Professional Integrity for Sale? “Sure,” Says Medscape!

Some chiropractors also practice homeopathy. According to Frank King, D.C., many more should be doing just that:

Homeopathy is an energetic form of natural medicine that corrects nerve interferences, absent nerve reflexes, and pathological nerve response patterns that the chiropractic adjustment alone does not correct. The appropriate homeopathic remedies will eliminate aberrant nerve reflexes and pathological nerve responses which cause recurrent subluxation complexes.

Not only does homeopathy correct nerve interferences, it empowers the doctor of chiropractic to reach the entire nervous system. What this means is that we can now better affect the whole person, and all of the maladies that affect us. Homeopathy’s energetic approach reaches deep within the nervous system, correcting nerve interferences where the hands of chiropractic alone cannot reach. Homeopathy is the missing link that enables the chiropractor to truly affect the whole nervous system!

But that’s not all:

Financial Rewards

Homeopathy means a multiple increase in business. Personally, I have been able to see and effectively help more patients in less time. The additional cash flow from broadening your scope of practice, increasing your patient volume and selling the homeopathic remedies is a wonderful adjunct. Better yet are the secondary financial benefits:

• Homeopathy is like an extension of you that the patient can take with them to apply throughout each day in between visits. The actual therapeutic benefits of homeopathy along with the inner comforts of the patient as they connect you with each dose they take.
• The dynamic broadening of your effective scope of practice multiplies the number of patients you can help and the multiple problems that each patient usually has. As you correct one set of problems, there are commonly other problems most patients don’t even tell their chiropractors. This doesn’t have to be the case anymore. Homeopathy empowers the chiropractor to correct conditions ranging from allergies to warts with incredible effectiveness!
• Obviously, the rule of multiples will exponentially increase when a homeopathic procedure is properly implemented into your practice. Many of the conditions people are suffering with have no viable solution without the dynamic duo of chiropractic and homeopathy.
  

You can be the doctor people will seek out, travel long distances to see, and pay cash for your valuable services. Take it from someone who has experienced it first hand, it’s a great position to be in.

This is no surprise. Most chiropractors relinquished whatever ethical integrity they might have had when they bought into the “subluxation” myth, and the field as a whole has a fine tradition of “practice building.”

Naturopaths, likewise, don’t mind winking at practice ethics in order to make an extra buck. Nor do MD quacks, of course. Hey, it’s getting harder and harder to make a living just by slogging through the morass of needy patients, onerous third-party billing requirements, diminishing payments, increasingly cumbersome practice guidelines, next-to-impossible-to-keep-up-with (nothing to say of tedious and technical!) medical literature, and all the rest. Why not sprinkle your practice with a little ‘diagnostic’ sugar that will appease those clingy patients—for a while, anyway—and that you won’t have to find billing codes for (because there aren’t any)? Heck, why not check out this offering from “bio-pro, inc. Amazing Anti-Aging Solutions (Healthier Patients, More Patients)”:

HOWW TOOOO ….

The “must do” seminars for those who own or are managing a Complimentary [sic]Medicine Practice.

Three day course teaches you:

How to relate to the patient, evaluate, test and diagnose

How to use solutions, mixtures, methods, supplies and equipment

How to protocol administration for Chelation, Oxidation, Chelox, TriOx, Ascorbates, UVBI

How to design and organize your office

How to hire and fire staff and to computerize

How to use public relations and marketing

How to manage compliance with Medicare, State Medical Boards and governmental regulatory agencies

Manuals included…

Each attendee receives one set of training materials, including:

Protocol Manual

Physicians Manual

Office Procedure Manual

Forms Book

Marketing Manual

Patient Results Manual

Employee Manual

Audio tapes

and other related material.

Bio-pro was founded in 1978 by the late Charles H. Farr, MD, PhD, the self-styled “father of oxidative medicine,” who was also a founder of the American College for Advancement in Medicine, the Mother of All Pseudomedical Pseudoprofessional Organizations (PPO). But none of this is surprising, right? After all, quacks quack.

What may have come as a surprise to beleaguered physicians who still play by the rules was this offering, just a few days ago, from Medscape Business of Medicine:

Six Ways to Earn Extra Income From Medical
Activities

You’re chasing after claims but watching reimbursement sink.

It’s a common story, and primary care doctors and even specialists are keeping their ears to the ground for other ways to boost their bottom line. Luckily, doctors have some fairly lucrative options that can help them maintain their income — and perhaps even increase it.

We looked at 6 avenues that physicians have taken to earn extra revenue. None of these activities require a tremendous amount of time. Participating in just 1 or 2 activities can put enough money in your pocket to allow you to breathe a little easier when the bills come in.

So what are those ‘6 avenues’? Let’s see:

• Work with Attorneys
• See Nursing Home Patients
• Serve as a Medical Director
  

So far, so not necessarily bad…

• Team Up with Pharmaceutical Companies
  

What??! Team up with pharmaceutical companies? Couldn’t that mean, like, just doing legitimate research and trying like hell to do it right? Uh, nope:

Drug and device companies spend billions of dollars each year to discover and promote new medicines and treatments, and they rely heavily on doctors to participate in these endeavors whether through clinical trials or serving as a speaker or consultant. It’s not uncommon for physicians to earn a minimum of 5 figures a year either speaking or doing clinical studies within their medical practice. Some doctors make in excess of $100,000 annually — on top of their income from seeing patients.

O’course, you gotta watch out for those pesky ethics killjoys, warns Medscape:

Although some extra money is nice, too much can turn heads — and not in a good way. In late January, The Boston Globe reported on an allergy and asthma specialist who was issued an ultimatum by his hospital, the prestigious Brigham and Women’s Hospital (Boston, Massachusetts): Stop moonlighting on behalf of pharmaceutical companies or resign from your staff position.

What it all comes down to is this:

Pros: With typical payments running about $1500-$2500 for a single talk, there’s substantial opportunity to supplement your regular income…

Cons: These arrangements are coming under increasing scrutiny from hospitals, legislators, regulators, and the media. In fact, some of the doctors whom we contacted for this article declined to talk about their involvement with drug companies.

Uh, no kiddin’. Funny that the “increasing scrutiny” doesn’t seem to come from organized medicine, medical schools, mainstream medical journals, state medical boards, or doctors in general. A couple of years ago I lamented the publication of a couple of book reviews, in the lofty New England Journal of Medicine, that celebrated trendy pseudomedicine. Shortly thereafter I received this from an emeritus editor:

I think the incursion into the bastions of medicine has to do with the fact that everything nowadays—absolutely everything—has become a market. If quackery appeals to the readers of the NEJM, it will be there. ”Is it true?” is no longer the question anyone asks, but “Will it sell?” And I think that applies to the editors of most major journals, as well.

True, dat. As for Medscape, this isn’t its first ethical gaff, and I agree with Bernard Carroll that it seems to have “a right hand – left hand problem.”

Oh yeah: what were the other 2 “avenues”? Those would be:

• Become a Media Personality
• Consult for Wall Street

Professional Integrity for Sale? “Sure,” Says Medscape!

Some chiropractors also practice homeopathy. According to Frank King, D.C., many more should be doing just that:

Homeopathy is an energetic form of natural medicine that corrects nerve interferences, absent nerve reflexes, and pathological nerve response patterns that the chiropractic adjustment alone does not correct. The appropriate homeopathic remedies will eliminate aberrant nerve reflexes and pathological nerve responses which cause recurrent subluxation complexes.

Not only does homeopathy correct nerve interferences, it empowers the doctor of chiropractic to reach the entire nervous system. What this means is that we can now better affect the whole person, and all of the maladies that affect us. Homeopathy’s energetic approach reaches deep within the nervous system, correcting nerve interferences where the hands of chiropractic alone cannot reach. Homeopathy is the missing link that enables the chiropractor to truly affect the whole nervous system!

But that’s not all:

Financial Rewards

Homeopathy means a multiple increase in business. Personally, I have been able to see and effectively help more patients in less time. The additional cash flow from broadening your scope of practice, increasing your patient volume and selling the homeopathic remedies is a wonderful adjunct. Better yet are the secondary financial benefits:

• Homeopathy is like an extension of you that the patient can take with them to apply throughout each day in between visits. The actual therapeutic benefits of homeopathy along with the inner comforts of the patient as they connect you with each dose they take.
• The dynamic broadening of your effective scope of practice multiplies the number of patients you can help and the multiple problems that each patient usually has. As you correct one set of problems, there are commonly other problems most patients don’t even tell their chiropractors. This doesn’t have to be the case anymore. Homeopathy empowers the chiropractor to correct conditions ranging from allergies to warts with incredible effectiveness!
• Obviously, the rule of multiples will exponentially increase when a homeopathic procedure is properly implemented into your practice. Many of the conditions people are suffering with have no viable solution without the dynamic duo of chiropractic and homeopathy.
  

You can be the doctor people will seek out, travel long distances to see, and pay cash for your valuable services. Take it from someone who has experienced it first hand, it’s a great position to be in.

This is no surprise. Most chiropractors relinquished whatever ethical integrity they might have had when they bought into the “subluxation” myth, and the field as a whole has a fine tradition of “practice building.”

Naturopaths, likewise, don’t mind winking at practice ethics in order to make an extra buck. Nor do MD quacks, of course. Hey, it’s getting harder and harder to make a living just by slogging through the morass of needy patients, onerous third-party billing requirements, diminishing payments, increasingly cumbersome practice guidelines, next-to-impossible-to-keep-up-with (nothing to say of tedious and technical!) medical literature, and all the rest. Why not sprinkle your practice with a little ‘diagnostic’ sugar that will appease those clingy patients—for a while, anyway—and that you won’t have to find billing codes for (because there aren’t any)? Heck, why not check out this offering from “bio-pro, inc. Amazing Anti-Aging Solutions (Healthier Patients, More Patients)”:

HOWW TOOOO ….

The “must do” seminars for those who own or are managing a Complimentary [sic]Medicine Practice.

Three day course teaches you:

How to relate to the patient, evaluate, test and diagnose

How to use solutions, mixtures, methods, supplies and equipment

How to protocol administration for Chelation, Oxidation, Chelox, TriOx, Ascorbates, UVBI

How to design and organize your office

How to hire and fire staff and to computerize

How to use public relations and marketing

How to manage compliance with Medicare, State Medical Boards and governmental regulatory agencies

Manuals included…

Each attendee receives one set of training materials, including:

Protocol Manual

Physicians Manual

Office Procedure Manual

Forms Book

Marketing Manual

Patient Results Manual

Employee Manual

Audio tapes

and other related material.

Bio-pro was founded in 1978 by the late Charles H. Farr, MD, PhD, the self-styled “father of oxidative medicine,” who was also a founder of the American College for Advancement in Medicine, the Mother of All Pseudomedical Pseudoprofessional Organizations (PPO). But none of this is surprising, right? After all, quacks quack.

What may have come as a surprise to beleaguered physicians who still play by the rules was this offering, just a few days ago, from Medscape Business of Medicine:

Six Ways to Earn Extra Income From Medical
Activities

You’re chasing after claims but watching reimbursement sink.

It’s a common story, and primary care doctors and even specialists are keeping their ears to the ground for other ways to boost their bottom line. Luckily, doctors have some fairly lucrative options that can help them maintain their income — and perhaps even increase it.

We looked at 6 avenues that physicians have taken to earn extra revenue. None of these activities require a tremendous amount of time. Participating in just 1 or 2 activities can put enough money in your pocket to allow you to breathe a little easier when the bills come in.

So what are those ‘6 avenues’? Let’s see:

• Work with Attorneys
• See Nursing Home Patients
• Serve as a Medical Director
  

So far, so not necessarily bad…

• Team Up with Pharmaceutical Companies
  

What??! Team up with pharmaceutical companies? Couldn’t that mean, like, just doing legitimate research and trying like hell to do it right? Uh, nope:

Drug and device companies spend billions of dollars each year to discover and promote new medicines and treatments, and they rely heavily on doctors to participate in these endeavors whether through clinical trials or serving as a speaker or consultant. It’s not uncommon for physicians to earn a minimum of 5 figures a year either speaking or doing clinical studies within their medical practice. Some doctors make in excess of $100,000 annually — on top of their income from seeing patients.

O’course, you gotta watch out for those pesky ethics killjoys, warns Medscape:

Although some extra money is nice, too much can turn heads — and not in a good way. In late January, The Boston Globe reported on an allergy and asthma specialist who was issued an ultimatum by his hospital, the prestigious Brigham and Women’s Hospital (Boston, Massachusetts): Stop moonlighting on behalf of pharmaceutical companies or resign from your staff position.

What it all comes down to is this:

Pros: With typical payments running about $1500-$2500 for a single talk, there’s substantial opportunity to supplement your regular income…

Cons: These arrangements are coming under increasing scrutiny from hospitals, legislators, regulators, and the media. In fact, some of the doctors whom we contacted for this article declined to talk about their involvement with drug companies.

Uh, no kiddin’. Funny that the “increasing scrutiny” doesn’t seem to come from organized medicine, medical schools, mainstream medical journals, state medical boards, or doctors in general. A couple of years ago I lamented the publication of a couple of book reviews, in the lofty New England Journal of Medicine, that celebrated trendy pseudomedicine. Shortly thereafter I received this from an emeritus editor:

I think the incursion into the bastions of medicine has to do with the fact that everything nowadays—absolutely everything—has become a market. If quackery appeals to the readers of the NEJM, it will be there. ”Is it true?” is no longer the question anyone asks, but “Will it sell?” And I think that applies to the editors of most major journals, as well.

True, dat. As for Medscape, this isn’t its first ethical gaff, and I agree with Bernard Carroll that it seems to have “a right hand – left hand problem.”

Oh yeah: what were the other 2 “avenues”? Those would be:

• Become a Media Personality
• Consult for Wall Street

The Editorial that Wasn't: Evidence for Systematic Research Manipulation Undetectable by Critical Review

Woe to those of us who have been advocates for evidence-based medicine.  A short description of the evidence-based medicine is medicine whose practice is informed by critical, rigorous review of the best available evidence from clinical research as revealed by systematic search of the published research literature, as well as by the clinician's understanding of biology and the medical and biopsychosocial context, and by the patient's own values.

Evidence-based medicine is based on some key assumptions.  One is that a systematic review will reveal all the results of research studies that are relevant to the issue at hand.  A second is that while the research studies may be flawed and imperfect, they are reported honestly.

Unfortunately, as we have repeatedly discussed, there is more and more evidence that a systematic review will not reveal all relevant results, because research studies may be suppressed, perhaps often, when their results are unfavorable to vested interests.  (Look here for further discussion.)  There is also considerable anecdotal evidence that the design, implementation, and analysis of research studies may be manipulated to make the results more likely to favor vested interests.  (Look here for further discussion.)

An article by Vedula et al just published in the renowned New England Journal of Medicine suggests that such manipulation might be systemic, and that the reporting of manipulated studies may not clearly show what manipulation was done. (1)

To summarize, the authors got access through legal proceedings to internal study protocols and research reports from clinical trials sponsored by Parke-Davis (later merged into Pfizer Inc) of gabapentin (Neurontin) for a variety of clinical problems other than seizures.  Gabapentin was originally marketed as an anti-seizure drug, but Pfizer later "admitted guilt for off-label marketing."  (We discussed the stealth marketing campaign for Neurontin here.)  Vedula et al compared the primary outcome variables specified in the original research protocols, internal research reports, and any publications of the trials' results.  They identified 21 trials, 13 of which were published.  For 12 of the 13, the authors had access to the internal protocol, report, or both.  The main results were:

For 8 of the 12 published trials, there was a disagreement between the definition of the primary outcome in the protocol and that in the published report.... Sources of disagreement included the introduction of an entirely new primary outcome in the published report (in the case of 6 trials); failure to distinguish between primary and secondary outcomes in the published report, even though the protocol did distinguish between them (2 trials); relegation of a primary outcome in the protocol to a secondary outcome in the published report (2 trials); and failure to include in the published report one or more primary outcomes specified in the protocol (5 trials).

Furthermore, it appeared that failure of published articles to clearly and fully report results in terms of the original, pre-specified primary outcome variables occurred when these comparisons were not favorable to gabapentin. As the authors summarized:

Thus, trials with findings that were not statistically significant (P≥0.05) for the protocol-defined primary outcome, according to the internal documents, either were not published in full or were published with a changed primary outcome.

As shown in Figure 3, all the changes that took place between what was specified in the protocol, what was known before publication (as presented in the internal company research reports), and what was reported to the public led to a more favorable presentation in the medical literature of gabapentin's efficacy for unapproved indications.

They concluded:

We are concerned that the reporting practices observed in our analysis do not meet the ethical standards for clinical research or maintain the integrity of scientific knowledge. Fair and honest treatment of patients enrolled in clinical trials of any kind requires full, open, and unbiased reporting. Journal publication, a formalized platform for scientific discourse and dissemination of knowledge, should not be used as a marketing tool for off-label drug use.

Reporting biases such as those we describe here increase the likelihood that interventions will appear to be effective when they are not. Such biases can lead to the omission of negative findings in systematic reviews of intervention effectiveness and in evidence-based guidelines. For example, the 2005 Cochrane systematic review regarding the effectiveness of gabapentin for acute and chronic pain concluded that it is effective on the basis of published findings and should now be updated with the inclusion of unpublished information made available through litigation.

I believe that the article by Vedula et al is particularly important because it shows what appears to be systematic manipulation of the analysis and reporting of multiple clinical trials of the same drug (but for different indications) that had the effect of making the drug appear efficacious when it likely was not. Furthermore, the manipulation was concealed. The published research articles did not completely describe what the intended primary efficacy outcome variables were, did not provide results in terms of these variables, and instead provided results only in terms of variables that were chosen post-hoc as new primary outcome variables.

To address that latter point, I independently reviewed three of the research publications cited by Vedula et al.(2,3,4) All three were noted to have reported significant results favoring gabapentin in terms of a primary efficacy outcome variable that was not identified as such in the corresponding studies' original research protocols or reports (see the supplementary data provided with the New England Journal article.) Per my review, none of the three published articles offered any hint that what they reported as primary outcome variables were not the variables originally chosen in that capacity, nor did they identify what those original primary outcome variables were, or how comparisons made using them turned out.

The implications of the article by Vedula et al are very important. Hence, I was surprised that the article appeared without an accompanying editorial to discuss these implications, and that its publication did not generate much media interest.

So that gives me an opportunity to comment further.

One could start with the implications for evidence-based medicine. As noted above, a short description of the evidence-based medicine is medicine whose practice is informed by critical, rigorous review of the best available evidence from clinical research as revealed by systematic search of the published research literature, as well as by the clinician's understanding of biology and the medical and biopsychosocial context, and by the patient's own values. Evidence-based medicine depends on critical, rigorous review, but the review process is generally done under the assumptions that research publications honestly describe what was done and what its results were. The review process was never designed to detect dishonest reporting or find information that was deliberately concealed. Manipulation of research (design, analysis, and implementation), concealment of that manipulation, and outright suppression of research threaten the foundations of evidence-based medicine. Yet the article by Vedula et al is part of a growing body of evidence that such manipulation, concealment and suppression are widespread, and done to serve vested interests, often commercial.

That is a huge problem for proponents of evidence-based medicine, but also for physicians who want their practices to be based on science, for patients who want their care to be based on science, and for all those in society who see the advancement of medical science as a way to improve peoples' lives.

As senior author Professor Kay Dickersin noted in an interview with Bloomberg "The trouble is, as a scientist, the publication has always been held up to me as the truth. It's the scientific record. What this study indicated is we can't believe that record."

Furthermore, to be a bit more concrete, most physicians, patients, and policy makers depend on what appears to be honest clinical research to make decisions about individual care and health policy. Deliberate and deceitful manipulation of clinical research to favor sponsors' products has likely lead to excessive use of and payments for drugs and devices that are less effective than advertised, if not useless or dangerous. Thus, it is likely that such manipulation is partially responsible for ever increasing health costs and poor health outcomes.

Finally, we need to start thinking about how we can detect and compensate for manipulation of clinical research in the past, and deter such manipulation in the future. One possible deterrent would be, as was noted by Vedula et al, detailed clinical trials registries that contain complete information about trial protocols.  For this to be effective, there need to be mechanisms to assure compliance, and penalties for non-compliance.  Moreover, since clinical research is now global, the registries must have global scope, and enforced assurance of compliance must also be global.

Registries might decrease future manipulation and suppression of research.   No one has suggested, as far as I know, a systematic way to detect and correct for previous manipulation. It would require a major, global investigative effort to uncover manipulation, and it would be a major scientific and policy endeavor to reveal most suppressed research and correct most manipulations.

However, before anything is done, patients, physicians and policy makers must acknowledge and understand the problem.  Yet it seems that even discussing these may be topics that are very uncomfortable for some of us. The longer we shrink from addressing them, however, the worse will be the results for patients, physicians, science and society.

References


1. Vedula SS, Bero L, Scherer RW, Dickersin K. Outcome reporting in industry-sponsored tirals of gabapentin for off-label use. N Engl J Med 2009; 361: 1963-1971. Link here.


2. Mathew NT, Rapoport A, Saper J et al. Efficacy of gabapentin in migraine prophylaxis. Headache 2001; 41: 119-128. Link here.


3. Vieta E, Goikolea JM, Martinea-Aran A et al. A double-blind, randomized, placebo-controlled, prophylaxis study of adjunctive gabapentin for bipolar disorder. J Clin Psychiatr 2006; 67: 473-477.  Link here.


4. Caraceni A, Zecca E, Bonezzi C et al. Gabapentin for neuropathic cancer pain: a randomized controlled trial from the gabapentin cancer pain study group. J Clin Oncol 2004; 22: 2909-2917. Link here.

The Editorial that Wasn't: Evidence for Systematic Research Manipulation Undetectable by Critical Review

Woe to those of us who have been advocates for evidence-based medicine.  A short description of the evidence-based medicine is medicine whose practice is informed by critical, rigorous review of the best available evidence from clinical research as revealed by systematic search of the published research literature, as well as by the clinician's understanding of biology and the medical and biopsychosocial context, and by the patient's own values.

Evidence-based medicine is based on some key assumptions.  One is that a systematic review will reveal all the results of research studies that are relevant to the issue at hand.  A second is that while the research studies may be flawed and imperfect, they are reported honestly.

Unfortunately, as we have repeatedly discussed, there is more and more evidence that a systematic review will not reveal all relevant results, because research studies may be suppressed, perhaps often, when their results are unfavorable to vested interests.  (Look here for further discussion.)  There is also considerable anecdotal evidence that the design, implementation, and analysis of research studies may be manipulated to make the results more likely to favor vested interests.  (Look here for further discussion.)

An article by Vedula et al just published in the renowned New England Journal of Medicine suggests that such manipulation might be systemic, and that the reporting of manipulated studies may not clearly show what manipulation was done. (1)

To summarize, the authors got access through legal proceedings to internal study protocols and research reports from clinical trials sponsored by Parke-Davis (later merged into Pfizer Inc) of gabapentin (Neurontin) for a variety of clinical problems other than seizures.  Gabapentin was originally marketed as an anti-seizure drug, but Pfizer later "admitted guilt for off-label marketing."  (We discussed the stealth marketing campaign for Neurontin here.)  Vedula et al compared the primary outcome variables specified in the original research protocols, internal research reports, and any publications of the trials' results.  They identified 21 trials, 13 of which were published.  For 12 of the 13, the authors had access to the internal protocol, report, or both.  The main results were:

For 8 of the 12 published trials, there was a disagreement between the definition of the primary outcome in the protocol and that in the published report.... Sources of disagreement included the introduction of an entirely new primary outcome in the published report (in the case of 6 trials); failure to distinguish between primary and secondary outcomes in the published report, even though the protocol did distinguish between them (2 trials); relegation of a primary outcome in the protocol to a secondary outcome in the published report (2 trials); and failure to include in the published report one or more primary outcomes specified in the protocol (5 trials).

Furthermore, it appeared that failure of published articles to clearly and fully report results in terms of the original, pre-specified primary outcome variables occurred when these comparisons were not favorable to gabapentin. As the authors summarized:

Thus, trials with findings that were not statistically significant (P≥0.05) for the protocol-defined primary outcome, according to the internal documents, either were not published in full or were published with a changed primary outcome.

As shown in Figure 3, all the changes that took place between what was specified in the protocol, what was known before publication (as presented in the internal company research reports), and what was reported to the public led to a more favorable presentation in the medical literature of gabapentin's efficacy for unapproved indications.

They concluded:

We are concerned that the reporting practices observed in our analysis do not meet the ethical standards for clinical research or maintain the integrity of scientific knowledge. Fair and honest treatment of patients enrolled in clinical trials of any kind requires full, open, and unbiased reporting. Journal publication, a formalized platform for scientific discourse and dissemination of knowledge, should not be used as a marketing tool for off-label drug use.

Reporting biases such as those we describe here increase the likelihood that interventions will appear to be effective when they are not. Such biases can lead to the omission of negative findings in systematic reviews of intervention effectiveness and in evidence-based guidelines. For example, the 2005 Cochrane systematic review regarding the effectiveness of gabapentin for acute and chronic pain concluded that it is effective on the basis of published findings and should now be updated with the inclusion of unpublished information made available through litigation.

I believe that the article by Vedula et al is particularly important because it shows what appears to be systematic manipulation of the analysis and reporting of multiple clinical trials of the same drug (but for different indications) that had the effect of making the drug appear efficacious when it likely was not. Furthermore, the manipulation was concealed. The published research articles did not completely describe what the intended primary efficacy outcome variables were, did not provide results in terms of these variables, and instead provided results only in terms of variables that were chosen post-hoc as new primary outcome variables.

To address that latter point, I independently reviewed three of the research publications cited by Vedula et al.(2,3,4) All three were noted to have reported significant results favoring gabapentin in terms of a primary efficacy outcome variable that was not identified as such in the corresponding studies' original research protocols or reports (see the supplementary data provided with the New England Journal article.) Per my review, none of the three published articles offered any hint that what they reported as primary outcome variables were not the variables originally chosen in that capacity, nor did they identify what those original primary outcome variables were, or how comparisons made using them turned out.

The implications of the article by Vedula et al are very important. Hence, I was surprised that the article appeared without an accompanying editorial to discuss these implications, and that its publication did not generate much media interest.

So that gives me an opportunity to comment further.

One could start with the implications for evidence-based medicine. As noted above, a short description of the evidence-based medicine is medicine whose practice is informed by critical, rigorous review of the best available evidence from clinical research as revealed by systematic search of the published research literature, as well as by the clinician's understanding of biology and the medical and biopsychosocial context, and by the patient's own values. Evidence-based medicine depends on critical, rigorous review, but the review process is generally done under the assumptions that research publications honestly describe what was done and what its results were. The review process was never designed to detect dishonest reporting or find information that was deliberately concealed. Manipulation of research (design, analysis, and implementation), concealment of that manipulation, and outright suppression of research threaten the foundations of evidence-based medicine. Yet the article by Vedula et al is part of a growing body of evidence that such manipulation, concealment and suppression are widespread, and done to serve vested interests, often commercial.

That is a huge problem for proponents of evidence-based medicine, but also for physicians who want their practices to be based on science, for patients who want their care to be based on science, and for all those in society who see the advancement of medical science as a way to improve peoples' lives.

As senior author Professor Kay Dickersin noted in an interview with Bloomberg "The trouble is, as a scientist, the publication has always been held up to me as the truth. It's the scientific record. What this study indicated is we can't believe that record."

Furthermore, to be a bit more concrete, most physicians, patients, and policy makers depend on what appears to be honest clinical research to make decisions about individual care and health policy. Deliberate and deceitful manipulation of clinical research to favor sponsors' products has likely lead to excessive use of and payments for drugs and devices that are less effective than advertised, if not useless or dangerous. Thus, it is likely that such manipulation is partially responsible for ever increasing health costs and poor health outcomes.

Finally, we need to start thinking about how we can detect and compensate for manipulation of clinical research in the past, and deter such manipulation in the future. One possible deterrent would be, as was noted by Vedula et al, detailed clinical trials registries that contain complete information about trial protocols.  For this to be effective, there need to be mechanisms to assure compliance, and penalties for non-compliance.  Moreover, since clinical research is now global, the registries must have global scope, and enforced assurance of compliance must also be global.

Registries might decrease future manipulation and suppression of research.   No one has suggested, as far as I know, a systematic way to detect and correct for previous manipulation. It would require a major, global investigative effort to uncover manipulation, and it would be a major scientific and policy endeavor to reveal most suppressed research and correct most manipulations.

However, before anything is done, patients, physicians and policy makers must acknowledge and understand the problem.  Yet it seems that even discussing these may be topics that are very uncomfortable for some of us. The longer we shrink from addressing them, however, the worse will be the results for patients, physicians, science and society.

References


1. Vedula SS, Bero L, Scherer RW, Dickersin K. Outcome reporting in industry-sponsored tirals of gabapentin for off-label use. N Engl J Med 2009; 361: 1963-1971. Link here.


2. Mathew NT, Rapoport A, Saper J et al. Efficacy of gabapentin in migraine prophylaxis. Headache 2001; 41: 119-128. Link here.


3. Vieta E, Goikolea JM, Martinea-Aran A et al. A double-blind, randomized, placebo-controlled, prophylaxis study of adjunctive gabapentin for bipolar disorder. J Clin Psychiatr 2006; 67: 473-477.  Link here.


4. Caraceni A, Zecca E, Bonezzi C et al. Gabapentin for neuropathic cancer pain: a randomized controlled trial from the gabapentin cancer pain study group. J Clin Oncol 2004; 22: 2909-2917. Link here.

No Such RUC - The New England Journal Takes on the Primary Care Crisis, Sort Of

The vast amounts spent globally on health care do not seem to translate into access for many patients, quality care, and improved outcomes. The US, in particular, spends huge amounts, now more than $2 trillion a year, without getting universal access, or superb quality and outcomes. While we spend all this money, the primary care and generalist practitioners on the front lines of care are paid less and less, are increasingly embattled and disgruntled, and their numbers are rapidly thinning.

Although these problems are huge, there is not much clear discussion of them.

Thus, it was encouraging to see the vaunted New England Journal of Medicine, the premier US journal of medicine, take up the issue of the "future of primary care." A few weeks ago, the journal published a series of commentaries on the issue,(1-6) and the transcript of a round table discussion among their authors.(7) It was touted as the views of experts on "the crisis in U.S. primary care."

Unfortunately, although the series acknowledged some surface characteristics of the US health care system that have lead to this crisis, it did not delve further into its causes.

On the surface, a major cause of the crisis is that payments to primary care physicians are so limited that we are driving them out of business, while we pay lavishly for new, high-technology, often risky and invasive procedures.

However, understanding how and why this happens requires dissecting layer after layer of complex details. Doing so can be frustrating, if not eye glazing, and this may be one reason why the discussion of this pivotal issue has been so limited.

The first layer of complexity was implicitly acknowledged, but not discussed in the NEJM series. Bear with me through it.

The First Layer of Causation: Low Payments for Face-to-Face Visits, Rising Overhead

Physicians are paid for each encounter with a patient. Their pay only covers what they do in the presence of the patient, and not other efforts on patients' behalf, e.g., communicating with patients when they are not in the office, communicating with other professionals, paperwork required by insurance companies, etc, etc. Furthermore, pay for office visits is available only in a very small number of categories, and the pay for more complex visits is not commensurate with the increase in time and effort that they require, so that physicians who spend a lot of time trying to deal with complex problems will not be paid commensurate with their work. Pay for office visits has not increased as fast as inflation, and certainly not as fast as the expenses of running physicians' offices, i.e., office overhead, has increased. Thus, to try to maintain income, and to support increasingly complex office operations and overhead, primary care physicians must limit the time they spend with any one patient.

The result is the 15 minute visit for nearly all patients. But it is ridiculous to try to manage complex problems in 15 minute visits. Furthermore, primary care physicians spend hours of unpaid time doing paperwork, communications, etc.

The NEJM special articles dealt briefly with the contrast between how primary care physicians and proceduralists are paid, and the adverse effects of the 15-minute visit. The series coordinator, Dr Thomas Lee, noted that "procedure-oriented specialties offer higher potential incomes."(1) Dr Allan H Goroll decried the "current volume-driven, fee-for-service approaches," the "piecework payment system that perpetuates our 'hamster-wheel' environment."(4) Dr Thomas Bodenheimer asserted that primary care physicians are"overstressed by large patient panels." He blamed this on "the over-burdened 15-minute clinician visit."(3) He mentioned the 15-minute visit three other times in his commentary. In the round table discussion that accompanied the articles, he protested, "it's the tyranny of the 15-minute visit. If you come in to your practice in the morning and you see that you have 12 to 15 15-minute visits in the morning and another 12 to 15 15-minute visits in the afternoon, and you know you can't do it all in 15 minutes...."(7) Finally, in the round table discussion that accompanied the series, Dr Katherine Treadway offered the longest and most impassioned discussion, first explaining the problem,

Since I’ve been in practice a long time and I have an elderly, sick population, that for every hour of face-to-face time, I have another hour, at least, of time that I spend that’s unreimbursed. So, if I’m there for 13 hours, I’m getting paid for about 6 of the hours I’m spending.

and

The RVU system is ...designed for specialty care and single problems. There is nothing in the RVU system that allows you to take into account the fact that you’ve just seen somebody with congestive heart failure, hypertension, hyperlipidemia, coronary disease, renal insufficiency, and diabetes.

Why Are Payments Low for Face-to-Face Visits?

However, none of the commentaries addressed how we got to this pass, or, to continue the analogy above, none dissected the next layer. At best, they seemed to imply that this came about due to the forces of nature or an act of God. For example, in the round table discussion, Dr Lee said,

And I want to go to the payment system next. But do you think — I mean, which comes first, the chicken or the egg? Is it in the water and in the culture, in the educational values? And then the payment system may just reinforce that? Or is it the other way around, the payment system’s where it begins and that’s why it’s in the water?

To which Prof Barabara Starfield could only reply,

Unfortunately, it’s the chicken and the egg cycle. It doesn’t start in any one place.

The Role of the RUC

Actually, one can find the next layer of explanations in one place. The current bizarrely distorted manner in which physicians are paid was the act of people, a few people operating largely in the shadows.

The US Medicare system determines what it pays physicians using the Resource Based Relative Value System (RBRVS). This system determines the pay for every kind of medical encounter according to a complex formula that is supposed to account for physicians' time and effort, physicians' practice expense, and the cost of malpractice insurance. The components of physicians' effort assessed are, in turn, technical skill and physical effort; the required mental effort and judgment; and stress due to the potential risk to the patient.

To keep the system, which was started in 1990, current, requires addition of new kinds of encounters, which means encounters involving new kinds of procedures, and updating of the estimates of various components, including physicians' time and effort. To do so, the Center for Medicare and Medicaid Services (CMS) relies almost exclusively on the advice of the RBRVS Update Committee (RUC). The RUC is a private committee of the AMA, touted as an "expert panel" that takes advantage of the organization's First Amendment rights to petition the government. Membership on the RUC is allotted to represent specialty societies, so that the vast majority of the members represent specialties that do procedures and focus on expensive, high-technology tests and treatments. However, the identities of RUC members are secret, as are the proceedings of the group.

This opaque and unaccountable process has resulted in increases outstripping inflation in fees paid for procedures, while fees paid for "cognitive"medicine, i.e., for primary care, and for services that involve diagnosis, management of acute and chronic disease, counseling, coordination of care, etc, but not procedures, have lagged inflation. The effects of the RUC have been amplified by the unexplained tendency of commercial managed care and health insurance to track the RBRVS system when making their own payments to physicians.

For further details about the RUC, see these posts on Health Care Renewal (here, here, here, and here) and important articles by Bodenheimer et al,(8) and Goodson.(9)

The Unanswered Questions

Understanding this layer of the process raises some major questions, whose answers could help dissect the next layers.

• How did the government come to fix the payments physicians receive? Government price-fixing has not been popular in the US, yet this has caused no outcry.
• Why is the process by which they are fixed allowed to be so opaque and unaccountable? Why are there no public hearings on the updates, and why is there no input from practicing physicians or organizations other than the RUC?
• How did the RUC become de facto in charge of this process?
• Why does the AMA keep the membership on the RUC secret, and give no input into the RUC process to its general membership?
• Why is the RUC membership so dominated by procedural specialists? Why were primary care physicians, who made up at least a sizable minority of physicians when the update process was started, not represented according to their numbers?
• Why has there been so little discussion of the RUC and its responsibility for an extremely expensive health care system dominated by high-technology, expensive, risky and invasive procedures?

Of course, since the NEJM series failed to address the role of the RUC in the collapse of primary care, it could not raise, much less begin to answer such questions. The series mentioned the RUC only once, and virtually parenthetically, (by Dr Gorroll, who noted, "the current system "relies on the Relative Value Scale Update Committee [RUC] of the American Medical Association to set values for primary care services, despite the committee's marked overweighting in favor of procedural specialties...."[4]) Despite having written a key article explaining the role of the RUC,(8) Dr Bodenheimer was apparently only asked to write about practice innovations that could somehow compensate for continuing limits on the length of primary care visits.(3) It appears that it remains politically incorrect to question the RUC.

However, failing to understand, or even address the causes of the collapse of primary care will make it all the more difficult to find a way to revive it.

"Those who cannot remember the past are condemned to repeat it." attributed to George Santayana

References

1. Lee TH. The future of primary care: the need for reinvention. N Engl J Med 2008; 359: 2085-2086. Link here.
2. Treadway K. The future of primary care: sustaining relationships. N Engl J Med 2008; 359: 2086, 2088. Link here.
3. Bodenheimer T. The future of primary care: transforming practice. N Engl J Med 2008; 359: 2086, 2089. Link here.
4. Goroll AH. The future of primary care: reforming physician payment. N Engl J Med 2008; 359: 2087, 2090. Link here.
5. Starfield B. The future of primary care: refocusing the system. N Engl J Med 2008; 359: 2087, 2091. Link here.
6. Roland M. The future of primary care: lessons from the U.K. N Engl J Med 2008; 359: 2087, 2092. Link here.
7. Lee TH, Treadway K, Bodenheimer T, Starfield B, Goroll A. The future of primary care: perspective roundtable: redesigning primary care. Link here.
8. Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306. Link here.
9. Goodson JD. Unintended consequences of Resource-Based Relative Value Scale reimbursement. JAMA 2007; 298(19):2308-2310. Link here.