Friday, February 19, 2010

Free To Buy Ineffective, Dangerous Supplements

As they did back in the 90s, the manufacturers of dietary supplements are revving up to protect their multi-billion dollar market from regulation, and they're getting help from liberals and libertarians who seem blind to how they are being manipulated.

It's sad. Clinging to the idea that government regulation is bad, bad, bad, champions of freedom are actually arguing that the public should continue to have the right to waste money on ineffective and possibly dangerous dietary supplements. In a response to my inquiry, the folks behind The Pen--who didn't bother to sign their names--actually equated Americans' right to privacy from government spying on our phone calls, etc., with the freedom to buy dietary supplements that have never been tested for effectiveness or safety.

Hello? Can't you tell when you're being used? Why should for-profit manufacturers be free to put anything on the market without first testing it for safety and effectiveness? Why should we trust these manufacturers any more than we trust auto manufacturers, or for that matter, drug manufacturers? Why do you trust them, you unnamed folks at The Pen? Because you believe, in the absence of any reliable reporting system, that no one died from using a supplement in 2008? (That is their primary argument.) Manufacturers right now aren't even required to register their existence, provide information on exactly what is in their products, or adhere to specific formulations for products so buyers can be sure about what's in those pills.

As I pointed out in my last blog, just because something is natural doesn't mean it's safe. Dr. Sidney Wolfe of the Health Research Group, offers the example of St. John's Wort. This plant, he says is pharmacologically active, just like a drug, and interacts with hundreds of other substances.

Under the 1994 legislation that unleashed the supplement industry from almost all regulation, the FDA has such weak authority that it has been able to ban only one supplement--ephedra--and instead has issued only warnings about comfrey and kava kava, both associated with liver toxicity, for example.

Sen. John McCain, ironically, is being vilified for proposing a bill that would only slightly improve regulation of supplements. This is all part of the right-wing effort to whip up opposition to someone who is not considered conservative enough. Read it yourself. You'll see there's nothing there to warrant the conclusion that anyone's trying to take away your vitamins.

Dr. Wolfe calls the proposal "a step forward" but adds that "80% of what's wrong with supplement regulation will still be wrong even if this bill passes."

What's wrong is that manufacturers, under this bill, would only have to prove the safety of new ingredients. All the ones already out there get "grandfathered" in. And, they need not prove effectiveness. As long as they don't make an actual claim of curing disease--which would then tip the product into the category of a drug--they can just imply it, saying things like "promotes prostate health" or "supports cardiovascular health."

So folks worried about their prostate or heart spend hundreds and thousands of dollars a year on these products, with no proof at all that they'll make any difference at all to their health.

We're babes in the woods when we approach the crowded shelves of supplements. We need help to figure out how to wisely spend our hard-earned money. Sure, the FDA has proven itself susceptible to political and corporate pressure. But let's focus on improving their performance instead of inflaming people with the false notion that someone is trying to take away their vitamins.

Shame on anyone who promotes that point of view.

Wednesday, February 17, 2010

Liberal Group "The Pen" Wrong on Supplement Bill

I'm on the mailing list for the liberal-leaning organization, The Pen, which also uses the name "The Peace Team" on a web page devoted to causes like impeaching George Bush. I usually find I agree with their stance, so I was quite surprised to see their attack on legislation that would require proof of safety before manufacturers could add a new ingredient to a dietary supplement.

The Pen's email starts with this alarmist and outrageous subject line: Big Pharma Is Trying To Kill Us By Trying To Outlaw Natural Food Supplements.

The message then opens with this far-fetched comparison: "It wasn't enough for Congress to kill off the public option. Now they want to kill us directly by trying to outlaw nutritious food supplements."

Wow. First blame Big Pharma, and then link the failure to legislate a public health insurance option with outlawing DANGEROUS food supplements.

Because that's what the bill would do: first, by requiring supplement manufacturers to have evidence that a new dietary ingredient "will reasonably be expected to be safe," and second, by giving the FDA power to recall supplements that "would cause serious, adverse health consequences or death."

The people behind The Pen seem to have forgotten about ephedra. That's the supplement that was a real favorite of athletes. In 2004, the RAND Corporation's Southern California Evidence-Based Practice Center reviewed 16,000 reports of adverse reactions to ephedra. It blamed the supplement for 2 deaths, 4 heart attacks, 9 strokes, 1 seizure and 5 cases of adverse psychiatric episodes.

Don't trust RAND? How about the Public Citizen Health Research Group, which is hated by Big Pharma, Big Insurance and corporate America in general. Director Sidney Wolfe, M.D. says 155 people died from using ephedra, and he castigated the FDA for not acting sooner to ban sales of the substance.

Remember, just because something is "natural" doesn't mean it's safe. The active ingredient in ephedra is ephedrine, which when chemically synthesized is regulated as a drug--and therefore can't be sold unless it is safe and effective for the specified use.

I emailed The Pen to find out if they had any facts to back up their accusations about this legislation. Let's see if they respond.

Right now, everyone should be supporting this proposal, even if one of the two main sponsors is Senator John McCain. Nobody's wrong all the time! And liberals aren't necessarily right--not if they ignore the facts!