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Sunday, June 01, 2008
My Total Cholesterol Is 326 And Why I Don't Need To Take Lipitor Or Crestor To Lower It
Of all the blatant lies we have been told about our health over the years, there is one that sticks out as the most egregious of them all because it has failed to be proven by any reputable science or through human experience. And yet millions upon millions of Americans are currently taking a prescription medication for this condition because that's what their doctor told them they needed to do to prevent the risk of heart disease. I'm of course referring to the cholesterol hypothesis.
We've all heard it throughout our lifetime that you better keep your cholesterol below 200 if you want to keep from having clogged arteries which could lead to a heart attack, stroke, or worse. These warnings have come from well-meaning physicians, dietitians, and other so-called health "experts" who are simply regurgitating what they have been taught in medical school, personal training, and from other sources.
One of those "other sources" of information are pharmaceutical companies which stand to profit greatly from a trumped-up condition that they can swoop in and come to the rescue of people with a susceptibility for atherosclerosis with a miracle pill. That's exactly what Pfizer has done marketing Lipitor, Astra-Zeneca with Crestor, and Merck/Schering-Plough with Zetia. These prescription medications are meant to treat "high cholesterol," but has anyone stopped to ask the obvious question that is that gigantic elephant in the room?
WHAT IS THE PROOF THAT HIGH CHOLESTEROL LEADS TO HEART DISEASE?
Surely you jest, Jimmy! Everyone KNOWS that you put yourself at risk when you allow your cholesterol, especially that dastardly LDL "bad" cholesterol, to rise above 200. Anyone who refuses to take a statin drug when their total cholesterol rises above this level is simply putting themselves at severe risk for some rather serious health consequences down the road. Why not just take your medicine like the rest of us are doing and put yourself out of harm's way?
You'd be surprised how many people feel EXACTLY like that. We've been so cleverly sold a bill of goods about cholesterol that it's almost sacrilegious to even suggest a contrary point of view without being looked at like you're some kind of space alien. Of course, those of us who are livin' la vida low-carb are already used to this kind of scrutiny, so what else is new? That said, what is the harm in taking a pill that supposedly will do you some good?
Well, there's PLENTY of harm that can happen. Although cholesterol numbers have come way down from where they once were, what is the cost to our health that these reductions have produced. In my podcast interview with Dr. Jim LaValle last week, he said that if you put 250 people in a room and put them all on a statin drug and just ONE of them reduced their risk of heart disease as a result of this therapy, the pharmaceutical companies believe that is good enough to put the pill on the market for the masses. But what about those other 249 people? What is the impact of a statin drug on THEIR health?!
Let's just be honest for a moment. Cholesterol drugs are about nothing more than one thing and one thing alone: MONEY! If there was no money to be had in reducing cholesterol numbers, then all this hoopla over cholesterol would never even exist. The fact is battling "high cholesterol" is big business and anything that stands in the way of that multi-BILLION dollar profit machine will be run over with a proverbial Mack truck! If word got out that livin' la vida low-carb did more to improve your risk of heart disease than statin drugs, then there would be a lot of unhappy pharmaceutical reps who have made a healthy living selling the facade that "high cholesterol" will kill you.
Let's talk about the pharmaceutical reps for a moment. Who died and made them the great purveyors of health knowledge in the United States? I understand doctors are limited on their time and ability to continue their education into the latest research that comes out about health. But why do the pharmaceutical companies get a free pass to waltz right into see my doctor--sometimes as many as six blaze in and out while I'm there--to explain about their new wonder drug for every ailment known to mankind? Can I have the same sort of privileges to go from doctor's office to doctor's office to give a presentation about the latest scientific evidence supporting a controlled-carb approach on weight and health? I think you know the answer.
So that's the system we're stuck with for now. Doctors go to medical school where they receive a grand total of maybe one week of nutritional education (two if they're lucky!) and then are forced to rely on highly-paid drug company representatives to give them "unbiased" reporting on what they need to be giving their patients for high blood pressure, obesity, and high cholesterol. It's the way we've always done it, so I guess we had better get used to it, right?
Not me. When I decided to go on the Atkins diet in 2004, I was sick and tired (literally!) of settling for the conventional wisdom for what constituted a "healthy" diet and instead chose a way of eating that would help me go on to shed 180 pounds. At the time when I still weighed over 400 pounds, I was taking Crestor after a very painful stint on Lipitor to control my "high cholesterol" which was around 250 at the time. They had me so scared of NOT taking this statin that I felt like it was my only option despite the agonizing pain these drugs have been shown to cause in more users than they even realize.
Nine months later after losing about 140 pounds, I decided to come off of statin drugs for good. And I've refused to take another one since because low-carb has worked better to make me healthier than I ever thought possible. And yet those boo birds in my head kept making a lot of noise in 2006 when I visited my doctor for a routine physical check-up. As soon as my doctor said I needed the "s" word again, I just about screamed! When I politely told him I would NOT be going back on Lipitor or Crestor again, he said he'd give me four months to lower my LDL down from 170 or else he would insist I take it.
Once you break through literally years of cholesterol indoctrination and instead challenge those who support the cholesterol hypothesis to prove having "high cholesterol" is unhealthy, then you are then ready to understand that there's more to it than simple terms like "good" and "bad" cholesterol. The particle size of LDL is the BETTER way to determine if that cholesterol number you see is harmful or protective. The large, fluffy LDL are protective while the small, dense LDL particle size is what you need to be wary of. You can check out the particle size of your cholesterol by having a VAP test done or something similar that would give you the breakdown of these cholesterol subsets. It's not as simple as LDL and total cholesterol anymore.
One of my readers frantically wrote to me an urgent message about their recent trip to the doctor and her diagnosis of "high cholesterol." Here's what she wrote:
Hi Jimmy,
I have been doing Atkins since April 2007 and have lost 40 pounds. I just recently went to my doctor and had some blood work done. I received the results and it came back that my cholesterol is too high. My LDL is around 250, my HDL is around 54 and my total cholesterol is at 300.
I don't know what to do!! My doctor prescribed me Crestor, but I have heard awful things about it. What do you think I should do? I have been eating lean meats, fish and veggies and staying away from excessive salt intake. I don't want to stop doing low-carb. Oh and I am exercising too! I appreciate any help or advice you can give me!!
I'm so glad she wrote to me because she is EXACTLY who I wanted this blog post to be for. She has been sold that bill of goods that her cholesterol is too high and the ONLY answer she has to this grave problem they have presented to her is to take a statin drug. Gee, imagine that! Sure didn't see that one coming!
Let me just say that her HDL of 54 is great and I would be willing to bet her triglycerides are below 100. Dr. Mary C. Vernon has said that one of the surefire ways of knowing someone is low-carbing correctly is their HDL is above 50 and their triglycerides are under 100. If that's the case, then her HDL/triglyceride ratio is FABULOUS and she really has nothing to worry about.
But what about the LDL and total cholesterol? Are they really irrelevant? Well, without seeing the results of her particle size test (which I don't know if they ran or not), it's impossible to know if she's at risk with those numbers. But I do happen to know someone with similar numbers who did have a particle size test done recently--ME!
You'll recall I went to see a low-carb doctor last month about my recent mysterious 30-pound weight gain and he ran my lipid profile numbers for me. When the results came back, they would no doubt be a bit stunning to someone who looks at cholesterol in a traditional way:
Total Cholesterol - 326 Total LDL - 246 Total HDL - 65 Triglycerides - 77 Insulin - 5.8
Yes, my total cholesterol is 326 and hopefully now you know why I don't need to take a statin drug like Lipitor or Crestor to lower it. Check out my HDL/triglyceride ratio. It's virtually 1-1 and that's FANTASTIC! Note that my HDL is above 50 and my triglycerides are below 100--a sign that I'm livin' la vida low-carb 100% right despite my weight gain. So what's up with the LDL? Is the particle size where it needs to be?
The answer is YES! My doctor said that when he analyzed the LDL subset breakdown, he saw a clear majority of the LDL was the large, fluffy kind that you want to protect against cardiovascular problems and very few if any of the small, dense kind. So, despite my astronomical LDL number, it's a non-factor. And neither is the total cholesterol. Keep in mind my HDL "good" cholesterol is high like it needs to be, so that contributes to the total number, too.
So if you've been to the doctor after being on a low-carb diet and you see numbers similar to mine and my reader's cholesterol, don't panic! Get your particle size so you can be armed with the facts about what to do in response. "High cholesterol" is a gimmick to sell more dangerous statin drugs to people who could stand to benefit from the healthy low-carb lifestyle. I'd never tell you what to do for YOUR health--that's YOUR decision. But one thing is for certain. I'm NEVER gonna take a statin drug again!
And I don't have to because I'm livin' la vida low-carb!
Nicki Anderson exposes a dirty truth about a risky new weight loss drug
My friend and fellow fitness lover Nicki Anderson who owns and operates the Naperville, IL-based Reality Fitness health center wrote an incredible article in her weekly "Happy Monday" newsletter this week about how the allure of "quick weight loss" can oftentimes deter you from the more important job of retaining your health.
Ever since I first blogged about Nicki early last year, I have grown to love and appreciate her perspective as a weight loss and health counselor for those who desire to get fit. She is arguably one of the most enthusiastic people in the health world you will ever meet and I count it a privilege to know her.
You'll recall I've come down pretty hard against the new over-the-counter weight loss drug called ALLI. In fact, I dedicated an entire podcast show (which became an instant classic and one of the favorites among my listeners!) to it which precipitated quite a response from both pro and con from those who had an opinion about taking it.
Well, Nicki shared what some of her own clients are saying about the use--or should I say ABUSE--of ALLI as part of the weight loss regimen of those they know. Keep in mind this ALLI drug is available EVERYWHERE now, including Wal-mart, drugstores, and anywhere there is a pharmacy. It ain't cheap, but price is no option for many when they just wanna lose weight ANY way they can.
Click here to read the shocking details of what Nicki's client told her about how some people are using ALLI in their desperate attempts to lose weight and to learn why eating healthy should ALWAYS take precedence over being skinny.
Dr. Jonathan Graff says "skinny gene" needs to be turned on in obese
The head of the British Medical Association caught a lot of flack last month for suggesting overweight and obese people should stop looking for another pill to pop to do something about their weight problem. But his concerns have fallen on deaf ears from every obesity researcher in the world still trying to find the next great anti-obesity drug!
This Globe & Mail column highlights a new study on a gene researchers have found in the body that allegedly makes you skinny and reverses high blood sugar and insulin levels in the body. They are working feverishly on developing a prescription medication to stimulate this gene.
Lead researcher Dr. Jonathan Graff, associate professor of Molecular Biology at the University of Texas Southwestern Medical Center, and his fellow researchers observed the adipose (Adp) gene in obese mice, fruit flies, and worms over a 5-year period and found that less stimulation of this gene existed which led to fat formation and insulin resistance leading to Type 2 diabetes.
At the same time, when more stimulation of the Adp gene was present in the mice, flies, and worms, they were thinner and healthier.
Dr. Graff said this proves anyone has the potential to be lean and healthy once this gene is properly regulated in the body.
"There's a 'skinny gene' out there, and when it's reduced in function, animals become fat," he explained. "It works in fat cells and not by changing appetite, and could account for what I would call this epidemic of obesity and diabetes."
Because human beings also have the Adp gene, Dr. Graff says further research will be needed to look into a possible new pharmaceutical treatment for obesity, diabetes, and other weight-related diseases.
"What we want to do now is to get a medicine to rev this thing up, to help you be skinny, to get your blood sugar down, to get your insulin down," he stated.
Bringing an oral medication to the market could take a decade.
I just have one thing to say about: OH BROTHER, NOT AGAIN!
You know, I see a regular trend happening here. Researchers find something in a study related to being fat, they justify continuing their research by claiming it can be turned into a drug for treating obesity, and then they keep pursuing it so the financial underwriting will continue. Is there no end to this hysteria?
Don't get me wrong, studying the culprits behind obesity and disease is wonderful, but the focus has all too often been on creating the next so-called "magic pill" for treating weight loss. Nevermind those outstanding researchers who are promoting natural and healthy dietary changes for reducing weight and improving health like livin' la vida low-carb (we even saw the researchers in this study published in Cell Metabolism last month regarding the TOR gene and the Atkins diet trying to push for a drug intervention--UGH!).
But there's no money in natural nutritional remedies, so those research studies are generally swept under the rug, ignored, and research dollars mysteriously shrivel up and disappear. Why? The cold hard reality is that obesity and disease have become BIG BUSINESS as Dr. William Davis so poignantly noted in my recent interview with him about heart healthcare.
Dr. Graff maintains the reduced Adp gene function, which was discovered a half century ago in obese fruit flies, just needs to be turned on and up in fat people.
"It's a volume control," he contended. "We can just keep making you skinnier by turning the volume of this up."
Um, with all due respect, Dr. Graff, I disagree that the overwhelming cases of obesity that exist in modern time is necessarily tied to the Adp gene. Instead, it's about what happens in the body metabolically when overconsumption of carbohydrate is combined with fat and protein to pack on the pounds and cause insulin resistance.
Instead of working on a pill which may or may not work even after years of testing, how about looking at and embracing the studies that HAVE come out about controlling metabolic syndrome with a naturally healthy diet? It's livin' la vida low-carb in case you missed it!
The low-carb lifestyle has a proven track record for reducing body fat, lowering triglycerides, raising HDL "good" cholesterol, improving blood sugars, and so many other health markers. Let's urge people to implore this kind of natural anti-obesity strategy rather than constantly looking for that next great miracle pill. Who in the research community has the guts to stand up and declare this truth?
Am I the only one who absolutely despises with a passion that infamous Zetia TV commercial that's been running this year? You know the one--a fat woman pretending to be a cooking show host on The Food Network cooking up a bunch of carb-loaded dishes while talking about her "high" cholesterol despite eating "healthy" and that she needs a prescription drug like Zetia made by Merck to help lower her cholesterol.
Just in case you may have missed it, watch the one-minute ad NOW:
There's so much I'd like to say about this asinine commercial that I'll transcribe it line-by-line for you along with my commentary in between. ENJOY!
FAT LADY:"Millions of people watch me cook, but I watch what I eat."
Um, only on a fake cooking show could you claim "millions" watch you. I'm sure Emeril and Rachael Ray get the largest audiences on The Food Network, but their numbers aren't in the MILLIONS. Come on! And then to trot this obviously overweight woman out as the poster child for being healthy making the claim, "I watch what I eat." Yeah, she watches every single bite of those high-carb foods go right into her mouth!
FAT LADY:"Still, when my doctor checked my cholesterol, it was slightly higher than we'd like."
FAT LADY:"For me, he chose Zetia. It works differently. Statins work mainly with the liver. Zetia works in the digestive tract like some other medicines. But Zetia is unique in the way it helps block the absorption of cholesterol that comes from food."
Well, this would matter if cholesterol was raised by consuming cholesterol in the diet. Respected bestselling low-carb author Dana Carpender explains why in her latest book Every Calorie Counts. Well worth reading!!!
FAT LADY:"Zetia, along with a healthy diet, lowered bad cholesterol by an average of 30 points, that's 18 percent!"
What if we didn't have Zetia, Ms. Fat Fake Cooking Show Host Lady? Would that "healthy diet" just be making us sicker by raising our cholesterol? Perhaps if you started livin' la vida low-carb, you would see IMPROVEMENTS in your lipid profile and wouldn't need no stinkin' drug. Gee, now there's an idea!
FAT LADY:"It complements what I'm already doing."
Obviously what you are "already doing" ain't working so hot! The low-carb lifestyle could really help you there, ya know!
VOICEOVER ANNOUNCER:"Zetia may not be right for people who have ever had liver problems, are nursing or pregnant, or may become pregnant. Your doctor will decide if Zetia is right for you."
Oh, he won't decide. But that Merck pharmaceutical rep sure will put enough ($$$) incentive ($$$) in front of him to coerce him into suddenly realizing that Zetia is "right" for a whole lot of his patients. It's disgusting how pills are being distributed like candy with no regard for what the patient REALLY needs to be healthy.
VOICEOVER ANNOUNCER:"Unexplained muscle pain or weakness could be a sign of a rare, but serious side effect and should be reported to a doctor right away. Common side effects included tiredness and stomach pain."
Oh, and he looks so real faking a countdown before the cameras roll!
FAT LADY:"Cook It Healthy!"
Can you imagine the laughing stock this lady would be if she was REALLY the host of a cooking show called "Cook It Healthy?" Talk about your irony of all ironies! Plus, that nasally voice would get to be a bit too obnoxious for me if I had to suffer through a half-hour show with her yappin' away about her low-fat recipes. Yippee...NOT!
FAT LADY:"Ask your doctor if Zetia is right for you. Zetia. A different way to help fight cholesterol."
It's no different than what we've seen before because it still pretends that you need a drug to take care of your cholesterol. Wanna REALLY know how to get your cholesterol under control? You can start by reading the absolute best book on the subject by Australian independent researcher Anthony Colpo called The Great Cholesterol Con.
Let me know what you think about Zetia after reading that book!
New OTC weight loss drug Alli at the center of obesity debate
Did you catch my latest podcast show about the new diet pill that everyone's talking about called Alli? If you missed it, then you need to go listen to what I think will go down as my favorite show ever! Hilarious doesn't even begin to describe it! :D
Anyways, here's what he said about the podcast on Alli:
Let me start by saying that you have A LOT of great information and good reading on your site, I really enjoy it.
I am in no way associated with any program, pill, or company so this is just a average Joe opinion here.
I just read your transcript from the program you did and it reads rather alarmist on one hand and used car salesman on the other. I got the sense of you pushing your way as the best & only way. When you say you are stuck taking it for the rest of your life, I sort of got a confused look.
From what I’ve read re this pill, it is not meant to be taken alone, but in conjunction with a healthier eating style. Ya you get the runs, and poo issues if you have to much fat in your diet, if its really bad just stop taking the pill. I have not taken it, I thought about it as an additional way to take off a few pounds faster in conjunction with my low carb, low to med fat intake.
If the runs are the worst of it I think some people would welcome the extra weight loss. As for being on it for a lifetime, that does not even make sense. If you get your weight down to a level where you can exercise, and you continue to eat healthy, why keep taking it?
Get to your ideal weight and maintain it. As for taking a multivitamin, how can that hurt ya? The key is to not rely on vitamins, diet pills, diets, or anything like that. Eat healthy and you won’t need them. If a pill helps you along the way and doesn’t hurt you, go for it.
Did this person even see all the possible negative reactions that Alli can cause? What's he been smokin'? Here was my response:
THANKS, LJM, but I respectfully disagree with you. There was nothing “alarmist” about my podcast (you REALLY need to listen to it, not just read the transcript!) except that which was found on the web site for both Alli and the FDA which approved the drug to be sold over-the-counter.
If you listen to virtually ANY of my previous podcasts, then you would know how ignorant your “I got the sense of you pushing your way as the best & only way” comment really is because I am all for people finding what works for them, following that plan exactly as prescribed, and then doing it for the rest of their life.
Livin’ la vida low-carb has been that for me and I realize it may not be for everyone. But this Alli is something tee-totally different because we’re not talking about a natural supplement to aid in weight loss. Instead, what we have is a truly dangerous drug that has not just gaseous side effects, but also the risk of COLON CANCER!!! Why even risk taking something like that just to lose only a few extra pounds.
I don’t say you’re stuck taking it for the rest of your life, that’s EXACTLY what the Alli commercial says when the announcer says, “You don’t just take Alli, you commit to it.” What do you think that means, LJM? Did you hear when I quoted from the FDA when they said if you ever get off the Alli pill, you will GAIN your weight back? Again, this is NOT me saying this, but the freakin’ group that approved this thing!
As for this “healthier eating style” crap, a high-carb, low-fat diet does NOT fit that description. When you lower the carbs, the fat is naturally going to increase as a percentage, so this Alli will become that much more harmful to people who are livin’ la vida low-carb. There’s just no wiggling out of this inevitable fate.
Face it, LJM, people are gonna still eat their high-carb and high-fat meals and will take this Alli OTC drug to ease their conscious about it. Boy, will THEY be in for a rude awakening!
I don’t know why people would put themselves through the torture of the side effects that Alli has just to lose a couple more pounds. Why not just work the low-carb plan you are on exactly as the author prescribes and the weight loss can and will happen as quickly as it needs to.
Don’t forget, I lost 180 pounds in 2004 without the use of any drugs or anything other than my all-natural, healthy low-carb Atkins diet. Alli would have been a disaster for me and I very likely would have given up from all the discouraging gas and “accidents.”
Finally, I cannot agree with you lumping vitamins in with something truly unhealthy like diet pills such as Alli. Vitamins are truly an important part of a healthy lifestyle and I have taken them daily for over three years. They are the lifeblood of ANY healthy living strategy and it is ignorant to think otherwise. They are completely safe, too!
While I appreciate your feedback, LJM, you could not be more off base if you tried. Again, you REALLY need to listen to this podcast show so you can hear how the information was presented and then check out past episodes so you won’t be as ignorant about my philosophy the next time you decide to mindlessly rant on a topic you obviously are clueless about.
Take care! :)
Care to add your two cents worth about Alli? Add your comments and join the conversation! And enjoy a laugh or two with this podcast. Kudos to my producer Kevin-Kennedy Spaien for having some fun with this one.
Have you considered becoming "committed" to Alli for weight loss?
Forgive me for not jumping for joy or being filled with excitement over the new over-the-counter weight loss drug being heavily promoted right now called Alli. But in Episode 61 of "The Livin' La Vida Low-Carb Show with Jimmy Moore" today, you'll hear exactly why anyone who is livin' la vida low-carb should stay very far away from this latest so-called miracle diet pill that some believe is the ever-elusive "magic bullet." But are they shooting themselves in the foot instead?
Let me warn you ahead of time...my producer had way to much FUN with this one. You'll see what I mean when you listen:
"The Livin' La Vida Low-Carb Show with Jimmy Moore" Episode 61 [13:30m]: Play in Popup | Download
Doesn't that just make you wanna run out and get your very own stash of Alli for yourself? NOT! It's truly amazing how a drug with so many well-known adverse side effects could actually be approved by the FDA to be sold over-the-counter while something as harmless as stevia has a tough time getting approved as a sweetener. That FDA is one messed up government entity, I'm telling you! This is a lawsuit worse than Vioxx or Avandia ever dreamed of becoming!
Low-carb podcasting is available to you anytime by:
Have you considered taking Alli, the OTC version of Xenical and orlistat, to help you shed a few extra pounds? Or did you, like one of my readers recently, decide against it because of the risky side effects? Tell us your thoughts about Alli and whether you would ever consider taking a drug like this one in conjunction with your low-carb lifestyle.
Oh, and have you seen what some creative marketing people who make other diet pills are doing lampooning the side effects of Alli? Check this out:
Um, in a word...EWWWWWWW! I think I'd be avoiding Alli if I were you.
Don't miss Thursday's episode of "The Livin' La Vida Low-Carb Show with Jimmy Moore" because we only have two interviews left from my trip to Nashville last month for the American Society of Bariatric Physicians obesity conference. Hear from the heart of a real doctor who is treating his overweight and obese patients with exactly what they need to be successful. And it ain't Alli!
Millions of diabetics take Avandia, but is it harming them?
We live in a society that says as long as you take your pills, you can live your life however you want to. Forget about making natural changes in your diet and lifestyle to manage your health, just go hog wild living it up and let the prescription drugs take care of the consequences of those foolish actions (like the American Diabetes Association's recommendation to go ahead and eat your carbs as long as you take your diabetes medicines--UGH!).
But doing that sometimes opens you up to certain health risks as we discovered in this USA Today column about the widely-used and prescribed diabetes drug Avandia. Have you heard this shocking story yet?
It seems the manufacturer of this diabetes medicine--#2 bestselling prescription drug at GlaxoSmithKline (GSK)--informed the Food & Drug Administration (FDA) as early as 2005 of a 30-percent increase in heart disease risk for patients taking this drug. So did the FDA do their own investigation into this to confirm the safety of Avandia? Was an effort made to inform patients of this known risk?
In a word--NOPE!
Instead, it took a study published in this week's New England Journal Of Medicine to shine the light of truth on this horrific discovery that may have already quite literally negatively impacted the health of millions of Americans. You know what that means, don't you? Lawsuits out the ying yang and rightfully so. More about that in a moment.
First, let's take a look at that study for a few moments.
Lead researcher Dr. Steven Nissen (who conducted this study on statin drugs I previously highlighted at my blog) from the Cleveland Clinic wrote in his report that both GlaxoSmithKline and the FDA should have (but didn't!) take the necessary steps to adequately warn people taking Avandia of the risks to their health. Uh-oh!
Dr. Nissen concluded from his examination of 42 different studies that have been conducted on the drug posted right there on the GlaxoSmithKline web site that there was an even higher risk of heart attack--an astounding 43 percent INCREASE--as well as a spike in the risk of death from heart disease--a stunning 64 percent INCREASE!
Yikes!
These study results were eye-opening for Nissen and should be a real wake-up call for everyone who mindlessly believes you can live your life as a diabetic so long as you pop your prescription diabetes pills.
"This is important because cardiovascular disease is the leading cause of death in diabetes and is responsible for between 65% and 80% of all deaths in diabetics," he said. "The reasons we give drugs to lower blood sugar is to prevent the complications of diabetes, the most important of which is heart disease. When a drug increases that risk, it can have profound public health consequences."
Well, this study got the attention of the FDA who has NOW issued a Safety Alert this week stating there is a "potentially significant" heart health risk. Ya think?! That's mighty bold of you, FDA! It's about freakin' time!
The lapse in judgment by the FDA has compelled Congress to set up an emergency hearing by the House Oversight and Government Reform Committee on June 6th to look at this issue surrounding Avandia. Some lawmakers are already calling this "another Vioxx," referring to the now-infamous arthritis drug that had its FDA-approval yanked because of similar heart health risks.
In 2006, there were 13 million prescriptions written by doctors for their diabetic patients raking in over $2 billion (yes, that's billion with a "b")! This is big time big bucks for GlaxoSmithKline that they really hate to see go up in flames over Nissen's silly little study. So it's not surprising that they sent out the big guns to try to debunk it.
"We are confident of the safety profile of Avandia and believe in its benefit for type 2 diabetic patients," exlaimed Ronald Krall, medical director for GlaxoSmithKline, who added that there are serious flaws in how the study was conducted.
But this is something Nissen does not deny. However, he said he could only base his conclusions on the information available to him directly from the GlaxoSmithKline web site.
"It was based on an analysis of publicly available material, not patient-level data for these trials," Nissen noted. "Nevertheless, we think the results will stand up over time."
In the meantime, financial analysts are already estimating GlaxoSmithKline is gonna have to pay through the nose for the negligence despite their insistence they did nothing wrong by not revealing the heart health risks to the diabetic patients taking Avandia. How much will it cost them? Early estimates are saying the costs could end up being as much as $5 billion--that's TWO AND A HALF TIMES the sales generated by the drug in 2006 alone.
OUCH, that's gonna hurt! Wah, wah, wah! Cry me a river.
Legal experts state that there could be up to 16,000 legal claims made against GlaxoSmithKline in response to the study. At a nominal $300,000 for each case, that would add up to $4.8 billion. Additionally, Avandia sales would plummet significantly--as much as 30-40 percent.
This is exactly what you get when you rely too heavily on medicines from the big pharmaceutical companies to be your permanent lifestyle change. What do you do when that magic pill you rely on to keep you healthy actually puts you at greater risk for disease and even death? Don't you think it's time to look at all-natural changes in your diet and lifestyle to manage conditions like diabetes? If this story doesn't convince you of that truth, then I don't know what will!
If you are like me and enjoy taking supplements as part of your low-carb lifestyle, then you will definitely want to read this World Net Daily story about something the Food & Drug Administration (FDA) is currently proposing that could directly impact your life. This may sound like a very sick joke, but it is DEAD SERIOUS!
According to FDA Docket No. 2006D-0480, aka the "Draft Guidance for Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration," the government agency would take over regulation of all vitamins, supplements, and any other natural health remedies. What would this mean? Well, any natural remedy items, even bottled water, would then be considered "drugs" coming under the strongarm authority of the FDA.
In fact, pretty much anything and everything that can be used to treat disease would fall under FDA control. Here's the language they use in this draft proposal:
Biologically based products include, but not limited to botanicals, animal-derived extracts, vitamins, minerals, fatty acids, amino acids, proteins, prebiotics and probiotics, whole diets and “functional foods.” A botanical product intended for use in treating a disease would be generally regulated as a drug. “Functional foods” may be subject to FDA regulation as foods dietary supplements, or drugs under the Act.
If the manipulative and body-based practices involve the use of equipment (such as massage devices) or the application of a product (such as lotion, cream, or oil) to the skin or other parts of the body, those products may be subject to regulation under the ACT.
Does all this sound preposterous? Think again. Imagine this:
Do you own a home gym for medical purposes? It would need FDA approval for use or commerce. How about heading down to your local drugstore to find your favorite vitamins? Good luck because the FDA would need to give their go-ahead. In fact, any store caught selling vitamins without the FDA's magic stamp could be prosecuted for "practicing medicine." Yikes!
FDA Commissioner Dr. Andrew C. von Eschenbach has put this draft guidance on the fast-track for implementation, but they are soliciting feedback from concerned citizens through May 29, 2007. The original date was set for Monday, April 30, 2007, but they decided to extend it for an additional month since there has been such an outcry from the public. You can send your concerned comments and reaction to the FDA about this by using their feedback form.
With one out of every three Americans using nondrug treatments for their health at an estimated cost of $5 billion annually, it appears the FDA is watching out for their buddies in the pharmaceutical industry. The medical establishment doesn't like the fact that people are getting healthy without the use of their overpriced medications. Sure, there are SOME drugs that do some fantastic work, but a lot of people find equally effective relief from all-natural homeopathic remedies.
Ever since I've been taking supplements like so many do on a daily basis as part of my low-carb lifestyle, I have not had to see the doctor because I haven't been sick. That's a fact that apparently doesn't sit too well with the medical profession. It's not all of them, but the people in powerful positions are none too happy that they're losing out on "business" from people who are supposed to be sick. Twisted, ain't it?
We've already seen severe restrictions to vitamins in our neighboring countries Mexico and Canada as well as in Europe where you even need a prescription from a doctor to have access to them. EEEEK! Don't you know the FDA would love to bring this policy to the good ole United States of America. They've been working on it for a while now.
I've previously blogged about the concerted effort to outlaw vitamins in this country before, but the FDA has stepped it up. What makes this bad is the outright corruption that already exists in that government entity and it's well-documented. Can you say Vioxx? Or their approval of the wheat gluten imported from China that was responsible for the pet food contamination that killed thousands of beloved pets? Shall I continue?
If you care about this issue as much as I do, then leave your feedback for the FDA TODAY! You have until May 29, 2007 to voice your concerns about this important issue. Let Commissioner von Eschenbach hear from us all!
What's GlaxoSmithKline doing sponsoring a new obesity series on PBS?
Something fishy is going on with an upcoming program about obesity on your friendly public television station and this Broadcasting & Cable story provides all the sordid details about what is going on.
From what I can see, the filmmakers are mainly going to highlight the problem rather than seek out solutions to the obesity epidemic. That's not really my concern, but it is an interesting sidebar. (Why examine a problem in a series of shows on public television if you aren't going to offer suggestions about how to address that problem? But I digress.)
While the subject matter is indeed an important one that needs to have a platform and is absolutely relevant programming for public television, it's the inclusion of one particular major sponsor--a pharmaceutical company--who just so happens to have a brand new over-the-counter weight loss pill to offer overweight and obese people that has many concerned.
The culprit in all of this is GlaxoSmithKline (GSK) who provided what is described on the PBS web site as "major funding" for this show set to be aired beginning on April 11, 2007. While their sponsorship deal with PBS may seem like it's just a generous act of care and compassion by a company concerned about the delicate subject matter of the series, it's difficult to ignore the fact that GSK recently got FDA approval to sell the first over-the-counter version of the diet drug orlistat called "Alli" which they have already invested a lot of time and money into bringing to the market.
Don't you know they'd love to get as many people as they can taking this drug as soon as possible. Sponsoring a show like this is one way to get their proverbial fingers in the wallets and purses of Mr. and Mrs. Fat America!
While the rules of public television prevent GSK from mentioning their new weight loss drug as part of their sponsorship, that hasn't stopped them from talking about obesity in suspiciously generic terms on their web site. With an image of a measuring tape beneath an article called "Obesity: Why Weight Matters," the link to "Find out more about obesity" takes you to a page full of a bunch of statistics about obesity without providing any real solutions (just like the documentary itself they are sponsoring!).
It's basically setting up a straw man argument that SOMETHING really needs to be done about obesity or else it'll keep getting worse and worse in the years to come. Hmmm, I wonder what we can do about all of this?! Does this sponsor GSK have an answer for us? Ding ding ding, oh that's right! Maybe I'll try "Alli" the next time I'm shopping at the pharmacy.
Sneaky, sneaky, sneaky is all I have to say about this. I take that back--it's SICKO! Unscrupulous for a company like that pushing their name out there in the hopes of selling a few of these diet pills! And what the heck is PBS doing taking money from a company like GSK?! Are they completely out of their minds? Talk about your conflict of interest!
Of course, PBS is denying any wrongdoing here stating that GSK as an underwriter has no control over any of the programming itself. While that may be true, the indelible connection between the content of this series (obesity) and the drug being peddled to address that subject matter ("Alli") is very conspicuous to say the least. Why else would GSK be a "major sponsor," hmmmm?
If this were ABC, CBS, NBC, Fox or any other television network that looks for paid advertisers to sponsor shows that meet their demographics, then it wouldn't be such a big deal. But we are talking about public television and there is a clear line of distinction that has no business being crossed.
The company producing this series, Twin Cities Public Television, has remained silent about this controversy surrounding GSK's sponsorship, but PBS has not. They issued the following statement regarding their position in this matter:
"PBS and The Corporation for Public Broadcasting provided the initial production funding for 'FAT: What No One is Telling You' through its 'Program Challenge Fund,' which also included a grant for an educational community outreach initiative. Production on 'FAT: What No One is Telling You' began in October 2005 and was nearing the end of production when the corporate sponsor, GlaxoSmithKline, came on board in January 2006 and provided additional funding for the broadcast, community outreach and Spanish language translation. As is always the case with corporate funders of PBS programs, at no time did the corporate sponsor have any editorial input into the show, nor have they seen it, and this strict separation was maintained throughout production. Lastly, the sponsor credit for GlaxoSmithKline is a corporate image spot and does not mention any drug product, including those used to treat obesity. 'FAT: What No One is Telling You' premieres April 11, 2007 on PBS."
Oh enough with the corporate speak here! You don't need a product to be mentioned in order to know why GSK is sponsoring this show?! It's just like what happened with this Super Bowl ad by King Pharmaceuticals that didn't mention a specific drug either, but they certainly benefitted from the exposure they received from their commercial.
Let's just call a spade a spade and be done with it. GSK is trying to sell their drug "Alli" and thought they could get away with this soft sponsorship of an obesity series. But I don't think they should be able to get away with it. We need to let PBS know how we feel about this and tell them they are wrong to accept money from GlaxoSmithKline.
Use this feedback form and let them know how you feel about a major pharmaceutical company with a weight loss drug to peddle sponsoring the program "FAT: What No One is Telling You." Be respectful, but firm in your conviction about this and share how unethical it is for public television to take money for this purpose.
Of course, I'd love to know what you think about this issue. Is PBS right to take the money and is GSK just doing a good-natured act of corporate responsibility? Or do you agree with me that this stinks to high heaven? Make your voice heard!
2-17-07 UPDATE: Now here's a unique perspective sent by one of my readers who is a long-time public television industry veteran.
Jimmy: I appreciate the idealism of your concern about who is allowed to sponsor which programs on PBS or NPR. The appearance of a "tainted relationship" is a very real concern of public broadcasters.
As a 40+-year veteran of public broadcasting, I can empathize but not concur with you. I know full well the hazards of inappropriate sponsorships but more than that, I know how difficult it is to get funding for any programming, no matter its hoped for popularity. I thought your quote taken from Twin Cities Public TV explained the situation very well.
What is not explained in criticisms of underwriting on public media is the context for funding and how precarious and difficult it is to obtain funding and how many different sources a producer has to tap and how many years it takes before having the funds to do a quality job.
Most people do not know that the majority of what public broadcasting does is not what is seen on its broadcast channel (redistributed on cable and satellite). There is a host of other distribution channels for education, training and outreach to target communities far in excess of that one channel.
So a producer must not only develop funding for the production of a program but also have the resources to market the program to all potential audiences, create publications and web sites to further provide the large amount of information necessary to truly inform people on the subject matter and provide funding for local outreach to target audiences which allows local people and organizations to contact target community organizations and groups that can make the best use of the information contained in the program itself and available in other forms, mostly free for the asking.
At best, ten (10%) percent of the American public voluntarily donate to public broadcasting. There is a large variety of other sources from whom a producer must aggregate funding to make production possible. Federal funding accounts for about 13% of funding for operations including production and most of that goes directly to local stations. The rest comes from states, underwriters (sponsors), non-profit partners, auctions and miscellaneous contributors.
There are and have been efforts over the years to create a Trust Fund that would throw off enough annual interest to fund productions free from any funder's potential for influence. That has remained a dream as a result, in part, of the pressures created by commentaries from the worlds of political and special interests.
You are cautious to question the potential influence of funders but there has been no shortage of "wanna be influentials" who would like to control content on public broadcasting. Bottom line, in my now 40+ years experience with public broadcasting at every level, I have yet to see it happen, and more to the point, have been witness to and directly involved in fierce resistance to those who would try to leverage editorial influence over program content.
THANK YOU for taking the time to share your actual experiences working in public television for four decades. We can only hope the past will continue to be an accurate predictor of the present and future. THANKS again!
2-17-07 UPDATE: The blog truefilm picked up on this story and quoted my post about this subject. They point to another example of this happening with Johnson & Johnson sponsoring a documentary releasing February 21st about inflammatory diseases called Innerstate. Guess what Johnson & Johnson makes that could help with inflammatory diseases? If these people were even TRYING to hide what they are doing, it would be one thing. But it doesn't look like they are concealing their motives at all!
2-18-07 UPDATE: PBS Ombudsman Michael Getler has now responded to the concerns about GlaxoSmithKline sponsoring this documentary about fat. Here's an excerpt of what he wrote:
"I sympathize with PBS’s constant search for funding, the difficulty of finding sponsorships to bolster more traditional funding, and that fact that some funders simply have an interest in seeing subjects aired and are willing to take their chances on how the program will come out. But in this case, there is little doubt how a program about obesity is going to turn out. Even though GlaxoSmithKline came in late and, under PBS policy, has no say in any of the content, this kind of possible conflict can undermine credibility and, without knowing the financial details, doesn’t seem worth it."
Nevertheless, the primary producer of "Fat: What No One Is Telling You" named Richard Dechert reacted to Getler's statement with the following:
Michael, thank you for your comprehensive critique of this ongoing "hot button" funding issue. As a longtime staffer at Twin Cities Public Television, the primary producer of "FAT: What No One Is Telling You," and as a longtime media-reform activist with national and local organizations, I have perspectives on the issue that few others have been able to develop. A key perspective is this:
Individuals and organizations who rightfully decry the increasing commercialization of PBS, NPR or any other federally funded programming must take even more vigorous and sustained action to prevent further cuts in Presidential, Congressional, and state support for public TV and radio, and to champion alternatives ways of supporting and improving their vital services--including an independent, self-sustaining national trust fund.
Public broadcasters have long-supported such alternatives, but all of them have been "DOA" in the Congress--with a lack of effective support from anti-commercialization activists being a major lethal factor. Sadly, from what I've been able to observe so far, the furor over "FAT" is on its way to being another dead-end case in point.
Dechert also contacted me about my blog post on this issue.
Jimmy,
As a progressive media activist, one of my roles has been to tell my activist colleagues when they haven't done their "homework" in slamming public TV or radio. In your following critique you say:
--"From what I can see, the filmmakers are mainly going to highlight the problem rather than seek out solutions to the obesity epidemic. That's not really my concern, but it is an interesting sidebar. (Why examine a problem in a series of shows on public television if you aren't going to offer suggestions about how to address that problem?. . . ."
Clearly, you failed to do your "homework" in carefully reviewing the Web links on the "Take One More Step" Web site. If you had you would know that the multi-media package of on-air, online, and community-based services for both "Heart" and "Fat" is modeled after Twin Cities Public Television's (tpt's) 2004 Primetime Emmy Award winning package for "The Forgetting: A Portrait of Alzheimer's." PBS lauded it for having the most powerful impact of all the shows it aired in its 2003-2004 national schedule. And tpt's senior producer for "Alzheimer's," Naomi Boak, is "FAT"'s senior producer. You can easily review that and many other National Production awards by clicking here.
--Among your several charges you also say: "Is PBS right to take the money and is GSK just doing a good-natured act of corporate responsibility? Or do you agree with me that this stinks to high heaven?. . ."
"Alzheimer's" also had a single corporate-financed funder, the MetLife Foundation, whose parent company is a major commercial provider of health care, disability and other related insurance and financial-planning services. Its underwriting of this production complied with the same PBS rules that governed "FAT's" production.
So, Jimmy, tell me how that underwriting "stinks"--or more appropriately how it adversely influenced "Alzheimer's." And when you've finally completed your pre-broadcast "homework," actually watched the show, then determined its national impact, competently answer the same question for "FAT." Conspiratorial fantasy is an unacceptable "homework" substitute for social reality.
I responded to these questions and concerns with the following.
THANKS for sharing your concern, Richard, and I certain sympathize with you about the funding. It is a MAJOR issue indeed which makes these corporate sponsorships all the more disconcerting. I know you have to do what you can to raise the dollars necessary and I certainly don't blame Twin Cities for finding a way to get their program on the air.
Don't get me wrong, I am looking forward to seeing what you have come up with and will probably find the documentary to be quite compelling. But it does make me wonder what all those viewers who see GSK's sponsorship will think when the series is finished. As someone who advocates a natural approach to weight loss, this is very disturbing to me.
THANK YOU again for sharing your thoughts with me.
A company called Acurian is conducting a clinical trial on cholesterol
You'll never guess what I got in the mail today. If they knew this would get into the hands of Mr. "Livin' La Vida Low-Carb" personally, then I would venture to guess it would have never been sent to my mailbox. :D Too bad for them, it was!
What is it? It's an invitation to participate in a brand new clinical trial on an "investigational medicine for high cholesterol." Yep, it a research study on yet ANOTHER drug promising to lower your cholesterol. As if we didn't have enough already with Lipitor, Crestor, Zetia, and other such medicinal nightmares! UGH!
Technically, this letter was not addressed to Jimmy Moore, but rather my wife Christine. She was recently diagnosed with high cholesterol by her doctor, including triglycerides around 300. EEEK!
I gave her the old "ya know, if you stopped eating and drinking all that sugar then your triglycerides would fall" lecture shortly thereafter. She's working on it now, but still has to make it a lifetime commitment. See, livin' la vida low-carb CAN be about health and not just weight loss!
We can only assume our doctor either gave or sold his mailing list of "high-cholesterol" patients to this place conducting the study named Acurian, a clinical trial administrative company based near Philadelphia in Horsham, Pennsylvania. Interestingly, they are headquartered very closely to just about every single one of the largest pharmaceutical companies in the world. Coincidence? Don't be a fool!
The letter itself is very limited in the information it provides about the trial itself. They are looking specifically for individuals with "high cholesterol" who are willing or have family members willing to participate.
Here's what they promise for those who do:
- Cholesterol screening and study medication at no charge - Potential compensation for your time and travel - The opportunity to help others who struggle with high cholesterol
That last one is what got me the most. How arrogant and presumptuous is it of them to ASSUME this latest drug is going to actually help people with their health, hmmm? We've been sold a sadistic bill of goods on this "great cholesterol con" as independent researcher Anthony Colpo has so succinctly put it.
Nevertheless, these pharmaceutical companies have still tried their darndest to fool people into thinking they have "high cholesterol" even when they may be perfectly fine.
This letter was actually "signed" (electronically, of course!) by someone named Dr. Christopher A. Haines, MD. I Googled Dr. Haines to see where he is from and found from this bio page about him that he is a clinical instructor in the Department of Family Medicine in the Division of Geriatric Medicine at Thomas Jefferson University Hospital located in (where else?) Philadelphia--yep, the same city where all those major pharmaceutical companies reside.
Undoubtedly, the Thomas Jefferson University Hospital is where the hundreds of clinical trials on a variety of new drugs are conducted and Dr. Haines is merely one among many involved in this process. Why would they keep all this kind of information such a secret from the recipients of this letter? It's nice to know they actually used a real person to sign the letter rather than a fake one, but it took a little digging to find out who this man actually is. Wassup with that?
Anyways, just out of curiosity, I decided to call up the toll-free telephone number that was provided about this clinical trial to see if they would give me some more information about it.
When I called 1-866-907-5526 between 8am and 10pm EST Monday through Friday, a very nice woman came on the line and asked me if I would like to sign up for the study. I told her I had a few questions about it first and if she would be willing to answer those for me. She responded in the affirmative, so I asked three questions.
1. What is your definition of "high cholesterol?"
Her answer: "A total cholesterol of over 200."
2. What is the purpose of the study? Raise HDL? Lower LDL?
Her answer: "To make both the HDL and LDL equal."
3. What is the name of the pharmaceutical company for the drug and is it a statin?
Her answer: "The identity of our client is unknown and they should be able to answer your specific questions about the investigational drug once you sign up for the study."
Fascinating! So, forget about LDL, forget about HDL, it's all about the total cholesterol (which is a big crock, especially for people following a low-carb diet!). I am somewhat interested in the idea of making HDL and LDL equal--but then I go back to the absurd "garbage trucks" analogy that low-fat diet apologist Dr. Dean Ornish likes to pull out of his hat and scratch my head on that one. Even still, reducing LDL and total cholesterol too low can be detrimental to your health as we learned in this recent study.
I thanked the very kind woman on the phone for answering my questions and she invited me to sign up for the trial online at AcurianTrials.com. Just for kicks, I went to the web site and checked it out for myself. When you enter the 866-907-5526 telephone number to access the study, you see on the screen that it is for "ACURIAN PROJECT CODE 1041 Hypercholesterolemia."
You are then asked to provide your name, address, phone numbers, e-mail address, and more so they can get back in touch with you about the study. The woman I spoke with on the telephone said you can drop out of the study at any time during the trial and you are not obligated to take any medications you don't feel comfortable taking (i.e. my concern about bone and joint-jarring statin drugs).
What do you think about this? Should I sign up for this clinical trial just to see what it's all about? Talk about the perfect topic for me to conduct an investigative journalism report on, wouldn't ya say? It could be an enlightening journey just to see what it's all about.
In fact, it doesn't even have to be me--YOU could sign up for this clinical trial if you wanted to and report back to me what you find out about it. I'd be happy to blog your experiences. Consider yourself properly deputized to carry out your duty to educate and inform the masses about this cholesterol drug that's coming down the pike! Let me know if you take me up on this so I can keep tabs with you on it.
Let's have some phrolicking phun with the pharmaceutical phools who keep peddling these crazy pills on the public just so they can fatten their wallets while sacrificing the health of those who take these dangerous drugs.
Anyone who wants to sign up for this clinical trial and willing to report on your experience can e-mail me any information you get at livinlowcarbman@charter.net. I'm not saying you need to take this drug, just find out what you can about it so all of us can learn more about it.
Do I have any takers? :)
2-14-07 UPDATE: One of my regular readers who works in the healthcare industry had something to share about my theory regarding how Acurian may have gotten Christine's name.
Hi, Jimmy!
I read the following on your blog and am concerned:
"We can only assume our doctor either gave or sold his mailing list of 'high-cholesterol' patients to this place conducting the study named Acurian, a clinical trial administrative company based near Philadelphia in Horsham, Pennsylvania."
Did Christine sign something that said her doctor could share her PHI (Protected Health Information) with a pharmaceutical company? If she did not, and if her doctor did that, he is violating the HIPAA Privacy Rule. She may wish to ask him about it. This is not a legitimate way to recruit for a drug study.
To be honest, I don't know whether she did or not. But I can't imagine how else they would know that Christine has high cholesterol if it wasn't from her doctor's office since nobody else would be privy to that information. THANKS for the heads-up about this.
2-15-07 UPDATE: Another reader schooled in the ins and outs of this issue shared his unique perspective about the legalities of how Acurian may have obtained Christine's name and address for this clinical trial.
Jimmy,
I don't know how well your other reader elaborated on the HIPPA violation but here is the website from the AMA that talks about what is or is not a violation.
I find the "coincidence" that Christine was diagnosed with "high cholesterol" and then receiving this a little too much to think that her name was not given out. This is a very big deal!!
We are trained and trained about HIPPA over and over again. If this information was given from your doctor's office, then someone there is breaking a federal law. It may not even be the doctor. It could be someone in the office who is being paid for this information.
In my position at work I fill out legal documents that go the centers for Medicare and Medicaid everyday. If I fill those out incorrectly or even willfully to make more money for my facility, I can be arrested, prosecuted and fined for fraud. Why would I do that? The answer is I wouldn't because I have a high morals and it wouldn't do anything for me financially.
This is just my opinion but I think you should talk to the doctor about it. If he is indeed foolishly risking his license, he needs to stop. Or, if someone in his office is doing this unbeknownst to him, he needs to know. I am giving him some amount of credit here because most doctors I know would not put their whole livelihood on the line for something like this.
You can tell me to butt out if you want. 8-) I just think that this needs to be nipped in the bud right away.
We may just do that today when we go see Christine's doctor for a cortisone shot in her knee. THANKS for your help!
2-15-07 UPDATE: We told our family doctor about this letter we got in the mail and he was QUITE concerned. He asked to make a copy of it and said he would try to find out how Christine's high cholesterol diagnosis got into the hands of Acurian. He said he didn't think it came from his office and that it is possible the mailing was random. But I retorted it was almost too coincidental. He agreed.
An OTC version of the weight loss drug orlistat gets FDA-approval
It wasn't a matter of if, but when.
This Washington Post story details the disappointing news that the United States government regulatory agency over approving medicines that can be sold without a prescription in this country has given its final blessing to an over-the-counter version of a prescription weight loss drug made by pharmaceutical company GlaxoSmithKline, who calls this "the only FDA-approved weight loss product available to consumers without a prescription." Yippee freakin' skippy!
You may recall last January when I blogged about the weight loss drug orlistat following an 11-2 recommendation by a group of medical "experts" who deliberated for all of one whole day about whether the risky prescription medicine Xenical should be made available in an OTC formula.
Today, the Food & Drug Adminstration (FDA) made it official and gave the rubber stamp to sell orlistat using the name "Alli." No, it's not pronounced like Muhammed Ali (AH-LEE), but rather like the word "ally" (AL-EYE) as in someone who is on your side.
The irony in that name is that the FDA is certainly no "Alli" to anyone desiring weight loss with their outlandish and irresponsible approval of this drug. They really ought to be ashamed of themselves for putting a drug like this one out there because obesity pills are just pie in the sky promises that don't deliver without a little effort on the part of the dieter. And the FDA even acknowledges that fact.
While they don't encourage children under the age of 18 take this drug (but who are we kidding? Parents will be buying this drug for their fat kids left and right!), it is absolutely open game for adults willing to combine it with a low-fat, low-calorie, portion control diet and exercise program. That's right, just in case you missed the fine print from the FDA about this latest cure-all for obesity, the dirty little secret is you STILL have to diet!
Don't even think about livin' la vida low-carb while taking the 60 mg capsules of "Alli" right before each of your three daily meals either because it only works well in people who eat little to no fat in their diet. Yep, not only do you get the unique pleasure of having most of the fat you put inside of your body sucked completely dry like a shallow river basin in 110 degree heat, but you also are FORCED to eat a low-fat diet in the process to make it work. Aren't you just so very happy about that?!
But wait, there's more!
In addition to not absorbing dietary fat (which can be dangerous on a number of levels that you don't even want me to get into!), this drug may very well prevent you from absorbing some of the most essential nutrients in the foods you eat. Therefore, they recommend you take a multivitamin before you go nighty-night sucking your thumb while holding a fuzzy wuzzy teddy bear.
Isn't this hilarious? While opponents of livin' la vida low-carb always chastise us for promoting vitamin supplementation on our very natural and healthy way of eating, here's the FDA telling people they need to eat a low-fat diet and take supplements if they decide to start using the "Alli" OTC weight loss pill. And this is the WEAK version of the drug Xenical--can you imagine what the full-strength one is like?
Like most drugs, "Alli" is not without some really nasty side effects. Try this on for size: loose stools, excess gas, fatty stools, possible uncontrollable bowel movements, flatulence with discharge, abdominal pain, and a general sense of poop-poopy-doop 24 hours a day, 7 days a week, non-stop fun between you and the porcelain goddess! Aren't you so glad you chose to lose weight this way? NOT! Sounds about as bad as the weight loss drug for dogs I blogged about last month!
Seriously, though, orlistat is NOT for everyone (I don't think it's for ANYONE, but that's just my take on it!). People who have had an organ transplant shouldn't take it because of drug interactions and neither should people on blood thinners, who are diabetic, have a thyroid problem, binge eating disorder, bulimia nervosa, or malabsorption syndromes. The FDA says people with these conditions should consult with their before using this over-the-counter drug.
Um, maybe I'm thinking too hard about this, but why make a drug OTC if there are very real dangers to a large segment of the population with all those ailments listed above? Has the FDA completely gone out of its mind here (don't answer that question because we already know the answer)?!
I'm telling you, this is a class action lawsuit just waiting to happen. The FDA has no idea what it has gotten itself into approving a drug like orlistat and making it available to anyone and everyone walking through the grocery store, Wal-mart, or drugstore. The end result will be more obesity and a lot more tummy aches.
I've said it before, but I'll say it again and again if I have to. People need to stop looking for the next great diet pill to come prancing in like Prince Charming to swoop them off their feet with promises of weight loss nirvana. Sorry to burst your fantasy everyone but it ain't gonna happen...nor should it!
Weight loss can be achieved safely and naturally without the use of ANY drugs whatsoever. Not once during my nearly 200-pound low-carb weight loss experience over these past few years have I felt compelled to add a drug, prescription or otherwise, to my diet for the purposes of aiding in my weight loss. NEVER! If I didn't trust my low-carb lifestyle to do everything I needed it to to shed the pounds and restore my health, then I'd start looking for another way to eat.
It should be quite disturbing to anyone who is eating a low-fat, low-calorie diet right now that their diet all by itself just isn't good enough to bring about weight loss and improved health. Nope, they have to have something like orlistat to be added to them in order for them to work better (although the jury is still waaaaay out on that claim!). Why put yourself through all of that?!
Come on over to livin' la vida low-carb and enjoy what REAL healthy living is like. No drugs, no forced diet plans, no disgusting foods to put up with--just delicious foods that help produce amazing positive results in your weight and health.
