Tag Archives: FDA

The worst way to lose weight

Surgery is supposed to be the ultimate shortcut when it comes to weight loss: Let the doc put you under, and when you wake up you’re on your way to a brand-new body.

If only it were that simple.

Now, the FDA is finally starting to crack down on the companies that promote one of the most common weight-loss procedures, the adjustable Lap Band that squeezes the stomach so you can fit less in it.

When your stomach holds less, you eat less… and when you eat less, you lose weight.

For many people, that’s all they need to hear. If their insurance covers it, they’re on their way to a new life that’s a lot more difficult than any of them ever would have guessed.

That’s because while the billboards and TV ads promise quick and easy weight loss, they don’t really talk about risks. And they barely even mention that this is a major surgery with serious side effects, up to and including death.

In some cases, the Lap-Band needs to be adjusted. Some patients need two or more surgeries before it’s on right, and they face the risks of complications each time they go under the knife.

Once the band is in place, patients often experience difficulty swallowing, severe and miserable heartburn, and nausea.

Although the FDA’s recent warning was specifically directed at a series of clinics offering Lap-Band in Southern California, those warnings could have been directed at clinics across the country. Because no matter where you live, odds are you’ve seen signs and heard ads that conveniently leave out those very real risks.

And believe it or not, this is actually one of the “safer” forms of weight-loss surgery. Other procedures, such as gastric bypass, promise more dramatic results — but come with even more risks, including an even higher risk of death than the Lap-Band.

So forget surgery. You can do a better job on your own anyway — and as I told you a couple of weeks ago, it starts with just two days a week of an easy-to-follow low-carb diet. (Read about it here.)

Start with two days a week — but don’t end there. Turn that two-day lifestyle into an everyday habit, and you’ll lose weight the right way… and enjoy all the benefits of a thin, new you without the risks of surgery.

Posted in House Calls, Topic 1.

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Drug company launches new attack on compounding pharmacists

It was the equivalent of David taking down Goliath: Earlier this year, compounding pharmacists stood up to a drug company — and won big.

But in this version of the tale, Goliath doesn’t lie down and die. He gets back up — and now, he’s really ticked off.

Before I get into that, let me recap the story so far: For years, compounding pharmacists made a generic version of 17-hydroxyprogesterone, a hormonal treatment given to pregnant women to lower the risk of a preterm birth.

Despite its wide availability, it was considered an “orphan drug” by the FDA — allowing KV Pharmaceuticals to swoop in, slap a patent on it, and re-name it Makena earlier this year.

Then, the company raised the price to $1,500 a shot and threatened legal action against any compounding pharmacist who continued to make the cheap generic version.

Naturally, women were outraged — and they remained outraged even when the company cut the price to “only” $690 a shot. And that’s when the FDA stepped in and told compounding pharmacists not to worry — they could keep making their own version of the drug.

Believe me, I’m still rubbing my eyes over that one.

But maybe it really was a dream after all, because the company is still trying to get the generic hormone pulled from the market.

And this time, they might succeed.

KV quietly ordered samples of 17-hydroxyprogesterone from a handful of compounding pharmacists, then hired a lab to perform tests on behalf of the company.

No conflict there, right?

Naturally, the tests “found” that the compounded product was indeed different from Makena, which isn’t the point.

Of course they’re different — they’re custom-made, but that doesn’t mean the product is bad. There’s no evidence that these variations make the treatment any less effective, and no evidence they pose any more of a risk than Makena.

In fact, the same people who produced these “bad” samples are the same compounding pharmacists who’ve been reliably making the treatment for years — giving them a much better real-world track record then Makena.

But the company sent its test results to the FDA, and the agency is now “investigating.” The feds even sent out a reminder saying that approved drugs like Makena come with a “greater assurance of safety and effectiveness” than those from compounding pharmacists.

Stay tuned… but I think that last bit is a sign that the writing’s on the wall: Goliath is back on his feet.

Posted in House Calls, Topic 1.

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Quit smoking — or die trying?

Nearly 70 percent of all smokers want to quit — and half of them have tried and failed over the last year, according to new numbers from the CDC.

Obviously, it ain’t easy.

But if there’s anything worse for you than tobacco, it’s when the meds that are supposed to help you kick the habit up your suicide and depression risk instead.

And researchers say Chantix, the med most commonly given to smokers, has been found to do exactly that — with one new analysis concluding that it’ll boost your odds of suicide or severe depression by a stunning 800 percent.

Not exactly the type of “quit” you’re looking for — but instead of warning smokers away from the med or even issuing a long-overdue recall for Chantix, the feds are actually defending it.

In fact, the FDA says its own review of data from two studies finds no difference in hospitalization rates for psychiatric problems. So case closed — go ahead and take your Chantix, smokers.

But before you fill that prescription, read the fine print on that reassuring new message from the FDA — because the agency admits it didn’t bother to look at psychiatric incidents that didn’t lead to hospitalization.

In other words, a suicide victim found dead wouldn’t count, nor would a seriously depressed person who’s never hospitalized (and remember — many depressed people never seek any help at all).

You know what’s even crazier than the fact that the FDA didn’t consider non-hospitalizations? It’s that the agency actually has that extra data… and didn’t even bother to look at it!

That’s where the new study comes in, because researchers combed the FDA’s own Adverse Event Reporting System and found 3,249 reports of serious self-injury or depression linked to anti-smoking products like meds and nicotine gum since 1998.

Chantix was only on the market four of those 13 years… but was involved in a whopping 2,925 of those cases, or 90 percent of the total.

Try to explain that one, FDA.

Other studies have also made the connection between Chantix use and serious behavioral issues — and not just suicide and depression. One found that Chantix users are 18 times more likely to be involved in violence than people who take other meds.

Violence, I should point out, also generally doesn’t lead to a hospitalization — although it could certainly end in prison or even death.

Bottom line here: Quitting smoking is a great goal — and with the New Year fast approaching (already!), it’s the one resolution you should put at the top of your list.

But do it without meds.

Posted in House Calls, Topic 1, Uncategorized.

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Beat the high price of beating gout

I know the cost of everything is rising, but this is ridiculous: A common remedy for gout and other inflammatory conditions has shot up by more than 2,700 percent.

The remedy is called colchicine, and it’s been used for literally thousands of years.

It’s been used for so long that it predates the FDA’s drug approval rules, making it technically an “orphan drug” allowed for use despite the fact that the FDA never officially signed off on it.

Well, it’s an orphan no more: A company called URL Pharma put it through a clinical trial — no real gamble since the drug has been effectively used since forever — and won itself a shiny new patent.

Now called Colcrys, the price of the average 23-day prescription shot up from $6.72 to $185.53, according to a recent CBS News report.

That’s a pretty hefty markup. And if that sounds familiar, it’s because it’s happening more and more as orphan drugs are captured — or maybe “kidnapped” is a better word — and dragged into the Big Pharma family.

Earlier this year, a drug company patented hydroxyprogesterone — an inexpensive hormone used for years to help lower the risk of a preterm birth in high-risk pregnancies — and boosted the price by 15,000 percent.

Then, the company had the nerve to send legal threats to compounding pharmacists who continued to make the cheaper version of the hormone on their own.

Eventually, the feds stepped in and told pharmacists they could keep making their low-cost version — but don’t expect them to do that for colchicine, and don’t expect them to do it for the estimated 1,000 other “orphan” meds out there waiting for a new Big Pharma family.

And that means any inexpensive remedy you rely on today could turn into a big-money nightmare tomorrow.

Luckily, in the case of gout, you don’t have to pay those outrageous prices — and since colchicine is actually toxic and can come with some pretty big risks up to and including death, you don’t have to put your life on the line, either.

There are inexpensive and completely natural solutions that have been used to fight gout for almost as long as colchicine — and one of them is the best-tasting cure around: Cherries.

One recent study fond that eating 20 cherries in 48 hours can cut the risk of a gout attack in half. If you don’t have any cherries handy, try cherry juice — the pure stuff, not some sugary cherry drink.

I had more on gout — including another completely natural and inexpensive treatment — back in September, and you can read it all for free right here.

Posted in House Calls, Topic 1.

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