Another Attempt to Show the RUC Behind the Curtain

In 2007, readers of the Annals of Internal Medicine could read part of the solution to a great medical mystery.(1)  For years, health care costs in the US had been levitating faster than inflation, without producing any noticeable positive effect on patients.  Many possible reasons were proposed, but as the problem continued to worsen, none were proven.

Prices are High Because They are Fixed That Way

The article in the Annals, however, proposed one conceptually simple
answer.

The prices of most physicians’ services, at least most of those that involved procedures or operations for Medicare patients, were high because the US government set them that way. Although the notion that prices were high because they were fixed to be so high was simple, how the fixing was done, and how the fixing affected the rest of the health system was complex, mind numbingly complex.

Perhaps because of the complexity of its implementation, the simplicity of the concept has not seemingly reached the consciousness of most American health care professionals or policy makers, despite the publication of several scholarly articles on the subject,.efforts by humble bloggers such as yours truly, a major journalistic expose, and recent congressional hearings.  The lack of discussion of this issue seemed to be a prime example of what we have called the anechoic effect, that important causes of health care dysfunction whose discussion would discomfit those who are currently personally profiting from the current system rarely produce many public echoes.  (For a review of what is known to date about how the offputtingly named Resource Based Relative Value Scale Update Committee (RUC) works, and previous attempts to makes it central role in fixing what US physicians are paid public, see the Appendix.)

The Washington Monthly Pulls Back the Curtain

Now another attempt to pull back the curtain that hides the RUC was just made by the Washington Monthly.  A long, detailed, well-written article by Haley Sweetland Edwards went through the major points, and included some new discoveries.  She asserted:

The RUC is Well Hidden

[The RUC is] probably one of the most powerful committees in America that you’ve never heard of.

The RUC Fixes Prices

when a roomful of professionals from the same trade meet behind closed
doors to agree on how much their services should be worth. It’s called
price-fixing. 

The Government Enables the RUC to Fix Prices

 this kind of ‘price-fixing’ is not only perfectly legal, it’s sanctioned
by the U.S. government. At the end of each of these meetings, RUC
members vote anonymously on a list of ‘recommended values,’ which are
then sent to the Centers for Medicare and Medicaid Services (CMS), the
federal agency that runs those programs. For the last twenty-two years,
the CMS has accepted about 90 percent of the RUC’s recommended
values—essentially transferring the committee’s decisions directly into
law.

The Government Fixed Prices are Endorsed by the Private Sector

 private insurance companies also use Medicare’s fee schedule as a
baseline for negotiating prices with hospitals and other providers. 

The Price Fixing Drives Up Costs and the Use of Services

 So if the RUC inflates the base price Medicare pays for a specific
procedure, that inflationary effect ripples up through the health care
industry as a whole.

These Incentives Cripple Primary Care

 These manipulated prices are also a major reason why specialists are in
oversupply in many parts of the country, while a worsening shortage of
primary care providers threatens the whole health care delivery system. 

These Incentives Benefit Big Corporations, not just Medical Specialists

 the incentives are perfectly aligned: ordering that extra test means
more money for a doctor’s practice or hospital, more money for the labs,
and often more money for the device makers and drug companies, too.
(Oh, and, by the way, the device makers and drug companies are, not
incidentally, major funders of the medical specialty societies whose
members vote on the RUC.)

[Art by Monte Wolverton for the Washington Monthly article]

What to Do and What Will Happen?

We previously wrote,

 Economists have beaten us over the head with idea that incentives
matter.  The RUC seems to embody a corporatist approach to fixing prices
for medical services to create perverse incentives
for physicians to do more procedures, and do less conversing with and
examining patients, examining the best clinical research evidence about
their problems, and rigorously thinking about how best to help them. 
More procedures at higher prices helps physicians who do procedures.  It
may help even more the corporations that provide the devices and drugs
whose use is necessitated by such procedures, and the hospitals who can
charge a lot of money as sites for performance of procedures.  It may
even help insurance companies by driving ever more money through the
health care system, and thus allow rationalization for higher
administrative expenses as a function of overall money flow.

Yet incentives favoring procedures over all else may lead to worse
outcomes for patients, and more costs to patients and society.  If we do
not figure out how to make incentives given to physicians more rational
and fair, expect health care costs to continue to rise, while access
and quality continue to suffer.

Ms Edwards ended her article with two specific suggestions:

take the process away from the control of the AMA and put it in the
hands of a well-resourced group of experts under the auspices of the
federal government. This might take the form of a panel of doctors
employed by the government, or of an advisory committee of
representatives of different medical societies but with greater
representation of primary care doctors.

Or

 get Medicare out of the business of funding fee-for-service medicine. 

I can only hope that the latest Washington Monthly article, which was accompanied by an editorial and a short first-hand account of how difficult is the lot of the modern primary care physician, will succeed in increasing awareness of the RUC and its essential role in making the US health care system increasingly unworkable.  Of course, such awareness may disturb the many people who are making so much money within the current system.  But if we do nothing about the RUC, and about the ever expanding bubble of health care costs, that bubble will surely burst, and the results for patients’ and the public’s health will be devastating.

APPENDIX – Background on the RUC

 We have frequently posted, first here in 2007, and more recently here,  here, here, and here, about the little-known group that controls how the US Medicare system pays physicians, the RBRVS Update Committee, or RUC.


Since 1991, Medicare has set physicians’ payments using the Resource
Based Relative Value System (RBRVS), ostensibly based on a rational
formula to tie physicians’ pay to the time and effort they expend, and
the resources they consume on particular patient care activities.
Although the RBRVS was meant to level the payment playing field for
cognitive services, including primary care vs procedures, over time it
has had the opposite effect, as explained by Bodenheimer et al in a 1997
article in the Annals of Internal Medicine.(1) A system that pays a lot
for procedures, but much less for diagnosing illnesses, forecasting
prognoses, deciding on treatment, and understanding patients’ values and
preferences when procedures and devices are not involved, is likely to
be very expensive, but not necessarily very good for patients.


 

As we wrote before, to update the system, the Center for Medicare and Medicaid Services (CMS) relies almost exclusively on the advice of the RBRVS Update Committee. 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 were opaque for a long time, and the proceedings of the
group are secret.  As Goodson(2) noted, RUC “meetings are closed to
outside observers
except by invitation of the chair.” Furthermore, he stated, “proceedings
are proprietary and therefore not publicly available for review.”


 

In fact, the fog surrounding the operations of the RUC seems to have affected many who write about it. We have posted (here, here, here, and here)
about how previous publications about problems with incentives provided
to physicians seemed to have avoided even mentioning the RUC. Up
until 2010, after the US recent attempt at health care reform, the RUC
seemed to remain the great unmentionable. Even the leading US medical
journal seemed reluctant to even print its name.


 

That changed
in October, 2010.  A combined effort by the Wall Street Journal, the
Center for Public Integrity, and Kaiser Health News yielded two major
articles about the RUC, here in the WSJ (also with two more spin-off articles), and here from the Center for Public Integrity (also reprinted
by Kaiser Health News.) The articles covered the main points about the
RUC: its de facto control over how physicians are paid, its “secretive”
nature (quoting the WSJ article), how it appears to favor procedures
over cognitive physician services, etc.


 

In 2011, after the “Replace the RUC
movement generated some more interest about this secretive group, and
its complicated but obscure role in the health care system, the current
RUC membership was finally revealed.  It was relatively easy for me to determine that
many of the members had conflicts of interest (beyond their specialty
or sub-specialty identity and their role in medical societies that might
have institutional conflicts of interest, and leaders with conflicts of
interest).  


 

Then that year a lawsuit was filed by a number of primary care
physicians that contended that the RUC was functioning illegally as a de
facto US government advisory panel.  It appeared that things might
change.  However, it was not to be.  A judge dismissed the lawsuit in 2012, based on his contention that the law that set up the RBRVS
system prevented any challenges through the legal system to the
mechanism used to set payment rates.  The ruling did not address the
legality of the relationship between the RUC and the federal
government.  The eery quiet then resumed, only punctuated briefly in early 2013, when a Senate committee held hearings with no obvious effect.      

ADDENDUM (15 July, 2013) – see also comments by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.  

ADDENDUM (18 July, 2013) – see also comments by Yves Smith on the Naked Capitalism blog.


References
1. Bodenheimer T, Berenson RA, Rudolf
P. The primary care-specialty income gap: why it matters. Ann Intern Med
2007; 146: 301-306. (Link here.)



2. Goodson JD. Unintended consequences
of Resource-Based Relative Value Scale reimbursement. JAMA 2007;
298(19):2308-2310. (Link here.)

Would You Like Fries With That? – The Fast Food Model for the Corporate Physician

Allegations that suggest the continuing degradation of the professionalism of employed physicians just appeared in the Palm Beach (FL) Post.  A former physician employee of Solantic Urgent Care, a for-profit chain of urgent care clinics, described to state investigators the life of employed physicians there.

Putting Revenue First

Physicians answered to managers who put revenue first:

Thirty-something business graduates lacking in any medical training supervised the clinics’ doctors and were encouraged to maintain an adversarial relationship with them, Prokes said.

Those clinic managers’ raises and bonuses depended on their achieving ambitious goals for patient visits, labor and overhead costs, per-patient revenues and customer satisfaction.

Prokes said clinic manager turnover was high, and a succession of managers wrote him up for a variety of infractions: arriving five minutes late, failing to suggest Solantic’s pharmacy at three points of contact and suggesting a patient might want to return later, when there would be less of a wait.

As is common elsewhere, there was pressure to see as many patients as possible:

Prokes told state investigators that he found the atmosphere increasingly untenable, as he was pressed to see 70 to 90 patients each day.

‘They actually told us not to sit down for 14-hour shifts,’ Prokes told state investigators. ‘[Former Solantic CEO Rick] (Scott) does not care about the quality of medicine. They care about how fast you see people.’

A Business Model from the Fast-Food Industry

A former Solantic executive admitted that the business model came straight from the fast-food industry:

[Former Solantic Chief Operating Officer Shaun] Ginter said the retail concept that he, Scott, and then-CEO Karen Bowling created drew on lessons from the fast food and other retail industries. Counters were built at standing height, for example, because it speeded workflow, he said.

‘The culture, the workflow, were all streamlined for a more efficient delivery, a more efficient method of care,’ said Ginter, who had previously managed drug stores with small clinics within. ‘The name of the game is keeping your costs tight, and Rick, Karen and myself were very focused on keeping costs down.’

Up-Selling Unneeded Services

Just as in the fast food industry, the help was expected to up-sell. In particular, Dr Prokes charged that physicians were strongly pushed to suggest services patients did not need, but that brought in more revenue:

Doctors were monitored with cameras in the clinics’ common areas, [Dr Randy] Prokes told investigators. Staff were expected to suggest extras, including vitamins and probiotics, and a colon cancer screening test considered unreliable and outdated by CDC officials.

The Background: Rick Scott, Columbia/HCA, and the State of Florida

Note that Rick Scott just sold Solantic LLC to private equity group Welsh, Carson, Anderson & Stowe, per the Jacksonville (FL) Business Journal. Note further that Scott was the former CEO of Columbia/ HCA, which ultimately paid a huge fine for fraudulant practices:

John Schilling was working as reimbursement supervisor for Columbia/HCA’s Southwest Florida division, where he oversaw Medicare and Medicaid compliance and the cost reporting.

‘Before HCA, when it was just Columbia, the CEOs of the hospitals were making up to 100 percent of their salaries as a bonus; the CFOs made 50 percent. Even some of the directors were making 25 percent bonuses,’ Schilling said.

It drove a do-anything-to-make-the-numbers mentality, he said. Schilling now runs a firm called Ethics Solutions, where he helps potential whistleblowers.

‘There were no incentives for being in compliance with Medicare and Medicaid rules,’ Schilling said. ‘It was about, how are we going to make it profitable, and if we meet our goals, it means we get our bonuses.’

He found that the hospitals in his area kept two sets of books. The one for Medicare auditors showed inflated costs, so that hospitals could justify higher reimbursement rates to take advantage of a funding formula that has since changed.

The hospitals also kept ‘real’ books with different numbers. The discovery put him in an ethical bind, he said. When he took his concerns to a supervisor, he was told not to rock the boat. Ultimately, his whistleblower lawsuit proved among the most damaging to his employer, which eventually paid $1.7 billion to the federal government to settle criminal fraud and abuse charges.

Scott, who wanted to fight the charges rather than settle, was never charged, and said he was unaware of what his managers had been doing.

After Scott left Columbia / HCA, he used the riches he acquired as its hired executive to help fund an ultimately successful campaign for the governorship of Florida, his current office. (See posts here and here.)

Summary

We have previously posted, most recently here, about how physicians are increasingly becoming employees of for-profit corporations. We have discussed other instances in which such corporations are appearing to pressure physicians to provide “care” to patients in such a manner as to increase corporate revenue, whether or not it is good for patients. We noted that when insurance companies hire physicians, they are likely to push them into providing less care across the board, since the insurers are paid per patient, not for what is done to each patient. When hospitals, hospital systems, and other entities that directly provide care hire physicians, they are likely to push them into channeling patients to get tests, drugs, and procedures for which the corporations are most highly paid.

In this current case, the allegations fit the latter pattern. Furthermore, At least one former executive admitted that “the name of your game is keeping your costs tight,” not providing the best patient care.

There is more and more evidence that doctors who provide direct patient care as employees of for-profit corporations, and possibly other large organizations, are being increasingly pushed to put corporate revenue ahead of their patients’ best interests. It should be obvious that this is unethical. Doctors swear oaths to put their patients’ interests first.

Patients should be extremely wary of the care provided by doctors who are employed by large organizations. Doctors should be extremely wary of working for such organizations to provide direct patient care.

Below, I have repeated my humble suggestions from last week, with some additions, for

What Is to Be Done?

Patients:
– Find out if their physicians are employed, and if so, by whom.
– Find out what incentives their physicians have, if employed, to recommend more or less care of certain types.
– Find out whether other aspects of the physicians’ employment arrangements, e.g., contractual confidentiality clauses, could affect his or her relationships with patients
– Avoid doctors employed by for-profit companies who have incentives to provide more or less care than what may be best for the patient

Physicians:
– Do not accept any employment offer or contract which has incentives to provide more or less care than is best for individual patients
– Who are already employed disclose to their patients such employment, and any incentives it may provide to provide more or less care
– Urge professional societies, and certifying and accrediting organizations to further investigate threats to physicians’ professionalism arising from employment, and develop strategies to mitigate such threats

Policy-makers:
– Rapidly investigate the extent that for-profit companies whose revenues depend on physicians’ decisions are hiring physicians to take care of patients, and the incentives and influences that these companies use to affect physicians’ decisions
– Develop regulations that force disclosure of all such employment and relevant incentives and influences
– Consider further regulation of organizations that so employ physicians
– Consider whether such “commercial practice of medicine” ought to be once again banned.

ADDENDUM (12 July, 2011) –  See also this related post on KevinMD.

Office of the National Coordinator for Health Information Technology (ONC): A One Man Show?

Generally, transparency in government means that the public it serves knows who that government is.

Yet the “Office of the National Coordinator: Key Personnel” page at HHS shows only this, the name of the Coordinator himself, Dr. David Blumenthal:

Only one person works at ONC? click to enlarge

What about the others as per the Org Chart?

ONC Org Chart (click to enlarge)

In the case of the Office of the National Coordinator for Healthcare IT, there are a number of possibilities for this apparent informational lapse:

  • There is only one person working in this office;
  • Only one person is considered “Key Personnel”;
  • This office, responsible for the national program for health IT and Electronic Medical Records in the U.S. that will “revolutionize” healthcare through better record keeping, has been careless in updating its Electronic Personnel Records;
  • The names are buried somewhere not easy to find, or the identities of the personnel are being entirely withheld from the public to prevent the public from knowing who they are and what their past and present affiliations might be.

Why might that be an issue? Pro-IT industry conflicts of interest, qualifications, and anti-physician biases come to mind as just a few possibilities.

Where’s the transparency?

Just asking.

— SS

Pay-for-performance and physician professionalism

At Netroots Nation (bloggers’ conference, formerly YearlyKos) in Austin today, Lawrence Lessig addressed the crowd on problems of corruption, mostly focusing on government. Stipulating that vaccines do NOT cause autism and that they are good, he stated that National Vaccine Advisory Committee members are generally exempted from conflict of interest requirements and may make as much as $250,000 from the industry. He correlated this with a rise in parents’ refusing vaccinations from 1% in 1991 to 2.5% in 2004. Whether or not money affects NVAC decisions, its presence (he insisted) erodes the basis of trust.

Pay-for-performance is the fashionable practice of the moment in bettering health care. But is it really a good idea?

It’s meant to address a real problem. Doctors and medical facilities are paid now for what they do, not for how well they do it or for how beneficial the care is. As a result, doctors and hospitals who provide only needed care or with sterling records in minimizing patient difficulties and complications are likely to find themselves in more financial difficulties than less careful and more average physicians and facilities. This problem is pressing – when good practice hurts the bottom line, it most certainly warps probity and professionalism .

The judgment of cardiac doctors, for example, has been distorted in our country by the fact that treating patients medically scarcely pays anything, while providing aggressive interventions is majorly lucrative. We are all human and more inclined to see benefit in something which benefits both us and a client.

However, the thesis that payers should instead reward good performance and pay bonuses to those who perform well, while sounding superficially fine, is actually fraught with problems. Providing doctors and hospitals substantial financial incentives to perform “according to specs” – like money provided to medical decision-makers and Congress by industry – will warp professionalism and patient trust.

  • The idea was introduced cleverly by saying Medicare and insurers should not pay for ‘never events’ – like amputating the wrong leg. Although I really have little or no problem with not paying for something so extreme, this was really a ‘nose under the tent’ approach. So-called ‘never events’ which won’t be paid for are quickly expanding to such things as post-op infections which yes, need to be minimized and reduced – but which also are sometimes going to occur.
  • Measuring outcomes is important, but tying remuneration to reported outcomes provides a built-in incentive for corruption. Hospitals are now going to be extremely concerned to diagnose as many conditions as possible in incoming patients lest they be penalized should something adverse occur later – and this will not likely always be objective. They also have incentives to reject less easy patients, when they can.
  • A complicated pay-for-performance remuneration system provides the need for physicians to take time and attention learning it and to “gaming the system.” This is not the best use of physician time.
  • Pay-for-performance provides de facto disincentives to attending to needed care that does not generate bonuses. If a physician is rewarded for discussing obesity with patients, his attention may be to that rather than to noticing another problem that might be more important to his patient.
  • Physicians are concerned – and rightly – that pay-for-performance will hurt doctors who are willing to work with non-compliant patients – often among those who most need medical care. My niece in California (a leading pay-for-performance state at this time) already last year got a not-very-nice form letter from her doctor firing her and all other patients who were not up-to-date on mammograms and Pap smears.
  • Pay-for-performance is insulting to physicians. It assumes that they are only motivated to provide good medical care when money carrots are waved in front of them. The truth is, if we remove some of the agonies of medical practice – including fiendishly complicated paperwork and supervision systems – doctors generally very much want to provide excellent medical care and will generally take pains to do so if job conditions permit.

I don’t know what the answer is in the context of our present system. We do need a better payment system than the existing one. But pay-for-performance – I think – is another bad set of problems on the way, and an invitation to corruption.

Lifestyles of Rich but Not So Famous Hospital Executives

The Hartford Courant just reported on the ballooning salaries of top executives of not-for-profit hospitals in the state of Connecticut.

The head of Middlesex Hospital earned $1.9 million last year, making him the highest-paid hospital administrator in the state. In just three years, CEO Robert Kiely’s compensation nearly tripled, part of a trend in soaring compensation packages for hospital leaders.

Last year, Kiely and seven other Connecticut hospital administrators – three of them top managers in the Yale-New Haven Hospital Health System – made more than $1 million.

The Courant ranked the highest-paid hospital CEOs in Connecticut using data recently filed with the state Office of Health Care Access.

Yet, a close look at the numbers shows how arbitrary compensation can be. In Middletown, Kiely heads a community hospital that has expanded its ER but is not a state-approved trauma center. In New Haven, [Marna] Borgstrom oversees a teaching hospital [Yale-New Haven Hospital] and two smaller hospitals that together bring in three times the revenue. Though both executives made roughly the same in salary, Kiely received an extra $395,000 in benefits-most of it retirement money.

At Stamford Hospital, [Brina] Grissler made $376,000 more last year than Hartford Hospital President John Meehan, who oversees a health system with three times more revenue. A spokesman said Grissler’s compensation takes into account his long tenure and the cost of living in Fairfield County.

The article provided some rationalizations for how much hospital executives now make.

The hospitals say they need to offer competitive pay to keep talented managers. The job of running a hospital has grown more complex, they argue, amid falling government reimbursement rates for services and rising demand for charity care.

‘We can’t do excellence on the cheap,’ said James Matschulat, head of the compensation committee at Middlesex and a retired insurance executive. ‘We compete with every hospital in the nation for top talent.’

Strong leadership is needed for hospitals to succeed financially, and therefore serve the public good, the hospitals contend. ‘These are very complicated and difficult businesses,’ said Robert Ritz, CEO at St. Mary’s, a Catholic hospital in Waterbury. ‘We have a charitable, social and healing mission.’

On the other hand, such lavish compensation of managers of not-for-profit organizations often considered charities makes some people uncomfortable. Although excellence may not come cheap, it is not clear that all hospital executives are excellent. And some of the explanations proposed for the phenomenon are not so rational as those above.

‘Think about how many uninsured people that would cover,’ said Ellen Andrews, head of the Connecticut Health Policy Project in New Haven.

Compensation at nonprofits is exploding because board members often come from the corporate world, where lavish CEO salaries are accepted, said Pablo Eisenberg, a senior fellow at Georgetown University’s Public Policy Institute. Compensation consultants are also driving up pay by referencing corporate salaries in their surveys. As the salary gap widens between top managers and their staff, teamwork and collegiality suffers, he argues.

‘Boards are not exercising their fiduciary duty,’ he said. ‘No one is questioning these excessive compensations.’

Note that we previously posted about arguments that hospital board members see their job mainly as a networking opportunity and a chance to go to fancy social events, at least in Massachusetts, Connecticut’s northern neighbor.

As briefly mentioned in the Courant article, Senator Charles Grassley, (R-Iowa) also views lavish pay of hospital administrators with a jaundiced eye, and the scope of his concern is not restricted to the states of Connecticut or Massachusetts. As noted in the Chronicle of Higher Education,

A powerful Republican senator has asked the Government Accountability Office, Congress’s investigative arm, to examine how much free care and other services nonprofit hospitals provide to the regions in which they are located.

Sen. Charles E. Grassley of Iowa said he is concerned that hospitals may not be providing enough services to their local areas to justify the tax breaks they receive. Mr. Grassley, the top Republican on the Senate Finance Committee, also said that some hospital executives and board members may be overpaid.

‘There have been alarming reports about the lavish lifestyle that some of these individuals lead courtesy of the nonprofit hospital as well as the business ventures that enrich these individuals to the detriment of the nonprofit hospital,’ he said.

In my humble opinion, there are some hospital executives who certainly earn every dollar they make.

But it seems that

  • hospital executives’ total compensation is often well concealed
  • the relationships among such compensation and hospital size, hospital performance, and CEO performance are not obvious
  • many anecdotes, most muttered quietly in hallways, suggest very well-paid CEOs live lavish life-styles disproportionate to their hospitals’ size, charitable mission, and struggling financial status
  • such disproportionate pay and life-style of some hospital CEOs may demoralize their employees and health care professionals, even while delighting their golf-playing buddies among the local gentry
  • I would believe the sincerity of those who espouse pay for performance (P4P) for physicians if they were equally enthused about applying some measure of rationality to the compensation of health care executives.

Note, for an interesting discussion of hospital CEO pay orchestrated by the one hospital CEO who sets an example of transparency by blogging, see this post on Running a Hospital, and its associated comments.

More on "More Vioxx Agony"

Regarding the post “More Vioxx Agony“, I can add the following opinion regarding Dr. Ed Scolnick.

As my former boss’s boss and perhaps the most prodigious individual user of the department I managed, the Merck Reseach Labs (MRL) scientific libraries (other than the remarkable late Dr. Maurice Hilleman, that is), I can opine that I do not believe these emails and actions were presented entirely in context by the newspapers and plaintiffs.

It is my personal belief that Dr. Scolnick would not have let a drug on the market that he truly believed had significant risks. While he was indeed tough-talking (as were many senior people in MRL), in my conversations with him I sensed very strong scientific and medical ethics.

In fact, it was he who expressed concern to me over lunch circa late 2000 that the appx. 6,000 scientists of MRL varied in their ability to use scientific information searching tools, and that this could impair their ability to engage in the best science possible. His belief in conducting the best science was strongly evident in this conversation. Proficiency in using these informatics tools, we both agreed, were essential to scientists staying abreast of the latest developments in their fields. He requested an educational initiative be developed. I suggested a worldwide, intranet-based training program in literature searching proficiency.

As a result of that conversation, my staff and I developed an online training program in scientific literature search proficiency that Dr. Scolnick personally approved and promoted, and I expanded access to the most critical of those tools via a rigorously-researched request for additional departmental funding that he supported. (The non-scientist, non-clinician IT execs controlling my budget were noticably not quite so eager to spend on such ‘intangible’ assets as informational tools where ROI, while obvious to scientists, was difficult to quantify.)

I believe problems ascribed in the articles and in the courtroom likely originated elsewhere, such as in the scientific approach to the issue of rare adverse event detection itself. In addition, articles like this recent one in PLoS point out that even the best approaches can fail when studying low-incidence events with studies of low positive predictive value. As mentioned in this article, the ‘biases’ fostered by scientific competition, the profit motive, etc. can make the situation even worse, even in the absence of deliberate errors of omission or commission.

These are personal beliefs, of course.

As far as Star-Ledger accounts of his calling FDA staff “devious,” “antagonistic,” filled with “bastards” and “grade D high school students,” I have little to say other than an anecdotal incident involving a former high-level FDA official that occurred after my time at Merck, when I was seeking new positions. This former official, only recently out of FDA in an adverse events capacity, was now running a pharmaceutical company adverse events data management group. I’d been interviewed by the hiring manager of the department, an Executive Director whose wife I’d worked with years prior at a hospital, and who had found my prior work of great interest to the department. A final interview was set up with his boss, the former FDA official, who worked at a distant branch of the company. My interview was to occur locally, at a company facility near me. However, just prior to the interview the ex-FDA official decided he could not travel due to a family member’s illness. I therefore offered to drive the nearly 100 miles to his out-of-town pharma office office instead, and did so.

When I arrived, the former FDA official offered me no thanks or acknowledgement for having gone to the trouble, only asking me with somewhat of a smirk what “I had been doing since being unemployed.” (To which I politely withheld the obvious answer “looking for a job, [meathead]…”) I began showing him my relevant prior work, e.g., development from the ground up of a comprehensive cardiology dataset of hundreds of data elements, accompanying institutional information system, analytics and reporting system for invasive cardiology device/intervention outcomes and adverse events. This was built for a regional center performing over 6,000 procedures per year and was evaluated by national cardiology figures as “outstanding.”

During my explanation of the project, the former FDA official rudely cut me off and stated “we don’t need Medical Informatics specialists in our adverse events department.” I had to hide my astonishment and dismissed myself from the presence of this SOB. Others told me this former FDA official had interviewed literally a hundred others in the preceding year and hired nobody despite an open position, and was basically devoid of social graces, not even greeting his staff when passing them in the halls.

Devious? Antagonistic? Bastards? Grade D high school students? Sample size of one, but a spectacular example nonetheless. What can I say?

Now, if only Dr. Scolnick had talked equally tough with the computer exec who decided upon laying me off as part of the 4,400-person reduction-in-force in late 2003…

Addendum: I should add that the biggest complaint of several clinicians and statisticians in the pharmaceutical adverse events data management department (the one presided over by the humble, well-mannered former FDA official above) was that access to the global adverse events database was often difficult and basically controlled by non-clinical IT personnel. This interview really ranked up there in the Annals of the Absurd.

— SS

Health Care and Gout

In days gone by, gout was considered to be the “disease of kings” largely because those who usually had this malady were very wealthy or royalty. The primary thought was that only rich individuals developed gout because only they could afford the food and drink that led to this health care problem. Actually, there is no substantive connection as anyone could develop gout regardless of their social status. However, there are certain dietary conditions related to this health issue.

Gout is a kind of arthritis that occurs when uric acid builds up in blood and causes joint inflammation, according to the National Institutes for Health (NIH). Here are some symptoms:

• Acute gout is a painful condition that typically affects one joint.
• Chronic gout is repeated episodes of pain and inflammation, which may involve more than one joint.

Gout, according to the NIH, is caused by having higher-than-normal levels of uric acid in your body. This may occur if:

• Your body makes too much uric acid
• Your body has a hard time getting rid of uric acid

If too much uric acid builds up in the fluid around the joints (synovial fluid), uric acid crystals form. These crystals cause the joint to swell up and become inflamed. The exact cause is unknown. Gout may run in families. It is more common in men, in women after menopause, and those who drink alcohol. People who take certain medicines, such as hydrochlorothiazide and other water pills, may have higher levels of uric acid in the blood. The condition may also develop in people with:

• Diabetes
• Kidney disease
• Obesity
• Sickle cell anemia and other anemias
• Leukemia and other blood cancers

The condition may occur after taking medicines that interfere with the removal of uric acid from the body. More information is available at this site: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001459/ .

Acute gout will typically manifest itself as an acutely red, hot, and swollen joint with excruciating pain, according to the Centers for Disease Control (CDC). These acute gouty flare-ups respond well to treatment with oral anti-inflammatory medicines and may be prevented with medication and diet changes. Recurrent bouts of acute gout can lead to a degenerative form of chronic arthritis called gouty arthritis. Weight loss lowers the risk for gout. More info can be found at this site: http://www.cdc.gov/arthritis/basics/gout.htm .

According to the CDC, gout can be viewed in four stages:

o Asymptomatic tissue deposition occurs when people have no overt symptoms of gout, but do have hyperuricemia and the asymptomatic deposition of crystals in tissues. The deposition of crystals, however, is causing damage.

o Acute flares occur when urate crystals in the joint(s) cause acute inflammation. A flare is characterized by pain, redness, swelling, and warmth lasting days to weeks. Pain may be mild or excruciating. Most initial attacks occur in lower extremities. The typical presentation in the metatarsophalageal joint of the great toe (podagra) is the presenting joint for 50% of people with gout. About 80% of people with gout do have podagra at some point. Uric acid levels may be normal in about half of patients with an acute flare. Gout may present differently in the elderly, with many joints affected.

o Intercritical segments occur after an acute flare has subsided, and a person may enter a stage with clinically inactive disease before the next flare. The person with gout continues to have hyperuricemia, which results in continued deposition of urate crystals in tissues and resulting damage. Intercritical segments become shorter as the disease progresses.

o Chronic gout is characterized by chronic arthritis, with soreness and aching of joints. People with gout may also get tophi (lumps of urate crystals deposited in soft tissue)—usually in cooler areas of the body (e.g., elbows, ears, distal finger joints).

The big toe is the most common target, but gout can attack the feet, ankles, knees, and hands as well, according to Health Magazine online. An attack or “flare” can last for days or months. Men and obese people are at greater risk. If you’re prone to gout, the foods you eat—and don’t eat—play a key role in keeping your joints pain-free. Find a lot of material at this site: http://www.health.com/health/gallery/0,,20448674,00.html .

According to a lot of web based material, there are many reasons why anyone suffering from gout should consult their primary care physician or a medical provider for care and treatment of this disease. If not treated properly, more severe complications can result. Always talk with your doctor if you suspect you may be seeing symptoms that appear to be gout related. Consider what options are available, and find out what medications may be good for you. Also, think about your diet, as some foods can cause an increase in uric acid that can lead to gout. Prevention and disease maintenance go a long way to help with this disease.

Until next time.

Transplanted Organs From A Pig


There are many more individuals with end stage kidney failure, heart failure, chronic lung disease, or liver failure who would benefit from a transplanted kidney, heart, lung or liver than are available. Similarly, there are many people with unstable, difficult to control diabetes that could benefit from a ready source of pancreatic insulin-producing islet cells.

Today the only option for more organs available for transplant is to encourage more individuals to pre-certify their desire for organ donation should they die in a traffic or other accident.

But another approach, still in the future but gaining traction, is to use organs from an animal – known as xenotransplantation.

Most efforts in xenotransplantation focus on the pig, in part because the organs are near to the same size as humans and the physiology is similar. Very real progress has been made in recent years. The steps required to make this approach effective include genetic modification of the pig so that the human immune system will no longer “reject” the transplanted organ. This has included removing the genes that produce the most important pig carbohydrate antigen that human immune cells recognize. Another step has been to add genes that create certain protective proteins in the complement regulatory system (another part of the body’s mechanism to eradicate “foreign” materials like bacteria, viruses or a cancer.) So far, these steps have been major advances but not sufficient so further efforts will be necessary in order for say, a pig heart or kidney to be successfully transplanted into a primate and eventually into a human. But the progress is real, exciting and promising. Stay tuned.

Multivitamins Not Worth the Money – Except…

Interesting, yet hardly surprising story that in most cases multivitamins are NOT worth the money.

The source is from an article from the Annals of Internal Medicine specifically:

  • the 161,808 postmenopausal women enrolled in the Women’s Health Initiative Study that took multivitamins there was no protective effect from common forms of cancer, heart attacks, or strokes.
  • during the eight years of observation, the numbers of deaths were the same between women who took and did not take vitamins.

There were situations, however, which are still every important vitamins are taken. These are:
* Folic acid supplements in women who are pregnant or plan to become pregnant can help to prevent serious neural-tube defects that affect the baby’s brain and spine.
* Supplements that contain more vitamin D and calcium than is present in regular multivitamin pills can help older men, and especially women, avoid osteoporosis and bone fractures.
* Supplements of vitamins C and E, beta-carotene, zinc, and copper may slow the progression of vision loss in people with early macular degeneration.

Check with your doctor to see if multivitamins are necessary or a waste of your money and time.

ALR IDR Committee Meeting

The ALR IDR Committee will meet July 28, 2016 at 10 a.m. at the Department. The public is welcome to observe or to listen to the committee discussion by calling 1.712.432.3066 and entering conference code 527044. Information on the location of the meeting will be available at the security desk in building A. 

If you have any questions, please contact Elaine Sabyan at 303.692.2815 or elaine.sabyan@state.co.us