Tuesday, October 3, 2017

Putting Our Health Before Their Dollars

You have to give CVS credit.  In early 2014 they announced that, as a health company, they would stop selling tobacco products in their stores, despite the estimated $2b in sales those represented.  Sure enough, by September of that year those products were gone.  A follow-up study suggested that many of those shoppers didn't just buy them elsewhere but actually reduced their consumption, with a significant number ceasing to buy them at all.  Credit to CVS.

This year CVS is doubling down, beefing up its selection of healthy food options and health-focused products, while moving candy and junk food to the back of the stores. "Pharmacy is the heart of our business and our focus on providing care to patients and customers defines everything we do in our stores," said their Pharmacy President. 

And yet, in those stores, right by those pharmacies, you can still find plenty of dietary supplements, including vitamins. 

This is not to fault CVS, at least not solely.  After all, other retailers with large pharmacy businesses -- e.g., Walmart or Walgreens -- never even stopped selling tobacco products.  Of course, they sell supplements as well.

It is no wonder: supplements are big business.  The industry itself says it is a $37b industry, although estimates range widely.  At least half of Americans take some kind of supplements, with use among people 60 and over even higher

Supplement use is so mainstream that we not only tell our physicians about using them, they are our leading source of trusted information about them.

The question is not whether supplements are mainstream.  The question is whether they should be.

Just last month a police officer died after taking kratom, an herbal supplement.  Kratom is banned in 6 states, and the DEA tried to ban it nationally, citing 15 deaths in three years.  That ban died due to intense lobbying by, believe it or not, the American Kratom Association.

The problem is that the supplement business is not what one would call heavily regulated.  It barely is regulated at all.  The FDA does not approve dietary supplements.  Companies making/selling them are responsible for ensuring their products are safe and that any claims about them are not false or misleading, but the FDA does not verify either safety or effectiveness. 

In theory, the FDA is allowed to inspect manufacturing processes and maintain adverse event reporting, and can take action if problems are discovered, but there is severe doubt about how well it can perform these tasks.  The FDA's Office of Dietary Supplements has a $5 million budget and about two dozen employees, to oversee an estimated 80,000 - 90,000 products on the market. 

It's not a fair fight.  Supplement manufacturers don't have to prove their products are either safe or effective, but to remove a product the FDA has to demonstrate it poses a "significant or unreasonable risk of illness."

This matters.  The U.S. Poison Control Center gets a call every 24 minutes, on average, related to dietary supplement exposures.  One study estimated there were 23,000 ER visits annually, and 2100 hospital admissions, due to supplements.  The number of deaths associated with them remains in dispute, although a rare FDA ban -- of ephedra, in 2004 -- drastically cut the number.  Shamefully, the industry had fought that ban, but ultimately lost in federal court. 

Part of the problem is that we don't really know what is in supplements.  In 2015 the New York State Attorney General's Office found that only 21% of ingredients listed on various store brands were actually in the products.  Another study looked specifically at one specific product -- "red yeast rice" (I am not making that up) -- from 28 manufacturers and found that the key ingredient varied wildly in dosage and wasn't even present in some versions. 

Keep in mind that there really is very little data that supplements -- even vitamins -- actually have a positive effect.  One study found no impact of vitamins or mineral supplements for cancer or heart disease.   Another study focused on antioxidant supplements taken to lessen risk of Alzheimer's or dementia, and similarly found no impacts.  Indeed, multiple studies have found at best no positive impact and sometimes negative impact.

S. Bryn Austin, a professor at Harvard's School of Public Health, pretty much summed up the industry, telling Business Insider:
Consumers should expect nothing from [supplements] because we don't have any clear evidence that they're beneficial, and they should be leery that they could be putting themselves at risk.  Whether it's on the bottle or not, there can be ingredients in there that can do harm.
And yet supplements are discussed one-in-four primary care visits, with at least 79% of physicians admitting that they have recommended them at some point.  Over half of physicians take supplements themselves.  Some physicians are even selling them directly, which has its own host of ethical and legal questions


It really shouldn't be a surprise that we fall for the supplement hype.  We like quick and easy solutions.  We are a nation of fad diets.  We'd rather get vitamins from a pill than from eating a balanced diet.  We'd rather take weight loss supplements than eat less and exercise more. 

And we fall for placebos of all sorts, mainstream and alternative, while allowing use of prescription drugs and medical devices that are not nearly as safe or effective as we think.  Supplements aren't an outlier; they fit quite nicely into the rest of our health care system. 

Part of me feels that if people want to spend their money on products with no validated efficacy, that's their choice, as long as those products are marketed accurately (which is a big caveat).  If they want to go to GNC, a health food store, even to the junk foods section of a drugstore to buy them, well, it's their money.

Just don't pretend they belong in the pharmacy.

A larger part of me, though, wishes that, rather than embracing supplements due to their popularity, "mainstream medicine" should be even more vigilant about requiring evidence for use of any treatments -- prescriptions, devices, procedures, tests, or supplements.

When CVS -- or other pharmacies, doctors, hospitals, or other health care professionals-- start only selling or recommending treatments that have proven value, then I'll believe they're putting our health above their dollars.

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