Posts Tagged ‘NIH’

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?

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?