Before You Take That Pill, Read This…
80 CommentsBy Ed Silverman // April 30th, 2008 // 6:24 pm
Several years ago, Emory University psychiatry and radiology professor Doug Bremner was immersed in a long-running controversy over Accutane and links to suicide. His research vexed the drugmaker, Roche, and he wound up as an expert witness in litigation. The experience and subsequent scandals about undisclosed side effects prompted him to write a book, “Before You Take That Pill: Why The Drug Industry May Be Bad For Your Health.” In his view, consumers need more info than they generally receive and so Bremner, who has also consulted for Glaxo, Novartis and Wyeth, details the risks, benefits and other background data on some 300 meds. This is an excerpt from a recent conversation…
Pharmalot: What made you write this book?
Bremner: It came out of my work with Accutane, after reading the material and how the side effects were dealt with internally - Accutane caused depression, but it was rewritten by the marketing team over concerns that it would effect sales. But in general, I was interested in the risks and benefits of drugs as they’re presented by the drug companies. It’s the job of drug companies to sell drugs, and they’re doing a good job of that. But I wanted to provide an alternative viewpoint.
Pharmalot: So the assumption is there’s a need for more info to counter-balance what companies disseminate?
Bremner: Consumers don’t have the time or means to obtain and read medical journals and primary literature. This is a way they can learn for themselves about risks and benefits. They should have some info to take with them when they talk to their doctor. Wouldn’t you want more information about statins if you were told to take a drug to treat high cholesterol? The marketers have done a good job of promoting drugs, but some are overpromoted. Through marketing and advertising, the potential risks may not be highlighted as much.
Pharmalot: But it’s not as if people don’t get useful info from their doctors, right?
Bremner: Most physicians are getting presented literature by a sales rep about a favorable clinical trial. But most physicians also don’t have the time to read all the clinical trials about a drug. I’m not saying the information is misrepresented. But the marketing affects how physicians write prescriptions. I think people should educate themselves. There’s no reason they shouldn’t know about the drugs they’re taking.
Pharmalot: I suppose you’ll say that product labeling, or package insert, is insufficient?
Bremner: Unfortunately, the package insert is based on clinical trials before a drug is approved, so it doesn’t include anything that happened later. And the insert is a massive gobbledy gook for the average person. They can’t figure out what’s relevant…I think it’s buyer beware. I think the public is becoming more aware of the side effects of excessive marketing. But they still need helpful information.
Pharmalot: Why aren’t you concerned that you’ll be tagged as yet another industry critic by focusing a great deal on safety?
Bremner: I’m not. I’ts not a journalistic expose or an anti-pharma book. I do go into detail about clinical trials and how they’re conducted. But there’s always two ways to present information. I believe my way is an alternative way to look at the facts. You know, someone involved in marketing, it’s their job to sell drugs. But whose job is it to present all sides of the story? Well, maybe it’s an academic physician like me.
Janet
>Bremner: Unfortunately, the package insert is based on clinical trials before a drug is approved, so it doesn’t include anything that happened later.
The package insert (PI) can be updated with recent clinical trials. Companies are not limited to pre-launch clinical trials.
> And the insert is a massive gobbledy gook for the average person
PIs can be difficult for even a professional to easily digest.
pg
“Accutane caused depression, but it was rewritten by the marketing team over concerns that it would effect sales.”
Which is a shame for a lot of families in the US and others outside the US.
http://www.ahrp.org/infomail/05/01/31a.php
“…For example, in 1999, Roche told the FDA that none of the 168 reports of suicidal behavior can be directly linked to Accutane.
In 2000, during an FDA dermatology committee meeting, the agency confirmed that 147 suicides were linked to patients taking Accutane…”
“…TAMPA, Fla. - Lawyers suing the makers of Accutane over allegations the acne drug increases the risk of suicide cannot share the company’s internal memos and other documents with the public or federal regulators, a judge ruled Friday…”
I agree, to a point, with Doug Bremner when he says:
“I think people should educate themselves. There’s no reason they shouldn’t know about the drugs they’re taking.”
Except, there is a reason, or reasons.
People who do try to educate themselves come up against a few major problems, like:
Drug companies hide what they need to know about the drugs they’re taking.
Judges put protective orders on the information that they, and their physicians, need to know.
The same applies re ’silencing’ to expert witnesses (who didn’t know either until they had access to the evidence) as to the lawyers.
Why would people think of spending a large chunk of their life researching medicines before going to a qualified physician who they trust has the training to understand illness or things like acne and the drugs they prescribe? Thats something they usually learn by hard experience some time AFTER they’ve visited their physician.
Just A Thought
Good for Bremner. I’m buying his book.
Justice in Michigan
Yet another book…I appreciate Ed’s question about whether this is not a “me-too book.” I’m not sure I get the answer.
Is the core idea a presentation of ways patients/consumers can educate themselves beyond what their docs suggest? Is it explaining the meaning of NNT, relative risk, and that sort of thing? Reiterating some of Health Research Group’s recommendations?
pg
I’m not criticizing Doug Bremner by the way, I expect his book his very good. Its just that people outside of the fields that have a particular interest in meds are usually busy practising their own skills, and when they go to a doc they assume they know what they’re doing.
Until the point they find from experience that there’s a huge need to look into meds and all that surrounds it because its fraught with misconduct, they get on with their own lives, their own professions, their own skills.
By the time they do realize. for most people the damage is already done, either to themselves or to someone they care about.
Just A Thought
What most interests me is how the clinical trials are spun and how ANDA after ANDA is submitted and approved, taking the drug in question further and further than it was originally approved to be.
pg
In 2000 FDA say 147 suicides were linked to Accutane. Now its seriously linked to birth defects as well, according to the Warnings & Precautions page here: http://www.rxlist.com/cgi/generic/isotret_wcp.htm
What interests me is WHY is it still on the market in 2008?
Its an ACNE ‘treatment’. There’s lots of them. So WHY is it still an ‘approved’ treatment?
Doug Bremner
Good points from all. I can’t make specific responses to individual posts because I might get sued. My general message is that people should educate themselves about prescription medications. For example, if there was a room of 100 men with elevated cholesterol without a history of heart disease, and I told them that if they took Lipitor or a similar statin drug, that one of them would be saved from a heart attack, but that three of them might get muscle pain, do you think that they would take that drug? Probably not. What if I told a room full of 100 men that if they took Lipitor that it would slash their risk of a heart attack by 25%? (with no mention of muscle pain). Would they take that drug? probably. Which pitch is used by pharma? the latter of course. But both pitches describe the same situation. In one 3/100 would have a heart attack on Lipitor over 5 years, while 4/100 would have a heart attack if not treated. That means one person is saved. But the difference between 3/100 and 4/100 is 25%!. Since the latter (25% risk reduction) is more likely to sell the drug, that is the one used.
Ok this is the illustration of relative risk vs. absolute risk, which is not new. And as for Just in Mich if this is a me too book, not trying to sell books here, but this is more about a physician who got a stack of papers of the clinical trials for all drugs and read them and made his own evaluation as a physician scientist as to the real risk and benefit, as opposed to a journalistic expose which is what the other related books represent (which I have read). I wasnt trying to do expose or anti pharma, just trying to tell it like it is. The fact that pharma marketing has led to a different view in the popular consciousness of the relative risks and benefits of prescriptions meds from the one presented in my book is in my opinion a product of the fact that pharma marketing has been doing their job. But how about another opinion? Any problems with that?
CMCguy
Being in R&D side I have direct concerns over pharma marketing tactics since it often can dilute or manipulate complexities of science for goals of profit. I also have not read this book yet it would seem to also hopefully present a coverage of benefits of drugs that are properly promoted/labeled as to risks (unless all 300 focused on have high risk/benefit, then would be anti-pharma catagory). If so then based on the sub-title “Why The Drug Industry May Be Bad For Your Health” and reviews on the weblink, my alternate view would suggest there are possible sensationalistic marketing present in order to sell this book.
Nathan
Doug,
I appreciate your trying to take a balanced approach. I’ve seen you take a balanced approach in your previous postings on this site, and I’m sure you did the same in your book.
Your Lipitor example is one that we’ve discussed previously on this site. The problem with that example is that Lipitor is PREVENTATIVE in nature (almost like a vaccine). In that sort of scenario, the classic NNT analysis doesn’t hold up very well. We don’t know ahead of time who will have the heart attack. It would be great if we could only give Lipitor to those 3 or 4 people in the room that were going to have a heart attack. But we don’t know who they are. It would also be great if we could only give vaccines to those people who were oneday going to be exposed to the HCV or HPV. But we don’t know who those people are.
If Lipitor treated baldness, then your analysis holds up. Why bother treating 100 people in order to save 1 from being bald? But that isn’t the case. We are treating 100 people in order to save 1 person from likely DEATH. That’s a big deal. I’ll gladly take the Lipitor.
Jack2
I would take Lipitor too.
Doug Bremner
Nathan and Jack2
Actually that example was for prevention of heart attack as primary prevention in males with risk factors without heart disease, not prevention of death. From the studies I reviewed there isn’t great evidence for prevention of death in those without a history of heart disease, unless you want to point to the WOSCOPS followup study, which I got in a back and forth on this site with ‘reality’ which I posted on my own web site, which now leads people to my website who google ‘what is reality?’ But anyway if you want to take Lipitor to prevent a heart attack, that’s fine. Just trying to give information in the name of education and let people assess their own risk/benefit ratio.
CMCguy
Don’t want to sound defensive. I guess you didn’t like the subtitle. My editor came up with that one. Sorry, I guess she is trying to sell books. That is her job afterall. Just like it is the job of pharma to develop and market prescription meds - I don’t hold that against them either. As for the website I guess you didn’t like my cartoon so I’ll put up some reviews from newspapers instead. As for whether the 300 meds were chosen to be the riskiest ones, they aren’t, they were chosen based on frequency of prescribing or to fill out a class, and there are more than 300, I lost track.
Justice in Michigan
Doug - Just so it’s clear, I don’t have a problem with more books; just wasn’t clear where yours fit.
I think the rel. risk kind of analysis is crucial for pts to understand, regardless of how they come out re: decision. The same is true, of course, when we hear relative risks of Avandia, etc., and what they mean in terms of how many people actually likely to be harmed, what other options are avoilable, what are the consequences it you’re the “outlier,” etc., etc.
With the exception of a few good articles on relative vs. absolute risk in the press, most pts. don’t understand the numbers they hear. Indeed, I know some docs who don’t either, which was amazing to me.
Doug Bremner
A lot of docs don’t know the difference between relative risk and absolute risk. Physicians need more training in how to critically evaluate clinical trials and read the literature. Healthcare consumers should learn more about health. They teach ancient history in schools– isn’t learning about health and your body just as important? People are naturally interested in health, because it has to do with… them.
As for the ‘another book’ comment, I can appreciate that actually. Reading yet another account about how neurontin was promoted off label isn’t that exciting after a while. However I tried to steer away from journalism because there was already books out there, so this one is more of a comprehensive guide. And also I reviewed all the major clinical trials in about 20 disease areas.
CMC guy
Doug (thanks for feedback BTW) I reacted to the limited info I viewed as I could not immediately determine if a balance was presented in the book which I think you have now clarified. I assumed, correctly it seems, that it was your editor who came up with the subtitle as means to help sell the book but this does further illustrate how buyers (books or drugs) need better info beyond promotional materials (which I do believe is your intent), especially “sound bites”. Even though I didn’t favor the cartoon I see no call to remove it and I do see a TOC and Introduction/Excerpts available(to counterbalance what I first perceived as a overall negative tone to pharma).
Doug Bremner
Well I changed the site to put links to newspaper reviews at the top of the page
http://www.beforeyoutakethatpill.com
so that it can be more objective. And I moved the cartoon down to the bottom of the page. Didn’t get rid of him altogether though. Kind of getting a personal attachment to that guy.
Apart from the subtitle which I admit can be provocative the people who have read it tell me that it does not read as anti-pharma. And as for the subtitle, I don’t think anyone would argue with the fact that prescription meds can cause harm in some people. Actually the publisher wanted to subtitle it ‘why the drug industry is bad for your health’ but I had them change it to ‘may be bad for your health’ because sometimes prescription meds save lives/improve quality of life, although at other times they may cause harm.
So overall not much that the commenters on this site would find too objectionable, with the exception of, perhaps, Horuscat… But she (?) hasn’t been around much lately anyways…
James
Dear Doug,
I haven’t read your book. However, based on the interview, I am very tempted to do so. I appreciate the fact that you want to provide knowledge and perspective to patients to inform their conversations with their doctors.
While I know it may not be your focus, I’m curious about your thoughts, if any, on the recent manufacturing issues with outsourced manufacturers (e.g. Heparin from China). To ensure that people get the drugs they are prescribed as they are intended and approved, do you support eliminating outsourcing? Disclosure of where APIs and excipients are manufactured? Increased inspections and enforcement of GMPs? Some combination of the above, or some other remedy?
Just A Thought
Geeee “sensationalistic marketing” of a book has never caused anaphylactic shock or kidney failure or seizures. Maybe a little tachacardia in the folks who are opposed to it’s content. The book COULD hurt you if someone chucked it at you though. For that reason… I would like to suggest a black box warning on the subtitle.
Marketing is just that.
Unless you have someone’s health, or way of life, or finances in your hands.
a PFE rep
pg,
The teratogenic affects of Accutane have been known for a long time; it is not news. My sister took Accutane in the 90s for cystic acne and had to sign a consent form stating that she was using reliable birth control.
As for why it is on the market, obviously, you have never had deep, cystic acne all over your face and back, leaving scars and pockmarks. Accutane is the drug of last resort for those who suffer from this. My sister has some scarring, but not nearly what she would have had without the Accutane. My brother, who did not take it (wasn’t out at the time), has significantly more pockmarks and scarring. OK for a man, maybe, but tough for a young woman.
HorusCat
HorusCat has been reading, but gave blood a week ago and has been too tired and apathetic to do much posting. HC has made an appointment with the vet to determine what is causing such crushing fatigue after donating only 470cc of blood.
HorusCat
Doug,
The other side of your RR vs AR argument is that people overblow the risk of some medications because of the way the risk is hyped in the media. If a drug causes a 25% increase in a serious side effect, but that means your AR goes from 4% to 5%, you haven’t increased your risk much. But the media will hype that to the high heavens.
Doug Bremner
James, about the Chinese manufacturing of pharmaceuticals, I think it is outrageous that the Chinese would suggest that they should be able to come inspect our facilities, when they are so obviously performing such poor manufacturing practices. As for GMP (general manufacturing principles, hope I got that right), they probably are not even close. I think the country of origin of the sources of all elements of pharmaceuticals should be disclosed, just as where our foods are coming from should be disclosed. If they don’t agree to inspections from the FDA we shouldn’t take their materials. Let’s put that manufacturing back in Flint, Michigan, or upstate NJ or wherever.
HorusCat,
Hope you are feeling better (not sure if Lisa S and pg would say the same). Good point about how both serious side effects and beneficial effects can both be blown the same way. btw how does a ‘give me an rx’ cheerleader drug rep know so much about AR and RR?
Doug Bremner
a PFE rep
Yes, the teratogenic effects of Accutane have been known for 20 years, affects almost half of those exposed. What is not so well known is that David Graham of the FDA recommended 20 years ago that it should not be given to any woman of child bearing age because of its potential teratogenic effects. Due to its teratogenic effects it is imperative that women be on birth control while on the drug. However during the Bush administration in deference to the ‘abstinence’ people one of the means of accepted birth control was ‘abstinence’, which is a pretty crappy method. Needless to say the number of Accutane related birth defects has not decreased over the past 10 years.
keeping them honest
As someone who wrote a book on medications, Dr. Bremner should know that GMP is a standard FDA term that refers to Good Manufacturing Practices.
Readers should also be alerted that Dr. Bremner was one of the signers of an ill-advised letter to the Wall Street Journal back in September 2006 defending the indefensible Dr. Charles Nemeroff, who is Dr. Bremner’s chairman at Emory University. Dr. Nemeroff is the poster boy for failure to disclose conflicts of interest in scientific publications and for “spinning” on behalf of Pharma. Just search on “Nemeroff” on Howard Brody’s blog or the Clin Psych blog or Danny Carlat’s blog or Roy Poses’ Health Care Renewal blog. So much for Dr. Bremner’s judgment.
Doug Bremner
Ha! Now things get interesting! You are right ‘keeping them honest’ the GMP is ‘good’ not ‘general’ manufacturing practices. I must admit that that I always found that regulatory crap boring (not to say that it is not important).
As for the Nemeroff comment we can scroll back to comment from CMC guy who says ‘based on the sub-title “Why The Drug Industry May Be Bad For Your Health” and reviews on the weblink, there may be sensationalistic marketing present in order to sell this book.’
So in summary you can say that I signed an ‘indefensible’ letter in defense of Dr Nemeroff (i.e. pharmawhore) or that I wrote a slam book against pharma, but you can’t have your cake and eat it too. So which is it, pharmaloters? defender of pharmawhores or pharmaslammer?
Maybe Ed Silverman could get up one of his ‘vote’ things.
Doug Bremner
OK, let’s not TIPPY TOE AROUND THESE ISSUES.
The Nemeroff issue was about an article in the journal Neuropsychopharmacology about Vagal Nerve Stimulation (VNS)for the treatment of depression. The authors of the article included members of the Scientific Advisory Board for Cyberonics, the maker of VNS. One of the authors was clearly identified as (at that time) an employee of Cyberonics, Steve Brannon MD (btw a friend of mine).
Since Nemeroff was the editor he recused himself from the review of the manuscript. In the process of having a guest eidtor somehow the disclosures got overlooked. Having Brannon as an author with fully disclosed employment at Cyberonices should have clued people in that industry was involved. In any case I can verify that there was no effort to cover up hidden influences related to this paper, just simple oversite.
Bob Freeman
Gee, HC, it’s taking you a long time to recover from giving blood. I’m tied up with end of semester duties such as writing a pharmacoepidemiology exam covering much of what is being discussed here.
I find it interesting watching pharmacy students try to master meta-analyses, relative and absolute risks, etc. The Accutane RiskMAP was one of the last topics we covered.
Doug Bremner
So that said, am I a pharmawhore or a pharmaslammer? A friend of mine said that if I had still been back at Yale, if I had written a book with a subtitle ‘Why the Drug Industry May be Bad For Your Health’ I would have been out of there in a minute. The fact that I am still employed is the best endorsement for Emory.
keeping them honest
Why set up the straw man question — pharmawhore or pharmaslammer? It’s your fund of knowledge and judgment that are in question.
Justice in Michigan
Nice to see HC and I making the same point RR and AA as relevant when we discuss Avandia or Vioxx, for example, as Lipitor. All of us value HC’s blood and hope she will be back to a full tank quickly.
If the reference to Neurontin redux was to Melody P, Amazon is offering your books together as a two-fer deal (I know that is not your decision), but maybe that can help.
Personally, I find MP at her best, not when she’s telling stories we know already, but when she’s telling it through the people _she_ knows who have lived them. In general, I think the best pop books related to industry have been written by docs who are also part time detectives and part-time journalists. I think of John Abramson, for example, and it sounds like this one. Avorn is two wonky for the average bird, but also has some of that quality.
pg
Confused about this answer to Keeping Them Honest: “In any case I can verify that there was no effort to cover up hidden influences related to this paper, just simple oversite.”
I took Keeping Them Honest’s advice and googled.
http://www.ahrp.org/cms/content/view/295/55/
“…Dr. Bernard Carroll, the retired chairman of the department of psychiatry at Duke University, who is a member of the ACNP, put it bluntly:
“This is about as classic an example as you’ll ever find of conflict of interest and manipulation by thought leaders who are beholden to corporations.” “This article is a piece of a slick, skillfully coordinated PR campaign directed by the corporation.”…
…Bloomberg News reports that Dr. Nemeroff offered the following explanation in an e-mail: “As a co-author of the manuscript, I, of course, completely recused myself, from any editorial responsibilities in relation to this submission. All of the authors provided their full financial disclosures.”
Dr. Nemeroff appears to be oblivious to the fact that financial disclosure requirements are not something private between authors and editors—but rather, a requirement for public disclosure…”
Horus I hope you recover from your fatigue soon and that there’s no real problem. Maybe you caught some bug in the days before you gave blood which ‘came out’ on that particular day and you’ll be better soon. Because we disagree (strongly) doesn’t in any way mean I’d wish you to remain feeling ill.
PFE rep, thanks for the info - I have every sympathy with people going through acne, especially the severe types. However I still wonder why some drugs are justified as being on the market because of those who benefit, rather than removing them because of those who die and will continue to die. Perhaps the drug industry should spend less time and money on marketing existing drugs to customers and influencing doctors and more time and money in the business of genuine scientific research for safer and more effective treatments?
Rushed coment so please forgive typos etc.
Nathan
Doug,
Why does it surprise you that a drug rep (HC) would be well aware of RR vs. AR issues? People on this site seem to be of the opinion that drug reps are akin to car salesman. I think HC has shown us all that our opinions need a little adjusting. Medical device sales reps serve almost as “technical advisors” to doctors on how to best utilize and install the device. It seems to me that drug reps may be moving more towards that role. Rather than just “company drug pushers”, they can actually offer genuine technical information on dealing with various prescription drugs - that includes relative vs. absolute risk issues.
BTW, I’d still take the Lipitor. I don’t need a study to show me that a lower heart attack risk leads to a lower death rate. That’s pretty obvious.
Doug Bremner
Keeping them Honest
If you have questions about my knowledge and judgment, why don’t you read the book, and then attack, rather than sniping from the sidelines.
HorusCat and Nathan
Not meaning to impugn the knowledge of drug reps. I’m glad to see they are up on AR and RR. Maybe you can educate the docs about it. They could use it.
pg
the disclosure on the paper was made to the journal - it was their fault they didn’t include it in the final paper. And yes it is a tragedy when fatal side effects of approved drugs are simply blown off by the industry.
HorusCat
Doug,
I think you’d be surprised if you met me. If you read my posts elsewhere on the site, you would see that I have a PhD in neuropharm. But specialty reps such as I get extensive training in reading clinicals and understanding statistics, so I am not alone.
Also, I am an information junkie, so I read a lot of medical texts for fun.
I don’t have an opinion on your book yet. Next trip to my drug dealer (Borders Books), I’ll look for it. I would whole-heartedly agree with you that the industry needs to clean up its act, and consumers need to educate themselves. One of the big problems the system engenders is not that reps push their meds too aggressively, it is that a doctor has such limited time to spend with a patient that full discussion of side effects, etc., gets short shrift. Add to that the sort of pedestal upon which we put doctors, which makes many patients reluctant to question them, and you have a recipe for disaster.
The final part of this Perfect Storm is the way our system deals with drug development and patent life. I think the system incentivizes companies to spin rather than to just be honest. So much money is invested and Wall Street is so reactive to events that the company has no incentive other than a moral duty to be upfront about problems. I think changes in patent life duration and revamping the clinical trial process would help this. In addition, thoughtful and curious people like you help to push the industry to do better.
a Pfe rep
pg,
There will always be side effects, some extremely serious, with prescription meds. Or all meds, for that matter. I don’t give my kids Tylenol because of the narrow therapeutic index it has for children. Nor do I take Tylenol if I have had even one glass of wine. If we pulled every med from the market that had serious side effects, we would be back in the 1920s.
I think the key is time. Time the doctor spends with the patient making sure the patient fully understands the risks and benefits. For someone like my sister (who at age 16 was not sexually active), Accutane made sense. She has a friend who at age 42 is having terribly bad cystic acne. Her husband has had a vasectomy, so she is taking a course of Accutane. It may only be cosmetic use, but I think that it should be available for those like my sister who suffer so acutely. Our society places great value on appearance.
I was always thankful that I escaped the scourge that afflicted my sister and brother. Of course now, I am getting wrinkly and my sis, with her oilier skin, is not. So, I guess everything has an upside and a downside.
HorusCat
pg,
Thanks for your good wishes. My iron level was low–they had to spin out a hematocrit to give me the ok to donate. I had slacked off on taking my daily iron and I don’t eat beef or pork, so I don’t get much iron in my diet. I would never believe that you would wish me ill–we disagree, but you don’t seem to be a malicious person. So again, thanks.
Lisa Van S
Doug Bremner,
“HorusCat, Hope you are feeling better (not sure if Lisa S and pg would say the same)” Pretty Cheeky on your part dont you think.
Actually it’s Lisa Van S,…. and those who know me, know, that, I am an Individual who wishes no “Ill Will” of anyone.
I am curious, as to your need, to invoke me into this discussion. Since you were a consultant w/GSK,.. I ask this question,… Were you a Clinical Trial Investigator, in any of the Paxil Studies done in children?
Doug Bremner
OK now we have it cleared up that noone wishes ill will of HorusCat, and I apologize to anyone for whom I might have suggested otherwise. But it was a pretty spirited discussion you guys had on the other antidepressant story. And remember humor is always the best medicine. And no I did not work on any of the paxil studies in children.
Doug Bremner
That said, at the risk of sounding self promoting, I would like to thank you all for coming to what has turned out to be sort of ‘virtual book publication party’, since the publisher didn’t have one for me or send me on a book tour. And the conversational tone amongst the ‘pharmalot friends’ has caused me to remember other commentors from the past and invoke their names, although not for any particular reason.
Lisa Van S
Doug Bremner,
I may actually purchase your book, or better yet place it on my Mother’s Day Wish List. Im an avid reader.
I have read your CV,.. quite impressive! My nephew is a Marine who is preparing for his second deployment to Iraq, so PTSD has been of great importance to me.
Was also quite fascinated with your interest in Brain Imaging,.. My daughter’s Brain Spectroscopy was quite revealing,.. ie Lyme Disease/Medication. Im not down on all in the Psychiatric Community, just those who choose not to look further than their own nose.
Bernard Carroll
Hat tip to ‘keeping them honest’ for his exchange yesterday with Dr. Bremner. IMO, Dr. Bremner does show poor judgment in this new whitewash of Charles Nemeroff’s behavior. Whether or not Dr. Nemeroff abused his position as editor to secure product placement for one of his corporate clients, he most certainly was accountable for the lack of required disclosure.
But don’t take my word for this. The American College of Neuropsychopharmacology (ACNP) saw the problem. Here is what ACNP president Kenneth Davis, MD said in a letter to members on August 27, 2006: “… there is no ambiguity over the fact that the paper’s acknowledgement section violated the stated policy of our journal.” Is Dr. Bremner saying that Dr. Davis and ACNP Council acted improperly in obtaining Dr. Nemeroff’s resignation?
And just in case Dr. Bremner is arousing sympathy for Dr. Nemeroff, be aware that, before he stepped down in December 2006, recidivist Nemeroff did it again in another infomercial, in the November 2006 issue of Neuropsychopharmacology. This article also was apparently ghostwritten by another of Dr. Nemeroff’s corporate clients, and it also spawned many questions about the authors’ scientific honesty and credibility. It has now been discredited and retracted. You can read all about it here and here and here and here.
I can only agree with ‘keeping them honest’: there is reason to question Dr. Bremner’s judgment. His original letter to the Wall Street Journal in September 2006 was ill-advised. By now repeating these tropes he puts himself in the same indefensible class as Dr. Nemeroff.
Bernard Carroll
The links did not appear in my previous post. Here they are.
http://www.ncbi.nlm.nih.gov/pubmed/16760927?ordinalpos=49&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
http://clinpsyc.blogspot.com/search?q=ARISE-RD
http://hcrenewal.blogspot.com/2008/01/antipsychotic-drugs-for-depression.html
http://hcrenewal.blogspot.com/2008/01/variations-on-theme-of-sleaze.html#links
http://brodyhooked.blogspot.com/2008/01/can-anyone-explain-nemeroff-phenomenon.html
CMC guy
Doug & HC may be bit of a tangent but in terms of limited time with doctors (reps to give info, patients to get info) where do you think the Pharmacists fit in current system? My experience probably is atypical having worked with number of good PharmDs but if I have questions on interactions or risks (that I can not sort out on my own) I would rather ask a Pharmacist than a MD since they often have more/updated knowledge.
And less seriously if there is a poll DB pharmawhore vs pharmaslammer would seem might need “none of the above” or “both the above” options too as these may not necessarily be exclusive positions (without further reading not sure how would vote). Could possibly inquire as to same of Congress or FDA.
Lisa Van S
Dr. Bremner,
As far as antidepressants in children are concerned,… their is no efficacy, w/ the exception of Prozac in the treatment of children and adolescent MDD, I am assuming you already knew that. One must remember that Prozac carries a Black Box Warning. I find nothing humerous in the fact that these meds cause self-mutilation,..psychosis,… suicide,… and Medical Damage!!! In NJ, The APA,.. AAP,. are in opposition of Informing Parents that these Meds carry a Black Box Warning,.. Id like to have your expert opinion?… Do Parent’s have the right to be informed of the truth?……
Doug Bremner
CMC Guy - I agree that pharmacists are good sources of information about prescription meds, and I’ll bet that a lot of people are using them for that purpose. Even though I spent two years writing a book about prescription meds I still have trouble keeping all of those zany brand names and generic names straight. As to the pharmawhore v pharmaslammer poll, I like the idea of something in between, appeals to me as a psychiatrist as not seeing things in black and white. Which leads us to our next blogger.
Bernard Carroll
“By now repeating these tropes he puts himself in the same indefensible class as Dr. Nemeroff”
At the risk of getting on his shitlist can I suggest (?) that Dr. Carroll not see only things as black and white, or us versus them, and remind him that this blog was about my book, which has the subtitle ‘Why the drug industry may be bad for your health,’ which got a random zinger from ‘Keeping them honest’ about a letter I signed with 26 others related to a dispute you had with the chairman of my department. The charge based on this was that I had ‘poor judgment’, but the context would be that I was a pharmawhore, which clearly is not consistent with said subtitle, which leads me to conclude that this is random rock throwing. That said, I think I have to thank you for all for painting me as pharmawhore, which makes me look ‘fair and balanced’, and alleviates the anxiety that may have been aroused in some of my colleagues about the title of the book, although not by the content, since the people who actually read it usually like it. But at the risk of seeming too self promotional, may I suggest that you actually read the book, and you can come back with an armful of rocks to throw, and maybe, at the worst, actually learn something.
Doug Bremner
As for ghost writing, there are few established academic phsyicians who were not ‘moved by the spirit’ at some point in time. Now articles in JAMA and elsewhere show how rife this practice has been, and the examples in Vioxx show much less ‘author involvement’ than in psychiatry. You can read about it on pharmalot
http://www.pharmalot.com/2008/04/vioxx-studies-ghostwriters-and-merck-sponsorship/
or my blog
http://www.huffingtonpost.com/doug-bremner/why-dont-drug-companies-j_b_96962.html
Bruce
I haven’t been back to this thread in awhile and I must say, it was very interesting to read.
I will be buying this book this weekend and I will give my opinion as soon as possible.
HorusCat, I hope your veterinarian gives you something good to make you better fast! But stay away from the catnip, just in case you have to have a random drug test at work!
Bernard Carroll
Dr. Bremner, perhaps you need to get a little distance from this. You did a stupid thing defending Dr. Nemeroff after ACNP obtained his resignation. You just make it worse now by repeating your defense.
Doug Bremner
Lisa Van S
“The APA,.. AAP,. are in opposition of Informing Parents that these Meds carry a Black Box Warning,.. Id like to have your expert opinion?… Do Parent’s have the right to be informed of the truth?”
Yes I agree, I am familiar with your proposed legislation in NJ related to this topic, and from what I know of it I think it sounds like a reasonable idea. And yes I am aware of studies of SSRIs in kids.
“I find nothing humerous in the fact that these meds cause…”
When I talked about humor I wasn’t referring to meds, but rather my taking gentle swipes at our pharmalot friends. (watch out for that paw).
Lisa Van S
Doug Bremner,
(”Watch out for that paw)” Can one asume that you mean the paw of a Momma Bear?!!…
Lisa Van S
DR.Doug,
I have had an oppertunity to meet Arianna Huffington,… Fascinating Lady,.. Have You?…
Doug Bremner
Lisa Van S
I was talking about the paw of HorusCat.
I haven’t met Arianna. I was recruited to write for them by Willow Bay. I got mad at them once when they were slow to post my blogs so I was going to write a blog comparing her to my cat Arianna (speaking of paws). btw if you want to get my blogs
http://www.beforeyoutakethatpill.com/blog.html
in your email you can email me at info@beforeyoutakethatpill.com with subject line ’subscribe’ (same goes for anyone else for that matter).
I have a mild case of hypographia
Lisa Van S
Dr. Doug,
” Speaking Of Paws” I have a cat named Woodstock, He recved the Red Carpet treatment upon our return to the United States from Belgium in 1999.
Hmmmm,… what is Hypograhia?.. Never heard about it.
I will reach out to you privately.
Doug Bremner
We will have to have a pharmacats party sometime. Maybe HorusCat can be Meowster of Ceremonies.
“what is hypographia”-someone who can’t stop writing.
pg
“pg
the disclosure on the paper was made to the journal - it was their fault they didn’t include it in the final paper.”
Doug - again I don’t understand what you’re saying. You signed some paper to defend Nemeroff? Is that right? And Nemoroff was the editor of that journal? Is that right?
So are you saying that it was the Editor of the Journal, ie Nemoroff, the person you signed to defend, whose fault it was?
Sorry, probably got it all wrong or something, probably look stupid too, BUT… is that what you are saying?
IF that it right, then you signed your name to protect scientific misconduct. Is that right?
Lisa Van S
Dr. Doug,
Gee, I have been accused by Family Members,.. of an inability to never stop talking. Have a Diagnosis for that?
My Grandfather once told me,.. that I can talk the ear off a Brass Monkey.
pg
Horus: We’ll no doubt be fighting like cat and dog when you feel better and I hope you feel better soon.
Doug Bremner
Lisa Van S “Gee, I have been accused by Family Members,.. of an inability to never stop talking. Have a Diagnosis for that?” I’ll have to dust off my DSM, but I’m sure there is
pg
He was the editor but also the author so they had to get a guest editor to take care of that particular manuscript. I think it was an oversight not to disclose. Don’t want to beat it to death, but hey, I thought my ‘virtual book launch party’ might be coming to an end, and I was hoping it would go as long as Melody Petersen (”Daily Meds”), however she is better looking than I am and works for the NY Times, whereas I am only a lowly psychiatrist from the land of pine straw and Eric Rudolph
http://www.beforeyoutakethatpill.com/blog.html
Ok, time to pack up my prescription pad and make my home.
Donna M
Lisa,
You can talk the ear off a brass monkey??? UH Yeah..lol
pg
OK Doug B, thanks for your answer. I’m sorry - but I will not be reading your book.
HorusCat
All,
The paws of HorusCat are gorgeous bec HC got a manicure in order to present a more professional feline image. So no swiping, at least with claws out, for now.
HorusCat
And a Cat Conference with me as Meowster of Ceremonies sounds purrfect. The REAL Horus (my Egyptian Mau) would like to be on the invitation list.
pg
Doug, I believe the problem I have on this is summarized by Dr Carroll when he said
“You did a stupid thing defending Dr. Nemeroff after ACNP obtained his resignation. You just make it worse now by repeating your defense.”
Its the ‘repeating’ thats the problem, not the original defense.
pg
As in: its important to know if a professor and researcher of psychiatry in an influencial position is aware, at least now if not before, of the importance of transparency in science, including disclosure of interests, and the harm that can result when issues such as financial interests are ‘overlooked’.
pg
For this reason:
“…According to its website, Scientific Therapeutics Information (”STI”) is “a full-service medical publishing group specializing in the development of scientific literature and other resource media with direct application to clinical therapeutics. STI has been serving members of the pharmaceutical industry and medical associations since 1985.” See [Link]
In point of fact, ghostwriters are hired by pharmaceutical companies to subvert science (”developing scientific literature”) into a marketing tool.
STI ghostwriters have crafted numerous misleading journal reports that were instrumental in turning ineffective, even lethal drugs into blockbuster sellers. For example, STI ghosted Merck’s Vioxx reports, Cyberonic’s VNS (Vagus Nerve Stimulation) report, and GlaxoSmithKline’s deceptive published report about Paxil study 329. The latter was identified as a key document in New York State Attorney General’s lawsuit that charged GSK with fraud (2004)…”
(Taken from http://ahrp.blogspot.com/2008/05/holding-fda-officials-to-same-standards.html#comments )
From that I would suggest the ‘guest editor’ was chosen very carefully in all three cases from a firm that appears to specializes in converting bad science into convincing publications? Look at the harm that has resulted in the case of their doing so for Vioxx and Paxil.
pg
For this reason:
“…According to its website, Scientific Therapeutics Information (”STI”) is “a full-service medical publishing group specializing in the development of scientific literature and other resource media with direct application to clinical therapeutics. STI has been serving members of the pharmaceutical industry and medical associations since 1985.” See link [http://www.stimedinfo.com/sti.htm ].
In point of fact, ghostwriters are hired by pharmaceutical companies to subvert science (”developing scientific literature”) into a marketing tool.
STI ghostwriters have crafted numerous misleading journal reports that were instrumental in turning ineffective, even lethal drugs into blockbuster sellers. For example, STI ghosted Merck’s Vioxx reports, Cyberonic’s VNS (Vagus Nerve Stimulation) report, and GlaxoSmithKline’s deceptive published report about Paxil study 329. The latter was identified as a key document in New York State Attorney General’s lawsuit that charged GSK with fraud (2004)…”
(Taken from http://ahrp.blogspot.com/2008/05/holding-fda-officials-to-same-standards.html#comments )
From that I would suggest the ‘guest editor’ was chosen very carefully in all three cases from a firm that appears to specializes in converting bad science into convincing publications? Look at the harm that has resulted in the case of their doing so for Vioxx and Paxil.
HorusCat
Doug,
I looked on your website for a way to email you…???
Horus
pg
Horus, a bit further up in a comment to Lisa, Doug has left and email address for contacting him.
Sorry to all for double post - it said it hadn’t posted so I did it again with the link in the article put in full in case that link had somehow messed it up, then posted and found the first one had posted after all.
HorusCat
pg,
Thanks! I wanted to tell him a story about the real Horus getting his first taste of the outdoors, but didn’t want to clutter up the site going off-topic like that.
HorusCat
pg,
If I can’t medicate my 14 year-old, can I medicate myself and use duct tape on him? :+)
Doug Bremner
pg
no, the guest editor was well known academic.
Doug Bremner
pg, no the guest editor was a well known academic
pg
Doug - was (is) the well known academic considered to be a ‘national key opinion leader’?
“Scientific Therapeutics Information, Inc (STI) hires full-time, in-house editors and medical writers who share our belief in a team effort. Editors and medical writers at STI work with national key opinion leaders in a variety of therapeutic areas, as well as with medical and marketing teams of leading pharmaceutical companies, to develop sound scientific publications.”
(http://www.stimedinfo.com/commitment01.htm )
I’m not sure what STI hold as a standard for ’sound scientific’ publications given the results.
“…The recent news about Dr. Nemeroff stepping down from his position as editor of the American College of Neuropsychopharmacology journal called Neuropsychopharmacology for not disclosing a conflict of interest with Cybertronics. Dr. Nemeroff is chairman of Cyberonics’ Mechanism of Action Advisory Board.
This comes on the heals a complaint filed with the United States Securities Exchange ommission against Cybertronics on August 18, 2006, for violation of the United States securities laws under sections 10(b) and 20(a) of the Securities Exchange Act of 1934 by:
making false and misleading statements regarding Cyberonics’ Vagus Nerve Stimulation Therapy System (the “VNS Device”) as a therapy for treatment-resistant depression (”TRD”)…”
(http://habamusrodentum.blogspot.com/2006_08_01_archive.html )
Doug Bremner
pt,
yes, he was a ‘national key opinion leader’.
I’m not sure what point you are trying to make here. The point I was trying to make is that the lack of disclosure was a mistake, not intentional. God forbid that any of us should ever make a mistake. That said no I do not condone intentional lack of disclosure or the use of ghost writing used purely for the promotion of pharmaceuticals. As for
“I’m sorry - but I will not be reading your book”
I don’t what the purpose of this statement is. Should I say “I’m sorry I won’t be reading your posts?” Because that is pretty much saying the same thing.
pg
I’m reading your posts too Doug :) How do you know it was a ‘mistake’? Its happened before with Nemeroff apparently, more than once.
“…His power, the cover story (in TEN: Trends in Evidence-Based Neuropsychiatry, 2000) notes, is measured by “the sheer enormity of his research grants, awards and scientific board appointments” and his “prolific authorship” (by the year 2000, his name was penned to 600 “scientific reports and reviews”). Since that article was published, Dr. Nemeroff has been at the center of considerable controversy, for repeatedly failing to disclose his extensive commercial ties to companies whose products he reviewed favorably in journal publications…”
About your book - I would want to read it IF I knew that you knew (!) that Nemeroff had repeatedly failed to disclose financial interests, and that you had made a mistake by signing that letter but now know it was a mistake back then ?
Partly because your field is psychiatry and many psychiatric drugs have been sold as safer than they were because of non-disclosure (of financial interests and negative data) that would have made ‘approval’ rather difficult.
Surely Nemeroff, being a big name in psychiatry, should have known how important disclosure was? So, given he must know and given his - I’ll call it a habit - of seemingly failing to disclose his financial ties, isn’t there something to worry about re defending that failure?
I must be that party guest who you find crashed out on your living room floor when you get up the next day, or two, or three!
pg
Sorry, link to the paragraph in the last comment is
http://www.ahrp.org/cms/content/view/345/27
Doug Bremner
I do have to admit I am getting tired of this ‘party’ (sigh). Oh well it was fun while it lasted (at least for a while). Pg, you and Nathan can form a club called “We’re not going to read Doug’s book.” although for different reasons. In the meantime I am going to go commune with the spirits of the ghostwriters as I enter a deep and contemplative state, examining my conflicts of interests, disclosures, and general ethical and moral compass, secure in the knowledge that my disclosures are resting safely on my web site, and that this post was conceived, written, and executed entirely by myself, with no assistance from any commercial entity…
Lisa Van S
Dr. Doug,
I have read your book,… It was excellent! I will recommend it to family and friends. With that said,.. your chapters on antidepressants and medicines in children was quite lean,.. would you please explain why.
I personally would have liked to have seen a chapter on the importance of medication guides.
Antidepressant withdrawal can be horrendous, and I felt you addressed this too lightly. May I suggest you converse w/Laurie on this if you intend to revise your book.
On Valerian– do you have a link to the studies you mentioned in your book. Valerian is widely use in Russian Orphanages.
Doug Bremner
Lisa Van S, thanks! Dr. B has been feeling a little over-criticized lately by both the left and the right, so to speak. The references for Valerian are on my web site at
http://www.beforeyoutakethatpill.com/citations.html
you can click on the link to Chapter 16 on insomnia and then there are hyperlinks to the references. Most of the citations I had to put on my website because there wasn’t room in the book. I tried to make the book as fact-based as possible and the people who read it thought it was ‘fair and balanced’, although I reserve the right to be ’snarky’ at times on my blog. Ha!
As for antidepressants I talked more to star.com
http://www.startribune.com/lifestyle/health/17926444.html
and medications in kids I elaborated a more in an article in the Atlanta SundayPaper last week.
http://www.sundaypaper.com/More/Archives/tabid/98/ArticleType/ArticleView/ArticleID/2259/PageID/1739/Default.aspx
Although I guess as a psychiatrist I could most likely be accused of being biased in the psychotropic field, although I try to look at things as objectively as possible.
All I can say is… Don’t take away my placebos! Ha!
Noni
If his stance in the book is as lame as he sounds here, I’m not rushing to the book store. I can get this information elsewhere, for example on statins at Beatrice Golomb’s Statin Effects Study, for CNS drugs and some others, at AHRP (mentioned above), in books already out there such as John Abramson’s Overdosed America, Shannon Brownlee’s Overtreated, Moynihan and Cassels’ Selling Sickness, Bitter Pill, etc.
Too little too late, and looking a lot like an attempt to cash in.