Tag Archives: side effects

The darkest shade of green

Imagine a drug that failed to meet basic targets set by the FDA, came with a higher risk of side effects than its predecessors, and was found to be so unimpressive and even dangerous that the agency’s own experts advised against approving it.

Now, stop imagining — and just take a look at Aricept 23, because an explosive new analysis in BMJ says that’s exactly how this drug reached the market.

How did it happen? Let me back up to 2010, when the original Aricept — a drug that did up to $2 billion a year in sales — was about to lose its patent protection.

Once cheap generics flood the market, it’s usually the end of the line for the money train — unless you have a few tricks up your sleeve, like what the industry calls “evergreening.”

That’s a slight tweak to help extend the drug’s profitable life. It might be a timed-release formula, the addition of a second drug to the mix, or even a change to the dosage itself — and when the FDA signs off on it, the “new” drug gets three more years of protection.

In this case, it was a change to the dose. While “old” Aricept had been approved in 5 mg and 10 mg doses, Aricept 23 is — as the name implies — 23 milligrams of the drug.

The feds said this high dose would be approved only if it beat the lower doses in two key areas: overall cognition and global functioning.

That shouldn’t have been too hard, since the old formula was thoroughly unimpressive itself. But Aricept 23 offered only tiny improvements in cognition and no changes at all in the more important measure of global function — and came with a higher risk of nausea and vomiting as well.

Those side effects are bad enough for a healthy person. But for an Alzheimer’s patient, they could be dangerous and even deadly.

No matter. An agency bigwig went against the advice of his own experts and approved the drug anyway — just four months before the expiration of the original Aricept patent.

Since the generics would only be available in the old 5 mg and 10 mg doses, even a combination of pills wouldn’t add up to the “new and improved” dose. The only way to get it was to keep buying the expensive brand-name version.

In other words, the new formula of Aricept didn’t protect dementia patients from the ravages of the disease — but it did protect the profits of the drug’s makers, with three years of fresh patent protection.

Posted in House Calls, Topic 1, Uncategorized.

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Feds finally own up to statin risks

Not long ago, those of us who pointed out that cholesterol meds can actually cause diabetes and other serious health problems were dismissed as alarmists.

Statins, we were told, are so safe they should be given to practically everyone – with some “experts” even pushing to give them out with every Big Mac. (That might sound like something I made up for an easy laugh – but believe it or not, it’s actually true.)

Well, maybe now the push to give everyone statins will start to slow a bit: The FDA has finally admitted that all those side effects the drug industry and its paid–for experts once brushed off are actually very real.

And now, they want the labels of these meds changed to reflect the increased risk of diabetes, confusion, memory loss, and serious muscle pain.

The feds say those side effects can hit anyone at anytime. They can strike after a single day on these meds…or they can come on after years of taking them without incident.

And they can happen to everyone across all age groups.

So who’s the alarmist now?

Of course, I can’t help but find it a little suspicious that this warning comes only after every Big Pharma statin except for one – Crestor – lost its patent protection, with Lipitor going generic just a few months ago.

It’s almost as if the feds were giving their drug company friends a chance to maximize profits before issuing the same warning those of us in natural health delivered years ago.

But even worse than the risks and the delayed warning is the fact that no one ever needed these meds in the first place.

In many cases, people taking statins don’t even have a cholesterol problem since mainstream LDL targets are set unrealistically low. And even when cholesterol does shoot up to high levels, taking a drug to “cure” it is akin to Homer Simpson putting a piece of tape over the “check engine” light on his car.

Super high cholesterol is a warning that something’s wrong – and lowering it without fixing the underlying issue won’t make you healthier any more than that piece of tape will fix Homer’s engine.

If your own levels start climbing too high for comfort, work on lifestyle changes first. Cutting out sugars and sticking to fresh foods will almost always bring cholesterol to where it needs to be.

If they’re still high, don’t visit a statin-slinging mainstream doc. Visit a naturopathic physician who can find and fix the real cause without meds.

And for one easy way to lower your cholesterol naturally, keep reading.

Posted in House Calls, Topic 1, Uncategorized.

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From KO’d to OK’d: Rejected diet drug stages a comeback

Nearly two years ago, an FDA panel rejected the Qnexa diet pill over safety concerns.

Now, that same panel has given the drug the OK, which means the agency itself will almost certainly approve it for sale soon.

But don’t be fooled by this about-face, because the drug hasn’t magically gotten any safer over the last two years.

Qnexa still comes with all the same potential risks that caused the panel to think twice back in 2010: birth defects, suicidal thoughts, depression, memory loss, attention problems, bone problems, kidney stones, and more.

Even worse, the drug can increase heart rate and cause heart palpitations — and the panelists who approved it admit they don’t know if those side effects will lead to heart attacks and other cardiovascular problems down the road.

But they went ahead and approved it anyway.

“The potential benefits of this medication seem to trump the side effects, but in truth, only time will tell,” Dr. Kenneth Burman of the Washington Hospital Center confessed to Time magazine.

Allow me to translate:

“It could help people lose a bunch of weight, and it could well kill a whole bunch of people at the same time. Let’s find out, shall we?”

I say let’s not — because if this drug’s history is any indication, its widespread use will lead to more problems than this panel is letting on.

Qnexa isn’t a new drug — it’s actually a combination of two older drugs: the amphetamine phentermine, better known as the “phen” in fen-phen (yes, THAT fen-phen), and the seizure drug topiramate.

It’s more of a side-effect cocktail than an actual drug — so much so that 40 percent of the people who took the high dose in a company-funded trial had to drop out.

Many of those who stuck with it were rewarded with weight loss of close to 10 percent of their body weight. But 10 percent for an obese person isn’t an achievement. It’s someone who’s just a little less obese — and it took them a full year to get there to boot.

What’s more, patients who take the drug still have to make diet and lifestyle changes and get more exercise. And if you have to do all that to get thin, why bother messing around with drugs like Qnexa in the first place?

Skip the meds and eat better instead.

Try a low-carb or Mediterranean-style diet, and the pounds will melt away as if by magic — and you’ll soon find yourself reaching in the back of your closet for clothes you never thought you’d wear again.

Posted in House Calls, Topic 1.

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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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