You Say You Want Some Revolutions? - Famed Academic Physician Dr Milton Packer's Endless Alternating Turns as Drug Company Spokesperson and FDA Advisor

Last week, we noted  we again discussed the web of conflicts of interest that is draped over medicine and health care, and seems responsible for much of our current health care dysfunction.  We have discussed examples of conflicts of interest affecting clinical research, clinical teaching, clinical care, and health care policy.  Each time I think we must have cataloged all the useful examples, a striking new one appears.

Only a few days later, yet another new variant has in fact appeared.

A New Kind of Revolving Door

A new version of the "revolving door" apparently was first noted by Public Citizen, and then reported by Ed Silverman at Pharmalot. 

The usual version of the revolving door occurs when a person transitions from a full-time job in industry to a government position which has regulatory authority or other influence over that same industry, or vica versa.  We have discussed various health care manifestations of that revolving door here.

The new version, as described by Mr Silverman, in its manifestation at the US Food and Drug Administration (FDA) is:

the agency allows some experts who serve on its advisory panels to also make presentations at other meetings of these same panels on behalf of drug makers. By allowing some people to wear different hats within a short amount of time, the advocacy group charges the FDA creates the potential for bias to creep into the proceedings.

The Public Citizen letter to the FDA summarized the problem,

In particular, a sponsor’s use of an individual who serves, or has recently served, as a voting member of an FDA advisory committee to present its case before that member’s colleagues on the committee takes advantage of the special collegiality existing among members in order to improve a company’s chances of a favorable vote. Furthermore, such a revolving door raises concerns about the objectivity of committee members who accept such paid arrangements, with FDA’s approval, at future hearings involving the same or a rival company.

Someone Familiar Going Round and Round

The Public Citizen letter used as an example one well-known academic physician who seemed to have made many revolutions in this sort of revolving door.  As summarized in the PharmaLot post,

As an example, Public Citizen cites a meeting this past March 27 of the FDA’s Cardiovascular and Renal Drugs Advisory Committee, which was held to review an application for a Novartis drug called serelaxin to treat acute heart failure. And Milton Packer, who chairs the department of clinical sciences at UT Southwestern, appeared as a paid speaker on behalf of Novartis.

In his opening remarks, Packer disclosed that Novartis paid for his time and travel, according to the advocacy group. But because he is also considered to be a ‘special government employee,’ which is how advisory panel members are classified, he obtained permission from the FDA to participate as a paid speaker for Novartis (see page 31 here).

However, Packer served as a temporary voting member of the same FDA advisory committee less than two months earlier. Moreover, Public Citizen says this was the sixth time, since Packer first presided as chair of this committee in 1997, that he had 'spoken on behalf of and/or served as a (presumably) paid consultant' to drug makers whose meds were being reviewed at those meetings.

The other occasions in which Packer appeared before the Cardiovascular and Renal Drugs Advisory committee involved speaking on behalf of Bristol-Myers Squibb in 2002; acting as a consultant and speaker for GlaxoSmithKline in 2003; appearing as a speaker for NitroMed in 2005; appearing as a speaker for Sanofi in 2009 and acting as a consultant on behalf of Pfizer in 2010.

In fact, the Public Citizen letter also asserted that

Dr. Packer’s presence as an FDA advisory committee member at hearings extends beyond the CRDAC, as he has also participated in at least three meetings of the Arthritis Advisory Committee and served at least once on the Endocrinologic and Metabolic Drugs Advisory Committee since 2005.

We note with concern that, as with his revolving-door tenure at CRDAC, Dr. Packer has similarly worked with industry in the following capacities at non-CRDAC advisory committees while intermittently serving as a recurring member of some of these same committees:

- As a consultant to Centocor for its presentation on infliximab (Remicade) to the March 4, 2003, meeting of the Arthritis Advisory Committee;
- As an 'external expert' cited by GlaxoSmithKline at the July 30, 2007, joint meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees to discuss the cardiac ischemic risks of the thiazolidinedione diabetes drugs, with a focus on rosiglitazone (Avandia); and
- As a consultant to Boehringer Ingelheim for its presentation concerning the drug tiotropium (Spiriva HandiHaler), made before the November 19, 2009, meeting of the Pulmonary-Allergy Drugs Advisory Committee.

Summary

Dr Milton Packer served as a presumably paid spokesperson for six different pharmaceutical companies advocating for six different drugs at meetings of the FDA Cardiovascular and Renal Drugs Advisory Committee.  Over roughly the same time period he served as the chair, acting chair, or voting member of that same committee in numerous instances.  Also, Dr Packer served as a presumably paid spokesperson for one of the same drug companies, and for two additional drug companies advocating for another three drugs at meetings of three other FDA advisory committees.  On various occasions he had also served as a member of these three committees.  Parenthetically, one of the drugs for which Dr Packer, a cardiologist, advocated, Avandia, to a non-cardiologic committee was subsequently pulled from the market because of concerns about excess cardiologic complications (look here). 

Dr Packer repeatedly went back and forth between roles as a paid advocate for drug companies and as a member or chair of federal advisory committees which could influence FDA decisions about the drugs for which he advocated and which were made by the companies that employed him.


It certainly seems that Public Citizen was right in that the sorts of transitions Dr Packer made constituted multiple conflicts of interest, and that his work for multiple drug companies was likely to have distorted the recommendations of the committees on which he served.  Rapid transitions between temporary committee memberships and paid advocacy positions before such committees does seem to be a new version of the revolving door, and newly discovered type of conflict of interest.  It seems that conflicts of interest now pervade every aspect of health care, with huge cumulative effects on clinical and health policy decision making.

Note also that the person whose conflicts of interest were used as examples by Public Citizen just appeared in Health Care Renewal in another capacity.  Earlier this month we discussed a study (PARADIGM - HF) of a new drug for congestive heart failure (sacubitril) which received prominent media attention.  After various people, not limited to yours truly, pointed out that this study seemed to have multiple flaws which undercut claims that the new drug would be a "game changer," the principal investigator of the study delivered a written whupping to a critic whose writing appeared prominently on a cardiology web-site .  The scathing comeback, however, seemed based on a volley of logical fallacies, including repetitive ad hominem attacks on the critic (look here).  The PARADIGM - HF Principal Investigator was none other than the same Dr Milton Packer whose revolving door cycles were discussed above.  Note that the company that sponsored, and largely ran and designed PARADIGM - HF, and which paid Dr Packer to serve as Principal Investigator, was the same Novartis for whom Dr Packer was a spokesperson in the first example above. 

We wondered whether Dr Packer's conflicts of interest contributed to confused, illogical thinking and his apparently logically fallacious response to his critic.  Now it appears that Dr Packer has been immersed much more deeply in conflicts of interest than were apparent a few days ago.  So should he be regarded mainly as a heart failure "expert," or mainly as a paid marketer and public relations man for drug companies?  Obviously, he is both, but the mixture is not so clear.  The concern is all the more important because Dr Packer has become such a prominent medical academic.

So once again, again, again,...  we call for all conflicts to be disclosed in the interests of honesty.  Beyond that, as we have been saying for years, patients' and the public's health would benefit from an aggressive effort to reduce conflicts of interest affecting clinical and health policy decision making.    

Merging Finance and Health Care Leadership - Robert Rubin Proteges Running DHHS, Spouse of Hedge Fund Magnate Running the FDA

Hidden between the lines of some not very prominent news stories were reminders of how close health care and financial leadership have become in these times of continuing economic unrest after the global financial collapse/ great recession.

After the events of 2008, it became more apparent that the dysfunction in academics and health care  paralleled that seen in finance.  One reason may have been the overlapping leadership of finance and health care.  For example, in 2008 we first posted about how Robert Rubin, who was then a Fellow of the Harvard Corporation, the top group responsible for the governance of that great academic and medical institution, bore responsibility for the global financial collapse/ great recession.  Mr Rubin as Treasury Secretary was a proponent of financial deregulation in the Clinton administration.  Later, he became a top leader of Citigroup, whose near collapse helped usher in the crisis of 2008 (look at our 2008 post here and our 2010 post here.  Rubin just stepped down from his Harvard position this year,)  Since 2008 we found many other links among the leadership of Wall Street and of academic medicine and of big health care corporations.  These links, if anything, seem to be getting stronger. 

From the Department of Health and Human Services to Citigroup and then back to the Department of HHS

A tiny, four sentence Reuters story noted an apparently routine appointment to upper management at the US Department of Health and Human Services.  The first three sentences were:

U.S. Health Secretary Sylvia Burwell named Citigroup Inc executive Kevin Thurm as senior counselor of the U.S. Department of Health and Human Services (HHS), which is implementing the controversial U.S. Affordable Care Act.

Thurm has served in a number of roles at Citi since joining the bank in 2001, including senior adviser for compliance and regulatory affairs and deputy general counsel.

Before joining Citi, Thurm, a former Rhodes scholar, was the deputy secretary of the U.S. Department of Health and Human Services.

Why is that significant?  First, the near bankruptcy of the huge, badly led Citigroup was widely acknowledged to be a cause of the global financial collapse.  A 2011 New Yorker article on the role of the revolving door between Washington and Wall Street ("Revolver," by Gabriel Sherman) summarized the plight of Citigroup and the role of Robert Rubin in it,

Citigroup was the most high-profile of Wall Street’s basket cases, the definitionally too-big-to-fail institution. With massive exposure to the housing crash and abysmal risk management, the firm cratered, surviving as a virtual ward of the state after the government injected billions and took a 36 percent ownership position. Along with AIG and Fannie and Freddie, Citi came to be seen as a pariah institution, felled by management dysfunction and heedless greed in pursuit of profits. Complicating matters for Citi, the wounded bank found itself tangled in the populist vortex that swirled in the crash’s wake. On the left, there were calls that Citi should be outright nationalized, stripped down, and sold off for parts. Pandit was called before irate congressional-committee members to answer for Citi’s sins, an ignominious inquisition captured on live television. In January 2009, under pressure, Citi canceled an order for a new $50 million corporate jet.

There was plenty of blame to go around at Citi. Chuck Prince, a lawyer by training who succeeded Citi’s outsize former CEO Sandy Weill, had little grasp of the complex mortgage securities Citi’s traders were gambling on. As late as the summer of 2007, when the housing market was in free fall, Prince infamously told the Financial Times that 'as long as the music is playing, you’ve got to get up and dance.'

Bob Rubin himself pushed the bank to take on more risk in order to increase its profitability, a move that Citi’s dismal risk management was ill-equipped to handle. Pandit, whom Rubin had helped to recruit in 2007 just as the economy began to unravel, was tasked with cleaning up the mess when he became CEO in December of that year, and his early tenure had a deer-in-headlights character. Eventually, he realized that the asset class Citi lacked most was human capital, of the blue-chip variety.  

The article also summarized Rubin's role in the fervor of deregulation in service of market triumphalism that lead to the financial collapse,

In tapping Rubin to run Treasury, Clinton was sanctioning a revolution in the Democratic Party, one that fundamentally redefined the party’s relationship with Wall Street. Rubin, along with Alan Greenspan and Larry Summers, believed in an enlightened capitalism, which would spread prosperity widely. This enchantment with the beneficence of markets became the dominant view in Democratic Washington, hard to argue with when the economy was booming, as it was in the second half of the nineties. Rubin recognized that derivatives posed a risk but effectively blocked efforts to regulate them and pushed for the repeal of the Glass-Steagall Act, the Depression-era legislation that prevented commercial banks from merging with investment and insurance firms (the new law essentially legalized the $70 billion merger in 1998 of Citicorp and Travelers Group that created Citigroup).

Circling back to recent events, Once he got to Citigroup, Rubin assembled a team, partially from his old associates in the Clinton administration,

He also recruited several former Clinton aides to Citi, including former Health and Human Services deputy secretary Kevin Thurm....

So Kevin Thurm became something of a Robert Rubin protege at Citigroup. In fact, he rose to an important leadership position at the same time Citigroup was getting ready to become a "basket case," in part apparently because of the advice of Robert Rubin.  According to a 2013 version of Mr Thurm's official Citigroup bio,

Kevin L. Thurm is Senior Advisor for Compliance and Regulatory Affairs at Citigroup.

Previously, Thurm served as the Chief Compliance Officer of Citi. In that role, Thurm led Global Compliance which protects Citi by helping the Firm comply with applicable laws, regulations, and other standards of conduct, and is responsible for identifying, evaluating, mitigating and reporting on compliance and reputational risks and driving a strong culture of compliance and control. Since joining Citi in 2001, Thurm has also served as Deputy General Counsel of Citi, where he led the Corporate Legal group, overseeing a number of Company-wide Legal functions and providing support on day to day matters, including issues involving the Board, senior executives, and regulators; Chief  Administrative Officer of Consumer Banking North America, where he helped lead the business group and was responsible for a variety of functions including Community Relations, Compliance, Legal and Public Affairs; Director for Administration in the Corporate Center; Chief of Staff to the President and Chief Operating Officer of Citigroup; and as the Director of Consumer Planning in the Global  Consumer Group.

To recap, Mr Kevin Thurm was a top compliance executive of Citigroup while the company was imploding, and being a protege of Robert Rubin, an architect of the financial deregulation that led to the global financial collapse, and a leader of Citigroup responsible for the risky behavior of that company that led to its near collapse, which was another precipitant of the global financial collapse or great recession.  It is not obvious that these are great qualifications to be Senior Counselor at DHHS.

Moreover, Mr Thurm's responsibilities at DHHS would not be limited to compliance or financial leadership.  According to the official DHHS press release announcing his appointment,

As a Senior Counselor, Thurm will work closely with the Department’s senior staff on a wide range of cross-cutting strategic initiatives, key policy challenges, and engagement with external partners.

Yet, there is nothing in Mr Thurm's public record to indicate that he has any actual experience in health care, medicine, public health, or biologic science.  So it is not obvious why he should be entrusted with leading "cross-cutting strategic initiatives, [and] key policy challenges."

On the other hand, Mr Thurm might be simpatico with the new Secretary of DHHS, Ms Sylvia Burwell.  According to a Washington Post article at the time of the hearings about her nomination,

despite her Washington experience, ... is not well known in health-policy circles, and, during her confirmation hearings, she gave little concrete sense of the direction in which she will take the complex department she will inherit.

This seems to be a polite way to see she also has no actual experience in health care, medicine, public health, or biologic science.   Her official biography lists no such experience.  However, she was also a Robert Rubin associate, and perhaps protege, during the Clinton administration,

During the Clinton administration, Burwell held several economic roles — as staff director of the White House National Economic Council, as chief of staff under then-Treasury Secretary Robert Rubin,...

To summarize so far, the new Secretary of the Department of Health and Human Services, and now her new Senior Counselor, were both closely associated with Robert Rubin, who seems to bear major responsibility for the global financial collapse, and the new Senior Counselor worked with Rubin at Citigroup, whose near bankruptcy helped accelerate that collapse.  On the other hand, neither of these leaders has any experience in health care, public health, medicine, or biological science. 

Hedge Funds, Tax Avoidance, and the US Food and Drug Administration

This story is even less obvious.  A July, 2014, report in Bloomberg recounted plans for a Senate hearing on tax avoidance by huge, lucrative hedge funds.  The basics were,

A Renaissance Technologies LLC hedge fund’s investors probably avoided more than $6 billion in U.S. income taxes over 14 years through transactions with Barclays Plc and Deutsche Bank AG, a Senate committee said.

The hedge fund used contracts with the banks to establish the 'fiction' that it wasn’t the owner of thousands of stocks traded each day, said Senator Carl Levin, a Michigan Democrat and chairman of the Permanent Subcommittee on Investigations. The maneuver sought to transform profits from rapid trading into long-term capital gains taxed at a lower rate, he said.

An accompanying Bloomberg/ Businessweek story described testimony at a Senate hearing by the Renaissance co-Chief Executive Officer Peter F Brown,

Renaissance was founded by the mathematician James H. Simons, whose fortune is now estimated by Bloomberg Billionaires Index at about $15.5 billion.

Brown became co-CEO with Robert L. Mercer in 2010 after Simons retired and became non-executive chairman. Before joining the firm in 1993, he was a language-recognition specialist at International Business Machines Corp.

Mr Brown testified that the company was not so much trying to avoid taxes by the complex strategy but simply to make even more money.    But, per the New York Times, Senator Levin

focused on the lucrative nature of the transactions, most of which took place using Renaissance employees’ money. Between 1999 and 2010, the fund used basket options to produce profits of more than $30 billion, Mr. Levin said. Barclays and Deutsche Bank together made more than $1 billion in revenue.

Mr Brown's firm seems, unlike Citigroup, to have a record of financial success, and no one is accusing Mr Brown or his firm of being responsible for the global financial collapse.  However, Mr Brown is certainly a very rich Wall Street insider.  Also, as we noted in 2009, his firm clearly has had major involvement in health care investments.   And the current hearings emphasize concerns that his firm has been executing questionable tax avoidance strategies.

Mr Brown has one other very major tie to health care.  As  noted in 2009 on Health Care Renewal, but apparently only parenthetically by one recent news article, (again from Bloomberg, written before the Senate hearing),

Brown lives in Washington with his wife, Margaret Hamburg, the commissioner of the U.S. Food and Drug Administration. She was appointed by President Barack Obama in 2009.

In 2009, we noted that as a condition of Dr Hamburg's leadership of the US FDA, her husband, Mr Brown, would have to divest his shares of four Renaissance funds.  However, it is obvious that he remained at and became the co-CEO of Renaissance since. 

While the current leader of the FDA clearly has medical and health care experience, she is also steeped in the culture of finance and Wall Street.

Summary

Thus we have two recent stories of how top health care leadership positions in the US government are held by people with strong ties to the world of finance, but not always with any direct health care or public health experience.  Why was the wife of a hedge fund magnate the best person to run the FDA?  Why was a person not known in "health policy [or health care] circles" the best person to run the Department of Health and Human Services?  Why was a Robert Rubin protege from Citigroup the best person to be a Senior Counselor at DHHS?  Presumably there were many plausible candidates for these government positions.  Why was it not possible to find people to fill them who were not tied to Wall Street?  Why was it not possible to find people with profound understanding of and sympathy for the values of health care and public health to fill all of them?   

The leadership of health care and finance continue to merge.  This seems to be one broad explanation for why both fields continue to be notably dysfunctional.  While Wall Street has spread around plenty of money to influence public opinion and political leaders, many still remember how its foolish and greedy leadership nearly caused another great depression.  It is likely that the influence of Wall Street culture on the leadership of health care organizations, be they governmental, academic, other non-profit, or commercial, has fostered the continuing financialization of health care, with its focus on "shareholder value," that is, putting short-term revenue ahead of patients' and the public's health.

I strongly believe health care would be better served by leadership that puts patients' and the public's health first.  Occasionally people with such values may come from a finance or economics background.  However, in an era where many people continue to believe "greed is good," we at least ought to confirm that health care leaders really are about health care first, and money a distant second.

ADDENDUM (20 August, 2014) - This was re-posted on the Naked Capitalism blog.

Medicare Pays $220 Million a Year for Acthar Without Any Controlled Trials that Prove it Works - While We Have No Money to Develop Ebola Vaccines or Treatment?

Introduction - No Money for Ebola Vaccine Development

While a new Ebola epidemic continues in Africa, people in developed countries are getting worried. Even the 0.1%, who may have rarely worried about our dysfunctional health care system before, are getting nervous. For example, this week, the Donald seemed panic stricken that Ebola infected American health workers might be allowed to return to the US, no matter what the precautions.  As reported by Politico,

Donald Trump has a message for the Ebola patient coming to the United States for treatment: Stay out.

'Ebola patient will be brought to the U.S. in a few days — now I know for sure that our leaders are incompetent,' Trump tweeted Thursday night. “KEEP THEM OUT OF HERE!”

Yet, as we posted here, money was the major barrier to developing treatments of vaccines that could have helped contain the epidemic in Africa, but whose availability in the US could also have reassured the Donald.  Dr John Ashton, a top public health physician in the UK, wrote in the Independent,

 

We must also tackle the scandal of the unwillingness of the pharmaceutical industry to invest in research to produce treatments and vaccines, something they refuse to do because the numbers involved are, in their terms, so small and don't justify the investment. This is the moral bankruptcy of capitalism acting in the absence of an ethical and social framework.

 

It seems that in the US and UK, our market based health care system can only cannot develop treatments for dangerous diseases when the treatments will produce huge returns on investment.   The irony is that even people (like Mr Trump) who preached market triumphalism and limiting government, presumably from doing things like developing drugs, may now fear diseases for which the market alone provides no remedy.  

 

Meanwhile, while there was no money to develop vaccines and drugs for Ebola, a story about how much money we are spending on questionable remedies has reappeared.  

 

But a Huge Increase in Money for Acthar

This week, writing in ProPublica and the New York Times, Charles Ornstein noted the huge amounts being paid by the US government for a previously obscure drug,

An obscure injectable medication made from pigs' pituitary glands has surged up the list of drugs that cost Medicare the most money, taking a growing bite out of the program's resources.

Medicare's tab for the medication, H.P. Acthar Gel, jumped twentyfold from 2008 to 2012, reaching $141.5 million, according to Medicare prescribing data requested by ProPublica. The bill for 2013 is likely to be even higher, exceeding $220 million.

Over approximately the same time course, commercial US health care insurers and the Tricare program for military dependents noted a surge in the amounts they were paying for this drug too,

 At a recent conference hosted by Sanford C. Bernstein, Dr. Ed Pazella, Aetna's national medical director for pharmacy policy and strategy, explained the shift on Acthar.

Questcor's 'combination of aggressive marketing and aggressive price increases finally caused it to become a line item that a finance guy looked at and said: 'What the hell are we paying for this? Why? What is it?' And that's when we started looking at what's our policy around this stuff,' Pazella said.

You Heard it Here First - a Huge Price Increase for an Old Unproven Drug

This problem's development took quite some time.  As we first discussed in 2007, some clever  maneuvering by corporate executives around loopholes in government rules benefited the executives, but maybe no one else.

The clinical background is that Acthar is a form of a hormone (ACTH) that stimulates the adrenal gland to produce more cortisol and other related hormones.  The formulation is made from pig pituitaries, and was developed in the 1940s.  It was approved by the US Food and Drug Administration at a time when this action did nor require proof of efficacy, that is, proof that the drug worked.  For years, the drug was only used for a rare form of infantile seizures, and occasionally for symptoms of multiple sclerosis in adults.  As noted in several reviews by the Cochrane Collaboration, there is little good evidence that the drug works for either condition, and no evidence that it is better than simpler, cheaper alternatives, like synthetic alternatives to cortisol, for the latter. (See this blog post).

The drug languished for years, but Questcor purchased the rights to it in 2001, apparently for a mere $100,000 (look here).  In 2007, the company jacked its price up in 2007 from $1650 a vial to $23,000 a vial.

A Further Price Increase, and a Big Marketing Push


As Mr Ornstein noted, its price is now $32,000 a vial.  One might expect that this huge price would quickly generate competition from generic drug manufacturers,  but, per Mr Ornstein,

Although it long ago lost patent protection, the drug is a complex biologic agent, and the manufacturing process is a trade secret. 

Furthermore, infantile spasms may be rare, but, 

Since Acthar came on the market in 1952, the rules about F.D.A. approval have changed. At the time, drug companies simply had to demonstrate that a drug was safe, rather than that it was effective. Acthar was initially authorized as a treatment for more than 50 diseases and conditions. (The list has since been cut to 19.)

Drug companies are barred by federal rules from marketing drugs for "off-label" indications, however, given the above, it was not obviously illegal when Questcor

 began marketing it for a broad menu of uses.

In addition, Medicare could not easily challenge the huge price Questcor was charging for this unproven remedy given to adults

Medicare cannot bar access to medications like Acthar, even in the face of rising expense and questions about efficacy, Aaron Albright, a spokesman for the Centers for Medicare and Medicaid Services, said in a written statement. The law mandates that Medicare's drug program, known as Part D, cover drugs for the uses authorized by the Food and Drug Administration, he said.

Questions about Questcor's Marketing

In fact, while it appears legal to promote Acthar for uses for which it has no proven efficacy, there are some questions about Questcor's marketing practices,

The company has disclosed in filings with the Securities and Exchange Commission that two United States attorney's offices and the S.E.C. are investigating its promotional practices.

A possible reason why was supplied by a companion ProPublica article, also by Charles Ornstein,

 Many of Medicare's top prescribers of the expensive specialty drug H.P. Acthar Gel have financial ties to the drug's maker.

Only 18 practitioners wrote 15 or more prescriptions for the drug in 2012. At least nine — and all of the top four — were promotional speakers, researchers or consultants for Questcor Pharmaceuticals, a ProPublica analysis shows.

Also, there are questions about whether Questcor has been concealing adverse events related to the increasing use of Acthar.  Until recently, as noted by Gretchen Morgenson in the NY Times in July, 2014,

For years, Questcor Pharmaceuticals has highlighted the potential benefits of Acthar, its immune-system drug, while saying little about its ill effects.

But as had been noted also by Gretchen Morgenson in the NY Times in June, 2014, more information about adverse events began coming out, not mainly for the benefit of patients, but apparently due to questions by investors about a pending takeover of Questcor by Mallinckrodt,

Since 2012, the events, as reported to the Food and Drug Administration’s Adverse Event Reporting System, or Faers (pronounced 'fares'), have included 20 deaths and six disabilities among patients reported to have been using Acthar and in which Acthar was recorded as 'suspect,' or the drug most likely to have been associated with the event. From January 2000 through 2011, by contrast, 13 deaths involving Acthar were reported to the F.D.A.’s system.

Although Questcor has reported some of these events to the F.D.A., as required, the company has not discussed the adverse outcomes in its financial filings. A Supreme Court ruling in 2011 concluded that reports of adverse events among patients using a drug, even if few in number, are of interest to investors weighing whether to buy or sell shares in the manufacturer.

The July, 2014 article by Gretchen Morgenson in the NY Times noted further,

according to a regulatory filing made by Questcor early Thursday, the number of patients reporting a so-called adverse event while using the drug last year represented almost 5 percent of prescriptions dispensed. The total number of events in 2013 reported by patients, who can experience multiple ill effects, was almost 14 percent of prescriptions, up from 9.1 percent in 2011.

 It was the first time Questcor, which has received a $5.6 billion takeover bid from Mallinckrodt Pharmaceuticals, had disclosed any problems experienced by Acthar patients, even though such information is of keen interest to investors.

That information might also be of interest to patients and doctors. 

Questions about Questcor's Executive Compensation

While Questcor brought in huge amounts of money from an old unproven drug using aggressive marketing that did not dwell on the drug's adverse effects, its executives have been making lots of money, sometimes in questionable ways.  For example, in February, 2014, Jesse Eisinger also reported for ProPublica that the timing of Questcor CEO Don M Bailey's stock sales has seemed unusually fortuitous,

Questcor Pharmaceuticals is a biotechnology company with a $4 billion market capitalization. Good things keep happening to Questcor in the middle of the month. Here’s what’s notable: The middle of the month just happens to be the time that the company’s chief executive, Don M. Bailey, sells stock through his regular selling plan.

The question is whether the company timed its favorable press releases to coincide with the times its CEO was known to be selling his shares?

Also, in May, a blog on The Street noted that the CEO's daughter also appears to have been quite fortunate, for no obvious reason,

As reported this morning by my colleague Herb Greenberg in his "Reality Check" newsletter (subscription required), Kirsten Fereday, a Questcor employee who also happens to be Bailey's daughter, received a huge salary bump in  in 2013, according to the compensation portion of its yet-to-be-filed proxy two days ago in an amended 10-K.

According to the filing:

Kirsten Fereday, the daughter of Don M. Bailey, our Chief Executive Officer, was employed by us during 2013 as our Senior Director, Business Analytics and Evaluation, and received total cash and equity compensation for the year ended December 31, 2013 equal to approximately $1,035,246 in cash compensation and $200,000 in restricted stock grants (value based on intrinsic value method). Ms. Fereday's employment was approved in accordance with the Related Party Transaction Policy and our Chief Executive Officer is not involved in the determination of Ms. Fereday's compensation. [Emphasis added.]

Why did her pay go up so much compared to that received in the previous year?

Furthermore, while Questcor derives a tremendous amount of revenue from the US government, a deal is in the works for it to be acquired by Mallinckrodt, now based in Ireland, which, if successful, will make top Questcor executives even richer, as Gretchen Morgenson wrote in the NY Times in June, 2014,

If the acquisition by Mallinckrodt goes through, Questcor’s top six executives could receive severance packages totaling $63.5 million under the terms of their contracts, the merger proxy shows.

Also,

During the time that adverse events involving Acthar have risen, Questcor’s top executives have been actively selling shares. So far this year, securities filings show, sales by the top five executives at the company, four of them under prearranged selling plans set up last year, have generated gains of $39 million.

Summary

As Andrew Pollack wrote in the first NY Times coverage of how Questcor used an old unproven drug to generate huge returns,

How the price of this drug rose so far, so fast is a story for these troubled times in American health care — a tale of aggressive marketing, questionable medicine and, not least, out-of-control costs.

 The sorry case of Questcor and Acthar reveal how crazy the costs of health care in the US have become, driven now by a system that itself now seems crazy.  Through clever use of regulatory loopholes, the company acquired rights to an old drug whose efficacy was unproven, hugely increased its price, began aggressive marketing even though the drug's efficacy was completely unproven, while remaining largely silent about the drug's substantial risks.  Fueled by hundreds of millions of dollars in revenue thus generated, mainly from the US government, the company richly rewarded its top hired executives, who then have decided to sell it to a company outside of the US in a deal that will make these executives millions more.  So patients received a drug whose benefits are unknown, and whose risks may be much higher than they were told, at a cost of hundreds of millions of dollars, much of it borne by US taxpayers, while company executives got rich.


Just coupling for now the story of how we spent hundreds of millions on Acthar to enrich company executives with the story that we have no money to develop vaccines or treatments for Ebola virus (look here) demonstrates the massive failure of our experiment to turn our health care system over to market triumphalists and laissez faire mercantilists.  As long as we let the health care system be run by people who put their own enrichment ahead of patients' and the public's health, things will only get crazier.  And even the rich may not be immune from the results of that craziness

So to repeat, true health care reform would put in place leadership that understands the health care context, upholds health care professionals' values, and puts patients' and the public's health ahead of extraneous, particularly short-term financial concerns. We need health care governance that holds health care leaders accountable, and ensures their transparency, integrity and honesty.

But this sort of reform would challenge the interests of managers who are getting very rich off the current system.  So I am afraid the US may end up going far down this final common pathway before enough people manifest enough strength to make real changes.

Big Door Keep Revolving - Our Latest Roundup About the Blurred Lines Between the Health Care Industry and the Government Bodies that are Supposed to Regulate and Make Policy Affecting It

The revolving door continues to turn connecting US government bodies that make health policy or regulate health care and the health care industry.  Sometimes these transitions are obvious, sometimes they are obscure.  The press sometimes makes the revolving door the subject, but more often it is just an aside.

The latest roundup of transitions through the door includes, in chronological order of media attention...

Former White House Press Secretary to Consultancy Serving Health Care Corporations

As reported by the Washington Post in April, 2014, Robert Gibbs was White House Press Secretary until he departed for the private sector,

Since departing the White House in 2011, Gibbs has taken a path familiar to other former White House officials who use their ties to a president to enrich themselves and establish a new career. 

In particular, he

co-founded The Incite Agency, a consulting and media relations firm that advises Fortune 500 companies, including health-care firms.

The story was apparently generated after the Democratic House Minority Leader openly criticized someone who served in the Democratic President's White House, so the thrust of the story was about how Mr Gibbs has apparently changed his ideas on Obamacare since his White House days,

House Minority Leader Nancy Pelosi (D-Calif.) suggested Sunday that former top Obama aide Robert Gibbs's comment that the employer mandate portion of the Affordable Care Act won't survive might be related to Gibbs's business interests.

'I don't know who his clients are or what his perspective is,' Pelosi told CNN's 'State of the Union.' 'But we are celebrating the fact that we have over seven million who have signed up.'

The Post also noted,

The speech Gibbs gave this past week in Colorado is consistent with how the Harry Walker Agency bills Gibbs as a potential paid speaker. On its Web site, pitches Gibbs by noting that he 'played a major role in the daily White House policy debates over the shape of healthcare reform.' It suggests that during such speeches, Gibbs 'articulates the future for the Patient Protection and Affordable Care Act.'

The pitch concludes by stating that 'The future of Obamacare -- and how it will affect your business -- is yet to be seen, and few are better prepared than Gibbs to guide you through that conversation.'

Again, note that this article seemed to be inspired by Rep Pelosi's direct criticism of a fellow Democrat, not by the revolving door transition per se.  

President of Global Government and Scientific Affairs at Natural Products Association to Director of the Division of Dietary Supplements at the FDA then Back to Natural Products Association as CEO

This round trip through the door was noted rather obliquely in a New York Times article in late April, 2014, focused on how slowly the FDA has reacted to apparently dangerous "dietary supplements,"

Before joining the F.D.A. in 2011, Dr. [Daniel] Fabricant was a top executive at an industry trade group, the Natural Products Association.

The article had previously identified Dr Fabricant as

the director of the division of dietary supplement programs in the agency’s Center for Food Safety and Applied Nutrition.

But,

The F.D.A. recently announced that Dr. Fabricant is leaving the agency this month to return to the trade group as its chief executive.

While the NY Times article thus mentioned as an aside that a government official with major responsibility for regulating dietary supplements had these relationships with the dietary supplement industry, it did not question whether that relationship had anything to do with slow responses by the FDA to reports of toxic dietary supplements. 

Spokesman for the Speaker of the House of Representatives to Spokesman for America's Health Insurance Plans

USA Today briefly but directly noted this in mid-May, 2014,

House Speaker John Boehner’s spokesman, Brendan Buck, has spent a lot of time over the years helping his boss and congressional Republicans criticize President Obama’s health care law.

Now Buck is leaving Capitol Hill to be spokesman for America’s Health Insurance Plans, the trade association that represents thousands of health insurance companies.

'Brendan’s experience and skill set will allow him to hit the ground running on Day One,' said Karen Ignagni, president and CEO of AHIP. 'He’s an effective communicator who knows how to tackle complex policy issues and skillfully navigate an ever-changing health care and media environment.'

What made this interesting seems to be how it represented a change of tune on Mr Buck's part.  Note that many people believe that commercial health insurers will benefit from all the new policy holders that Obamacare sends them, so

As the health insurance  industry’s trade group, AHIP supports the law’s mandate that individuals obtain health insurance. The trade group has praised the Affordable Care Act’s ability to expand insurance coverage.

But never mind that the man in the government for whom Mr Buck previously worked,

Boehner likes to call Obamacare a 'train wreck.'

FDA Director of the Office of Medical Policy for the Center for Drug Evaluation and Research to Greenleaf Health Consultancy

This so far has appeared only in a mid-May, 2014,  press release.   It describe Dr Sherman's career at the FDA,

During her FDA tenure, Sherman was a driving force for innovation, new programs and policy. Sherman was responsible for spearheading and implementing the Sentinel Initiative, the Critical Path Initiative, biosimilars policy and the new Breakthrough Therapy Designation.

As Director of CDER’s Office of Medical Policy and Associate Center Director for Medical Policy Sherman was responsible for developing, coordinating, and implementing medical policy programs and strategic initiatives as well as establishing and chairing CDER's Medical Policy Counsel [sic]. This included overseeing the regulation of prescription drug promotion and advertising.

Sherman began her career with FDA in the Division of Antiviral Drug Products at CDER in 1989—first as a medical reviewer and then as a clinical team leader. In 1998, she was appointed Deputy Office Director for the Office of Drug Evaluation I. In 1999, she assumed the duties of Deputy Office Director for the newly established Office of Medical Policy in CDER. 

But now she will be "Principal, Drug and Biological Drug Products" for Greenleaf, described as,

Greenleaf Health is a full service regulatory consulting firm that provides strategic guidance to companies regulated by the FDA and those developing innovative solutions to pressing public health challenges around the globe

Note that Greenleaf was already well populated with FDA officials who had previously transited the big revolving door,

Patrick Ronan, former FDA Chief of Staff and currently president of Greenleaf; Dr. Daniel Schultz, former Director of the Center for Devices ('CDRH') and Radiological Health and currently Greenleaf's Principal for Medical Devices and Combination Products; Michael Chappell, former Associate Commissioner for Regulatory Affairs, and currently Greenleaf's Principal for Regulatory Compliance; Heather Rosecrans, former Director of CDRH's 510(k) staff and currently Senior Vice President for Medical Devices and Combination Products; Linda Carter, formerly Associate Director of CDER's Office of Evaluation I and currently Vice President of Drug and Biological Drugs; and Taryn Fritz Walpole, former FDA Deputy Chief of Staff, and currently Chief Operating Officer and Senior Vice President for Regulatory Affairs

So maybe it has become so routine for middle and upper level FDA managers to go to work for consultancies that help industry to deal with the FDA that no journalist found this revolving door transition interesting.

Summary

Again, there appears to be constant traffic among health care corporations and the government bodies that regulate them and make policy that affects them.  The traffic may be so heavy and routine that it no longer appears to be news, unless accompanied by an ironic detail or two.

However, as we have said many times before, the constant interchange of health care insiders among government, large health care corporations, and the consultancies, marketing, public relations, lobbying and legal firms which represent them certainly suggests that health care, like many other sectors, seems to be run by an amorphous group of insiders who owe allegiance neither to government nor industry.

However, those who work in government are supposed to be working for the people, and those who work on health care within government are supposed to be working for patients' and the public health.  If they are constantly looking over their shoulders at potential private employers who might offer big checks, who indeed are they working for?

Attempts to turn government toward private gain and away from being of the people, by the people, and for the people have no doubt been going on since the beginning of government (and since the Constitution was signed, in the case of the US).  However, true health care reform  would require curtailing the severe sorts of conflicts of interest created by the revolving door.

Real heath care reform would require multi-year cooling off periods before someone who worked in the commercial world can get a job in a government whose work has direct effect on his or her previous employer or industry sector, and before someone who worked in government whose work had direct effect on a particular economic sector can accept a job for a company in that sector.   

EHR Story for Mother's Day 2014: Even The Formerly Simple Act Of Giving IV Fluids in ICU's Can Kill Babies. But's Let's Be Objective and Happy!

[Note to the humorless:  this post is satirical and sardonic to make a very serious point about the perversity of downplaying/ignoring health IT risks, issues too often ignored by those who know better.  If you don't like satire, don't read it.]

I've been critiqued for posting in too gloomy a manner for some's taste, even those who like me are in the Medical Informatics field.  For example, in the Feb. 2013 Kaiser Health News article "Health Technology’s ‘Essential Critic’ Warns Of Medical Mistakes" at http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx:

... Many say he comes on too strong. Even admirers cringed when he began blogging about the 2011 death of his mother, which he blames in a lawsuit on a computer error that allegedly caused Abington Memorial Hospital to overlook a key medication. (Both he and the hospital said they couldn’t comment on a pending suit.) Personalizing his campaign, some thought, made him seem less objective.

Of course, if a close relative of these unnamed "many" were killed by, say, a drunk driver (something this unobjective group of mothers takes seriously:  http://www.madd.org/), or if their child were abducted and decapitated (http://en.wikipedia.org/wiki/Murder_of_Adam_Walsh), or if something like this event (https://www.youtube.com/watch?v=55XJivhjB4U) happened, their response would surely be "oh well, stuff happens, let's all be 'objective', not 'personalize' things, not advocate with our personal stories, and above all, be happy!   

 

I really do admire the unnamed "many" for their ability to detach, so am presenting the following story of "anecdotal" patient harm to a child in a pediatric ICU in the spirit of happiness, joy, and Mother's Day love!

Here's the event we should all be happy about, reported via FDA - I note the FDA's said these devices are not "sufficiently risky" to warrant a high level of their attention even though they secretly admitted in an internal memo that there's no way to really know te true level of risk and harm (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html), so clearly they're all a really jolly bunch:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?id=117690

FDA MedSun report

Type of device: medical device data system
Device brand name: PowerChart
Device manufacturer's name: Cerner Corporation
Date of this report: (mm/dd/yyyy) 03/04/2014

Describe the event or problem:    

Medication Error. This event was related to Health Information Technology. Specifically, the manner in which the system processed an order for free water replacement. Order was intended to be 20ml/hr for 6 hours for a total of 120ml. It was a 1000 ml bag so first they put 20ml/hr which would have defaulted the infuse over time to 50 hrs. They tried to change the infuse over to 6 hours which then changes the ml/hr rate to 167 ml/hr. They did not notice this had changed. 

Well, that's WONDERFUL!!  :-)  that the computer recalculates the flow rate for them when they change the infusion time, by paternalistically assuming that's what they wanted to do - change the RATE of infusion - when what they actually did is manually change the TIME (duration) of infusion. 

How LOVELY of some programmer to have given them this FANTASTIC convenience!!

Aren't computers wonderful!!!

Even the following should not be cause for ardent technophiles to wipe the smile from their downside-ignoring faces!!

... They did not realize that they needed to go into details tab to show the time frame so the patient got 167ml/hr instead of 20ml/hr for 6 hours. 

How obvious!!!  Every doctor, nurse, medical student and janitor knows from time immemorial knows you have to go into the detail tab to show the time frame!  (Smile)

... Order was verified by pharmacy and administered at that rate via peripheral IV. After approximately 1L of fluid had infused, patient showed seizure activity.  PICU (pediatric ICU) team called to bedside. Treatment provided for seizures and critical sodium and potassium. 

Awww ...  some seizures and critical sodium and potassium levels in the PICU.  Awww.....too bad!!!  We should be happy anyway!  For if this child died...the sacrifice would have been WORTH IT for the betterment of electronic medical records worldwide, and the parents no doubt would be flattered and joyous about their contribution to computing science.  After all, how better to figure out how to make this technology work??

After all, it takes a few broken eggs to make an omelette, and a few bumps in the road (like grave mounds) should be of little concern.

Because, remember ... w.e. c.a.r.e!

i c.a.r.e!!!!  As at U. Arizona Healthcare System, let's only use Happy Words with our patients about these systems! (click to enlarge, see http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html )

Further, we should use only Words That Work to describe the wonders of these systems in their current state!!!

Some flowers from Cerner CEO Patterson to momma to make up for her little baby having seizures and critically deranged potassium and sodium levels from those big, bad doctors' EHR mistake!

... The Cerner powerchart software system has functionality for continuous medications/fluid ordering that does not prevent "user error." 

Ut oh ... Looks like I'm going to have to be a sourpuss for just a moment and re-introduce the nasty, ill-tempered, non-objective idea of what the dastardly National Institute of Technology and Standards (NIST) calls "use error" (as opposed to "user error", A.K.A. "Blame the User",  http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html):

... The EUP (EHR usability protocol) emphasis should be on ensuring that necessary and sufficient usability validation and remediation has been conducted so that use error [3] is minimized.

[3] “Use error” is a term used very specifically to refer to user interface designs that will engender users to make errors of commission or omission. It is true that users do make errors, but many errors are due not to user error per se but due to designs that are flawed, e.g., poorly written messaging [or lack of messaging, e.g., no warnings of potentially dangerous actions - ed.], misuse of color-coding conventions [see below], omission of information, etc.

Awwwwww....aren't I just mean and non-objective?

That mean doctor Silverstein's just not happy and objective!!  Bad, bad, bad man!

... When the provider orders the fluid, example is D5W, the screen opens to a "continuous details" ordering window. Within the screen, the ordering provider is presented with a preselected bag volume and type of fluid with a brownish background. They have the ability to modify bag volume but it was made this color to discourage that change by Cerner. 

Golly gee!  There's something to be happy about once again!  Brown, the universally-understood color, in any language, means "Warning, do not change this value, it could kill someone!!!" See how GOOD this technology really is!!!  Why use alerts and confirmation dialogs when a mere COLOR like brown suffices!!

... The rate and "infuse over" fields are a yellow color to show that they need to be completed. The intent [of the programmer, clearly an expert in human-computer interaction and communication by color and smoke signals - ed.] is for an ongoing continuous fluid and not to limit the time. 

Golly Gee Times Two!  Yellow, the absolutely universal color for "Warning, you need to complete this to prevent killing someone!"  

Yellow!  Don't you just think every time you see this color that "warning, you need to complete data entry to avoid killing someone?  Who needs WORDS?

It's all so CLEAR!!!!

... Providers can misinterpret this field to mean the length of time they want the order to infuse over, when the system intent for that field is to be the system-calculated length of time until the next bag supply will need to be sent to maintain the continuous infusion. 

See how simple!!!!   Isn't it OBVIOUS!!!!

The completed fields turn white. Cerner does not have an intermittent fluid administration order [who the hell needs that, says Cerner and the hospital executives who bought this package for the PICU!! Never a need for that in ICU's!! - ed] so providers are expected to go to a second tab, the "details" tab, where they have the options for identifying the duration of the infusion in terms of # doses or time. If the provider does not have awareness of this intent and modifies the "infuse over" field from the "continuous details" tab, they may inadvertently order a higher rate than intended.

Ha ha!  Those silly doctors can't even figure out a simple thing like that!!  What stooges they are!!

NYUK NYUK NYUK ... Hey Moe!!  Those silly doctors and nurses cannot understand the simple fact that Cerner does not have an intermittent fluid administration order so providers are expected to go to a second tab, the "details" tab, where they have the options for identifying the duration of the infusion in terms of # doses or time. If the provider does not have awareness of this intent and modifies the "infuse over" field from the "continuous details" tab, they may inadvertently order a higher rate than intended. 

See how much FUN health IT problems can be?  After all, in this ANECDOTAL case, all that happened was:

The device(s) may have caused or contributed to: Potential for patient harm, Serious Injury

But nobody died of this particular problem (that we know of), so this technology is SAFE!!!!

Happy mother's day!!!

--------------------

Additional not-so-funny thought:  depending on brown, yellow etc. instead of clear, written alerts/warnings, plus the fact that the system likely "knew" the weight of the child and should have alerted that the infusion of a liter was a very dangerous thing, reflect Bad Health IT on its face:

Bad Health IT ("BHIT") is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.  

Had I been a pre-marketing tester of this system working for FDA, those fluid-ordering characteristics would have been changed before the system would have been released to market.

Oh, wait ... there is no premarketing testing process for health IT, and FDA, via advice from the FDASIA committees as in the linked FDA-related post above, writes that none is really needed.

And who wants to damage TRUE INNOVATIONS like this - turning something that takes 5 seconds for a clinician to write, "D5W, 20 ml/hr x 6 hrs" (meaning dextrose 5% in water, 20 milliliters per hour for 6 hours) into a cryptic and muddled exercise with tabs, colors and numerous caveats - via regulation?

-- SS

Hypocrisy at the FDA: Let's regulate E-cigarettes ... E-medical records, E-medical ordering and related Bad Health IT? They get a gentleman's pass.

Bad health IT is defined at my Medical Informatics academic site (http://cci.drexel.edu/faculty/ssilverstein/cases/) as follows:

Bad Health IT ("BHIT") is health IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.

Health IT is unregulated, and Bad Health IT results in patient injuries and deaths.   This is unarguable from the data cited in this post and related posts I've linked to.  The levels of harm are unknown.

At my April 9, 2014 post "FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html) I observed how the FDA bent over backwards to avoid regulating Electronic Medical Records systems and other healthcare IT systems:

To recap that post:

Out of one side of their mouth FDA wrote this:

... products with health management heath IT functions, includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software.

Products with health management health IT functions are of sufficiently low risk and thus, [even] if they meet the statutory definition of a medical device, FDA does not intend to focus its oversight on them.

While out of the side of their mouth that was not intended for public viewing, discovered by investigative reporter Fred Schulte, they wrote this:

...In summary, the results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs [device reports] and impedes a more comprehensive understanding of the actual problems and implications.
 

FDA is thus claiming "we know what we non-publicly concluded it is not possible to know, and Health IT is not worth regulating ... even in face of dangers we do know" (e.g., see the alarming ECRI Institute data at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html).

Note that everyone who needs medical care (which is. essentially, everyone) is increasingly exposed to these electronic products with health management heath IT functions, against their will and without any informed consent processes.  The only people exposed to E-cigarettes are those who willingly buy and consume them.

With E-cigarettes, however: 

CBS/AP  April 24, 2014 
FDA: Ban sales of electronic cigarettes to minors 

http://www.cbsnews.com/news/fda-ban-sales-of-electronic-cigarettes-to-minors/

WASHINGTON -- The federal government wants to ban sales of electronic cigarettes to minors and require health warning labels and approval for new products under regulations being proposed by the Food and Drug Administration.

Wonderful.  How thoughtful.  (E-cigarettes are plastic or metal tubes, usually the size of a cigarette, that heat a liquid nicotine solution instead of burning tobacco. That creates vapor that users inhale.)

While the proposal being issued Thursday won't immediately mean changes for the popular devices, the move is aimed at eventually taming the fast-growing e-cigarette industry.

The agency said the proposal sets a foundation for regulating the products but the rules don't immediately ban the wide array of flavors of e-cigarettes, curb marketing in places like TV or set product standards.

Any further rules "will have to be grounded in our growing body of knowledge and understanding about the use of e-cigarettes and their potential health risks or public health benefits," Commissioner Dr. Margaret Hamburg said.

(Perhaps the E-cigarette industry hasn't figured out who to pay off yet?)

... "By being able to regulate e-cigarettes, we'll get a lot more information about what's in them, how they're made and we're already studying e-cigarettes in terms of how they're being used and what are their implications for health," Hamburg told CBS News.

"At the present time, when we can't regulate cigarettes, it's like they wild, wild West" she said. "Companies can do anything they want. They can market in ways that they want. ... Unless they make a therapeutic claim that it is a product for actual cessation of nicotine use, we can't regulate them. If they make a therapeutic claim, we can regulate them as a medical product."

The "Wild, wild west" is a perfect descriptor of the health IT market.  And claims of benefits?  How about some 'Words that Work?'  (http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html)

Hamburg stressed to CBS News that, "Until we have the authority to regulate e-cigarettes, we cannot provide the information that the American public wants about the relative risk and safety of these products. ... We cannot put in place certain restrictions that might be appropriate with respect to how the products are made, the kind of flavorings, the kind of marketing, etc. So we see this as really a crucial first step."

The health IT industry has special accommodations in that regard that the E-cigarette company lawyers need to closely examine.

Smokers like e-cigarettes because the nicotine-infused vapor looks like smoke but doesn't contain the thousands of chemicals, tar or odor of regular cigarettes. Some smokers use e-cigarettes as a way to quit smoking tobacco, or to cut down. However, there's not much scientific evidence showing e-cigarettes help smokers quit or smoke less, and it's unclear how safe they are.

It's undeniably unclear how safe clinical IT devices are, either.  The ECRI Institute, for instance, found 171 mishaps in 9 weeks at 36 hospitals voluntarily reported, leaving 8 patients harmed and possibly three of them dead.   (A likely far more than serous problem than GM cars with defective ignitions that killed ~13 in a decade...)   The FDA found many injuries and several deaths in their own self-admitted limited dataset as well.  (See FDA Internal Memo on HIT risk at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html).

... Companies also will be required to submit applications for premarket review within two years. As long as an e-cigarette maker has submitted the application, the FDA said it will allow the products to stay on the market while they are being reviewed. That would mean companies would have to submit an application for all e-cigarettes now being sold.

There is no premarket review of clinical IT of the types categorized by FDA as "with health management heath IT functions" as above, even if those devices meet the statutory requirements as a medical device that falls under the Food, Drug & Cosmetic Act.  These systems increasingly mediate and regulate every transaction of healthcare.

E-cigarettes, however, are a major concern that are being reviewed in earnest?

Unbelievable.

-- SS

DISCLAIMER:  I neither use tobacco products in any form nor E-cigarettes, never did, and have no conflicts of interest of any kind with either the tobacco or E-cigarette industries.

Healthcare IT Amateur Kathleen Sebelius Resigns - Good Riddance

The Secretary of the U.S. Department of Health and Human Services (HHS) is resigning.

Press reports say she is resigning in large part due to the Exchange Website debacle.   This from the New York Times:

Health Secretary Resigns After Woes of HealthCare.gov
http://www.nytimes.com/2014/04/11/us/politics/sebelius-resigning-as-health-secretary.html?_r=0

... Officials said Ms. Sebelius, 65, made the decision to resign and was not forced out [Yeah, right - SS]. But the frustration at the White House over her performance had become increasingly clear, as administration aides worried that the crippling problems at HealthCare.gov, the website set up to enroll Americans in insurance exchanges, would result in lasting damage to the president’s legacy.

It's not as if there's no literature out there on how to create good health IT.  Doing so is not a state secret.  Simple (and free, unlike the hundreds of millions spent on incompetent beltway-bandit 'consultants') Google searches on the term "healthcare IT failure" or similar return ample resources that could have prevented the "lasting damage to the president's legacy."

Way to go, Ms. Ex-Secretary.  Another health IT amateur bites the dust, as my early computer mentor, Philadelphia's George Washington High School math instructor Fred Holzwarth (http://www.historicbuckscounty.org/nths/HISTORIA/PDF/Historia_Nov2005.pdf) would have said.

However, even worse ... far worse ...

Under this Secretary of the Department of Health and Human Services, the principal watchdog agency over medicine and medical device safety under her aegis, the FDA, found that:

... products with health management heath IT functions, includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software.

Products with health management health IT functions are of sufficiently low risk and thus, if they meet the statutory definition of a medical device, FDA does not intend to focus its oversight on them.

Thus, patients are condemned to injury and death, probably at ECRI Deep Dive study levels [1], for the foreseeable future (see my post on that FDA decision at my April 9, 2014 post "FDA on health IT risk: reckless, or another GM-like political coverup?" at http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html).

This is especially outrageous at the time massive investigations are ongoing about the 13 deaths caused by apparent coverups of a faulty General Motors ignition switch.

It was your FDA agency, Ms. Ex-Secretary.  You own that decision.

Good Riddance, indeed.  

The person at this link: http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html would certainly agree, if she were alive; she is not thanks to the very devices your FDA just perversely found to be of "sufficiently low risk."

-- SS

Note:

[1]  In 9 weeks in 36 PSO-member hospitals, 171 IT mishaps sufficient to cause harm were voluntarily reported; 8 injuries occurred, some severe, and 3 deaths may have been the result.  See http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html.

FDA on health IT risk: reckless, or another GM-like political coverup? "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it."

In my Sept. 16, 2013 post "An Open Letter to David Bates, MD, Chair, ONC FDASIA Health IT Policy Committee on Recommendations Against Premarket Testing and Validation of Health IT" (http://hcrenewal.blogspot.com/2013/09/an-open-letter-to-david-bates-md-chair.html) I wrote:

David Bates, Chair, ONC FDASIA Health IT Policy Committee
via email
   
Dear David, I am disappointed (and in fact appalled) at the ONC FDASIA Health IT Policy Committee's recommendations that health IT including typical commercial EHR/CPOE systems not be subjected to a premarket testing and validation process.  I believe this recommendation is, quite frankly, negligent.

The resultant April 2014 report is out: "FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework."  It is available at http://www.healthit.gov/sites/default/files/fdasiahealthitreport_final.pdf.

The report is an academic idealist's and industry's dream.  It is a patient's nightmare.

Instead of regulation, the report recommends the creation of a nebulous "Health IT Safety Center" (pgs. 16 and 25) as a "public-private entity with broad stakeholder engagement, that includes a governance structure for the creation of a sustainable, integrated health IT learning system that avoids regulatory duplication and leverages and complements existing and ongoing efforts."  In other words, a toothless organization without true regulatory authority.

The recommendations of the Health IT Policy Committee have apparently been taken seriously by FDA. 

This FDA announcement recently appeared (FDA is part of HHS):

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm390988.htm

HHS News Release
For Immediate Release: April 3, 2014

Proposed health IT strategy aims to promote innovation, protect patients, and avoid regulatory duplication

HHS today released a draft report that includes a proposed strategy and recommendations for a health information technology (health IT) framework, which promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication. The congressionally mandated report was developed in consultation with health IT experts and consumer representatives and proposes to clarify oversight of health IT products based on a product’s function and the potential risk to patients who use it.

... As proposed in the draft report, posted on the ONC, FDA and FCC websites, there would be three health IT categories, based on function and level of risk, that focus on what the product does, not on the platform on which it operates (mobile medical device, PC, or cloud-based, for example).

The first category, products with administrative health IT functions, poses little or no risk to patient safety and as such requires no additional oversight. They include software for billing and claims processing, scheduling, and practice and inventory management.

The second category, products with health management heath IT functions, includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software.

Products with health management health IT functions are of sufficiently low risk and thus, if they meet the statutory definition of a medical device, FDA does not intend to focus its oversight on them. Instead, the draft report proposes relying primarily on ONC-coordinated activities and private sector capabilities that highlight quality management principles, industry standards and best practices.

The characterization of these admitted medical devices as "sufficiently low risk" is in my opinion grossly negligent (if not criminal).

For instance, GM concealed an ignition flaw that resulted in 13 deaths.  Look what's happening now in that sector.  Revelations of corporate wrongdoing and Congressional investigations:

http://www.nytimes.com/2014/03/31/business/us-regulators-declined-full-inquiry-into-gm-ignition-flaws-memo-shows.html

U.S. Agency Knew About G.M. Flaw but Did Not Act
By MATTHEW L. WALD
MARCH 30, 2014

Federal regulators decided not to open an inquiry on the ignitions of Chevrolet Cobalts and other cars even after their own investigators reported in 2007 that they knew of four fatal crashes, 29 complaints and 14 other reports that showed the problem disabled air bags, according to a memo released by a House subcommittee on Sunday.

Then in 2010, the safety agency came to the same decision after receiving more reports that air bags were not deploying.

The memo also revealed that General Motors approved the faulty design of the switch in 2002 even though the company that made the part, Delphi, warned the automaker that the switch did not meet specifications. This followed a warning the year before — when the Saturn Ion was being developed — but G.M. said that “a design change had solved the problem,” according to the memo.
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The striking new details in the memo bolster the contention that both G.M. and the National Highway Traffic Safety Administration, more than previously acknowledged, ignored or dismissed warnings for more than a decade about a faulty ignition switch that, if bumped, could turn off, shutting the engine and disabling the air bags. General Motors has recalled nearly 2.6 million cars and has linked 13 deaths to the defect.

13 deaths, and we get this:

A House subcommittee, which gathered more than 200,000 pages of documents from G.M. and 6,000 pages from the agency, will hold a hearing on Tuesday. Mary T. Barra, General Motors’ chief executive, and David Friedman, the acting administrator of the safety agency, are scheduled to testify. Both are also scheduled to testify before a Senate panel on Wednesday.

“The problems persisted over a decade, the red flags were many, and yet those responsible failed to connect the dots,” Fred Upton, a Republican of Michigan and the chairman of the House Energy and Commerce Committee, said in a statement.

The most damaging finding in the memo concerned the four fatal crashes that went unheeded by regulators.

In a presentation dated Nov. 17, 2007, the safety agency’s investigators reported to its Office of Defects Investigation on the fatal crashes, as well as broad range of complaints and other reports about cars shutting off.

“The panel did not identify any discernible trend and decided not to pursue a more formal investigation,” the House memo said. The findings reinforce an analysis by The New York Times published March 8 that found the agency had received more than 260 complaints about Cobalts, Ions and other cars in the recall, citing potentially dangerous shutdowns.

While GM is being grilled and raked over the coals, the health IT industry is likely going to get the healthcare industry's most generous and unprecedented special regulatory accommodation by FDA due to its products being deemed of "sufficiently low risk" (?) not to merit attention.

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The FDA statement is particularly reckless, perhaps criminally so, given the following ten points.

I add that the following are just highlights off the top of my head, and non-inclusive of all known facts on health IT risk:

(1)  FDA's own 2010 "Internal Memo on HIT Risk", "not intended for public use" but exposed by Center for Public Integrity investigative reporter Fred Schulte (http://www.publicintegrity.org/authors/fred-schulte) when he was with the Huffington Post Investigative Fund (as described at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html), stated:
 

...In summary, the results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs [device reports] and impedes a more comprehensive understanding of the actual problems and implications.

They then go on to categorize the known risk factors and the impediments to knowing about their occurrence: 

Limitations of the MAUDE search and final subset of MDRs include the following: 

1. Not all H-IT safety issue MDRs can be captured due to limitations of reporting practices including
...(a) Vast number of H-IT systems that interface with multiple medical devices currently assigned to multiple procodes making it difficult to identify specific procodes for H-IT safety issues;
...(b) Procode assignments are also affected by the ability of the reporter/contractor to correctly identify the event as a H-IT safety issue;
...(c) Correct identification by the reporter of the suspect device brand name is challenged by difficulties discerning the actual H-IT system versus the device it supports.
2. Due to incomplete information in the MDRs, it is difficult to unduplicate similar reports, potentially resulting in a higher number of reports than actual events.
3. Reported death and injury events may only be associated with the reported device but not necessarily attributed to the device.
4 Correct identification by the reporter of the manufacturer name is convoluted by the inability to discern the manufacturer of the actual H-IT system versus the device it supports.
5 The volume of MDR reporting to MAUDE may be impacted by a lack of understanding the reportability of H-IT safety issues and enforcement of such reporting.

In other words, FDA does not know the level of risk due to systematic impediments to information diffusion.

Internal FDA Memo ("not intended for public use") on potential dangers of health IT.  Download the full PDF by clicking here.

I think it axiomatic to state that it is, at best, seriously misleading to now state a technology is of "low risk" while internally having admitted that the risk level is not known due to impediments to that knowledge.  That situation has not changed since this memo's internal FDA dissemination, and its disclosure by Schulte.

This is inexplicable on its face on scientific grounds.

Further, another HHS agency, the Agency for Healthcare Research and Quality (AHRQ, http://www.ahrq.gov/) has also taxonomized in detail a rich tapestry of "how health IT can cause harm."  See "AHRQ Health IT Hazards Manager Report" at http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf and its contained list of harms on pg. 29, reproduced below.

AHRQ has no regulatory authority.  These failure modes are expensive to deal with, thus many will likely only be dealt with by the industry (if at all) after patient harms or near-misses.  Patients, however, are not experimental subjects for the debugging and "improvement" of experimental IT systems.

AHRQ Health IT Hazard Manager Report - Hazard Modes of Health IT (click to enlarge)

Surely FDASIA is aware of this.

(2)  FDA CDRH Director Jeff Shuren MD, JD's own statement that the known risks are "the tip of an iceberg" at the HIT Policy Committee, Adoption/Certification Workgroup on February 25, 2010, where the topic was "HIT safety" (The text is available at this link):

...... In the past two years, we [FDA] have received 260 reports of HIT-related malfunctions with the potential for patient harm – including 44 reported injuries and 6 reported deaths. Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist.

Considering the admitted impediments to information diffusion, it's likely even at this point that FDA knew the number of injuries and deaths was far larger than GM's mere 13 ignition defect-related deaths.

(3)   FDA's MAUDE (Manufacturer and User Facility Device Experience) database is a voluntary medical device defects reporting system, but is not specifically purposed for health IT and is almost unknown to typical health IT users as a resource for reporting flaws. 

MAUDE reports show health IT devices are literally festooned with an incredible number of flaws, as if they come from dirt-floor-covered software sweatshops with little oversight.

These are defects that have made it into live hospital and caregiver devices, and have led to reported harms and death (see http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html).

The voluntary nature of this MAUDE reporting by just a few HIT sellers, and lack of knowledge of it by health IT users as a resource, cannot fail to lead to the conclusion that the problems are far worse than this limited dataset indicates.

(4)  The prestigious U.S. Institute of Medicine of the National Academies (http://www.iom.edu/), perhaps the top scientific authority in this country, also admitted the risk levels of health IT were unknown due to systematic impediments to knowing.  IOM noted this in their late 2011 study on EHR safety:

... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk.

Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks.

The IOM did note, contrary to FDA's current finding that these systems are of "sufficiently low risk", that:

These barriers to generating evidence pose unacceptable risks to safety.[IOM (Institute of Medicine). 2012. Health IT and Patient Safety: Building Safer Systems for Better Care (PDF). Washington, DC: The National Academies Press, pg. S-2.]

Also in the IOM report:

… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect.

More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”

IOM could not have stated the reality more explicitly than via their statement "the magnitude of the risk associated with health IT is not known."

(5)   Surely FDA (and the FDASIA committees responsible for the new Report) are aware of  the ECRI Institute's Deep Dive study results from a study they carried out within their PSO-member hospitals (http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html).  I would call 171 voluntarily-reported health IT-related mishaps in 36 hospitals over 9 weeks, with 8 injuries and 3 possible deaths, an alarming study.

In fact, in 2014 based on their PSO data, the ECRI Institute identified health IT as #1 of the "Top Ten Technology Risks in Healthcare" (http://hcrenewal.blogspot.com/2014/04/in-ecri-institutes-new-2014-top-10.html):

CONCERN #1: Data integrity failures with health information technology systems 

With the federal government offering financial incentives for hospitals and physician practices to adopt EHR systems, use of these systems more than tripled from 2009 through 2012. “Health IT systems are very complex,” says James P. Keller, M.S., vice president, technology evaluation and safety, ECRI Institute. “They are managing a lot of information, and it’s easy to get something wrong” if the systems are not designed and implemented well. While appropriately designed and implemented systems can provide complete, current, and accurate patient care information so that the clinician can make appropriate treatment decisions, the presence of incorrect data can lead to incorrect treatment, potentially leading to patient harm.

Karen Zimmer, MD, medical director of the ECRI Institute, says the reports of so many types of errors and harm got the staff's attention in part because the program captured so many serious errors within just a nine-week project last spring.  The volume of errors in the voluntary reports was she says:

"an awareness raiser.  If we're seeing this much under a voluntary reporting program, we know this is just the tip of the iceberg; we know these events are very much underreported" (http://www.healthleadersmedia.com/print/TEC-290834/HIT-Errors-Tip-of-the-Iceberg-Says-ECRI).

I certainly would NOT aver that this technology's risk level is of "sufficiently low risk" to not warrant formal regulation by a body skilled in software regulation, as is FDA., e.g., for medical devices and for IT used in pharmaceutical clinical trials data management and drug manufacturing.

See for example "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" at http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm.

(I would really not enjoy being in a position to have to make such an averment about "sufficiently low risk" under GM ignition investigation-like conditions... )

(6)  Surely FDA (and the FDASIA committees responsible for the new Report) are aware of the data reported by the medical malpractice insurer CRICO, that insures the Harvard medical community (see http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html):

... CRICO recently analyzed a year’s worth of medical malpractice claims in its comparative database [from numerous sources] and found 147 cases in which EHRs were a contributing factor. Computer systems that don’t “talk” to each other, test results that aren’t routed properly, and mistakes caused by faulty data entry or copying and pasting were among the EHR-related problems found in the claims, which represented $61 million in direct payments and legal expenses.  ... Half of the 147 cases resulted in severe injury.  [Death numbers are unstated - ed.]

Note that these numbers were an examination of lawsuits filed; most medical malpractice never gets to the point of an actual filed lawsuit due to the unfavorable economics of the medical malpractice industry.  Perhaps 5% of actual events ever get filed, thus CRICO's data is also a "tip of an iceberg."

(7)  Surely FDA (and the FDASIA committees responsible for the new Report) are aware of mass risk introduced by faulty systems such as in the incident in Rhode Island, at Lifespan Healthcare (http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html), where thousands of prescriptions were altered by faulty HIT without physician knowledge.  Suffixes for the long acting version of a drug (e.g., "XL" or "XR") were dropped:

PROVIDENCE, R.I. (WPRI) - Rhode Island State Senator Jamie Doyle says he is shocked to hear a Lifespan computer glitch caused thousands of patients to receive the wrong types of medication. [Appx. 2,000 across five Lifespan hospitals according to the Providence Journal, see below, and the WaPo - ed.]

Doyle is now calling for an independent review of all the hospitals Lifespan runs, and a review of the Rhode Island Department of Health.

The DOH is investigating after learning patients who were supposed to receive medications taken once a day instead received medications meant to be taken more than once per day.  [In other words, they were taking short acting drugs on a long-acting once a day schedule, thus being massively under-dosed - ed.]

(8)  The FDA (and the FDASIA committees responsible for the new Report) surely cannot be unaware of all of the "glitches" reported on in-situ health IT systems, as cataloged at this blog under the tag "glitch" and as of this writing numbering 25 posts, some including patient deaths.  See the results of the query link: http://hcrenewal.blogspot.com/search/label/glitch.

(9) Surely FDA (and the FDASIA committees responsible for the new Report) cannot be unaware that FDA itself had to recall health IT with flaws "serious enough to cause patient death":

FDA recall.  McKesson Anesthesia Care – Patient Case Data May Not Match Patient Data:  Use of this affected product may cause serious adverse health consequences, including death. 
http://hcrenewal.blogspot.com/2014/03/ehr-recall-use-of-this-affected-product.html

FDA Recalls Draeger Health IT Device Because "This Product May Cause Serious Adverse Health Consequences, Including Death"
http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html

FDA Recall: Philips Xcelera Connect - Incomplete Information Arriving From Other Systems
http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html

FDA recall:  An ED EHR "Glitch" That Mangles Prescriptions
http://hcrenewal.blogspot.com/2013/08/a-good-way-to-cynernetically-harm-or.html

(10)  FDA (and the FDASIA committees responsible for the new Report) are surely not unaware of my own report to its MAUDE database (because the hospital denied my request to issue the report itself) of a fundamental defect in a widely used health IT system, Eclipsys Sunrise, that nearly caused the death of my mother... AFTER she was seriously injured due to a flaw in an ED's EHR that did lead a year later to her death:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1729552

ECLIPSYS SUNRISE CLINICAL MANAGER      
Event Date 06/12/2010
Event Type  Injury   Patient Outcome  Hospitalization,Other,Life Threatening,Required Intervention
Event Description

The eclipsys sunrise clinical manager emr/cpoe is in use at (b) (6) hospital. This system appears to have a serious deficiency: an apparent lack of date constraint validity checking when users are seeking information on prior medication orders and administration. (b) (6), (b) (6) was admitted (b) (6) 2010, for cerebrovascular problems. Famotidine iv was started prophylactically to prevent gastric problems, but was discontinued and changed to protonix a few days later due to suspicion of causing severe agitation and confusion, causing her to pull her lines. Around (b) (6) 2010, patient was transferred to physical therapy floor in the hospital. Hospital considers such a transfer to be a "discharge" and "readmission. " however, patient did poorly, had to be sent back to med-surg floor several days later. Due to having pulled a percutaneous endoscopic gastrostomy tube -peg tube-, she was started on TPN on (b) (6) 2010. In the first bag of tpn solution was 40 mg. Famotidine. Patient's mental status began deteriorating and she began to get very, very agitated and confused once again. Eclipsys sunrise problem/bug was noted when son, a physician informaticist -and author of this report- noted the 40 mg famotidine in the tpn bag, and reported to the floor rn that this was contraindicated. The rn pulled up the medication order and administration records on the eclipsys sunrise clinical manager system to confirm famotidine had been administered previously. Famotidine was shown only as being ordered for tpn on (b) (6), but not prior. The rn selected a date constraint entry box, at which time a calendar widget popped up. The rn set the date constraint back to (b) (6), then (b) (6), then (b) (6) 2010, but the use of the famotidine at that time did not appear. Son of patient demanded the famotidine be stopped anyway, which it was, and that an allergy entry be entered. However, it was fortunate son was a physician and remembered the name of the medicine. In tracing this error today, it was found that the data from admission on (b) (6) to "discharge" to physical therapy floor (b) (6) 2010, was unavailable since it was considered a "prior admission" although the patient had never left the hospital physically. The sunrise system, however, failed to flag the (b) (6) 2010 date constraint entries as 'out of bounds' for the current admission. The validity of the date constraints was not checked, preventing the rn user from realizing he should have called up the prior admissions records. If son of patient had not been a physician, famotidine might have been continued and patient might have suffered more severe consequences than she did after the 40 mg was given in the first tpn bag. As it was, she spent the next three days in a severe delirium and is only slowly recovering. That the eclipsys sunrise ehr did not alert its user that the date constraints they set for seeking medication ordering and administration data were out of bounds -beyond the range of the current "admission" -is a significant and severe oversight and/or bg, and a danger to patients not fortunate enough to have a physician informaticist son closely monitoring their care.

Addendum May 4, 2014:

(11)   CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  (But let's spend hundreds of billions of dollars anyway.)

CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  [But let's spend hundreds of billions of dollars anyway.]  Click to enlarge.

--------------------------------------------

Note that these ten points themselves, all I had time to write about this morning, themselves represent a "tip of the iceberg" regarding health IT risks.

In my opinion it's immensely reckless for FDA to make a statement that "products with health management heath IT functions, includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software ... are of sufficiently low risk" so as to not warrant formal regulation that is already in place for other healthcare software sectors.

Fortunately, the public gets to comment via this announcement:

Proposed Risk-Based Regulatory Framework and Strategy for Health Information Technology Report; Notice to Public of Availability of the Report and Web Site Location; Request for Comments
http://www.regulations.gov/#!documentDetail;D=FDA_FRDOC_0001-4678

I feel, however, that the decision is a given, and that the health IT industry has such regulatory capture that public comments will be ignored.  (Not that I won't try.)

Finally:

I ponder what ever happened to the inquiry responses about health IT defects and harm sought by the Senate Finance Committee, as reported in the Washington Post:

Electronic medical records draw frequent criticisms
By Alexi Mostrous
Washington Post Staff Writer
Sunday, October 25, 2009

http://www.washingtonpost.com/wp-dyn/content/article/2009/10/24/AR2009102400967.html?hpid%3Dtopnews&sub=AR

... the Senate Finance Committee has amassed a thick file of testimony alleging serious computer flaws from doctors, patients and engineers unhappy with current systems.

On Oct. 16, the panel wrote to 10 major sellers of electronic record systems, demanding to know, for example, what steps they had taken to safeguard patients. "Every accountability measure ought to be used to track the stimulus money invested in health information technology," said Sen. Charles E. Grassley (Iowa), the panel's ranking Republican.

The results of that request seem to have gone to the recycle bin.

-- SS