Friday, April 18, 2008

A Bad Week for Professional Liars

This was a very bad week for those whose careers depend on the use of deceptive marketing tactics.

1. JAMA (the Journal of the American Medical Association) published this article written by Joe Ross and colleagues exposing Merck’s use of ghostwriters to disseminate studies in support of Merck’s ill-fated arthritis drug, Vioxx.


2. The same JAMA issue reported that Merck had hidden its knowledge of the Vioxx dangers in studies of the drug in Alzheimer's disease
. Those still looking for evidence that relying on industry sources of information can lead to bad outcomes—in this case, death—need look no further than this article.

3. The editor in chief and deputy editor of JAMA wrote this scathing commentary in response to these articles, which began with the following statement: “The profession of medicine, in every aspect—clinical, education, and research—has been inundated with profound influence from the pharmaceutical and medical device industries. This has occurred because physicians have allowed it to happen, and it is time to stop.”


4. The New York Times published this article by Gina Kolata interviewing three high profile academic doctors who have relinquished industry ties and feel better about themselves and their profession as a result.

5. The current issue of the Journal of Nervous and Mental Diseases contains this paper by Speilmans and colleagues showing that only half of drug ads in psychiatry cite sources for their marketing claims, and of that half, only 65% of the cited sources support the claims. Steven Sharfstein, former president of the American Psychiatric Society, wrote an accompanying editorial. He urges both the FDA and the journals themselves to better evaluate drug advertising claims. He concludes: “The doctor-patient relationship should not be a market-driven phenomenon. If patients are to trust their physicians, they need to know that their interests are paramount and that the physicians’ knowledge base is up-to-date and accurate.”

6. Prescribing for Better Outcomes, a website devoted to educating physicians about inappropriate marketing tactics, released a journal supplement and a webinar helpful for those who are interested in a non-industry perspective on the use of epileptic medication in bipolar disorder.

It looks like the era of post-deception medicine is finally dawning.

34 comments:

therapyfirst said...

Thank you for this posting. You accompanying comments to each reference say what is necessary.

The question is, can people who are addicted, to money and/or power in this case, get into recovery? We'll see, right!?

Supremacy Claus said...

This is like a snow storm of left wing misleading propaganda. We are going to be here a while.

One author named as a false author has denied the allegation, saying he contributed significantly to a paper.

The first name is the name of the person writing the draft, and often the junior person. The leader of a group often puts his name last, a sign of not needing publications for a fulfilled career. If an author contributed input without which the article could not be completed, then the order does not matter. The first name is often the most junior.

One of the authors in the Merck article worked for the plaintiffs. This article is plaintiff propaganda. I would not believe any conclusion from such a biased source.

I still await an instance or data on any harm done to patients. So far, this is all gotcha games by left ideologues, seeking to intimidate companies into transferring their promotional funds to the accounts of left wing institutions. The left wing media for example, cites Dan. It fails to provide a disclaimer on his views as totally hate filled, as evidence by the inappropriate name calling in the title. Gotcha games go only one way, in the out of control biased media.

Supremacy Claus said...

Dan needs to append this link providing balance to the left wing lying in the body of the post, and not hidden in the Comments.

http://www.pointoflaw.com/archives/2008/04/vioxx-jama-publishes-litigatio.php

Supremacy Claus said...

Dan: You should also change the intemperate language in the title. Don't be a knucklehead like me, stop talking like me. You are supposed to be responsible and mature.

Daniel Carlat, M.D. said...

SC--Sorry if the title is offensive. Perhaps "A Bad Week for Professional Deceivers" would have been more temperate! But honestly, I do appreciate your point of view and I like the www.pointoflaw.com website. Thanks for the tip.

Roy M. Poses MD said...

What is left-wing about criticizing deceptive marketing? Criticizing dishonest tactics used by some people in some corporations does not imply that the preferred alternative is control by the state of the means of production. One can support free enterprise, but also support honest conduct by capitalists.

Yet accompanying almost every blog post on this blog and many others that criticizes specific actions by particular people within health care corporations are (almost always anonymous) denunciations of the posters as left-wingers, if not Stalinists.

Supremacy Claus said...

Roy: I still await the citing of a harm done to the patient of a clinician.

In the absence of such harm, I see such criticism of corporations as pretextual (a false, wrongful use of the law). These are motivated by the desire to capture the $1.5 bil in CME for academic institutions, all appalling left wing, big government front organizations for the lawyer profession. The government is a 99% owned subsidiary of the lawyer profession, run solely for their interests. This explains its incompetence.

The second aim is to set up class action lawsuits for false harms, and lawyer gotcha focusing on improper paper work.

You are the consumer for the drug companies. When the lawyer makes a $ bil you do not get an additional tool to help your patients.

If you are a clinician, we have no dispute. I accept all criticism, even your personal remarks, as constructive.

If you are an academic or an administrator, we are adversaries.

therapyfirst said...

It's amazing two postings ago is now in the 70's for responses. As asked, I will not use any more analogies that offend, but it has to be asked why people can't let it go. I could wax psychiatric, but I am not reponding as an evaluator, but as an invested provider. As Jim was interested in my take of this posting, I'll offer an opinion.

I am intrigued by Dr Sharfstein writing an editorial on this matter when he was a defender of managed care in the 90's. If you follow the trail of this process that has lead to pharmacology controlling psychiatry's choices in treatment, it does start with the intrusion of managed care into mental health care. So, unless he has had some epiphany and has renounced his dealings from his past, I am at the very least wary of him being a leader in requesting "the FDA and Journals to better evaluate drug advertising claims". Yeah, I'm a cynic; watching 15 years of my so called leaders in my profession sell out those of us who were green with experience, but stayed true to the principles of our training is not just painful, but frank betrayal.

I like the title: "professional liars"! Remember the line in a Seinfeld episode when Jerry was going to take a lie detector test, and he asked George how to beat it?
Costanza's reply echoes in me to this day: "if you believe the lie, it becomes the truth." How prophetic such a line is with the pervasiveness of pharmacology sold as the first line intervention in psychological distress universally.

I'm glad Dr Poses picks up on our lone dissenter. Jim wrote a wonderful reply to lone dissenter that was expectly rejected. Civil discourse might be one of the founding principles to this country and culture, but when does rigidity and inflexibility get relegated to its place in the back of this debate?
Sadly, not here.

I'm a fan of Star Wars, and I believe art imitates life; we are in the shroud of the dark side, folks, and until we as responsible and dedicated physicians, invested patients, educated politicians, and a willing public can form the alliance to repel these dark forces, continuous our senses be dulled shall we.

Yoda, I ain't! got a busy weekend ahead, so I doubt I'll be reading or able to comment until later.

Munch on some matzah. Then you'll know why we wandered in the desert 40 years and only eat it 1 week a year now! If I ate that stuff for a month, I'd be on Seroquel!

Good times, good luck, good weekend

Supremacy Claus said...

"It's amazing" how biased left wing ideologue cannot cite a harm caused by drug company promotion. They are obsessed with irrelevant paperwork lawyer gotcha.

I have cited examples of the consequences of their shenanigans, the assassination of 100's of kids a year who committed suicide after deprivation of treatment, the disruption of the good care of millions of past and future patients, and the generation of $bils in legal costs after unscientific, bogus pretextual claims. These evaporated the money for research that could have generated a dozen new blockbuster tools to treat the sick.

The crybaby, irresponsible, supercilious left wing ideologues here, including Dan, lack intellectual ability or even honesty. They are so stupid, they do not even know that they serve as Trojan Horses for the vicious land pirate profession. The lawyers intend to take over control clinical care, and its $trillions.

Supremacy Claus said...

Dan: I read your nice editorial here:

http://www.clinicalpsychiatrynews.com/article/S0270-6644(08)70226-1/fulltext?issue_key=&issue_preview=no&search_preview=no&select2=no&select2=no&start=&startPage=

Again, you cited no actual harm to a patient, nor a rumor of a harm to a clinical patient. You failed to admit in print that these events serve many benefits I listed in a prior comment. Your lack of balance hurts your credibility.

Here is the fact that knocked me back. I was quite dismayed, and distressed. You left me a bit breathless.

You made $150,000 last year. That is the value the public placed on your services. Moonlighting residents from 10 years ago had better years than yours. I pray you made that in 500 hours, and spent the rest of the year futzing around in policy time wasting. Money is not everything, but that take home was painful and demeaned the profession.

Friends get $1500 per visit, not your $750. Still, most speakers make a huge sacrifice of income, time and harassment to exchange personal experiences with their equals. Including travel, and the three hours of a dinner, they are taking a real bath on lost income to improve the profession. In your case, given your low income, I can see how an event that increased your hourly rate could corrupt. The reverse is true of just about all other doctors.

I request that you make a correction to your editorial. You should state that your situation is atypically adverse. It does not reflect that of 90% of your colleagues, except for part-time Moms, or people on part-time disability.

therapyfirst said...

I'm at the sedar tonight, having good laughs and conversation with my wife's family, and then I hear how one of her inlaws has drug reps take him to a sports museum opening and at another time has a famous ex-athelete give a talk, about sports, to 50 docs. Everyone at the table listens and chimes in comments about the experiences, I just sit there silent. This doc is a good guy, but I feel he is typical of what is out there among physicians. As I'm driving home tonight, I realize that CMEs sponsored by pharma will never be reeled in, because there are physicians out there who are pigs. they'll take whatever is offered to them if it's a perk, hell, especially if it's a party perk.

So next week or so, the spin doctors for Merck will drown out the importance of the JAMA articles and other revelations, as they'll just bribe docs to forget it. It's about money and power folks; pharma won't give it up, doctors who are misguided or just damn greedy won't give it up, and society will still clamor for the alleged quick fixes these drugs falsely claim.

Enjoy the week that was. Professional liars succeed as they are professionals, so they are good at it. Just read the work of lone dissenter here; he'll just badger you until you agree or leave. I prefer the truth, so I'll leave. I'll still pass out the blog postings as they apply to interested colleagues, but this comment bs leaves me empty of desire. Good luck to you all.

By the way, the Board of Psychiatry proved me wrong; they got the board scores out earlier so I didn't have to anguish another 3-4 weeks. I'm still Board certified. Hoo-ray (emphasis on sarcastic tone). I hope my new job opp's get me further away from reps. Now if I could just get away from insurance, so I could practice more psychotherapy.

Cheers.

Supremacy Claus said...

TF: "... the alleged quick fixes these drugs falsely claim."

What company falsely alleged what quick fix?

Supremacy Claus said...

Dan: Your income may explain the disagreement. Thought experiments about extremes help to understand. If you made $10 an hour, $750 an hour might influence decision making. If your made $1000 an hour, $250 an hour would be a nuisance, and a sacrifice. That would not have any influence on decision making. No one would jeopardize a high salary from a good reputation by making less than optimum clinical choices.

If there is to be a reform, it should require paying the doctor his usual hourly fee. For most doctors, payment would have to increase from today's amounts. In your case, you should get $75 an hour door to door. I doubt you could be unduly influenced by that pay.

The other negative? These talks do not involve physical patient care. That means any regulatory hassle does get covered by malpractice. All drug companies should obtain speakers' liability coverage for the doctor, or include an indemnity clause in any agreement. Do you recall how some companies got fined $400 million? The doc is considered an entity subject to such actions, with no upper limit. If fraud has taken place, drug company will totally disavow the speaker. They will provide no support at all, for fear of the appearance of endorsement of the wrongful act.

Proposals for change should recommend such insurance coverage for regulatory hassles. These have taken place in the real world, big time. If these actions were fully disclosed, what doc would want to be a speaker?

Any committee might compile the list of such actions against speakers, and prosecutions, to educate, not to intimidate. Those actions would be facts.

Supremacy Claus said...

Correction: Malpractice insurance will NOT cover regulatory hassles from speaker activity. No patient care nor medical negligence has taken place in that activity.

Stephany said...

First, I think the title of this post is a great one! Good post too.

TF- why not do more psychotherapy? not sure how insurance plays out for you, but some docs [like mine] do not bill or accept insurance any longer. we[patients] pay up front, and if we have insurance have to turn in paperwork on our own. it's a direct payment to the doctor from patients and cut out the insurance hassles for the doctors. good luck.

Roy M. Poses MD said...

Re: "Supremacy Clause's" comment that Dr Carlat's pay is determined by how the public values his work.

To use a polite term, that is utter baloney.

His pay, and essentially all US doctors' pay is set by Medicare. The Center for Medicare and Medicaid Services (CMS) pays physicians according to the "resource-based relative value system" (RBRVS). RBRVS uses an complex formula to determine pay for each "billing code." The values plugged into the formula are updated by CMS essentially only according to the "RBRVS Update Committee" (RUC). The RUC, in turn, is an AMA committee whose membership is secret, but which is dominated by doctors in the procedural specialties. Over the years, the RUC has biased the Medicare payment system increasingly in favor of procedures, to the detriment of doctors who merely interview and examine patients, make diagnoses, and prescribe treatments other than procedures.

For background, see these posts on Health Care Renewal:
http://hcrenewal.blogspot.com/2007/03/on-disparities-between-reimbursement-of.html
http://hcrenewal.blogspot.com/2007/12/is-sustainable-growth-rate-main-problem.html
http://hcrenewal.blogspot.com/2007/12/more-ruc-muck-raking.html

Also, see these posts on DBs Medical Rants:
http://www.medrants.com/index.php/archives/3395
http://www.medrants.com/index.php/archives/3399

Since "Supremacy Clause" purports to be a conservative and libertarian, I am amazed he or she does not realize that the prices paid for physicians' services, and hence physicians' pay are determined by the government, and that the process used by the government to do so is secretive and not subject to effective challenge by outsiders.

Furthermore, re "Supremacy Clause's" challenge to find evidence suggesting that dishonest marketing practices by pharma and other health care corporations do harm.

Would "Supremacy Clause" care to provide any evidence that conflicted key opinion leaders, ghost-written and guest-authored articles, and gifts given to physicians by pharma reps do any good for patients?

Supremacy Claus said...

Roy: No need for formality. Please, just call me, Supremacy. I am from the Claus family, not from the Clause family, a lawyer term.

The government is a 99% owned subsidiary of the criminal cult enterprise that is the lawyer profession. This is not a conspiracy theory, but a criminal cult enterprise theory. Will gladly explain if requested. The rebuttable presumption is that all government programs are incompetent, and many are evil, being in furtherance of the rent seeking aims of the criminal cult enterprise.

The set up at Medicare you described is lawyer oppression of the doctor. Any doctor who deals with Medicare has to be suicidal. Why not insult and shove a drug dealer and make signs from an opposing gang? That would be less dangerous than dealing with the our good friends the lawyers, in charge of the three branches of government.

Dan's salary is low for whatever reason. For example, he does not see enough patients. He works too few hours.

If he makes $75 an hour, then his fee of $750 for a lunch with a doctor may distort his clinical decisions.

If someone makes $300 an hour, and a lunch with a doctor will consume 3 hours, then $750 causes a net loss, and only altruism will motivate it. For the person making $300 an hour, only a $3000 fee might have the same impact as $750 did on Dan.

I listed benefits to patients of drug company promotion. I repeat them here for your benefit.

1) transmit questions requiring extensive literature review to the science department;

2) transmit complaints about medication to the leadership, about unavailability of low doses, routes of administration (liquid, depot); those black box warnings dump future liability on the clinician are adversarial to the clinician; inability to get insurance coverage;

3) help cash strapped agencies with supplies, meals during continuing education that double attendance; assist their patients obtain applications for long term scholarships; providing coupon numbers off hours for emergency filling of prescriptions;

4) arrange for meals for physicians who openly bash the product, sharing problems, and chastening others who have not yet tried the product. These remarks and questions are transmitted to the leadership of the company. High officials will travel long distances to review such complaints in person. Drug reps hearing such reports will help busy doctors fill out Medwatch forms to report any adverse event to the FDA on the spot or later.

Roy, what do you think of this promotion?

Drug companies, HMO'S, and patient advocacy arrange the following all day seminar, with free CME, with lunch, and all kinds of goodies thrown in. The title is, "Anti-depressants Reduce the Sudden Death Rates of Depressed Post-AMI Patients." They take this show to every major metropolitan area in the nation. During that session, family docs and internists learn how to diagnose depression in 5 minutes. They put all depressed patients on anti-depressants. The decrease in the sudden death rate within a year dwarfs the entire complement of suicide victims. The studied anti-depressants are sertraline and citalopram. Both are generic. One is available for $4 for 30 tablets at Walmart or at Target.

Would that promotional activity be OK with you?

therapyfirst said...

To Dr Poses:

Since you seem to be a new commenter to this blog site, let me advise you of this "lone dissenter" I now call this person.
Dialogue is a waste of time, as if you looked up rigidity and inflexiblility, there would be a picture of this individual with the definition. There is no rationalizing, reasoning, or compromise with lone dissenter. His/her goal is to shout you down into submission or escape. It is pathetic this person is encouraged, much less allowed, to participate in this commentary without limits. But, I have no say, just continue to say.

Your comments about reimbursement are right on the mark. It is why physicians need to realize that their tolerance of third party payers is a major cause to their dwindling infuence in health care decisions. As radical and outrageous as it sounds, if physicians would show some guts and go on strike providing routine health care, government would pay attention real fast and listen to us. Sure, 100,000 physicians would be jailed for antitrust violations! Dream on, to those who are cowards. It takes radical action to get people to realize the system is failing.

As to Stephany's question why I do not take cash only, I did it in the past and here was the outcome:
most of my referral sources got lazy and did not tell patients I was not taking insurance, and after weeks of getting phone calls from patients who wanted to see me and use their insurance, and who got nasty with me when I politely explained my policy, I went back to salaried positions. A sell out, maybe, but I have a family to feed, and working with all these cowards who won't take a stand if it held up one week of pay isn't worth being a martyr or a freak in their eyes. This is what goes on in medicine, and I believe moreso in psychiatry. Call me harsh, call me rude, call me insensitive, but in the end, call me honest and direct,'cause that's what I am!

To patients out there reading this blog and commentary section, pay attention to what your doctor does, not just in the office but how they carry themselves in the community. Deeds, not words is what defines us. At the end of the day, you get paid what is fair and reasonable, but as the patient, you get what you pay for.
Focus on a copay, expect to be compromised. Doctors spend twelve or more years after high school getting an education and perfect an expertise to help you as people function, thrive, and survive. It's not a right though, it's a service. As crucial as maintaining a home, accessing a vehicle, and having structure to your days. None of those are rights, but to live in this society, pretty damn strong expectations!! We take an oath to serve and respect, but not of poverty and sacrifice to live our lives as able.

Everyone screaming for univeral health care, you'd better be ready to be held to living responsible, disease-preventable lifestyles. This free pass attitude has to be refuted.

That's the way it is in my opinion, folks. We are all factors to the dysfunction to the system as it is. Anyone who claims they are not involved is clueless, ignorant, or is looking for an angle.

And you all think CME funding sources are going to change in the foreseeable future? Yeah, when medicare increase our reimbursement rates at least 5-7% yearly for the next 5 years. My guess it will be Jesus authorizing that decision.

Gotta fight for what's right!

Supremacy Claus said...

TF: You are wrong. I am not rigid. I immediately change a view if a fact rebuts it.

You are correct. The Supreme Court supported the prosecution on anti-trust grounds, of lawyers striking for higher wages. They were public defenders. If one strikes or boycotts for non-self serving aims, the Supreme Court supports that.

If you had made a statement about a boycott, at a meeting of an organized medicine organization, by official policy, any official of the organization, would have been forced to stand up, loudly denounce your proposal, and immediately walk out. I find that funny.

Nevertheless, psychiatry should be among the highest net paid specialties. It can gross like internal medicine, but with overhead like psychologists. Employment is also hell.

No one does private practice. One has to be insane to have a commercial lease, or an employee. Nor does anyone work as an employee. Only people with personal problems, and no choice do that anymore.

I hope that if you, Roy, and the other left wing ideologues ever get enough of lawyer oppression of the doctor via its wholly owned subsidiary, the government, you will become more open to remedies that can be achieved, and without a trip to federal prison.

Meanwhile, stop falling for these pretextual, lawyer gotcha, bogus attacks on drug companies and on doctors. They are Trojan Horses for future litigation and additional regulatory restrictions.

Michael S. Altus, PhD, ELS said...

Supremacy Claus wrote:
The first name is the name of the person writing the draft, and often the junior person. The leader of a group often puts his name last, a sign of not needing publications for a fulfilled career. If an author contributed input without which the article could not be completed, then the order does not matter. The first name is often the most junior.

Not quite.

For guidance about the order of authorship in clinical medicine articles, you need to go to the doctor. Make an appointment to read AMA Manual of Style, 10th edition, section 5.1, Authorship Responsibility. There you will learn that in clinical medicine, authorship order is in descending order of the extent of contribution to the work. Thus, clinical medicine articles offer only one first prize—first named authorship—and from there on through the authorship list, it's downhill all the way.

The order of authorship in basic science articles offers two first prizes. The first first-prize goes to the first-named author, the one who made the greatest contribution. This author is typically an inferior such as a graduate student or postdoctoral fellow. The second first-prize goes to the final author, who is typically the superior, the team leader. This works well and makes a whole lot of sense to me. The inferior needs first-named authorship to attain an independent position, and the superior needs final-named authorship to maintain an independent position. For more about this, see the following: Altus MS. Culture of science and order of authorship [letter]. Science Editor 2001;24:17.Freely available ta http://tiny.cc/br1WV.

James M. La Rossa Jr. said...

First a quick note:
roy poses's postings sparked very informative responses from TF, SC and Stephany, so I hope we keep hearing from him.

"A bad Week for Professional Liars," was like reading about the Stalinist "Night of the Long Knives," in which he purged thousands of enemies on one night. What a compelling group of evidence was my first response. Then I read through it.

JAMA's article about guest authorship and ghostwriting (Ross et al.) and the editor's accompanying editorial illustrate how the proliferation of Medical Education Companies (MECCs) since 1999 have changed the game utterly and completely. Because of the way the FDA wrote the 1997 Modernization Act, pharmaceutical companies began to use MECCs at a higher rate for two reasons: First use is that the MECCs made sure that the company got what they paid for. Secondly, and quite ironically, the sponsors also convinced themselves they were creating a firewall between the pharma company and the end-user. As the MECCs began to hire MDs and become accredited to give CME, the illusion of the firewall grew stronger, the FDA were appeased because it appeared that its guidelines were being adhered too, and the >$5 billion CME free-for-all was underway.

Today, you'd never (patently) see the level of conflict of interest between Merck and published peer review articles because the MECCs are more careful. The granting of an UNRESTRICTED EDUCATIONAL GRANT means that the grantor cannot be involved in the creation of the editorial. So you would not see the paper trail today that you did in the Merck documents. But, make no mistake about it, the MECCs want the companies' future business and are looking out for the sponsor's best interests (albeit, sotto voce). And the MECCs are very smart bout it -- they follow the ACCME regulations to the letter. But like I've said before, you cannot have ONE COMPANY PRE-PLAN THE MATERIAL WITH THE SPONSOR, HIRE THE AUTHORS, GHOSTWRITE THE ARTICLES, AND ACCREDIT THE CME--WITHOUT THE PERCEPTION OF A CONFLICT OF INTEREST.

Another curiosity: as pharma companies restrict honoraria to physicians because of all the heat, the authors/speakers become more willing to delegate work to the MECCs, because they are not being remunerated like they once were and need to make money elsewhere -- which is why you hear about a "lead author" who never reviewed a draft of her own article. It's obvious that the readers of this blog are unsympathetic to these authors. Admittedly ... hard to be. But everyone is making a lot of money: the MECCs, the University CME Dep't in some cases, the publications (in the case of sponsored supplements), so why NOT the docs? I'm not defending some of these more biased "thoughtleaders" who Stephany has brought up many times, but why is it always the docs that get the screw? I wholeheartedly agree with SC, who wrote recently that "psychiatry should be among the highest net paid specialties."

Lastly, the Holy Supplement from the Journal of Psychiatric Practice. I'm sorry Ladies and Gentlemen, but a supplement FUNDED BY A GRANT ADMINISTERED BY A CONSORTIUM OF STATE ATTORNEYS GENERAL is nothing but a bone thrown by states which have extorted "blood money" from industry. Pure and simple. Pioneered by none other than Eliot Spitzer when he was AG in NY, all Holy Rollers take note.

While I have nothing but fondness for John Oldham, who was on the front line on 9/11 along with many of us, and who is listed as an author throughout this supplement -- except for the last article -- which is a procedural and not a scientific article, there is absolutely nothing of note here. So, if this is what "independent" money gets us, you can keep it. This is a "dumbed down" supplement to make political points. (Would someone from Lippincott Williams & Wilkins tell us the amount of the grant please? Is it in there and I missed it?)

Supplements aside, I would like to applaud The University of North Carolina at Chapel Hill program, Prescribing for Better Outcomes. I wish you luck on your venture. Please consider submitting manuscripts to Psychopharm Bulletin. We would be honored to receive them and the editors will review the manuscripts quickly and efficiently. Thank you.

James M. La Rossa Jr.
MedWorks Media Global
Los Angeles, CA
ceo@medworksmedia.com

James M. La Rossa Jr. said...

Michael: I also adhere to AMA style, though many journals, as you can imagine, use the APA style book. Is APA style identical to the AMA's as far as authorship is concerned?

A personal question which you might be able to help me with. When I went to school we used New York Times style (and Strunk & White of course). Today, my kids use Chicago style. Do you know anything about this shift? Is it universal among school age kids? Thanks, jim

Supremacy Claus said...

Michael: Anything the AMA or JAMA generates has a presumption of being wrongheaded, idiotic, and of being for the purpose of bashing clinicians. You have to rebut that presumption whenever citing anything by those jackasses. Personally, I cannot use the word, AMA without the jackass modifier.

Because of the Free Speech Clause, authors can do as they damn well please, and nobody may tell them otherwise.

It is a quaint anomaly to publish in such idiot outlets. If one has data, it should go directly to the Internet. The original data should get posted without patient identifiers, and the peers and public should go at it.

If the taxpayer has funded a study, then its entire content should be subjected to Freedom of Information Act, outside of patient identification. The researchers have acted as sub-contractors.

"The Office of Federal Contract Compliance (OFCCP) regulations, likewise, define subcontractor as any business that provides goods or services that are necessary to the performance of a government contract." Publication in copyrighted journals may violate this rule.

James M. La Rossa Jr. said...

Freedom of information? Don't forget you subpoena.

Likewise, JAMA now wants to collect a fee to reference the articles which DC linked. The AMA, which is subsidized by taxpayer dollars, and, thus, its publications, should be in the public domain and not restricted. This from a journal that has 50-pages of advertising revenue per issue.

Under these circumstances, and with the immense $$ the association enjoys, this is NOT the example they should be setting. If any publisher can afford to be open access, it is the AMA. If I could afford it, I would in a heartbeat.

James M. La Rossa Jr. said...

TF: Please don't punch out of the debate just as I weigh in. A selfish request, I admit, but sincere. The talking heads on Sunday didn't resonate with you. Va bene. Basta!

With the APA convocation around the corner, we need all the best marksmen on the rooftops. -j

Michael S. Altus, PhD, ELS said...

Jim,

I don't know about journal preferences in style manuals or how the APA style manual and the AMA style manual compare on order of authorship. The only up-to-date style manual that I have next to my desk is AMA 10. The reason is for that is that I try to avoid using style manuals as much as possible. The reason for that I do mostly author's editing (substantive editing), not copyediting. In substantive editing "the editor considers a document's concept and intended use, content, organization, design, and style. The purpose is to make the document functional for its readers, not just to make it correct and consistent. Substantive editing is almost entirely analysis-based.... Contrast this work with copyediting, most of which is rules-based and concerned with grammar, spelling, punctuation....Both types of editing are essential...." This is from an excellent article, "What is substantive editing?", on technical editor Jean Weber's website, www.jeanweber.com/howto/substant.htm.

And as for what style manual school kids use to use and what they use now: I don't know, and I didn't use a style manual when I was a school kid, either.

Michael S. Altus, PhD, ELS said...

Supremacy Claus wrote:
Michael: Anything the AMA or JAMA generates has a presumption of being wrongheaded, idiotic, and of being for the purpose of bashing clinicians. You have to rebut that presumption whenever citing anything by those jackasses

Supremacy Claus, you are absolutely right! YES! The AMA Manual of Style, now in its 10th edition, is yet another demonstration of how the AMA is a wrongheaded, idiotic clinician basher!

You are correct! I realize now that I should have rebutted that assumption! But I cannot! Never mind that the AMA style manual is the product of devoted work of many editors and many other contributors throughout the years! Never mind that the AMA style manual and other editorial efforts have striven to improve the editorial quality of many journals!

There're all a bunch of left-wing or right-wing or whatever other contemptuous descriptors one may choose!

Supremacy Claus said...

Michael: I am interested in your opinion of the Instructions to the Authors of JAMA.

http://jama.ama-assn.org/misc/ifora.dtl

Michael S. Altus, PhD, ELS said...

Supremacy Claus,

Editorially, I find JAMA's instructions to authors to be awsome. It is comprehensive and thorough.

Yet I recalled the firing of the previous editor, Dr. George Lundberg (www.bmj.com/cgi/content/full/318/7178/213) when I read the sentence, "JAMA has complete editorial independence of its owner and publisher, the American Medical Association. (1), DeAngelis CD, Maves MD. Update of the editorial governance plan for JAMA. JAMA. 2004;291(1):109; at http://jama.ama-assn.org/cgi/content/full/291/1/109#FIGJED30104F1.)

I hope that the editor has complete editorial independence.

Supremacy Claus said...

I find the instructions to be lawyerized, and oppressive. It oppresses only those who wish to submit article written in good faith. If I wanted to lie, they would not prevent me from doing so. So it deters submissions by those it seeks to encourage, achieving the opposite of its intent.

The prior editor was left wing. He left after publishing a survey on whether blow jobs were sex. It coincided with the Monica Lewinsky story. He became editor of a good on line journal.

Right now, people should publish direct to their own web site. That means the raw data can get published. Peers and the public can have at it. Revised versions can be added as enhancements, based on mass criticism by insiders and outsiders, not just the student of a busy senior insider who is a competitor, an intellectual opponent, or just in a cranky or good mood the day of the review.

Today, all med journals are jive turkey enterprises, idiotic looking exercises in futility, $1400 a year charging rip offs.

James M. La Rossa Jr. said...

SC: I am curious to know if you have a higher opinion of the open-access journals, such as plos.org?

Supremacy Claus said...

People ask, is there anything the lawyers do right according to you?

Yes. Here:

http://www.ssrn.com/lsn/index.html

It is missing a comments section. Hundreds of peers could review the article, as well as members of the public. The article could get revised accordingly. Judges could even ask for clarifications if they wish to use the material as persuasive source of law.

So, yes, this is a step in the right direction, and needs to go even farther.

Anonymous said...

Recently published on www.brainblogger.com

The Human Injury of Lost Objectivity

If I were to rate the corruptive tactics performed by big pharmaceutical companies, the intentional corruption of implementing fabricated and unreliable results of clinical trials by pharmaceutical companies by hired third parties who manipulate these trials they sponsor because of their power to control others involved in such trials that is largely absent of regulation would be at the top of the list, and likely the most damaging to the requirement of authenticity and, more importantly, assuring the safety of the public health, as I understand that this does in fact occur.

Decades ago, clinical trials were conducted at academic settings that focused on the acquisition of knowledge and the completely objective discoveries of meds. Then, in 1980, the Bayh-Dole Act was created, which allowed for such places to profit off of their discoveries that were performed for pharmaceutical companies in the past. This resulted in the creation of for-profit research trial sites, called Contract Research Organizations, which is often composed of community research sites with questionable investigators possibly void of necessary research experience or quality regarding their research purpose and ability. Since they are for- profit, with some CROs making billions of dollars a year. The trials conducted at such places are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial being conducted involving their med being studied in the trial. This coercion is done by various methods of deception in subtle and tacit methods. As a result, research in this manner has been transformed into a method of marketing, which includes altered results of the trial to favor the sponsor’s med. Their activities are absent of true or applied regulation, and therefore have the autonomy to create whatever they want to benefit what may be a collusive relationship between the site and the sponsor.

Further disturbing is that once the creation of the trials is completed, they are then written by ghostwriters often, although no one seems to know how often. These people are not identified and acknowledged by the sponsor, and may not be trained in clinical research overall, as they are simply freelance writers, as one does not need research training or certification in order to perform this function. Rarely do trial ghostwriters question their instructions about their assignment, which is clearly deceptive and undocumented by the sponsor. Also, these hired mystery writers are known to make about 100 grand a year. This activity removes accountability and authenticity of the possibly fabricated clinical trial even further. The corruptive act is finally completed by the sponsor hiring an author to be placed on the trial that likely had no involvement with the trial, and, along with others, was paid by the sponsor for doing this deceptive act.

To have the trial published, the sponsor pays a journal to do this in various ways, I understand, such as purchasing thousands of reprints of their study from the journal. Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers and research sites to support the pharmaceutical industry. So benefits of meds studied in such a malicious way potentially can harm patients and their treatment options and safety risks. The purchased reprints are distributed to the sponsor’s sales force to share the content with prescribers which may lack validity.
Such misconduct discussed so far impedes research and the scientific method with frightening ethical and harmful concerns, if in fact true based on reports by others. If so, our health care treatment with meds is now undetermined in large part with such corruptive situations, as well as the possible absence of objectivity that has been intentionally eliminated. Trust in the scientific method in this type of activity illustrated in this article is absent. More now than ever, meds are removed from the market are given black box warnings. Now I understand why this may be occurring.

Transparency and disclosure needs to happen with the pharmaceutical industry for reasons such as this as well as many others, in order to correct what we have historically relied upon for conclusive proof, which is the scientific method. More importantly, research should not be conducted in a way that the sponsor can interfere in such ways described in this article, requiring independent sites with no involvement with the drug maker. And clearly, regulation has to be enforced not selectively, but in a complete fashion regarding such matters. Public awareness would be a catalyst for this to occur, after initially experiencing a state of total disbelief that such operations actually are conducted by such people, of course. We can no longer be dependent on others for our optimal health. Knowledge is power, and is also possibly a lifesaver.


“Ethics and Science need to shake hands.” ……. Richard Cabot



Dan Abshear

Anonymous said...

Recently published on www.brainblogger.com

The Human Injury of Lost Objectivity

If I were to rate the corruptive tactics performed by big pharmaceutical companies, the intentional corruption of implementing fabricated and unreliable results of clinical trials by pharmaceutical companies by hired third parties who manipulate these trials they sponsor because of their power to control others involved in such trials that is largely absent of regulation would be at the top of the list, and likely the most damaging to the requirement of authenticity and, more importantly, assuring the safety of the public health, as I understand that this does in fact occur.
Decades ago, clinical trials were conducted at academic settings that focused on the acquisition of knowledge and the completely objective discoveries of meds. Then, in 1980, the Bayh-Dole Act was created, which allowed for such places to profit off of their discoveries that were performed for pharmaceutical companies in the past. This resulted in the creation of for-profit research trial sites, called Contract Research Organizations, which is often composed of community research sites with questionable investigators possibly void of necessary research experience or quality regarding their research purpose and ability. Since they are for- profit, with some CROs making billions of dollars a year. The trials conducted at such places are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial being conducted involving their med being studied in the trial. This coercion is done by various methods of deception in subtle and tacit methods. As a result, research in this manner has been transformed into a method of marketing, which includes altered results of the trial to favor the sponsor’s med. Their activities are absent of true or applied regulation, and therefore have the autonomy to create whatever they want to benefit what may be a collusive relationship between the site and the sponsor.
Further disturbing is that once the creation of the trials is completed, they are then written by ghostwriters often, although no one seems to know how often. These people are not identified and acknowledged by the sponsor, and may not be trained in clinical research overall, as they are simply freelance writers, as one does not need research training or certification in order to perform this function. Rarely do trial ghostwriters question their instructions about their assignment, which is clearly deceptive and undocumented by the sponsor. Also, these hired mystery writers are known to make about 100 grand a year. This activity removes accountability and authenticity of the possibly fabricated clinical trial even further. The corruptive act is finally completed by the sponsor hiring an author to be placed on the trial that likely had no involvement with the trial, and, along with others, was paid by the sponsor for doing this deceptive act.
To have the trial published, the sponsor pays a journal to do this in various ways, I understand, such as purchasing thousands of reprints of their study from the journal. Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers and research sites to support the pharmaceutical industry. So benefits of meds studied in such a malicious way potentially can harm patients and their treatment options and safety risks. The purchased reprints are distributed to the sponsor’s sales force to share the content with prescribers which may lack validity.
Such misconduct discussed so far impedes research and the scientific method with frightening ethical and harmful concerns, if in fact true based on reports by others. If so, our health care treatment with meds is now undetermined in large part with such corruptive situations, as well as the possible absence of objectivity that has been intentionally eliminated. Trust in the scientific method in this type of activity illustrated in this article is absent. More now than ever, meds are removed from the market are given black box warnings. Now I understand why this may be occurring.
Transparency and disclosure needs to happen with the pharmaceutical industry for reasons such as this as well as many others, in order to correct what we have historically relied upon for conclusive proof, which is the scientific method. More importantly, research should not be conducted in a way that the sponsor can interfere in such ways described in this article, requiring independent sites with no involvement with the drug maker. And clearly, regulation has to be enforced not selectively, but in a complete fashion regarding such matters. Public awareness would be a catalyst for this to occur, after initially experiencing a state of total disbelief that such operations actually are conducted by such people, of course. We can no longer be dependent on others for our optimal health. Knowledge is power, and is also possibly a lifesaver.


“Ethics and Science need to shake hands.” ……. Richard Cabot



Dan Abshear