Vested Interests in Direct-to-Consumer Drug Advertising

As a physician, my blood pressure goes up every time I see the ad about the little purple pill, or the ad involving the guy throwing the football through the old tire (but which is not about throwing, or footballs, or tires), etc., etc., etc. I am convinced that such advertisements provide almost no education to patients. But they probably persuade quite a few to pressure their physicians for drugs that they may not really need, or that may not be the best choices for them. Promoting little purple pills shoves aside the complex balancing of benefits, harms, and costs that should underly choice of therapeutic agents. For how many patients with dyspepsia or GERD will that little purple pill really work better than a generic H2-blocker or proton pump inhibitor?
What has made the current news about the Cox-2 inhibitors so troubling is that the drugs were advertised heavily as generally useful for arthritis, and all sorts of aches and pains. Thus, many patients for whom the drugs provided no particular advantage were exposed to their risks of adverse effects. Will the lessons learned from this episode lead to decreased, and/or more informative and realistic direct-to-consumer drug advertising?
The NY Times today reported the extent of vested interests in keeping such direct-to-consumer advertising going. Merck’s spending on advertising Vioxx was $78 million a year. Pfizer was planning to spend more than $87.6 million on advertising Celebrex this year until it canceled the campaign. $3.8 million is now spent yearly on all direct-to-consumer drug advertising. This is not a trivial business for advertising agencies. Furthermore, $110 million, about one-third of the advertising revenue of the big three network evening news programs, comes from direct-to-consumer drug advertising. It remains to be seen whether such vested interests will resist down-sizing direct to consumer advertising, or at least making it more realistic and less like “marketing for Cheerios.”

How to Reduce the Conflicts of Interests in Health Care in a Country Whose Leader Has Flagrant, Unconstitutional Conflicts of Interest?

Introduction: Conflicts of Interest in Health Care

Our first post about conflicts of interest appeared on December 22, 2004, and was about “senior NIH scientists [who] were collecting hundreds of thousands of dollars in consulting fees and stock from industry.”  We were not the first to be concerned about the problems resulting from financial relationships among health care professionals, academic health care institutions, and other health care non-profits on one hand, and the commercial health care industry on the other.

In 2009, the US Institute of Medicine, now part of the National Academy of Medicine published a report entitled “Conflict of Interest in Medical Research, Education, and Practice” which included specific recommendations for reducing them.  Unfortunately, despite the prestige of the then IOM, the report seemed to vanish without much of a trace (look here)

A report from the IOM which recommended decreasing conflicts of interest affecting the production of clinical practice guidelines was similarly anechoic (look here and here). Egregious examples of conflicts of interest in medicine and health care continue to appear in the media. For example, per a Dec 6, 2019, ProPublica article, a newly disclosed US government database listed 8000 that shows that  disclosed “8,000 ‘significant’ financial conflicts of interest worth at least $188 million since 2012” affecting researchers funded by the National Institutes of Health.  Moreover, the conflicts disclosed in such databases or discussed in the media may just be the tip of the iceberg.

It should be no surprise that conflicts of interest remain prevalent despite various reform efforts.  Such conflicts benefit the parties involved inthem but harms to other people may not be obvious.  Consider, for example, a pharmaceutical company paying a key opinion leader thousands of dollars to give talks and write articles that might help it market a particular product.  The key opinion leader makes more money.  The pharmaceutical company may sell more product.  Disadvantaged are the patients whose physicians were persuaded by this ploy to prescribe the drug when other drugs or approaches might have benefited those patients more.  But these patients and physicians may never connect their less than optimal outcomes with the conflicts of intereat that enabled their bad results.  Those who do not realize how conflicts of interest hurt them are not likely to campaign against these conflicts.  Howver, those who benefit from the conflicts are likely to resist any efforts to reduce them.

But if at first you don’t succeed, try, try again…

The New BMJ Article

In December, 2019, the British Journal of Medicine published “Pathways to independence: towards producing and using trustworthy evidence” (Moynihan R, Bero L, Hill S et al.  BMJ 2019; 367: l6576. Link here.), with authors from eight different countries.  They argued that:

endemic financial entanglement is distorting the production and use of healthcare evidence, causing harm to individuals and waste for health systems. Building on the evidence and practical examples cited below, we propose pathways towards financial independence from industry across healthcare decision making.

The article provided a good quick summary of the reasons that various kinds of conflicts of interest can harm patient care, education, research, and health policy making, and proposed the following:

Research

Governments require independent production of evidence used for healthcare decision making, including the evaluation of new treatments, tests, and technologies

Governments require that public healthcare organisations, including regulatory and health technology assessment agencies, receive no industry funding and that their advisers have no financial relationships with industry

Groups conducting research synthesis, including systematic reviews, ensure reviewers have access to all information on study methods and all relevant study results, including clinical study reports, and are conducted without industry funding and by authors with no financial relationships with companies that could benefit from the outcomes

Education

Professional, advocacy, or academic groups engaged in educational activities for health professionals or the public or advocacy affecting regulatory or policy decisions, move to end reliance on industry funding and end financial relationships between their leadership and industry

National governments work with professional associations and licensing bodies to develop policies that ensure educational activity supported by industry cannot contribute to accreditation of health professionals

Medical journals and their editors move to end reliance on healthcare industry income

Practice

Professional groups, hospitals, health services, and governments prohibit marketing interactions between industry and decision makers, including practising professionals, and actively support development of healthcare information independent of commercial interests

Professionals, policy makers, and the public move to reliance on practice guidelines produced and written by groups that have no financial relationships with industry and that have access to evidence, including research synthesis, free of industry influence

Research funding bodies and academic institutions modify academic metrics and incentives explicitly to reward academic collaboration with public agencies and civil society groups as well as industry

These proposed pathways arise from our analysis of the relevant evidence and examples from around the world. The list is not comprehensive or definitive and is designed to inform intensified debate and development of detailed recommendations.

The authors did not claim their pathways were “comprehensive or definitive,” but hoped they would “encourage development of more detailed practical recommendations for change.”  Will this new push to challenge prevalent conflicts of interest in medicine and health care make a difference?  On one hand, the international approach could be more successful than the previous Institute of Medicine reports which focused only on the US.  On the other hand, since the IOM reports came out, the reign of conflicts of interest in the US has only gotten worse, especially within the US government.  Yet the new BMJ article depends on government to go down many of the proposed pathways.  

Emoluments from Home and Abroad

Concerns about conflicts of interest affecting the US government date back hundreds of years, but had largely been forgotten.  The actions of the current Trump administration have awakened interest in how the framers of the US Constitution tried to forestall conflicts of interest affecting the executive branch of government.The Constitution includes two clauses that appear to forbid certain specific conflicts of interest.  They had been largely forgotten, and their meaning obscured by their use of now archaic language.

Article I, Section 9 states:

No Title of Nobility shall be granted by the United States: And no
Person holding any Office of Profit or Trust under them, shall, without
the Consent of the Congress, accept of any present, Emolument, Office,
or Title, of any kind whatever, from any King, Prince, or foreign State.

Article II, Section 1 states:

The President shall, at stated Times, receive for his Services, a Compensation, which shall neither be encreased nor diminished during the Period for which he shall have been elected, and he shall not receive within that Period any other Emolument from the United States, or any of them.

The word “emolument” is now rarely used  However, at the time of the writing of the Constiution its meaning was payment, thing of value, profit, advantage, or gain.  An NPR article described the efforts of one law professor, John Mikhail, a professor at Georgetown Law School, to research the meaning the framers would have understood.  He:

looked at all the known dictionaries between 1604 and 1806 that define emolument — 40 books in all. He said only three gave definitions in ways favorable to Trump, ‘kind of a narrow, even technical meaning, tied to the salary or official duties of an office,’ while the other 37 used ‘a broader meaning that would encompass sort of the profits of ordinary market transactions.’

Almost all of the dictionaries used the word profit in their definitions. The two other go-to words were advantage and gain.

The Foreign and Domestic Emoluments Clauses As Prohibitions of Conflicts of Interest Involving the US President and Other Government Officials

John Medwed, the WGBH legal analyst, explained the origin of the “foreign emoluments clause,” (Article I, Section 9)  this way,

it emerged out of a fear that wealthy Europeans would ply American ambassadors with gifts and somehow curry favor and influence foreign policy. And back in the 1700s, that was a real concern. Benjamin Franklin famously received a diamond encrusted box from the king of France. And that caused titillation all through the upper crust, this concern that the French would dictate our foreign policy. That’s what led to the emoluments clause.

So the foreign emoluments clause seems to forbid all officials of the US government from receiving any payments, gifts, or anything else of value from foreign governments. 

In Vox, Ian Milhiser, a senior legal correspondent with extensive legal background, put it this way:

There is a reason the Constitution singles out transactions with foreign governments as forbidden. As Alexander Hamilton explained in the Federalist Papers, ‘one of the weak sides of republics, among their numerous advantages, is that they afford too easy an inlet to foreign corruption.’ In a monarchy, the chief executive shares an identity with the state, so a king or queen ‘has so great a personal interest in the government and in the external glory of the nation, that it is not easy for a foreign power to give him an equivalent for what he would sacrifice by treachery to the state.’

But in a republican state, where leaders serve temporarily and keep their finances separate from that of the nation, ‘persons elevated from the mass of the community, by the suffrages of their fellow-citizens, to stations of great pre-eminence and power, may find compensations for betraying their trust.

The framers, in other words, believed that federal officials would be uniquely vulnerable to the corrupting influence of a foreign state. The foreign emoluments clause offers a shield against that corruption — assuming that it is enforced.

So there seems to be a very good argument that the framers of the US Constitution tried very hard to prevent a certain kind of conflicts of interest,
those arising from a US government official receiving financial or
material benefit from a foreign government.

Similarly, Milhiser succinctly wrote,

the domestic emoluments clause limits the president’s ability to profit off of either the federal government or a state government.

Thus the framers also sought to prevent the President and other officials form self-dealing, and from having conflicts of interest involving state governments.

President Trump’s Numerous and Conspicuous Violations of the Emoluments Clauses, that is, Numerous and Flagrant Conflicts of Interest

The emoluments clauses remained largely obscure for over 200 years, probably because they were mostly respected, until the regime of Donald Trump.

We noted, most recently here, several well documented sources listing thousands of examples of Trump and cronies’ conflicts of interest and corruption, including many instances about his conflicts of interest that seem to violate the emoluments clauses.

These conflicts largely arise from a historically unprecedented situation.  Trump is the only known president to have maintained ownership of extensive business operations while in office.  Per Wikipedia,

The Trump Organization is a group of about 500 business entities of which Donald Trump is the sole or principal owner. About 250 of these entities use the Trump name. The organization was founded in 1923 by Donald Trump’s grandmother, Elizabeth Christ Trump, and father, Fred Trump, as E. Trump & Son. Donald Trump began leading it in 1971, renamed it around 1973, and handed off its leadership to several of his children in 2017.

The Trump Organization, through its various constituent companies and partnerships, has or has had interests in real estate development, investing, brokerage, sales and marketing, and property management. Trump Organization entities own, operate, invest in, and develop residential real estate, hotels, resorts, residential towers, and golf courses in various countries. They also operate or have operated in construction, hospitality, casinos, entertainment, book and magazine publishing, broadcast media, model management, retail, financial services, food and beverages, business education, online travel, commercial and private aviation and beauty pageants. Trump Organization entities also own the New York television production company that produced the reality television franchise The Apprentice. Retail operations include or have included fashion apparel, jewelry and accessories, books, home furnishings, lighting products, bath textiles and accessories, bedding, home fragrance products, small leather goods, vodka, wine, barware, steaks, chocolate bars, and bottled spring water.

Since Trump is the major owner of the Trump Organization, profits made by it largely go to him.  Thus a payment to that organization, less operating costs and whatever interest other owners, essentially his children, have, is a payment to him.

Emoluments from Foreign States

As summarized in the voluminous “Tracking Corruption and Conflicts in the Trump Administration” report section of the Global Anti-Corruption blog, the Trump Organization has been paid numerous times by foreign government.

Payments to Trump Organization Hotels

Attention has particularly focused on a single property, the Trump International Hotel in Washington, DC.  Per the report,

A number of concerns center on the Trump International Hotel in Washington, D.C., and in particular on whether foreign governments, or agents of foreign governments, may seek to curry favor with the Trump Administration by booking rooms and events at the hotel.

[Interior, Trump International Hotel DC]

In particular,

a leaked email from September 2017 indicated that, despite public assurances to the contrary, President Trump is ‘definitely still involved’ in the D.C. hotel’s business. Moreover, shortly after the election, the hotel hosted a promotional event aimed specifically at foreign diplomats, which almost 100 diplomats attended. Since then, there have been numerous reports of private companies and foreign governments paying for rooms and events at the Trump International Hotel, including in 2018 an Amazon subsidiary with billions of dollars in government contracts. As of May 4, 2018, the patrons at the hotel included 59 political groups, eight foreign governments, and 25 business interest events (industry or lobbying).

The report notes that the foreign governments that have “spent substantial sums at this D.C. hotel, with the possible intention to ingratiate themselves with the administration” included Bahrain, Azerbaijan, Saudi Arabia, Kuwait, Turkey, Malaysia, Philipines, Afghanistan, Iraq, Ukraine, and Romania.

More broadly, in the Citizens for Responsibility and Ethics in Washington (CREW) report on Trump’s conflicts of interest:

Since President Trump took office, officials from 65 foreign governments, including 57 foreign countries, have visited a Trump property. Altogether, foreign officials account for 137 visits in total, 97 of which have been made to the Trump International Hotel in Washington, D.C.

Many of these visits have come from large events hosted by foreign governments, some of which switched venues to hold annual events at Trump properties after he became president. The embassy of Kuwait had, for example, typically held its annual national day celebration at the Four Seasons prior to President Trump’s election. The last three years, however, it’s held the event at the Trump hotel in D.C. In 2018, the Romanian consulate in Chicago moved its own national day celebration to the Trump hotel in Chicago after hosting it at the Chicago Cultural Center five years in a row.

While events like these are likely to be incredibly costly—and thus raise the likelihood of the president financially benefiting from payments made by foreign entities—neither the Trump Organization nor the Trump administration has released the financial details beyond an annual payment to the Treasury the Trump Organization claims represents profits from foreign government funds.

Turkish officials have made 14 visits to Trump properties, more than any other country. This can partially be credited to two annual conferences on U.S. relations with Turkey that have been held at President Trump’s D.C. hotel. This year, two advisors to President Recep Tayyip Erdoğan and the ministers of trade, defense, and treasury all attended the event.

Other events have drawn officials from countries that span continents or regions. In February, the Embassy of Kuwait in D.C. held a Kuwaiti independence day celebration at the Trump Hotel, with officials from all over the Middle East and North Africa in attendance. The 13 foreign officials in attendance included representatives from Kuwait, Yemen, Saudi Arabia, Oman, Iraq, Sudan, Yemen, and Libya.

Other officials have patronized Trump businesses around the time they met with President Trump. The Romanian President and Nigerian Vice President both visited the Trump hotel while in D.C. for meetings at the White House, and the Romanian Prime Minister is known to have stayed there.

[Trump Tower Chicago]

Payments Derived From Real Estate Transactions

If that were not enough, there are numerous instances of payments to or benefits received by the Trump Organization from foreign governments that do not involve its hospitality business. 

The Global Anti-Corruption Report noted that foreign governments and entities associated with them have rented and purchased Trump real estate.  These included “foreign government banks such as the Bank of India and Industrial & Commercial Bank of China.”  Also,

the government of Qatar bought an apartment in one of President Trump’s New York towers for $6.5 million. As of June 2018, Qatar owned four units in the building for which it has paid a total of $16.5 million. Additionally, at least seven foreign governments—including Iraq, Kuwait, Malaysia, Saudi Arabia, Slovakia, Thailand, and the European Union—rented units at Trump World Tower in New York in 2017. (The Trump Organization does not own Trump World Tower, but it does manage the building, which means it benefits indirectly from renters in the form of management fees paid by those who own the units.) While most of the governments had also rented their units in 2015 and 2016, two of them—Iraq and Slovakia—only began renting in 2017.

Then again,

President Trump has a long history of lucrative financial dealings with Saudi Arabian partners, including those in or close to the Saudi government.

The Trump Organization is currently developing a luxury resort on the Indonesian island of Bali. The Bali local government provided public land for the project, granted numerous licenses and permits, and is planning to build (at government expense) a toll road extension that will substantially shorten the drive from the airport to the Trump resort—a decision that has raised concerns that the government may be deliberately undertaking an infrastructure project to curry favor with the U.S. president. (On August 13, 2019, Donald Trump Jr. attended an event in Indonesia to celebrate the development of two Trump properties in the country. Though the event was not affiliated with the United States government, pictures of the event reveal that several Indonesian government officials)

In addition,

The Trump Organization developed a luxury hotel in Panama City, and the Panamanian government has stepped in to aid the project in various ways, including government-funded repair of privately-owned sewage and drainage systems, use of the hotel for various government functions, and favorable permitting and tax decisions—decisions that, while not illegal or necessarily improper, raise significant concerns about conflicts of interest. The drama concerning this property continued in February 2018, as the building’s majority owner, Orestes Fintiklis, tried to fire the Trump Organization for mismanaging the hotel’s finances, but the Trump Organization refused to leave, instigating a standoff in which the police were called; the Panamanian government is currently investigating whether there was ‘punishable conduct’ by the Trump Organization.

Other Payments to the Trump Organization by Foreign States

Other Trump Organization operations have benefited from the actions of foreign governments, in particular,

in February 2017 President Trump reaffirmed the U.S. commitment to the so-called ‘One China Policy.’ Within a week of this announcement, the Chinese government granted the Trump Organization long-coveted Chinese trademarks for the ‘Trump’ brand. As of June 2017, the New York Times reported that President Trump had 123 trademarks registered and provisionally approved (meaning they would be approved within three months if there were no objections) in China.

Emoluments from the US Government

Independent of the salary and benefits President Trump receives from the government, the Trump Organization has received payments made by the US government.  The Global Anti-Corruption blog report noted in general that

One of the most direct ways that President Trump can profit from the presidency is by making decisions that effectively require U.S. government agencies to purchase goods or services from the Trump Organization.

Specific instances it listed included:

One of the most direct ways that President Trump can profit from the presidency is by making decisions that effectively require U.S. government agencies to purchase goods or services from the Trump Organization.

Department of Defense at Trump Tower: The Department of Defense has followed its standard practice of setting up a separate headquarters near the President’s private residence—in this case also in Trump Tower.

Trips to Mar-a-Lago and other Trump Properties: As of September 3, 2019, President Trump had spent 293 days at properties owned by the Trump Organization, with the bulk of that time at the Trump National Golf Club in Bedminster (90 days) and Mar-a-Lago resort in Florida (99 days)…. On these visits, the Secret Service must pay the Trump Organization directly for any costs related to protecting the president. In fact, a Government Accountability Office report concluded that the Secret Service paid about $60,000 to the Mar-a-Lago resort for four trips between February and March 2017 alone

Trump Properties Abroad: If President Trump or his immediate family travel abroad and choose to stay at a Trump property, the U.S. government will pay the Trump Organization to rent space for the Secret Service and any additional necessary support. For example, the State Department paid at least $60,000 to the Trump Organization’s golf resort in Scotland when President Trump stayed there in July 2018.

Emoluments from US States

Payments by state governments to Trump via the Trump Organization have not been tracked so assiduously, but the Global Anti-Corruption Blog report noted,

At least 33 state-level officials also visited Trump properties, including nine governors, two lieutenant governors, and 15 members of state legislatures…. If these visits are taxpayer funded—and ongoing public records requests are seeking to find out—officials could be diverting public funds into the president’s private trust. This concern appears to have been borne out in a recent investigation by the Portland Press Herald, which found that former Maine Governor Paul LePage and his staff spent at least $22,000 in Maine taxpayer money staying at the Trump International Hotel over a two-year period—an amount far in excess of the state spending limit for this type of expense.

Furthermore,

Public pension funds in California, New York, Texas, Arizona, Montana, Michigan, and Missouri—with more than five million members—have millions of dollars invested in The CIM Group, a Los Angeles-based investment group that owns The Trump SoHo Hotel and Condominium. Through 2017, the CIM Group paid Trump International Hotels Management LLC 5.75% of Trump SoHo’s operating budget, resulting in millions of dollars in payments. Thus, these state pensions paid millions of dollars almost directly to the Trump Organization through the CIM Group.

Also,

In 2017, the Trump Organization announced a new mid-priced hotel chain, Scion (soon followed by another chain, American Idea). The first Scion hotel was granted a tax break in 2018 worth over $6 million from the Mississippi Development Authority.

Summary

The article by Moynihan et al in the BMJ is the latest effort to challenge conflicts of interest affecting health care professionals and academic health care organizations.  There are many barriers to the success of such reform efforts, most notably resistance from people who are directly benefiting from ongoing conflicts: in this case, health care professionals and management of the commercial firms making the payments to them that generate the conflicts.

In the US, we now have a particular barrier to addressing conflicts of interest in health care. Moynihan et al call on national governments to take various actions to reduce such conflicts.  However,  the US government is now led by a President whose personal conflicts of interest are voluminous, severe, and brazen.  Many of them appear to directly violate provisions of the US constitution that forbid emoluments (payments, gifts, or transmission of other things of value) to the President by foreign states, the US government, or state governments.  The government under Trump has shown little interest in challenging conflicts of interest or corruption unless doing so would politically benefit the president. So once again, it is difficult to see how we might meaningfully
challenge conflicts of interest affecting American health care without
challenging the monstrously conflicted executive branch of our own
government.

That will not be easy.

Discussion of Trump’s conflicts of interesti the media, and several civil lawsuits targeting them have not discouraged the President from continuing to enrich himself from foreign, the US, and state governments.

It is not obvious how these presidential conflicts of interest could otherwise be reduced or eliminated.  While the US House of Representatives has recently focused on possible impeachment of President Trump, unconstitutional conflicts of interest have not been a focus.  A New York Times op-ed just noted his continuing conflicts of interest, but lamented

The Democratic-controlled House has done an especially poor job of calling attention to this corruption. It hasn’t even conducted good oversight hearings — a failure that, as Bob Bauer, an N.Y.U. law professor and former White House counsel, told me, ‘is just astonishing.’

It is possible that Trump will lose the next election.  However, that would leave him, unconstitutionally conflicted, in office until 2021, if he does not attempt to ignore such electoral results, as he has threatened.  He has already threatened to ignore election results he deems illegitimate (look here).

So it seems that we in the US are stuck with the continuing prevalence of conflicts of interest and corruption adding to health care dysfunction, unless health care professionals and the public band together to do something more direct to challenge them. 

Computer woes hit Banner hospital system: Another large EHR outage … but patient safety was not compromised

Here is yet another story in the genre of “EHRs go out, but patient care has not been compromised.” (See query link at http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised; there are more than 20 posts there now):

Computer woes hit Banner hospital system
Ken Alltucker, The Arizona Republic 12:30 a.m. EST February 20, 2014
http://www.usatoday.com/story/news/nation/2014/02/19/computer-woes-slam-banner-hospital-system/5630829/

The Phoenix-based health system used backup paper records to help provide patient care.

PHOENIX — Banner Health grappled with a widespread computer outage Wednesday as hospitals and doctors resorted to backup paper systems to provide care for patients.

The Phoenix-based health system did not immediately know what triggered the computer troubles that started just before 10 a.m. PST. An official described the computer troubles as a rolling outage of computer systems at hospitals and other health care facilities in Phoenix, Colorado and Nevada.

“Not knowing” means that you are not in control of your life-critical information systems; rather, they are in control of you.

By late Wednesday, a spokesman said, technicians had identified the problem and were fixing it. They expect to investigate the root cause of the problem Thursday.

It took from 10 AM to “late Wednesday” to identify a problem causing a mass outage.  That should give anyone pause about dependency on fragile information systems in the hands of hospital IT departments (whose personnel undergo an ocean’s less qualification-vetting than the medical personnel who depend on their work product) for one’s medical care.


Banner Health, the Phoenix area’s largest health care system, activated “downtime procedures” that included using paper-based systems to track medications and other care provided to patients, officials said.

Banner’s emergency departments still provided care to patients and accepted new patients.

Some non-emergency surgeries and appointments were delayed because of the computer troubles.

“There have been some delays and inconveniences, but we are still providing care,” said Bill Byron, Banner Health’s senior vice president of public relations.

In other words, what they are saying is “we really don’t need these systems, that cost hundreds of millions of dollars, to provide care with the same degree of safety as with our ‘downtime procedures’ (a.k.a. paper)” … and that patient safety was not compromised by this mass outage.

Banner Health, which operates 24 hospitals and several primary-care offices and outpatient centers in more than a half-dozen states, was working to “reboot” the computer systems Wednesday evening through a series of sequential fixes, Byron said.

In the meantime, Banner officials were able to retrieve computer-based records that detailed patients’ medical histories, including any medications, laboratory results and procedures that were previously performed.

Officials?  What about line clinicians?  And when did this capability start if the systems needed to be “rebooted?”

Nurses and doctors shifted to writing on paper records after the computer systems experienced trouble Wednesday morning.

Information from those paper charts will be keyed into the patients’ computer-based health records after the problem is fixed.

Sure, and nothing will be lost that could adversely affect patients in the future….

Banner Health has been among the most advanced health systems in the nation in converting to computer-based health records.

Banner Estrella Medical Center was among the first hospitals to open as an “all-digital” facility in the past decade. Banner’s other hospitals have largely completed the final stages of installing computerized record-keeping in areas such as physician order and entry and electronic documentation.

If they are the most advanced, what does this event say about those less advanced?

Arizona law does not require hospitals to notify state health regulators in the event of such a widespread outage.

Health IT, as usual, enjoys widespread and extraordinary regulatory accommodation.

However, some hospitals have internal policies requiring that they notify health accrediting organizations or federal regulatory agencies, such as the Centers for Medicare and Medicaid Services, an Arizona Department of Health Services spokeswoman said.

And how many do?  Not many, I predict.

— SS

Just Say "No" to the Term "Anecdotes"; and HIT as a Medical Metadevice

A New Year’s thought: there needs to be a push in healthcare for dropping of the word “anecdote” to describe case reports of health IT-related errors.

This word even appears in the late 2011 IOM report on HIT safety (PDF), e.g., the preface:

… We found that specific types of health IT can improve patient safety under the right conditions, but those conditions cannot be replicated easily and require continual effort to achieve. We tried to balance the findings in the literature with anecdotes from the field but came to the realization that the information needed for an objective analysis and assessment of the safety of health IT and its use was not available.

The “A” word needs to be dropped from the healthcare IT lexicon, since such reports from reliable sources are in fact incident reports purposed for risk management activities.

Incident reports do not need peer review for consideration for that purpose.

Of note, I do not believe the incident reports filed in hospitals when something awry occurs are labelled “anecdotes”, either.

See the Aug. 2011 post “From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things” for more on this topic.

And on another vein, the issue of HIT being a medical device:

As the good State Rep. Marino of my home state of Pennsylvania and others oddly proffer – that ‘certification’ of health IT, having nothing to do with safety or usability, relieves HIT from being a device [1] – and as the IOM itself debates exactly what to call HIT and under what guidelines to regulate it, another term/category for HIT devices is needed.In the spirit of the naming of the UMLS Metathesaurus, and in consideration of HIT’s informational governance/orchestration of other medical devices and personnel (including the ‘carbon units’ known as clinicians and patients) — I suggest the term “metadevice” for HIT.

Healthcare metadevices need their own specific regulation, apart from traditional medical devices.

— SS

Note:

[1] As in line 21- 24 on page 6 of the “Safeguarding Access For Every Medicare Patient ActBill (PDF) that I wrote about here. The Bill states: “CLARIFICATION OF AUTHORITY. Certified EHR’s shall not be considered a device for purposes of the Federal Food, Drug, and Cosmetic Act.

(This proposal, of course, raises the question of whether Rep. Marino believes non-certified HIT shall be considered a medical device, a topic for another time.)

St. Jude Medical Settles

We could not let more than a week go by without discussing another legal settlement by a major health care organization.  From the Pioneer Press,

Little Canada-based St. Jude Medical will pay $3.7 million to resolve allegations the medical device company provided kickbacks to hospitals in Kentucky and Ohio to secure sales of heart devices, the U.S. Department of Justice announced Friday.

The government alleged that St. Jude Medical provided rebates that were retroactive and paid based on a hospital’s previous purchases of heart device equipment from the company. Prosecutors also charged that St. Jude Medical paid rebates for purchases of heart-device equipment sold by its competitors to induce purchases of similar equipment from St. Jude Medical in the future.

As I understand it, the issue was that the rebates did not amount to a simple volume discount, but were given only if the hospital allowed St. Jude to become its dominant supplier of certain devices, for example,

One such rebate was offered to Parma Community General Hospital in Parma, Ohio, a suburb of Cleveland, according to settlement papers made available by the government on Friday. The medical center could earn discounts on products if it gave St. Jude Medical 90 percent of its annual usage of mechanical heart valves, 80 percent of its annual usage of conventional pacemakers and 50 percent of its annual usage of conventional implantable defibrillators, according to the settlement agreement.

The two-year contract began in April 2003 and St. Jude Medical at the time did not have government approval to sell newer ‘biventricular’ pacemakers and ICDs. A rival company, however, did have approval for such products, and the settlement agreement asserts that St. Jude agreed to give the Ohio hospital a rebate for each biventricular pacemaker and ICD purchased from the competitor so long as Parma hospital maintained market share targets on St. Jude Medical products.

‘The contract also mandated that once (St. Jude Medical) gained Food and Drug Administration approval for its own biventricular devices, the rebates would end, and (Parma) could earn discounts by giving (St. Jude Medical) 80 percent of its annual usage of biventricular pacemakers, and 50 percent of its annual usage of biventricular ICDs,’ the settlement agreement states.

What was the problem with this?

‘Hospitals should base their purchasing decisions on what is in the best interests of their patients,’ Tony West, assistant attorney general for the Justice Department’s civil division, said in a statement.

St. Jude’s response was that it was all so trivial and so long ago,

In a statement issued Friday, St. Jude Medical said: ‘The allegations centered on small, isolated product rebates that the company paid more than five years ago. The company entered into a settlement agreement in order to avoid the potential costs and risks associated with litigation.’

So add another marcher in the parade of legal settlements. While most of the marchers in this parade seem to be pharmaceutical companies, it appears that device manufacturers are trying to catch up.

We have been noting new entrants to this parade for a while mainly as a way to document how often health care organizations, including some of the largest and seemingly most respectable organizations, have been accused of unethical conduct.  Often this conduct seems likely to increase health care costs, by driving up the prices of goods or services, or by encouraging the use of expensive tests or treatments when perhaps something simpler and cheaper would be just as good for the patient.  Sometimes, this conduct seems likely to decrease health care quality, and worsen patient outcomes because the tests or treatments being pushed by the unethical behavior may be less effective, and/or more likely to cause harm than other credible alternatives.

We also have repeatedly said that the usual sorts of legal settlements we have described do not seem to be an effective way to deter future unethical behavior.  Even large fines (and the one described above would be peanuts to a large health care corporation) can be regarded just as a cost of doing business.   Furthermore, the fine’s impact may be diffused over the whole company, and ultimately comes out of the pockets of stockholders, employees, and customers alike. It provides no negative incentives for those who authorized, directed, or implemented the behavior in question. My refrain has been: we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

BLOGSCAN -PharmaLot Bows Out

Health Care Renewal: BLOGSCAN -PharmaLot Bows Out


BLOGSCAN -PharmaLot Bows Out

Say it ain’t so, Ed. PharmaLot, one of the best health care blogs, in my humble opinion, and the premiere news blog about the pharmaceutical industry, is ending its run. Its author, Ed Silverman, took a buyout from the Newark Star-Ledger, the blog’s parent organization. I hope somehow, somewhere, a replacement spring up, and that Ed Silverman goes on to bigger and better things. So long, Ed, we’ll miss you.

 

More Bloggers Address Pfizer’s Marketing of Viracept and Maraviroc

[Revised 4 August, 2007] A complicated story about questionable pharmaceutical marketing practices is now playing out on several other blogs. Basically, the issue is allegations about how Pfizer Inc, the world’s largest drug company, marketed two anti-viral drugs, its aging anti-viral drug Viracept (nelfinavir), and the new drug maraviroc. We had previously posted a little about this here and here. But most of the real reporting about the maraviroc issue can be found on Question Authority with Dr Peter Rost, and now on BrandweekNRX, for which Dr Rost is now also blogging. Furthermore, most of the real reporting about Viracept can be found on PharmaLot by Ed Silverman, most recently here (and previously here, here, and here.) And recently the Carlat Psychiatry Blog just did an excellent summary of the story so far.

The main allegations were that Pfizer promoted maraviroc, a new anti-viral drug, before the US Food and Drug Administration (FDA) approved it, and that Pfizer marketing people used continuing medical education (CME), which is, of course, supposed to be educational, as a marketing tool for nelfinavir.

Carlat’s summary was “The bottom line: When your marketing plan is always teetering on the edge of corruption, you’re gonna get burned. It’s only a matter of time.”

[Note, the original version of this post did not give adequate credit to the reporting by Ed Silverman on PharmaLot. See his comment below. I hope the new version is more adequate. ]

Conflicts of Interest and Connecticut’s Stem Cell Research Program

Connecticut was one of four states to set up its own grant program to promote human stem cell research, funded with $100 million over 10 years. But as the state gears up to start giving away money, the Hartford Courant reported “the state stem cell advisory committee is dominated by members with connections to Yale and UConn [University of Connecticut], the two institutions expected to get the lion’s share of the state funds.”
A line from the movie Independence Day might be appropriate here, “Oops.”
Another day, another conflict of interest.
In 1915, the American Association of University Professor’s monumental Declaration of Principles said that the purposes of the university are

  • To promote inquiry and advance the sum of human knowledge.
  • To provide general instruction to the students.
  • To develop experts for various branches of the public service.

And where do we fit the universities’ complex relationships with the Connecticut stem cell advisory committee?

The End of Blockbuster Drugs?

In “The End of Blockbuster Drugs“, Adam Feuerstein of TheStreet.com writes:

The FDA approved Iressa in 2003 under a program that allows drugs for serious, life-threatening diseases like cancer to be approved based on certain surrogate markers for clinical benefit … Under the so-called subpart H regulatory guidelines, the FDA approved Iressa with the condition that AstraZeneca would run another clinical study to show that Iressa’s ability to shrink tumors would lead to improved survival, which is the gold standard in cancer drug efficacy …

AstraZeneca ran that confirmatory study, and it failed. Now, the FDA has to decide whether to pull Iressa off the market … The Iressa mess could have been avoided back in 2003 if AstraZeneca had conducted a randomized, controlled study (Randomized Clinical Trial or RCT) of the drug, such as comparing Iressa with a placebo or best supportive care to see if the drug improved survival. If that study had been conducted and the results had turned out as those released Friday, the FDA probably wouldn’t have approved Iressa, and therefore, wouldn’t be facing a difficult decision today. AstraZeneca could have put together a controlled study of Iressa; after all, that’s exactly what OSI and Genentech did.&13;
&13;
My point here is not to be a Monday morning quarterback. Instead, looking ahead, I think that some top FDA officials will use the Iressa situation to argue even more strongly against the use of single-arm, uncontrolled studies as the basis for future drug approvals. While everyone wants to see the FDA work quickly to approve life-saving drugs, we should also be concerned when the agency approves drugs that turn out to be nothing more than expensive placebos, and often with dangerous side-effects, to boot.

Caution should be exercised along this line of thought regarding use of non-RCT studies. There is a marked asymmetry between evaluating a drug for positive effects vs. evaluating a drug’s risk.

When a successful RCT shows a therapeutic drug effect at p<.05 this="" means="" that="" there="" is="" only="" chance="" in="" or="" less="" the="" drug="" actually="" not="" useful="" downside="" being="" simply="" a="" waste="" of="" money.="" basis="" for="" using="" rct="" and="" setting="" confidence="" level="" at="" p="" approval="" process.="" wp_automatic_readability="42.423752310536">

However, if some other non-RCT (e.g., a retrospective analysis of insurance company records) suggests adverse effects, but p>.05 , dismissing such an analysis is quite cavalier, as the downside is potentially quite serious. This is especially true in the setting of “blockbusters” with millions of users, where the absolute number of affecteds could be relatively large (e.g., 100,000 MI’s and CVA’s).&13;

The FDA analysis of a Kaiser Permanente database reportedly showing that 27,785 heart attacks and sudden cardiac deaths might have occurred due to VIOXX was controversial. In an interview in the Boston Globe, Merck CEO Raymond Gilmartin refutes the study’s findings because it was based on a review of medical records, not a clinical trial. “You can’t take a study like this and take a patient population and extrapolate those kinds of numbers,” he said. “It’s just not valid to do that.” Such retrospective studies are subject to confounding factors in the data.&13;

This does not make such studies automatically wrong, however, and pharmaceutical companies and regulatory agencies that ignore such studies on a dogmatic basis (due to a belief in the absolute ascendancy of controlled clinical trials) do so at their own peril. (In fact, in this case the retrospective studies were shown to be correct by later RCT’s and the resultant VIOXX withdrawal has significantly harmed a company with a century’s reputation for excellence.)&13;

Such non-RCT, retrospective studies need to be factored into the overall risk portfolio of drugs to be consumed by millions, where even a small risk of major side effects could lead to catastrophe due to volume. In recent testimony to the a U.S. Senate committee, Dr. David Graham of the FDA said the FDA’s Office of New Drugs “unrealistically maintains a drug is safe unless reviewers establish with 95 percent certainty that it is not” [via clinical trials]. That rule does not protect consumers, Graham told the Senate committee. “What it does is it protects the drug,” he said.&13;

Let’s hope FDA understands the asymmetry between testing drugs for efficacy via small RCT vs. monitoring them for adverse effects in large populations.&13;

Our Fifteenth Anniversary – Welcome Back to Health Care Renewal

Today is the fifteenth anniversary of Health Care Renewal.

As a reminder of where we began, below is a re-post of our welcome to the blog.

Welcome to HCRENEWAL

Health care around the world is beset by rising costs, declining access,
stagnant quality, and increasingly dissatisfied health care
professionals. Discussions with physicians and other professionals
revealed pervasive concerns that the core values of health care are
under seige. Patients and physicians are caught in cross-fires between
conflicting interests, and subject to perverse incentives. Free speech
and academic freedom are threatened. Psuedo-science and anti-science
are gaining ground. Causes include the increasing dominance of health
care by large organizations, often lead by the ill-informed, the
self-interested, and even the corrupt. (1) However, such concentration
and abuse of power in health care has rarely been discussed openly.
This blog is dedicated to the open discussion of health care’s current
dysfunction with the hopes of generating its cures.

Reference

1. Poses RM. A cautionary tale: The dysfunction of American health care. Eur J Int Med 2003; 14: 123-130. Link here.