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	<title>House Calls &#187; FDA</title>
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	<link>http://healthrevelations.com</link>
	<description>Medicine&#039;s Most Independent Source for Health News You Can Trust</description>
	<lastBuildDate>Fri, 10 Feb 2012 01:00:31 +0000</lastBuildDate>
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		<title>The worst way to lose weight</title>
		<link>http://healthrevelations.com/2012/01/10/lose-weight-2/</link>
		<comments>http://healthrevelations.com/2012/01/10/lose-weight-2/#comments</comments>
		<pubDate>Tue, 10 Jan 2012 01:00:33 +0000</pubDate>
		<dc:creator>Health Sciences Institute</dc:creator>
				<category><![CDATA[House Calls]]></category>
		<category><![CDATA[Topic 1]]></category>
		<category><![CDATA[death]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[gastric bypass]]></category>
		<category><![CDATA[Lap Band]]></category>
		<category><![CDATA[side effects]]></category>
		<category><![CDATA[stomach]]></category>
		<category><![CDATA[surgery]]></category>
		<category><![CDATA[weight loss]]></category>
		<category><![CDATA[weight-loss procedures]]></category>
		<category><![CDATA[weight-loss surgery]]></category>

		<guid isPermaLink="false">http://healthrevelations.com/?p=3841</guid>
		<description><![CDATA[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.
]]></description>
			<content:encoded><![CDATA[<p>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&#8217;re on your way to a brand-new body.</p>
<p>If only it were that simple.</p>
<p>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.</p>
<p>When your stomach holds less, you eat less&#8230; and when you eat less, you lose weight.</p>
<p>For many people, that&#8217;s all they need to hear. If their insurance covers it, they&#8217;re on their way to a new life that&#8217;s a lot more difficult than any of them ever would have guessed.</p>
<p>That&#8217;s because while the billboards and TV ads promise quick and easy weight loss, they don&#8217;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.</p>
<p>In some cases, the Lap-Band needs to be adjusted. Some patients need two or more surgeries before it&#8217;s on right, and they face the risks of complications each time they go under the knife.</p>
<p>Once the band is in place, patients often experience difficulty swallowing, severe and miserable heartburn, and nausea.</p>
<p>Although the FDA&#8217;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&#8217;ve seen signs and heard ads that conveniently leave out those very real risks.</p>
<p>And believe it or not, this is actually one of the &#8220;safer&#8221; forms of weight-loss surgery. Other procedures, such as gastric bypass, promise more dramatic results &#8212; but come with even more risks, including an even higher risk of death than the Lap-Band.</p>
<p>So forget surgery. You can do a better job on your own anyway &#8212; 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 <a href="http://healthrevelations.com/2011/12/27/part-time-diet/" target="_blank">here</a>.)</p>
<p>Start with two days a week &#8212; but don&#8217;t end there. Turn that two-day lifestyle into an everyday habit, and you&#8217;ll lose weight the right way&#8230; and enjoy all the benefits of a thin, new you without the risks of surgery.</p>
]]></content:encoded>
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		<item>
		<title>Drug company launches new attack on compounding pharmacists</title>
		<link>http://healthrevelations.com/2011/12/09/pharmacists/</link>
		<comments>http://healthrevelations.com/2011/12/09/pharmacists/#comments</comments>
		<pubDate>Fri, 09 Dec 2011 01:00:16 +0000</pubDate>
		<dc:creator>Health Sciences Institute</dc:creator>
				<category><![CDATA[House Calls]]></category>
		<category><![CDATA[Topic 1]]></category>
		<category><![CDATA[17-hydroxyprogesterone]]></category>
		<category><![CDATA[compounding pharmacists]]></category>
		<category><![CDATA[drug company]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[generic hormone]]></category>
		<category><![CDATA[KV Pharmaceuticals]]></category>
		<category><![CDATA[Makena]]></category>
		<category><![CDATA[pregnant women]]></category>
		<category><![CDATA[preterm birth]]></category>

		<guid isPermaLink="false">http://healthrevelations.com/?p=3742</guid>
		<description><![CDATA[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.
]]></description>
			<content:encoded><![CDATA[<p>It was the equivalent of David taking down Goliath: Earlier this year, compounding pharmacists stood up to a drug company &#8212; and won big.</p>
<p>But in this version of the tale, Goliath doesn&#8217;t lie down and die. He gets back up &#8212; and now, he&#8217;s <em>really</em> ticked off.</p>
<p>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.</p>
<p>Despite its wide availability, it was considered an &#8220;orphan drug&#8221; by the FDA &#8212; allowing KV Pharmaceuticals to swoop in, slap a patent on it, and re-name it Makena earlier this year.</p>
<p>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.</p>
<p>Naturally, women were outraged &#8212; and they remained outraged even when the company cut the price to &#8220;only&#8221; $690 a shot. And that&#8217;s when the FDA stepped in and told compounding pharmacists not to worry &#8212; they could keep making their own version of the drug.</p>
<p>Believe me, I&#8217;m still rubbing my eyes over that one.</p>
<p>But maybe it really was a dream after all, because the company is still trying to get the generic hormone pulled from the market.</p>
<p>And this time, they might succeed.</p>
<p>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.</p>
<p>No conflict there, right?</p>
<p>Naturally, the tests &#8220;found&#8221; that the compounded product was indeed different from Makena, which isn&#8217;t the point.</p>
<p>Of course they&#8217;re different &#8212; they&#8217;re custom-made, but that doesn&#8217;t mean the product is bad. There&#8217;s no evidence that these variations make the treatment any less effective, and no evidence they pose any more of a risk than Makena.</p>
<p>In fact, the same people who produced these &#8220;bad&#8221; samples are the same compounding pharmacists who&#8217;ve been reliably making the treatment for years &#8212; giving them a much better real-world track record then Makena.</p>
<p>But the company sent its test results to the FDA, and the agency is now &#8220;investigating.&#8221; The feds even sent out a reminder saying that approved drugs like Makena come with a &#8220;greater assurance of safety and effectiveness&#8221; than those from compounding pharmacists.</p>
<p>Stay tuned&#8230; but I think that last bit is a sign that the writing&#8217;s on the wall: Goliath is back on his feet.</p>
]]></content:encoded>
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		<title>Quit smoking &#8212; or die trying?</title>
		<link>http://healthrevelations.com/2011/12/01/quit-smoking-2/</link>
		<comments>http://healthrevelations.com/2011/12/01/quit-smoking-2/#comments</comments>
		<pubDate>Thu, 01 Dec 2011 01:00:12 +0000</pubDate>
		<dc:creator>Health Sciences Institute</dc:creator>
				<category><![CDATA[House Calls]]></category>
		<category><![CDATA[Topic 1]]></category>
		<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[anti-smoking products]]></category>
		<category><![CDATA[behavioral issues]]></category>
		<category><![CDATA[Chantix]]></category>
		<category><![CDATA[depression]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[hospitalization]]></category>
		<category><![CDATA[nicotine gum]]></category>
		<category><![CDATA[psychiatric problems]]></category>
		<category><![CDATA[smokers]]></category>
		<category><![CDATA[suicide]]></category>
		<category><![CDATA[tobacco]]></category>
		<category><![CDATA[violence]]></category>

		<guid isPermaLink="false">http://healthrevelations.com/?p=3710</guid>
		<description><![CDATA[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.]]></description>
			<content:encoded><![CDATA[<p>Nearly 70 percent of all smokers want to quit &#8212; and half of them have tried and failed over the last year, according to new numbers from the CDC.</p>
<p>Obviously, it ain&#8217;t easy.</p>
<p>But if there&#8217;s anything worse for you than tobacco, it&#8217;s when the meds that are supposed to help you kick the habit up your suicide and depression risk instead.</p>
<p>And researchers say Chantix, the med most commonly given to smokers, has been found to do exactly that &#8212; with one new analysis concluding that it&#8217;ll boost your odds of suicide or severe depression by a stunning 800 percent.</p>
<p>Not exactly the type of &#8220;quit&#8221; you&#8217;re looking for &#8212; but instead of warning smokers away from the med or even issuing a long-overdue recall for Chantix, the feds are actually defending it.</p>
<p>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 &#8212; go ahead and take your Chantix, smokers.</p>
<p>But before you fill that prescription, read the fine print on that reassuring new message from the FDA &#8212; because the agency admits it didn&#8217;t bother to look at psychiatric incidents that didn&#8217;t lead to hospitalization.</p>
<p>In other words, a suicide victim found dead wouldn&#8217;t count, nor would a seriously depressed person who&#8217;s never hospitalized (and remember &#8212; many depressed people never seek any help at all).</p>
<p>You know what&#8217;s even crazier than the fact that the FDA didn&#8217;t consider non-hospitalizations? It&#8217;s that the agency actually has that extra data&#8230; and didn&#8217;t even bother to look at it!</p>
<p>That&#8217;s where the new study comes in, because researchers combed the FDA&#8217;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.</p>
<p>Chantix was only on the market four of those 13 years&#8230; but was involved in a whopping 2,925 of those cases, or 90 percent of the total.</p>
<p>Try to explain that one, FDA.</p>
<p>Other studies have also made the connection between Chantix use and serious behavioral issues &#8212; 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.</p>
<p>Violence, I should point out, also generally doesn&#8217;t lead to a hospitalization &#8212; although it could certainly end in prison or even death.</p>
<p>Bottom line here: Quitting smoking is a great goal &#8212; and with the New Year fast approaching (already!), it&#8217;s the one resolution you should put at the top of your list.</p>
<p>But do it without meds.</p>
]]></content:encoded>
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		<title>Beat the high price of beating gout</title>
		<link>http://healthrevelations.com/2011/11/03/beating-gout/</link>
		<comments>http://healthrevelations.com/2011/11/03/beating-gout/#comments</comments>
		<pubDate>Thu, 03 Nov 2011 01:00:27 +0000</pubDate>
		<dc:creator>Health Sciences Institute</dc:creator>
				<category><![CDATA[House Calls]]></category>
		<category><![CDATA[Topic 1]]></category>
		<category><![CDATA[cherries]]></category>
		<category><![CDATA[cherry juice]]></category>
		<category><![CDATA[colchicine]]></category>
		<category><![CDATA[Colcrys]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[FDA's drug approval rules]]></category>
		<category><![CDATA[gout]]></category>
		<category><![CDATA[gout attack]]></category>
		<category><![CDATA[hydroxyprogesterone]]></category>
		<category><![CDATA[inflammatory conditions]]></category>
		<category><![CDATA[orphan drugs]]></category>
		<category><![CDATA[rising prices]]></category>
		<category><![CDATA[URL Pharma]]></category>

		<guid isPermaLink="false">http://healthrevelations.com/?p=3605</guid>
		<description><![CDATA[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.]]></description>
			<content:encoded><![CDATA[<p>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.</p>
<p>The remedy is called colchicine, and it&#8217;s been used for literally thousands of years.</p>
<p>It&#8217;s been used for so long that it predates the FDA&#8217;s drug approval rules, making it technically an &#8220;orphan drug&#8221; allowed for use despite the fact that the FDA never officially signed off on it.</p>
<p>Well, it&#8217;s an orphan no more: A company called URL Pharma put it through a clinical trial &#8212; no real gamble since the drug has been effectively used since forever &#8212; and won itself a shiny new patent.</p>
<p>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.</p>
<p>That&#8217;s a pretty hefty markup. And if that sounds familiar, it&#8217;s because it&#8217;s happening more and more as orphan drugs are captured &#8212; or maybe &#8220;kidnapped&#8221; is a better word &#8212; and dragged into the Big Pharma family.</p>
<p>Earlier this year, a drug company patented hydroxyprogesterone &#8212; an inexpensive hormone used for years to help lower the risk of a preterm birth in high-risk pregnancies &#8212; and boosted the price by 15,000 percent.</p>
<p>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.</p>
<p>Eventually, the feds stepped in and told pharmacists they could keep making their low-cost version &#8212; but don&#8217;t expect them to do that for colchicine, and don&#8217;t expect them to do it for the estimated 1,000 other &#8220;orphan&#8221; meds out there waiting for a new Big Pharma family.</p>
<p>And that means any inexpensive remedy you rely on today could turn into a big-money nightmare tomorrow.</p>
<p>Luckily, in the case of gout, you don&#8217;t have to pay those outrageous prices &#8212; and since colchicine is actually toxic and can come with some pretty big risks up to and including death, you don&#8217;t have to put your life on the line, either.</p>
<p>There are inexpensive and completely natural solutions that have been used to fight gout for almost as long as colchicine &#8212; and one of them is the best-tasting cure around: Cherries.</p>
<p>One recent study fond that eating 20 cherries in 48 hours can cut the risk of a gout attack in half. If you don&#8217;t have any cherries handy, try cherry juice &#8212; the pure stuff, not some sugary cherry drink.</p>
<p>I had more on gout &#8212; including another completely natural and inexpensive treatment &#8212; back in September, and you can read it all for free right <a href="http://healthrevelations.com/2011/09/27/natural-solutions-for-gout/">here</a>.</p>
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