 upper heart chambers, known as the atria, begin to contract quickly and in an irregular fashion. As electrical signals leave the atria and enter the 2 lower heart chambers known as the ventricles, they too begin to contract quickly and in an irregular fashion.  This irregular and rapid heart rate is unable to pump the blood through the heart and out to the body in a strong, efficient manner. Thus blood can pool in the heart and the lower extremities allowing clots to form. These clots dislodge and travel to the heart, lungs, and brain leading to a stroke. Therefore it is important to prevent the clots from forming by correcting the abnormal heart rhythm,  and by lowering the blood’s ability to form dangerous clots.

The press release noted an estimated 2.3 million Americans have atrial fibrillation and the number is expected to increase to 5.6 million by 2050. A large US-based managed care organization used their data to show 95% of all persons with atrial fibrillation have no heart valve problems. Atrial fibrillation increased the risk of stroke 5 times, and is an underlying condition in 15% of all US strokes. Atrial fibrillation related strokes are twice as likely to be fatal or severely disabling when compared to strokes from other causes.

MedicineNet.com today reported recent studies by the New England Journal of Medicine and the American Heart Association found Pradaxa was also more effective in preventing clots in patients experiencing acute coronary syndrome. Sweden reports the drug can be safely used in conjunction with Plavix and Aspirin drug therapies.

WHAT ARE THE DOWNSIDES?

With the good news, comes the drug’s downside. The company is forthcoming in reporting Pradaxa when administered in 150mg doses results in a higher rate of gastrointestinal bleeding related complications when compared to Coumadin. This dose was reported to also cause an increase in adverse GI reactions such as dyspepsia, abdominal and gastric pain, GERD, esophagitis, gastritis, and ulcer. Importantly, in patients older than 75 years of age, the risk of bleeding complications may be greater than Coumadin. Also noteworthy is the finding that the risk of myocardial infarction was greater in studies with patients taking the 150mg dose than those taking Coumadin.

The company warns patients taking other blood thinners, non-steroidal anti-inflammatory medicines, St. John’s Wort, and any drug that can cause abnormal bleeding reactions need to be avoided. Over the counter medications are included in this warning. The company’s public package leaflet notes the drug will interact with Amiodarone and Verapamil and Pradaxa dosing will need to be reduced. The drug may also affect the liver but not more then Coumadin. It is contraindicated in patients who are in kidney failure, liver failure, and pregnancy. Some report a Quinidine interaction.

The FDA has approved dosing in capsule forms of 75mg and 150mg twice a day. Those persons taking larger doses of 150mg need to be fully informed of the above possible complications before switching from Coumadin to an easier life with Pradaxa.

EASIER TO LIVE WITH, BUT WHAT WILL IT COST?

It will take 3 to 6 months before distribution begins and pricing is not known. As with any new drug introduced in the US, speculation is the cost will be just short of prohibitive. Canada Pharmacies online sell Pradaxa 60 capsules both 75mg and 150mg doses at approximately $350.00 each. Generic Coumadin 100 pills at variable doses sell for approximately $34.00 to $50.00. The high drug price for US patients may offset the life style improvements for many who pay out of pocket for drugs. It is not known if prescription drug plans will approve partial or full payment for the drug.

It is generally reported that Coumadin is not a popular drug. Consumers and physicians alike resound with the same low opinion of the drug.  It is a difficult drug for physicians to manage, and it has a great impact on quality of life for patients. If Pradaxa continues to show its improved lifestyle value with no hidden serious side effects, patients will be the winners. Hopefully over time competitors will surface and prices will be driven into an affordable range for the growing US atrial fibrillation patient population.

UPDATE: Interesting piece by Dr. Wes on Pradaxa just posted today. Thought you may want to read. The comments have been coming in fast and furious on this new “wonder drug.”  Here’s the post by Dr. Wes – Pradaxa, Your Days are Numbered

Related Post:

Follow-Up Blog: Important Questions and Answers on Pradaxa