Tag Archives: FDA

FDA misses the point on supplements… again

The Food and Drug Administration often completely misses the point when it comes to supplements.

In fact, they usually want nothing to do with nutritional healing. It’s so backwards that when it comes to natural health, even the tiniest acknowledgement from the FDA is a huge victory.

Take their new stance on selenium, a mineral that, in tiny amounts, can help our bodies in a number of ways. Some promising research even shows that selenium could help lower your risk for certain cancers.

The FDA said in June that it’s willing to let supplement makers mention that link, albeit in a very limited way. In fact, the wording the FDA says it will allow is downright unusable. But when you consider the usual stance it takes on supplements, this is a radical departure.

The research on selenium is still ongoing, but so far it’s been very encouraging in areas well beyond cancer prevention. Selenium has been shown to be necessary for thyroid hormone activation, and may have some fantastic antioxidant properties. Both of these roles help you fight off illnesses and even aging.

Maybe next the FDA will admit we’re onto something after all, not just with selenium but the many other vitamins and minerals that can help fight disease and illness better than all of Big Pharma’s meds put together.

Maybe, but I doubt it.

After all, there are so many supplements out there that have helped millions of people treat their illnesses without having to rely on prescription drugs, yet the FDA has barely glanced in our direction.

So while I wish that little opening in the door might be a signal that the FDA is opening its collective mind to natural healing, the cynic in me sees something else at work.

A couple of Big Pharma’s over-the-counter vitamins are starting to include selenium. They’re finally catching on to what the rest of us already know: There’s enough emerging evidence in its favor that people want to make sure they’re getting enough of it.

One of those vitamins got into some hot water in June for making a mild claim about those cancer-fighting properties.

So I see this is as the FDA rushing to the defense of some of its most favored clients, not a signal that the winds are finally shifting in favor of truth.

Too bad. One more missed opportunity.

Posted in House Calls.

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FDA admits risk in approved drugs

I’ve always said the FDA rushes drugs to market before we know everything we should about them.

I just didn’t expect the FDA to agree with me!

On the one hand, the feds are constantly defending their system, claiming that drugs are only approved after a careful and thorough process, and are safe as a result.

On the other hand, the FDA now has a portion of its Web site devoted to letting the public know about the problems under investigation in the drugs it’s already approved.

It’s so absurd it’s almost comical, but you can check it out right now at in the Guidance, Compliance and Regulatory section of the FDA Web site.

There, you’ll find that a popular weight-loss drug is under investigation for a possible connection to a liver disease; a drug used to help smokers battle their addiction is being looked at as a possible cause of accidental injury and vision problems; and a bladder-control med is being linked to a serious skin condition.

This only serves to underscore the FDA’s approve-first, ask-questions-later approach to drugs. It’s almost like these later studies and concerns constitute a secondary approvals process – but one that takes place only after the drugs are in the hands of patients everywhere.

If our system was a ranch, it wouldn’t be one with a hole in the fence – it would be one with almost no fence at all. And now, it’s like they’re finally building that fence after all the animals have fled.

Almost every day I run across a study showing a new or previously unknown side effect of a common drug.

And I always ask the same question: Why are we learning this now?

A truly deliberative process might not catch every possible flaw and side effect in a drug, but it would certainly catch many of the bad meds that regularly slip through our current system.

The feds may still not act fast enough or early enough, but at least it’s now easier for the millions of Americans who take these drugs to get the latest information about them.

So take a moment and poke around that Web site. See if anything you’re taking made the list. It’s also important that you check it regularly for updates, so be sure to bookmark it.

If you find anything worrisome about the drugs you’re taking, ask your doctor about alternatives.

Or better yet, use this as an opportunity to explore the many drug-free options available to you.

They’re out there – and they work.

Posted in House Calls.

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FDA targets Cheerios

I always cringe when I turn on the TV and see a commercial where outrageous claims are made about a breakfast cereal.

Sometimes, they tell you that replacing meals with cereal will help you lose weight.

The latest ones, for Cheerios, promise to lower your cholesterol.

And while these toasted little carbs are usually dunked in milk, right now they’re in hot water over that claim.

The FDA says the packaging blurbs that claim the cereal can lower your cholesterol levels by 4 percent in six weeks make it sound like a drug. And Cheerios, the agency notes, is not approved as a drug.

I don’t know what the more ridiculous part of this story is: the fact that the FDA is ignoring Big Pharma’s worst offenses and targeting a breakfast cereal, or the fact that anyone really would believe that Cheerios is the right way to lower their cholesterol.

Why the FDA is throwing its resources there is beyond me, especially when you consider the big problems we’re having with food and prescription drugs in this country. The only thing I can imagine is that some of those statin makers are starting to get a little nervous.

After all, lowering cholesterol is supposed to be their game – so I wouldn’t be surprised if Big Pharma quietly put some pressure on the FDA behind the scenes. Those statins are some of their biggest moneymakers, and they don’t want a cheap breakfast food muscling in on their turf.

Now, the fact is loading up on cereal is not a great way to reduce your cholesterol. To me, even a cereal as seemingly harmless as Cheerios is little more than a box of carbs, and most of us don’t need any more of those.

Sure, if you replace one extremely unhealthy meal per day with a less unhealthy meal, you might see some minor improvements – and that’s where cereals get to make these claims.

But you can do so much better by making some real changes to your lifestyle, which is the only way to truly get your cholesterol levels under control.

Avoid carbs, stick to fresh meats and healthy veggies – organic if you can – and move around a little more. I guarantee you’ll see some improvements over time.

Some of you might need a little more help than that – but that’s no reason to turn to some cereal-based diet or, worse yet, medications.

If you find that lifestyle changes alone haven’t quite made enough of a difference on your cholesterol levels, be sure to check out the July issue of Health Revelations, where I’ll have a detailed plan to help you control your cholesterol levels on your own, without drugs or fad diets. Subscribe now and get complete access to our online archives, too.

Now, go eat a real breakfast – but skip the cereal.

Posted in House Calls.

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Banning popular painkillers proving to be an ugly process

by Dr. Alan Inglis

There’s an old saying that governing is a lot like making sausage – a disgusting practice you’d never want to witness firsthand.

Well, the FDA made some revolting, stomach-turning, Grade A sausage recently – and it showed again how out of touch the agency is with reality.

An FDA panel recently recommended that the painkillers Darvon and Darvocet be pulled from the market. And it’s about time. These addictive drugs, which have been linked to heart disease and death when combined with alcohol and other drugs, have been sold in the U.S. for half a century. And they’ve been causing mayhem since day one.

What’s more, there’s strong evidence that Darvon and Darvocet aren’t even that effective. They’re weaker and present more dangerous side effects than most painkillers that have been developed since.

Should be an open and shut case, right? Except it’s not. First, the FDA is under no obligation to accept the panel’s recommendation. And the panel didn’t exactly send a strong signal that it considers removing these drugs a pressing health issue. The vote was 14-12.

That’s right – two dangerous, ineffective drugs were under consideration, and if one vote had gone the other way, there would have been no recommendation for the FDA to take action at all.

What really shocks me is that Darvocet continues to be one of the 25 most prescribed drugs in the country. The side effects aside, there’s evidence that the drug isn’t very effective! If you ever wanted smoking-gun evidence that doctors just write prescriptions for whatever they’ve been prescribing for years, without really keeping up on the research, this is it.

I certainly hope the FDA takes the bold and necessary step of getting these dangerous, outdated drugs out of our health care system. But I’m not holding my breath. This should have been a clear-cut case – and it came down to one vote.

In the end, though, the only vote that really counts is yours, as the consumer. If a doc tries to prescribe you Darvon or Darvocet, vote no. You’ll be safer for it.

Posted in House Calls.

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