Before You Take That Pill » Book Review of Your Body's Red Light Warning Signs

JANUARY 24, 2009

Moving On Up!

I picked up WordPress so I am currently posting here.

Blogs from 2007-2008 are here, and the current posts for 2009 and on are here,

I was writing this blog using a version of html from 1992 originally and then xml and css, and I finally figured out that the Yahoo! host wouldn't let me host proper comments, so I uploaded WordPress onto my site, which means that the blog will no longer be

http://www.beforeyoutakethatpill.com/blog.html

but now will be

http://www.beforeyoutakethatpill.com/index.php which you can access here,

and the old feed will change from

http://www.beforeyoutakethatpill.com/feed/

http://www.beforeyoutakethatpill.com/index.php/feed/ which you can access here.

How tedious this all is!

But at least I hopefully will now have proper comments. Any feedback on broken RSS, inability to comment, or other issues will be appreciated.

JANUARY 16, 2009

Book Review: Your Body's Red Light Warning Signals

I was having some pain in the esophagus while swallowing this weekend and started to freak out about it a little. Being a doctor myself I naturally didn't want to go to a doctor about it so I grabbed Your Body’s Red Light Warning Signals by fellow MD author Neil Shulman. Fortunately I found out that I wasn't going to die right away and I got better with some OTC Prilosec and Mylanta. That is why I was glad to see a new revised and updated version come out that got great reviews this weekend in the local AJC paper. Here is an excerpt.

When the little red light on your car’s dashboard flashes, you know to check the oil or battery. But if one of your eyelids droops and your vision gets blurred, you might not know what to do —- or react as quickly. Atlanta physician Neil Shulman, who penned the book that became the 1978 hit movie "Doc Hollywood," is out with a new volume that aims to help you decode your body’s codes.

In the newly revised and updated edition of Your Body’s Red Light Warning Signals (Delta, 496 pages), the Emory University professor provides an owner’s manual-style overview of the body and explains how to read the signs of potential health danger. Shulman helps explain the differences between simple conditions and immediate health threats, such as when a pain in the tummy is more than indigestion and could be an ulcer.

Health care is a two-way street, and the best way to make the system work better is to make people more medically literate and empower them to advocate for themselves, he said. "You shouldn’t just turn over your body to a doctor and say, 'Take care of me,' " said Shulman, who describes himself as obsessively compulsive about patients.

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JANUARY 15, 2009

Book Review: Your Body's Red Light Warning Signals

When the little red light on your car’s dashboard flashes, you know to check the oil or battery. But if one of your eyelids droops and your vision gets blurred, you might not know what to do —- or react as quickly. Atlanta physician Neil Shulman, who penned the book that became the 1978 hit movie "Doc Hollywood," is out with a new volume that aims to help you decode your body’s codes.

In the newly revised and updated edition of Your Body’s Red Light Warning Signals (Delta, 496 pages), the Emory University professor provides an owner’s manual-style overview of the body and explains how to read the signs of potential health danger. Shulman helps explain the differences between simple conditions and immediate health threats, such as when a pain in the tummy is more than indigestion and could be an ulcer.

Health care is a two-way street, and the best way to make the system work better is to make people more medically literate and empower them to advocate for themselves, he said. "You shouldn’t just turn over your body to a doctor and say, 'Take care of me,' " said Shulman, who describes himself as obsessively compulsive about patients.

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JANUARY 12, 2009

Spurious Advances in Antipsychotics, Indeed

An article from the Jan. 3 2009 issue of The Lancet used a meta analysis to show that so-called first generation antipsychotics (FGAs) and second generation antipsychotics (SGAs) are not that much different in terms of efficacy, safety, and side effect profiles. The purported superiority of SGAs for negative symptoms and fewer side effects for SGAs were primarily the results of comparator studies that put them up against high dose haloperidol.

I have been reading a book called Hooked: the Medical Profession and the Pharmaceutical Industry by Howard Brody, MD PhD, of the University of Texas, Galveston, which I highly recommend as an interesting book that adds a lot even for those of you who feel you are "read out" on this topic, and this episode of comparing new drugs to old drugs given at doses that cause more side effects without providing more efficacy (which is stacking the deck in favor of the new drugs) is a pharmaceutical industry tactic that he identifies, although this is the first time we have heard of it as applied to antipsychotic "life saving drugs".

Psychiatrists moved en masse from the FGAs to the SGAs largely because of concerns about tardive dyskinesia, extra pyramidal side effects, and what may have been a misguided belief that these drugs worked better, fueled by pharmaceutical marketing. As the paper shows, most studies in the literature were found to be using high dose haloperidol (>7.5 mg/day) (Haldol) as the comparison drug, which biased the trials in favor of showing a better side effect profile for the newer drugs. When studies using lower potency first generation drugs were focused on, the differences in safety and efficacy were considerably diminished. Specifically, the SGA drugs as a whole were not seen to be specifically better for negative symptoms of schizophrenia, which does not support marketing claims to the contrary. The drugs that were better for negative symptoms were also equally better for positive symptoms and depression. Although clozapine, olanzapine, and risperidone were marginally better for extra pyramidal side effects, which is largely why psychiatrists moved so heavily into SGAs in the first place, the effects were not large, and there were no significant differences for the other SGAs. The only SGAs that were shown to be better for psychotic symptoms than low dose FGAs were amisulpride (Solian, Sultopride), clozapine (Clozaril), olanzapine (Zyprexa) and risperidone (Risperdal). These drugs, however, caused more weight gain than haloperidol (but not low potency FGAs). Only Amisulpride and sertindole (Serlect) were better for quality of life. Aripiprazole (Abilify) was only better for depression and quetiapine (Seroquel) was better for positive symptoms and depression. Sertindole (Serlect), ziprasidone (Geodon), and zotepine (Zoleptil) were not better for any symptom area.

The recent CATIE study compared SGAs to the FGA perphenazine (Trilafon), and found that most of them were not better for efficacy or side effects, only olanzapine had a longer time to discontinuation (the primary outcome) and clozapine was better for symptoms. However, clozapine has bothersome blood monitoring requirements because of the risk of aplastic anemia, and olanzapine has some worrisome diabetes risks. What was most amazing about the CATIE study, however, was the fact that half of people stopped taking their meds after a couple of months, which indicates that people feel really lousy on these drugs.

The article was accompanied by an editorial by Turner and Horton entitled "The Spurious Advance of Antipsychotic Therapy" in which the authors said that psychiatrists had been "beguiled" (presumably by the pharmaceutical industry) into believing that the SGAs were superior (a point highlighted by others like Vera Sharav of the Alliance for Human Research Protection (AHRP). Although I wouldn't agree with the emphasis that there is no difference between these drugs, it is true that the safety and efficacy of these drugs have been greatly distorted, that we should stop using the distinction of SGA-FGA or talking about unique profiles of "atypicals". In addition, It is unclear if the extra cost of these drugs justifies their use when there is an increased risk of obesity and diabetes with not that great of an advantage for extra pyramidal side effects. Certainly for the drugs not better than low potency FGAs there is not.

Guess we got duped by pharma. Yet again.

Sigh.

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JANUARY 9, 2009

PIMPING FOR NEURONTIN

This has been quite a year for disturbing revelations about the corruption of the medical literature by pharmaceutical company interests. I wrote previously about ghost writing by Merck and others, and how papers were produced by drug companies that said "insert author here" and then they went out and shopped around for an author at an academic institution. Academics are always worried about damage to their reputations, but in these cases, what can your say...?

I previously wrote about a study showing that the overwhelming majority of negative trials never get published while the positrive ones always do, which leads to a false sense of the efficacy of the drug. The worst extreme of course is the sorry example of trials of SSRIs in kids where multiple studies of paxil were "shoved in the desk drawer" as we say here in the industry, and a bs campaign to get kids on paxil was launched.

In the study I previously wrote about on suppression of the literature on antidepressants if you only looked at the medical literature, you would think that 94% of the studies show that antidepressants work, when in fact only 51% were positive.

I remember a couple of years ago standing at a poster with a glass of wine in my hand at the American College of Neuropsychopharmacology (ACNP) which presented similar data (maybe it was the same study). Someone from pharma commented that you can't get negative data published. Well that is a lot of hooey. You can get data published somewhere. For instance, Psychopharmacology Bulletin, where I am an Associate Editor (at least for now), and that publishes its stuff online, makes a policy of taking in negative clinical trials.

In this week's NEJM there is an editorial about the promotion of Neurontin (gabapentin) for off label uses ranging from bipolar disorder to neuropathic pain. This editorial includes references to online documentation of how data was suppressed and manipulated, marketing tactics were used to illegally promote off label use, and academics, government, and the FDA either colluded or did nothing. Other news comes from an article by Ray Moynihan in bmj showing that the pharmaceutical industry has used a strategy of "grooming" the Key Opinion Leaders (KOLs) (their terms, not mine) to promote their "message", and how they measure prescribing practices before and after a "KOL" gives a talk to check their impact on local prescribing practices, and then reward "good" KOLs with more talks with lucrative speaking fees and "drop" under performers. Of course this unconsciously drives speakers to push their product. I for one went through this mill back in 2001 and was probably dropped for not performing and arguing with them about using their slides. I gave a talk last year for grand rounds at a med school and a friend of mine told me I was not "approved" by the drug company sponsors and therefore they had to scramble to find funds to pay for talk. More news from the bmj article is that there are organizations that offer to "manage" your "KOLs", like kolonline.com. You can read for yourself, but they basically offer their services to drug companies to manipulate or control KOLs to deliver the "right" message to the other docs who will follow their lead about how to prescribe. They offer to "validate and manage" the KOLs and "identify rising stars" (sounds like grooming young girls to participate in prostitution and/or incest to me). Disgusting. Can you say...?

Pimping for KOLs

Anita Ghazarian provided the following link What's It Going to Take To Lock Up Company Execs? on alternet.

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JANUARY 7, 2009

ANNOUNCING THE LAUNCH OF DSM-V SHADOW TEAM

There has been some press that most of the members of the Diagnostic and Statistical Manual for Psychiatry (DSM-V) task force are on the pharma payroll, but although sites like Public Citizen quote that 16/28 members are on the payroll, if you actually look at the list on the APA web site there are only about six who don't report pharma ties, and these include NIH employees. Now a series of investigative reports from David Wilmer from the LA Times in 2003-4 showed that many scientists from NIMH were receiving consulting fees from pharma that they were not disclosing, so maybe they aren't reporting it or they were too lazy to flee once the truth got out. The few others are employees of the APA so it isn't clear what they are actually doing on th committee. Others have received educational grants and other perks from pharma, making pretty much everyone compromised, so it isn't surprising that a lot of people are worried about the potential corrupting influence that the pharmaceutical industry may be having on our beloved "bible" of psychiatry. Not to mention the fact the members of the task force were required to sign confidentiality agreements that they wouldn't talk to anyone until the book was published. Oh, here is another one. They apparently decided that dissociative disorders don't exist, since they didn't even include that as one of their diagnostic groups. I guess there isn't a pill for that, and that's the whole purpose of this exercise, isn't it anyway? To create diagnoses that increase the number of under identified Americans who need a psychotropic pill? Anyway, with all of these concerns, some of us psychiatrists when we were at the Annual Meeting of the American College of Neuropsychopharmacology in Scottsdale, AZ, recently decided to form...

DSM-V SHADOW TEAM!

DSM-V Shadow Team, Doug Bremner, Christian Schmahl,
Ruth Lanius, Eric Vermetten

Doug Bremner MD in front (Emory), (back), from left to right, Christian Schmahl MD (U. Mannheim), Ruth Lanius MD (U. Western Ontario), and Eric Vermetten MD (U. Utrecht). Photo credit: Rickey Gillespie, MD PhD (Emory)

...to express some dissenting opinions in the field of psychiatry. The idea is that we can "shadow" the "real" DSM-V task force and provide our own version of the DSM that is free of influence of pharma! (since we have either pissed off pharma by being to unsocial or ugly or asking embarassing questions or maybe we farted at the wrong time or live in Canada so that none of us have significant financial conflicts of interest!)

I got the inspiration for this idea when I responded to an article on pharmalot.com about conflicts of interests in FDA Advisory Boards by volunteering to work (for free) on an FDA advisory board as I have no significant conflicts, and I pointed out that I have alot to contribute (top in my field of PTSD based on ISI citations, 200 publications, drug trial expertise based on the last book I wrote). Henry Greenspan (Justice in Michigan) commented on pharmalot that maybe we could form our own "shadow" committees to parallel the FDA Advisory Committees for drug approvals that are so hopelessly corrupted by the fact that all of the members are paid consultants to pharma. I said I thought that was a wonderful idea.

I am not pointing out my own accomplishments for self aggrandizement but to demonstrate without equivocation that when the pharma shills say that the best and brightest always consult to pharma that they are full of bullshit.

Pharma pick and groom their candidates and them highlight them at circuses like the Annual Meeting of the American Psychiatric Association which further increases the glitter of their "thought leaders".

We are a serious looking bunch in the picture, but, well this is serious business, I mean determining who gets psychiatric diagnoses and all. You'll notice I couldn't get any American psychiatrists to join the team. There are a few readers of the Drug Safety and Health News Blog that are on the "real" DSM-V work groups and we tried to get them to come over from the dark side but they just rolled their eyes.

Still time to reconsider guys! Won't have a chance like this for another ten years!

OK, let's get down to business. I am going to propose that one of the new diagnoses should be Narcissistic Psychiatrist Syndrome (NPS). This syndrome is characterized by:

Inability to look patients (or anyone else for that matter) directly in the eye
Delusional belief in the ability of psychopharmacology (as opposed to therapy) to heal all woes
Inability to discuss emotions or feelings, whether in self or others
Inability to perform self reflection
Difficulty answering direct questions without somehow turning it around to the questioner
Feelings of entitlement
Inability to take blame
Gravy spots on the tie
Tennis shoes and jacket with patches on the elbows; pipe

Here is another one, Deviant Drug Rep Syndrome (DDRS)

Commonly lies to people while looking them straight in the eye
Compulsion to engage in risky behaviors associated with driving up drug sales (e.g., risky sexual behavior (possibly in doctor's offices))
Inability to reflect on the consequences of one's actions
Cries out loud in joy when sites like pharmalot close down saying things like 'that will certainly make my job easier!'
Incrongruent emotional responses; e.g. persistently perky and cheerful behavior even in situations were sadness or other emotions are appropriate

Which brings me to my next diagnosis, Pharmalot Withdrawal Syndrome (PWS). I must say that my experience working with adult survivors of childhood abuse helped me in the recognition of this disabling disorder. You see, back in 1993 when I was working in the Mental Hygiene Clinic (as they used to call it) of the West Haven CT VA, I wanted to set up a program for research of childhood abuse survivors. None of the other psychiatrists were even willing to *ask* their patients if they had been abuse for fear of the fact that they might crumble into dust if asked. So I had to do the evaluations for them and offer to do a group to treat these patients once identified. One of the persons I screened said that he had been in treatment with the state community mental health for 30 years and noone had ever found his problem and on the first visit to the VA the doctor (me) doing the screening had found his problem just by asking if he was abused as a child! (he was) I ran the group with a nurse who grew up in an Amish family and had been sexually abused in childhood. We ran the group for two years and at the end of the time decided that the group should come to an end. Every week for the next year though the patients kept coming back to my office on the day and time we held the group. Well, that is how I feel now about pharmalot. Anyway, enough sentimentality, and on to the Shadow Team's DSM-V criteria for PWS!

Feelings of sadness, anger, or tearfulness when contemplating the closure of pharmalot.com
Obsessive internet activity involving reading comments about feelings of outrage related to a pharma HR exec who took a helicopter to work while rank and file employees were being laid off
Having feelings of attachment to people you've never met who use false names like 'Atlex' and 'Former Pharma Exec'
Checking email inbox obsessively for pharmalot feeds
Fantasizing about Ed Silverman's laptop

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JANUARY 5, 2009

ARE DERMATOLOGISTS DIPPY?

Rather than admit that one of their silver bullets, Accutane (isotretinoin), which was a "goose laying the golden egg" for F. Hoffmann-La Roche Pharmaceuticals (and their various "Roche" associates world-wide) to the tune of a billion dollars a year, could make kids kill themselves or cause grotesque birth defects in the kids of over half of women exposed when pregnant, dermatologists have sung themselves a lullaby that their magic pills don’t make kids depressed, they actually make them better, by clearing up those ugly zits that drive them to despair. In what can only be described as a tragic collusion of conflicts of interest (COI) amongst their Key Opinion Leaders (KOLs) and willful denial amongst the lowly rank and file, they have decided to say "What? Me Worry?"

When the heat got turned up on Roche Pharmaceuticals after the son of Congressman Bart Stupak's (D-Mich) son Bart Jr. died of suicide while on Accutane in 2000, they got busy and called a “Scientific Advisory Board” meeting at the Ritz Carlton in Alexandria, Virginia, to opine on the topic of the relationship between Accutane treatment and depression. This meeting included figures from psychiatry like Kathleen Merikangas, PhD, Stuart Montgomery, PhD, and David Nutt, MD, Chair of Dermatology David Bickers MD, and psychiatrist Douglas Jacobs, MD. Between the lot of them I think they have written about one paper total in the literature on the subject. But they did get paid a nice consulting fee for their efforts, of course.

Accutane and depression

Their conclusion? No relationship, of course.

I wasn’t aware you were an Accutane expert, Kathleen!

I challenge them all to a debate. I’ll fight them with one hand behind my back!

Fact is Accutane’s efficacy for acne was discovered a decade before Roche put a patent on it, in a paper in the New England Journal of Medicine.

I have communicated with two of the authors, both dermatologists, Frank Yoder MDand Gary Peck, MD.

Both of them agreed with my opinion that Accutane can cause depression in some individuals.

What is really sad about this whole sordid tale is how degenerated the so-called dermatology “literature” has become on the topic.

For example, the most commonly cited study to support the statement that acne is associated with depression, a study that has been cited several hundred times by dermatologists writing in the literature, involved only ten patients with acne and no comparison subjects (Gupta et al., 1990). No statistics were performed (obviously since there was no comparison group). Scores on the questionnaires for anxiety and depression were not related to severity of acne.

And the fact is that the rest of the literature isn’t any better. Objective measures of acne do not correlate with severity of anxiety or depression. Acne does not cause major depression. It is simple as that.

Sure, kids worry about their zits and feel better when they go away, but the studies do not support the conclusion that acne causes major depression, and that treatment of acne cures depression.

In spite of this the manufacturer of Accutane, Hoffmann-LaRoche, has consistently downplayed the risks of suicide and depression and has denied a causal association (McCoy, 2004). The dermatology community has joined with the manufacturer in praising the merits of this medication for the treatment of acne which they describe as the "penicillin of dermatology". It took only 10 months for the FDA to approve Accutane for the treatment of cystic and nodular acne in May of 1982, however controversy has followed it from the time of its initial launch. In January of 1983 one of the authors of the first paper to describe the use of isotretinoin for the treatment of acne in 1977, Dr. Frank Yoder, wrote about the potential dangers of Accutane (Yoder, 1983). In 1990 Dr. David Graham of the FDA highlighted the inability of the Dermatological Medications Advisory Committee to the FDA to be impartial since it was made up entirely of dermatologists (Green & Hutt, 2002). At that time he stated that Accutane should be taken off of the market, mainly because of the risk of birth defects. Indeed its use has always been curtailed or highly restricted in European countries, unlike the US where it is often prescribed for minor blemishes. Strong feelings about the utility of isotretinoin for the treatment of acne in the dermatology community, and forceful marketing by the manufacturer in the US, have caused a delay in awareness of the potential risks in the US. In 1998, the year that the FDA first approached Hoffmann-LaRoche about adding a warning related to suicide with Accutane to its label, the manufacturer ran an ad that stated, "Effective treatment of severe recalcitrant nodular acne minimizes progressive physical scarring, as well as negative psychosocial effects such as depression and poor self image" (Green & Hutt, 2002). This was in spite of the fact that less than half of patients prescribed the medication actually had nodular acne. The FDA required that Hoffman-LaRoche pull the ad.

In 2000 Congressman Bart Stupak’s son, Bart Jr., committed suicide while on Accutane. Congressman Stupak called for congressional hearings on the safety of the drug and in September of that year the FDA called a Dermatologic Advisory Committee meeting on the topic. In November of 2001 an educational grant from Roche funded a supplement of the Journal of the American Academy of Dermatology on isotretinoin which followed the Scientific Advisory Board Meeting in Alexandria VA they held on the topic. The basic science-related articles focused on retinoids and the skin, essentially ignoring the large extant literature on retinoids and the central nervous system. Psychiatric side effects merited literally two sentences, and one article, written by one of Roche’s hired guns, stated that there was no evidence for any association (Jacobs et al., 2001), ignoring the reported challenge-rechallenge cases which have been cited in the pharmacoepidemiology literature as adequate in and of themselves to establish causality (Strom, 2005). This led members of the FDA to write a letter of response, "in the interest of public health," admonishing the authors of these articles for the short shrift they paid to the issue of Accutane and psychiatric side effects (O'Connell, Wilkin, Pitts, 2002).

The degree to which dermatologists have thrown science and logic out of the window in order to protect their magic bullet is simply remarkable. For instance in a 2004 article entitled "Myths of Isotretinoin Therapy" (Alcalay, 2004) "isotretinoin causes depression and suicide attempts" was listed as a "myth". The article went on to state that any risk needed to be "weighed against the increasing prevalence of depression among adolescents and young adults and the psychological impact of acne." [In fact, depression is not increasing amongst teenagers and acne has not been associated with clinical depression, rather only changes in self esteem].

Here are some authentic mythic figures for you, Dr. Alcalay! And they don't have any pharmaceutical industry COIs!

Mythic figures

Aktan, S., Ozmen, E., Sanli, B. (2000). Anxiety, depression, and nature of acne vulgaris in adolescents. International Journal of Dermatology, 39, 354-357.

Alcalay, J. (2004). Myths of isotretinoin therapy in patients with acne: A personal opinion. Journal of Drugs in Dermatology, 3(2), 179-182.

Green, J., Hutt, P. (2002). Babies, blemishes, and FDA: A history of Accutane regulation in the United States., Leda. Cambridge, MA.

Gupta, M. A., Gupta, A. K., Schork, N. J., Ellis, C. N., Voorhees, J. J. (1990). Psychiatric aspects of the treatment of mild to moderate facial acne: Some preliminary observations. International Journal of Dermatology, 29(10), 719-721.

Jacobs, D. G., Deutsch, N., Brewer, M. (2001). Suicide, depression, and isotretinoin: Is there a causal link? Journal of the American Academy of Dermatology, 45, S168.

Kellett, S. C., Gawkrodger, D. J. (1999). The psychological and emotional impact of acne and the effect of treatment with isotretinoin. British Journal of Dermatology, 273-282.

McCoy, K. (2004, December 7, 2004). Drug Maker rebuffed call to monitor users. USA Today, pp. 1-2.

O'Connell, K. A., Wilkin, J. K., Pitts, M. (2002). Isotretinoin (Accutane) and serious psychiatric adverse events. Journal of the American Academy of Dermatology, 48(2), 306-307.

Shuster, S., Fisher, G. H., Harris, E., Binnel, D. (1978). The effect of skin disease on self-image. British Journal of Dermatology, 99(Suppl 16), 18-19.

Smithard, A., Glazebrook, C., Williams, H. C. (2001). Acne prevalence, knowledge about acne and psychological morbidity in mid-adolescence: a community-based study. British Journal of Dermatology, 145, 274-279.

Strom, B. L. (Ed.). (2005). Pharmacoepidemiology (4 ed.). New York: Wiley.

Van der Meeren, H. L. M., van der Schaar, W. W., van den Hurk, C. M. A. M. (1985). The psychological impact of severe acne. Cutis, 36(1), 84-86.

Wu, S. F., Kinder, B. N., Trunnell, T. N., Fulton, J. E. (1988). Role of anxiety and anger in acne patients: Relationship with the severity of the disorder. Journal of the American Academy of Dermatology, 18, 325-333.

Yoder, F. W. (1983). Isotretinoin: A word of caution. Journal of the American Medical Association, 249(3), 350-351.

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DECEMBER 17, 2008

FLU SHOTS ARE [STILL] FOR IDIOTS

Well it is flu season now and I was asked by a reader if there was anything new from last year's post on "Flu shots are for idiots".

Flu shots are for idiots

Well I have had some delay because, well, I had the flu.

But that doesn't mean I am going to get a flu shot!

Since last year the Centers for Disease Control (CDC) here in my home town of Atlanta, GA, have gone from thinking that everyone under the age of 6 should get a flu shot to stating that everyone under 18 should get one, in addition to everyone over the age of 50, as well as other groups of people with specific medical conditions, and healthcare workers. In fact, government agencies world-wide seem to be hyper-eager to get everyone to get those flu shots. But, personally, before I do anything like submit myself to having a needle jammed in my arm that I have to pay for, I always ask myself, is there any evidence that this is going to actually help ME? In the case of the flu shot the answer is… probably not. Sure it will help the manufacturer of the flu shot make their sales projections. And why the CDC has gotten itself into the sorry ass position of recommending vaccines for people in whom the evidence does not exist to support a real benefit is beyond me. In fact the data that flu vaccines save lives in these age groups is just not that great (translation: doesn't exist). The problem is that there are many strains of flu and the vaccine targets only one, and you need the shots every year cuz the viruses keep changing.

And that oft quoted figure of 30,000 deaths per year? Half of those cases of the "flu" are actually flu-related illness that is not actually caused by an influenza virus (and not prevented by flu shots). And most of the rest are in the elderly who often have impaired immunity so the flu shot wouldn't work for them anyway.

I have reviewed the literature and the ONLY group for which there is ANY evidence that flu shots might save lives is with people with chronic obstructive pulmonary disease (COPD) which is caused by smoking. So if you want to avoid dying from the flu, stop smoking. And no, they don't reduce days lost from work overall.

As for the guilt trip that hospital workers should get the shot to prevent spread to patients, the flu is infectious for one day before the onset of symptoms and five days after the start of symptoms, so if you get sick, stay at home for five days

The experts in the literature are actually saying not to use flu vaccines, although noone seems to listen to them. Quoting epidemiologist Tom Jefferson below: from an article in BMJ.

The optimistic and confident tone of some predictions of viral circulation and of the impact of inactivated vaccines, which are at odds with the evidence, is striking. The reasons are probably complex and may involve a 'messy blend of truth conflicts and conflicts of interest making it difficult to separate factual disputes from value disputes' or a manifestation of optimism bias (an unwarranted belief in the efficacy of interventions).

Translation: Politicians that fell asleep in science class in high school are getting a lot of money from vaccine manufacturers. Through a combination of greasing the wheels and the fact that they are too stupid to know better, they actually think that they are helping us out by using government resources to try and 'educate' us that we need to get a flu shot that actually will do nothing for us.

Should you take Tamiflu or similar drugs to prevent the flu? As I have written about before it will only reduce your days of symptoms from 7 to 5, hardly a great deal for a drug that might make you want to off yourself.

Bird flu drugs are for bird brains

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NOVEMBER 25, 2008

SIDE EFFECTS OF THE PHARMACEUTICAL INDUSTRY: BULLYING, CORRUPTION, DISTORTION, AND HARM TO PATIENTS

I am reading Alison Bass's book Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial. Overall it makes for a good read, a story about distortion of study results related to SSRI antidepressants, and the corruption of leaders in the academic psychiatry field for the purposes of promoting profit for pharma.

Side Effects by Alison Bass

My only criticism is that at times it seems like there is too much narrative detail about taxi rides and other things that slowed the story down and are not directly relevant to the story flow.

However I have to admit that the part I found most fascinating was the part about Martin Teicher, MD, a psychiatrist I know personally, have had dinner with, read his papers and grant applications, and whose research interests overlap with mine (i.e. effects of childhood abuse on the brain).

You see, Marty Teicher had the guts to say that Prozac could make some people (emphasis mine) suicidal, back in about 1990, at a time when we were all "listening to Prozac", or maybe drooling over Prozac, or whatever.

The "miracle drug" results in a two point increase over placebo on a 56 point scale, which pharma now acknowledges, because it is off patent and they want to promote their new miracle drug Abilify (which is actually an antipsychotic, which will literally make you drool).

I actually skipped chapters to read the accounts of Dr. Teicher. You see I had heard that Eli Lilly had used rumors that he had had sex with a patient to silence him in expressing his views that SSRI antidepressant medications could increase suicidal thoughts. Not very good PR when they were launching their drug as the miracle cure for depression.

And they were pretty effective. Most of Dr. Teicher's recent research is on the effects of childhood abuse on the brain (NOT Prozac and suicidality).

I know that tune.

It's kind of hard to do research when your data gets subpoenaed before you have had a chance to go over it and fact check it. I know from experience.

In the schools I came from they call that bullying.

In Alison's book she gives a compelling narrative about an attorney for Eli Lilly named Nina Gussack who "softened up" Dr. Teicher and then hit him with accusations of a patient that he had had sexual relations with her. She spent two days deposing him after which he decided that he wouldn't testify again. Eli Lilly hired his ex-wife (leading her to move to Indiana for four years THE VERY DAY they deposed him, taking with her his kids), only to dump her when they had no further use for her.

Congratulations, attorney Nina Gussack, counsel for Eli Lilly, I hope you can sleep at night (try some Ambien).

From my reading of the book and my personal interaction with Dr. Teicher I think the whole thing is a bunch of bullshit, Eli Lilly manipulating someone with borderline personality disorder for their own interests. In fact the Massachusetts Medical Board found no evidence of any sexual relationship.

The only "evidence" they had was that Dr Teicher had given the patient a card saying "love marty" on her birthday and a pair of ear rings valued at $3.50.

I write cards to my kids saying "love dad". That doesn't mean I am having sex with them. Give me a f**king break.

Here is my card for Eli Lilly: "Thanks for making us suicidal! Love, Doug Bremner MD"

Birthday Card for Eli Lilly

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NOVEMBER 21, 2008

THE INFINITE REACH OF THE PHARMACEUTICAL INDUSTRY: HAVE A PROZAC WITH YOUR CHEESEBURGER

Well it is not enough that pharma has spread its influence through the medical industrial complex, it looks like they also have infiltrated the medical media as well. The psychiatrist host of the National Public Radio show "The Infinite Mind", which deals with psychiatry and brain related topics, Fred Goodwin MD, was found to have taken more than $1.2 million in speaking fees from Glaxo since 2000 which was not disclosed on the show or to the producers of the show, in violation of NPR's policies. Some of the shows came out in support of the diagnosis of childhood bipolar disorder and against the idea that SSRI antidepressant medications can make you suicidal, showing evidence of bias in favor of pharma that is not consistent with the actual evidence. He also had as a guest on the show Peter Pitts who was introduced as a "Former FDA Commissioner" when in fact he was at the time working for a PR firm that had pharma companies as their clients, a fact that was not disclosed. Topic? SSRI antidepressants are safe and effective, and cannot make you have suicidal thoughts. [Not true, read the literature guys].

It makes you wonder, though. Why would anyone think that people wouldn't figure out that they were getting income from pharma when they are jetting all around the country giving talks? And didn't the psychiatrists listening to the talks wonder who was paying for all this?

Duh!

It really is sad but I guess we shouldn't expect much from a news service that was little more than a couple of people sitting around commenting on the news collected by others until the heiress of the McDonald's cheeseburger chain, Joan Kroc, dumped $200 million of her wealth onto NPR in one big fat donation.

McDonald's cheeseburger

It is a little known fact that that donation allowed them to mushroom (or should I say ballooned?) with new bureaus at multiple sites throughout the world. However to retain their image as the "people's news" they continued to have those stupid fundraising telethons where you have to listen to the mournful voice of the This American Life guy laying a guilt trip on us about donating. And you never hear them yacking about the pile they got from the cheeseburger queen. I guess maybe they feel a little guilty about that. We used to hear them give little announcements from Kaiser Permanente about how blueberries might prevent Alzheimer's Disease, so eat some blueberries. I wrote a blog about that making fun of them after which they stopped, although I don't know if they were one of the ten readers of my blog at that time, so I am not sure if it was in response to my scathing criticism of their idiotic public "health" service announcements.

I have some other public health service announcement suggestions they could use. How about, why don't you use a medicated stent for your coronary artery disease (CAD) so that you can be more likely to have a coronary artery clot off? Or why don't you take some Nexium with your Plavix so that you can increase your risk of heart attack? Or why don't you go cold turkey on your Paxil so you can become acutely suicidal? Or why don't you take Abilify so that you can feel like jumping out of your skin? Or why don't you take some Accutane for that zit so you can become depressed? Or take some Chantix to stop smoking, which can make you suicidal, so that you can stop wondering about whether or not your life will be cut prematurely short by cancer.

I could, of course, go on and on.

I personally would give more to NPR if they stopped sending me letters addressed to my first name with my wife's last name. How... de-testosterone-izing [I couldn't think of a good word so I had to make one up].

Here's some health news you won't hear on NPR. People who eat in fast food restaurants like McDonald's three or more times a week have a greater than 90% chance of developing heart disease or diabetes. The increase in diabetes world wide can be directly linked to the spread of McDonalds and similar fast food restaurants throughout the world. The increase in obesity related to reliance on fast food restaurant diets is predicted to lead to a decrease in life expectancy in the current century.

Thanks, guys!

On top of that eating that food can make you feel depressed, as evidenced by Morgan Spurlock in his film Super Size Me, when he ate nothing but McDonalds food for a month.

So the next time you pull yourself up to your cheeseburger, have a Prozac with it.

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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)

Baby needs to take her Respirdal

Meanwhile sales of antipsychotic drugs to children continues to climb (data from NJ)

Sales of antipsychotic drugs to children

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.")

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

Jupiter

(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.

Hands in the cookie jar

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.

The Hollywood Pitch

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

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.

A woman with 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.

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?")

Abilify Me Please

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.

Searching for my marbles

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.]

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.

Hands in the cookie jar

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.

Kids on Prescription Medications

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.

Viola Vaccarino commented [follow read more link to read]

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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).

FDA's Four Horses of the Apocalypse

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.

Sad Face with Smiley Faces

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.

Study 329 Paxil in Children with Depression

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).

Effects of zoloft on anxiety in children

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.

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...

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...

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...

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...

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...

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...

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...

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 ...

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 ...

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...

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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JANUARY 24, 2009

Moving On Up!

JANUARY 16, 2009

Book Review: Your Body's Red Light Warning Signals

JANUARY 15, 2009

Book Review: Your Body's Red Light Warning Signals

JANUARY 12, 2009

Spurious Advances in Antipsychotics, Indeed

JANUARY 9, 2009

PIMPING FOR NEURONTIN

JANUARY 7, 2009

ANNOUNCING THE LAUNCH OF DSM-V SHADOW TEAM

JANUARY 5, 2009

ARE DERMATOLOGISTS DIPPY?

DECEMBER 17, 2008

FLU SHOTS ARE [STILL] FOR IDIOTS

NOVEMBER 25, 2008

SIDE EFFECTS OF THE PHARMACEUTICAL INDUSTRY: BULLYING, CORRUPTION, DISTORTION, AND HARM TO PATIENTS

NOVEMBER 21, 2008

THE INFINITE REACH OF THE PHARMACEUTICAL INDUSTRY: HAVE A PROZAC WITH YOUR CHEESEBURGER

NOVEMBER 20, 2008

BAD BABY! TAKE YOUR RESPIRDAL!

NOVEMBER 19, 2008

FIRST THEY'RE DRUGGING OUR DRINKING WATER, NOW OUR KIDS? WHAT NEXT?

NOVEMBER 12, 2008

REMIND ME WHY I SHOULD BE ON PLAVIX?

NOVEMBER 11, 2008

WILL YOU BE MY FRIEND?

NOVEMBER 10, 2008

JUPITER IS NOT LIKELY TO TURN ON APHRODITE

NOVEMBER 8, 2008

DEAR DOCTOR, CIPRO, AVELOX AND LEVAQUIN CAN MAKE YOUR TENDONS SNAP OFF

NOVEMBER 7, 2008

OUR PRESIDENT'S [SECRET] PARTING GIFT TO CORPORATIONS: A GET OUT OF JAIL FREE CARD

NOVEMBER 6, 2008

WOW! A DRUG THAT WILL LET ME HAVE SEX ONCE MORE A MONTH? SIGN ME UP!

NOVEMBER 6, 2008

ABILIFY ME TO HELP ME FIND THE USEFULNESS OF THIS DRUG FOR DEPRESSION

NOVEMBER 5, 2008

UPDATE ON PHYSICIAN CORRUPTION BY PHARMA

NOVEMBER 3, 2008

DOUBLING OF PRESCRIPTION MEDICATION USE IN KIDS DURING A THREE YEAR PERIOD

NOVEMBER 2, 2008

HERE COME THE FOUR HORSEMEN OF THE APOCALYPSE

OCTOBER 31, 2008

Effects of Zoloft (Sertraline) On Childhood Anxiety Are Incredible, Indeed

OCTOBER 29, 2008

The Naked Emperor and Saturated Fats, by David Diamond

OCTOBER 28, 2008

(Re) Introducing, Dr. Bremner's Chamber of Horrors!

OCTOBER 26, 2008

Hey Buddy, Want a Placebo? How About a Statin for Your Wife?

OCTOBER 23, 2008

Vytorin Sales Continue to Tank, and With Good Reason

OCTOBER 22, 2008

In Vitro Fertilization and Cancer, by Jennifer Schneider, MD

OCTOBER 21, 2008

What Me Worry? The FDA Will Protect Me from Toxic Drugs (NOT!)

OCTOBER 20, 2008

Some of Us Doctors Actually CARE About Our Patients!

OCTOBER 20, 2008

The Prevention of Ignorance

OCTOBER 17, 2008

DON’T PANIC!! KEEP TAKING YOUR VYTORIN! (I MEAN ASPIRIN)!

OCTOBER 16, 2008

Before You Take That Pill, Read This Letter from Vexed Former Pharma Exec

OCTOBER 15, 2008

A Reader Notes That Evidence for Harm from Saturated Fats is not that Great

OCTOBER 15, 2008

More Bullshit Healthcare Proposals From Our So-Called Future Leaders