Archive for the ‘FDA’ Category

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?

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?

 

Why do so many patients die when their in-hospital alarms go unheard or unheeded?

Thursday, February 17th, 2011

ICU alarm monitor

Sunday’s edition (February 13, 2011) of the the Boston Globe online (boston.com) tells a chilling story of how many times the alarms used to monitor patients go unheard and unheeded by medical staff leading to death or catastrophic injuries for patients throughout this country. The story, which was a two part series (for the second installment, see For nurses, it’s a constant dash to respond to alarms) by Globe reporter Liz Kowalczyk, narrates numerous incidents in which alarms simply went unnoticed, ignored or unmonitored. Numerous other issues such as lack of education of hospital staff as to how to properly connect the devices, failures to realize the batteries had gone dead, turning the alarms so low in volume they could not be heard, taping over amplification systems to avoid the “annoyance” of the alarms and the like are also chronicled in this series. While it is documented by an analysis of the FDA’s database of adverse events involving medical devices that 216 patients died nationwide between 2005 and mid-2010, it is also certain that this number of alarm-related deaths is probably much higher. The ECRI Institute, which was hired by the Globe to analyze the FDA database, believes that the health care industry under-reports these cases to the FDA.

Some examples of alarm-related deaths

Since links to the Globe’s original articles are provided above, I will not go into the level of detail that is otherwise available through reading the original reports. Here is a sampling of the types of “alarm failures” leading to patient deaths:

  • staff misprogrammed complicated monitors
  • staff had forgotten to turn the monitors on
  • batteries had gone dead leading and failed to function (one instance where a man had a “flat line” for more than two hours that went undetected)
  • defective wires or connections on the monitors
  • malfunction or design flaws in the monitoring devices
  • staff ignored the device warnings because of “alarm fatigure

Alarm Fatigue

According to one computation at Johns Hopkins Hospital in one 15 bed unit as to how often alarms go off during the course of day, it was documented that there were 942 alarms per day – “about 1 critical alarm every 90 seconds.” There is no doubt that the number of alarms and the clinical settings in which they are used have increased over the years. As Ms. Kowalczyk noted, “[W]ith the use of monitors rising, their beeps can become so relentless, and false alarms so numerous, that nurses can become desensitized – sometimes leaving patients to die without anyone rushing to their bedside.”

In some cases, busy nurses have not heard or ignored alarms warning of failing batteries or other problems not considered life-threatening. But even the highest-level crisis alarms, which are typically faster and higher-pitched, can go unheeded. At one undisclosed US hospital last year, manufacturer Philips Healthcare, based in Andover, found that one of its cardiac monitors blared at least 19 dangerous-arrhythmia alarms over nearly two hours but that staff, for unexplained reasons, temporarily silenced them at the central nursing station without “providing therapy warranted for this patient.’’ The patient died, according to Philips’s report to federal officials.

Keep in mind that many of these alarms are not only audible in the patient rooms; they also sound at the central nurse’s station. In some instances, hospitals have put up hallway speakers for nurses to hear the alarms more readily. In other facilities, in addition to audible alarms, various pieces of critical data information (e.g. heart rhythm, heart rate) are visible on displays at nurses stations and in some places, it is reported, “on brightly colored scrolling signs in corridors.”

The article quotes one nurse at Boston Medical Center, who addresses some of the issues at the heart of this “alarm fatigue” phenomenon.

Everyone who walks through the door gets a monitor. We have 17 [types of alarms that can go off at any time. They all have different pitches and different sounds. You hear alarms all the time. It becomes...background

False Alarms - the cry wolf issue

It is well known that some alarms can go off when a patient sits up, coughs, turns or makes other normal movements. According to the Globe report, "'[s]ome studies have found that more than 85 percent of the alarms are false.” I have no idea how this statistic was compiled, but even if it is accurate (which is debatable), that still leaves dozens if not hundreds (if not thousands) of alarms going off daily in every hospital throughout this country that are an indication of a patient in need of rapid response life-saving care.

Another nurse is quoted by the Globe in expressing both the frustration and the need for attentiveness when the alarm goes off. “You have to respond to the alarm[, b]ut there are some days when you feel you’re just running from alarm to alarm. It can be exasperating.”

The Fix

The short answer appears to be: there is no easy, quick fix. Here are some of the measures institutions have taken to address this problem:

  • working with engineers at prestigious institutions (e.g. MIT’s work with Boston’s Children’s Hospital) to develop more sophisticated monitors to identify true crisis alarms.
  • hiring of dedicated monitor technicians and/or nurses, who man the central nurses’ station to triage alarms.
  • specialized education programs to avoid misprogramming or connection mistakes due to lack of knowledge by staff
  • establishing tighter standards of which patients should be connected to alarmed monitors – to cut down on the “background noise” of alarms.
  • replacement of old equipment for more advanced, accurate alarm/monitor systems
  • implementation of new programs in-hospital to require bioengineers to check the monitors daily to make sure they are working properly.
  • implementation of standardized settings on machines so that alarms are not turned so low they are non longer audible. (One case of a patient death was attributed to staff turning the the “vexatious” alarm down to a 40% of full volume – no one responded to an arrhythmia alarm for 40 minutes because no one heard the reduced volume alarm during that time.)
  • changing batteries every day in monitors to make sure they are, in fact, charged and working

The Blame Game

As you might suspect, the finger-pointing that takes place after a patient is found dead or severely injured is rampant. As the Globe reports, “Initially, hospitals almost always blame the monitor’s alarm for not sounding when it should have, according to reports. But the company investigations show the assertion is often false.”

In 40 of the cases reviewed by the Globe, the alarms did not sound, usually because the staff had not properly programmed or turned on the machines.; in only eight cases was there a malfunction or design flaw.

[I]n nearly 100 cases, manufacturers ere unable to determine exactly what went wrong, often because they didn’t have enough information, or they told federal regulators they still were reviewing the death.

Where to from here?

While I certainly don’t have to contend with the incessant noise of alarms going off all day long, nor am I required to jump away from what I’m doing to respond to a false alarm, I can’t help but think that in a health industry as advanced as ours allegedly is, there must be some steps that can readily be taken so that others don’t die because some nurse has “alarm fatigue,” or a battery died, or the volume was turned down too low to avoid the annoyance of the alarm or some other ill-conceived and unacceptable reason.

What suggestions do you have for the healthcare industry to deal with this problem? Have you ever worked in a setting where this is a problem? If so, how did you and/or your institution deal with this issue? There are a lot of smart people in bioengineering and in our health institutions; why is this still such a problem in a country that claims to be so advanced?

Image by ectopicinteractive.com

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

Who’s Hawking Rx Drugs? Is It Really an Effective Medication or Just Effective Marketing?

Thursday, October 28th, 2010

We have all seen the non-stop drug ads on TV – a pill or injection that will cure whatever it is that ails us. Public advertising, however, is just one way that pharmaceutical companies get their drugs into the market place. Behind the scenes, there is a full-blown marketing campaign that the public never sees in which drug companies hire doctors (tens of thousands of doctors) to spread the word on their drugs, primarily by giving talks to other doctors.  An ongoing investigation by ProPublica reveals that some of these doctors have significant disciplinary actions in their past:

A review of physician licensing records in the 15 most-populous states and three others found sanctions against more than 250 speakers, including some of the highest paid. Their misconduct included inappropriately prescribing drugs, providing poor care or having sex with patients. Some of the doctors had even lost their licenses.  More than 40 have received FDA warnings for research misconduct, lost hospital privileges or been convicted of crimes. And at least 20 more have had two or more malpractice judgments or settlements. This accounting is by no means complete; many state regulators don’t post these actions on their web sites.

There is no doubt that the pharmaceutical industry (sometimes referred to as Big Pharma) is a huge industry.  According to IMS Health,a healthcare information and consulting company, prescription drugs generate $300 billion in sales in the United States alone.  Therefore, the pressure on drug companies to market their products is immense. For the doctors out there, doing free-lance work for drug companies can be a very lucrative side-business, with some physicians earning as much as $1,500 to $2,000 for giving a single talk to a group of doctors. While there is nothing wrong with marketing a legal product, the public must be assured that the marketing is honest and that the drugs in question are being prescribed because they are effective drugs, not simply because the drug companies have an effective marketing campaign.

“Without question the public should care,” said Dr. Joseph Ross, an assistant professor of medicine at Yale School of Medicine who has written about the industry’s influence on physicians. “You would never want your kid learning from a bad teacher. Why would you want your doctor learning from a bad doctor, someone who hasn’t displayed good judgment in the past?”

Big Pharma appears to be turning a relatively blind eye to the situation. As part of its investigation, ProPublica compiled a database of physicians who work for the drug companies, and then cross-checked these doctors’ credentials and state disciplinary records.  The drug companies themselves could have taken this approach in vetting their doctors, but most do not bother to do so. Most companies “rely on self-reporting and checks of federal databases.”  However, it is the state disciplinary records that typically contain the relevant data on doctors who have been disciplined (and even state authorities do not always post such infractions on their websites). Lisa Bero, a pharmacy professor at University of California, San Francisco, questions the way that Big Pharma checks on its doctors:

Did they not do background checks on these people?  Why did they pick them? If they did things in their background that are questionable, what about the information they’re giving to me now?

In addition to disciplinary actions, ProPublica also raises questions as to these doctors’ credentials, e.g. medical research, academic appointments and professional society involvement, that would make them especially qualified to speak on medical conditions and ways to treat them. The investigation highlights a Las Vegas endocrinologist who has earned over $300,000 from Big Pharma. However, ProPublica contends that it was unable to locate any credentials on this doctor other than his schooling and some 20-year-old research articles. Furthermore, an online brochure from a recent presentation given by this doctor indicated that he was the chief of endocrinology at a local hospital, but “an official there said he hasn’t held that title since 2008.” Such stories only add to the serious questions as to how Big Pharma is selecting its doctors.

Certainly, a lot of good can come from honest marketing of effective new drugs. Especially in out-of-the way places, a talk by a knowledgeable physician can be a great source of information on new treatments available for a certain disease. If a new drug is truly effective, then by all means the word needs to get out on that drug because such drugs allow us to live longer and to live more comfortably with what were once debilitating diseases.  However, the public must demand honest assessment of these drugs. When drug companies allow unscrupulous doctors to hawk their wares, it raises legitimate suspicion as to whether these drugs are so popular because they are truly effective or simply because they had a good marketing blitz.

If you are curious about a specific doctor, ProPublica has a searchable database of doctors who do work for drug companies. Also, ProPublica has published several follow-up and/or related articles which can be found here.

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

FDA Commissioner Hamburg’s Report Card: NEJM provides a “perspective.”

Friday, October 15th, 2010

On October 6, 2010, The New England Journal of Medicine published a well written “perspective” on FDA Commissioner Dr. Margaret Hamburg’s efforts to “revive the FDA.” Her principal deputy commissioner, Dr. Joshua Sharfstein, echoed the same sentiment: “I keep a list of things I wish were moving faster and  a list of things moving at just the right speed, and these nothing on the second list.” (emphasis added). Dr. Hamburg is just completing her first year as commissioner at the FDA. We can only hope she remains and stays steadfast to the goals and objectives she has set out to achieve.

Since the NEJM is a subscription journal, I’m not sure if you will be able to access the full article, but I certainly hope you can.

Of significance for those of us who deal with FDA’s actions on virtually a daily basis, Commissioner Hamburg’s first quoted comment is of particular interest: ““You feel it differently at the FDA — how long it takes to move things through the system.” Welcome to bureaucracy at its finest, Commissioner.

What Commissioner Hamburg has done, however, deserves a lot of credit – at least in my non-politically based opinion.

Her objectives are listed by the NEJM article as being making “the FDA more nimble and proactive, restoring its credibility and refocusing staff on its public health mission, persuading Congress to boost funding for its expanding portfolio of responsibilities [and] sharpening its ability to deal with new science and globalization.” A very healthy list in all senses of the word.

Here is a list of just some of the actions taken and projects underway:

  • major recalls of over-the-counter pediatric medications
  • major recalls of salmonella-contaminated eggs
  • engaging in major debates over direct-to-consumer genetic testing
  • addressing safety concerns over the “blockbuster” diabetes drug, rosiglitzone
  • implementation of a 2009 law making the FDA responsible for tobacco regulation
  • making food-package labeling more evidence based
  • launching initiatives to “clarify and standardize” processes for evaluation drugs and medical devices
  • making more information public

As far as dealing with the issue of bureaucratic lethargy, Hamburg, Sharfstein and other key people at the FDA have created a new process known as “risk control review.” Under this program, field inspectors, who had previously been required to simply file reports that would eventually wend their way through the bureaucratic maze, when they detect “urgent health threats,” can now initiate direct meetings with key agency personnel to discuss taking emergency action. As a result of another initiative, an agency food-safety registry, in the first seven months of Hamburg’s leadership, more than 100 food-safety reports were submitted.

For those familiar with how the FDA worked, it is common knowledge that regulators of drugs and medical devices have been under pressure to approve them quickly. In response to criticisms of this so-called approval process, Dr. Hamburg and her staff have created an internal task force to review the way such decisions are being made at the Center for Drug Evaluation and Research (CDER). This approval process, called the 510(k) clearance process, was first met with outright dissent. After a “scathing internal FDA review” identified some of the major problems with the former way of doing business, officials at CDER adopted some of the recommended reforms – hopefully leading to “a clearer, fairer decision-making process.” Another IOM panel report is due next year; it is anticipated that further reforms in such process will be recommended.

Dr. Hamburg’s mantra has been – “follow the science.” Her response to the questions from her people at FDA in terms of what they can do about concerns of immediate public health safety is reported as being – “What do you think the right thing to do is from a public health perspective?” Seems like the Commissioner is a good listener and a pro-active responder.

Needless to say, Dr. Hamburg’s activities could well fill pages of text. She faces issues relating to globalization (ensuring products made overseas and entering our marketplace are safe), funding for her agency (a never-ending task seeking dollars for her projects and people in a seemingly pitiful federal budget), improvement of post-marketing safety studies, implementing and overseeing a data-mining system used to analyze electronic safety records (Harvard Pilgrim Health Care’s Sentinel System) to improve numerous aspects of patient safety, and forging key partnerships with private industry and academia scientists to “get it right” – to name just some of the projects for which her agency is responsible.

All one can say – thank goodness the Doctor is in the house! We wish her continued strength, patience, perseverance and success.

Bone-Strengthening Drugs and Esophageal Cancer – Potential Link Should Not Be Ignored

Monday, September 6th, 2010

In the last year, there has been considerable debate about the link between bone-strengthening drugs, also known as bisphosphonates, and esophageal cancer. It started last year when the FDA released information regarding nearly two dozen cases of esophageal cancer in patients that have been taking oral bisphosphonates such as Fosamax. According to Diane Wysowski, PhD, the FDA official who first claimed that there may be a link between bisphosphonates and esophageal cancer, the FDA has continued to receive reports of esophageal cancer in patients on bisphosphonates since 2009.

The FDA’s announcement was followed by the release of a research study of more than 80,000 people, which focused on the link between bisphosphonates and esophageal cancer. The study, which was recently published in the Journal of the American Medical Association, claims that the link between bisphosphonates and an increased risk for developing esophageal cancer is insignificant.

“[Researchers] compared the rates of esophageal and stomach cancer in 83,652 people, half of whom had received at least one prescription for oral bisphosphonates in the previous decade. Just over 80% of the participants were women, and the average age was 70. … Eighty-nine and 92 cases of esophageal cancer were reported in the bisphosphonate and control groups, respectively, as were 49 and 57 cases of stomach cancer—a negligible difference.”

The authors conceded, however, that the study was not perfect.  For example, the study lasted for only 4.5 years, an insufficient period of time to measure the risk of esophageal cancer among patients on bisphosphonates.  Researchers were also not able to insure that all of the study participants actually took bisphosphonates as prescribed. Additionally, they did not account for other comorbidities and risk factors that might increase the risk for esophageal cancer.

According to Chris Cardwell, PhD, the study’s lead author: “Our study is the largest to date, but on the basis of our results we cannot rule out small increases in esophageal cancer risk in individuals taking bisphosphonates.”

A more recent study on the same subject was published last week in the British Journal of Medicine.  This study concluded that that there is an increase in the incidence of esophageal cancer among patients who have been taking oral bisphosphonates for several years (ten or more prescriptions or prescriptions over the course of five years).

“Researchers tracked almost 3,000 people with cancer of the esophagus or throat for eight years and compared them with a group of 15,000 people who did not have the disease. All were over age 40. The scientists found that 90 of the cancer patients had been prescribed the bone-building drugs, while 345 people in the larger group were taking the medication.”

According to this latest research study, the normal incidence of esophageal cancer among patients 60-79 who are not on oral bisphosphonates is about one per 1000. In the same age group, researchers found that the incidence of esophageal cancer doubled among those patients that have been on oral bisphosphonates for several years. It is suspected that bisphosphonates cause inflammation of the esophagus that may predisposes the patient to esophageal cancer.

Both of these studies seem to indicate a positive correlation between oral bisphosphonates and esophageal cancer.  Whether or not the correlation is significant is a determination the patient should be making with his or her physician.  The risk for developing esophageal cancer should not be ignored considering the number of people who take oral bisphosphonates on a regular basis. It is estimated that about 10 million women are diagnosed with osteoporosis in the U.S.  In this population, about 4.7 million take oral bisphosphonates on a regular basis.

If you have been taking oral bisphosphonates for five years or longer, discuss the risk of developing esophageal cancer with your physician and explore available alternatives if you are at risk. More important perhaps, be on the lookout for signs and symptoms consistent with esophageal cancer. They include throat, chest and digestive discomfort as well as difficulty swallowing.  If you have these symptoms, consult a physician immediately.

Contributing author: Jon Stefanuca