Solstice occurred last month, but for most of us in California, June gloom diminished our urgency for heightened skin security. (This is clearly not the case, but this article is not meant to go into the physics of UV radiation.) Now that the sun is so visible (and hot), we are certainly more aware of our need for sunscreen. If you are like me, you dab some moisturizing sunscreen lotion on your face under your makeup before you venture out in the morning. And that’s it, unless perhaps you expect to spend a day at the beach or lie by the pool. This is, of course, not enough to prevent cancer (or aging) in the largest organ in our body; our skin.

A new study conducted in Queensland, Australia has provided evidence that regular use of “adequate” sunscreen significantly prevents melanoma. The study, which appeared in the “Commentary” section of JAMA, included 1621 adults randomized to regular sunscreen use or to discretionary use, which included no use at all. Those who were in the “use-a-lot-of-sunscreen” group were given an unlimited supply of broad-spectrum sunscreen with SPF of 16 and asked to apply it to head, neck, arms and hands every morning for 5 years. They were also told to reapply it after heavy sweating, bathing or long-sun exposure. Ten years after the end of the trial, 11 new melanomas were found in the 812 persons assigned to the daily sunscreen group and 22 melanomas among the 802 persons assigned to the discretionary group. That’s a 50% reduction. (Just so you don’t question other factors which could have led to this: both groups were similar for known risk factors such as light skin color, frequent outdoor sports, sunburn history, number of moles and history of skin cancer at the start of the trial.)

The author of the article points out that the only modifiable cause of melanoma is exposure to UV radiation. Individuals are considered to be at high risk for skin cancer if they have fair skin, freckling and tendency to sunburn, if they live or visit sunny climates or have a family tendency for melanoma. There seems to be no question that they (and this includes me) should routinely apply sunscreen before going out, especially if they live in locations with relatively high levels of ambient UV radiation such as Arizona, CALIFORNIA and Florida. This advice is also relevant to those living in temperate climates, but who vacation in sunny places.

Now what really got me interested: the amount of sunscreen we should be using… 2 coats (sounds like we are painting ourselves) or about 1 teaspoon of sunscreen to each body part prior to going outside. This should include the head, neck and ears; front of the trunk (our chest and décolletage); each arm, top of the hands and shoulders; the lower legs, upper legs, as well as the top of  the feet (for flip flops or sandals). Your legs should be divided into upper and lower segments with each getting 1 teaspoon of slathered sunscreen. If you sweat heavily or towel off after exercise or swimming, you should reapply the sunscreen right after the activity, even if the sunscreen “offers” 8 hours of protection or claims to be water -resistant or sweat-resistant.

There were over 68,000 new patients diagnosed with melanoma in the U.S. in 2010.  It may not be too late for each if us to change our sunscreen use and help prevent this form of potentially fatal skin cancer. Guess I’ll stock up, and even more importantly use it!

So a patient comes in to my office (sorry if this sounds like the beginning of one of those bar jokes) and as part of my due diligence I update her chart with her current medications. Upon enquiring as to what she is now taking, I may be given a container of various pills with the statement “I take these once a day”. Or I might get a description of the medication “I now take the pink pills that lower cholesterol; I’m not sure of the name…it’s a small dose; it used to be yellow”. Yes, this sounds ridiculously ambiguous but it’s not her fault. The names, colors and shapes of medications are no longer stable. (And this has nothing to do with their expiration date.) At least 70% of U.S. prescriptions are generic. The good news is that they are a lot less expensive than brand prescription drugs and indeed make up less than 20% of current prescription drug costs in the U.S..

An article about our lack of pill recognition titled “Why Do the Same Drugs Look Different? Pills, Trade Dress, and Public Health” was recently published in The New England Medical Journal. I thought I would share it with you in this week’s newsletter.

The clinical effects of brand and generic medications are supposed to be the same (or according to the authors “interchangeable”) but they often look very different. Whereas a brand medication will always appear identical with each refill, generic medications can vary in size, color and shape depending on the manufacturer supplying the pharmacy. (Need I say the cheapest brands will most likely be the ones that are supplied?) They all have to be approved by the FDA, so cheaper does not mean that quality or concentration of the medication has been compromised. An example that was given in the article (along with pictures) is fluoxetine (brand name Prozac). There are at least 10 generic versions that are pharmacologically equivalent to the original drug yet they vary in their color patterns.

No, this was not done on purpose to confuse the consumer or test the memory of her physician. It turns out that color and shape-shift has its basis in U.S. intellectual-property law. Drug manufacturers have had exclusive ownership of the physical aspects of their products, including their size, shape, color, texture, aroma and flavor. These properties are considered private property under a subset of trade law called “trade dress”.  (I immediately associated this title with words like designer, exclusive and whatever other branding adjectives makes “not-off-the-rack” fashion so unique.) To be fair…. the companies that do research and development of drugs should be compensated for the tremendous costs they assume. Often millions of dollars are spent on trials that have to be abandoned, because the medications that undergo testing are not significantly effective or are found to cause serious side effects in humans.  Without pharmaceutical company development of new drugs that meet the standards that are required for FDA approval, many diseases and conditions would remain untreated and we would all suffer. (Lack of special designer clothes would obviously not have the same effect!)

There were several reasons that pharmaceutical companies were granted broad based legal protections in the mid-20th century.  There was a valid concern that counterfeit drugs would be “palmed -off” to unsuspecting patients (and even their pharmacies) if they had the same appearance and packaging as brand-name drugs. At some point, the Third Circuit Court of Appeals upheld trade-dress protection because near-identical pills would facilitate the practice of “unscrupulous pharmacists” in “substituting less expensive generic drugs for the brand name drugs prescribed without informing their customers and without passing along the benefit of the lower price.” The courts also felt that allowing trade-dress protection served a public health function by preventing the substitution of one drug that was similar but not identical to another.

The 1997 FDA guidelines for expanding direct -to -consumer advertising of prescription drugs also made the images of pills more important to the drug companies. An example is sildenafil (you know it as Viagra, that diamond shaped light blue pill.) We all know about that “little blue pill”…it has become a stand up cultural phenomenon.

But now, that legal protection has begun to unravel. In 2003, there was a legal dispute about Adderall, a medication prescribed for children with attention deficit-hyperactivity disorder. The company that first produced it in 1996 stated that the color, shape and size of various doses helped children adhere to their prescribed regimens. When a generic company (Barr) tried to copy these color schemes the court agreed to let them; after all the original company (Shire) had claimed the importance of the color trade dress.  In the tradition of “if you can’t beat them join them” over the last 5 years, brand-name pharmaceutical companies have begun to license their trade dress to the manufacturers of authorized generics. And (for a price), some generics look the same as the name brand.

The suggestion offered by the authors of the article in NEJM seems to be truly appropriate: “Instituting a more consistent and organized system of pill appearance would increase patient adherence, reduce the complexity of medical regimens, reduce medication error, and encourage the rational use of bioequivalent generic drugs.”  I would also suggest that you bring in your bottle of current drugs so that your doctor or nurse can check the name, dosage and directions for use. None of us should rely on color, shape, aroma or flavor to identify a medication… No matter what it now looks like, it should be taken as directed.

In the past 100 years, our life expectancy has risen more than 65%. (Or to put it in more amazing terms, life expectancy at birth in the U.S. was only 47.3 years in 1900 and is 83 (for females) in 2010.  Much of this is due to past public health achievements, which have continued at an amazing rate in the first decade of the 21st century. We can all enjoy the results of these achievements without becoming public health experts; but I thought it would be nice to share the top ten choices for “public health award” nominated by those who should know… the public health scientists at the CDC.  So here they are in a non-ranked order, published in the July 6 issue of JAMA:

Vaccine -preventable diseases

New vaccines have been developed for intestinal viruses, meningitis, herpes, pneumonia and cervical cancer (HPV) as well as tetanus, diphtheria and pertussis. Overall, 17 diseases are targeted by our current U.S. immunization policy. If all children in our country were to receive these immunizations 42,000 deaths and 20 million cases of disease would be prevented!


Advances have also been made in the use of older vaccines so that cases of hepatitis A and hepatitis B as well as varicella (chicken pox) are at record lows for this decade. (This is where I suggest you make sure you have received all your vaccinations and get this year’s flu shot when it becomes available.)


Prevention and Control of Infectious Diseases

There has been a 30% reduction in the past decade in reported U.S. cases of tuberculosis.


The ability to detect and test food contamination has undergone major advancement. (Although, the source of contamination in our pan-global food supply may be difficult to follow. An example is the recent virulent E. coli infection in Europe that may have been the result of contaminated seeds from a crop grown in Egypt that was exported to farms in Europe over 2 years ago and planted in the past year.)


Efforts to extend HIV testing now include screening of all persons aged 13-64. This will mean that as many as 250,000 people in the U.S. who don’t know they are infected with HIV will get earlier access to life-saving treatment and care and be able to protect their partners.


Testing for viruses in blood including hepatitis, HIV, and West Nile virus has made blood donations much safer.


And in 2004, after more than 60 years of effort, rabies in dogs has been eliminated in our country.


Tobacco Control


Smoking has decreased but frankly not enough; the decline seems to depend on location, socioeconomic status and state. By 2009, 20.6% of adults and 19.5% of youths were current smokers, compared to 23.5% of adults and 34.8% of youths 10 years earlier. As of 2010 we now have 16 states (including California) that have enacted comprehensive smoke-free laws (i.e. prohibiting smoking in worksites, restaurants and bars). And individual state and federal excise taxes have increased; so that the average combined federal and state excise tax for cigarettes is $2.21 per pack. The FDA has banned flavored cigarettes, making them less appealing to young persons and there will now be graphic warning images that may help discourage current and future smokers. (Seeing a picture of a corpse may, at least initially, give pause for breath.)


Maternal and Infant Health


There has been a 36% decrease in newborn neural tube defects (spina bifida) as a result of mandatory folic acid fortification of cereal grain products.


A significant expansion of screening tests in pregnancy (blood tests, structural ultrasound and when necessary CVS and amniocentesis), now allow for very early diagnosis of fetal genetic disorders and malformations. And mandatory screening of newborns for at least 26 disorders leads to early life-saving treatment and intervention.


Cardiovascular Disease Prevention


Over this last decade, there has been a decline in the age-adjusted coronary heart disease death rate (it went down from 195 to 126 per 100,000 population) and stroke death rates (which declined from 61.2 to 42.2 per 100,000 population).   Much of this death rate decline can be attributed to treatment of hypertension, elevated cholesterol, improvements in diagnosis and treatment of heart disease, medications, quality of care and finally a decline in smoking. (I don’t want to be negative here, but obviously the obesity rates are working against all this.)


Occupational Safety


This includes prevention of back injuries among health-care workers (and thankfully, physicians do fall in this category) with the use of mechanical patient lifting equipment, and better patient handling practices. (At many hospitals, we have special lift teams.)


There have been laws and guidelines that prevent children from injury while helping with farm work.


I found it somewhat interesting that the article in JAMA did not address other occupations…. heavy or light industry, factory work, construction and mining, all of which have had major changes in worker safety regulations.


Cancer Prevention


This is where we see the effect of improved screening rates for breast cancer, colorectal cancer, stomach cancer and cervical cancer…all of which have reduced mortality rates.


Childhood Lead Poisoning


This was an interesting choice for the CDC’s “top ten.” It turns out (and I didn’t know this) that in 2000, childhood lead poisoning was a very major environmental health problem in the U.S. Only 5 states had comprehensive lead poisoning prevention laws; by 2010, 23 states have such laws. Between 1976 and 1980, an astounding 88.2% of children aged 1-5 years had elevated lead levels, this declined to 0.9% in 2010.


Public Health Preparedness and Response


This includes response to international and domestic terrorism actions. In the first half of the decade, efforts were focused in purchasing supplies and equipment; in the second half, the focus was on improved surveillance, laboratory testing and response. And as viral treats such as H1N1 occurred, there were improvements in rapid detection, deployment of laboratory tests, development and administration of vaccine.


Barbra Streisand wrote on the jacket for one of my books; “Life without health means nothing”. It sums up much of what I have tried to convey through out my career.  As the age -adjusted death rate in the United States has declined and continues a downturn trend; more of us will attain and maintain our health. We should give due credit to public health achievements. And of course we have to acknowledge the need for the medical information that helps foster our individual health behaviors.

Every once in a while I have a culinary break down and snack on potato chips….they gratify so many tastes: salt, fat, crispy carbs and empower a feeling of “so what.”  Turns out that I (and you) would be better off snacking on nuts. At least that’s the conclusion of a prospective investigation of lifestyle behaviors and diet published in the June issue of The New England Journal of Medicine. The authors combined questionnaires on lifestyle factors and weight change for 120,877 women and men who were free of chronic disease and who participated in 3 studies with follow-up periods ranging from 1986 to 2006 (The Nurses Health Study), 1991 to 2003 (the Nurses Health Study II…this involved younger nurses; Nurses I and II were all women) and 1986 to 2006 (the Health Professionals Follow-up Study… all male). Their diets were assessed as to consumption of fruits, vegetables, whole grains, refined grains (what I call the white stuff), potatoes (including boiled, mashed potatoes and french fries), potato chips, whole-fat dairy products, low-fat dairy products, sugar-sweetened beverages, sweets and desserts, processed meats, unprocessed red meats, fried foods and trans fats. In other words, pretty much everything we know that can be bad for our health. The studies also evaluated nuts, 100%-fruit juices, diet sodas and subtypes of dairy products and potatoes. The participants were questioned about their physical activity, television watching, alcohol use, sleep duration and cigarette smoking.

The participants’ food and weight changes were assessed every 4 years. When the average weight gain was calculated for the 3 groups it was 3.35 lb…doesn’t sound like a huge amount, but when calculated over 20 years this comes to 16.8 lb. (There goes a size 6, an 8 and even a10!) And here are the foods and behaviors that were associated with weight gain, as well as those that were related to weight loss:

FOOD OR BEHAVIOR

WEIGHT GAIN (+) or L0SS (-) PER 4 YEARS

  • Potato Chips
  • Potatoes
  • Refined grains
  • Sweets and desserts
  • Sugar Sweetened beverages
  • Unprocessed Red Meats
  • Processed meats
  • Vegetables
  • Whole grains
  • Fruits
  • Nuts
  • Yogurt
  • Physical activity
  • Alcohol use
  • Smoking cessation (new quitters)
  • Former smokers
  • Sleep (weight gained with less than 6 hours or more than 8 hours)
  • Television watching

+ 1.69 lb
+1.28 lb
+0.37 lb
+ 0.41 lb
+1.0 lb
+ 0.95 lb
+ 0.92 lb
- 0.22 lb
- 0.37 lb
- 0.49 lb
- 0.57 lb
- 0.82 lb

- 1.76 lb

+ 0.41 lb per drink per day
+ 5.17 lb

+ 0.14 lb

+ 0.31 lb per hour per day

I’m sure you will (and should) now ask: How many potato chips or nuts does one have to consume to gain or lose weight during that 4 year period? Just one serving per day! (And for the amount that constitutes a serving, you have to look on the package or bottle insert and/or use common nutritional sense.)

Please note that the weight gain that was associated with refined grains was similar to that of a serving of sweets and desserts. Inverse associations with weight gain (i.e. loss) were seen with the consumption of vegetables, whole grains, fruits, nuts and yogurt. No significant differences in weight gain were seen for high-fat versus low-fat and skim milk. The authors weren’t sure why yogurt consumption helped prevent weight gain. They hypothesized that changes in colonic bacteria caused by the yogurt might prevent weight gain. And they thought that even though vegetables, nuts, fruits and whole grains provide calories (and according to thermodynamic law a calorie is a calorie and energy put in the body will be stored unless it is used up); their consumption reduced the intake of  the other foods that were more likely to cause weight gain. It was interesting that drinking 100%-fruit juice was associated with less weight gain than sugar-sweetened beverages. The reason may be that the fruit juices are consumed in smaller portions. (It’s hard to drink a “big gulp” of orange juice!)

Finally, (and we would expect this) the women and men with who exercised daily lost 1.76 pounds within each 4-year period.

Now for the smoking issue… I don’t want this data to stop anyone from deciding to stop.  Smoking is thought to alter the distribution of body fat, promoting internal abdominal fat (called visceral fat) rather than fat on the rest of the body. So weight might be less while smoking but this visceral fat is dangerous and is linked to a high risk of diabetes. Any so called weight loss from smoking is ultimately harmful. (Just think of the fat going invisibly inside your abdomen as your thighs, arms and the tush lose circumference; and that this bad fat can kill you!),  The immediate weight gain that can occur after smoking cessation actually represents a healthier distribution of fat, moreover that weight eventually declines.
Here are some stats that match the overall data from these 3 studies: Between 1971 and 2004 the average dietary intake of calories in the United States increased by 22% among women and 10% among men, mainly due to increased consumption of refined carbohydrates, starches and sugar-sweetened beverages. Just 50 to 150 extra calories a day will cause the gradual weight gains, and over time those pounds add up and demolish our figures (and health).

Bottom line: Eat those vegetables, whole grains, fruits, nuts and yogurt.  Cut down on all those processed carbs and starches. Limit your TV time (you are more likely to eat the bad stuff while sitting there watching TV, even if you Tivo out the commercials for potato chips), make sure you exercise (at least 30 minutes most every day) stop smoking as soon as possible (better yet never start) and  sleep 7 to 8 hours a day. Well our mothers knew all that!

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