How Big Health Care Charities Rely on Lying Telemarketers

A modern day Diogenes searching for an honest organization in health care would have a very hard time.  Close to the "you can't make this stuff up" category is a new investigative report from Bloomberg on deceptive - to use a polite word - practices at some of the US' biggest health care charities.

Using Commercial Telemarketing Firms that Keep Nearly All Money Raised

The report showed how major US health care charities use privately held for-profit telemarketing firm InfoCision Management Corp to raise money, but most of the money raised went back to InfoCision.  The opening example was of a particular telemarketing call:

A woman named Robin said she was representing the American Diabetes Association.

Robin didn’t ask for money. She asked Patterson to stamp and mail pre-printed fundraising letters to 15 neighbors. Both of Patterson’s parents and one grandmother had been diabetic, so she agreed to do it, Bloomberg Markets magazine reports in its October issue.

'I thought since it does run in the family, it wouldn’t hurt for me to help,' says Patterson, 64, a retired elementary school teacher. She guessed, based on what she knew about charity fundraising, that about 70 to 80 percent of the money she brought in would be used for diabetes research.

The truth was almost the exact opposite. The vast majority of funds Patterson, her neighbors and people like them throughout the country would raise -- almost 80 percent -- would never be made available to the Diabetes Association. Instead, that money collected from letters sent to neighbors would go to the company that employed Robin and an army of other paid telephone solicitors: InfoCision Management Corp.

Just 22 percent of the funds the association raised in 2011 from the nationwide neighbor-to-neighbor program went to the charity, according to a report on its national fundraising that InfoCision filed with North Carolina regulators.

So while some American health care charities boast that most of the money they receive goes to programming, not management or fund raising, in this case, the opposite was true.

Many of the Biggest US Health Care Charities Were Involved

As the article stated,

Many of the biggest-name charities in the U.S. have signed similarly one-sided contracts with telemarketers during the past decade. The American Cancer Society, the largest health charity in the U.S., enlisted InfoCision from 1999 to 2011 to raise money.

Also,

In the past decade, many of the nation’s biggest health charities have hired InfoCision, including the American Heart Association, American Lung Association, American Society for the Prevention of Cruelty to Animals, March of Dimes Foundation and National Multiple Sclerosis Society.

Note that the Bloomberg article was focused on InfoCision. I suspect that if one were able to look at arrangements with similar telemarketing firms made by all US health care charities, the results might be even more extreme.

The Fund Raisers and the Charities Lied

The article contained instances in which the telephone callers lied about who they were or about where the money they were trying to collect would go.

First, regarding who the callers were:

The ruse begins with the name that flashes on your caller ID when a telemarketer is phoning on behalf of a charity. It’s the charity’s name that often shows up, not that of the telemarketing firm.

The misrepresentation can continue on the call itself. Solicitors in recordings obtained by the Ohio Attorney General’s Office sometimes identify themselves to potential donors as 'volunteers.' They’re not; they’re paid employees of InfoCision.

Second, regarding where the money would go:

The bigger lie telemarketers tell is what they say about how much money will go to the charities they’re working for.

According to documents obtained through an open records request with the Ohio attorney general, the Diabetes Association approved a script for InfoCision telemarketers in 2010 that includes the following line: 'Overall, about 75 percent of every dollar received goes directly to serving people with diabetes and their families, through programs and research.'

Yet that same year, InfoCision’s contract with the association estimated that the charity would keep just 15 percent of the funds the company raised; the rest would go to InfoCision.

This deception appears to be sanctioned by the leaders of the charities for whom InfoCision worked,

[American Diabetes] Association Vice President [Richard] Erb offers no apologies for the script, saying the association runs many fundraising campaigns and, overall, about 75 percent of the money goes to its programs. He acknowledges that the contract with InfoCision estimated that the telemarketer would get to keep 85 percent of the funds it raised.

Erb also says he isn’t happy that volunteers are upset upon learning the truth.

'Obviously, if people feel betrayed or that we’re not being honest with them, it doesn’t make me feel well,' he says.

The American Cancer Society similarly seemed to sanction deceptive fund raising practices.

The Cancer Society, in a Sept. 1, 2009, contract with InfoCision, estimated that the charity would get 44 percent of the amount the company collected in the following fiscal year.

The telemarketer script for the same year approved by the society for InfoCision asks solicitors to say something different: 'Overall, about 70 cents of every dollar received goes to the programs and services that we provide.'

Predictably, an executive for the society dodged responsibility for such lying:

[Greg] Donaldson, the society’s senior vice president, declined to comment on the contradiction between the contract and the script, saying the society doesn’t provide 'proprietary competitive information regarding individual programs.'

The Telemarketing Firm Stonewalls

While the Bloomberg reporters were able to get some health care "charity" executives to respond to the issues, InfoCision was not even slightly forthcoming. The best they could do was get an InfoCision executive to protest the company's importance for charity:

InfoCision Chief of Staff Steve Brubaker says his company is vital to the success of charity fundraising. Many nonprofits have stayed with InfoCision for more than 20 years, proving the firm offers value and integrity, he says.

'We’ve developed that high level of trust by being good stewards of their money and mission,' he says. Campaigns to develop new donors are more expensive than those seeking money from previous supporters, he says. He declined to answer specific questions, saying such information is proprietary to the company or its clients.

He turned down a request for interviews with Taylor and InfoCision executives.

Previously, the company owner had taken on the mantle now familiar in the current US election campaign, "job creator,"

[InfoCision founder Gary] Taylor was an outspoken opponent of efforts by the Federal Trade Commission in 2003 to begin the National Do Not Call Registry, allowing people to block calls from for-profit solicitors. In an interview with Customer Interaction Solutions, a trade journal, he said:

'The most pressing issue, without a doubt, is excessive governmental regulation. It seems that the politicians and regulators are ignoring the significant benefits we provide through job creation, economic growth and the goods and services we cost-effectively market for our clients.'

Keep in mind that the article documented how much of those jobs are minimum wage, and they may involve lying.

Note further that Taylor "got his start raising money for evangelical preachers." The company also " did fundraising for Citizens United, the conservative group best known as the plaintiff in the Supreme Court case that allowed unlimited independent spending by corporations and unions on behalf of political candidates."

Health Care Charities are Really Just "Businesses"

Underlying all this seems to be the transformation of health care from a calling to a business. While US health care charities have reputations as organizations out to do good, one executive, the American Diabetes Soceiety's Mr Erb, admitted that doing good was no longer really the focus,

'But the thing is, we’re a business. There has never been a time or a place where we said, 'Most of this money is coming to us.''

An expert the Bloomberg reporters interviewed said that the fund raising tactics these organizations used meant they were no longer charities. Per Ken Berger, "who runs Glen Rock, New Jersey- based Charity Navigator, the nation’s largest nonprofit watchdog group,"

'These organizations were created to provide public benefit,' he says. 'The fact that the vast majority of money is instead lining the pockets of telemarketers defies the whole reason behind the very creation of these charities.'

The Experts Say It's Fraud

Bloomberg reporters interviewed several experts on philanthropy and law. They were not amused. One suggested that the fund raising tactics described in the article were fraudulent:

Charities should be held accountable for deceptive fundraising done in their name, says James Cox, a professor at the Duke University School of Law in Durham, North Carolina, and co-author of 'Cox and Hazen on Corporations' (Aspen Publishers, 2003).

'If that’s what they do systematically, then they’re obtaining money under false pretenses,' he says. 'I don’t just think it’s incredible. I’d be surprised if it isn’t criminal.'

Another labeled the practices "deceitful."

Bloomberg cited a 2003 US Supreme Court decision:

While telephone solicitors have no obligation to volunteer what the firm’s cut is of each donation, they don’t have a constitutional right to lie, the court ruled in a 2003 Illinois case.

'States may maintain fraud actions when fundraisers make false or misleading representations designed to deceive donors about how their donations will be used,' the court said.

Summary

This horrendous story illustrates how the mission of health care has been undermined by the last 30 years' push to turn health care organizations into businesses at a time managers were indoctrinated that they only thing that matters is short-term revenue (that is, they have become "financialized," look here). Here we see ostensibly charitable organizations that solicit donations from the public supposedly to aid patients and support medical education and research willing to do whatever it takes to raise money, including deception, and what might be fraud. This is just disgusting.

In my humble opinion, patients, health care professionals, and the public should insist that health care non-profit organizations disclose their fund-raising tactics, and abandon any that are dishonest. Law enforcement should investigate to see if prosecutions for fraud or related crimes are warranted. Organizations that refuse to change their ways should lose their tax exempt status.

Meanwhile, I would suggest that everyone should be extremely skeptical of fund raising by major health care charities. In no instance should anyone give money solely based on telephone solicitations.

If we, health care professionals, patients, the public do not take our heads out of the sand and realize how dishonest health care has become, we will have only ourselves to blame when it collapses.

More Hospices Pretending Patients are Terminally Ill

In the US, we have been engaged in an experiment involving handing over an ever increasing proportion of direct patient care to for-profit corporations, and non-profit organizations that act increasingly like for-profit corporations (as opposed to mission oriented non-profit organizations or individual health care professionals).  The results have been particularly striking for the care of one of the most vulnerable patient groups, the chronically ill. 

Over the last months, a number of stories about the hospices enrolling patients who are not terminally ill have accumulated.  Keep in mind that hospices are supposed to provide compassionate palliative care to the terminally ill.  While they are supposed to make such patients as comfortable and free of pain as is possible, they are not supposed to otherwise aggressively treat other medical problems (based on the assumption that such treatment would benefit dying patients.)  However, such treatments could benefit, or even save the life of patients who are not dying.  (See posts here and here.)

Hospice of the Bluegrass

Back in March, there was very brief report on Kentucky.com that the non-profit Hospice of the Bluegrass "agreed to pay the federal government $685,000 for submitting claims to Medicare to receive reimbursements for services it provided patients who did not qualify for Medicare services,..."  Note that the main requirement for Medicare payments for hospice services is that the patients receiving these services have no more than six months of survival expected.

However, then in June a detailed investigative report also on Kentucky.com recounted numerous conflicts of interest affecting that hospice's board,

The non-profit Hospice of the Bluegrass has spent more than $1.82 million since 2005 on business deals with several of its board members and the spouses of its executives.

In particular,

On its tax returns from 2005 to 2010, Hospice reported paying at least:

■ $540,178 for political lobbying and legal representation to the law firm of McBrayer, McGinnis, Leslie & Kirkland. One of the firm's partners and co-owners, Lisa English Hinkle, was a Hospice board member and a former board chairwoman. Hinkle rotated off the board at the end of 2011. She was preceded on the board by another partner in the firm, James Frazier.

■ $837,999 for insurance to the firm of Powell-Walton-Milward, whose managing director, John Milward, is a Hospice board member. His brother Greg Milward, who also works at the insurance firm, previously was on the Hospice board and was board chairman in 2007.

■ $392,042 for printing to Pat Byrne Printing, owned by the husband of Deede Byrne, Hospice's chief clinical officer.

■ $22,506 for heating and air conditioning to Gary Merckle, husband of Carol Ruggles, Hospice's chief financial officer.

■ $28,577 for advertising to the Lexington Herald-Leader while then-editor Marilyn Thompson sat on the board.

The article also noted that the hospice CEO seems very well-paid given the context,

CEO Gretchen Marcum Brown, whose 2010 compensation was $238,650 in base pay, $10,570 in bonus pay and $84,978 in other reportable compensation. The other compensation included Hospice's payment into Brown's deferred-compensation account, from which she can draw in the future.

Hospice also paid for a membership in Brown's name at The Club at Spindletop Hall, which offers swimming, tennis and dining.

Such a pay package may provide incentives to maximize revenue by maximizing enrollment, regardless of whether enrolled patients really should be in hospice.
Hospice Family Care

As reported by the Phoenix Business Journal in May,

Hospice Family Care Inc. has agreed to pay the federal government $3.7 million to settle civil allegations that the Mesa-based company violated the False Claims Act by submitting false bills to Medicare.

Also,

The U.S. Attorney’s Office had alleged that Hospice Family Care submitted claims for payment to Medicare for patients who were either completely or partially ineligible for hospice,...

So this settlement is partly for charges that the hospice enrolled patients who were not terminally ill.

Note that in this particular case, the government made an effort to punish the owners of the company, who found a way to evade such punishment:

However, on the day the U.S. Attorney’s Office announced that settlement, Hospice Family Care’s owners closed on a deal to sell the company.

So,

Neither the company’s attorney, Frederick Petti, nor government officials would disclose the name of the buyer.

“Unfortunately, I can’t provide that information because it’s not in the public domain,” said Assistant U.S. Attorney Bill Solomon.

The company’s co-owners, Nancy Smith and Nancy Turner, deferred all comments to Petti.

'Believe me, if my clients weren’t in the process of selling this company, we would have fought this to the bitter end,' Petti said. 'We would have prevailed. This is a business decision.'

He emphasized that the settlement agreement was not an admission of guilt.

Smith and Turner agreed to be excluded from Medicare and Medicaid and all other federal health care programs for seven years, effective immediately. However, Petti said the company’s new owners will not be affected by that settlement agreement and will be free to accept reimbursement from government payers.

Such maneuvers obviously reduce any deterrent effect of settlements like this on bad behavior, and particularly on the behavior of enrolling patients who are not terminally ill in hospice.
Harden Healthcare

Then in June the Wichita (Kansas) Eagle reported,

A Kansas hospice care provider and its Texas-based parent company will pay $6.1 million to resolve allegations that they submitted false claims to the federal Medicare program. The case arose from a whistleblower lawsuit filed by a nurse more than six years ago, the U.S. Justice Department said Thursday.

Justice officials said in a news release that they hope the settlement with Wichita-based Hospice Care of Kansas LLC and Fort Worth-based Voyager HospiceCare Inc. will serve as a warning to other hospice providers.

Prosecutors alleged the companies submitted false claims to the federal health care program for the elderly and disabled between 2004 and 2008 for patients who weren’t expected to die in less than six months, a requirement for the benefits in question.

Note that this report makes very explicit the allegation that the hospice was enrolling patients who were not terminally ill. Further note that while the beginning of the report makes it appear that the company that owns the hospice is regional, it actually is larger

The agreement includes no admission or determination of wrongdoing, Harden Healthcare, the owner of Voyager HospiceCare and Hospice of Kansas, said in a statement.

Harden Healthcare, according to the Austin (Texas) Business Journal, is the largest private employer in that city, with over 3800 employees and revenues of over $810 million.

Hospice of the Comforter

The Orlando Sentinel reported in late August,

The federal government is taking over a whistleblower lawsuit against the Altamonte Springs-based Hospice of the Comforter — a suit that alleges the nonprofit routinely over-billed Medicare for patients who didn't qualify as terminally ill, sometimes keeping them in hospice care for as long as five years.

These are allegations of course, but it turns out that both sides of the action agree on certain facts of interest,

Both sides agree that Hospice of the Comforter officials discharged a large number of Medicare patients after the federal government began scrutinizing the ballooning number of hospice patients nationwide.

In fact, Stone said, the initial sampling by government auditors showed Hospice of the Comforter had an error rate of 18 percent, just slightly over the 15-percent rate the government allowed and therefore triggering a second, more intense review.

That phase, in January 2010, revealed a troubling 77 percent denial rate, Stone said — meaning that Medicare officials believed the hospice was improperly billing the government in 77 percent of the cases it reviewed. According to the government, hospice care should be limited to patients certified by a hospice physician as having six months or less to live.

Meanwhile, though, an internal hospice committee did its own review of patients, discharging more than 133 of them and noting they were, 'no longer terminally ill,' the lawsuit states. Some had been designated 'FOB' for 'Friends of Bob [Wilson, the CEO of the hopsice],' and Wilson later insisted some be readmitted and their care billed to Medicare, the lawsuit says.

Let me just note that for someone truly terminally ill, the way to become no longer terminally ill is to die.

A column in the Orlando Sentinel suggested that the hospice CEO had a strong personal incentive to enroll patients who were not terminally ill,

there are facts not in dispute — such as Wilson's financial incentive to keep his patient counts high: bonuses of $50,000 every three months on top of his base salary of $120,000.

Again, maintaining lucrative compensation could be an inducement for hospice executives to sanction enrollment of patients who were not really terminally ill.
Summary

Hospices arose to provide compassionate care for among the most vulnerable of patients, the terminally ill.  Hospices began as mission oriented non-profit organizations, often affiliated with hospitals or religious groups.  However, the generous payments for hospice care provided by Medicare and commercial insurance, and the increasingly laissez faire supposedly "market-based" health care context lead to the growth of for-profit hospices, and the emulation of their management by ostensibly non-profit organizations.  In the Orlando Sentinel, Scott Maxwell used the example of the Hospice of the Comforter to assert

you've been duped when it comes to waste, fraud and abuse in America's health-care system.

Politicians love to rant about it. They often do so when explaining why they're about to cut your benefits.

They're right that fraud happens. But the individual scammers they portray as the problem are nothing compared to the systemic white-collar fraud perpetrated by corporations — and, yes, faith-based nonprofits.

This is America's dirty little health-care secret.

We all know health-care costs are soaring. But we have done little to address the organized fleecing — often because the fleecers are either campaign donors or nonprofits wrapped in a cloak of altruism.

In this country, you can go to prison for stealing a TV. But if companies get caught stealing millions from taxpayers, the fines are simply viewed as the cost of doing business.

We have made similar assertions about systemic misbehavior in the US health care system, and how failure of local through national government to impose any penalties on the individuals who authorize, direct or implement bad behavior just allow the problem to get worse. However, the consequences of increasing hospice enrollment (hence short-term revenue, and hence the compensation of top hospice executives) by enrolling patients who are not terminally ill go well beyond just increasing health care costs. As we have said before, enrolling patients into hospice who are not already really doomed to die soon denies them the possibility of treatment for new acute illnesses and worsening of chronic illnesses, which then could hasten their deaths. (Pretending those patients were terminally ill could have fooled their relatives into thinking those deaths were inevitable, instead of results of bad practice and potentially fraud.)

So the pattern of fraud now increasingly documented to be taking place in for-profit and even non-profit hospices is particularly reprehensible. It preys on vulnerable patients, and may cost some patients their lives who otherwise might have lived for a long time. This is a prime example of what goes wrong when our main health care policy seems to be based on letting the good times roll.

I hope that the realization that enrollment of patients who are not terminally ill into hospices can result in their untimely death may lead to some reconsideration of our experiment in lightly regulated, "market based" health care. Those who directly care for patients ought to be motivated by professional values, not short-term revenue.

A Message for Xerox: Americans Not 'Resistant to Change'; They Are Resistant to Reckless Change That Endangers Them

A press release from Xerox Healthcare Provider Solutions:

Jul 31, 2012
Only 26 Percent of Americans Want Electronic Medical Records, Says Xerox Survey

The subtitle is a rhetorical question:

When it comes to healthcare, are Americans resistant to change?

This is analogous to the refrain of calling physicians and nurses "Luddites" regarding their not happily and passively accepting today's clinical IT.  I addressed that issue at my post on pragmatist clinicians v. health IT hyper-enthusiasts at this link.

Jul 31, 2012

ROCHESTER, N.Y. – Americans routinely use electronic files to manage their finances, communicate with friends and family and even take college courses – but when it comes to medical records – only 26 percent want them digital. The findings come from the third annual Electronic Health Records (EHR) online survey of 2,147 U.S. adults, conducted for Xerox (NYSE: XRX) by Harris Interactive in May 2012. 

According to the survey, only 40 percent of respondents believe digital records will deliver better, more efficient care. That response fell two percent from last year’s survey, and matches the response reported in 2010. Overall, 85 percent of respondents this year expressed concern about digital medical records.

Americans have a healthy skepticism of putting their private information online to be hacked, of the disruptive effects of today's commercial health IT on their clinicians, and the costs of doing so.  This likely comes from common sense, reading and observation.

As one reader of this blog wrote:

Xerox kindly shared all three years of their annual Electronic Health Records (EHR) online surveys by Harris Interactive. The media, industry and government unrelentingly promote health technology as the latest, greatest best stuff. But the public ain’t buying it. They want smart phones, but they don’t want EHRs.

The Xerox article paternalistically continues:

“We continue to see a resistance to change from consumers – meaning providers need to continue to educate Americans on the value of EHRs,” said Chad Harris, group president, Xerox Healthcare Provider Solutions.

(Note the use of the 'EHR' acronym.  As I've written, the acronyms 'EHR' and 'EMR' are anachronisms used to describe what are no longer innocuous filing systems, but greatly intrusive enterprise clinical resource and workflow control systems.  I think the public increasingly understands that.)

This patriarchal statement by Chad Harris about "resistance to change" by "healthcare consumers" needing re-education is, in a word, depraved, because I think the person uttering the sentence knows better.  Let's define depraved:

Depraved (adj.):  morally bad or debased; corrupt; perverted

This statement implies is that health IT is a perfected technology without significant flaws, whose benefits are well-proven and whose drawbacks and risks are well understood.

Unfortunately, none of those are true.  From my May 2012 post on ONC's embarrassing "Health Data Palooza", worth repeating here, with hyperlinks:

• There is a markedly unscientific "irrational exuberance" pushing clinical IT into wide use at a dangerously rapid pace. This exuberance is contradicted by a growing body of literature that shows the benefits are likely far less than stated, e.g., by way of example, the ad-hoc set at http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist;
• The technology remains experimental, its rollout is a human subjects experiment on a massive scale lacking nearly all the protections of other human subjects experimentation and for IT in mission critical settings (e.g., informed consent, formal quality control/validation/regulation, formal postmarket surveillance and reporting) due to extraordinary legal and regulatory special accommodations afforded the technology and its purveyors;
• Defects of in-use systems are rampant, inappropriately turning patients and clinicians into software alpha and beta testers (e.g., as in the voluntary FDA MAUDE database, http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html which contains information for just one HIT vendor, Cerner, who voluntarily reports such issues);
• The technology is unsupportive of clinician cognitive needs (2009 National Research Council study, which also stated that accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering will be essential to perfect this technology);
• The roles of scientific discovery and anecdote have been turned on their heads. RCT's of clinical IT are nearly non-existent and lower-level evidence (e.g., weak observational, pre-post, qualitative, and other study types) are cited as "scientific proof" of efficacy and safety justifying hundreds of billions of dollars of taxpayer (or is it Chinese loan?) expenditures.  Yet, risk management-relevant case reports of harmful events and near misses, crucial to help organizations and regulatory agencies understand risks are dismissed as "anecdotal" (e.g., Blumenthal: "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's could impede patient safety," he said, while ONC issued an article based on questionable research methods entitled "The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results" extolling the virtues of HIT, written about at http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html).
• Risks are definite, with known patient injury and death, but the magnitude is admittedly unknown as admitted by JC (2008 Sentinel Event Alert), FDA (2010 Internal memo on HIT risks and statements of Jeffrey Shuren MD JD about known harms likely being "the tip of the iceberg"), IOM (2011 report on HIT risk), ECRI Institute (Top ten healthcare technology hazards for 2011 and 2012), NORCAL Mutual Insurance Company 2009 report on EHR risks, others;
• Existence of severe impediments to information diffusion about risks explicitly admitted by FDA (2010 memo), IOM (2011 report), others;
• Usability of commercial products in real world settings is often poor (e.g., NIST 2011 study on usability), promoting "use error" (user interface designs that engender users to make errors of commission or omission, where many errors are due not to user error per se but due to designs that are flawed, e.g., poorly written messaging, misuse of color-coding conventions, omission of information, etc.)
• These systems promote capture and display of clinically irrelevant information in the interest of charge capture, and result in reams of "legible gibberish" with many negative characteristics that make it difficult for other clinicians and reviewers to establish a cohesive, definitive narrative of clinical events and timelines.

The article continues:

Despite consumers’ misgivings of the value of EHRs, caregivers [largely hospitals and healthcare systems who force it on their staffs and owned physician practices - ed.] are quick to adopt digital technology.  [Thanks to incentives and looming penalties - ed.] When asked how their healthcare provider recorded medical information during their last visit to a doctor or hospital, 60 percent of respondents – who have visited a doctor or hospital – reported that the information was entered directly into a tablet, laptop or in-room computer station versus 28 percent who reported the information was taken via handwritten notes. 

As the numbers don't justify the practice, even if the numbers as stated are valid, my response is:

So what?

To help caregivers do more with this patient information, Xerox is working with researchers at PARC, A Xerox Company, to explore EHRs as a gateway to a variety of healthcare innovation possibilities. The resulting technology tools will simplify back-office and front-line processes, reduce errors, and free up caregivers to spend more time and attention on day-to-day patient care.

The "possibilities" will accomplish all these things?  

Not only does that not follow logically, but where's the data, or is this simply wishful thinking? 

The latter "possibility that will come true" - "free up caregivers to spend more time and attention on day-to-day patient care" - is the most laughable.   These systems do anything but, as for example here regarding the the time costs of data acquisition and the time costs of data input.  I have yet to see serious studies that consistently demonstrate any time savings at all for clinicians.  Quite the reverse, actually.

Of course, the mandatory marketing puffery:

“A big part of PARC’s healthcare work for Xerox is using ethnography and other social science methods to observe and analyze actual work practices – not just what people say they do,” said Steve Hoover, CEO, PARC, A Xerox Company. “If there’s one thing that this survey tells us, coupled with our own experiences, it’s that you should never develop or deploy technology outside of the human context.”

Precisely what is being done now, and on a national scale in the 'National Program for IT in the HHS.'

Xerox, either you're part of the solution or part of the problem.

Which is it?

-- SS

How Many Legal Settlements Does it Take... to Lead to Real Change in Johnson and Johnson Leadership?

And the latest Johnson & Johnson settlement is (as described in Bloomberg/ BusinessWeek):

Johnson & Johnson (JNJ) will pay $181 million to resolve claims by 36 states that it improperly marketed and advertised the antipsychotic drugs Risperdal and Invega.

J&J and its Janssen unit settled claims that it promoted the drugs from 1998 through 2004 for uses not approved by the U.S. Food and Drug Administration. New York Attorney General Eric Schneiderman said today the accord is the largest multistate consumer protection-based pharmaceutical settlement.

'This landmark settlement holds the companies accountable for practices that put patients in danger, and serves as a warning to other pharmaceutical giants that they must play by one set of rules,' Schneiderman said in a statement.

J&J agreed it won’t promote the drugs for off-label uses or tout them falsely.

Specific Bad Behaviors

The allegations were of the sorts of behavior that should make health professionals cringe,

Using speaker programs on unapproved uses, sham consulting programs for physicians, and lucrative agreements with doctors who prescribed off-label, J&J 'sought to enhance Risperdal’s off-label market penetration across a wide range of diagnoses and patient populations, according to Florida’s complaint.

So reading slightly between the lines, the behaviors included various ways to pay physicians ("sham consulting," "lucrative agreements") for prescribing drugs, providing physicians monetary incentives to violate the most core of their core values, putting the individual patient's welfare and needs ahead of personal enrichment. Why these were not labeled kickbacks or bribes is not obvious.

No Individuals Pay any Penalty

Nonetheless, as in nearly every other legal action by state or federal law enforcement against a big pharmaceutical company or other big health care company, the entire settlement involved no penalties to any individuals who may have authorized, directed or participated directly in the misbehavior. In fact,

The company, based in New Brunswick, New Jersey, settled 'to resolve the concerns of the attorneys general under state consumer protection laws and to avoid unnecessary expense and a prolonged legal process,' it said in a statement.

J&J didn’t admit wrongdoing or pay a fine or penalty.

The tough law enforcers claimed

The agreement 'sends a message to all pharmaceutical companies that these practices will not be tolerated,' Florida Attorney General Pam Bondi said in a statement.

Of course, there was another part to the settlement. The company promised not to do these sort of bad things again,

Bondi said Janssen agreed to several steps over five years. They include having policies to ensure that financial incentives aren’t given to encourage off-label marketing; sales and marketing employees can’t develop the medical contents of responses to health-care providers; and it must describe the effectiveness and risks of drugs in a balanced manner.

Should we believe them? Their record is not promising.

Earlier this year Johnson & Johnson was fined $1.1 billion by a judge in Arkansas for deceiving patients and physicians about the very same drug at issue in this suit, Risperdal (look here). That was just the latest in a remarkable string of legal cases suggesting an ongoing pattern of unethical and illegal behavior by this very large health care corporation. As we wrote recently, this included
- Convictions in two different states in 2010 for misleading marketing of Risperdal, as noted above
- A guilty plea for misbranding Topamax in 2010
- Guilty pleas to bribery in Europe in 2011 by J+J's DePuy subsidiary
- A guilty plea for marketing Risperdal for unapproved uses in 2011 (see this link for all of the above)
- Accusations that the company, which makes smoking cessation products, participated along with tobacco companies in efforts to lobby state legislators (see post here)
- A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post here)
- More recently, in 2012, testimony in a trial of allegations of unethical marketing of the drug Risperdal (risperidone) by the Janssen subsidiary revealed a systemic, deceptive stealth marketing campaign that fostered suppression of research whose results were unfavorable to the company, ghostwriting, the use of key opinion leaders as marketers in the guise of academics and professionals, and intimidation of whistleblowers. After these revelations, the company abruptly settled the case (see post here).
- Most recently, there are reports that the company is in negotiation with the US Department of Justice to settle other lawsuits about the marketing of Risperdal, perhaps for as much as $1.8 billion (see this BusinessWeek story.)

One might think that the leadership on whose watch this all occurred would be in disgrace. There has been, however, no major changes in leadership of the company. The CEO who was in power during the time when these settlements, and much of the behavior leading to them, will be retiring, after earning huge compensation, and with a retirement package valued somewhere between $143 and $197 million (see this post). Rather than disgrace, he recently was put on the committee responsible for investigating JP Morgan Chase's $5.8 billion dollar trading loss (as reported by Bloomberg, via NJ.com).

Summary

As we have noted again and again and again, many of largest and once proud health care organizations now have recent records of repeated, egregious ethical lapses. Not only have their leaders have nearly all avoided penalties, but they have become extremely rich while their companies have so misbehaved.

These leaders seem to have become like nobility, able to extract money from lesser folk, while remaining entirely unaccountable for bad results of their reigns. We can see from this case that health care organizations' leadership's nobility overlaps with the supposed "royalty" of the leaders of big financial firms, none of whom have gone to jail after the global financial collapse, great recession, and ongoing international financial disaster (look here). The current fashion of punishing behavior within health care organization with fines and agreements to behave better in the future appears to be more law enforcement theatre than serious deterrent.  As Massachusetts Governor Deval Patrick exhorted his fellow Democrats, I exhort state, federal (and international, for that  matter) law enforcement to "grow a backbone" and go after the people who were responsible for and most profited from the ongoing ethical debacle in health care.

As we have said before, true health care reform would make leaders of health care organization accountable for their organizations' bad behavior.

Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?

At my Aug. 31, 2012 post "Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?" I wrote that healthcare IT vendor EPIC was advising customers in what to write in their "Public comments" regarding the proposed Meaningful Use Stage 2 Final Rule, the requirements of which permit financial incentives to be received by a user if met by an EHR.

It appears they may have been successful.

Note their apparent boilerplate "recommendations" regarding § 170.314(a)(9) - Electronic notes.  This comes from the numerous filings with the accidentally unredacted "Informational Comments for Organizations Using Epic (remove before submitting to ONC)" note, and others without.   Pay specific attention to the "Tertiary Recommendation":

Major Concern

As detailed in our introduction, we are significantly concerned that the scope of the certification program is endangering some of the goals of Meaningful Use by introducing unnecessary overhead and burden.

As electronic notes are not proposed as a Meaningful Use objective with the rationale that electronic notes are already in common use, we do not think certification on this criterion is necessary, and suggest removal. Introducing unnecessary certification criteria creates expense for ONC, certifying bodies, and EHR developers, and does not provide significant value to the marketplace.

Recommendation
Keep consistent with CMS and remove this criterion from the Final Rule.

Secondary Recommendation
If this criterion is retained in the Final Rule, we suggest that the criterion should be an optional certification for the same reasons, and we make the following suggestions:

We agree with your assessment that having notes be searchable provides increased value over notes that are part of a scan or other formats that are not able to be searched. Our experience shows that note search capabilities is complex with potential for innovation in how information is found and displayed. Prioritization of such capabilities is best left to the marketplace. Search is not essential to meet the not-proposed objective drafted by CMS. Focus certification on the minimum floor set of capabilities required to complete meaningful use objectives. Therefore, we suggest that search capabilities be excluded from certification.

Tertiary Recommendation
If this criterion is retained in the Final Rule and is not made optional, a reasonable requirement for certification would be the ability to search for a free-text string within a particular open note. Other search capabilities should be left as competitive differentiators within the marketplace. Specific certification requirements could interrupt innovative ways to do effective chart search and information display.

Informational Comments for Organizations Using Epic (remove before submitting to ONC)

We’ve heard your requests for a chart search feature, and our desire to see this certification criterion removed does not mean we don’t want to develop such a feature. In a future version of Epic, we want to develop the best possible chart search feature based on your input. However, if this criterion stays in the Final Rule, we worry we’ll have to divert attention from future chart search features you’ve requested to focus on a simplified, less valuable version of the feature to meet certification.

Our comments [presumably, those above - ed.] stem from the fact that we believe that you prefer we focus our attention on the more sophisticated chart search feature you have requested in a future version.

The ability to search for a free-text string within an already open [on-screen] note is not of very much value (near useless perhaps?) compared to the ability to search an open patient's record for all notes that contain a string, or across a set of many records, for free-text strings or other values. Think Windows 7 "Search programs and files" at the Start menu, the MS Win XP add-on Windows Search 4.0 for Windows XP, or MacOS's Spotlight.

(Is there, I ask, a commercial EHR that cannot search for a free-text string within a "particular open note"?  Further, any web browser can search screen contents for text strings, I add, so if the EHR is using a browser, that feature comes as a freebie.)

Now note from the MU Stage 2 NPRM (Proposed Rule as in the Notice of Proposed Rulemaking) that appeared in the Federal Register on Mar. 7, 2012.  The relevant passage about note searching is highlighted in green:

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
45 CFR Part 170
RIN 0991-AB82
Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology
AGENCY: Office of the National Coordinator for Health Information Technology (ONC), Department of Health and Human Services.
ACTION: Proposed rule.

§ 170.314(a)(9) - Electronic notes

• Electronic notes

MU Objective Record electronic notes in patient records.

2014 Edition EHR Certification Criterion § 170.314(a)(9) (Electronic notes)

The HITSC recommended a certification criterion similar to the 2014 Edition EHR certification criterion we propose at § 170.314(a)(9) (with specific reference to "physician, physician assistant, or nurse practitioner" electronic notes) to support the MU objective and measure recommended by the HITPC. CMS has not proposed the MU objective and measure for Stage 2, but has requested public comment on whether the objective and measure should be incorporated into Stage 2.

Consistent with our discussion in the preamble section titled "Explanation and Revision of Terms Used in Certification Criteria," we have replaced the terms "modify" and "retrieve" in the recommended criterion with "change" and "access," respectively. Additionally, we are providing the following clarifications for the electronic "search" capability. "Search" means the ability to search free text and data fields of electronic notes. It also means the ability to search the notes that any licensed health care professional has included within the EHR technology, including the ability to search for information across separate notes rather than just within notes. We believe that this certification criterion would encompass the necessary capabilities to support the performance of the MU objective and measure as discussed in the MU Stage 2 proposed rule.

Note the robust "search" capability proposed - the ability to search the notes that any licensed health care professional has included within the EHR technology, including the ability to search for information across separate notes rather than just within notes.

Now, finally, note the Final Rule:

On pg. 300 of final rule at http://www.ofr.gov/OFRUpload/OFRData/2012-21050_PI.pdf it says:
 

Stage 2 Measures:

Enter at least one electronic progress note created, edited and signed by an eligible professional for more than 30 percent of unique patients with at least one office visit during the EHR reporting period.

Enter at least one electronic progress note created, edited and signed by an authorized provider of the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) for more than 30 percent of unique patients admitted to the eligible hospital or CAH's inpatient or emergency department during the EHR reporting period.

Electronic progress notes must be text-searchable. Nonsearchable notes do not qualify, but this does not mean that all of the content has to be character text. Drawings and other content can be included with searchable text notes under this measure.

pg. 553:

Enter at least one electronic progress note created, edited, and signed by an eligible professional for more than 30 percent of unique patients with at least one office visit during the EHR reporting period.

Enter at least one electronic progress note created, edited and signed by an authorized provider of the eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) for more than 30 percent of unique patients admitted to the eligible hospital or CAH’s inpatient or emergency department during the EHR reporting period.

Electronic progress notes must be text-searchable. Nonsearchable notes do not qualify, but this does not mean that all of the content has to be character text. Drawings and other content can be included with searchable notes under this measure.

It would appear, and readers, please correct me if I am mistaken, that the very short criteria specified here - "Electronic progress notes must be text-searchable" - would be satisfied by "the ability to search for a free-text string within a particular open note" per the vendor-authored Tertiary Recommendation, shown supra.

I've searched the MU Stage 2 Final Rule (Adobe Acrobat can do that, but I probably could have used Windows search itself depending on document length) seeking terms from the NPRM such as "search", "information across", "notes", "free-text" etc.  However, I cannot find anything approaching the NPRM § 170.314(a)(9) clarification regarding the meaning of "electronic search capability."

I ask:  what was the role of the Tertiary Recommendation received by ONC from multiple EPIC user organizations?

-- SS

Realizing EHR potential, or avoiding patient endangerment?

I noted an interesting comment posted in the comment thread of Bob Wachter's post "Putting the “A” Back in SOAP Notes: Time to Tackle An Epic Problem."

The comment by Dr. Christine Sinsky reads (there seems to be no way to link directly to it):

Great post Bob.  Ambulatory records are equally in need of brevity and clarity. These notes are often 6 pages of mostly nonsensical boiler plate, formatted on a billing template, leaving the reader asking your question: “but what is going on with the patient?”

After 10 years with our clinic’s EHR (McKesson HAC) and 9 years with our hospital EHR (Cerner), the most important issues I’ve encountered have been

• The time costs of data acquisition: Remember the graphic on a clipboard at the foot of the bed? It was a concise and convenient source of information that has not been reproduced in our EHR. It is now a laborious process to unearth this same information. I/Os and daily weights have become lost data points.

• The time costs of data input: One night on call I did a time trial on six of my admissions: it took an average of 73 seconds to record the admitting orders on paper vs 17 minutes to enter the same orders electronically. And in the electronic world I find myself at higher risk of forgetting the orders I meant to write, as the rigid sequence mandated by the EHR is not always the logical clinical sequence in my mind, and it requires parking orders in my mind until I finish marching through laborious tick boxes.

• Diminished situational awareness. Nurses, doctors and others have a more myopic view of the patient, as it is harder to see trends and to see the big picture. Nurses may only know the meds and the orders that pertain to their shift for example.

• Barriers to synthesis: I find it harder to synthesize the diverse sources of data for a patient when each data bit is tucked away in hard to reach electronic silos, often down long navigational pathways. Sometimes one has to scroll both vertically and horizontally (without freeze frames, so the column and row headings disappear while you scroll) creating a cognitive nightmare.

EHRs will continue to be an important tool going forward; improved usability and a better alignment with clinical workflows are needed if we are to fully realize their potential.

I thought the bullet list not at all surprising, and added the following comment in reply to amplify an implied but unstated point:

Re: “EHRs will continue to be an important tool going forward; improved usability and a better alignment with clinical workflows are needed if we are to fully realize their potential.”

You just described what could indisputably be called serious impediments to care. 73 seconds to 17 minutes? Loss of easily accessed data on I/O and daily weights? Diminished situational awareness?

Perhaps it’s time clinicians stopped sugar coating their statements with PC [politically correct - ed.] niceties such as "... if we are to fully realize their potential”, and were more forceful with a more apt “improved usability and a better alignment with clinical workflows are needed if we are to avoid patient endangerment.”

Disruptive effects like these, in my view, lend more import towards speaking of the latter than of the former.

-- SS

Who Really Makes Brand-Name Pharmaceuticals?

A striking illustration of the hazards to patients' and the public's health from health care organizational leaders using fashionable management techniques to maximize short-term revenue appeared in Reuters. 

Background: The Contaminated Heparin from China

The particular issue got public notice after US patients started to get sick and die after being infused with heparin, the common anti-coagulant drug. As we have discussed repeatedly starting in 2008 (look here, and see the summary at the end of the post), Baxter International was selling contaminated heparin under its label which was made in unregulated workshops in China, and then transmitted through a complex chain of Chinese and US companies.  What helped to further obscure the problem was what Baxter was buying was called the active pharmaceutical ingredient (API), which actualy means it was buying the active drug from poorly documented foreign sources.  In other words, it had entirely outsourced the manufacturing of a drug it sold as if it had been made by Baxter in the US.

Continued Outsourcing to Questionable Drug Manufacturers

Reuters reported on a new investigation of outsourcing of drug manufacturing to China.  The main point was:

Four years ago, Beijing promised to clean up its act following the deaths of at least 149 Americans who received contaminated Chinese supplies of the blood-thinner heparin. But an examination by Reuters has found that unregulated Chinese chemical companies making active pharmaceutical ingredients (API) are still selling their products on the open market with few or no checks.

Interviews with more than a dozen API producers and brokers indicate drug ingredients are entering the global supply chain after being made with no oversight from China's State Food and Drug Administration (SFDA), and with no Good Manufacturing Practice (GMP) certification, an internationally recognized standard of quality assurance.

'There is falsification of APIs going on, we know it,' said Lembit Rago, coordinator for Quality Assurance and Safety in Medicines with the World Health Organisation (WHO).

In fact, the article made the point that the majority of drugs sold worldwide are the product of outsourced, often unregulated, and potentially contaminated and adulterated manufacturing:

'Illegal ingredients in bulk are a big problem, but nobody talks about it,' said Guy Villax, chief executive of Hovione, an API supplier based in Portugal with factories there and in China, the United States and Ireland.

About 70 to 80 percent of all active drug ingredients - the biologically active component in medicines - originate in China and India, estimate industry experts, with China accounting for the lion's share. Its export market in these products is worth $22 billion in annual sales, according to the China Chamber of Commerce for Import and Export of Medicines and Health Products.

'If China for some reason decided to stop exporting APIs, within three months all our pharmacies would be empty,' said Villax.

How Dodgy Manufacturers Continue to Operate

Apparently, a particular problem in China is that APIs, that is, the particular drugs in question, can be made by chemical as opposed to officially designated "pharmaceutical" companies, and these chemical companies are not regulated,

A key regulatory weakness in China is the distinction between pharmaceutical and chemical companies. While the former are regulated by the SFDA, the latter, making everything from sweeteners to solvents, are not. Yet many chemical companies also churn out drug ingredients, exploiting a loophole by describing the products as chemicals, which they are, rather than the more specific designation of APIs.

For example, the article recounted how an unregulated chemical company was apparently a source for a well-known branded pharmaceutical sold by two big pharmaceutical companies headquartered in developed countries,

[A]company, Jinan Hongfangde Pharmatech (JHP), of Jinan city in Shandong province, had a product list showing at least five patented products for sale. They included tiotropium bromide, a blockbuster lung drug co-promoted by Boehringer-Ingelheim and Pfizer Inc and sold under the name Spiriva,...

Both Boehringer-Ingelheim and Pfizer spokespeople claimed that they only bought drugs from known sources, but then it would be pointless for Jinan Hongfangde Pharmatech to manufacture tiotropium bromide.

The Use of Brokers

More questions were raised by the pharmaceutical company's apparently common practice of buying drugs through brokers,

The rise of the Internet has facilitated exports of drug ingredients. An online search brings up websites offering hundreds of Chinese API sellers. Those not GMP-certified or SFDA-registered are not necessarily substandard, but buyers lack independent quality assurance.

The pervasive presence of brokers in the supply line is another risk. Pharmaceutical companies looking to source APIs in China typically hire middlemen to help them navigate the language, red tape and protocol. That system helps Chinese companies making substandard APIs avoid detection.

The reason corporate executives choose to buy drugs in China rather than having their companies manufacture them themselves seems to be to reduce costs. A post on the In-Pharma blog quoted Lembit Rago, the same WHO official quoted by Reuters, thus,

There are Chinese manufacturers supplying APIs of high quality to multinational companies, but there are also companies producing APIs of poor or not defined quality.

So,

As long as there are customers for substandard APIs they will be produced and sold.

The cheapest Chinese drugs, of course, come from the most questionable manufacturers, and that may not be apparent to companies who use brokers to facilitate purchases.

'Any number of foreign pharmaceutical companies go no further than looking for API suppliers at CPhI (an international pharmaceutical fair) based only on price,' [manaing director of Samsara Biopharma Consulting Robert] Walsh said.

Reuters spoke to brokers who said an API made by an unregulated chemical company would cost less than one from a company that had a GMP certificate.

'Different (API) grades have different prices. Sometimes we accept an order sheet and we happen to find a factory that can do it cheaper than our factory, we will outsource to them and make a bigger margin,' said one broker based in China who sources for a South African outsourcing firm.

In China there are few legal repercussions for broker firms who relabel or misrepresent products, and tracing counterfeit and substandard APIs is extremely difficult.

'There are a lot of brokers who are relabeling (APIs) which means you can't trace where the API comes from and that adds to the risk,' said the WHO's quality assurance expert Rago.

Andre, the Belgian drug detective, estimates he has uncovered fraud or misrepresentations in as many as 25 percent of cases where he has been hired to audit factories all over China. 'If you can substitute an API that is expensive to make and manufactured at a high level with something that costs much less, then that can happen,' Andre said. 'It's impossible to give an exact number, but it's not rare. It's a minority, but not tiny minority.'

Use of Substandard Raw Materials

Meanwhile, a post on PharmaLot suggested that the supposedly regulated Chinese "pharmaceutical" companies may implement questionable manufacturing practices,

A subsidiary of the Joincare Pharmaceutical Group reportedly used reprocessed cooking oil – otherwise known as ‘gutter’ oil – to make a widely used antibiotic in China. If the term gutter oil is unfamiliar, this refers to reprocessed oil made from kitchen waste dredged from gutters behind restaurants. The State Food and Drug Administration is now investigating the charge after media reports over the past several days, China Daily reports.

Why might gutter oil be purchased to produce antibiotics? The oil is cheaper than the more expensive soybean oil used to make 7-aminocephalosporinic acid, or 7-ACA, a chemical for produce cephalosporins. Joincare produces 25 percent of the total amount of the chemical, although up to a dozen other drugmakers may have purchased gutter oil from various suppliers, according to various Chinese media reports. For its part, Joincare reportedly denied using gutter oil.

The companies reportedly bought the recycled cooking oil from a company called Huikang Grease Co., which is facing prosecution over its alleged processing and selling of thousands of tons of gutter oil in 2010 and 2011. The Shanghai Daily reported that Huikang received around $22.5 million for roughly 14,700 tons of gutter oil sold to Jiaozuo Joincare Biological Product, a unit of Joincare.

Summary

There is increasing evidence that a substantial proportion, probably the majority of drugs sold by big pharmaceutical companies based in developed countries were actually made by often poorly regulated firms based elsewhere, often China or India. To put it more directly, most so called pharmaceutical companies in the US and other developed countries have outsourced the actual manufacturing of drugs. Thus, most companies that appear to be pharmaceutical manufacturing companies are really just pharmaceutical marketing and development companies. (And not so much the latter, look here:  Light DW, Lexchin JR. Pharmaceutical R&D; what do we get for all that money? Brit Med J 2012; 345: 22-25.  Link here.) Pharmaceutical companies appear to be abandoning their core essence, but are content to market drugs  under their logos without telling the patients who take them the real source of these products.  This would appear to be a big scandal, but one that stays curiously anechoic.

I have yet to see any discussion with pharmaceutical executives about why their companies hardly make drugs anymore. In the absence of such discussion, I can only speculate that most likely, this is first a product of financialization. Drug company executives, like most organizational leaders, have fallen under the spell that says their only goal should be to increase short-term revenues. It may be cheaper to buy drugs from perhaps dodgy outsourced suppliers rather than manufacturing them them themselves. Continuing stories like those above, and that of the contaminated Chinese heparin suggest that these outsourced drugs are cheap for a reason. It appears that to save money short-term, pharmaceutical executives may be abandoning their most central mission, to provide pure, unadulterated drugs.

The continuing story of outsourced pharmaceutical manufacturing provides yet more evidence that current management dogma may be literally toxic. Once again, I suggest that true health care reform requires leadership of health care organization who put patients' and the public's health ahead of short-term revenue (and the personal enrichment that may result).

It is likely that a number of policy changes will be needed to reduce the threats posed by contaminated or adulterated outsourced pharmaceuticals.  There is one simple step that ought to be taken quickly to at least make the problem more transparent.  In the US, most manufactured products have a label disclosing the country of origin.  In parallel with that, all pharmaceutical containers, and all pharmaceutical labels and marketing materials ought to disclose the country in which the active pharmaceutical ingredient was manufactured, and the name and location of the company responsible for that manufacture. 


Appendix - Heparin Case Summary

- We have posted several times, recently here about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late in 2007, hundreds of such reactions, and 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International.

- We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart. (See posts here and here.)

- We found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post here.) Further testing revealed that the contamination seemed to have taken place in China prior to the provision of the heparin to Changzhou SPL. (See post here.) It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there.

- The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."

- Leaders of all organizations involved, Baxter International, Scientific Protein Laboratories, Changzhou SPL, the Chinese government, and the US Food and Drug Administration, and the US Congress assigned blame to each other, but none took individual or organizational responsibility. (See post here.)  Note that SPL was recently bought out and taken private, making its current leadership even less transparent (see post here).  A 2010 inspection of an SPL facility by the FDA revealed ongoing manufacturing problems (see post here).

- Researchers (who turned out to have financial ties to a company which is developing an anti-coagulant drug that could compete with the heparin made by Baxter International) investigated the biological mechanisms by which the contamination of the heparin lead to adverse effects, but no one investigated further how the contamination occurred, or who was responsible. (See post here.)

- Hundreds of lawsuits against Baxter have now been filed, so far without resolution. (See post here.)  Efforts to make documents to be used in these cases public so far have not succeeded (see post here).

- A government report which attracted little attention warned of the dangers of pharmaceutical ingredients made in China and subject to virtually no oversight. (See post here.)

-  Despite requests from the US, the Chinese government did not investigate the production of the heparin that lead to the deaths (see post here.)

-  In February, 2011, a congressional investigation of the case was announced, but results are so far unavailable (see post here.)

-  In June, 2011, a jury returned the first verdict in a civil case about the contaminated heparin, awarding money from Baxter International and Scientific Protein Laboratories to the estate of a man who apparently died due to tainted heparin (see post here).

"MetroHealth, Explorys use huge patient database to revolutionize medical research"

As I have written in the past, beware claims of "revolutions" where healthcare or medical research are involved.  As in a slide in my recent presentation to the Health Informatics Society of Australia on healthcare IT trust, I asked:

In that same talk, I pointed out the "revolutions" usually have downsides, and IT always produces winners and losers (per the empirical research of Social Informatics). 

I also asked "have we suffered a complete breakdown in the scientific method with regard to EHR and clinical IT?" in a 2009 post on uncontrolled EHR data and comparative effectiveness studies at this link.  

In the Aug. 29, 2012 article "MetroHealth, Explorys use huge patient database to revolutionize medical research"  in The Plain Dealer (Ohio), the following claims are proffered.  I am assuming regarding this article, as in newspaper articles I make contributions to, that the researchers were involved in its provenance and content:

Large databases of electronic medical records hold great promise for medical research. In theory they can provide doctors access to huge amounts of anonymous patient data, allowing large-scale population studies without the cost and hassle of patient recruitment, review boards and staff training.

Now, a team of data experts at MetroHealth Medical Center and the Cleveland Clinic Innovations spinoff company Explorys has shown just how powerful such medical records can be: In three months, they've replicated a major medical study that took a Norwegian team 14 years to research and report. And they've done it at a fraction of the cost, with a sample about 40 times as large.

The local effort, led by MetroHealth Chief Medical Informatics Officer Dr. David Kaelber, was possible because of Explorys' database of 14 million electronic medical records gathered from 12 major health systems.

14 million records gathered from 12 major health systems, which may in fact be using disparate EHR systems or versions, is almost indisputably not controlled data.

A comparison to a more rigorous study was conceptualized and performed:

Most of all though, he [Kaelber] needed to prove that it worked -- that he could get exactly the same results as traditional research studies that required more time and resources.

Enter the Norwegian study. In 1994, a group of researchers started registering 26,714 people in the northern region's largest city, Tromso. It was part of a much longer study on the population's heart disease risk. They recorded height, weight and other measures of obesity, then followed participants for 13 years, recording any blood clots they had.

Their conclusion: the combination of obesity and a tall stature significantly increases risk of blood clots, especially in men.

The same hypothesis was tested with the uncontrolled EHR data, with claims that (obviously) the time and expense were lower, at least in the instant sense (costs of EHR implementation and maintenance in 12 major health systems could be in the billions of dollars at a time when a health system can easily spend $100 million each over just a few years as Bob Wachter points our here - one hundred million dollars for UCSF):

... The sample: 959,030 patients with medical records in the Explorys platform. The method: using software to search for blood clots in the health and claims records contained in the database, and then looking for patterns in those patients' height and weight. The result: Exactly the same as the Tromso study.

"And actually the statistical significance of our study was much, much higher because our sample size was 40 times greater," Kaelber said. Kaelber and his team published their results online in July in the Journal of the American Medical Informatics Association.

The conclusion to the article here (subscription required) was:

With the right clinical research informatics tools and EHR data, some types of very large cohort studies can be completed [and, by implication, trusted and acted upon at local, regional or societal levels - ed.] with minimal resources.

This data was, and I don't think this can be refuted, poorly controlled.  There are limits to what "data cleansing" and standardization can accomplish with such data. In methodologies like this, confounders are too numerous to list comprehensively, but just a few - missing data; variability in observations (inter- and intra-observer variability); data originating from different vendor systems with different terminology and definitions, input by myriad people of different backgrounds with differing interpretations of terminologies (students/MD's/RN's etc); different pressures creating bias (time, reimbursement maximization, litigation avoidance); to name just a few.

Several questions: 

• What is the likelihood these results were themselves a chance outcome? Correlation is not proof, especially where n=1. 

• How do we reliably identify ante hoc the "types of very large cohort studies" that we can complete?

• What is the likelihood that such techniques are generalizable to all studies (such as comparative effectiveness research, currently a governmental initiative), especially where issues and confounders might be subtle?

• Related to generalizability supra, where are the scientific studies that prove methodologies like this are valid and reliable for other than, say, low-granularity epidemiological purposes?  Put more colloquially - how do we know what these efforts attempt to do, in what is almost indisputably a radical deviation from controlled-trial norms, is not "computational alchemy" (i.e., attempting to turn lead into gold)?

• Is there rigorous data on attempted studies like this that failed to correlate with more traditional research?  Unless the latter is studied and/or attempted and some sense gained of whether a radical approach using uncontrolled data such as this does not fail to a concerning extent, then claims of "revolutions" need to be postponed.

Worst case scenario: large dataset, radical analytics and a political agenda can lead to undesired outcomes.  We need to know what we are doing.

More on these issues in a 2009 article I authored here. 

I have invited Dr. Kaelber to comment on the questions I raise. 

Note:  I am not challenging this specific study per se, which is an experiment, but am challenging the generalizability of this type of "from data rags to information riches" methodology, as I've done in other posts on similar topics. Not to mention, the overconfidence as expressed in the press, which is what the public including our lawmakers and people responsible for resource allocation read.  I think it's highly premature to write of "revolutionizing medical research."

Sep. 4, 2012

Here is the reply from Dr. Kaelber -

We actually cover many of the points you raise in the discussion of the article.

I think it is important if we are focusing on a scientific discussion of a scientific article to focus on the primary source - the scientific article itself, and not a secondary source - the reporting of the scientific article.

One of the major points in the discussion (quoted from the published manuscript) is that we feel that there are three keys to using pooled, standardized, normalized, and de-identified EHR data, including:

1. Understanding data sources - understanding of the characteristics of the underlying EHR data sources, including a data dictionary and ontologies used.

2. Corroborating data findings - internal and/or external methods to corroborate retrospective EHR cohort study data and/or findings. For example, manual chart review of a sample of the EHR data (internal validation), or other studies demonstrating similar results (external validation), ideally coupled with a biologically plausible hypothesis.

3. Clinical data versus research data - recognizing that retrospective EHR data were typically collected for clinical and not research purposes. Therefore, depending on the type of data, the quality may not meet typical research standards. In some cases, the large quantity of clinical data may help mitigate the fact that it was not collected with the higher precision and accuracy that can occur as part of a prospective research study.

As I was also quoted in the Plain Dealer article as saying this is like a new type of power drill for those who have been used to using hand drills for retrospective (electronic or paper) chart reviews. To be used appropriately, researchers need to understand the opportunities and disadvantages of using of the new tool and be trained on how to use it.

I would also add that, again, as was stated in the introduction for the published paper that clinical research informatics as a field is in its infancy and we need more people involved in the field, more tools for people in the field, and more experience of people using tools in the field to really understand both the contributions and limitations for electronic health record data to advance clinical research.

I hope these comments are of some interest/use.

-David

My thoughts are that use of of experimental EHR-based methodologies like this, that could have significant social implications, requires significant caution and validation.  I think we are in agreement on that point.  The methodology of use of EHR data from myriad sources needs to be shown valid, as well as proven not to be invalid, before the findings of "new" studies that are not attempting to duplicate prior ones are translated to the bedside or beyond.

The disadvantages include, among other issues (and perhaps most important) the spread of premature over-optimism about health IT such as in newspapers.  That problem has, I believe, contributed greatly to the prevalent hyper-enthusiasm and "there's little supportive data - nevertheless, we believe - so let's spend $15+ billion dollars" attitudes about current health IT as I wrote about, for instance, here (ONC's 'Data Palooza') and here (on MU Stage 2 justifications).

Finally, I would question whether increasing the quantity of data could ever reliably compensate for lack of quality (unless, perhaps  the additions were themselves of high quality).  Adding low quality data to already low quality data should not produce better results, it seems to me.

-- SS

Two recent interesting settlements at Massachusetts General Hospital (MGH), both involving technology

Two recent interesting settlements at Massachusetts General Hospital (MGH), both involving technology.

The first case involved a medication error (from a 'miscommunication between doctors and nurses', an infusion pump snafu, and failure to perform obvious follow up labs;  if health IT was involved it would not surprise me).  The second case involved alarm fatigue.

These amounts are interesting considering the age and condition of the patients.


1.  http://www.lubinandmeyer.com/cases/medication-error.html

Medication Error Lawsuit against MGH Settles for $1.25 Million

The plaintiff’s decedent was a 76-year-old woman who died on 11/24/10 from a hemorrhage. Her death occurred following a preventable medication error involving the drug Lepirudin. The patient was given over 30 times too much medication which resulted in uncontrollable internal bleeding and her subsequent death.

Her past medical history included cirrhosis with well preserved hepatocellular synthetic function. She also had Type 2 diabetes, hypertension and hypercholesterolemia, and a history of splenectomy for treatment of severe thrombocytopenia.

and


2.  http://www.masslive.com/news/index.ssf/2011/11/mass_general_hospital_alarm_fa.html

Mass. General Hospital 'alarm fatigue' lawsuit settled for $850,000

BOSTON (AP) — The family of an 89-year-old man who died at Massachusetts General Hospital when nurses did not respond to alarms on his cardiac monitor has settled its case against the hospital for $850,000.

I see potential lessons for at least two healthcare stakeholders in these cases:

Hospital executives:  bad technology is not your friend.  get it right before rolling it out, with robust, validated safeguards, to save lives - and to save your organizations from costly litigation and reputational damage.

Clinicians:  bad technology is your enemy.  While hyper-vigilance is mentally exhausting, that's what's required to avoid the fate of the patients - and the clinicians - in the above cases.

Reporting bad technology and making sure the problems are remediated promptly, not glossed over, is equally essential.

Note: my interpretation is that both technology and people issues probably played a role in both these accidents, based on my own knowledge and experience, but that is of course a personal opinion. 

-- SS