The Rise Of Marketing-Based Medicine
138 CommentsBy Ed Silverman // January 28th, 2010 // 7:57 am
You’ve heard of evidence-based medicine. Well, a new paper summarizes a panoply of practices employed over the past two decades or so - ghostwriting, suppressing or spinning data, disease mongering and managing side effect perceptions among docs - that the authors call marketing-based medicine. And they rely on internal documents from litigation - such as the much-publicized lawsuits over antipsychotics and antidepressants - to illustrate their point.
“While much excitement has been generated surrounding evidence-based medicine, internal documents from the pharmaceutical industry suggest that the publicly available evidence base may not accurately represent the underlying data regarding its products,” they write in Bioethical Inquiry (see here). “We propose that while evidence-based medicine is a noble ideal, marketing-based medicine is the current reality…Although many internal industry documents are legally available on the internet, there are as yet few publications in the biomedical literature based primarily on internal industry sources. These internal documents, as well as material drawn from other sources, provide insight into the intersection between marketing and
science within the pharmaceutical industry.”
The essay refers to revealing emails in which execs remonstrate over trial data that contradict desired marketing messages; instances where a company ‘cherry picked’ trial results for publication; behind-the-scenes thinking about the use of ghostwriters, and materials given sales reps to help them downplay side effects when pitching docs. Much of this is familiar to those who have followed any of these issues, but the authors attempt to gather it all together to argue that marketing has all too easily trumped science. They also lament that medical journals have, at times, been manipulated.
One interesting email is from AstraZeneca’s Seroquel litigation about cherry picking data in which one employee writes to others that hiding data may come back to haunt everyone. “There has been a precedent set of cherry picking data…Thus far, I am not aware of any repercussions regarding interest in the unreported data. That does not mean we should continue to advocate this practice,” the AZ employee writes.
“There is growing pressure from outside the industry to provide access to all data resulting from clinical trials conducted by industry. Thus far, we have buried trials 15, 36 and 51 and are now considering COSTAR.
The larger issue is how do we face the outside world when they begin to criticize us for supressing data. One could say our competitors indulge in this practice. However, until now, I believe we have been looked upon by the outside world favorably with regard to ethical behavior. We must decide if we wish to continue this distinction. The reporting of the COSTAR results will not be easy. We must find a way to diminish the negative findings. But in my opinion, we cannot hide them.”
We should also note that, as psychologists, the lead researcher may advocate therapy before, or instead of, medication, an issue that has been raised before on this site when discussing psychology’s views of antidepressants.
John Kamp
We must provide the same skepticism to literature driven by enterprising lawyers trying their cases in the court of public opinion as to marketing materials. Lets not pretend that legal advocates are pure while marketing plans are tainted. Good medical journalism requires hard work, careful fact checking, and a full understanding of the difference between facts and opinion.
John Kamp
Executive Director
Coalition for Healthcare Communication
jkamp@cohealthcom.org
Jack Friday
This is a well researched and written piece of work.
I would say it is a “MUST READ”!
SteveM
The marketing abuses were/are all with psychotropic drugs. Which illustrates what a dysfunctional therapeutic catastrophe psychiatry has become.
And ironically, rather than putting out the fire of psycho-pharmaceutical Rome, the psychiatric cognoscenti fiddle with DSM V.
Mary Webster
Yes, let’s not pretend that special interests don’t influence our positions.
Coalition for Healthcare Communication
2008 Annual Report
http://64.33.81.11/pdf/ar_2008.pdf
The article in question is, *From Evidence-based Medicine to Marketing-based Medicine: Evidence from Internal Industry Documents* written by Dr. Glen Spielmans, associate professor of psychology, at Metropolitan State University in St. Paul, Minnesota and Dr. Peter Parry, a child and adolescent psychiatrist and senior lecturer at Flinders University in Adelaide, Australia.
This work is incredibly important and I applaud Drs. Spielmans and Parry for their continued efforts to wave the cautionary flag. The article is an exceptional piece of research and calling it to our attention is evidence of good medical journalism.
patrons99
The biggest risk to adoption of electronic medical records is that pharma and insurers will access this data with impunity to further their own agendas ($$$), which are very distinct from the interests of the patients. Right to privacy? Secure electronic databases? Who would control access to such information? It’s ultimately all about controlling us.
SteveM, “psychopharmaceutical Rome”. Can you elaborate?
Justice in MI
Is there any evidence that lawyers had anything to do with this publication?
The email Ed cites is one of those I mentioned the other day from the collection that came out in a WSJ story last year.
But the centrality of marketing over benefit is not disguised. I just received an email pitch for a marketing guide that includes chapters like this:
Feelings Outweigh Facts
When it comes to choosing prescriptions,
consumers value how drugs make
them feel over how they can actually
help them.
David Rees, Health Strategies Group
That’s right from the Table of Contents.
Sourcewatch
In the interest of accurate reporting, here is the sourcewatch summary on “Coalition for Healthcare Communication,” represented above.
http://www.sourcewatch.org/index.php?title=Coalition_for_Healthcare_Communication
Jack Friday
The Coalition for Healthcare Communication is an organization, comprising primarily advertising and publishing company members, that defends the role of the drug industry in direct-to-consumer advertising, drug promotion and ‘educating’ health professionals.
The CHC describes itself as defending the “right of health professionals and consumers to receive truthful information regarding pharmaceuticals and medical products, as safeguarded by the Constitution of the United States.” [1] The CHC was formed in 1991.
Members
* American Association of Advertising Agencies
* American Advertising Federation
* American Business Media
* American Medical Publishers Association
* Association of Medical Publications
* Association of National Advertisers
* Healthcare Businesswomen’s Association
* Healthcare Marketing and Communications Council
* Medical Marketing Association
* Midwest Healthcare Marketing Association.
Personnel
* John Kamp, Executive Director
Contact Details
Coalition for Healthcare Communication
405 Lexington Ave
NY, NY 10174-1801
(NYC) 212-850-0708
(DC) 202-719-7216
Email: info AT cohealthcom.org
Web: http://www.cohealthcom.org
harpy
Seems to me that when you equate marketing materials/plans to good medical journalism you’ve already got a problem.
Sourcewatch
John Kamp, represented above, is himself a lawyer (not that there’s anything wrong with that) who works at Wiley, Rein the primary firm that represented Wyeth in the Levine case.
http://www.wileyrein.com/professionals.cfm?sp=bio&id=107
SteveM
Re: “SteveM, “psychopharmaceutical Rome”. Can you elaborate?”
Was just a play on Nero fiddling while Rome burned. I.e., Noodling DSM V is pointless in the context of a Big Pharma polluted therapeutic discipline.
Justice in MI
Whatever the source, I have long believed that no two sentences better represent the current crossroads on which the industry finds itself than these, taken from the email Ed cites:
” I believe we have been looked upon by the outside world favorably with regard to ethical behavior. We must decide if we wish to continue this distinction.”
patrons99
Historically, the practice of medicine has, in general, been looked upon as a very honorable profession, held in high esteem by society. Yes, JiM, “we must decide if we wish to continue this distinction”. Big pharma, big insurance, and a whole array of parasites, need to “butt out”. They shouldn’t get past the front door. Just one doc’s opinion.
Glen Spielmans
Thanks for your interest in the topic. We had no contact with lawyers as we wrote the paper. Attorneys were responsible for the process by which the documents were released. Perhaps that somehow invalidates the content of all the documents?
As for John Kamp’s comment: “Good medical journalism requires hard work, careful fact checking, and a full understanding of the difference between facts and opinion.” - I agree. Please point out any errors so that we may correct them. But if this is just a throwaway statement used to instill doubt in our paper, then it should be disregarded.
elmore
This is a really important paper.
Lisa Van Syckel
Mr Kamp,… For the sake of transparency, would you care to share, who pays you your salary, and how much money has your organization received from the Pharmaceutical Industry over the past five years?
Jaynesday
Marketing is fine for products that are cosmetic but has no place in the persuasion to ingest pharmaceuticals.
Marketing is based on the idea of fabricating perception and/or stretching the truth.
Then the more you stretch the truth the easier it is to fabricate lies or the more that lying becomes required to compete in the market.
Mr. Kamp’s comment at the top is a good example of marketing.
joanna
Marketing-based medicine is usually for off-label marketing. sell the drug to as many patients as possible and downplay the risks. The justice department released exhibits related to the Pfizer case, which give an insight into these marketing practices.
Pharma Conduct Guy
As a former employee of Wyeth and Pfizer, I feel more than qualified to speak on the topic of pharma research. When trying to understand someone’s real motives, I think of the truism, “Don’t tell me your priorities or values; show me your budget.”
Look at any pharmaceutical company’s annual report, specifically, the amounts allocated to R&D, Sales/Marketing/Advertising, and you’ll get a sense of where pharma’s priorities are today.
Pfizer loves to tout that they spend more on R&D than virtually all other companies. However, they always seem to omit how much they spend on Sales, Marketing and Advertising.
In Pfizer’s 2008 Financial report (http://media.pfizer.com/files/annualreport/2008/financial/financial2008.pdf), their SI&A expenses (sales, marketing, advertising, etc) were $14.5 billion. Quote: “Advertising expenses totaled approximately $2.6 billion in 2008, $2.7 billion in 2007 and $2.6 billion in 2006.”
Guess how much was spent on R&D?. The 2008 report says it was $7.9 billion. And, many question what Pfizer calls R&D. For example, should payments to physicians for answering a five question survey after writing 50 prescriptions count as “research?” Based on this information, which do you think Pfizer places a greater emphasis on, scientific research or sales/marketing?
On the flip side, if you were Pfizer’s CEO and you knew what your return on investment for sales/marketing would be, but you had no concept of the relationship between R&D spending and profit, where would you put your money?
Find out more on http://blog.pharmaconduct.org/?src=PharmalotComments20100128.
Sourcewatch
Wow. Mr. Kamp has appeared to provoke “skepticism to literature driven by enterprising lawyers.”
In this case, the main enterprising lawyer seems to be Mr. Kamp.
joanna
http://www.justice.gov/usao/ma/Press%20Office%20-%20Press%20Release%20Files/Pfizer/exhibits/Farina%20Trial%20Exhibit%2022A.pdf.
riv
“marketing based is the current reality”.
No s*it Sherlock.
Where can I apply to earn my living this way?
pharmavet
Here’s the way to turn a so-so postmarketing study into a positive study. I know how because it is standard industry practice from my years in pharma R&D. Let’s say that we want to do an equivalce study of my company’s marketed drug vs the market leader. Ww include a placebo group merely as an internal control. We’re probably no better than the leader, and when the data come out as such, no journal is probably going to be interested in it, even if both drugs beat placebo. The results show both drugs equivalent and both beat placebo. It’s certainly not in our interest to publish a study that shows us as no better than placebo. Presto, Marketing tells us to proceed as follows (remember I said from another post that Marketing runs the show). 1) For publication purposes, remove the comparator arm and publish it as a simple placebo-controlled trial. 2) For marketing purposes, re-draw the graphs to include the comparator arm. Marketing then adds the tag line “unsurpassed efficacy” (we actually got away with that line for about 3 years before DDMAC slapped our wrists 3)Delay publication so that there is no conflict between the paper and the detail piece and so that the detail piece can be referenced as “Data on File”.
Another time I worked for a company that made a very popular antibiotic that Marketing wanted to increase sales for even further. They asked me to do a retrospective study of 100 patients to show how great our drug was. I proceeded to do a standard case-control type of study, when Marketing said that that left too much to chance. Instead they wanted me to cherry pick the literature to find 99 glowing case reports on our drug, with 1 bad report thrown in for “fair balance”. The idea was so ridiculous that even the Marketing manager nixed it.
PS, my case control study never got done either.
pharmavet
Sorry, meant to say not in our interest to publish study showing our drug no better than comparator.
Justice in MI
Thanks, vet.
In “fairness”–if that’s the right word– to the AZ guy quoted in Ed’s post, my understanding is that they decided _not_ to bury the particular study in question, although they had buried earlier ones.
Rather, as he suggests (and vet describes a case of above), it was spin and distract rather than fully suppress: “We must find a way to diminish the negative findings. But in my opinion, we cannot hide them.”
Viva free speech! (I mean that, even in the face of obvious manipulation, exploitation, and sociopathy.)
Terry
John Kamp is also a collaborator with the American Association of Clinical Researchers and Educators.
http://carlatpsychiatry.blogspot.com/2009/11/tom-sullivan-of-acre-fame-is-swimming.html
These guys never stray far from their industry dog houses.
patrons99
KUDOS to Dr Spielmans and Dr Parry. Very well researched and written.
When does “scrubbing inconvenient data from database” to enable the morphing of a trial from showing questionable or poor efficacy and safety to a definite statement of efficacy and safety cross the line and become fraud?
Was there motive, means, opportunity to commit fraud? Was there an agreement which can be inferred from the totality of the circumstances? Have lives been lost? Was the federal healthcare fisc damaged?
A very similar expose could/should be written for the asthma/allergy medical literature, which is a 20 year long “river” of ghostwritten “research” articles which is wide and deep and extends from coast to coast.
Former Big Pharma
These authors have called it right. Big Pharma is all about making the most money and marketing rules. The scientists and physicians that may raise concerns are ignored and pushed aside by the salesmen. Ethics and morals are long gone from the industry. The top dogs don’t care if they hurt patients as long as they make lots of money. It’s very sad!
SP Guy
Ever since pharma was taken over by MBAs, the industry have taken the lower road and landed in the gutter. The execs are slime!
Anna
it’s panoply, not panalopy. otherwise, great article
Evelyn Pringle
I’m sure Doctors Spielmans and Parry knew what to expect when they undertook the task of publishing a paper critical of Pharma.
I’m nearly as surprised as I am grateful that there are still some medical professionals out there in the world still willing to risk the consequences.
Doc
The avarage person has no idea that marketing departments in big pharma have all the power. They even decide what medical studies to do as well, with the end goal of dollars in mind, not patient well being.
Isn’t it comforting to know that some MBA from grad school is telling scientists and physicians what to do? Hey, they probably took Gen Bio 101/102 with a lab, so I guess they are qualified.
Justice in MI
So, as usual, I’ll ask another question–
If what Doc and others describe is true, why do the scientists and docs do it?
Is it all/mainly about paying the rent and college tuitions (which needs I totally respect)? Is there any sense that things can change? As asked in another thread, is there any room at all for pushback?
Justice in MI
I do have this critique of the article as a whole. Aside from the inclusion of court documents to reinforce main points, the overall analysis here has been done many times by others–Thomas Bodenheimer, John Abramson, Melody Petersen, Jerry Kassirer, et. al.
The fact that these other folks are nowhere cited raises an issue of academic integrity for me. I would welcome the authors’ response.
pharmavet
Dear Justice: As to the question “why do they do it?, that question can be posed to virtually any member of the medical/scientific/academic/industrial establishment. Take a very simple example. Today, practicing psychiatrists are hurting financially because insurance only pays for limited amount of psychotherapy but much more generously to see a psychologists (because they charge less). Here’e the set-up. The psychologist gets reimburesed for a full 45 minute session whereas the psychiatrist only gets paid for a 15 minute “medication management” session, which any shrink will tell you is completely inadequate. So he has the choice of seeing the patient for a 45 minute medicine evaluation and get paid for only 15 minutes, or seeing three patients for “medication management” sessions times three (45 min total) which will lead to poorer treatment but better reimbursement. These are every decisions in all aspects of medicine, and by no means limited to pharma.
Glen Spielmans
Again, thanks for all the comments.
Justice - Yes the overall conclusions of our paper jive with the conclusions of many others, some of whom you named in your comment. I have read some of those authors more than others (I can’t speak for Dr. Parry on this). We really hit the limit in terms of length and couldn’t add much else. Neither Dr. Parry nor myself intended to minimize the important work of others - we just didn’t have room to cite everyone who has done work in this area.
We wanted to spend most of our space citing evidence from internal documents as opposed to discussing items that had already been published and were relatively well-known. Finally, I’ll add that we cited, among several researchers: Smith, Chan, Healy, Sismondo, and Applbaum (and Angell, albeit very briefly), who have also contributed significantly to the literature in this area. In a primarily investigative paper such as this, it’s hard to cite everyone.
Former Pharma Marketing Director
Great article and great discussions, thanks to Patronss 99 (Doc), Doc, JiM and Pharmavet….
On that note, a really special thanks to Pharmavet for telling it like it is…Marketing does control it all.
Marketing has trumped science, and unless we fix this we are all doomed…… I mean that in every sense of the word.
I really hope there is some follow up to this.
Spielmans, have you thought about looking at how these tactics have been employed in other diseases including cancer…With the cost of the newer cancer drugs it is becoming a three ring circus….
Justice in MI
Thanks, Vet. And thanks, Glen. I understand…there’s always a wall somewhere.
So, rather than get on your case (!), I’ll just include a link to a ten-yr-old piece of Tom Bodenheimer’s which covers a lot of waterfront in a few pages.
http://www.hhs.gov/ohrp/coi/bodenheimer.htm
Ed Silverman
Peter Parry, one of the authors, asked me to post this note….
Glen Spielmans alerted me to this blog. Thankyou for the supportive comments.
I would just like to confirm what Glen stated - neither of us are lawyers. We are both clinicians, I think Glen has a more academic role but most of my time is practising child & adolescent psychiatry and the 100s hours I spent researching this paper were separate to my main job. We did not have communication with lawyers for the writing of this paper. We accessed all the documents from the public domain, all being released and legally available from court cases involving pharmaceutical companies.
I am a member of http://www.healthyscepticism.org having been an intern at the Royal Adelaide Hospital way back in 1983 with the founder Dr Peter Mansfield.
Glen is not a member of healthy scepticism (yet anyway). But last year I constructed a webpage (with Glen’s help) with many of the excerpts from the documents that later we used for our paper on the old healthy s(k)epticism website:
http://www.healthyskepticism.org/documents/Antipsychotics.php
Our webpage links to websites holding most of the documents - like http://www.furiousseasons.com and bloggers like Philip Dawdy and Jim Edwards deserve a lot of credit.
As Glen notes, our paper focussed on trying to get as much evidence out there within the word count. The powerpoints on the webpage contain many more examples and also includes the powerpoint of a presentation I gave at the RANZCP (Aust & NZ College of Psychiatrists) Congress last year. Also the full AstraZeneca email about Investigator Initiated Trials (near foot of webpage) is well worth reading.
The over-medicating of young children primarily in the USA was the issue that prompted me to look at the documents in the first place. I wrote about this in the Australian media here: http://www.abc.net.au/unleashed/stories/s2701780.htm
“panoply” - thanks Anna I’ll remember that, there’s always got to be at least one typo ;-)
Justice for MI - I reiterate Glen’s views on our not citing more authors, but it was not a systematic review but rather presentation of ‘evidence’ of ‘MBM’ from internal documents and at the same time joining the threads of evidence from RCT manipulation to ghost writing to disease mongering to CME and detailing together into a coherent readable account. Also I have to confess I am mainly a busy clinician who reads mainly developmental psychology and child psychiatry literature so some of those names I am unfortunately unfamiliar with. As to your other comment you should read the Indian Medical Council’s statement which has been leaked ahead of official pronouncement - and that if truly implemented should turn the tide at least in that country from MBM towards EBM. It gives hope that other medical bodies around the world will follow suit - see http://brodyhooked.blogspot.com/2010/01/india-on-gifts-to-docs-just-say-no.html
Also see - http://www.healthyskepticism.org/documents/Antipsychotics.php
thanks
Peter
Justice in MI
Thanks, Ed. And thanks, Peter, if you see this. Absolutely fantastic links. Great resources.
Peter Parry
This didn’t get rejected as spam. my last comment clearly too long and with too many links.
Thanks for the reference to Tom Bodenheimer’s work - truly much has been said about the problem for many years, finally as the Indian Medical Council are showing the tide is turning. Just a correction to my last comment - the IMC policy announcement wasn’t leaked but was officially released prior to publication, clearly the IMC see this as a major statement.
Interesting and not sure why (Pharma has less influence and monetary control in India over the profession?) that such a major step comes from India and not Europe, the USA or Australia…
Jan Henderson
Great article. Thank you, Pharmalot! I was especially interested in the section on disease mongering – convincing primary care physicians to prescribe for bipolar disorder based on vague symptoms (anxiety, irritability, disruptive sleep) rather than diagnosis. Also interesting was the behind-the-scenes discussion of how to manipulate doctors based on their personality type – appealing to the vanity of “High Flyers” and arranging for “Rule Bound” physicians to be surrounded by doctors who would claim prescribing olanzapine is “what everyone is doing.” There are a lot of negative things one could say about Pharma marketing, but I don’t hear anyone saying these folks aren’t smart.
This is the world we live in. As long as medicine is willing to define health as whatever marketing can create a demand for – cosmetic psychopharmacology, increasing lower definitions “high” cholesterol, extensive cosmetic surgery – marketing will reign supreme. It may be true that many psychiatric disorders were scarcely noticed until Pharma claimed to have a remedy, at which point they became epidemic. But it takes three to play this game – Pharma, the medical profession, and the consumer. Are the Pharma marketing professionals really all that much smarter than the rest of us? I know they’ve been doing evil things behind our backs, as this article documents, but could it also be that we’ve been willing victims? Just a thought.
Justice in MI
A brief response (I’ll try) to Jan’s thoughtful post.
I agree with your takes-three-to-tango model. I’ve been focused on the ways pharma has targeted young adults–and their parents–as “consumers.” Marketing manuals have sliced and diced “Generation Y” to determine how to get into their heads, and–beyond that–into their wallets via their bodies. As a university prof who tends to care about his students, this is mostly grotesque. It is also informative.
What becomes clear is that the wider pressures to “succeed” have played directly into pharma’s hand. On one level, this is reflected in the widespread use of speed–not recreationally–but to enhance “performance.” A lot of this is black market, students who have rx’s selling their meds to others. But that is simply a darker side of the ways many have been convinced to locate competence outside of themselves, and thus to need “performance enhancement” not only to do well, but simply to be OK. (And thus all the other “stabilizing” meds on sale.)
So there is a kind of learned helplessness which the marketing cowboys (and gals) foster and upon which they play. But, in the end, it is not difficult to pull back the curtain. And to see that the Wizard of Oz is just some dork from Kansas, but a lot more malign.
The good news: When students learn that, which they do, they are both outraged and free.
John Blenkinsopp
I am the ex-AZ employee who spoke on the recent BBC File on 4 radio programme.
http://news.bbc.co.uk/1/hi/health/8478924.stm
I was asked at the time to “sign off” promotional claims for Seroquel in the UK which I believed didn’t reflect the totality of the data.
This I refused to do.
I would like to congratulate Drs. Spielmans and Parry on a fine piece of work.
The release of the legal documents pertaining to the US litigation last year was the first opportunity I had to piece together the shenanigans my US and HQ colleagues were up to.
Once again - kudos to Spielmans and Parry for their forensic dissection of this grey literature
Larry Lobbyist
Let me say this for those that seem to be missing from this conversation.
“Without freedom to acquire profit through marketing, pharma will not be able to support research and development of new life saving drugs, therefore more will suffer and die.”
The last portion of that sentence (pharma will not be able to support…) has been use to justify any number of contentious industry practices and beliefs. A review of this and similar blogs would reveal its use hundreds of times.
Is this really the way some in pharma think?
Is it OK to say that we must to be allowed to be unethical so that we can do more good?
Is this what goes through the heads of those in the marketing dept, researcher dept, finance, CEO, etc. when they come to that decision point that tugs at their ethical conscience?
Mark McCulloch
I have been searching for this for a very long time now and I have not been able to find such top quality information untill I came to your blog today.
Mark McCulloch
pharmavet
I would be cautious in comparing raw numbers for R&D spending versus Sales and Marketing (S&M as we say in the trade). Having worked in both worlds I can say that there is tremendous wastage in both areas. When I started in Pharma Clinical R&D, budgets were a fraction of what they are now. I ran the Phase IV clinical group for Abbott Laboratories, and our ENTIRE budget for clinical trials was $1 million in 1984. We had to stretch that across four therapeutic areas, and we watched every penny. My most frequent critics were clinical investigators, who labeled us as “cheap”, and they were right, but that didn’t bother me as long as we got the job done.
I firmly believe that one reason for the ballooning cause of R&D Clinical is that Pharma people have forgotten the fine art of hard negotiation with investigators to get the most work for the least money. We’ve delegated budgets to CRO’s, who in most cases can’t or won’t negotiate budget with investigators, as they have no loyaly to the sponsor or the investigator. If we went back to the old way of the Medical Director jawboning the budget lower with the investigators, we could lower costs. Another way to significantly bring down costs is to simply refuse to accept the overhead percentage from the investigator or contracts person. Many pharma folks think this is non-negotiable, but the reality is that EVERYTHING is on the table. By being firm, I have never paid more that 10-15% overhead on a study, even to a university. You’d be surprised when push comes to shove when I tell the institution that I’ll take my study elsewhere how quickly they come around.
riv
Which life-saving drugs would that be that a requirement of honest marketing, efficacy and safety would bring down the towers of capitalism?
Vioxx, Baycol, Prepulsid, Paxil, the one a Toronto researcher found harmful in the midst of her trial, and was and is sued by pharma for telling her patients what she’d found?
I am thoroughly disgusted at the lack of ethics and shoddy morality which seems to be a requirement for pharma employees. Thank god they’re also too stupid to hide it so it’s out- there blatant.
pharmavet
Patrons, the insurance industry has long made use of electronic medical records in decision making. In fact insurance companies are the largest data miners around, and since their software is proprietary by design, they cannot be accessed from the outside for purposes good or ill. Everything that comes from the insurance cos that ultimately relates to reimbursement is based on analyses that are the product of data mining. Likewise physician targeting by Pharma is the result EMR’s via database purchase from IMS.
Justice in MI
Thanks to John Blenkinsopp for posting here and for not being rolled…You are proof that, hard as they are, choices like this are, in the end, our own.
Jan Henderson
Justice in MI - Thanks for your comments. I liked your insights into the pressure to succeed, students locating competence outside themselves, the opportunity this offers Pharma, and especially your optimistic conclusion. I don’t mean to take things off topic here, but it does seem like understanding the consumer is relevant to pharma marketing.
I don’t currently have any “short people” around, so I lack firsthand information. I read Jean Twenge’s The Narcissism Epidemic and, if she’s to be believed, children grow up with a huge sense of entitlement these days. Perhaps that’s not inconsistent with locating competency outside oneself. If you’ve published anything on pharma’s marketing to Generation Y, I’d be interested in a reference.
It’s been years now since I taught undergraduates and the drug of choice continually evolves. These days it does seem to be prescription meds. They’re readily available, doctors prescribe them so they must be safe, and DTC advertising tells us everyone else is doing it so why shouldn’t I. Brittany Murphy, the actress who recently died at age 32, had no alcohol, illegal drugs, or paraphernalia in her room, but she had Topamax, Methylprednisolone, Fluoxetine, Klonopin, Carbamazepine, Ativan, Propranolol, Biaxin, and Hydrocodone.
gpawelski
I did a paper on taxol and one of the researchers listed in the foot notes of my paper had told me that the study he finally published in the journal Oncology, was rejected by all other American & Europen cancer journals (Journal of Clinical Oncology, Cancer, Annals of Oncology, European Journal of Cancer, International Journal of Cancer) where it had been submitted. The journals were reluctant to publish such a scientific report, simply because taxanes (both taxol and taxotere) were at the time very intensively advertized in these journals.
Less than 20 percent of registered clinical trials of cancer drugs are eventually published in medical journals, according to a review published online by the The Oncologist medical journal.
A search of the National Institutes of Health’s ClinicalTrials.gov web site identified 2,028 registered research studies of cancer treatments. Major medical journals require all studies considered for publication be registered at ClinicalTrials.gov or another publicly accessible database.
And a subsequent search of the National Library of Medicine’s PubMed database showed that just 17.6 percent of the trials were eventually published in peer-reviewed medical journals.
The publication rate was particularly low for industry-sponsored studies, such as those funded by drugmakers (just 5.9% compared to 59% for studies sponsored by collaborative research networks. Of published studies, nearly two-thirds had positive results in that the treatment worked as hoped. The remaining one-third had negative results like the outcome was disappointing or did not merit further consideration of the tested treatment, they report.
The finding raises concern about publication bias in cancer treatment trials, according to the researchers, Scott Ramsey and John Scoggins of University of Washington and Fred Hutchinson Cancer Research Center in Seattle.
The researchers suspect the rate of negative results is much higher in the studies that have gone unpublished. “It is likely that many unpublished studies contain important information that could influence future research and present practice policy,” they wrote.
Of course, we know why a registered trial may not be published, some fail and a researcher may decide the result doesn’t enhance knowledge or one’s reputation. And some sponsors don’t want negative results out there. Same goes for some journal editors.
But “unpublished trials may have special importance in oncology, due to the toxicity and/or expense of many therapies,” they wrote. In other words, the knowledge base is incomplete. And who does that help?
A well-done article Drs. Spielmans and Parry!
Former Pharma Marketing Director
Thanks gpawelski - this is exactly as I thought it was.
We wonder why we can’t cure cancer? We spend a great deal of time and money trying keep pushing square pegs in round holes….
Hopefully in the not too distant future I will share my particular journey through the cancer drugs area. Nothing will be a surprise, same old same old. But the information has to get out there!
patrons99
A recent ABC news article titled “Low Vitamin D Linked to Colon Cancer” by Michael Smith on January 22, 2010, bears on the topic of cancer studies:
“A case-control study found that people in the top fifth of vitamin D levels had 40 percent lower risk for colorectal cancer than those in the bottom fifth, according to Mazda Jenab of the International Agency for Research on Cancer in Lyon, France, and colleagues.”
http://abcnews.go.com/print?id=9636657
Pip
I am absolutely amazed over the comments on this post. Stunned actually. Sourcewatch? (in action!) Lobbyists? Former Pharma people? Marketing people? And a lead off by Astroturf. Followed later by the studies authors.
Thank Goodness you people are here.
jpawelski - could you please elaborate your comment “Major medical journals require all studies considered for publication be registered at ClinicalTrials.gov or another publicly accessible database.” Is this only for cancer research? Or all branches or research? What is the other publicaly accessible database? What if its a e-study?
Okay, we get the antidepressants/antipsychotics and crooked psychs loud and clear! When are they going to move on to biologics and rheumatologists?
I intend to go thru the links posted to try and find more info on the biologics - if anybody is studying that aspect of MDM vs EBM? Or if there are any studies about them, please point me in the right direction.
Pip
Justice in MI
Thanks, Jan. You write, “but it does seem like understanding the consumer is relevant to pharma marketing.”
Heck, yes! There is a whole industry devoted to doing psychological, sociological, and every other ogical analyses of “high writers” (prescribers), which studies are, in turn, passed on to maketeers.
If the product is legit and worthwhile, and the marketing is honest, I have no problem with that. But when it is aimed to increase rx’ing beyond proven efficacy, for unapproved indications, etc. etc. it is obviously scuz.
I am not a big “fan” of Twenge’s analysis; if it was ever true, it is long out of date. But, yes, young adults are also targeted, analyzed, lied to (see, for example, Yaz), in order to perform walletectomies on them, their parents, their docs.
When you’re willing to throw away kids for profit, it takes it to a different level.
Justice in MI
p.s. Good example re: Brittany Murphy
In general, young adults are about as cynical about the industry as adults in general. But they are no less willing to use the products, which is also true of most adults in general. So distruct in the companies happily co-exists with trust (or trust enough) in what they manufacture.
That said, it is always interested when young adults specifically read marketing reports about to “reach” them (and their moolah). I guess it would like a deer reading Sports Afield.
Justice in MI
To write the last sentence fully:
That said, it is always interessting when young adults specifically read marketing reports about how to “reach” them (and their moolah). I guess it would be like a deer reading Sports Afield.
Matthew Holford
Justice in Michigan wrote:
“…If what Doc and others describe is true, why do the scientists and docs do it?”
Have you ever seen “Cube”? It’s a good piece of sci-fi/horror. Several seemingly ordinary people are imprisoned within a vast cube, made up of “rooms” that move around inside the overall structure.
At one point, one of the prisoners, who realizes that he had worked on the project, declares that nobody knows what’s going on: everybody performs their one, tiny contribution, but nobody ever sees what becomes of it. Everybody’s just glad that they’ve got a cushy job that pays well.
Does that answer your question?
Matt
Justice in MI
Hi Matt–”Diffusion of responsibility,” as they call it in sociology, is, of course, part of a lot of things. And one could list a lot of other social psych. similars–groupthink, obedience to authority a la Milgram, Abilene paradox, etc. etc.
Still, in a lot of the situations we raise, people do have some idea of how their piece fits into a wider whole It takes a very unusual person not to “go with the flow.” I doubt I would be such a person myself.
But I wondered whether people felt there was even the beginning or a way to buck the tide, well short of whistleblowing, that has or can be tried.
John Blenkinsopp
J I M
This might help explain behaviour: Complicity Theory.
For “coxibs” read “atypicals”!
http://jrsm.rsmjournals.com/cgi/content/full/99/6/273
There are generally two schools of thought on how we get into a mess of this sort: the conspiracy theory and the cock-up theory. I generally believe in cock-up rather than conspiracy. But in this case there has been much talk about conspiracy and cover-ups within the industry. One can see why. The potential profits that can come from a good anti-inflammatory drug are enormous, and it is sometimes hard to believe that any drug company would not be `influenced’ by the prospect of those profits. And I think their marketing divisions have been. The money and expertise that went into the launches of celecoxib and rofecoxib was truly obscene. The more serious accusation is that the science done by and for the industry has also been biased and corrupted by these financial interests. Maybe it has, but little direct evidence has emerged to support such accusations. In this instance, I believe the main problem belongs within the province of a third `how-to-get-into-a-mess-like-this-one’ theory—complicity theory.10
Complicity works like this. All those with a vested interest in an enterprise get sucked into the rhetoric associated with it, and they soon `believe’ in everything that is going on within that enterprise. If personal financial gain is involved, corruption may also occur. So, in the case of drugs such as anti-inflammatory agents, researchers and prescribers work with the industry to promote the development, testing and use of these drugs. Personal financial gains come through company shares, consultancies and free trips to exotic locations (for those who do research or actively promote the drugs), trips to educational meetings (for specialists), or `just’ free lunches (for just about everybody—does any doctor still buy his/her own lunch?).11 If this goes on for long enough (and it has), everyone starts to believe that they are doing the right thing when they accept company largesse, and to believe in the drugs. And they do not realize that their ability to look at data critically, and at drug use objectively, has been compromised. So, when data comes along that says that rofecoxib causes heart attacks, lots of people say `wait a minute, rofecoxib is wonderful, so maybe the explanation for this is that the NSAID comparator (naproxen) is also a wonder drug and is protecting people against heart attacks’.12 The marketing pressures make all of this worse, of course. So when a paper gets published that says that celecoxib is wonderful, it gets distributed to everyone (as they attend the free lunch event). And when it turns out that the data are flawed (fraud?) the papers still go on being distributed to everyone.13
patrons99
Fascinating discussion! This is why I love this blog. God help me, if I am overzealous at times. Complicity theory goes to the heart of Whistleblowing.
More than a decade ago, I found myself in a situation, none of which was of my own choosing, wherein a pattern of repeated, related intentional endangerment of clinical research subjects was occurring, during my employment. I knew that the junior clinical research staff also knew of this “problem”. Could I have simply “walked away”? You bet! Would my life have been much happier if I had? Almost certainly! Was I or any of the clinical research staff either knowing or unwitting accomplices? Only if we had walked away. We did not walk away. My conscience is very clear.
Complicity theory also goes to the heart of the current “pandemic” flu nightmare we have recently endured. And by the way, we are not out the woods, not by any stretch of the imagination. This is not the last “pandemic” scenario we will ever face. It will now take an act of God to force WHO to change the definition of pandemic back to what it had been. The new definition is much more conducive to pharma’s shift towards biotech from chemistry-based development. Biotech now requires a much lower burden of proof to gain expedited market approvals with the non-inferiority margin as the choice of control, wherein pharma need now only show that their new biological is no more acutely toxic than those biologicals already in the marketplace. Unregulated biotech “research” is fraught with immense risk of accidental releases or laboratory “accidents”.
Are we lemmings marching towards a cliff? Are we hapless gulls? Do we fully understand the risks of a global vaccine and biotech research policy dictated by “pharma gone wild” and the WHO?
Stephany
“The pharmaceutical industry has developed a position of extraordinary power over governments, medical research and medical practice.[14,15] But complicity theory makes it clear that this would not have been possible without others going along with their story.”
http://jrsm.rsmjournals.com/cgi/content/full/99/6/273
Nice journal addition to the discussion, Blenkinsopp. Interesting comments here.
Justice in MI
John–Thanks for “stopping by” and adding your thoughts and the reference. And thanks to others as well.
Dare I ask…what is the “cock-up theory” (somehow, I missed that). The inevitable one-liners are available, but I’ll let them go for the moment…
Also, there is this quoted bit: “The more serious accusation is that the science done by and for the industry has also been biased and corrupted by these financial interests. Maybe it has, but little direct evidence has emerged to support such accusations.”
Haven’t so many of the documents released supported precisely such accusations–as illustrated in the buried and cherry-picked studies with which this thread began? Or is the point that the studies were OK, but their “metabolizing” wasn’t….?
Thanks!
John Blenkinsopp
J I M
Re “cock-up theory” = “Never assume malice when stupidity will suffice”
Re bias and corruption of science. I guess Dieppe’s paper came out in 2006 and focused on the coxibs. More evidence has come out since then.
I wonder what other examples readers might have?
Here’s my first contribution:
http://www.helenjaques.co.uk/blog/2009/bmj-tamifl/
Jaynesday
In answer to the question - what can be done?
Maybe there is nothing that can overcome the power of money to influence behavior, other than the power of the forfeit of that money x 2.
Jack Friday
Lets get a few marketeers in bracelets doing the “perp walk”!
That’ll make ‘em think twice!
But some legal experts say they’re still not careful enough. A former Justice lawyer who now represents whistleblowers said these big settlements aren’t deterrent enough. “It’s not going to stop until the government puts some of these executives in jail,” Shelley Slade of Vogel, Slade & Goldstein tells the Journal. “Many of these companies view the fines as a small fraction of what they have gained through illegal schemes, and just a cost of doing business.”
Read more: http://www.fiercepharma.com/story/can-government-probes-change-drug-marketing/2010-01-29#ixzz0eEkOEGAy
Jaynesday
Jack,
No lawyers, no politicians, just 2x all profits that would be dispersed equitably to all harmed through a review board.
Justice in MI
re: corrupted science, certainly there have been no shortage of examples of FDA reviewers pressured to change their conclusions or head for the hills re: NDA reviews.
And the Bodenheimer piece cited up thread notes a variety of ways in which trials can be designed _before_ analysis and publication to produce an intended result.
Personally, I was myself recently recruited to be in a study in which the doc admitted to me that I did not actually qualify–he needed one more body.
And I know investigators who have been offered bribes _not_ to do research that could be detrimental to a particular product.
All this sounds like corrupted science to me.
Jack Friday
“The Beguiled”!
http://rrtt.ucsd.edu/Tyrer%20et%20al.%20Lancet.%202009%20Jan3.pdf
Pip
Patrons99 - can you link to any more information on Biotech requiring lower burden of proof vs controls?
In answer to the question - what can be done? - somehow, someway, the patients need to become involved. The problem becomes that most patients are too sick to question the experts and how those experts determined safety and efficacy.
As an example, when Celebrex was pulled from the market because of adverse events, it was the patients (with some help from Pharma) who demanded their options be restored.
Its the same with the TNF inhibitors as well as other arthritis/autoimmune disease medications like Tysabri. Those medications have black box warning that read like a litany of horror. But if you have no other options you’re going to demand what’s left and hope for the best.
I’d really like to see mandatory, vs our current voluntary, reporting of serious adverse reactions.
Pip
Mark Chalek
Nothing like preying on the most vulnerable patients whose cognitive ability is already impaired such that distinctions are opaque.
The hustlers and their patrons should be drawn and quartered for putting profits before patient safety
patrons99
Pip, here’s a sample of links re: noninferiority margin. Ed has had several posts on prevnar-13 and David Phillips at BNET has had a post on peramivir. I know I’ve more links on this topic. It will take me a bit longer to find them.
http://www.ema.europa.eu/pdfs/human/ewp/215899en.pdf
http://www.pharmalot.com/2009/11/pfizer-vaccine-missed-some-goals-fda-review/
http://www.pharmalot.com/2009/11/pfizer-vaccine-banned-by-dutch-over-infant-deaths/
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM190734.pdf
http://industry.bnet.com/pharma/10005074/biocryst-pharmaceuticals-antiviral-peramivir-aims-to-keep-influenza-body-count-low/?tag=content;top-active#comments
patrons99
Pip,
A great example of biotech having a lower burden of proof (versus placebo controls) is gardasil. Apparently, FDA let Merck put aluminum in the placebo arm. The FDA website has apparently inactivated the link to their biological review of Gardasil:
http://www.fda.gov/cber/review/hpvmer060806r.pdf
See also:
http://www.generationrescue.org/binstock/090318-GardasilPlacebo-Binstock.htm
http://www.renewamerica.com/columns/janak/080723
http://www.renewamerica.com/columns/janak/070227
http://www.cogforlife.org/gardasilNVIC.htm
Here are two more links on the noninferiority margin:
http://www.ema.europa.eu/pdfs/human/ich/036496en.pdf
http://www.efspi.org/PDF/publications/position_papers/E1202.pdf
The last link is of particular interest because of its date and the involvement of AZ and GSK. I hope these links are of help to you.
patrons99
Pip,
I found another link to the FDA Gardasil clinical review of June 8, 2006. At page 45, Table 24, it is clear that Aluminum salts were present in the placebo arms of 5 of the pivotal Phase IIb-III trials.
In fact, one of the Phase III pivotal trials, actually had Hep B vaccine along with Aluminum salts in the “placebo” arm.
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM111287.pdf
pharmagossip
http://pharmagossip.blogspot.com/2010/02/medical-ghostwriting-is-threat-to.html
patrons99
KUDOS to Jeffrey Lacasse and Jonathan Leo for their article “Ghostwriting at Elite Academic Medical Centers in the United States” of February 2, 2010. Another MUST READ. Another very important article. Bravo Healthy Skepticism!
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000230
The Spielmans/Parry article and Lacasse/Leo article can both be considered “classics”, at least in my opinion.
patrons99
It just now occurred to me that, in the spirit of full disclosure, I should state that I am a member of Healthy Skepticism. I completely support their mission statement. Healthy Skepticism is an international nonprofit organization dedicated to reducing harm from misleading drug promotion.
Suzanne
No NNTs in the peds trials for biologics for JIA/JRA! Is that because it is the same or higher than the NNH?
pharmavet
I think Patrons started a good thing with full disclosure. Other than DIA I hold no active memberships. As Groucho Marx once said, I would never belong to an organization that would have me as a member. Anyone else on these boards willing to disclose their affiliations?
patrons99
Suzanne, Do you have link(s) for the particular peds trials you reference? Practice “guidelines” for use of TNF inhibitors in the context of NNH/NNT and therapeutic indices might be of general interest. What controls were used in the pivotal studies upon which the market approvals were based?
Suzanne
Patrons99,
I found this after looking at peds Enbrel and Humira studies and not being able to find NNTs:
http://blue.regence.com/trgmedpol/drugs/dru081.pdf
Top of page 7: “There is reliable evidence that entanercept, adalimumab, and abatacept (when given with methotrexate)are effective in the management patients with juvenile idiopathic arthritis (JIA). The design of the clinical studies prevents calculation of “number-needed-to-treat” (NNT) for this use.”
This pdf says it is reviewed annually; was last revised Nov. 2009.
Why would they design a study in that manner? The adult studies have NNTs.
patrons99
Thanks, Suzanne. I’ll look into this. I don’t know the answers…yet.
Dianne
Thank you, Ed, for posting this important report.
I couldn’t agree more with the statement:
“Thus, one cannot blame one or two ‘bad apples,’ as it appears data suppression is part of the industry’s standard operating procedure.”
Which means there are millions of men, women and children, world-wide, taking dangerous drugs—with no idea that what they are swallowing could make them deathly ill, or dead. How can we protect ourselves? Legally, the average American has little help, as Big Pharma has promoted tort reform to the point that laws intended to protect us are now protecting big business. But then, big corporations get sick and bleed, like real people, and they need to be protected from humans.
Some see healthcare reform as an opportunity for even more tort reform. Phrases like, (from the article) “Through litigation, one research team gained access to documents…” might become a thing of the past.
john
If the FDA regulated the automobile industry:
Each advertisement would be required to prominently state the number of people who died, were maimed in automobile accidents each year.
All of the most common injuries would have to be listed along with their relative frequency in each automobile advertisement.
Warning letters would be sent to manufacturers when advertisements appeared to show drivers operating vehicles at unlawful speeds, or when ads showed more attractive scenery than is typically found alongside highways.
Minor deviations from these regulations would spur industry critics to fill blogs like this one with posts blasting the immorality of automobile company executives.
Dianne
John: The FDA doesn’t regulate the automobile industry. However, the automobile industry is, also, required to report defective and dangerous products. Both industries have been caught hiding their own research data. Obviously, there needs to be more regulation and disclosure, not less.
Did you mistake Pharmalot for an auto industry blog? God help us if Pharma starts building automobiles.
pharmavet
Dianne, unfortunately since scientists don’t lead drug cos. anymore, we went from building Cadillacs to Pintos.
NameIt
I agree with Vet that a lot got worse over the past 15 years or so. Nevertheless, there was a fair amount of cover-up and the like before–Panalba case, etc. etc. When you read Senate hearings on these issues of the late 70s, they could be taken, almost verbatim, for what we hear today. Likewise, most of the same recommendations–independent office of drug safety, more post-approval surveillance in general, more resources and enforcement options to FDA, etc.
On some level, plus ca change….
Pip
jpawelski - could you please elaborate your comment “Major medical journals require all studies considered for publication be registered at ClinicalTrials.gov or another publicly accessible database.” Is this only for cancer research? Or all branches or research? What is the other publicaly accessible database? What if its a e-study? - I’m sorry to ask again but I have some friends working on a study as patients for patients and hoping to get it published. When they contacted the ACR they were told nothing about this.
Patrons99 - thank you so much for all the links you provided. It’s going to take me a long time to go thru them but I will and will probably be asking for more information. I cannot thank you enought for your kindness.
Mark - yes, that’s exactly what it is. The patients themselves are in no condition to organize or uprise (is that a verb?) and are at the mercy of Pharma.
Pharmavet - unfortunately I have to reveal my ignorance as I’m not sure what DIA is. As for personal memberships - I’m on patient BB’s all over the net, does that count? My interest in all this is because I’m a patient diagnosed with a rare form of RA. And the meds for my disease are really scary. Really scary.
Last time I checked, IMS Health listed anti-psychotics at $14.6 Billion in sales. Thats a drop in the bucket compared to the Pharmaceutical market of $291 Billion + the 75 Billion in Biologics. Now I’m told that the bar is lowered for biologics? That explains why we’re dropping like flies all over the net.
Finally, at serious risk of sounding like a conspiracy theorist (as opposed to the cock-up theory as I’m not seeing stupidity, rather malice) there are people that appear to be marketing reps on all the major boards telling people to ‘go for the big guns’ and ‘aggressive medicine only’. We spin thru these biologics within a few years and are then told to volunteer for clinical trials.
I hope my anger isn’t too off-putting, but I think you can see why I’m upset. This is my future.
Pip
John
My point was that we all need to look at risk in context. People do get injured and die because of side effects of pharma products. But injuries from auto accidents hurt just as much as injuries from drugs, and no one expects car companies to highlight the dangers of driving in their advertisements. No one claims a conspiracy because Honda ads do not contain a detailed listing of the exact types of injuries that have been suffered by Honda drivers.
There were nearly 6,420,000 auto accidents in the United States in 2005. The financial cost of these crashes is more than 230 Billion dollars (in the same ballpark as total US pharmaceutical sales). 2.9 million people were injured and 42,636 people killed. About 115 people die every day in vehicle crashes in the United States — one death every 13 minutes.
Suzanne
Maybe this will be required of car companies when their sales people prescribe cars as opposed to sell them?
Anonymous Patient
Here is some marketing based medicine for you.
This is a real trial going on right now. I hear that patients are calling it the PNOVMS trial which stands for Protect Novartis Market Share…. The background, Gleevec (The magic cancer bullet) patent expires in 2015. No worries, Novartis has Tasigna - see whistle blower case on this blog, and notice black box cardio toxicity warning in the US…But I digress…95% of patients on Gleevec do not achieve a stable enough response that would allow for drug discontinuation. European trials have shown combos with IFN can get 80% of patients off drugs. Novartis Vasella projects $5 billion sales in 2010, see his bonus take on this blog…The trial is rigged to accrue patients with a “sub optimal, but acceptable” response to Gleevec (price sticker is $40k- $80k per year depending on the dose) to either stay on Gleevec for two more years or get randomized to Tasigna (price sticker $98K US/Year). Patients have to commit to four years on the study (voila! - Gleevec patent expires….): http://clinicaltrials.gov/ct2/show/NCT00760877
IRB’s in Canada, Australia and Brazil accepted this - who is zooming who? No science or medicine in this trial, but lots of money…and business as usual…
Jaynesday
John, what your example doesn’t excuse (IMHO)
1. The pharmaceutical industry’s poor safety performance. And using these kinds of examples only serves to excuse that.
2. The fact is that pharma can do a better job of product safety and this should be reinforced. The best minds reside there. Push yourself or be pushed toward safety above profit.
Also it should be noted that whenever we get into our car we know we are at risk, even a risk of loss of life. No one can deny this. Driving a two thousand pound piece of equipment at 40mph within inches of others is dangerous. Our society knows this and for the most part has accepted that fact.
When we take a drug we trust that we will get better. The intention of a drug or device is to improve health not to transport. But increasingly we see that we are surprised by the fact that many end up with worse health or dead. There is an increasing need to inform patients of this especially given that it is the apparent intention of pharma to hide or obscure this fact from us.
John
So is your argument that
1) the human body is so much less complicated that a car, that pharmaceutical scientists should be able to provide completely safe products even if automobile engineers cannot, or
2) That driving an automobile is so much more important than treating your diabetes, cancer, or rheumatoid arthritis, that the safety bar for new pharmaceutical products should be higher than it is for cars?
Sorry to be so sarcastic, but I’m really confused by your expectations. I spent 15 years in research working on diabetes, AIDS, cancer, and Alzheimer’s disease, and everytime I come on this blog all I see is people calling everyone who works in my industry a scumbag. I really don’t get it.
Suzanne
John, I expect to be able to find facts and not marketing spin when considering a drug with a black box warning for my child. I’m confused by your defensiveness - no one says not to treat these diseases; where did that comment come from? However, we need the truth to be able to determine if the benefit outweighs the risk.
If you ever had to make these decisions for a child, you would never confuse it with driving an car. At least I hope not.
John
Once again I would ask, do you put your child in your car? Will you feel less awful if your child dies in a car accident than from a rare adverse effect of a drug? Why is one risk acceptable but the other morally repugnant. I apologize if this sounds personal, I would not bring your children into this debate if you had not done so first.
I really don’t think I’m being at all defensive here. Scroll up above and see what percentage of the posts use words like “parasite” and “criminal”.
Suzanne
When I put my child in a car, I put her in the carseat required by law, in the backseat where she is the safest according the current guidelines, and drive the speed limit and obey all of the traffic laws. I do everything I can to insure her safety. In most instances, driving would be safer than walking to our destination. The benefit outweighs the risk.
Yes, I would feel worse if she suffered an adverse event from a drug that we chose, given that there are several options for treating her condition.
harpy
that’s because he’s a troll, Suzanne, and trying to twist the discussion through a string of fallacies
Jaynesday
John,
The angst here (at least for me) stems from what I see the pharma industry getting away with. Of course I admit I am jaded a bit but still, the constant barrage of less than above board antics tends to make one sensitive and sometimes emotional about these things. I understand your suspicions of many of the views expressed here.
I would hazard to guess that most of those that are emotionally against pharma have been harmed or have seen someone harmed by pharma. Couple that with reports of questionable practices and you tend to have explosions.
Obviously the human body is much more complicated than a car. And that’s part of the problem, even the pharma industry doesn’t understand it to the degree that it should for some of the products that it produces. Honestly I resent being a guinea pig so to speak, to some degree.
A car is mostly mechanical. Mechanical things are easy to understand for most people. Therefore problems are hard to hide if that would be your desire. If you crash test one car all same cars will react pretty much the same way.
It is much easier to hide problems with drugs and devices. Sometimes statistics are all you need. Much more trust is needed to take a pill verses taking a ride in a car. Mistrust is the issue.
I for one don’t hate the pharma industry. I just feel that they can do better than they have settled for. I think easy money sometimes breeds complacency.
I commend and thank you for expressing your opinion here. Both sides need to understand the other better and that’s why I come here.
John
Suzanne, I do not mean any disrespect here, and please note that unlike many others here, I am not calling people names. I understand that you care about your children and do not mean to call you a bad parent because you put your kids in the car, I am just trying to create some perspective that zero risk is not an achievable goal in any aspect of life.
By and large, those of us who work in the industry 1) have children of our own, 2) have friends and family members who have cancer, diabetes, or whatever, and are likely to take the drugs we discover and market, and 3) took jobs in the industry because we love science and want to have a favorable impact on the human condition.
Yes, there are problems in the industry, just like any other. Some of the stories are truly awful. But if you take the good and subtract out the bad, I think the net sum is that we do a lot more good than the folks who make cars, design new cell phones, operate luxury hotels, or whatever. And I take a lot of pride in what I do and what my industry has accomplished.
I’m sure that this post will be followed up with a lot more posts similar to the previous “troll” remark. By all means enjoy yourselves.
Suzanne
John, I’m not looking for zero risk. I know the risks.
John
No disrespect intended Suzanne, and I wish you the best.
Justice in MI
The analogy to problems with autos is pure horse manure (no disrespect intended).
The odds of being hospitalized or killed from an rx drug is 1 in 25. The odds of being injured or killed from a defect in an auto is 1 in many 1000.
That is part of why rx drugs are rx’d–generally, with appropriate care, warnings, and indications.
No one needs a prescription to buy a car. And for good reasons.
Justice in MI
p.s. John–If you actually read the posts on this blog, what you’ll find is that almost nobody calls “everyone who works in my industry a scumbag.”
Only scumbags are called scumbags.
It happens that some of the released documents do, indeed, appear to have been authored by scumbags. Don’t you agree?
Christopher
JiM - ‘Scumbag’ aside there are inappropriate epithets used by those who are evidently anti-pharma or anti those who work in it. And, actually, even to those who are ‘assumed’ to work in pharma. Differing opinions are OK. Flaming those who possess such opinions is not.
I don’t mean you by the way. I think it should be apparent who the recidivists are.
Justice in MI
Totally agree, Christopher. Flaming a whole industry, let alone those who work on it, would be equivalent to trashing “sports” with no further differentiation.
john
“Justice”, if you can cite a peer-reviewed scientific article as a source for your statistic that the odds of being hospitalized or killed by a prescription drug are 1 in 25, I would be interested to see it.
If things are really as bad as you say, I suggest that when you develop a serious bacterial infection, high blood pressure, AIDS, stroke or cancer, you tell your doctor that you don’t want to be treated with any pharmaceutical products. I’m sure he’ll prescribe you a mega dose of vitamin C and it will fix you right up.
john
Sorry, that last comment wasn’t very nice.
Condor
Hello John — I think the basis for JiM’s 1 in 25 is here (at least, this is where I first ran across it):
. . . .This is the central theme of two important new books, Patients as Partners: How to Involve Patients and Families in Their Own Care, by Meghan McGreevey, and You: The Smart Patient, An Insider’s Handbook for Getting the Best Treatment, by Michael F. Roizen, MD and Mehmet C. Oz, MD.
Both books are quick to point out that countless medical errors occur and that a great majority of them are preventable. Roizen and Mehmet reveal that “you have a 1 in 25 chance of developing a serious unexpected complication (such as a fatal infection) when you check into the hospital…[and] your odds of being affected by that potentially deadly, unforeseen complication might be as high as 2 in 5.” McGreevey asserts that “more than two in five, or 42%, of adults’ lives have been touched by a medical error in some way.” Both also go on to report that about 70%-75% of these complications or medical errors are completely preventable. . . .
~~~~~~~~~~
1. McGreevey M. Patients as Partners: How to Involve Patients and Families in Their Own Care. Oakbrook Terrace, Illinois: Joint Commission on Accreditation of Healthcare Organizations, 2006.
2. Roizen MF, Oz MC. You: The Smart Patient - An Insider’s Handbook for Getting the Best Treatment. New York: Free Press, 2006.
Condor
A couple more thoughts, here, John:
. . . .1.5 million preventable adverse drug events happen in the U.S. each year. And the 400,000 that occur in hospitals result in $3.5 billion in additional costs. So how can you improve medication safety?. . . .
. . . .Forty-four percent of Americans are intermediate prose-literate, which means that they can read moderately dense information and break it down to simple conclusions. However, medication instructions, consent forms, and insurance forms can be extremely complex. In a recent study published in the December 19, 2006 issue of Annals of Internal Medicine, Terry Davis, PhD, professor of medicine and pediatrics at Louisiana State University gave 395 study participants 5 prescription bottles and asked them, “How would you take this medicine?” She found that even consumers with adequate literacy levels did not understand the instructions on at least one prescription bottle. The conclusion of the study was that prescription drug labels are not necessarily clear and that mistakes are common.
Those who provide health care need to improve their ability to make the patient understand or this communication gap will adversely affect the patient’s health outcome. . . .
Namaste
PS: Please do yourself a favor and forget the supposed-car-safety analogy. It is transparently silly, given the above — and there are better arguments for your side.
Make them — if you are able.
Josh
Condor….the 1 in 25 number quoted in your article actually refers to the chances of getting a serious infection when one is admitted into a hospital…not a drug AE.
We can let JiM answer his own question….
Jaynesday
Additionally serious adverse events have increased at a much higher rate than the increase in outpatient prescriptions.
Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005
Thomas J. Moore, AB; Michael R. Cohen, RPh, MS, ScD; Curt D. Furberg, MD, PhD
We have two views here. One is that pharma provides many good products so we shouldn’t complain or two - pharma needs to seriously consider its current course.
Condor
Thanks Josh —
JiM can answer.
I suppose the small point you quibble with — in mine — is then actually intended to obscure the larger, more important point.
Seriously, would you rather read it directly from the FDA (at page 2 of that PDF)? The danger of misuse of prescription drugs is obvious beyond peradventure.
And so, Josh — it is a patently specious argument to suggest that prescription drug safety policies should be no more rigorous than auto safety policies.
Prescription drugs are inherently opaque goods (one cannot assess the beneift/risk without an expert’s interposed advice), and therefore — drugs are inherently dangerous goods.
Don’t get lost in the detail, here: John is without any logical basis for his goofy assertions.
1.5 million annual preventible medication errors in the US alone, is a national tragedy.
Let’s address the issues — not waste time knocking over the supposed straw men you and John would care to offer.
Namaste
Justice in MI
Re: John’s comment (he asked the question, not me), the 1 in 25 stat was in a slide in a recent presentation I heard Sid Wolfe give. I will try to get the source from him.
In the meantime, here is the HRG’s site with plenty of references, although I don’t see the 1 in 25 stat there. Whether you believe the rest of what is there is up to you. Jaynesday’s reference is also excellent. Tom Moore has been following this stuff for a long time.
http://www.worstpills.org/public/page.cfm?op_id=4
I agree–the last part of your initial post was unfortunate. It was also irrelevant. By citing the numbers about the odds of death/injury from rx drugs, I was not suggesting–even in the slightest–that anyone shouldn’t use them. I use them, and with great benefit and appreciation. The point was to respond to your earlier stuff about putting warnings on automobiles, which analogy I found silly. But I will apologize for “horse manure,” which was over (or under!) the top.
Justice in MI
I’d also add this. Tom Moore and others have ranked rx drugs as between the 4th and 6th leading cause of death in the U.S. (depending on year and how counted). Deaths caused by defective automobiles are infinitesimal by comparison. That was my point when I rejoined this thread.
Still, that does _not_ mean that the drug-related deaths they were all “preventable” or that many more people weren’t saved by drugs and killed by them–which is true.
The “preventable” number, as estimated by Janet Woodcock, is about half of the total for rx drugs.
That is obviously the issue of concern.
Jaynesday
“… between 1998 - 2005 serious adverse events have increased 4 time faster than the amount of prescriptions written. Deaths have increased 2.7 times.” Arch Inter Med.2007;167(16):1752-1759
I’m curious what the trends have been from 2005 to current with the liftoff of Market Based Medicine.
Condor
Okay I can’t resist this:
FDA reports (via Dr. Tom Kirsch, speaking as a rep of ER doctors, nationwide) that there are a little over 100 million visits to Emergency Rooms per year in the US.
FDA also reports 4 million are due to drug adverse evenets:
“. . . Adverse events from drug use result in more than 4 million visits to emergency departments, doctors’ offices, or other outpatient settings annually. . . .”
4/100 = 1 in 25.
Q.E.D.
Namaste
Josh
Condor,
I wasn’t defending a horrible analogy, nor was I trying to knock over “straw men”, so please stop trying to put words in my mouth. I was actually looking for factual information that 4% of the population get an AE each time they take medicine. I was trying to see where his numbers came from. I run reports of AEs for work and a 4% rate sounded high. According to JiM, “The odds of being hospitalized or killed from an rx drug is 1 in 25.” (4% by my calculations).
Pulling the data from the data for total AE’s in 2008, (562,527): http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070434.htm and then grabbing data from the internet for total prescriptions in the US in 2008 (3.8 billion from Kaiser) http://www.kff.org/rxdrugs/upload/3057_07.pdf shows a .015% of AE’s to total prescriptions, not 4%.
Your paper from the FDA actually details the amount of “preventable” AEs, not overall rate. To quote the paper: “These potentially avoidable injuries and deaths, resulting from medication errors, unintentional exposures, drug abuse, misuse, or self harm, represent a collective failure of society to adequately manage medication risks.”. You are pulling numbers that don’t back up the figures that you are trying to support.
There is always an inherent risk of putting something in one’s body. I work in the industry and I would rather not take drugs if I don’t have to. It isn’t about the safety of the medication, it is more about letting my own body try to repair itself.
I agree that the industry is not perfect and definitely has room for improvement in many categories. Cherry-picking data is just as bad in my book as poor manufacturing…it does the industry no favors in the long run.
Justice in MI
Good grief. Lies, damn lies, and statistics.
No one said “4% of the population get an AE each time they take medicine.”
The 1 in 25 figure was the odds of people having a serious AE (causing death or requiring hospitalization) over a lifetime. That’s how such risk information is generally understood (whether it’s taking a drug, being in a plane crash, being hit by a meteor, etc.).
Condor’s numbers suggest the actual risk is quite a bit higher than what I suggested–his are by the year, not by the lifetime.
In any event, they are enormously larger than the odds of serious injury or death as the result of a defectively manufactured car, which is where all this began.
There are so many straw men on this field, I’m gettin’ itchy.
John
Well, “horse manure”, “transparently silly”, and “troll” I may be, but it seems that I’ve livened this blog up a bit, with people still coming back to this page several days after the story ran to comment on my posts….
The pivotal clinical trials for top selling drugs like Lipitor, Nexium, and Plavix included patient populations of 5,000 or more typically followed for at least a full year. In each case the rate of adverse events were comparable to similar sized placebo groups. I would conclude that there is enough statistical power in these studies to show that these drugs are at least as safe as eating hot dogs, maybe more so. Certainly more safe than driving a car.
So where are all these deaths and adverse events that Condor “can’t resist” telling me about coming from? Well, I would guess that an awful lot of them are coming from cancer drugs. About 25% of the US population dies of cancer, and the vast majority of these will be treated with drugs that are very toxic. Doctors deliberately dose patients with quantities of these drugs that carry considerable risk of death because the cancer itself is likely to kill the patient within a short period, and higher doses increase the chances of a cure or remission. So a drug adverse event is the listed cause of death, but realistically the patient died because he or she had cancer.
So like the comparison of cars and drugs, its once again about risk to reward ratios. Heartburn drugs are expected to be safer than cancer drugs, and the evidence shows that they are.
Justice in MI
Getting back to a question John never answered, I asked above: “It happens that some of the released documents do, indeed, appear to have been authored by scumbags. Don’t you agree?”
Let’s park the derisive term. But I genuinely do wonder how John, Josh, and others respond when the read some of the documents included in the piece that began this thread. For example:
1. The AZ memo: “They [Lilly] are able to spin the same data in many different ways through an effective publications team. Negative data usually remains well hidden…Publications should be more creative spinning the data, aka Lilly.”
2. The email which Ed quoted: “Thus far, we have buried Trials 15, 31, 56 and are now considering COSTAR…Until now, I believe we have been looked upon by the outside world favorably with regard to ethical behavior. We must decide if we wish to continue to enjoy the distinction.”
3. Or Jeff Kindler’s recent statement, which was in very public talk, not in a trial document: “Well, we’ve begun to change. We know we need to be straight with people. No one has any tolerance any more for corporate spin.”
Anyone who has followed my posts on this blog knows that when I ask industry folks (or anyone else) where they “file” such statements, I really _am_ asking.
And I am still asking, even though I very rarely get answers.
Justice in MI
still waiting, lively guy!
Josh
I usually see some sort of quantifying measure whenever I see ratios….so my bad!
Josh
You know JiM, I don’t think you will find anyone defending those idiots. Most of us in the industry find this reprehensible.
While there are some companies that try to skirt the law, there are companies out there that are doing things right (I like to think our company is as we have not run into these sort of issues).
I think some of these people are under pressure to make numbers that they will do anything including sacrificing the lives and trust of our customers. I guess I enjoy working for a private company and not having to deal with satisfying shareholders.
John
JiM, as you stated above, it was never your intent to argue that drugs should never be used.
Similarly, It was never my position that every action ever taken by anyone in the industry was morally acceptable. What I object to is the broad brush in which most on this blog paint the entire industry.
I don’t know what you do for a living, but I think my industry has done more for human welfare than most, even after taking into account the problems.
I ignored your rhetorical question because I found it silly.
Justice in MI
Uh oh, there we go with silly again. Hard to auppress, isn’t it?!
Anyway, thanks, Josh, for your comment. And thanks, John, for yours. If you knew my posts here, you’d read me saying just what you do above.
John
Jaynesday, the article you cited is an interesting one. I pulled it and read the entire article. I do not think the data supports the conclusion that older drugs are safer than newer ones.
I could pull a lot of data from this paper supporting my position, but the simplest and most telling is that the number of reported adverse events for insulin increased by fourfold over this time period. Insulin is a very old drug, and its use tends to be fairly stable over time. Did it suddenly become more toxic????
JaT
Hi John,
I don’t know if this is what Jaynesday was referring to- but to quote an old post here:
“This is an argument used by diabetics who were forced to switch from natural (animal) insulin to rDNA insulin when all natural products were removed from the U.S. market. BUT MOST DOCTORS would not listen. Most doctors dismissed patient ‘anecdotal’ reports, in favor of pharma propaganda. Using only blood-glucose-lowering effect (average bG’s or HbA1c’s), manufacturers could advance specious claims of identical-ity; the ‘regulatory’ bar was set VERY low; and the ‘evidence’ disappears. Insulin manufacturers NEVER had to prove bioequivalency . . . and to my knowledge, analytical technology does not exist today that would allow them to prove this. Additionally, since batch-testing requirements were removed from insulin production, some diabetics feel that each new ‘batch’ of rDNA genetically-engineered insulin is a GENERIC . . . and no one listens, no one investigates.”
The same person had other posts on the subject but this is the gist.
John
I know that when recombinant insulin first came out there was a controversy that some patients felt that they were less able to anticipate a hypoglycemic episode that with animal derived insulin. There was some sort of FDA investigation, but I think that was a few years earlier.
The data provided by this paper is fascinating, but the soft relationship between voluntary reports and actual underlying events makes it hard to draw any conclusions. It would have been great if they had been able to draw some correlation between their data, prescription volume data for individual drugs, and the AEs seen for those drugs in clinical trials. I bet you would have seen some fascinating variations in the way that physicians view different drug classes, and their likelihood of filing reports on observed AEs from different drug classes.
For example, most of the 15 “worst offender” drugs in the paper were opiates. But opiates are used mainly in cancer patients, and in spite of being highly toxic, no anticancer drugs made the list. I would conclude that since typical anticancer drugs cause AEs in almost every patient who takes them, this is just a reflection of low physician expectations.
Jaynesday
John,
I think the authors make the point that it is difficult making specific conclusions given the ridiculous (my word) AE system that the FDA uses (or doesn’t). However this study did make attempts to control for over reporting. For example, not using AE’s that generally escalate after a drug is pulled off the market.
Here’s what I would say – don’t throw the baby out with the bath water.
And note the graph that is shown in the paper. The pitch of the total AE’s line is steeply heading north while the increase in prescriptions is going east. There may be issues with the study but I would think that such a drastic difference in AE’s to prescriptions should have raised some eye brows.
It is unfortunate that the FDA accepts an AE reporting system that is so pathetic. This system should be a mainstay of drug/device safety, not something that can only gives you a general understanding of trends and then mostly debated and ignored.
For having such intelligent people involved I can’t believe the ignorance and blind sightedness of it all.
Pip
The pivotal clinical trials for statins (Lipitor) had patients followed for a least a full year. What percentage of Lipitor patients are on continual therapy and had adverse reactions? Because a quick look in Pubmed shows 4737 studies/case reports of ’statins and adverse effects’ and over 1000 under ’statins adverse events.
Just think what would show up if we had mandatory reporting of AE’s.
As for PPI’s - they’ve been linked quite strongly to the onset of autoimmune diseases.
Both regulate the liver and processing of toxins out of the body.
So saying ‘these drugs are at least as safe as eating hot dogs, maybe more so” is disingenuous at best.
And amazingly, this ‘blame it on the cancer’ drug rhetoric is what’s showing up on all the major Bulletin Boards for the rheumatic diseases. What is it with you guys, do you coordinate your responses by company?
No, how about these miracle meds that are supposed to save us actually increase our odds for developing more diseases (CDC info on increases for all rheumatic diseases during the last decade) thereby increasing revenue streams and/or out and out kill us.
So much for human welfare, eh?
Jaynesday - thank you so much for the information on insulin etc. It actually impacts my world and might be somewhat of a factor in for my reaction to John’s specious arguements.
I’m very interested in finding out more information on the FDA’s AE reporting system. Any information you can provide would be greatly appreciated.
Pip
JaT
To have people directly contacting MedWatch, or contact through their doctors, only then to have FDA pick over reports for specific data, results in those reports becoming diluted. To misunderstand the severity of the situation.
Drug makers can interject opinion while FDA dismisses the opinion of the consumer. Words like consternation and non-compliance. How do they get away with that- having no clue if those issues existed at all?
When you trust a drug maker (and we did) and they say it’s only the appearance (though it wasn’t), sprinkle it with a little “consternation” & “non-compliance” and it seems easy enough.
Why do our doctors buy it? They (doctors) are picking sides, so to speak, on who’s analysis they believe- despite clinical evidence. We are the ones swallowing the cr… (erm) stuff, and you might think our doctors would ‘get’ that we know better what this drug is doing to us.
FDA screwed up by allowing my drug to be called “New Look” as that was not the extent of the situation. Very misleading. We swallowed it in good faith and then were treated so badly because we were damaged. Really, how ridiculous is that?
DoJ dropped the ball.
And we are supposed to embrace government suggested Best Practices? I suspect that pharmaceutical related deaths are much higher than the numbers that have been provided here. Those only include what consumers and their grieving loved ones were able to prove, if they had it in them to bother to try. Drug companies having the faith of doctors, FDA surely not wanting to be responsible for approving a bad product.
Consumers are alone.
John
Ok, this will be my last post on this particular page.
I admit the hot dog comment was flippant. But they do contain a lot of fat and nitrites, so at least I was not comparing Lipitor to brocolli. And I do still stand by the automobile comparison, even if I haven’t convinced anybody.
I think we can all understand the world a little better if we try to keep our minds open, avoid overgeneralization, and get our information directly from Pubmed unfiltered by the pharmaceutical companies or Sidney Wolfe.
Nice meeting Y’all.
John
Sorry, one more just for fun…., some additional statistics from the CDC on what we have been debating here.
http://www.medpagetoday.com/EmergencyMedicine/EmergencyMedicine/4311
Jack Friday
JiM
Here are the 5 major sources of market distrust of the pharmaceutical industry:
1. Lack of honesty and full disclosure about product information (Corporate, Marketing, Sales, and Scientific integrity issues)
1. Not disclosing, not acknowledging or downplaying potential serious adverse reactions and side effects (e.g., many including Fen-Phen, Vioxx®, OxyContin® , Ketek®)
2. Exaggerated product claims in marketing or in sales presentations…especially comparative claims
3. Scientific data manipulation to highlight benefits, exaggerate efficacy while carefully downplaying side effects and adverse reactions
4. Deception in advertising (paid actors or celebrities to project credibility as they play healthcare providers or miraculously recovered or satisfied patients)
2. “Off-label” promotion (e.g., many such as Neurontin® and Bextra®)
1. Companies not willing to spend the money to prove the claims but willing to encourage physicians to subject patients to uncontrolled experimental use
3. Questionable physician payments, inducements, and “conflicts of interest”
1. Extraordinary Speaking fees and resort location training programs
2. Excessive consulting fees, including suspect clinical study payments
3. Board of Director fees (hundreds of thousands of dollars)
4. Office practice meals, tchotchkes, and other perks
5. Expensive meals, cultural or sporting events (e.g., Broadway shows, golf outings) for physicians and other healthcare providers who can influence prescribing
4. Pervasiveness of industry influence on scientific and medical communications
1. Promotional programs presented as CME
2. CME program development and sponsorship
3. Medical Science Liaisons as safe harbors for scientific exchange of product information
4. Publications, including sponsoring ghostwritten articles and books
5. Journal advertising in medical journals
6. Scientific and medical conference participation and exhibits
7. Internet medical information sites
5. Pricing practices
1. Pricing fraud (especially as it relates to Medicare and Medicaid)
2. Unsubstantiated high prices (lacking credible rationale or cost benefit data)
3. High price increases (recent 9.3% increase compared to -0.3% for general inflation (CPI-U)
Adam Jacobs
Glen Spielmans:
“Please point out any errors so that we may correct them.”
I would like to point out quite a serious error. Your article describes my company, Dianthus Medical Limited, as one that participates in ghostwriting and other unethical practices.
We don’t, and I’m very puzzled as to why you think we do. In fact I have been one of the most outspoken critics of ghostwriting in the medical writing community for a number of years.
I look forward to the correction.
Glen Spielmans
Hi Adam,
The journal let us know that you have concerns with our article. We are drafting a formal response to your concerns which we hope will be published in the journal.
Adam Jacobs
Despite my pointing out the error in the article, and much subsequent email correspondence between myself, Spielmans, and the editor of the journal concerned, the article remains uncorrected.
It appears that the offer to correct errors was merely a bluff, rather than a genuine offer.