New Injector of Epinephrine

The EpiPen® has long been the standard prescription for patients who may suffer from anaphylaxis due to food insect and other allergies.

Several years ago a new device for delivering epinephrine came out, the Twinject®. The advantage of this device was that each unit contained two doses. Patients have long been cautioned that epinephrine doses only last 15-20 minutes, so Twinject touted its advantage as giving the patient an additional back-up dose and more time to seek treatment.

Sciele Pharmaceuticals is soon releasing a new epinephrine device called Adrenaclik. It, like the Epipen, is a single dose injector. Actually it looks much like the EpiPen and the instructions for use are similar, although with the Adrenaclik, two gray caps need to be pulled off from either end, rather than one on the Epipen.

I wonder if we will see more of these auto-injectors? I wonder if that means the price will come down? It's pretty expensive to have several on-hand, isn't it? I did find documentation that states the EpiPen patent doesn't expire until Sept. 2025. I don't understand all the legalese on patents and generic drugs. Anyone else?

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A History of Our Healthcare Future

When Stage III of Meaningful Use is fully implemented in 2015, what will our healthcare system look like? Here's my future forward look at the changes in the provider, patient, payer, and researcher experience five years from now:

*Clinicians will become healthcare coordinators, working in partnership with patients to manage wellness using a shared lifetime electronic health record.

*Clinicians will produce a record that is designed to be shared with the patient, instead of just supporting the billing process.

*Hospitals will compete based on the results they achieve rather than the grandeur of their buildings. Transparency in the reporting of quality and outcomes will transform the healthcare marketplace. Patients will have a much better understanding of quality, cost, and outcomes.

*Patients will undergo fewer tests and take fewer medications because redundant and inappropriate care will be reduced. Healthcare value will improve - higher quality for less costs, since less care is often the right answer.

*Patients will have much more choice as consumers. Access to the electronic records including their genomes will enable personalized medicine - selecting the treatments that best align with their care preferences, risk taking thresholds, and physiology.

*Payers will reimburse providers for quality rather than quantity since electronic health records will document the care given and not given.

*Researchers will have access to novel data sources (with patient consent) and be able to discover which treatments are the most effective. This knowledge will be integrated into electronic health records and personal health records so that providers and patients can make the optimal care decisions. Today, there is more literature published every year than a clinician can read in a lifetime, so best current evidence is not rapidly incorporated into practice.

Change is hard, technology is easy. As we navigate the stages of meaningful use in the years ahead, be prepared for amazing shifts in workflow, process, and behavior that will accompany them. Let's hope we can tell our children the history of how we did it!

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Solving Secure Transport

I've written extensively in my blog about the need for the healthcare IT industry and government to implement a single (or maybe 2) ways to transport healthcare data securely. I feel that content and vocabulary standards are on the right track, but transport is still in need of a breakthrough. Here's a brief description of where the industry is today:

e-Prescribing - transport is an industry specific SOAP 1.2 implementation by Surescripts

Administrative - transport is often CAQH Core Phase II, an industry specific SOAP 1.2 implementation. The Workgroup for Electronic Data Interchange (WEDI) has suggested SMTP, so currently CAQH and WEDI are debating transport.

Lab - transport is Minimal Lower Layer Protocol (MLLP) and TCP/IP

Personal Health Records - Google and Microsoft Healthvault use proprietary RESTful approaches

Federal agency submissions (Social Security Administration, Food and Drug Administration) - NHIN FHA Connect, which is XDS.b, a specific implementation of SOAP 1.2

Clinical summary exchange - heterogeneous as implemented by various stakeholders

What is needed in the short term?

1. The Clinical Summary exchange transport is the place to focus, which is what we've done in Massachusetts with the NEHEN CDX gateway. An industry or government reference implementation that becomes widely adopted would help significantly.

2. Many Personal Health Record vendors have told me that they are ready to create a single RESTful front door for their PHRs to receive information.

3. Some industry stakeholders have talked about creating open source and vendor supported health hub software that offers SMTP, SOAP and REST in an appliance.

Of course, there could be other approaches.

There is an emerging technology, just implemented by eClinicalWorks in their EHR. It's called eClinicalWorks P2P and it works like linkedIn, Plaxo, Facebook i.e.

I'm a clinician and want to share patient data (after obtaining patient consent) with another clinician. I send an invite via regular email (SMTP ) that contains an embedded URL. If the clinician accepts the invite, that clinician is added to my "friend" list and I can push a record to them at anytime, which is delivered as a URL via email. Interestingly, if the clinician uses eClinicalWorks, my EHR can natively send and receive CCD's with "friends" via a RESTful approach.

Meaningful use requires many data exchanges among stakeholders. I'm confident that we'll see several reference implementations in 2010 that will accelerate interoperability by unifying approaches to transport.

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Physician Pleads Guilty to Fraud for Fabricating Celebrex (and Other) Study Data

As reported by the Springfield, MA, Republican:

A former chief of acute pain at Baystate Medical Center has agreed to plead guilty to falsifying medical research and must pay $420,000 in restitution to pharmaceutical companies, federal court records show.

Dr. Scott S. Reuben, of Longmeadow, was charged on Thursday with health care fraud. He signed a plea agreement with prosecutors a week earlier.

Reuben prompted a furor in the medical community in March, when he was accused of making up research results in at least 21 published studies and inventing patients in certain instances.

In one notable instance,

In 2005, Reuben received a $74,000 research grant from pharmaceutical giant Pfizer, agreeing to test Celebrex as a component of the multimodal therapy. He claimed to have treated 200 patients, 100 with Pfizer's product and 100 with a placebo.

'In fact, Reuben had not enrolled any patients into that study and the results reported both to Pfizer and to the Anesthesia and Analgesia Journal and in turn to the public were wholly made up by Reuben,' the charge states.

Albert said the fabrications were discovered by medical staff within the hospital during a routine review at the hospital's 'research week,' when clinicians design poster displays of their studies.

A report in the New London, CT, Day indicated the scope of Reuben's fake research:

Anesthesia & Analgesia later had to retract 10 papers authored by Reuben, and medical experts at the time said at least 21 journal articles by the anesthesiologist appeared to have been fabricated.

The agreement calls for Reuben to pay restitution of $296,557 to Pfizer and $16,000 to Wyeth Pharmaceuticals, two companies that merged last fall. Merck & Co. would receive $49,375 from the agreement, according to documents.

In addition to his fabricated Celebrex studies, Reuben had pretended to do research that backed the effectiveness of other pain drugs, including Pfizer's Bextra and Merck's Vioxx, according to prosecutors. Bextra and Vioxx later were pulled from the market because studies showed they increased the risk of death from heart attacks and strokes.

In addition, Reuben published data showing that Pfizer's antidepressant Effexor had exhibited painkilling properties.

Reuben's studies had been considered pioneering at the time they were published. His data had supported the use of two of Pfizer's major products - Celebrex and Lyrica - in combination to treat certain types of post-operative pain.

Reuben 'was a regular on the medical lecturing circuit,' according to court documents, and 'had become a well known figure in the anesthesia and pain management medical communities.'

Pfizer said previously that it had supported five of Reuben's research initiatives. Pfizer, which declined at the time to reveal how much it paid Reuben over the years to be part of its speakers' bureau, said the company played no part in the fraud.

Asked for a comment Friday, Pfizer was not able to provide a timely response.

Note that we usually do not post about stories of individual's clinical research misconduct, not because it is unimportant, but because individual misconduct may be related more to an individual's motives and character than to concentration and abuse of power in health care.

However, in this case it appears that Dr Reubens was enabled, at least in the psychological and logistical senses, by pharmaceutical companies happy to sponsor research which suggested the effectiveness of their products.  Since Dr Reubens apparently fabricated most of his data, notice that he apparently deliberately fabricated data that made Pfizer's Celebrex, Bextra, Lyrica, and Effexor, and Merck's Vioxx look good.  Perhaps there was careerism here.  Positive studies about "innovative" effective drugs are more likely to get published than negative studies or studies of old drugs.  However, we have noted before that pharmaceutical (and biotechnology and device) companies like to sponsor studies with results that make their products look good. 

One bit of good news in this story is that Reuben's colleagues at the hospital apparently were able to uncover the fabrications when they had an opportunity to critically look at data from several of his studies.

Certainly some Pfizer employees had easy access to the same data.  But perhaps they would not have thought to look at it critically as long as it was so unrelentingly positive about their company's products. 

As we have said before, health care professionals, policy makers and patients ought to be extremely skeptical of clinical studies sponsored (and often deeply influenced) by those with vested interests in the studies' turning out in certain ways.  We ought to reconsider national research policies that have turned over sponsorship of the majority of clinical research to those with such vested interests.

Hat tip to Prof Margaret Soltan on the University Diaries blog.

ADDENDUM (19 January, 2010) - see also comments on the Alison Bass Blog.

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Not Just an American Disease

We have written about attacks on rigorous evidence-based medicine, and particularly on comparative effectiveness research from those with vested interests in having clinical research come out a certain way (e.g., see this most recent relevant post). Those who see such research primarily as a marketing opportunity tend to be offended by the notion of rigorous, unbiased research that may not be so easily turned to marketing purposes. Since I, like the other current Health Care Renewal bloggers, am based in the US, we tend to focus on local examples. But it turns out that the American malady described above has spread to Germany.

From the Science blog, ScienceInsider:

A long-running feud between pharmaceutical companies and the German institute that evaluates the effectiveness of medical treatments could cost the institute director his job. Although the post is supposed to be apolitical, members of Germany�s new coalition government have called for Peter Sawicki, founding director of the Institute for Quality and Efficiency in Health Care (known by its German acronym IQWiG, pronounced ICK-vig), to be replaced with someone who is friendlier to the pharmaceutical industry. The institute�s board of directors are expected to decide on 20 January whether Sawicki, a clinical researcher and diabetes expert, will be replaced when his contract runs out later this year.

Sawicki�s supporters say the move would endanger the institute�s reputation for impartial and rigorous science, and earlier this month a petition signed by 600 doctors and clinical researchers called on the health minister and the board to keep Sawicki on. Gerd Antes, director of the German Cochrane Centre in Freiburg, a not-for-profit organization that analyzes health care effects, says that replacing Sawicki would significantly undermine IQWiG and its work. Antes views the anti-Sawicki push as 'part of the political game to soften and to weaken rigorous procedures for new drugs and medical devices in Germany.'

And it turns out that the American-based pharmaceutical industry has jumped right in.

Big pharma�s attacks have even come from outside Germany. In March 2009, the Pharmaceutical Research and Manufacturers of America petitioned the Obama Administration to put Germany on a trade and intellectual property 'priority watch list' chiefly because of IQWiG�s influence on the German drug market. The petition complained that the institute has 'inadequately taken into account the value of innovative pharmaceuticals,' among other complaints. The Obama Administration declined to put Germany on its watch list.

Parenthetically, "innovation" seems to be a favorite term that those with vested interests in selling products or services use to describe those products, sometimes in the absence of any data that shows them to be superior to the alternatives in terms of important clinical outcomes, that is, outcomes that patients may care about.  "Innovative" was also how complex financial products which contributed to the global economic meltdown were described by those who stood to make money selling, or sometimes simultaneously short-selling them, - but maybe that's guilt by association. 

I hope the Germans are able to preserve their stake in honest, comparisons of tests and treatments that are not influenced by those with vested interests in selling those tests and treatments.

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The Annotated Federal Register IFR and NPRM

Thanks to Robin Raiford of Eclipsys for bookmarking the Federal Register versions.

Here's the Interim Final Rule

Here's the Notice of Proposed Rulemaking

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Electronic Medical Records and Going For Broke: Jackson Health System's Financial Future Appears Grim

I have written on numerous occasions that health IT in its present form, often poorly designed and implemented under current IT leadership structures, is often a waste of precious healthcare resources. The resources might be better spent on essentials such as patient care for the poor or improved human staffing, until this experimental technology is perfected.

As at my site on health IT difficulties and mismanagement I observed:

Healthcare information technology (HIT) holds great promise towards improving healthcare quality, safety and costs. As we enter the second decade of the 21st century, however, this potential has been largely unrealized. A significant factor impeding HIT achievement has been mismanagement of the technology. Mismanagement of HIT is largely due to false assumptions and na�vet� concerning the challenges presented by this still-experimental technology, and underestimations of the expertise essential to achieve the potential benefits of HIT. This results in mission-hostile HIT design, and HIT leaders and stakeholders operating outside (often far outside) the boundaries of their professional competencies. Until these issues are acknowledged and corrected, HIT efforts will waste precious healthcare resources, will not achieve claimed benefits for many years to come, and may actually cause harm. Numerous reports in the 2009 articles link corroborate this view, including those from the U.S. Joint Commission and National Research Council.

The following may bring my observations to life.

This from 2007:

RedOrbit.com/News
Jackson Memorial Hospital Uses State-of-the-Art Technology to Drive Improved Patient Outcomes for South Florida Families

Posted on: Thursday, 6 September 2007, 09:11 EDT

Jackson Memorial Hospital (JMH), part of Jackson Memorial Health System, South Florida's leading/largest healthcare provider, recently implemented 11 Cerner Millennium� solutions.

[Including EMR, nursing, pharmacy, radiology, HIM, Eligibility Management, Master Person Index, Registration Management, Scheduling Management, Emergency Department, etc. - ed.]

This marks the hospital's first step in a multi-stage healthcare information technology implementation. With Cerner Millennium� solutions, JMH clinicians now have access to real-time resources to better manage patient care with improved access to cross-department information, evidence-based clinical decision support and streamlined hospitals operations.

"Cerner is pleased to partner with Jackson Memorial Hospital, an institution continually ranked as one of the best hospitals in America," said Trace Devanny, Cerner -- president. "JMH's decision to implement a solution-oriented information technology system reinforces its vision to improve healthcare communitywide. Cerner worked together with JMH to implement multiple Cerner Millennium solutions specifically designed for various roles, venues and conditions that will ultimately improve the patient experience."

These implementations, a mere "first step" towards "streamlining operations," and their maintenance, modification, remediation, and staffing were undoubtedly multimillion-dollar expenses and are likely still ongoing. (See other examples of mass hospital IT expenditures here and here.)

Now, fast forward to 2010. This is stunning:

Jackson Health System's financial future appears grim
Miami Herald
BY JOHN DORSCHNER
Posted on Wednesday, 01.13.10

Looking forward and back, Jackson Health System's grim financial picture just keeps getting worse.

Members of the Public Health Trust, the system's governing board, are being told:

� Patient volume has dropped by 6.5 percent recently, meaning that with all the cost cutting and new revenue plans, Jackson is facing an $88 million loss this fiscal year, and this estimate is likely to get worse.

� The government system may have lost much more money last year than the $56 million it reported in unaudited statements. That loss could conceivably go as high as $150 million.

� Cash on hand to pay bills -- the measure of how the three-hospital system is doing at this moment -- continues to be awful. ``Perhaps a cash hemorrhage,'' PHT member Marcos Lapciuc called it.

The bad news came at PHT committee hearings late Tuesday afternoon. ``Very drastic measures need to happen'' to stem the growing losses, said Chief Executive Eneida Roldan. She said the losses were likely to increase, because considerable funding for poor patients comes from Tallahassee, and the Legislature is expected to cut back on healthcare funding programs as it deals with its own budget crisis.

``We're making very drastic decisions that no hospital wants to do,'' Roldan told the board, including ending contracts for 175 unfunded patients to receive dialysis at out-patient centers.

Ending contracts for unfunded patients to receive dialysis after spending tens of millions of dollars on IT to "streamline operations?" Could this be an example of "Blood for Computers?"

Board members were upset in particular about how the institution, with 12,000 employees and $1.9 billion in revenue, could be so uncertain about its financial performance last year.

The central issue appears to be the proper amount of accounts receivable -- money that the system expects to collect from insurers -- as contrasted with bad debts that are unlikely to be collected. As of Nov. 30, Jackson was listing its accounts receivable at $431.8 million.

``It just doesn't tie in,'' said board member Martin Zilber. ``We talk about $400 million or $500 million like it's buying lunch.''

Ernst & Young, Jackson's auditors, are expected to present the official audited returns within the next month. ``We know there's going to be a sizable adjustment,'' Chief Financial Officer Frank Barrett told the board. But he's uncertain how much.

Uncertain how much money will be "adjusted" in accounts receivable? Apparently all this computerization has not realized a ROI on basic financial management.

Could problems with the IT (e.g., mismanaged design, mission hostile user experience, bugs, etc.) and/or mismanagement of its implementation actually be responsible for the chaos, I ask?

... Perplexed board members heard several explanations. One is that the system has switched computer systems, and the old financial software may have been calculating bills as accounts receivable from years ago, when those items should be listed as uncollectable bad debts.

If that was the case (and I note the "may have", implying the organization is not even certain of this explanation), why was this discrepancy not noted before or during the transition? Who, exactly, was managing this project? This would be a stunning example of IT mismanagement making what happened at Yale some years ago look like a cakewalk, and on par with the mismanagement at another Miami hospital, Mt. Sinai, as I posted here.

... On Monday, the board was shown a presentation on bill collecting with a complex grid of flow charts and time lines. Still, some board members expressed concern about why Jackson's financial people didn't have a better handle on key measures of the system's condition.

A question arises regarding whether the massive IT implementations are causing data irregularities, confusion, or are not functioning properly in other ways affecting financial management.

``I don't totally understand the reasons,'' said [board member] Ernsto de la F�.

... The fiscal 2009-2010 budget had calculated a loss of $6.5 million. Of that, $107 million was the baseline loss, reduced by $59.8 million in new revenue building ventures and $41.5 million in cost-cutting.

"Cost cutting" usually is synonymous with "layoffs." How many millions were spent on computing instead of jobs, I wonder?

Additional information on these financial difficulties are available at the Miami Herald:

� Jackson Health System faces more financial losses

Jackson Health System faces more financial losses

Looking forward and back, Jackson Health System's grim financial picture just keeps getting worse.

Members of the Public Health Trust, the system's governing board, are being told:

Patient volume has dropped by 6.5 percent recently, meaning that with all the cost cutting and new revenue plans, Jackson is facing an $88 million loss this fiscal year. This estimate is likely to get worse.

�Donna Shalala tries to mend fences with Jackson Health

Donna Shalala tries to mend fences with Jackson Health

While Jackson Health System's governing body struggled Tuesday to find more ways to cut costs and increase revenue, University of Miami President Donna Shalala made a rare appearance before the Public Health Trust to ``personally apologize for statements by members of the university leadership team last week.''

She was referring to UM Board of Trustees Chairman Phillip George's comments to Jackson leaders that he was disturbed about the quality of doctors that Jackson had been hiring in recent years. ``I wouldn't send my family to many of them,'' George said.

Shalala noted that the Jackson doctors, all fully credentialed, were often approved by UM department heads to practice at Jackson. ``If they are good enough for Jackson patients, let me tell you, they are good enough for me and my family.''

�Jackson Health System may close clinics, nursing homes

Jackson Health System may close clinics, nursing homes

Needing to present a balanced budget for Miami-Dade Commission's approval Thursday, the Jackson Health System is proposing to close two primary care centers, both of its nursing homes, outsource inmate healthcare and reduce support to other entities that care for the poor and uninsured.

``We are in an extremely unique position,'' Chief Executive Eneida Roldan said Wednesday. The public health system is having to cut services to meet an estimated budget deficit of $133 million for its next fiscal year at a time when the commission must also deal with filling a shortfall of more than $400 million in other county programs.

Some doctor services at Jackson Memorial may also be curtailed, Roldan said. ``Because Jackson has been forced to reduce its funding for the annual operating agreement with the University of Miami,'' she wrote in a message to employees, ``the university is also planning to reduce its services offered at our facilities.''

�Jackson Health System's cash pot falls to dangerous levels

Jackson Health System's cash pot falls to dangerous levels

Even after plans to reduce staff and close units, Jackson Health System is getting dangerously close to its bare minimum for cash-on-hand -- a key indication of financial health.

As of Oct. 31, Miami-Dade's public hospital system had 20.8 days of cash to pay its bills, including payroll and keeping the lights on. Its governing body, the Public Health Trust, has set 20 days as the lowest Jackson should go.

``When it gets below 20 days, that's when I declare an emergency,'' said Frank Barrett, chief financial officer. He said he is already talking to county administrators about getting an advance to fund payroll if the system runs out of cash.

�Jackson Health's finances continue to deteriorate

While IT is not a definite cause or contributor to these problems, I sense familiar patterns. Perhaps forensics related to hospital computing, the decisions to spend so many millions on the technology, and the actual impact of the implementations might shed additional light on the reasons for this apparent financial debacle.

Perhaps the hospital system would have better spent that money on buttressing its financial stability, and hiring smart people to have kept better track of its finances.

An analysis of these issues might likely provide a cautionary tale for hospital executives planning on massive new HIT expenditures to "streamline operations."

Addendum:

This is a good time to once again call attention to this paper by a perspicacious author from Down Under:

Pessimism, Computer Failure, and Information Systems Development in the Public Sector. (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand). Cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure, the lack of attention to the issues responsible, and recommending much more critical attitudes towards IT. link to pdf

Feb. 11, 2010 Addendum:

CFO at Miami health system resigns

MIAMI � Frank Barrett, chief financial officer and executive vice president at Miami's Jackson Health System, has resigned after five years in the position. The health system's board of directors criticized Barrett strongly last week after he reported miscalculated financial losses. Barrett had revealed to the board that Jackson Health lost $203.8 million in fiscal 2009, although he had originally reported a $46.8 million loss. The projected loss for fiscal 2010 rose $87 million to $229 million.

-- SS

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