A recurring theme at SBM is the regulation of supplements, and the impact and consequences of the Dietary Supplement Health and Education Act of 1994 (DSHEA). As one of SBM’s international contributors, I thought it might be helpful to look at how the DSHEA stacks up against the equivalent regulations of its neighbor to the north, Canada. Given the multiple calls for overhauls and changes to DSHEA, an international comparison may help focus the discussion around what a more science-based framework could look like.
Briefly, the DSHEA is an amendment to the U.S. Federal Food, Drug and Cosmetic Act that establishes a regulatory framework for dietary supplements. It effectively excludes manufacturers of these products from virtually all regulations that are in place for prescription and over-the-counter drugs. The FDA notes:
Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading. FDA’s post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.
I’ve previously described the consequences of acute and chronic sun exposure, and the rationale for topical sunscreen products. But wouldn’t it be easier to just take a pill that can boost our skin’s resistance to to the harmful effects of the sun? Is it possible to get all the benefits of sunscreen without the bother of creams, or even clothing? (more…)
If there’s one thing the media love, it’s a “bungling bureaucrats” story. Yep, the FDA, wrapped up with their science dogma, enslaved to Big Pharma, pushing toxic, unnatural chemicals and ignoring safety data. And that’s the story being told about sunscreens:
“Study: Many Sunscreens May Be Accelerating Cancer”
“Did The FDA Ignore Proof That Sunscreens May Speed Up Cancer?”
“FDA Coverup Of Sunscreen Cancer Risk”
What’s a consumer to do? If you only read the headlines, you may get the impression that sunscreens do more harm than good. The impetus was the release of the Environmental Working Group’s (EWG) 2010 Sunscreen Guide. EWG is an environmental advocacy organization that focuses on consumer products, and has been conducting annual reviews of sunscreens since 2007. Of the 500 products it reviewed, it only recommends 8%, or 39 products in total. Why were so many products deemed “not recommended”? Reasons for negative ratings included the following:
- any product containing retinyl palmitate (vitamin A), which is described as a photocarcinogen
- any product containing oxybenzone, called a “potential hormone disrupter”
- any sunscreen packaged as a spray or powder, due to inhalation concerns
EWG also raised concerns about nano-sized particles in sunscreens. But before we dive into the report, let’s consider what we’re trying to do with sunscreen.
The scientific understanding of vitamins has evolved over time, from the identification of frank deficiencies, to exploring the value of supplements to prevent chronic diseases. Among health professionals, taking a multivitamin “for insurance” has long been considered to be a reasonable strategy. But as more robust evidence has emerged about the benefits and possible harms of vitamins, even that advice is facing scrutiny.
This Friday, June 11, I’ll be appearing on the Skeptically Speaking radio show, giving a science-based perspective on vitamins. Call in, listen online, or submit your questions in advance. The show is live at 6pm MST (find your time here).
What evidence standard should exist for health products sold in pharmacies? That’s today’s bleg, and I’m seeking your input.
In most countries, pharmacy is a registered, self-regulated health profession, with a responsibility to optimize the use of drugs. Pharmacist education consists of several years of university-level education and practical training in real-world health care settings. Pharmacists with advanced degrees and post-graduate residencies are common. Not all pharmacists work in community (retail) pharmacies, but that’s where many pharmacists end up, and it’s the public face of the profession.
In most countries, pharmacies are private businesses, either owned by a pharmacist or by a corporation. They are granted a privileged and exclusive right in the provision of health care: certain health products (both prescription and non-prescription) are only available in pharmacies, because pharmacist consultation and availability has been deemed necessary to maximize the safe use of these products. While it’s a setting for health care (and often the first point of contact into the system), retail pharmacy is a business. Pharmacies count on the retail sale of products for revenue and traffic. And in general, pharmacies have the legal right to stock and sell whatever products they want. Tobacco is one exception, where it is no longer sold in most Canadian pharmacies, but remains prevalent in American pharmacies. And as I discussed in a prior post, when we look internationally there can be considerable differences between which drugs are prescription, and these that can be sold over-the counter.
How Much Evidence?
The evidence standard for products sold in pharmacies is facing increasing scrutiny. Concerns have been raised in several countries that pharmacies may be taking advantage of their privileged status as provers of prescription drugs, and are selling products that aren’t supported by good scientific evidence. Some recent examples:
For SBM readers in the Toronto area, I’ll be speaking on Friday, May 28, at the Centre for Inquiry on how science advocates can help support better health decisions:
Despite the dramatic improvements in the extent and quality of our lives, largely owing to modern medicine, our current health care system has fostered a backlash, manifested in part by the emergence of non-science-based “alternative” health care practices. This trend has driven a need for dialogue on how best we should balance evidence-based decisions against demands for consumer choice – regardless of the science. In this presentation, Scott Gavura will discuss how health care decision-making differs from other goods and services, and how this impacts on the choices we make, both as individuals, and in aggregate. Through an interactive discussion, he will facilitate a dialogue on the opportunities for science advocates to effect positive change in health at the patient- and population-level.
Science advocates have the evidence to support their positions. How do we translate this evidence to support effective decision making? On May 28, join the conversation.
Get the event details, and you can RSVP on Facebook. The talk is great value-for-money: $5, $4 for students, and free for CFI members.
Imagine you’re an FDA reviewer looking at a new drug application. Drug A relieves a symptom, but doesn’t cure any disease. It doesn’t conflict with other medications. It’s considered safe in pregnant and breastfeeding women. At normal doses, there are virtually no side effects. There’s one unfortunate problem: If you take ten times the dose, liver damage is very likely and may be fatal. In other countries, Drug A is the number one cause of acute liver failure.
Should Drug A be available without a prescription?
Now consider another drug. Drug B also treats a symptom, but can also be used to treat a number of acute and chronic conditions, some of which require monitoring by specialist physicians. Drug B should generally be avoided in children, as it is associated with a rare but fatal toxicity. Even at normal doses, it can cause an array of side effects, and severe digestive system toxicity, resulting in hospital admission, is not uncommon. It interacts with other prescription drugs, and can be fatal in overdose situations.
Should Drug B be available without a prescription?