NOVEMBER 20, 2008
BAD BABY! TAKE YOUR RESPIRDAL!
After
posting about the increase in psychotropic drug use in children and commenting that
doctors should stop giving antipsychotics to children without schizophrenia
I got some
words of praise from Philip Dawdy at Furious Seasons and some
interesting information from
Lisa Van Syckel who gave me a list of ages and drugs given to kids in NJ which I found shocking, as well as data on
antipsychotic drug sales to kids in NJ. Here are some examples of kids given antipsychotics in NJ:
-
A months old infant on chloral hydrate (sleeping pill).
-
A two year old on Strattera (ADHD psychotropic drug).
-
A three year old on methylin (methylphenidate, or Ritalin, a stimulant ADHD drug)
-
A four year old on Concerta (extended release methylphenidate for ADHD)
-
A two year old and a three year old on Risperdal (risperadone)
-
A three year old on Adderall (amphetamine salts)
-
A two year old on Ativan (lorazepam) (sedative, sleeping pill)
-
A three year old on Ritalin
-
A three year old on Focalin (dexmethylphenidate, ADHD stimulant drug)
-
A four year old on Zyprexa (olanzapine)
-
A three year old on Paxil (paroxetine)
-
A three year old on Seroquel (quetiapine)
-
An infant on Valium (diazepam)
-
A four year old on Ambien (sleeping pill)
-
A four year old on Prozac (fluoxetine)
Meanwhile sales of antipsychotic drugs to children continues to climb (data from NJ)
Shocking!
Come on guys! Here is some more free continuous medical education (CME) that is not funded by pharma!
Babies don't sleep through the night but they don't need a pill! Toddlers have tantrums but don't have bipolar disorder in need of
antipsychotic drugs! It doesn't matter if three year olds don't concentrate because they aren't in school
anyway and they don't need ADHD drugs! Three year olds don't develop "major depression!"
Stay tuned for more CME.
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NOVEMBER 19, 2008
FIRST THEY'RE DRUGGING OUR DRINKING WATER, NOW OUR KIDS? WHAT NEXT?
It's bad enough that they are
drugging our drinking water but now I guess they are afraid that our kids are going to be drinking out of mud puddles
instead of the faucet or toilet so now they are giving their drugs directly to our kids in the form of a prescription.
An article in the NY Times
today by Gardiner Harris described the findings of an FDA outside expert advisory panel that concluded that antipsychotic
(or neuroleptic) medications are being given too often to children. 389,000 children were treated last year with Risperdal alone, many of them for ADHD.
This is in spite of the fact that neuroleptic medications like
Risperdal (risperidone) and Zyprexa (olanzapine) are not approved for the treatment of Attention Deficit Hyperactivity Disorder
(ADHD). The use of these
drugs has increased five fold in the past decade and a half.
We also have the specter of two year olds being diagnosed with bipolar disorder and treated with these medications.
Well I have already given you my opinion about the diagnosis of bi-polar disorder (caption reads "What are you so upset about?
I told you I was bi-polar.")
The committee said they were "frustrated" and that a stronger label warning was needed because of the risks of diabetes,
obesity, and tardive dyskinesai. But the FDA basically shrugged their shoulders and said that the problem lies with the prescribing doctors and that the
medical societies need to do more education.
I would have to agree with
other writers on the topic that a medical culture of overuse of these medications and underemphasis of risk is largely to blame
for the problem.
OK, here's your education
Stop giving antipsychotics to kids who don't have the diagnosis of childhood schizophrenia.
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NOVEMBER 12, 2008
REMIND ME WHY I SHOULD BE ON PLAVIX?
A
study of 16,690-persons whose results were released today by Medco Health Solutions found that patients taking Plavix (clopidogrel) with a
proton pump inhibitor (PPI) like Nexium or Prilosec have a 50% increase in risk of major cardiovascular event and 74% increase in heart attacks
compared to people taking Plavix alone. Since Plavix is given to prevent heart attacks as an expensive alternative to aspirin, it
seems these people are losing their benefit.
Where does that leave us? Well since about half of plavix users are on Nexium or another PPI to prevent stomach bleeding,
we have to ask what is the benefit of Plavix for these people? So what has the data been for Plavix in the prevention of
cardiovascular events been up to now.
In the CAPRIE study Plavix treated patients showed an 5.32% annual rate of a composite measure of stroke, heart attack, or vascular death,
compared with 5.83% on aspirin treated patients, a difference that was barely statistically significant (CAPRIE 1996).
In the CHARISMA trial of patients with heart disease or risk factors for heart disease there was no significant difference
between those who were given clopidogrel plus aspirin or aspirin alone in the combined incidence of heart attack, stroke, or
death from cardiovascular causes (Bhatt, Fox et al. 2006). In the CLOpidogrel and Metoprolol Infarction Trial (COMMIT) 45852
patients with a heart attack within the past 24 hours were given clopidogrel or placebo in addition to aspirin. Clopidogrel patients
had a 9% reduction in a combined measure of death, heart attack or stroke, a difference that was statistically significant (COMMIT 2006).
An analysis of all of the published studies showed a 10% reduction in heart attacks and strokes in patients with a history of
cardiovascular disease when clopidogrel was added to aspirin (ATC 2002). These differences, however, translate into a less than 1% reduction in absolute risk.
In the Management of ATherothrombosis with Clopidogrel in High-risk patients (MATCH)(Diener, Bogousslavsky et al. 2004) study 7599
patients with recent stroke or TIA with one other risk factor for heart disease were randomly assigned to receive clopidogrel or
clopidogrel plus aspirin. There was no difference in rates of combined stroke, heart attack, or hospitalization between clopidogrel
(17%) and clopidogrel plus aspirin (16%); a 1.3% increase in bleeding was not statistically significant. In a study of 320 patients
who had developed a bleeding ulcer while taking aspirin to prevent heart disease, after the patients’ ulcers healed they were randomized
for a year to re-treatment with aspirin or clopidogrel. All of them also received esomeprazole. The patients who took clopidogrel had
more gastrointestinal bleeding (8.6%) than aspirin patients (0.7%), a difference that is striking (Chan, Ching et al. 2005).
It looks like with these new study results it looks like whatever meagre advantage Plavix has over aspirin are more than
offset in people on Nexium as well. It is hard to see what role Plavix has now in heart attack prevention relative to the cheaper aspirin.
ATC (2002). "Antithrombotic Trialists' Collaboration: Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients." British Medical Journal 324: 71-86.
Bhatt, D., K. A. a. Fox, et al. (2006). "Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events." New England Journal of Medicine 354: 1706-1717.
CAPRIE (1996). "A randomised, blinded trial of Clopidogrel versus Aspirin in Patients At Risk of Ischaemic Events (CAPRIE)." The Lancet 348(9038): 1329-1339.
Chan, F. K. L., J. Y. L. Ching, et al. (2005). "Clopidogrel versus aspirin and esomeprazole to prevent recurrent ulcer bleeding." New England Journal of Medicine 352(3): 238-244.
COMMIT (2006). "Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial." The Lancet 366: 1607-1621.
Diener, H.-C., J. Bogousslavsky, et al. (2004). "Aspirin and clopidogrel compared with clopidogrel alone after recent ischaemic stroke or transient ischaemic attack in high-risk patients (MATCH): randomised, double-blind, placebo-controlled trial." The Lancet 364: 331-337.
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NOVEMBER 11, 2008
WILL YOU BE MY FRIEND?
OK, enough of gods, goddesses, cardiologists and the beings that they impregnate. Those cardiologists will
never listen to me any way. Soon everyone over 50 will be on a statin! Anyway, back to the humble
world of emotion, psychiatry, and the question of...
...will you be my friend?
That's right, folks, facebook time. And blogging. Front and center.
I had a story about the 'will you be my friend' quote but it isn't appropriate for public consumption.
Anyhoo, you know what I am talking about. Using your mouse to point your cursor at someone's name on Facebook and
then waiting for their response, and then...
...voila! You have a new friend!
[heart goes pitter patter, etc]
I have become 'friends' with people I have never met, who 'friended' me
because they read my book, and then 'introduced' me to others who had written books on similar topics, or had similar views, or were liberals like me,
and I became 'friends' to them site unseen.
I found the exchange all quite exhilarating, liking being at a fancy ball. It didn't matter much to me that I
had never met them. I just liked reading their posts, causes, status updates. And for old college friends
and the like the where are you now stuff is kind of interesting.
My fellow shrinks blogging on
ShrinkRap have written about the psychological meaning of
facebook.
I agree with them that you should not "friend" your patient, your doctor, your children or your parents. You can, however, friend nieces and nephews, siblings, spouses, old schoolmates, and (disagreeing with them, I feel that if you want you can friend) people you have never met but who share similar interests.
As I wrote on their site, facebook is a way for vapid narcissists (such as myself) to form weak relationships with others through the internet. In my "book" it is fine to friend people you don't know who share a similar interest, in my case health and drug news.
However, I have attempted to 'friend' others who had similar interests, who responded:
Hi Doug, Have we actually ever met?
To which I had to reply in the negative, although I said I had read his writing, and sent him a link to my blog, which he never responded to, which left me with a feeling of...
sadness... [head down, sniff]... emptiness (especially since Mrs. Bremner is away at the AHA this week)
Which leads me to the next topic, being 'out there' on the internet.
A friend of mine was sending some of my post to a yahoo group and so I joined, not knowing anything about these groups.
And then when I quoted some of the things they were saying someone said they felt 'violated' because these comments were not for
public discussion. She informed me that the 'rules' were that comments in the 'group' were private.
I realized I really knew nothing of these 'groups' or whether the comments were public or private. I needed Emily Post for the internet.
Here is another example. In my initial enthusiam for my blog when I got copied on emails for health related things I would
put people on my email list. I posted that they should say 'unsubscribe' if they wanted off. But I have since learned that some people think that is
a violation to have to say 'unsubscribe'. So I no longer put people on my list unless they ask. Now I have figured out RSS feed (say Dinosaur, Duh!) people can choose for themselves.
And if you want to get off of this list say *unsubscribe* or f**k off!
Or, if you don't take me off of this list I will blog about you! (real comment)
Ciao.
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NOVEMBER 10, 2008
JUPITER IS NOT LIKELY TO TURN ON APHRODITE
Mrs. Bremner [DOCTOR BREMNER to YOU guys!] is attending the Annual Meeting of the American Heart Association
this week in New Orleans and texted me some news about the release today of results from the
JUPITeR study
("Justification for the Use of statins in Prevention: an Intervention Trial evaluating Rosuvastatin (JUPITeR)")
published in the New England Journal of Medicine
.
(gasp), Oh really. I think this one would definitely not have been a turn on for
Aphrodite.
Ha, ha.
Based on the results of this study, that a biomarker of heart disease, C-reactive Protein (CRP), predicts response
to the drug Crestor (rosuvastatin) (and not just total cholesterol or LDL cholesterol), the authors of this
study would apparently like us to come to the conclusion that, basically, all of us should
be on a statin medication for the prevention of heart disease. In fact, I can already hear the shills and the
media saying "revolutionary" and "likely to change practice"! In fact there is even a cheesy site on the New England's
website asking us how it will change our practices (gasp, shame).
We've been through this drill before, when our country's "leading" cardiologists informed us that statins were so great that they should be
put in the drinking water.
But now, let us turn our attention to the results of the JUPITeR trial.
17,802 healthy men and women with LDL cholesterol of less than 130 mg per deciliter and
CRPs of greater than 2.0 mg per liter were given either rosuvastatin 20 mg per day or placebo. They were
then followed for the occurrence of the "combined primary endpoint" of heart attack, stroked,
arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes.
First of all, whenever doctors start combining real disease outcomes (like dying of a heart attack) with what
are primarily... er... inconveniences, like going to the hospital, you have to start wondering about the study.
OK. So what about the results, you say. I am going to ignore their cheesy primary endpoint and look
at what to me matters, which is heart attacks. There was a difference of 0.2% per year in heart attacks between the two groups,
which would have amounted to a 1% difference over five years if the study had continued for that long, but the
study committee cheerfully "stopped" the study after 1.9 years since they thought things were going so well
that it would be "unethical" to continue the study (Hooray!).
I guess that 1% of responders outweighs the 3% or so that will develop liver toxicity or muscle damage.
Study results that will change clinical practice, indeed.
BTW, look at the end of the article
for the long list of consulting agreements to the pharmaceutical industry engaged in by the authors of the study.
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NOVEMBER 8, 2008
DEAR DOCTOR, CIPRO, AVELOX AND LEVAQUIN CAN MAKE YOUR TENDONS SNAP OFF
That's a translation into person speak from a letter I got today from Bayer Healthcare
Pharmaceuticals that started out with "Dear Healthcare Professional" and went on to their new
"black box warning" for their antibiotic drugs Avelox (moxifloxacin hydrochloride) and Cipro
(ciprofloxacin). Here is their warning:
Fluoroquinolones, including Avelox/Cipro, are associated with an increased
risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients
usually over 60 years of age, in patients taking corticosteroid drugs, and in patients
with kidney, heart or lung transplants.
Well it's about time. I wrote about this nasty habit of cipro to snap tendons and
mess up joints over a year ago in my
book because at the time
Cipro was the most poorly rated drug on
askthepatient.com.
I hate to say I told you so, but, I did tell you so. It's just too bad that it took the
manufacturers a couple of years to get the word out. I wish people in the healthcare
industry would read these website, which patients go to only out of desperation.
Unfortunately,
81% of the time this toxic drug, Cipro is prescribed inappropriately,
and
32% of women get this drug inappropriately for new onset urinary tract infections,
when the preferred first drug is Septra.
Another drup in the same class as Cipro is Levaquin, which is the third most discussed drug on
medications.com, just behind my other two
faves,
Yasmin (the birth control pill that might make you nuts) and
Singulair (asthma drug with similar problems). Levaquin and like drugs also seems to drive people nuts,
which reinforces my conclusion that when it comes to drug companies,
if they don't kill you they might drive you crazy.
So let's all sing "I need a drug that won't drive me crazy" to the tune of
I need a lover that won't drive me crazy," by John Cougar Mellencamp.
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NOVEMBER 7, 2008
OUR PRESIDENT'S [SECRET] PARTING GIFT TO CORPORATIONS: A GET OUT OF JAIL FREE CARD
President George Bush's lasting legacy may very well be a revamping of the judicial system.
Our country is based on a balance of the judicial, executive, and legislative branches of the
government, and an appropriate balance between the power of the states and the federal government.
However, in a bizarre subversion of the supposed aims of the Republican party to diminish the
role of the federal government in everyday lives, the Bush administration over the past
eight years has carried on a secret campaign to take away individual liberties and build
a Big Brother type of government which controls everything. This includes things like the
Patriot Act, but more subtley in a pay-back to the corporations that got him elected,
he has worked to give corporations a get out of jail free card in the form of immunity from prosecution.
As described in a recent
report prepared by the American Association for Justice,
based on Freedom of Information Act requests for correspondence within multiple US agencies
that regulate everything from prescription medications to automobiles, there has been a systematic
effort to insert language into the rules written by these regulatory bodies to remove
corporations from liability for the products that these federal agencies cover. The report states:
This language
would effectively block all product liability lawsuits from being adjudicated and would let corporations "get out of
jail free" even when their products seriously injure or even kill Americans.
I have been primarily interested in how this plays out in the field of prescription medications,
where the FDA has been pushing the concept of
preemption, which means that citizens can't sue a drug company in state courts if a drug has
been approved by the FDA, since the federal government "preempts" state law.
This concept is a misinterpretation of the law and represents an attempt to eviscerate one of
the three branches of our government, the judicial. Considering how the executive branch has ignored
the legislative (not responding to subpoenas etc) I guess they would prefer a fascist-style dictatorship.
And you may think you don't have to worry because of the recent election results but the placement of like-minded individuals in the
judicial branch from the Supreme Court on down is a lasting legacy that we will have to deal with for
years to come. The current case of
Wyeth v Levine
before the Supreme Court will represent the first ruling on preemption related to prescription drugs.
Emails contained in the report document how agencies within the federal government have corresponded
with one another to promote this concept. To give one example, Dan Troy, ex chief counsel for the FDA,
had bona fide credentials as member of the American Enterprise Institute and other conservative
organizations, and made over $100,000 per year consulting to the drug maker Pfizer. He was given
his pick of where to go in the new Bush administration and chose to go to the FDA where he was
effectively the leader since there was no permanent Director. As documented in the AAJ report, in the two year period he was there
he met 129 times with representatives of the pharmaceutical industry [his predecessor met with
them once] before he eventually
resigned under
a growing cloud related to his promotion of pharma. While at the FDA he told representatives
of pharma that they should "give a Hollywood pitch" to the FDA to get them to file friends of the
court briefs on behalf of drug companies being sued for toxic side effects of their drugs under
the rationale that if the FDA approved it, they had an interest in seeing that no liability
was found.
Troy eventually concluded that filing all those briefs took too much time, so he
came up with the language of preemption, and the administration worked to stack the courts in favor
of this bogus idea, and the rest is history (e.g Wyeth v Levine).
It will probably take legislation to undo this crime, that is if the legislative branch still exists.
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NOVEMBER 6, 2008
WOW! A DRUG THAT WILL LET ME HAVE SEX ONCE MORE A MONTH? SIGN ME UP!
I don't care if it may give me breast cancer or heart disease. Thanks, APHRODITE Study Team!!
APHRODITE Study Team? ROTFL!!
I SWEAR TO GOD I am NOT making up this goofy study name.
I wonder if the study investigators ever got horny at one of their research meetings? Or by looking at their data?
Anyway, seriously folks. The results of the
"A Phase III Research Study of Female Sexual Dysfunction in Women on
Testosterone Patch without Estrogen (APHRODITE)" study published in the NEJM today showed that if
post-menopausal women who have a loss of libido put a testosterone patch on their arms that
they will have satisfying sex once a month more than they are currently having, although there
may be a risk of breast cancer or cardiovascular disease
[read on]
I've got a tip for the marketers of this testosterone patch. If the women are
having satisfying sex only once a month, and now they have it twice, why don't you
say that the drug results in a 100% increase in satisfying sex!!!
Ha ha ha ha ha!
OK folks all fun aside lets look at the data. In this
study Davis et al
(Davis SR et al NEJM 2008; 359(19): 2005-2017. November 6 2008) studied
814 women treated for 52 weeks with 300 or 150 microgram testosterone patches or placebo patches.
There was an increase in "satisfying sexual episodes" of 2.1 in treated versus 0.7
for placebo, an increase that was statistically significant.
There was about a 10% difference in scores on a sexual pleasure scale.
30% grew unwanted hair v 23% for placebo. Breast cancer was diagnosed
in 4 out of 527 treated women and in none of the women on placebo.
That's right folks, sex once a month. And possible risk of getting breast cancer.
And a beard.
Nonconclusive results about cancer you say. And Mrs Robinson asks if she has anything to worry about.
Well a recent
study by
Tamimi et al (J Natl Cancer Inst 2007; 99(15): 1178-1187) found that women who naturally had the highest
testosterone levels (top 25%) had a two fold increase in breast cancer compared to women in the lowest 25%.
And another
study by Maturana et al (Metabolism, 2008; 567 (7):961-965) found that
postmenopausal women with elevated testosterone had increases in markers of inflammation and endothelial dysfunction, C-reactive protein (CRP) and endothelin,
that have been associated with increased risk of atherosclerosis.
And let's not forget the increased risk of heart disease and cancer associated with hormone replacement therapy (HRT)
which I have written about before, and testosterone has to have a suspicion of similar risk.
The authors of the current study point to the fact that about a third of post-menopausal
women have sexual dysfunction, and imply that even the meager gain they eak out with their
patch is worth it in terms of keeping their mans happy. However they need to provide evidence
for their implied claim that libido is killed by menopause and that women need to use
a hormonal patch for that. They seem to hark back to the physician author of Feminine Forever,
who implied that menopause was a disease to be treated with HRT, and that women became old crones,
wrinkled and ugly, nasty, and incapable of sex, and that they needed HRT to treat this malady.
Well I won't belabor that now, and you can follow the links on this web site if you want to learn
more about HRT, but I can tell you that controlled studies show it has no effect on libido,
and only increases risk of cancer and heart disease. So there.
The authors imply that menopause is associated with an inevitable decline in libido
for women, and that they need to take a drug to correct that. But I am not aware of
any literature to support this conclusion, and if anyone has something, let me know.
I mean, Mrs. Bremner seems to be doing OK so far.
As far as I know these testosterone patches are approved for hypogonadism in men with low
testosterone, but are widely used off label for loss of libido in men and women.
The APHRODITE study results may be used to promote off label use of the patches. Stay tuned.
The FDA posted some slides on this topic
here.
Thanks to Marilyn Mann for sending me articles and comments on this topic.
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NOVEMBER 6, 2008
ABILIFY ME TO HELP ME FIND THE USEFULNESS OF THIS DRUG FOR DEPRESSION
Bristol Myers Squibb (BMS) recently started a TV ad for their drug Abilify (aripiprazole) which has
gotten
a lot of people in a tizzy
prompting me to look closer at this new claim for a psychiatric drug. First of all,
I previously gave honorable mention to Abilify as one of the medications with the goofiest names
"Where Do They Come Up with those Goofy Names for Prescription Medications Anyway?")
Back then I mused that
perhaps the manufacturers thought that their anti-psychotic pill would make non-functional mental
patients jump out of their chairs and start climbing the corporate ladder. Well I don't know if
it will make you climb the corporate ladder, but the akathisia you could get might make you
feel like you wanted to jump out of a chair. Not to mention wanting to jump up and go pee
if you develop second generation antipsychotic induced diabetes. This medication is an antipsychotic
(apparently not mentioned in the TV ads) and these drugs can can have some nasty side effects.
So is this drug really useful for depression? The ads hype the fact that over half of people
may not respond to antidepressant medications, but that seems like a self serving turnaround
on the part of the drug companies (including BMS maker of Serzone (nefazodone)) who have been
telling us for years that their antidepressant drugs are magic bullets for depression.
So what do the studies actually show?
In the
first study
of Abilify, 362 patients were randomly assigned to Abilify or placebo for six weeks after a failed trial of
antidepressants. There was a
-8.8 v -5.8 change on the Montgomery Asberg Depression Rating Scale (MADRS), a difference of 11.5%.
23% of patients on Abilify versus 5% on placebo had akathisia, a potentially very disturbing side effect
where you feel like you are jumping out of your skin or cannot sit still. Restlessness was seen in 14% v 3%. Fatigue
was also more common.
Berman RM et al J Clin Psychiatry 2007; 68: 843-53.
In the second
study of Abilify, 381 patients who had failed at least one antidepressant medication
trial were treated for eight weeks with an antidepressant followed by the addition of Abilify
or a placebo for six weeks. Abilify showed an -8.5 change on the 26 item Montgomery Asberg Depression Rating Scale
(MADRS) versus -5.7 for placebo, a difference of 2.8 points, a difference of 11%.
26% of patients on Abilify versus 4% on placebo had akathisia, and 10% versus 1% had restlessness.
Marcus RN et al, J Clin Psychopharm 2008; 28(2):156-165
.
Conclusions? Abilify is more likely to make you want to jump out of your skin than it is
to cure your depression.
An 11% improvement over placebo is not that great and is set off by the
fact that Abilify has a lot of nasty side effects and doesn't work better than other treatments of
refractory depression like lithium (which also can have nasty side effects).
I don't watch TV ads because I have TiVo but I can only imagine how it was presented by BMS
That settled, now we can move on to my favorite study that I found in the literature:
Egashira N et al, Aripiprazole inhibits marble-burying behavior via 5-hydroxytryptamine (5-HT)1A receptor-independent mechanisms.
European Journal of Pharmacology. 592(1-3):103-8, 2008 Sep 11.
I wonder if the September 11 publication date is a coincidence? OK, conspiracy theory time now. Maybe BMS is trying
to tell us that if our government officials had been on Abilify they wouldn't have lost their marbles and
allowed 9/11 to become a reality?
Any other theories?
[disclosures: In addition to consulting to competing drug companies listed in my "disclosures" link I have
also co-authored papers both with some of the authors of the Abilify studies as well as physicians
who have given CME activities that endorsed the use of Abilify for the treatment of depression.]
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NOVEMBER 5, 2008
UPDATE ON PHYSICIAN CORRUPTION BY PHARMA
In
today's issue of JAMAthere is a letter to the editor by Ross et al describing the
results of a study of payments to physicians by drug companies in the State of Vermont,
which has a law requiring disclosure of these payments. Physicians got a total
of 21,409 payments in a two year period totalling $4.9 million, 56% of which
was designated "trade secret". The authors were able to obtain details of
these so called "trade secret" payments only through litigation and extensive
efforts. However the "trade secret" information turned out to be payments
for talks, education, and dinners.
How do those things count as trade secrets?
Why are they trying to keep these payments a secret?
Why can't physicians just pay for their own talks anyway?
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NOVEMBER 3, 2008
DOUBLING OF PRESCRIPTION MEDICATION USE IN KIDS DURING A THREE YEAR PERIOD
There has been a dramatic increase in the number of children on prescription
medications in the last few years, as Liz Szabo wrote today in USA Today
"Number of kids on medication jumps alarmingly:
Most of the illnesses related to obesity". From 2002-2005 there was a doubling
of kids on prescription medications for Type 2 diabetes. There was also an increase
in kids on medications for cholesterol, asthma, and ADHD. The article noted
that diet and lack of exercise are responsible for the increase.
However, I don't
think that our main stream media are giving us very good advice about what we
should be doing to help our kids avoid these trends. Maybe that is because us doctors
doing the research are so muddled and mucked up with our preconceived notions, conflicts of
interest, and various biases.
One of the mainstream medias main
recommendations are that we should choose a low-fat diet, but as others have
pointed out, low-fat means subsituting calories in the form of carbohydrates,
which probably are worse in terms of inducing diabetes. There has been some discussion on this blog (e.g., see
"The Naked Emperor and Saturated Fat"
about the nature of fats, carbohydrates and cardiovascular
disease and diabetes, and I have been reading some new books on the topic and will
post on that later.
The Diabetes Prevention Program Research Group Study, however, did implicate diet and lack of exercise in Type 2 diabetes.
The
study showed that at-risk individuals who met with a
nutritionist who helped them change their diet and lifestyle (more exercise, less fat and
saturated fat, more fiber) cut their risk of developing diabetes by 58%, even though they
only lost 8 pounds on average. Prevention of diabetes with lifestyle intervention was better
than medication (metformin), with a 58% reduction in new onset diabetes in at risk patients,
compared to 31% for metformin. Eleven percent of patients on placebo developed diabetes in
one year, compared to 8% on metformin, and 5% with the lifestyle intervention (DPPRG 2002).
Patients on metformin had more gastrointestinal side effects than the other groups.
DPPRG (2002): Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. Diabetes Prevention Program Research Group. New England Journal of Medicine 346:393-403.
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NOVEMBER 2, 2008
HERE COME THE FOUR HORSEMEN OF THE APOCALYPSE
Well today it is All Soul's Day, so I thought it appropriate that our own four horsemen
of the apocalypse are ushering in our day of doom which will come in the form of the Supreme
Court hearing the case of Wyeth v Levine tomorrow, described as the 'Business Case of the century'. As noted in a
comment on pharmalot by Justice in Michigan, the only four people to comment on the
Drug and Device Law website in favor of
Wyeth's stance in favor of
preemption (where FDA approval means you no longer have the right
to a day in court if something goes wrong with a prescription medication) were current and former members of FDA counsel,
Seth Ray, Sheldon Bradshaw, Gerald Masoudi and Dan Troy. Whadya know, they're all lawyers, which isn't surprising since only lawyers are in favor of preemption, and only FDA and pharma lawyers at that, some of whom are political appointees.
And so I thought I'd bring them to you, the
four horsemen of the apocalypse!
(depending on your browser you may have to scroll down the page).
In the book of Revelations 6:1-8, the Lamb (Jesus) opens four seals, and with each one a colored horse and
its rider jump out.
I watched as the Lamb opened the first of the seven seals. Then I heard one of the four
living creatures say in a voice like thunder, "Come!" I looked, and there before me was a white horse!
Its rider held a bow, and he was given a crown, and he rode out as a conqueror bent on conquest.
Enter the first rider, Sheldon Bradshaw, former FDA chief counsel, who came online to say that complaints
of FDA doctors (remember those guys who actually have some expertise in drug safety?)
that preemption was a bad idea (as outlined in a
report from Henry
Waxman's office to the Supreme Court)
shouldn't be taken seriously, as this was just a few grousers amongst "thousands of FDA employees",
and that ruling against preemption would "open the flood gates" of over-warning and other evils.
When the Lamb opened the second seal, I heard the second living creature say, "Come!" Then another horse came out,
a fiery red one. Its rider was given power to take peace from the earth and to make men slay each other. To him was given a large sword.
Enter the second rider, Dan Troy, former counsel for pharma who got a political appointment by Bush
as chief counsel for the FDA, where he carried the large sword given to him by the pharma-supporting Republicans across the land, filing friends of the court briefs on behalf of drug companies
involved in drug safety litigation, under the logic that if the FDA approved it they had an interest in fighting
causes that claimed medication related harm. He was the brainchild of preemption, which truly
will take peace from the earth. 'You come from the earth and to the earth you return.' Well in
Dan's case he came from pharma, worked for a few years at the FDA pushing pharma interests,
and then went back to a cushy job with pharma.
My, my! That revolving door is enough to make your head spin!
When the Lamb opened the third seal, I heard the third living creature say, "Come!" I looked, and there
before me was a black horse! Its rider was holding a pair of scales in his hand. Then I heard what sounded like
a voice among the four living creatures, saying, "A quart of wheat for a day's wages, and three quarts of barley for a
day's wages, and do not damage the oil and the wine!"
Enter the third rider, Gerald Masoudi! Who continued the work of his predecessor Dan Troy in carrying the sword
of preemption across the land.
And our tax payer dollars are paying the salaries of these guys? Wheat and barley, indeed.
When the Lamb opened the fourth seal, I heard the voice of the fourth living creature say, "Come!" I looked, and there
before me was a pale horse! Its rider was named Death, and Hades was following close behind him. They were
given power over a fourth of the earth to kill by sword, famine and plague, and by the wild beasts of the earth.
I couldn't find a picture of Ray, so I substituted
Peter Pitts, a former FDA official who now lobbies
on behalf of pharma in favor of preemption through his PR firm and the Center for Medicine in the Public Interest.
He is a better substitute for the rider of Death, since he consistently takes positions that put
the profits of pharma over the lives of people taking their medicines.
Peter uses their blog to take swipes at the likes of Drs. David Graham and Steven Nissen, whose only
sins were uncovering risks of Vioxx and Avandia, which god forbid might cut into the profit margins of
his beloved pharma.
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OCTOBER 31, 2008
Effects of Zoloft (Sertraline) On Childhood Anxiety Are Incredible, Indeed
A quote from a physician describing the results of
study published this week in the
New England Journal of Medicine on the effects of Zoloft (sertraline) or cognitive behavioral therapy
(CBT) or a combination of the two on childhood anxiety disorders, describing the results of the study
as "incredible", lead me to take a look at the study myself to see if this claim was in fact, er, credible,
or more of the same fare we have been dished out regarding the use of SSRIs in children, such as the infamous
Study 329 of paroxetine (Paxil) in the treatment of depression in teenagers.
The current study looked at 488 children between the ages of 7 and 17 years who had the diagnosis of separation
disorder, social phobia, and/or generalized anxiety disorder (GAD). They received 14 sessions of
cognitive behavioral therapy, sertraline (up to 200 mg per day), a combination, or placebo for 12 weeks.
The authors reported a score of "much improved" or greater on the Clinical Global Impression-Improvement
Scale in 81% of kids treated with combination drug/therapy, 60% for CBT alone, 55% for sertraline, and 24%
for placebo.
However, using a categorical outcome like "improvement" can be misleading. Take the example of the
infamous Study 329 which pointed to the outcome of a 50% or greater improvement on the Hamilton Depression Scale
as evidence for benefit of paroxetine in the treatment of childhood depression. The original primary
outcome of the 329 Study was improvement in depression as measured by the Hamilton Depression Scale.
The authors later "changed their minds" about what they should focus on, a fact that came out later.
It is important to define a primary outcome in advance, otherwise there is a tendancy to fish
around for a positive result, which may lead to something that is just a fluke being interpreted
as due to something real.
In the sertraline/CBT study, the authors (as far as we know) had "improvement" as their
primary outcome. However improvement can be misleading. Let's focus on the sertraline treated
group alone, since CBT has no side effects and I am fine with people using CBT, and since
the authors did not report a statistically better outcome of the combination therapy
compared to CBT alone (although the press releases trumpet, incorrectly, that the combination is better)
Say the primary goal is to run a mile in 10 minutes
(or whatever, I say as I sit on the couch). If out of 100 people running, people wearing
green shirts do it, on average, in 9 minutes 45 seconds, and people wearing red shirts do it in
10 minutes 15 seconds, you could have a result where 60% of the green shirts make the goal
versus 25% of the red shirts, which sounds like a big deal, even though there is only a
5% difference in their times.
So lets look at these studies. In the case of Study 329, 66% of kids treated with Paxil (paroxetine)
were "much improved" or better as measured by the Clinical Global Impression Scale (CGI) [criteria used in the Zoloft study]
versus 48% of those treated with placebo, which they reported as statistically significant. Not bad, you say,
however they did not find a significant change in their primary outcome, and to report the study
as positive is a violation of the rules of clinical trials, as pointed out in a subsequent
letter to the editor.
In fact, if you look at the actual data, the Ham D score went from a baseline of 19.0 in both groups,
to 8.2 in the paroxetine group and 9.9 in the placebo group, a paltry 3% difference in a 56 point
scale which was not reported as significantly different because it was not, well, different.
So now let's turn to the "incredible" results of this week's study of sertraline (Zoloft) in kids.
Although there was a difference in "responders" based on much improved on the CGI of 60%
versus 24% for placebo, when you look at the actual data, the Pediatric Anxiety Scale, a
30 point scale, went from 18.8 at baseline to 9.8 in the zoloft group, and from 19.6 to 12.6 in the placebo group, a
difference of 9%, again, not reported as statistically significant because it was not, in fact, very different.
In fact only CBT (not combination) was better than placebo on the anxiety scale. My clinical methodology experts
tell me that a study is pretty weak if it only shows a positive outcome on a single categorical (yes/no)
outcome and not on the continuous (multi item) scale. And the combination group had no comparison group.
Just, here is your psychotherapy (66% get better), and now open up your mouth and let me give
you a yummy blue pill that Mommy says is going to make you better (80% get better).
OK, dictionary time.
Incredible; Pronunciation [in-kred-uh-buhl];
Adjective
1. so extraordinary as to seem impossible; incredible speed.
2. not credible; hard to believe; unbelievable: The plot of the book is incredible.
[Origin: 1375–1425, late ME incredibilis]
Related forms:
incredibility, incredibleness, noun
incredibly, adverb
Incredible, indeed.
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OCTOBER 29, 2008
The Naked Emperor and Saturated Fats, by David Diamond
A guest post
The misinformation about saturated fat, cholesterol and heart disease, the so-called "heart-diet" connection,
reminds me of the story about the emperor's new, but nonexistent, clothes. An emperor hires tailors who promise
to make him a set of remarkable new clothes...
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OCTOBER 28, 2008
(Re) Introducing, Dr. Bremner's Chamber of Horrors!
I made up a little website of the who's who list of drug disasters while researching my
book on drug safety as a way to entertain
myself...
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OCTOBER 26, 2008
Hey Buddy, Want a Placebo? How About a Statin for Your Wife?
This week there are a couple of related articles, one in bmj showing that half of doctors prescribe
their patients placebos, and the other in Journal of Empirical Legal Studies showing that
23% of patients on statins were women without heart disease for whom there is no evidence of benefit...
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OCTOBER 23, 2008
Vytorin Sales Continue to Tank, and With Good Reason
This has been an interesting week, and an interesting year, for that matter.
The cholesterol lowering drug Vytorin is back in the news because the good folks at
Shearlings-Got-Plowed
wrote about how Vytorin sales continue to tank.
Also the stop smoking drug Chantix
got up there with tainted Chinese heparin as causing the bulk of recently reported
adverse events and deaths (See my prior post
"Time To Die! (Oops) I Mean Time to Quit!"). Seems like country music singers
trying to give up the tobacco leaf now have to add driving their cars off of the road...
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OCTOBER 22, 2008
In Vitro Fertilization and Cancer, by Jennifer Schneider, MD
[invited blogpost for "Before You Take That Pill, Read This" blog]
Hi, Doug,
My daughter, Jessica Grace Wing, died of metastatic colon cancer at age 31, some 7 years
after undergoing 3 cycles of egg donation to infertile couples. She had no family history of colon
cancer, and genetic tests showed she had no genetic risk. To produce multiple eggs for egg donation...
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OCTOBER 21, 2008
What Me Worry? The FDA Will Protect Me from Toxic Drugs (NOT!)
Tomorrow’s issue of JAMA has the results of an interesting
study by T.J. Giezen et al that examined 174 prescription medications (136 in the US,
the rest in Europe, and 67 approved in both places), as well as some letters on preemption
and an editorial that discusses these related topics. In the study of Giezen et al, 24% of the drugs had a
regulatory action after approval by the FDA or a European regulatory agency...
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OCTOBER 20, 2008
Some of Us Doctors Actually CARE About Our Patients!
The drug maker Wyeth has issued a
press release
on the topic of
preemption, as related to the case before the Supreme Court of Levine v. Wyeth.
Simply put, preemption strips away the rights of consumers to have redress in court
if they have a toxic or fatal side effect from an FDA approved prescription medication.
The
good people of Michigan have been struggling with this law for a decade...
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OCTOBER 20, 2008
The Prevention of Ignorance
A guest post, by Dan Abshear
Historically, information sources provided to American citizens were limited due to the few methods available to the public,
such as radio, TV, or news print. And also this information was subject to being filtered and, in some cases, delayed. This occurred for a number of reasons...
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OCTOBER 17, 2008
DON’T PANIC!! KEEP TAKING YOUR VYTORIN! (I MEAN ASPIRIN)!
A study in the British Medical Journal published today
showed that aspirin confers no benefit in the prevention of heart attack or stroke, and may increase the risk of bleeding,
in patients with diabetes...
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OCTOBER 16, 2008
Before You Take That Pill, Read This Letter from Vexed Former Pharma Exec
Still reading your book. The HTN chapter now. Way to go discussing the ALLHAT trial. I was selling
an ARB when the results were released, and was glad actually what the results were from that trial...
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OCTOBER 15, 2008
A Reader Notes That Evidence for Harm from Saturated Fats is not that Great
by David Diamond
hi Doug
I just read your book, before you take that pill, absolutely fantastic work, beautifully written.
Imagine that, an MD warning people about taking drugs as commonly prescribed as statins and antidepressants,
and recommending exercise and diet - you’re quite a rebel!
the only criticism I’d like to offer is that your concern about saturated fat/meat is based on poorly conducted and biased research of the last 40 years,
the fear of saturated fat is completely unsupported by rigorous research...
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OCTOBER 15, 2008
More Bullshit Healthcare Proposals From Our So-Called Future Leaders
I am watching the Obama-McCain debate on TV right now and I thought I should offer some
’’medical perspective’...
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OCTOBER 14, 2008
WE COME IN PEAS
I wanted to let everyone know that today is a special day.
It was announced several months ago that on today, October 14, 2008,
an 800 mile long
space craft will appear above the United States ...
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OCTOBER 14, 2008
DISCLOSURES... and paxil, paroxetine, seroxat, etc etc
My disclosures are on my web sites (click the link called "disclosures"), and interested readers can
follow the links to see the topics of my research, which include the effects of paroxetine
...
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OCTOBER 10, 2008
An Open Letter to Senator Charles Grassley (R-Iowa) From a Professor of Psychiatry at Emory University
This week the Chairman of my department at Emory, Charles Nemeroff, M.D., Ph.D., got caught up in a
a broo-ha-ha
about unreported earnings from outside activities related to giving lectures that were supported by the pharmaceutical industry.
This led to his resignation pending the result of an inquiry into the allegations raised by Senator Charles Grassley.
Mind you, I am not here to justify other people's behavior... Nevertheless, I have some questions for the Senator...
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OCTOBER 10, 2008
Response to University Diaries
I was attending a
memorial for my mother who died in 1966 this Saturday which
was a little fraught with conflict since my father remarried and the
"old mom" wasn’t always the most popular topic of conversation, when...
...the chairman of my department
imploded.
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Here is the Emory press release for my ’Pill’ book that was never... released (sniff, sniff)
The Missing Press Release
DRAFT COPY
EMORY Health Sciences News
http://www.whsc.emory.edu
XXX, 2008
Medications Put to the Test in New Book by Emory Researcher and Author
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SEPTEMBER 30, 2008
The Ups and Downs of the Dow Jones Industrial Average, Interpreted from a Personal Perspective (Literally)
We’ve known for some time that noone can predict the stock market, and that the efforts of stock pickers routinely
come out worse than chance. Now we are learning that noone has a clue about what to do about the current financial
meltdown, or where the Dow Jones Industrial Average (DJIA) will go in the future.
So I thought I would try a new approach. Why not interpret the stock market from the point of view of my personal life?
Yes, me. Doug Bremner. I mean why not? Maybe the events of my life and those of my family have an influence on the stock market...
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SEPTEMBER 28, 2008
Health News You Won’t Read About in the New York Times
Here’s a forgotten chapter from pharmaceutical history. The acne drug, Accutane, manufactured by Roche Pharmaceuticals, has been associated with hundreds of birth defects. Since 2005 the iPLEDGE program has required that patients, doctors, and pharmacists register and that patients prove they are on birth control before they can be prescribed this potentially dangerous drug.
But it wasn’t always that way...
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SEPTEMBER 9, 2008
Out-FOXed Again!
Last night I got a chance to watch the rest of the
Mike and Juliet Show
entitled "M&J Investigates" Accutane on TiVo. I am glad they put "investigates" in quotes because
the shoddy shuffling out of bogus MDs and random opinions hardly qualifies as "journalism".
Well things only got worse after the commercial break...
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SEPTEMBER 5, 2008
NO REDEMPTION FOR PREEMPTION
While Americans sit mesmerized by Sarah Palin clapping into the microphone and rambling on about
Greek Columns while her daughter wipes down her youngest child’s hair with her own spit, they are
utterly unaware of yet another attempt by the government to steal even more of their civil
rights and liberties. As if the 'Patriot' Act wasn’t enough, the war mongerers now want to take away
your civil rights in the form of redress in the event that you or your family are damaged by dangerous
prescription drugs...
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July 17, 2008.
Blogmersion, Part 2: McProfessor.com
Now that I got on the psychiatry roll it’s hard to stop. After all I went into psychiatry because I was
really interested in philosophy and writing but they told me I couldn’t make a living that way. But what
about Socrates? Didn’t he live off of donations?
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July 16, 2008.
Blogmersion, Part 1: YouTube & Me
Salim Hamdan was a driver for Osama Bin Ladin who recently went on trial for terrorist activities. He seemed to have no interest
in the trial proceedings, being only interested in being moved from cell block 4 (where he was kept in isolation)
to cell block 5...
"What do I have a lawyer for if you can’t help me?" (i.e. get me back into cell block 5) he asked his lawyers, rhetorically.
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July 15, 2008.
More Bad News About Osteoporosis Drugs
Well it’s back from summer vacation and reviewing what happened while I was away
and today there was an article
in the New York Times about the potential for increased risk of fracture with bisphosphonate drugs like Fosamax
used for the treatment of osteoporosis.
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June 11, 2008.
Time To Die! (Oops! I Mean Time To Quit!)
I was sitting in my car dealership today waiting to get service on my car and working
on my laptop while the television was droning on in front of me. I mean this is one of the rare
times when I watch TV without the benefit of Tivo to pause the commercials or otherwise avoid them.
And it was like one prescription medication ad after another...
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June 2, 2008.
Mommy, Can I Have a Yummy Blue Pill?
Pharmaceutical companies are great about turning out prescription medications with hip designer
colors like deep blue, lavender, brightly colored red, and let’s not forget ’the purple pill’
(Nexium, for those of you without a TV). Those lovely colors make us say ’Yummy!’ and
increase our desire to wolf them down as fast as possible...
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