Category Archives: Food and Drug Administration

Sunscreen–and a father who cared

August is on its last legs, but the sun’s rays are still potent. Potent enough to require that we use sunscreen. Especially those of us whose skin is most vulnerable to those rays.

I’ve been vulnerable to the harsh effects of the sun since birth.  And I now apply sunscreen religiously to my face, hands, and arms whenever I expect to encounter sunlight.

When I was younger, sunscreen wasn’t really around.  Fortunately for my skin, I spent most of my childhood and youth in cold-weather climates where the sun was absent much of the year.  Chicago and Boston, even St. Louis, had long winters featuring gray skies instead of sunshine.

I encountered the sun mostly during summers and a seven-month stay in Los Angeles.  But my sun exposure was limited.  It was only when I was about 28 and about to embark on a trip to Mexico that I first heard of “sunblock.”  Friends advised me to seek it out at the only location where it was known to be available, a small pharmacy in downtown Chicago.   I hastened to make my way there and buy a tube of the pasty white stuff, and once I hit the Mexican sun, I applied it to my skin, sparing myself a wretched sunburn.

The pasty white stuff was a powerful reminder of my father.  Before he died when I was 12, Daddy would cover my skin with something he called zinc oxide.

Daddy was a pharmacist by training, earning a degree in pharmacy from the University of Illinois at the age of 21.  One of my favorite family photos shows Daddy in a chemistry lab at the university, learning what he needed to know to earn that degree.  His first choice was to become a doctor, but because his own father had died during Daddy’s infancy, there was no way he could afford medical school.  An irascible uncle was a pharmacist and somehow pushed Daddy into pharmacy as a less expensive route to helping people via medicine.

Daddy spent years bouncing between pharmacy and retailing, and sometimes he did both.  I treasure a photo of him as a young man standing in front of the drug store he owned on the South Side of Chicago.  When I was growing up, he sometimes worked at a pharmacy and sometimes in other retailing enterprises, but he never abandoned his knowledge of pharmaceuticals.  While working as a pharmacist, he would often bring home new drugs he believed would cure our problems.  One time I especially recall:  Because as a young child I suffered from allergies, Daddy was excited when a brand-new drug came along to help me deal with them, and he brought a bottle of it home for me.

As for preventing sunburn, Daddy would many times take a tube of zinc oxide and apply it to my skin.

One summer or two, I didn’t totally escape a couple of bad sunburns. Daddy must have been distracted just then, and I foolishly exposed my skin to the sun.  He later applied a greasy ointment called butesin picrate to soothe my burn. But I distinctly remember that he used his knowledge of chemistry to get out that tube of zinc oxide whenever he could.

After my pivotal trip to Mexico, sunblocks became much more available.  (I also acquired a number of sunhats to shield my face from the sun.)  But looking back, I wonder about the composition of some of the sunblocks I applied to my skin for decades.  Exactly what was I adding to my chemical burden?

In 2013, the FDA banned the use of the word “sunblock,” stating that it could mislead consumers into thinking that a product was more effective than it really was.  So sunblocks have become sunscreens, but some are more powerful than others.

A compelling reason to use powerful sunscreens?  The ozone layer that protected us in the past has undergone damage in recent years, and there’s scientific concern that more of the sun’s dangerous rays can penetrate that layer, leading to increased damage to our skin.

In recent years, I’ve paid a lot of attention to what’s in the sunscreens I choose.  Some of the chemicals in available sunscreens are now condemned by groups like the Environmental Working Group (EWG) as either ineffective or hazardous to your health. (Please check EWG’s 2018 Sunscreen Guide for well-researched and detailed information regarding sunscreens.)

Let’s note, too, that the state of Hawaii has banned the future use of sunscreens that include one of these chemicals, oxybenzone, because it washes off swimmers’ skin into ocean waters and has been shown to be harmful to coral reefs.  If it’s harming coral, what is it doing to us?

Because I now make the very deliberate choice to avoid using sunscreens harboring suspect chemicals, I use only those sunscreens whose active ingredients include—guess what– zinc oxide.   Sometimes another safe ingredient, titanium dioxide, is added.  The science behind these two mineral (rather than chemical) ingredients?   Both have inorganic particulates that reflect, scatter, and absorb damaging UVA and UVB rays.

Daddy, I think you’d be happy to know that science has acknowledged what you knew all those years ago.  Pasty white zinc oxide still stands tall as one of the very best barriers to repel the sun’s damaging rays.

In a lifetime filled with many setbacks, both physical and professional, my father always took joy in his family.  He showered us with his love, demonstrating that he cared for us in innumerable ways.

Every time I apply a sunscreen based on zinc oxide, I think of you, Daddy.  With love, with respect for your vast knowledge, and with gratitude that you cared so much for us and did everything you could to help us live a healthier life.

 

A Day Without a Drug Commercial

Last night I dreamed there was a day without a drug commercial….

When I woke up, reality stared me in the face.  It couldn’t be true.  Not right now.  Not without revolutionary changes in the drug industry.

Here are some numbers that may surprise you.  Or maybe not.

Six out of ten adults in the U.S. take a prescription medication.  That’s up from five out of ten a decade ago.  (These numbers appeared in a recent study published in the Journal of the American Medical Association.)

Further, nine out of ten people over 65 take at least one drug, and four out of ten take five or more—nearly twice as many as a decade ago.

One more statistic:  insured adults under 65 are twice as likely to take medication as the uninsured.

Are you surprised by any of these numbers?  I’m not.

Until the 1990s, drug companies largely relied on physicians to promote their prescription drugs. But in 1997, the Food and Drug Administration revised its earlier rules on direct-to-consumer (DTC) advertising, putting fewer restrictions on the advertising of pharmaceuticals on TV and radio, as well as in print and other media.  We’re one of only two countries–New Zealand is the other one–that permit this kind of advertising.

The Food and Drug Administration is responsible for regulating it and is supposed to take into account ethical and other concerns to prevent the undue influence of DTC advertising on consumer demand.  The fear was that advertising would lead to a demand for medically unnecessary prescription meds.

It’s pretty clear to me that it has.  Do you agree?

Just look at the statistics.  The number of people taking prescription drugs increases every year.  In my view, advertising has encouraged them to seek drugs that may be medically unnecessary.

Of course, many meds are essential to preserve a patient’s life and health.  But have you heard the TV commercials?  Some of them highlight obscure illnesses that affect a small number of TV viewers.  But whether we suffer from these ailments or not, we’re all constantly assaulted by these ads.  And think about it:  If you feel a little under the weather one day, or a bit down in the dumps because of something that happened at work, or just feeling stressed because the neighbor’s dog keeps barking every night, might those ads induce you to call your doc and demand a new drug to deal with it?

The drug commercials appear to target those who watch daytime TV—mostly older folks and the unemployed.  Because I work at home, I sometimes watch TV news while I munch on my peanut butter sandwich.  But if I don’t hit the mute button fast enough, I’m bombarded by annoying ads describing all sorts of horrible diseases.  And the side effects of the drugs?  Hearing them recited (as rapidly as possible) is enough to make me lose my appetite.  One commercial stated some possible side effects:  suicidal thoughts or actions; new or worsening depression; blurry vision; swelling of face, mouth, hands or feet; and trouble breathing.  Good grief!  The side effects sounded worse than the disease.

I’m not the only one annoyed by drug commercials.  In November 2015, the American Medical Association called for a ban on DTC ads of prescription drugs. Physicians cited genuine concerns that a growing proliferation of ads was driving the demand for expensive treatments despite the effectiveness of less costly alternatives.  They also cited concerns that marketing costs were fueling escalating drug prices, noting that advertising dollars spent by drug makers had increased by 30 percent in the previous two years, totaling $4.5 billion.

The World Health Organization has also concluded that DTC ads promote expensive brand-name drugs.  WHO has recommended against allowing DTC ads, noting surveys in the US and New Zealand showing that when patients ask for a specific drug by name, they receive it more often than not.

Senator Bernie Sanders has repeatedly stated that Americans pay the highest prices in the world for prescription drugs.  He and other Senators introduced a bill in 2015 aimed at skyrocketing drug prices, and Sanders went on to rail against them during his 2016 presidential campaign.

Another member of Congress, Representative Rosa DeLauro (D-Conn.), has introduced a bill specifically focused on DTC ads.  Calling for a three-year moratorium on advertising new prescription drugs directly to consumers, the bill would freeze these ads, with the aim of holding down health-care costs.

DeLauro has argued, much like the AMA, that DTC ads can inflate health-care costs if they prompt consumers to seek newer, higher-priced meds.  The Responsibility in Drug Advertising Act would amend the current Food, Drug, and Cosmetic Act and is the latest effort to squelch DTC advertising of prescription meds.

The fact that insured adults under 65 are twice as likely to take prescription meds as those who are not insured highlights a couple of things:  That these ads are pretty much about making more and more money for the drug manufacturers.  And that most of the people who can afford them are either insured or in an over-65 program covering many of their medical expenses.  So it’s easy to see that manufacturers can charge inflated prices because these consumers are reimbursed by their insurance companies.  No wonder health insurance costs so much!  And those who are uninsured must struggle to pay the escalating prices or go without the drugs they genuinely need.

Not surprisingly, the drug industry trade group, the Pharmaceutical Research and Manufacturers of America, has disputed the argument that DTC ads play “a direct role in the cost of new medicines.”  It claims that most people find these ads useful because they “tell people about new treatments.”  It’s probably true that a few ads may have a public-health benefit.  But I doubt that very many fall into that category.

Hey, Big Pharma:  If I need to learn about a new treatment for a health problem, I’ll consult my physician.  I certainly don’t plan to rely on your irritating TV ads.

But…I fear that less skeptical TV viewers may do just that.

So please, take those ads off the air.  Now.

If you do, you know what?  There just might be a day without a drug commercial….

 

[The Wellness Letter published by the University of California, Berkeley, provided the statistics noted at the beginning of this post.]