I am researching my next post, so I’ll just write a blurb about a visit to GNC. It seems like this blog has become all about supplements lately, and Happyman said he thinks supplements often do make wild claims, which seems to go against the DSHEA rule I cited in my post “BLANK MD II”, which basically forbid saying they can treat or mitigate a disease, unless the FDA has stated they can.
So I went to GNC to take a look for myself at some of the labels.
Turns out this was a waste of time.
For anyone who hasn’t been to a GNC lately, here’s what I learned:
1) They have a smoothie/energy drink bar, similar to what you find in the lobby of gyms and health clubs, or a typical jamba juice. You can get all kinds of additives, and the calories are listed.
2) The owners were all Indian or Pakistani. I’m not sure if this is just in New York or everywhere, but I got the feeling they were laughing at the customers.
3) Their supplements are all GNC labeled, so there isn’t a good representative sample for supplement labels. As far as their own products go, however, their labels were very vague, and always carried the disclaimer at the bottom about how the stuff isn’t regulated, etc etc.
4) Abut 90% or more of what they sell is geared toward gigantic muscle bound gym rats. The back of the store (and front) is FILLED with huge canisters of powdered muscle “milk” with labels that have lightning bolts and lettering that looks EXTREME!!! There is also a large shelf of power bars and the like.
I think I’ll have to visit the Vitamin Store or InVite to get a better sampling. The GNC labels were very fair.
Thursday, May 31, 2007
Wednesday, May 30, 2007
HEARTBURN MD
My last post introduced what I consider an obnoxious set of products sold by a company called Iovate (whose website appears to be just their address and logo… seems like a waste) that have the names “Blank MD”, and substitute “Heartburn” or “Cholesterol” for “blank”. I described my feelings about calling the products “conditions”, rather than the supplements they contain, and using the phrase “MD” in the names, as if OTC supplements were the same as prescription medication.
So what’s in these witches’ brews? I’ll start with “Heartburn MD”. As I said in my last post, the main ingredient is Calcium Carbonate, which is fine. That’s no different than what you’ll get in Rolaids, Tums, Mylanta, Maalox, or just about any other over the counter instant relief antacid. But for you supplement-types, there’s also some “orange peel extract”.
What does “orange peel extract” do? Does it really treat reflux? Well, a Pubmed search turns up about 10 to 20 small studies on possible cancer protective effects of orange peel extract, mostly in mice and rat journals (i.e. research done on little furry mammals). However, many places on the internet claim it is good for heartburn. One page in particular caught my attention, something called “Ask the Doctor”., which is an interview with a guy named Dr. Decker Weiss who, ironically enough, is NOT a doctor. (not a medical doctor anyway, though it goes on to say he did a Cardiology residency, so, go figure). He is a “naturopath”. I’ll write about those another time.
He helpfully tells us that orange peel extract is PROVEN to reduce symptoms of acid reflux. That’s great “Doctor” Weiss. The problem is, he only cites one study, OVER AND OVER AGAIN as the “proof”. And guess what? That study is PROPRIETARY!!! So you can’t look it up anywhere. Apparently it was based on a questionnaire with NO control group. Oy vay!
On the advertisement for “Heartburn MD”, a footnote at the bottom tells us that:
“In a two phase clinical trial, subjects taking just one of the key compounds (???) of Heartburn MD reported significant relief of occasional heartburn”
Gee, want to bet that the “key ingredient” they were referring to was the CALCIUM CARBONATE??? We’ll never know, because there is no citation.
Heartburn MD also contains a delicious helping of Garcinia mangostana extract which has many reported medicinal uses. On the Asian continent, it appears to be used for dysentery, colitis, eczema, cystitis, gonorrhea… yeah, okay. I’ll take penicillin thanks. There’s some other things, extract of Ginger, caraway seeds, and pomegranate. Funny. In medical school, I don’t remember discussing the healing powers of pomegranate for reflux. Must be a conspiracy by the medical community to keep us from these powerful natural medicines.
Bottom line: buy Tums à cost on drugstore.com… 4.99.
Heartburn MD à cost on drugstore.com… 17.99
Don’t be a sucker, please. Much more to follow on this subject.
So what’s in these witches’ brews? I’ll start with “Heartburn MD”. As I said in my last post, the main ingredient is Calcium Carbonate, which is fine. That’s no different than what you’ll get in Rolaids, Tums, Mylanta, Maalox, or just about any other over the counter instant relief antacid. But for you supplement-types, there’s also some “orange peel extract”.
What does “orange peel extract” do? Does it really treat reflux? Well, a Pubmed search turns up about 10 to 20 small studies on possible cancer protective effects of orange peel extract, mostly in mice and rat journals (i.e. research done on little furry mammals). However, many places on the internet claim it is good for heartburn. One page in particular caught my attention, something called “Ask the Doctor”., which is an interview with a guy named Dr. Decker Weiss who, ironically enough, is NOT a doctor. (not a medical doctor anyway, though it goes on to say he did a Cardiology residency, so, go figure). He is a “naturopath”. I’ll write about those another time.
He helpfully tells us that orange peel extract is PROVEN to reduce symptoms of acid reflux. That’s great “Doctor” Weiss. The problem is, he only cites one study, OVER AND OVER AGAIN as the “proof”. And guess what? That study is PROPRIETARY!!! So you can’t look it up anywhere. Apparently it was based on a questionnaire with NO control group. Oy vay!
On the advertisement for “Heartburn MD”, a footnote at the bottom tells us that:
“In a two phase clinical trial, subjects taking just one of the key compounds (???) of Heartburn MD reported significant relief of occasional heartburn”
Gee, want to bet that the “key ingredient” they were referring to was the CALCIUM CARBONATE??? We’ll never know, because there is no citation.
Heartburn MD also contains a delicious helping of Garcinia mangostana extract which has many reported medicinal uses. On the Asian continent, it appears to be used for dysentery, colitis, eczema, cystitis, gonorrhea… yeah, okay. I’ll take penicillin thanks. There’s some other things, extract of Ginger, caraway seeds, and pomegranate. Funny. In medical school, I don’t remember discussing the healing powers of pomegranate for reflux. Must be a conspiracy by the medical community to keep us from these powerful natural medicines.
Bottom line: buy Tums à cost on drugstore.com… 4.99.
Heartburn MD à cost on drugstore.com… 17.99
Don’t be a sucker, please. Much more to follow on this subject.
Monday, May 28, 2007
BLANK MD II
In my last post, I opined about a print ad I saw for a line of products I call “BLANK MD”, and how I objected to the use of “MD” in the product names. But upon further reflection I realized the MAIN REASON why I find the “BLANK MD” ad campaign so objectionable.. It is not just the use of MD in the name that is obnoxious. It is the name of the products themselves that is obnoxious!
What do I mean? Well, most health food supplements are named what they are. For instance, if one went to GNC and bought a box of Gingko biloba on the recommendation of a friend or a radio show host, presumably to help memory or ward off a cold, or whatever the particular interest in the supplement, then you would simply look for a product called “Gingko biloba”. That is all well and good. And the product may make such claims.
Incidentally, supplement companies do not get a pass under DSHEA regarding labeling of their products. To quote Dr. Stephen Holt, MD, who wrote an article in 1996 on this topic in a journal I don’t read called “Alternative and Complementary Therapies”:
It is of utmost importance to note that labeling statements made under the DSHEA cannot make a claim to diagnose, mitigate, treat, cure, or prevent diseases. Only those specific claims linking a supplement to a disease state that have been preapproved by the FDA under the NLEA, such as soluble fiber and heart disease, may be made.
So the manufacturer of Gingko biloba cannot write on the label “Can cure Alzheimer’s disease”. Instead they write something like “May support mental sharpness”. In this way, we can separate medicine from supplement.
But, o-HO, Iovate, being the clever company it is, figured out a way around this problem. By calling the product a DISEASE, rather than the supplement it contains, and slapping a respectable “MD” after it, they create the appearance of a legitimate medicine, while making absolutely NO wild claims! Instead of selling a product called “Oramge peel extract” and making the claim “Believed to relieve symptoms of acid reflux”, one can just call it “Heartburn MD” and then technically need not say anything! The phrase “Joint MD” is even more vague and open to flights of imagination. They could sell Gingko biloba mixed with some other garbage and call it “Memory MD” or “Alzheimers MD”.
I find this abhorrent. They should not be allowed to sell this garbage under these names. It should be called what it is.
My next few posts will examine the supplements in question and the doctors behind them.
What do I mean? Well, most health food supplements are named what they are. For instance, if one went to GNC and bought a box of Gingko biloba on the recommendation of a friend or a radio show host, presumably to help memory or ward off a cold, or whatever the particular interest in the supplement, then you would simply look for a product called “Gingko biloba”. That is all well and good. And the product may make such claims.
Incidentally, supplement companies do not get a pass under DSHEA regarding labeling of their products. To quote Dr. Stephen Holt, MD, who wrote an article in 1996 on this topic in a journal I don’t read called “Alternative and Complementary Therapies”:
It is of utmost importance to note that labeling statements made under the DSHEA cannot make a claim to diagnose, mitigate, treat, cure, or prevent diseases. Only those specific claims linking a supplement to a disease state that have been preapproved by the FDA under the NLEA, such as soluble fiber and heart disease, may be made.
So the manufacturer of Gingko biloba cannot write on the label “Can cure Alzheimer’s disease”. Instead they write something like “May support mental sharpness”. In this way, we can separate medicine from supplement.
But, o-HO, Iovate, being the clever company it is, figured out a way around this problem. By calling the product a DISEASE, rather than the supplement it contains, and slapping a respectable “MD” after it, they create the appearance of a legitimate medicine, while making absolutely NO wild claims! Instead of selling a product called “Oramge peel extract” and making the claim “Believed to relieve symptoms of acid reflux”, one can just call it “Heartburn MD” and then technically need not say anything! The phrase “Joint MD” is even more vague and open to flights of imagination. They could sell Gingko biloba mixed with some other garbage and call it “Memory MD” or “Alzheimers MD”.
I find this abhorrent. They should not be allowed to sell this garbage under these names. It should be called what it is.
My next few posts will examine the supplements in question and the doctors behind them.
Friday, May 25, 2007
"BLANK MD"
For my first post since my long hiatus, I’d like to discuss an anger-inducing advertisement I saw in my newspaper the other day. It was the Enquirer (yes, I read the Enquirer, so sue me) magazine and it was a full page spread pushing a product line by Iovate named “blank MD”. For instance, they sell “Heartburn MD” or “Cholesterol MD”.
Many things about this ad and product line got me ANGRY!!! I’ll detail in the next few posts more details about why, but I’ll just begin with the first and most obvious… the use of the letters “MD” in the product line.
“What is so wrong with that?” you ask. Well, the ad shows a group of very friendly doctors with knowing smiles and crossed arms at the bottom of the page, and their website describes their qualifications and they do appear to be physicians (one is a DO). So they aren’t really misleading anyone, right?
I suppose not, technically. However, one must acknowledge the trend nowadays to have scientific-sounding outlets for nutty positions. For instance, the global warming “debate” has been invaded by all kinds of “journal” articles and “research” conducted by people who are no more scientists than your average “American Idol” watcher. Ditto with abortion studies that purport to show an increased risk of breast cancer or sucide risk among women who’ve had an abortion.
So my feeling here is that by invading the marketplace with “supplements” (because that’s what these products are, which I’ll detail in my next post) and putting “MD” in the name, and having a team of doctors who are actually board certified behind them, they can convince a gullible public that they are somehow equivalent to prescription medicine, which has been TESTED (most of the time).
To be fair, the “Heartburn MD” product appears to be mostly calcium carbonate, so its no different than your average pack of Rolaids. But of course its also laced with bat wings and eye of newt (an exaggeration obviously) so they have a “proprietary” product.
Whatever they need to do to make a living. In my next few posts, I’ll take a closer look at these doctors and these products.
Many things about this ad and product line got me ANGRY!!! I’ll detail in the next few posts more details about why, but I’ll just begin with the first and most obvious… the use of the letters “MD” in the product line.
“What is so wrong with that?” you ask. Well, the ad shows a group of very friendly doctors with knowing smiles and crossed arms at the bottom of the page, and their website describes their qualifications and they do appear to be physicians (one is a DO). So they aren’t really misleading anyone, right?
I suppose not, technically. However, one must acknowledge the trend nowadays to have scientific-sounding outlets for nutty positions. For instance, the global warming “debate” has been invaded by all kinds of “journal” articles and “research” conducted by people who are no more scientists than your average “American Idol” watcher. Ditto with abortion studies that purport to show an increased risk of breast cancer or sucide risk among women who’ve had an abortion.
So my feeling here is that by invading the marketplace with “supplements” (because that’s what these products are, which I’ll detail in my next post) and putting “MD” in the name, and having a team of doctors who are actually board certified behind them, they can convince a gullible public that they are somehow equivalent to prescription medicine, which has been TESTED (most of the time).
To be fair, the “Heartburn MD” product appears to be mostly calcium carbonate, so its no different than your average pack of Rolaids. But of course its also laced with bat wings and eye of newt (an exaggeration obviously) so they have a “proprietary” product.
Whatever they need to do to make a living. In my next few posts, I’ll take a closer look at these doctors and these products.
Thursday, May 17, 2007
DSHEA II
Yesterday I wrote a blog entry about the WSJ Health Blog survey which stated that a third of young doctors didn’t know about the DSHEA and the complete non-regulation of dietary supplements.
Fair enough. A patient looking for information on these supplements might be told otherwise by a well-meaning, but ill informed doctor. In fact, data regarding dietary supplements from placebo controlled trials has been lacking until recently. In other countries (like Germany, which published “The complete German Commission E monographs— therapeutic guide to herbal medicines.” In 1998) there is more data regarding these products. They take these products more seriously. The UK’s “Medicine Control Agency” in 2002 published a list of supplements it was calling “medicinal” and therefore illegal to be sold without regulation. I personally think that’s overkill.
In the U.S., the attitude taken is that these supplements are often not worth testing because:
1)The quality of the products is so variable, since there is no standardization
2)They appeal to a crowd who wouldn’t believe a negative study anyway
But, I have to say I’m seeing a lot more supplement related studies, and guess what? No surprise that all of them appear to be NEGATIVE!
Anyway, none of this has anything to do with what got me so angry. It’s this comment from Christian Goodman:
“Makes one wonder what else doctors are misleading their clients about. That’s one reason why I always say; get a second opinion.”
- Christian
I see. So because a doctor wasn’t aware of federal regulations regarding products which are essentially placebos, you deduce that doctors are “misleading” patients about other things which are more important. That makes about as much sense as saying an English teacher not knowing about what’s inside a number 2 pencil.
I also object to the word “client”, as if we were lawyers trying to sue a 7-11 for a slippery floor. We see “patients” Christain, NOT “clients”.
Why is there an incessant drumbeat of negativity about doctors and what they don’t know and won’t say? The public has no idea how much new medical information occurs EVERYDAY! Fifty years ago there were like fifty drugs. Now there are HUNDREDS, but Pharmacology is still taught in the same amount of time. Medical school is still only four years.
So forgive us doctors if we weren’t cognizant of the oversight on BOGUS NUTRITIONAL SUPPLEMENTS THAT DON’T DO ANYTHING!! I’ll just stick to learning about medicine that is actually proven to work, thank you.
Anyway, I'm off with the family on vacation for a few days. See you next week. And STAY ANGRY!!!!
Fair enough. A patient looking for information on these supplements might be told otherwise by a well-meaning, but ill informed doctor. In fact, data regarding dietary supplements from placebo controlled trials has been lacking until recently. In other countries (like Germany, which published “The complete German Commission E monographs— therapeutic guide to herbal medicines.” In 1998) there is more data regarding these products. They take these products more seriously. The UK’s “Medicine Control Agency” in 2002 published a list of supplements it was calling “medicinal” and therefore illegal to be sold without regulation. I personally think that’s overkill.
In the U.S., the attitude taken is that these supplements are often not worth testing because:
1)The quality of the products is so variable, since there is no standardization
2)They appeal to a crowd who wouldn’t believe a negative study anyway
But, I have to say I’m seeing a lot more supplement related studies, and guess what? No surprise that all of them appear to be NEGATIVE!
Anyway, none of this has anything to do with what got me so angry. It’s this comment from Christian Goodman:
“Makes one wonder what else doctors are misleading their clients about. That’s one reason why I always say; get a second opinion.”
- Christian
I see. So because a doctor wasn’t aware of federal regulations regarding products which are essentially placebos, you deduce that doctors are “misleading” patients about other things which are more important. That makes about as much sense as saying an English teacher not knowing about what’s inside a number 2 pencil.
I also object to the word “client”, as if we were lawyers trying to sue a 7-11 for a slippery floor. We see “patients” Christain, NOT “clients”.
Why is there an incessant drumbeat of negativity about doctors and what they don’t know and won’t say? The public has no idea how much new medical information occurs EVERYDAY! Fifty years ago there were like fifty drugs. Now there are HUNDREDS, but Pharmacology is still taught in the same amount of time. Medical school is still only four years.
So forgive us doctors if we weren’t cognizant of the oversight on BOGUS NUTRITIONAL SUPPLEMENTS THAT DON’T DO ANYTHING!! I’ll just stick to learning about medicine that is actually proven to work, thank you.
Anyway, I'm off with the family on vacation for a few days. See you next week. And STAY ANGRY!!!!
Wednesday, May 16, 2007
DSHEA
The Wall Street Journal Online Health Blog reported that a third of young doctors (residents and their supervisory attendings) didn’t know that herbal and dietary supplements were NOT regulated by the FDA. I am unsurprised by this. While in medical school and during residency, I don’t think anyone brought up this topic even once. In fact the only reason I know anything on the subject is because of my own curiosity. While presenting at a morning conference, I prepared a slide show about herbals, mainly so I could learn me a little something.
And do you know what I learned? Pretty much what every doctor and supplement manufacturer already knows… they DON’T WORK!!
A little background: The U.S Congress in 1994 enacted the Dietary Supplement Health and Education Act (DSHEA) of 1994, which did the following:
• Removed the FDA’s authority to regulate “dietary supplements”
• Not required to provide research or testing
• Not mandatory to provide proof of effectiveness
• Proof of safety is also not required… the FDA must prove the product is unsafe
• No standards on the accuracy and amount of information that has to be supplied on the label
Why did the Congress do this? Because if the companies who made these products had to undergo the stringent requirements that pharmaceuticals do, including safety trials, then they would have to charge a lot more for their product. Since they are now treated as “food”, they can be sold at much lower prices to a public that wants them. And I one hundred percent agree with this thinking. Because as I said above, these products DON’T DO ANYTHING!!!
How do I know they don’t do anything? Because if they DID do anything, then doctors would be using them. But every hack likes to concoct conspiracy theories, like Kevin Trudeau, a former jailbird who published “Natural Cures They Don’t Want you To Know About”. Who is THEY??? I would love to know about them.
I’ll post part II of this rant tomorrow, including the reason why this blog entry made me so ANGRY!!!.
And do you know what I learned? Pretty much what every doctor and supplement manufacturer already knows… they DON’T WORK!!
A little background: The U.S Congress in 1994 enacted the Dietary Supplement Health and Education Act (DSHEA) of 1994, which did the following:
• Removed the FDA’s authority to regulate “dietary supplements”
• Not required to provide research or testing
• Not mandatory to provide proof of effectiveness
• Proof of safety is also not required… the FDA must prove the product is unsafe
• No standards on the accuracy and amount of information that has to be supplied on the label
Why did the Congress do this? Because if the companies who made these products had to undergo the stringent requirements that pharmaceuticals do, including safety trials, then they would have to charge a lot more for their product. Since they are now treated as “food”, they can be sold at much lower prices to a public that wants them. And I one hundred percent agree with this thinking. Because as I said above, these products DON’T DO ANYTHING!!!
How do I know they don’t do anything? Because if they DID do anything, then doctors would be using them. But every hack likes to concoct conspiracy theories, like Kevin Trudeau, a former jailbird who published “Natural Cures They Don’t Want you To Know About”. Who is THEY??? I would love to know about them.
I’ll post part II of this rant tomorrow, including the reason why this blog entry made me so ANGRY!!!.
Tuesday, May 15, 2007
DIE WITHOUT DIGNITY
An interesting editorial appeared in this Sunday’s New York Times concerning end-of life decisions in New York (where I practice). I think I’ll let Eliot Spitzer sum up the current law on the subject:
…under current New York law, no one, not even a family member, has the right to decide about your medical treatment if you are unable to do so, unless you have given them the legal authority to make decisions for you or leave clear and convincing evidence of your treatment wishes. (full text and citations here)
You got that? So if you told everybody you know that you would NEVER want to be hooked up to machines, and then you are hit by a car and become comatose, you WILL BE hooked up to machines! Period! And nobody CARES that everyone overheard you say this over and over.
“Oh, but you should have signed a health care proxy.” Yeah, well, that isn’t reality. I’m 35 and I have never thought about doing that. AND I’M A DOCTOR!
This situation in New York is different than many other states. So why would a forward-thinking state like New York, home to a great metropolis, be so backward on their thinking here? (Here’s a clue… most of the New York State Senate are Republicans.)
A bill floating in the Senate right now, the Family Healthcare Decisions Act, championed by Eliot Spitzer, could put decisions back into the hands of family members, but as the New York Times tells us “Semate Republicans are worried about same sex partners being named surrogates. Abortion rights activists are worried about pregnant comatose patients.” Preganant comatose patients? Are you kidding me??? How many of those could there be??? Is that a good reason to block the ENTIRE legislation?
Being a physician who has attended to so many situations where patients’ wishes are not fully known, and all kinds of ethical dilemmas occur (including conflicts of interest among family members), it would be nice to eliminate ONE of the obstacles. I hope the Senate can finally put aside stone-age thinking and face the reality of end-of-life decision-making… it ain’t pretty.
…under current New York law, no one, not even a family member, has the right to decide about your medical treatment if you are unable to do so, unless you have given them the legal authority to make decisions for you or leave clear and convincing evidence of your treatment wishes. (full text and citations here)
You got that? So if you told everybody you know that you would NEVER want to be hooked up to machines, and then you are hit by a car and become comatose, you WILL BE hooked up to machines! Period! And nobody CARES that everyone overheard you say this over and over.
“Oh, but you should have signed a health care proxy.” Yeah, well, that isn’t reality. I’m 35 and I have never thought about doing that. AND I’M A DOCTOR!
This situation in New York is different than many other states. So why would a forward-thinking state like New York, home to a great metropolis, be so backward on their thinking here? (Here’s a clue… most of the New York State Senate are Republicans.)
A bill floating in the Senate right now, the Family Healthcare Decisions Act, championed by Eliot Spitzer, could put decisions back into the hands of family members, but as the New York Times tells us “Semate Republicans are worried about same sex partners being named surrogates. Abortion rights activists are worried about pregnant comatose patients.” Preganant comatose patients? Are you kidding me??? How many of those could there be??? Is that a good reason to block the ENTIRE legislation?
Being a physician who has attended to so many situations where patients’ wishes are not fully known, and all kinds of ethical dilemmas occur (including conflicts of interest among family members), it would be nice to eliminate ONE of the obstacles. I hope the Senate can finally put aside stone-age thinking and face the reality of end-of-life decision-making… it ain’t pretty.
Monday, May 14, 2007
FAIT ACCOMPLIA
On the Wall Street Journal Health Blog, a March 27th entry talked about some of the problems for Sanofi Aventis’ hotly-awaited blockbuster obesity drug Accomplia…oh, I’m sorry, now its being called “Zimulti” (apparently, “accomplia’ was too suggestive???) Unfortunately, it also makes you a little too aggressive. I guess the FDA isn’t so quick to pull the trigger after recent developments.
So while overweight people everywhere salivate over the promise of “exercise in a pill”, comments like this appear:
“I am so disappointed. I have struggled with weight problems all of my adult life, and I have been waiting for this drug to become available in the USA for two years. I wish all the people at the FDA would gain 100 pounds apiece overnight. Then, maybe they could have some sympathy for those of us who need help in shedding pounds. If a doctor prescribes it, he/she should follow up with the patient to see if they have unpleasant side effects. Why keep it from all the others who need it? “
Comment by Mary - March 29, 2007 at 2:43 pm
Yes, your doctor will surely follow up. And if anything goes wrong… then he can go DOWN!!! After all, your safety watchdog shouldn’t keep honest, hard-working Americans from the drugs that are RIGHTFULLY THEIRS!!! It’s everyone’s right to have all the drugs they want, right?
Someone tell that to the guys who convicted Dr. William Hurwitz who was convicted of drug trafficking in an Alexandria, VA court.
Please! Doctors are on the hook for everything. We are supposed to be able to predict which side effect you get. We are supposed to recognize every side effect. We are supposed to predict who will have an allergic response to a drug, even if they have no history of allergies. We are supposed to predict who will take a drug, and who will sell it on the street. Since when did doctors become DEA agents??? Now this moronic woman wants doctors to run their own individual safety studies.
I’m sure she’d be willing to sign something that says “If I die or have some other horrible side effect, I and my family agree not to sue my doctor” And guess what? If she did sign it…they’d STILL sue! Because their douchebag lawyers would argue that it was signed “under duress”. It’s a no-win situation, and the brilliant (and obviously overweight) scribe quoted above just doesn’t get that.
So while overweight people everywhere salivate over the promise of “exercise in a pill”, comments like this appear:
“I am so disappointed. I have struggled with weight problems all of my adult life, and I have been waiting for this drug to become available in the USA for two years. I wish all the people at the FDA would gain 100 pounds apiece overnight. Then, maybe they could have some sympathy for those of us who need help in shedding pounds. If a doctor prescribes it, he/she should follow up with the patient to see if they have unpleasant side effects. Why keep it from all the others who need it? “
Comment by Mary - March 29, 2007 at 2:43 pm
Yes, your doctor will surely follow up. And if anything goes wrong… then he can go DOWN!!! After all, your safety watchdog shouldn’t keep honest, hard-working Americans from the drugs that are RIGHTFULLY THEIRS!!! It’s everyone’s right to have all the drugs they want, right?
Someone tell that to the guys who convicted Dr. William Hurwitz who was convicted of drug trafficking in an Alexandria, VA court.
Please! Doctors are on the hook for everything. We are supposed to be able to predict which side effect you get. We are supposed to recognize every side effect. We are supposed to predict who will have an allergic response to a drug, even if they have no history of allergies. We are supposed to predict who will take a drug, and who will sell it on the street. Since when did doctors become DEA agents??? Now this moronic woman wants doctors to run their own individual safety studies.
I’m sure she’d be willing to sign something that says “If I die or have some other horrible side effect, I and my family agree not to sue my doctor” And guess what? If she did sign it…they’d STILL sue! Because their douchebag lawyers would argue that it was signed “under duress”. It’s a no-win situation, and the brilliant (and obviously overweight) scribe quoted above just doesn’t get that.
Friday, May 11, 2007
BOGUS BONIVA
I was at a shocking dinner for Boniva the other night. Obviously the dinner was meant to coincide with the study in NEJM about Zometa (don’t forgot about your old friend Boniva). The talk was given by a reproductive endocrinologist who sounded very smart. I was accidentally learning all kinds of things that night. She forgot that we went there to eat a free steak, NOT listen to a lecture.
But I guess the biggest eye opener came near the end of the talk when she talked about the non-inferiority study (I want to write about those soon) that gave Roche and GSK the bonanza they so desperately wanted. Apparently she was one of the principle investigators for the study (gee, what a surprise) and she was describing a funny thing that happened during enrollment.
But first I should probably remind everyone (in case you forgot, and how could you with news being on EVERY FREAKIN RADIO AND TV SHOW) that bisphosphonates might cause osteonecrosis of the jaw, and that part of the reason stopping it before dental procedures does no good is that it hangs out in your bones for freakin TEN YEARS!!!
OK, so back to the story. The lecturer states that the women being enrolled were excluded if they had previously taken other bisphosphonates (for the reason cited above). So one patient is enrolled, she swears up and down she has never taken a bisphosphonate. And so everything seems hunky dory. Now part of the process involves routine review of any prior lab tests, for instance bloodwork, bone mineral density tests, etc. etc.
So our hero is flipping through these old results and finds an old BMD result. Everything looks cool, except… WAIT! As she scans the result, she sees the clinical history that was given “Elderly female, rule out osteoporosis, on Fosamax…” HUH?
Did she just read that right? “ON FOSAMAX”!!!
OK. So even though this enrollee swore up and down she never took a bisphosphoante before, and even though she’s already passed the screening process, we discover she should have been excluded… and COMPLETELY BY ACCIDENT! And obviously, the next question is… how many MORE of these forgetful women made it into the study???
Well, I asked the lecturer this very question, with what most likely was a very shocked look on my face. She just nodded and accepted that “yeah, it’s a problem.” Audible laughter went up from those assembled.
I’m speechless.
So, to summarize, you can’t believe any studies from drug companies. I know, it goes without saying. Just more evidence. And this Boniva study is more tainted than the scallions at Taco Bell.
But I guess the biggest eye opener came near the end of the talk when she talked about the non-inferiority study (I want to write about those soon) that gave Roche and GSK the bonanza they so desperately wanted. Apparently she was one of the principle investigators for the study (gee, what a surprise) and she was describing a funny thing that happened during enrollment.
But first I should probably remind everyone (in case you forgot, and how could you with news being on EVERY FREAKIN RADIO AND TV SHOW) that bisphosphonates might cause osteonecrosis of the jaw, and that part of the reason stopping it before dental procedures does no good is that it hangs out in your bones for freakin TEN YEARS!!!
OK, so back to the story. The lecturer states that the women being enrolled were excluded if they had previously taken other bisphosphonates (for the reason cited above). So one patient is enrolled, she swears up and down she has never taken a bisphosphonate. And so everything seems hunky dory. Now part of the process involves routine review of any prior lab tests, for instance bloodwork, bone mineral density tests, etc. etc.
So our hero is flipping through these old results and finds an old BMD result. Everything looks cool, except… WAIT! As she scans the result, she sees the clinical history that was given “Elderly female, rule out osteoporosis, on Fosamax…” HUH?
Did she just read that right? “ON FOSAMAX”!!!
OK. So even though this enrollee swore up and down she never took a bisphosphoante before, and even though she’s already passed the screening process, we discover she should have been excluded… and COMPLETELY BY ACCIDENT! And obviously, the next question is… how many MORE of these forgetful women made it into the study???
Well, I asked the lecturer this very question, with what most likely was a very shocked look on my face. She just nodded and accepted that “yeah, it’s a problem.” Audible laughter went up from those assembled.
I’m speechless.
So, to summarize, you can’t believe any studies from drug companies. I know, it goes without saying. Just more evidence. And this Boniva study is more tainted than the scallions at Taco Bell.
Thursday, May 10, 2007
DUNCAN HUNTER
I don’t want to discuss politics on this page because I don’t feel that has a lot to do with why I am blogging.
But may I just identify a disturbing item relating to last weeks’ Republican Presidential Debate. I specifically want to mention a quote made by Duncan Hunter. Who is Duncan Hunter you ask? He’s the congressional representative from San Diego, CA. He is a Vietnam veteran who served his country in the 173rd airborne. He also, apparently, is a douchebag.
Why do I say this? Well, it has nothing to do with his great initiatives, including his idea that somehow a big “fence” can keep out Mexican immigrants, or that abortion is a no-no against human life. No, I don’t want to discuss these things.
I do want to discuss his response to Chris Matthews’ question about having a Clinton in the White House again. Here’s his response:
HUNTER: You know, Bill Clinton cut the U.S. army by almost 50 percent. In this war against terror, he's the wrong guy to have in there. And incidentally, on the Schiavo case, you know, Ronald Reagan said, on the question of life, "When there's a question, err on the side of life." I think Congress did the right thing.
This is an unambiguous statement. He is basically saying “Despite what doctors think about brain death, and even though we were clearly wrong when we intervened on the Schiavo case, (which we know after autopsy which proved her brain was a soupy mess) Congress should make decisions regarding end of life issues, because as we all know, Congress is all-wise and all-knowing about everything”
Is this what doctors have to choose between? Either Democrats who want universal health care, or Republicans who want to control doctors’ decision making? Talk about a rock and a hard place.
But may I just identify a disturbing item relating to last weeks’ Republican Presidential Debate. I specifically want to mention a quote made by Duncan Hunter. Who is Duncan Hunter you ask? He’s the congressional representative from San Diego, CA. He is a Vietnam veteran who served his country in the 173rd airborne. He also, apparently, is a douchebag.
Why do I say this? Well, it has nothing to do with his great initiatives, including his idea that somehow a big “fence” can keep out Mexican immigrants, or that abortion is a no-no against human life. No, I don’t want to discuss these things.
I do want to discuss his response to Chris Matthews’ question about having a Clinton in the White House again. Here’s his response:
HUNTER: You know, Bill Clinton cut the U.S. army by almost 50 percent. In this war against terror, he's the wrong guy to have in there. And incidentally, on the Schiavo case, you know, Ronald Reagan said, on the question of life, "When there's a question, err on the side of life." I think Congress did the right thing.
This is an unambiguous statement. He is basically saying “Despite what doctors think about brain death, and even though we were clearly wrong when we intervened on the Schiavo case, (which we know after autopsy which proved her brain was a soupy mess) Congress should make decisions regarding end of life issues, because as we all know, Congress is all-wise and all-knowing about everything”
Is this what doctors have to choose between? Either Democrats who want universal health care, or Republicans who want to control doctors’ decision making? Talk about a rock and a hard place.
Wednesday, May 9, 2007
DAN-ACTIVE REDUX
I just want to make a few last comments regarding the DAn-Active commercial I've been discussing over the last few days, which, by the way, you can watch here.
One aspect is the initial statement about "stress". There is NO evidence that Dan Active decreases stress effects on the immune system. And they never visit this topic on their website. So I'm not sure why they even mention this fact at the beginning of the commercial.
Secondly, they say that "70% of your immune system is in your GI tract". Even if this is true, that doesn't mean that your GI tract is primarily responsible for the health of your immune system. The GI tract is HUGE, so naturally you would have a lot of immune cells there. Their implication is that this is where our immune system mostly "hangs out".
Finally, they claim it can give your immune system a "boost". I don't know if its just me, but the takeaway message appears to be that you can down some of this stuff, and then just inhale all the virions you want, and this will somehow reduce the chance of infection, which is bogus.
Also, they don't mention the sugar content, which is probably rotting their kids' teeth. Its flavored with some sweet strawberry crud.
I think the FCC needs to regulate these commercials better, especially if they're going to hawk this stuff as medicinal.
One aspect is the initial statement about "stress". There is NO evidence that Dan Active decreases stress effects on the immune system. And they never visit this topic on their website. So I'm not sure why they even mention this fact at the beginning of the commercial.
Secondly, they say that "70% of your immune system is in your GI tract". Even if this is true, that doesn't mean that your GI tract is primarily responsible for the health of your immune system. The GI tract is HUGE, so naturally you would have a lot of immune cells there. Their implication is that this is where our immune system mostly "hangs out".
Finally, they claim it can give your immune system a "boost". I don't know if its just me, but the takeaway message appears to be that you can down some of this stuff, and then just inhale all the virions you want, and this will somehow reduce the chance of infection, which is bogus.
Also, they don't mention the sugar content, which is probably rotting their kids' teeth. Its flavored with some sweet strawberry crud.
I think the FCC needs to regulate these commercials better, especially if they're going to hawk this stuff as medicinal.
Tuesday, May 8, 2007
DAN-ACTIVE III
In my first post, I described a sickening commercial airing on your evening news promoting the “immune boost” you can get from Danactive.
Next, I quoted their studies, to give a sense of how meager their effects really are (though not strictly ‘lying).
Here I offer some interesting studies about probiotics that I think are real benefits. A great number of studies on L. reuteri are grouped on a nice page here.
In Mexico City, a place where diarrhea is just expected, they performed a randomized, placebo-controlled trial for 4 months of 250 infants and found that the ones drinking milk spiked with L. reuteri had significantly less episodes of community acquired diarrhea. (76% vs 64%).
Another tasty experiment involved giving women intravaginal and perineal L. casei strain GR 1 who had frequent UTI. Apparently, they had increased infection free periods, and they didn’t have to take antibiotics. Unfortunately, they couldn’t just drink it (if you know what I mean), but they didn’t suffer any yeast infections, which is a known side effect of antibiotics.
One of the more intriguing studies of probiotics is the possibility of reducing the incidence of atopic disease by exposing young children to the Lactobacillus rhamnosus GG strain. They fed it to mothers prenatally and to the infants 6 months postnatally, and there was a significant risk reduction (almost 50%) in the incidence of atopic eczema.
So why doesn’t Dannon mention these studies? Because their strain (L. casei DN 114001) isn’t proven to do any of these things. And you can buy any of the known products at a health food store.
The take home message is that the immune boost advertised on their commercial is extremely misleading (so what else is new) and even more disturbing is their lack of supporting data on their website. Before you decide to start pouring this down your kids’ throats for YEARS to shorten their diarrheal episodes by one or two days, check out this page. Their list of strains is more reliable. It's only 2.29 for a four pack, but check out this page for a quote you wont believe, that just proves my point:
The drink contains the active culture L. Casei, which is supposed to provide balance in your digestive tract and strengthen your immune system. That caught my attention, because my younger son had been battling a mild flu-like virus for several days and I felt his symptoms starting. I drank DanActive for four successive days. After the second day all my viral symptoms went away. My poor son had suffered for a week. I’m not sure if DanActive was responsible for my quick recovery, but it sure didn’t hurt.
Next, I quoted their studies, to give a sense of how meager their effects really are (though not strictly ‘lying).
Here I offer some interesting studies about probiotics that I think are real benefits. A great number of studies on L. reuteri are grouped on a nice page here.
In Mexico City, a place where diarrhea is just expected, they performed a randomized, placebo-controlled trial for 4 months of 250 infants and found that the ones drinking milk spiked with L. reuteri had significantly less episodes of community acquired diarrhea. (76% vs 64%).
Another tasty experiment involved giving women intravaginal and perineal L. casei strain GR 1 who had frequent UTI. Apparently, they had increased infection free periods, and they didn’t have to take antibiotics. Unfortunately, they couldn’t just drink it (if you know what I mean), but they didn’t suffer any yeast infections, which is a known side effect of antibiotics.
One of the more intriguing studies of probiotics is the possibility of reducing the incidence of atopic disease by exposing young children to the Lactobacillus rhamnosus GG strain. They fed it to mothers prenatally and to the infants 6 months postnatally, and there was a significant risk reduction (almost 50%) in the incidence of atopic eczema.
So why doesn’t Dannon mention these studies? Because their strain (L. casei DN 114001) isn’t proven to do any of these things. And you can buy any of the known products at a health food store.
The take home message is that the immune boost advertised on their commercial is extremely misleading (so what else is new) and even more disturbing is their lack of supporting data on their website. Before you decide to start pouring this down your kids’ throats for YEARS to shorten their diarrheal episodes by one or two days, check out this page. Their list of strains is more reliable. It's only 2.29 for a four pack, but check out this page for a quote you wont believe, that just proves my point:
The drink contains the active culture L. Casei, which is supposed to provide balance in your digestive tract and strengthen your immune system. That caught my attention, because my younger son had been battling a mild flu-like virus for several days and I felt his symptoms starting. I drank DanActive for four successive days. After the second day all my viral symptoms went away. My poor son had suffered for a week. I’m not sure if DanActive was responsible for my quick recovery, but it sure didn’t hurt.
Unreal!
Friday, May 4, 2007
DANACTIVE II
Happyman asked for the link to Dannon’s cited studies. I’ll discuss each one below in turn. They also link to a page called the scientific summary where you can read about cellular permeability and other esoteric effects that don’t seem to be clinical.
The first study cited is a British study looking at about 1,000 babies aged 6 to 24 months and the incidence of self limited diarrheal illness (you know it’s a British study, because they spell it “diarrhoea”) in babies randomized to either standard yogurt and the Lactobacillus casei yogurt. The study lasted four months. Well, it didn’t decrease the number of diarrheal episodes, but it did decrease the duration by about 4 days.
The next study is from Spain. 136 university students randomized to receive either a glass of skim milk a day or milk spiked with this Lactobacillus frappe. They wanted to see if they could attenuate the known decline in lymphocytes from stress prior to exams, and thereby reduce anxiety. (I wish they had looked at exam performance). Well, there was no difference in anxiety, but there was a difference in lymphocyte count, as well as the amount of CD56, which the DAnnon website tells us is “one of the most important cells for the defense system of our body” (???). Not too impressive methinks.
Next they cite a British study looking at 360 elderly people to see if yogurt spiked milk could reduce diarrheal illness in the elderly. Oops, it didn’t reduce the number of diarrheal illnesses. But it did cut the duration from about 9 days to about 7. (Are any of these studies done in the U.S.? I guess because the DAnnon center is in Italy, Europe gets all the free spiked milk).
I’m not going to even bother looking at their last quoted study because the claim is only that the decrease in NK cells during exercise is less in those drinking their spiked cultures. What an accomplishment! Nowhere do any of these citations point to any improved outcomes.
Does that mean there is nothing to the claims about the benefits of this “probiotic”? I’ll quote you some studies tomorrow that might show some benefits. However, I just want to take this opportunity to point out that it isn’t as relevant to point out the limited benefits of this product, as it is to identify how misleading their advertising is.
The problem is the assumption people will make about the immune system they are referring to. People hear that phrase and think “the common cold” or other respiratory and bodily infections. That’s the conclusion they want you to reach. Ridiculous. What is the FCC thinking letting them run this commercial?
The first study cited is a British study looking at about 1,000 babies aged 6 to 24 months and the incidence of self limited diarrheal illness (you know it’s a British study, because they spell it “diarrhoea”) in babies randomized to either standard yogurt and the Lactobacillus casei yogurt. The study lasted four months. Well, it didn’t decrease the number of diarrheal episodes, but it did decrease the duration by about 4 days.
The next study is from Spain. 136 university students randomized to receive either a glass of skim milk a day or milk spiked with this Lactobacillus frappe. They wanted to see if they could attenuate the known decline in lymphocytes from stress prior to exams, and thereby reduce anxiety. (I wish they had looked at exam performance). Well, there was no difference in anxiety, but there was a difference in lymphocyte count, as well as the amount of CD56, which the DAnnon website tells us is “one of the most important cells for the defense system of our body” (???). Not too impressive methinks.
Next they cite a British study looking at 360 elderly people to see if yogurt spiked milk could reduce diarrheal illness in the elderly. Oops, it didn’t reduce the number of diarrheal illnesses. But it did cut the duration from about 9 days to about 7. (Are any of these studies done in the U.S.? I guess because the DAnnon center is in Italy, Europe gets all the free spiked milk).
I’m not going to even bother looking at their last quoted study because the claim is only that the decrease in NK cells during exercise is less in those drinking their spiked cultures. What an accomplishment! Nowhere do any of these citations point to any improved outcomes.
Does that mean there is nothing to the claims about the benefits of this “probiotic”? I’ll quote you some studies tomorrow that might show some benefits. However, I just want to take this opportunity to point out that it isn’t as relevant to point out the limited benefits of this product, as it is to identify how misleading their advertising is.
The problem is the assumption people will make about the immune system they are referring to. People hear that phrase and think “the common cold” or other respiratory and bodily infections. That’s the conclusion they want you to reach. Ridiculous. What is the FCC thinking letting them run this commercial?
Thursday, May 3, 2007
DAN-ACTIVE
I wanted to write a post about the number of drug and drug industry-related ads you see on TV, and I do want to talk about direct-to-consumer advertising and what isn’t being done about it.
But then I saw a commercial and I just feel compelled to write about it. It was for Dannon Yogurt’s product “DanActive”. This commercial is hilarious. It starts out with a family sitting around a table and the father is reading the newspaper. He suddenly announces a startling factoid in the newspaper: “It says here that stress….(LONG PAUSE)…can weaken our immune system!” (Cue scary music).
Well, GAWWWWWLLL-LEE! Thanks for telling me Gomer Pyle. I can see being compelled to tell my whole family this incredibly shocking bit of news. I’m sure nobody ever noticed that you tend to get sick when you're under a lot of stress and feeling run down. I’m so riveted at this point, I keep watching with bated breath.
Then their seventeen year old daughter announces knowingly from the refrigerator “Annnnd… about 70% of our our imuuuune (she drags out the word, as if to say ‘Dad, you are such a dummy. Everyone knows this’) system is in our digestive tract.” And just in case you can’t hear her, this sentence is planted along the bottom of the screen. AND just in case you didn’t see THAT, a huge number “70%” graphic appears on the screen along the left. I’m so glad a teenager is up on current medical knowledge. Heck, I didn’t even know that and I’m an internist. She also gives her father a bit of a seductive look. Left me a little disturbed, I have to say.
Then the father helpfully offers this information, glancing back at his newspaper: “Apparently, a culture called L. casei immunitas (rhymes with ‘gravitas’, I guess) can help. It’s clinically proven to help strengthen your body’s defense system.” The paper breaks away to an impressive animated sequence of purple thingies being magnetized or something. I’m not quite sure.
The rest of the commercial is not very interesting, and at the end the graphic reads “DAnActive! Help strengthen your body’s defenses”
Wow! I’m no longer sure if they are trying to sell me food… or medicine! What about their claims? Does DAnActive indeed strengthen your immune system, as the narrator and play actors suggest? Can I get a boost? Can I counteract the stress effect on that 70% of my GI tract?
I visited the website and perused some of their citations and I’m not too impressed. I’ll speak more about it tomorrow, but I wouldn’t start downing a ton of DAnActive at the first sign of a cold.
But then I saw a commercial and I just feel compelled to write about it. It was for Dannon Yogurt’s product “DanActive”. This commercial is hilarious. It starts out with a family sitting around a table and the father is reading the newspaper. He suddenly announces a startling factoid in the newspaper: “It says here that stress….(LONG PAUSE)…can weaken our immune system!” (Cue scary music).
Well, GAWWWWWLLL-LEE! Thanks for telling me Gomer Pyle. I can see being compelled to tell my whole family this incredibly shocking bit of news. I’m sure nobody ever noticed that you tend to get sick when you're under a lot of stress and feeling run down. I’m so riveted at this point, I keep watching with bated breath.
Then their seventeen year old daughter announces knowingly from the refrigerator “Annnnd… about 70% of our our imuuuune (she drags out the word, as if to say ‘Dad, you are such a dummy. Everyone knows this’) system is in our digestive tract.” And just in case you can’t hear her, this sentence is planted along the bottom of the screen. AND just in case you didn’t see THAT, a huge number “70%” graphic appears on the screen along the left. I’m so glad a teenager is up on current medical knowledge. Heck, I didn’t even know that and I’m an internist. She also gives her father a bit of a seductive look. Left me a little disturbed, I have to say.
Then the father helpfully offers this information, glancing back at his newspaper: “Apparently, a culture called L. casei immunitas (rhymes with ‘gravitas’, I guess) can help. It’s clinically proven to help strengthen your body’s defense system.” The paper breaks away to an impressive animated sequence of purple thingies being magnetized or something. I’m not quite sure.
The rest of the commercial is not very interesting, and at the end the graphic reads “DAnActive! Help strengthen your body’s defenses”
Wow! I’m no longer sure if they are trying to sell me food… or medicine! What about their claims? Does DAnActive indeed strengthen your immune system, as the narrator and play actors suggest? Can I get a boost? Can I counteract the stress effect on that 70% of my GI tract?
I visited the website and perused some of their citations and I’m not too impressed. I’ll speak more about it tomorrow, but I wouldn’t start downing a ton of DAnActive at the first sign of a cold.
Tuesday, May 1, 2007
UNSAFE DISCHARGE
I work in a nursing home and a patient who was admitted after a hospitalization for alcohol withdrawal is apparently being considered for discharge. However, he is not participating well in his rehab, and the physical therapists are writing that he is “unsteady” and “at high risk of falls”.
Fine. So they are looking to me to discharge him and I’m like “PT is writing that this guy isn’t steady and you want me to just sign off on his discharge?” The head of PT insists this is fine, and that “It’s up to the doctor to discharge”. Right in front of a family member. Thanks a lot for selling me out.
I can just see what will happen. He goes home, falls, hits his head, is found days later in a coma. Then I’m dragged into court with some lowlife attorney saying “Well, YOU’RE the doctor, YOU should have known it wasn’t safe to send this man home.” None of these ancillary staff people can understand this level of liability. At a “multidisciplinary meeting” (similar to having root canal, but no anesthesia) I ask “Do you have a med alert bracelet”? Get this: the patient doesn’t even have a PHONE! And I’m the only one who asked this. The social worker didn’t know.
I just hate this trend where doctors have become social workers. Even in the office, you have to consider not just the treatment, but the COST of the drug. You don’t just consider the test, but which LAB you have to send the patient so their insurance will cover the test. This is not what I was trained to do, and I don’t understand how medical doctors became responsible for so many of these issues. No wonder we don’t have time to keep up on new developments or talk with the patient.
Fine. So they are looking to me to discharge him and I’m like “PT is writing that this guy isn’t steady and you want me to just sign off on his discharge?” The head of PT insists this is fine, and that “It’s up to the doctor to discharge”. Right in front of a family member. Thanks a lot for selling me out.
I can just see what will happen. He goes home, falls, hits his head, is found days later in a coma. Then I’m dragged into court with some lowlife attorney saying “Well, YOU’RE the doctor, YOU should have known it wasn’t safe to send this man home.” None of these ancillary staff people can understand this level of liability. At a “multidisciplinary meeting” (similar to having root canal, but no anesthesia) I ask “Do you have a med alert bracelet”? Get this: the patient doesn’t even have a PHONE! And I’m the only one who asked this. The social worker didn’t know.
I just hate this trend where doctors have become social workers. Even in the office, you have to consider not just the treatment, but the COST of the drug. You don’t just consider the test, but which LAB you have to send the patient so their insurance will cover the test. This is not what I was trained to do, and I don’t understand how medical doctors became responsible for so many of these issues. No wonder we don’t have time to keep up on new developments or talk with the patient.
Monday, April 30, 2007
PDUFA
In future posts I will detail more about the history of the FDA and its makeup, but I want to comment on the recent illuminating editorials published in this week’s NEJM.
Let me say first that I am not a Communist and I am not a believer that government can fix all of society’s ills. I like freedom in general and am not a fan of too much government interference.
Except in areas where an industry cannot police itself. For instance, it’s pretty clear after Enron and all of the post dating options scandals that Wall Street cannot police itself. Obviously they need MORE regulation, NOT less.
Well, when it comes to the drug approval process, I guess you could say it’s an argument between freedom to have access to drugs, and restriction in the name of public safety. It was an environment of lawlessness depicted in books like Upton Sinclair’s “The Jungle” that led to President Theodore Roosevelt signing the Wiley Act in 1906, which created the agency that eventually became known as the FDA. The need to prevent interstate adulteration of foods and drugs was rampant. The industry needed POLICING!
Fast forward to 1992, and things are a lot better. But the FDA is understaffed. Their budget is not large enough. Congress can only appropriate 125 million dollars for their “Drug Regulation and Safety” division, not nearly enough resources to adequately study all the new drug applications. Also, AIDS activists are demonstrating in Washington because they want access to new, potentially life-saving medicines, and the understaffed, under funded FDA is taking too long to approve these drugs. Whatever can be done to resolve this crisis.
Well, our 102nd Congress had an idea (majority of Senate were Democrats, by the way). They passed the Prescription Drug User Fee Act, or PDUFA. (I like to call it “P-douche-A). Thanks to this bit of legislation, the pharmaceutical industry would now be PAYING THE SALARIES OF FDA EMPLOYEES!! Let’s repeat that: the very industry that the FDA would be policing, was PAYING THEIR SALARIES! If anyone thinks this is a good idea, after this whole Ketek debacle, then I must be on the wrong planet. The act has a lifespan of five years and we’re currently on PDUFA III. But here’s what is key: even though we now know the FDA is in a sorry state in light of these troubling reports, Congress is going to do… NOTHING! In fact, according to the editorial, it looks like reapproval is a done deal once the act expires on September 30th. They love the idea of all that free money from the “user fees” (read: Pharma grift). But guess what? That money isn’t free.
I’ll talk more about PDUFA in future posts.
Let me say first that I am not a Communist and I am not a believer that government can fix all of society’s ills. I like freedom in general and am not a fan of too much government interference.
Except in areas where an industry cannot police itself. For instance, it’s pretty clear after Enron and all of the post dating options scandals that Wall Street cannot police itself. Obviously they need MORE regulation, NOT less.
Well, when it comes to the drug approval process, I guess you could say it’s an argument between freedom to have access to drugs, and restriction in the name of public safety. It was an environment of lawlessness depicted in books like Upton Sinclair’s “The Jungle” that led to President Theodore Roosevelt signing the Wiley Act in 1906, which created the agency that eventually became known as the FDA. The need to prevent interstate adulteration of foods and drugs was rampant. The industry needed POLICING!
Fast forward to 1992, and things are a lot better. But the FDA is understaffed. Their budget is not large enough. Congress can only appropriate 125 million dollars for their “Drug Regulation and Safety” division, not nearly enough resources to adequately study all the new drug applications. Also, AIDS activists are demonstrating in Washington because they want access to new, potentially life-saving medicines, and the understaffed, under funded FDA is taking too long to approve these drugs. Whatever can be done to resolve this crisis.
Well, our 102nd Congress had an idea (majority of Senate were Democrats, by the way). They passed the Prescription Drug User Fee Act, or PDUFA. (I like to call it “P-douche-A). Thanks to this bit of legislation, the pharmaceutical industry would now be PAYING THE SALARIES OF FDA EMPLOYEES!! Let’s repeat that: the very industry that the FDA would be policing, was PAYING THEIR SALARIES! If anyone thinks this is a good idea, after this whole Ketek debacle, then I must be on the wrong planet. The act has a lifespan of five years and we’re currently on PDUFA III. But here’s what is key: even though we now know the FDA is in a sorry state in light of these troubling reports, Congress is going to do… NOTHING! In fact, according to the editorial, it looks like reapproval is a done deal once the act expires on September 30th. They love the idea of all that free money from the “user fees” (read: Pharma grift). But guess what? That money isn’t free.
I’ll talk more about PDUFA in future posts.
Friday, April 27, 2007
MORE FDA NONSENSE
As a follow up to my original post about the FDA approval of Ketek, I did myself a favor and listened to the 16 minute interview Dr. David Ross gave to Rachel Gotbaum on the NEJM website. My goodness, this man deserves a medal of freedom way more than Wolfowitz and Tenet.
I plan to talk more about the FDA in future posts (its becoming my personal mission), but I just want to highlight some of the things Ross said in this interview.
Apparently, the fraud that occurred with Sanofi Aventis’ safety study (you know, the one where the top enroller is in a federal prison, and the second top enroller…is ALSO going to prison)… the company KNEW ABOUT IT and DIDN’T TELL ANYONE!!! What the f&%$!!! Is anyone going to jail for this? When confronted, they basically said “We’re sorry, and we promise we won’t do it anymore.” And the FDA claims in their letter to the Journal they only had “preliminary” evidence that fraud occurred at the approval committees. But, GUESS WHAT??? Dr. Ross says that that’s a bunch of BULLS%^&$!!! They knew the whole time!
In January of this year, the FDA wisely withdrew the indications of AECB and acute sinusitis from the Ketek label because “the risks outweigh the benefits”. Thank goodness they realized it after three long years. BUT WAIT…Dr. Ross told them exactly that…IN 2003!!!!! When he presented his opinion, he was told by his manager to “soften” up his report.
Why would his manager ask such a thing, the interviewer posits. And that’s when Dr. Ross issues my favorite phrase of the interview. He says that as of 10 years ago, the FDA’s mission has changed, and now there is… are you ready?... a “culture of approval”! Yes, that’s what we need at the nation’s safety-in-drugs watchdog.. a culture of approval.
The interview is a tour-de-force. I was speechless. He never mentions von Eschenbech, or any top person at the FDA by name because he is obviously too much of a gentleman or statesman. But one cannot deny that based on this report, the FDA are:
1)liars
2)greedy
3)lazy
4)EVIL!
Why do I say “evil”? Well, I don’t know what else to call approving a shoddy drug that led to 4 people dying of liver failure and dozens of others getting liver toxicity NEEDLESSLY!! This wasn’t like they made a medical mistake. They KNOWINGLY approved a drug based on flawed safety data made by a company who covered up the fraud.
As Neil Rogers would say “UN-believable!”
I plan to talk more about the FDA in future posts (its becoming my personal mission), but I just want to highlight some of the things Ross said in this interview.
Apparently, the fraud that occurred with Sanofi Aventis’ safety study (you know, the one where the top enroller is in a federal prison, and the second top enroller…is ALSO going to prison)… the company KNEW ABOUT IT and DIDN’T TELL ANYONE!!! What the f&%$!!! Is anyone going to jail for this? When confronted, they basically said “We’re sorry, and we promise we won’t do it anymore.” And the FDA claims in their letter to the Journal they only had “preliminary” evidence that fraud occurred at the approval committees. But, GUESS WHAT??? Dr. Ross says that that’s a bunch of BULLS%^&$!!! They knew the whole time!
In January of this year, the FDA wisely withdrew the indications of AECB and acute sinusitis from the Ketek label because “the risks outweigh the benefits”. Thank goodness they realized it after three long years. BUT WAIT…Dr. Ross told them exactly that…IN 2003!!!!! When he presented his opinion, he was told by his manager to “soften” up his report.
Why would his manager ask such a thing, the interviewer posits. And that’s when Dr. Ross issues my favorite phrase of the interview. He says that as of 10 years ago, the FDA’s mission has changed, and now there is… are you ready?... a “culture of approval”! Yes, that’s what we need at the nation’s safety-in-drugs watchdog.. a culture of approval.
The interview is a tour-de-force. I was speechless. He never mentions von Eschenbech, or any top person at the FDA by name because he is obviously too much of a gentleman or statesman. But one cannot deny that based on this report, the FDA are:
1)liars
2)greedy
3)lazy
4)EVIL!
Why do I say “evil”? Well, I don’t know what else to call approving a shoddy drug that led to 4 people dying of liver failure and dozens of others getting liver toxicity NEEDLESSLY!! This wasn’t like they made a medical mistake. They KNOWINGLY approved a drug based on flawed safety data made by a company who covered up the fraud.
As Neil Rogers would say “UN-believable!”
Thursday, April 26, 2007
ASK YOUR DOCTOR ABOUT....
When I was a little kid, I saw an episode of 20/20 where they did an expose on doctors who had defaulted on their student loans. (I think it was John Stossel). And they followed some doctors to their front door and asked why they were such deadbeats! Now, I grant you, defaulting on a student loan isn’t a stand up thing to do. But let’s put this in perspective: According to the Health and Human Services website (click here), approximately 150 million dollars in HEAL loans (now discontinued) is still owed by professionals, and guess how much of that is from allopathic doctors…19 million! So 90% of these defaulted HEAL loans is owed from non-physicians. The New York Times doesn't highlight this, as the title of this article from 1981 clearly indictaes who their beef is with. “Those deadbeat doctors” they scolded.
I mention this, not to talk about the student loans racket (we can take that up another day), but to give you an idea about how doctors are generally portrayed in the media, and how the media can make it more difficult for doctors to practice medicine. A recent article appeared in the Archives of Internal Medicine examining the effects of aspirin on mortality in women, and looked specifically at the effects on cardiovascular disease and cancer. I can’t link to the article, but the conclusion was that there was a 43% reduction in the risk of mortality from cardiovascular disease with the use of aspirin! That’s great! The Associated Press started their press release thusly:
Aspirin in low to moderate doses may lower the risk of death in women, particularly those who are older and prone to heart disease, a 24-year study of nearly 80,000 women suggests
Fantastic! Oh, but wait, this result disagrees directly with FIVE other good studies that said there is NO benefit for women from aspirin for cardiovascular disease. What gives? The AP doesn’t really specify. They do say this:
However, experts cautioned that the results are not definitive and that women should not take aspirin as a health preventive without talking to their doctor.
Nice! They manage to weasel out of it by putting it on the doctor to sort out the confusion. Thank you, o’ glorious AP! I guess they didn’t want to enter into a boring discussion about why observational studies aren’t so good, and how superior, placebo-controlled trials like the Woman’s Health Study are often more conservative in their findings, but also more reliable. No, why bother. Let’s just let a patient read this item, then he can scratch his head, and inundate his doctor with a bunch of conflicting advice. Or, maybe the patient will just throw up his hands and say “Gee, the doctors can’t even agree with themselves. So screw it. They probably don’t even know what they’re doing.”
Why did the Associated Press even write this piece? It doesn’t change the current thinking that aspirin does not prevent primary coronary disease in women and this information only confuses patients. The reason is the AP has to write articles for junk newspapers so we all have something to read on the subway.
This is just one example of studies published in the mainstream press, with no responsibility taken by the media for the disinformation that can spread. Some might argue that a well-informed patient is a better off one. That may be true. But with limited expertise, this knowledge can hamper patient care, as illustrated above. Also, the public doesn’t realize that one study alone proves nothing! Because the mainstream media don’t want to mention this uninteresting fact!
Please, a plea from me to the media: STOP making things worse!!! Leave the conclusions and the education of patients to scientists and doctors.
I mention this, not to talk about the student loans racket (we can take that up another day), but to give you an idea about how doctors are generally portrayed in the media, and how the media can make it more difficult for doctors to practice medicine. A recent article appeared in the Archives of Internal Medicine examining the effects of aspirin on mortality in women, and looked specifically at the effects on cardiovascular disease and cancer. I can’t link to the article, but the conclusion was that there was a 43% reduction in the risk of mortality from cardiovascular disease with the use of aspirin! That’s great! The Associated Press started their press release thusly:
Aspirin in low to moderate doses may lower the risk of death in women, particularly those who are older and prone to heart disease, a 24-year study of nearly 80,000 women suggests
Fantastic! Oh, but wait, this result disagrees directly with FIVE other good studies that said there is NO benefit for women from aspirin for cardiovascular disease. What gives? The AP doesn’t really specify. They do say this:
However, experts cautioned that the results are not definitive and that women should not take aspirin as a health preventive without talking to their doctor.
Nice! They manage to weasel out of it by putting it on the doctor to sort out the confusion. Thank you, o’ glorious AP! I guess they didn’t want to enter into a boring discussion about why observational studies aren’t so good, and how superior, placebo-controlled trials like the Woman’s Health Study are often more conservative in their findings, but also more reliable. No, why bother. Let’s just let a patient read this item, then he can scratch his head, and inundate his doctor with a bunch of conflicting advice. Or, maybe the patient will just throw up his hands and say “Gee, the doctors can’t even agree with themselves. So screw it. They probably don’t even know what they’re doing.”
Why did the Associated Press even write this piece? It doesn’t change the current thinking that aspirin does not prevent primary coronary disease in women and this information only confuses patients. The reason is the AP has to write articles for junk newspapers so we all have something to read on the subway.
This is just one example of studies published in the mainstream press, with no responsibility taken by the media for the disinformation that can spread. Some might argue that a well-informed patient is a better off one. That may be true. But with limited expertise, this knowledge can hamper patient care, as illustrated above. Also, the public doesn’t realize that one study alone proves nothing! Because the mainstream media don’t want to mention this uninteresting fact!
Please, a plea from me to the media: STOP making things worse!!! Leave the conclusions and the education of patients to scientists and doctors.
Wednesday, April 25, 2007
FOCUS!
Just thought I’d share a recent bizarre experience.
I was invited by a company called Schlesinger Associates to participate in some kind of focus group or something, for which they would pay me 175 bucks (pre tax). In retrospect, it wasn’t enough, but anyway, I went to the address sometime in the afternoon. It was being held at an advertising firm in midtown, near the Manhattan Mall. I was led through a labyrinth of cubicles and was thanking GOD I don’t work in one of those.
I was placed in a medium sized boardroom by an unattractive young woman. It was just me and her, so I got nervous. Then I was told we were being filmed and there people in the NEXT ROOM watching me and my responses. Can you say “interrogation”?
Ostensibly, I knew the topic was vaccines, but because I’m not in an office setting (yet), I’ve never met the vaccine reps of any company. So I get questions like this:
“When you think of Merck vaccines, what animal do you think of and why?”
Huh?
I had no idea what to say. I mean NONE! So I think I just said “leopard”. Leopard?? HAH!
Then she asked what animal do I think of when I think of Sanofi Aventis vaccines.
Oh jeez. I think I said “Owl”. They are very wise, aren’t they???
Then I was shown three plasterboards full of pictures that appear to have been taken in the 70’s, and asked which three pictures reminded me the most of the vaccine division of Merck. I don’t know about you, but I usually do NOT think of ANYTHING when I think of a vaccine maker.
I spent about thirty minutes making up a bunch of crap, was asked to fill out some paperwork, was handed an envelope filled with cash, and I booked it OUT of there.
So this is one of the places the $9 billion spent by the pharmaceutical companies per year on advertising goes: paying advertising firms to ask doctors what kind of animal Merck reminds them of. Ridiculous.
Tomorrow I’ll speak about how the media hurts doctors and practicing medicine.
I was invited by a company called Schlesinger Associates to participate in some kind of focus group or something, for which they would pay me 175 bucks (pre tax). In retrospect, it wasn’t enough, but anyway, I went to the address sometime in the afternoon. It was being held at an advertising firm in midtown, near the Manhattan Mall. I was led through a labyrinth of cubicles and was thanking GOD I don’t work in one of those.
I was placed in a medium sized boardroom by an unattractive young woman. It was just me and her, so I got nervous. Then I was told we were being filmed and there people in the NEXT ROOM watching me and my responses. Can you say “interrogation”?
Ostensibly, I knew the topic was vaccines, but because I’m not in an office setting (yet), I’ve never met the vaccine reps of any company. So I get questions like this:
“When you think of Merck vaccines, what animal do you think of and why?”
Huh?
I had no idea what to say. I mean NONE! So I think I just said “leopard”. Leopard?? HAH!
Then she asked what animal do I think of when I think of Sanofi Aventis vaccines.
Oh jeez. I think I said “Owl”. They are very wise, aren’t they???
Then I was shown three plasterboards full of pictures that appear to have been taken in the 70’s, and asked which three pictures reminded me the most of the vaccine division of Merck. I don’t know about you, but I usually do NOT think of ANYTHING when I think of a vaccine maker.
I spent about thirty minutes making up a bunch of crap, was asked to fill out some paperwork, was handed an envelope filled with cash, and I booked it OUT of there.
So this is one of the places the $9 billion spent by the pharmaceutical companies per year on advertising goes: paying advertising firms to ask doctors what kind of animal Merck reminds them of. Ridiculous.
Tomorrow I’ll speak about how the media hurts doctors and practicing medicine.
Tuesday, April 24, 2007
Acu-PUNK-ture
While the Journal of the American Medical Association has lost tons of credibility over the last few years, it is still cited and sought-after by many doctors looking to get published, is quoted in the news, and is widely read. So it is very anger-inducing to see them pander to the lowest rung of society…those who believe in homeopathy/quackery.
Their “Clinical Crossroads” section in this weeks’ issue is especially ulcer-inciting. The mere title alone gives me dyspepsia “A 60 year old woman Considering Acupuncture for knee pain”. If the article was simply two lines that said “Acupuncture is bogus and a waste of money. No doctor should recommend it” I might have enjoyed the article and even applauded the authors of JAMA.
However, instead I find the following disturbing comments. I’ll just list two of my “favorites”.First, and I cannot explain what possible reason they could have for doing this, they actually have the patient describe their scenario. (In this case, an active 60-ish female with knee pain).And I’m not just talking about describing their symptoms. She tells a classroom of eager medical students the following blather:
“I think there is a placebo effect and I think its curious. But that doesn’t
bother me. That doesn’t mean it doesn’t work. I think the process of our
brains is so interesting, and I don’t get it at all. But I’m okay with
that. If somebody told me it was just a “placebo effect” – fine.”
I see. She doesn’t understand the “brain process”, but she finds it so interesting. Why are we quoting this genius who hasn’t practiced medicine one day in her life and apparently is so stupid, even though she accepts it could all be a placebo effect, she’s STILL willing to pay for something she KNOWS is bogus? (I didn’t include the previous paragraph, where she complains about how much the sessions cost, and that you have to have a lot of them to achieve success… gee, doesn’t that sound an awful lot like a SCAM???) I can’t believe the editors printed this crap. And listen to Dr. Brian Berman pander to this class of rejects. Here’s a brilliant quote:
" To deal with the pain, Mrs. A emphasized that she felt it
important for physicians to take a holistic approach, with
emphasis on the mind-body interconnection. I agree with her. "
I added the boldface for emphasis. This jackass just sold out every allopathic doctor who stands against quackery. He probably sells growth hormone and does that cartilage removal procedure that was discredited years ago. (click here). These people should burn in hell.
Their “Clinical Crossroads” section in this weeks’ issue is especially ulcer-inciting. The mere title alone gives me dyspepsia “A 60 year old woman Considering Acupuncture for knee pain”. If the article was simply two lines that said “Acupuncture is bogus and a waste of money. No doctor should recommend it” I might have enjoyed the article and even applauded the authors of JAMA.
However, instead I find the following disturbing comments. I’ll just list two of my “favorites”.First, and I cannot explain what possible reason they could have for doing this, they actually have the patient describe their scenario. (In this case, an active 60-ish female with knee pain).And I’m not just talking about describing their symptoms. She tells a classroom of eager medical students the following blather:
“I think there is a placebo effect and I think its curious. But that doesn’t
bother me. That doesn’t mean it doesn’t work. I think the process of our
brains is so interesting, and I don’t get it at all. But I’m okay with
that. If somebody told me it was just a “placebo effect” – fine.”
I see. She doesn’t understand the “brain process”, but she finds it so interesting. Why are we quoting this genius who hasn’t practiced medicine one day in her life and apparently is so stupid, even though she accepts it could all be a placebo effect, she’s STILL willing to pay for something she KNOWS is bogus? (I didn’t include the previous paragraph, where she complains about how much the sessions cost, and that you have to have a lot of them to achieve success… gee, doesn’t that sound an awful lot like a SCAM???) I can’t believe the editors printed this crap. And listen to Dr. Brian Berman pander to this class of rejects. Here’s a brilliant quote:
" To deal with the pain, Mrs. A emphasized that she felt it
important for physicians to take a holistic approach, with
emphasis on the mind-body interconnection. I agree with her. "
I added the boldface for emphasis. This jackass just sold out every allopathic doctor who stands against quackery. He probably sells growth hormone and does that cartilage removal procedure that was discredited years ago. (click here). These people should burn in hell.
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