Thursday, July 21, 2016

Law and Order? - Bristol-Myers-Squibb Settles Case Alleging Fraud and Kickbacks, No Admissions of Guilt, No Individuals Charged

Introduction 

Donald Trump, Republican candidate for the US presidency last week announced he is the "law and order" candidate, accompanied by then vice presidential contender and New Jersey Governor Chris Christie.



I wonder if all this interest in law and order will lead to increasing the effectiveness of enforcing laws when large US health care corporations are accused?

For years, we have been watching a parade of legal settlements made by big US health care organizations.  These have included the biggest drug companies, biotechnology companies, device companies, insurance companies, etc, etc.  Many involved accusations of fraud, kickbacks, and other seeming crimes.

In many cases, the alleged white collar crimes could have resulted in harms to patients.  For example giving physicians kickbacks to promote particular drugs or devices could have led them to prescribe treatments that could have been useless for particular patients, yet subjected those patients to risks of adverse effects.

Yet few of these cases were resolved with findings of guilt.  Many resulted in financial penalties for the accused organization, but which were tiny compared to that organization's revenue.  Almost none resulted in any consequences for the people in the organization who might have individually profited from the alleged actions, particularly the top executives who were making millions of bonuses, suggesting their apparent impunity.

This parade of settlements does not look like instantiation of law and order to me, in my humble opinion.

Bristol-Myers-Squibb Settles Allegations of Kickbacks

And the parade continues.  The latest case, which barely was noticed in the media, involved huge pharmaceutical company Bristol-Myers-Squibb.  It was best documented by Ed Silverman in Stat,

After nearly a decade of litigation, Bristol-Myers Squibb on Monday agreed to pay $30 million to settle charges by California officials of paying kickbacks to induce doctors to prescribe several of its medicines.

The settlement with the California Department of Insurance stemmed from a whistleblower lawsuit that was filed in 2007 by three former Bristol-Myers employees. They alleged that from 1997 through 2003, the drug maker used a wide variety of inducements to generate revenue. The state later joined the lawsuit in 2011 and, last year, the former employees were dismissed from the case by a state court.

The kickbacks included box seats at sporting events where doctors were given food, drinks, and parking; enrollment in a Los Angeles Lakers basketball camp for doctors and their children; prepaid golf outings at luxury courses; tickets for doctors and their families to see Broadway shows in California cities; and lavish dinners, resort hotel trips, and concert tickets for doctors who were especially big prescribers.

Among the many medicines for which doctors were persuaded to write more prescriptions were the Pravachol cholesterol pill; the Plavix blood thinner; the Abilify antipsychotic; the Glucophage diabetes treatment; and the BuSpar antianxiety drug.

A Bristol-Myers spokesman wrote us that the company denied any wrongdoing, but also noted that the firm began adhering to a voluntary industry marketing code in 2002. 'We are pleased to put this matter behind us so that we can focus on making transformational medicines for patients battling serious diseases,' he wrote.

Note that in this case, as is typical for such cases, the financial penalty seems to be minimal compared to the company's total revenues (more than $16.5 billion according to Google finance.)  The company was allowed to deny wrongdoing (although in absence of same, why should it pay a fine?)  No individuals who might have personally profited from the actions in question suffered any negative consequences.

Why Not More Severe Penalties for a Repeat Offender?

Furthermore, the outcome seems to have nothing to do with the accused's track record.  Anyone who follows the news knows that in general, penalties in criminal cases are likely to be different for first offenders and habitual criminals.  Penalties in civil cases also may depend on the defendant's track record.

However, this case, like most other cases involving big health care organizations, seems to have occurred in a vacuum, separate from the company's track record.  Yet a bit of searching reveals that BMS, like many other big health care corporations, seems to have a pretty bad record.


- In 2003, for $617 million, BMS settled suits alleging it tried to prevent competition from low cost generic versions of its products Taxol and Buspar (per the NY Times).
- In 2004, for $150 million, BMS settled suits by the SEC alleging accounting fraud (per the NY Times here).
- In 2007, BMS paid a $1 million dollar penalty while pleading guilty to lying to federal agents about a deal with the Canadian drug company Apotex (per Law360).   In 2009, it paid additional financial penalties in response to a US Federal Trade Commission charge about this case (per the FTC).
 - In 2007, for $515 million, BMS settled a suit alleging it used kickbacks to induce use of Abilify for dementia and by childeren, despite evidence that the drug was not suitable for either.  The settlement included a five year corporate integrity agreement.  (Look at our post here).
 - In 2014, BMS settled allegations its subsidiary Lantheus Medical Imaging Inc evaded state taxes (per the Corporate Crime Reporter)
 - In 2015, Bristol-Myers-Squibb settled allegations by the US Securities and Exchange Commission (SEC) that it bribed physicians in China to induce them to prescribe its drugs.  (Look at our post here).

(Parenthetically, I apologize that many of these previous cases have not been previously mentioned on Health Care Renewal.  For that I apologize.  Yet some simple Google searches were all that were required to find them.)

Why did none of the law enforcers involved in the later cases do similar searches, and why did the company's track record not figure into how the current case was resolved?

Chris Christie and the Rise of the Deferred Prosecution or Corporate Integrity Agreement for Too Big to Jail Organizations

The answer to that will not be easy.  At best, it now seems to be standard operating procedure for law enforcement to treat big health care organizations very gently.  However, there is one clue in BMS track record that it might be helpful to discuss in this political season.


Note that in one of the biggest settlements listed above, BMS agreed to a corporate integrity agreement.  According to a 2015 article in Time, the use of such agreements, coupled with apparently large fines but no other penalties, for corporate offenders was pioneered by none other than then US Attorney Chris Christie, (who spoke in the video above).

Christie was apparently horrifed by the criminal prosecution of Arthur Andersen, a big accounting firm, in the wake of the Enron scandal.  At that time, federal prosecutors acted so that

The company itself—not its employees who might have been responsible—was indicted and found guilty. The trial put the company out of business. The conviction was overturned on appeal, but not before the company’s reputation was destroyed and its employees forever branded with a Scarlet Letter, representing Andersen, not Adultery.

The article described Mr Christie's response:

Christie had watched wall-to-wall coverage of the case, and it made him uncomfortable. He decided he did not want to run his office in that way. Instead of bulldozing New Jersey companies facing smaller-scale fraud cases and leaving their employees out of work, Christie preferred to build a case against the firms and then bring their leaders in for a take-it-or-leave-it chat. Ultimately, seven New Jersey corporations accepted deferred prosecution agreements, or deals with the government that let them avoid trial in exchange for the companies hiring independent monitors to oversee operations and put in place guards against future wrongdoing.

Christie often was relieved they were open to the deals. 'Put the company itself out of business? Lose all the jobs?' Christie asked when asked about the alternatives. He pointed to a corruption case he built against St. Barnabas Health Care System, the state’s largest, for double- and over-billing Medicare and Medicaid services. St. Barnabas paid $265 million to settle the case. 'What are you going to do?' Christie asks. 'Close the hospital, the largest hospital that serves the poor?'

Neither Time, nor Mr Christie seemed to notice that this reasoning involved a logical fallacy, a false dilemma.  True, there are two options:
1) criminally prosecute the whole company
2) allow the company to operate under a deferred prosecution or corporate integrity agreement.
But there is a third option:
3) Criminally prosecute the individuals in the company who were most involved in and most benefited from the bad behavior.

So in the St Barnabas example, what he could have done was prosecute the people at St Barnabas who were most responsible for the over-billing, and let the hospital itself go with a fine. Mr Christie for some reason never seemed to think about that option.  Neither have most other US law enforcers who have dealt with large organizations since.

Ironically, Mr Christie has got himself into some ethical hot water because of how he managed corporate integrity or deferred prosecution agreements involving BMS and other health care organizations.  Some have alleged that Mr Christie found some other advantages to using such agreements, advantages that accrued mainly to Mr Christie and his cronies.  As the Time article noted, re BMS

As part of its penance, the company also proposed paying for a professor of business ethics at a law school. The company initially offered to pick up the tab at a school in New York. No way, Christie said. 'This is a New Jersey case. Pick a New Jersey school,' Christie replied. Rutgers already had such a program, and there was only one other law school in New Jersey. It just happened to be Christie’s alma mater, Seton Hall. 'It couldn’t have mattered less to me,' Christie says. 'I didn’t get anything out of it. I was long graduated from Seton Hall.' (The Justice Department signed off on the agreement, but would later limit U.S. Attorneys’ ability to negotiate such deals.)

Christie’s critics pounced on the $5 million payment to Seton Hall, and to this day are trying to use it as a way to suggest he is another pay-to-play New Jersey politician.

And in two other health care cases:

Christie hired former Attorney General John Ashcroft, his one-time boss, to monitor Zimmer Inc., one of the firms that settled with the government. In turn, Ashcroft’s company charged between $1.5 million and $2.9 million a month to monitor the medical device company. By the time Christie arrived in Washington to answer lawmakers’ questions, The Ashcroft Group had earned $52 million on that case. 'To me, that is outrageous,' Rep. Steve Cohen chided Christie. 'I don’t care what you did. It is not worth $52 million,' the Tennessee Democrat continued. 'Even if you took steroids and hit 70 home runs, it is not worth $52 million.'

Lawmakers also wanted to know why he named David Kelley to a post to oversee the Bristol-Myers Squibb settlement. Kelley two years earlier, as a former prosecutor, declined to bring securities fraud charges against Todd Christie, the future-Governor’s brother. Was this payback for sparing a Christie Family?

Mr Christie defended his conduct in the BMS case:

Christie to this day says he has no regrets about the deferred prosecution agreements, including the professor position. To him, it matters less about whether there was a conviction than whether the illegal behavior ended. 'The goal as the U.S. Attorney is to stop the conduct,' Christie says. 'If you’ve stopped the conduct, you’ve won.'

But of course the current case, and those involving BMS from 2014 and 2015, shows that Mr Christie's corporate integrity agreement did not "stop the conduct" at least in the case of BMS.  That rationale was fallacious too.


Summary

Now that political campaigners are once again shouting about law and order, maybe this is the time to call for effective and equal enforcement of the laws regarding white collar crime in health care.  For years, we have watched perpetrators of small scale Medicaid and Medicare fraud go to jail.  Yet when big companies are accused of big scale crime, almost no one ever goes to jail.

It is time for equal justice for all in health care.

Let me end with a quote from a report by Senator Elizabeth Warren (D - Massachusetts) published in January, 2016, entitled "Rigged Justice: 2016 - How Weak Enforcement Lets Corporate Offenders Off Easy."

 Laws are effective only to the extent they are enforced. A law on the books has little impact if prosecution is highly unlikely.

This country devotes substantial resources to the prosecution of crimes such as murder, assault, kidnapping, burglary and theft, both in an effort to deter future criminal activity and to provide victims with some degree of justice. Strong enforcement of corporate criminal laws serves similar goals: to deter future criminal activity by making would-be lawbreakers think twice before breaking the law and, sometimes, by helping victims recover from their injuries.

When government regulators and prosecutors fail to pursue big corporations or their executives who violate the law, or when the government lets them off with a slap on the wrist, corporate criminals have free rein to operate outside the law. They can game the system, cheat families, rip off taxpayers, and even take actions that result in the death of innocent victims—all with no serious consequences.

The failure to punish big corporations or their executives when they break the law undermines the foundations of this great country: If justice means a prison sentence for a teenager who steals a car, but it means nothing more than a sideways glance at a CEO who quietly engineers the theft of billions of dollars, then the promise of equal justice under the law has turned into a lie. The failure to prosecute big, visible crimes has a corrosive effect on the fabric of democracy and our shared belief that we are all equal in the eyes of the law.

Under the current approach to enforcement, corporate criminals routinely escape meaningful prosecution for their misconduct. This is so despite the fact that the law is unambiguous: if a corporation has violated the law, individuals within the corporation must also have violated the law. If the corporation is subject to charges of wrongdoing, so are those in the corporation who planned, authorized or took the actions. But even in cases of flagrant corporate law breaking, federal law enforcement agencies – and particularly the Department of Justice (DOJ) – rarely seek prosecution of individuals. In fact, federal agencies rarely pursue convictions of either large corporations or their executives in a court of law. Instead, they agree to criminal and civil settlements with corporations that rarely require any admission of wrongdoing and they let the executives go free without any individual accountability.

And end with a video of her speaking on the subject.




Tuesday, July 19, 2016

UnitedHealth's Optum Division Settles Case Alleging it Enrolled Non-Terminally Ill Patients in Hospice, Thus Risking Their Deaths Due to Treatable Illnesses

Fraudulant hospice enrollment is a uniquely dangerous practice, yet the latest cases of it have, as usual, attracted little attention.

Background

As we have discussed before, hospice care was initially designed to provide more humane treatment of the terminally ill, particularly patients with advanced cancer.  The idea was that rather than subjecting such patients to futile, but often painful or dangerous treatment, they would receive humane, palliative care.  Hospice care initally was provided in the US by small, local non-profit organizations.  But since Medicare pays for hospice care fairly well, for-profit corporations soon got into the act.  As we have discussed previously, some hospices, often but not always for-profit, began to admit patients who were not terminally ill.

The danger is that hospice care specifically excludes potentially curative care, such as antibiotics for infection or surgery for appendicitis.  So if a patient who is not terminal is in hospice and that patient develops severe bacterial pneumonia, that patient may not get antibiotics and thus may die of a potentially curable disease. 

We have been writing about this dangerous aspect of modern hospice care since 2011 (look here).  In various posts here we have detailed particular cases of non-terminal patients admitted to hospice who later died, seemingly of the neglect of treatable illness mandated by the concept of hospice care.  There have also been cases in which patients with chronic pain, but no terminal illness, may have died from hospice's overly aggressive use of narcotics .  For example, in a 2014 Wasthington Post story,

Clinard 'Bud' Coffey, 77, a retired corrections officer, did the crossword in The Charlotte Observer after breakfast every morning, pursued his hobby of drawing cartoons, talked seven or eight times a day to his son Jeff and, just two weeks before his death, told a pal that he still felt 'like a teenager.'

He did, however, have some chronic back pain, and in late March he was enrolled in hospice care 'essentially for pain management,' his doctor said. Over a two week period, he received rising doses of morphine and other powerful drugs, grew sleepy and disoriented, and stopped breathing, dying peacefully at home, according to his family and medical records they provided.

The Latest UnitedHealth/ Optum Case

The latest case of allegations of fraudulant hospice enrollment involved a very big, very profitable corporation.  As reported in detail only in the Minneapolis Star-Tribune,

A division at Minnetonka-based UnitedHealth Group is paying $18 million to settle allegations that it submitted false claims to Medicare for hospice patients who were not terminally ill.

The payment announced this week resolves a whistleblower lawsuit against Optum Palliative and Hospice Care that alleged the company tried to boost the number of patients for whom it could bill the federal Medicare program, without regard to whether they were eligible for and needed hospice services.

UnitedHealth Group's Optum subsidiary is a fairly big player in the commercial hospice world,

Optum/Evercare provides hospice care in 12 U.S. markets, including Arizona and Colorado. It does not operate in Minnesota.

The Strib provides a bit more detail about what seems to have happened.

The government alleged that false claims in the case were submitted to Medicare from Jan. 1, 2007, through Dec. 31, 2013. The lawsuit argued that Optum discouraged doctors from recommending that ineligible patients be discharged from hospice, and failed to ensure that nurses accurately and completely documented patients’ conditions.

The allegations were first raised by former employees in whistleblower lawsuits, which let private parties sue on behalf of the government and share in any recovery. The share to be awarded in the Optum case has not yet been determined, the Justice Department said in a news release.

As is now tediously typical in legal settlements involving large health care organizations, the government allowed the case to settle without any determination of guilt or innocence, and of course, without any individual who may have profited from the alleged bad behavior having to suffer any negative consequences.

'We are pleased to resolve this issue and are proud of our long record of providing high-quality, compassionate hospice care consistent with the needs of patients and supported by their doctors and family members,' Optum said in a statement. 'We believe Evercare Hospice acted properly and did not engage in wrongdoing.'

Also,

'The claims resolved by the settlement are allegations only, and there has been no determination of liability,' the Justice Department said in a news release.

As is also usual in these cases, the monetary value of the settlement, while it might appear large to a middle-class lay-person, is tiny compared to the revenue of UnitedHealth. For example, according to Google Finance, the corporation's 2015 total revenue exceeded $157 billion.

All that would be bad enough if the case only involved financial fraud.  Again, as noted above, it is possible that some patients without terminal disease who were enrolled in UnitedHealth's Optum hospice could have died of treatable conditions.  Yet this possiblility was not addressed by the limited press coverage of this case, or even by the US Department of Justice's news release about the settlement

Other Recent Cases

In 2016, there have been nearly anechoic media reports of cases of smaller hospices at least alleged to have deliberately enrolled non-terminal cases.  Perhaps because these organizations involved were not "too big to jail," some of these cases involved findings of guilt.

Home Care Hospice

In February, 2016, according to the Philadelphia Business Journal,

Nearly three years after fraud charges against a Philadelphia nurse first surfaced, a jury found 68-year-old Patricia McGill guilty for her role in scamming Medicare out of $9.32 million.

McGill was the director of professional services for Home Care Hospice for roughly three years beginning in 2005. During that time, she authorized and supervised the admission of patients for hospice services that they did not need or were not eligible for, according to court records.

This was not the first finding of guilt in this case involving a small, local for-profit hospice.

Alex Pugman and Matthew Kolodesh, the owners of the defunct Home Care Hospice – at one time located along Grant Avenue in Northeast Philly – were previously convicted for their part in the crime. Kolodesh, of Bucks County, was sentenced to 14 years in prison after being found guilty on more than 30 separate counts.

Note that the sentences were severe, but as far as I could tell, not based on the possible danger to patients without terminal illness created by their admission to hospice.

Horizon Hospice Subsidiairy of  JourneyCare

As reported by the Pittsburgh Post-Gazette in March, 2016,

The former top executive at Horizons Hospice in Monroeville is set to enter a guilty plea Friday in connection with charges of scheming to send patients to the center who weren’t terminal so she could bill Medicare and Medicaid.

She was not the first person to be found guilty in this case.

One of the key witnesses was expected to be Oliver Herndon of Peters, the medical director at Horizons from 2008 to 2012.

Herndon was sentenced in July to 33 months in prison after pleading guilty to certifying patients for hospice care who weren’t terminal and keeping them there longer so Horizons could continue billing the government.

Again, the possible danger to the fraudulantly enrolled patients was not discussed in the media accounts. Note that Horizons Hospice is a subsidiary of JourneyCare, which appears to be a non-profit organization.

Multiple Michigan Hospices

As reported in April, 2016, by the Washington Free Beacon,

Five individuals who have donated to Democratic politicians pleaded guilty to a scheme that drained Medicare out of $33 million dollars.

Two physicians and three owners of hospice and home care companies based out of Detroit, Mich., were charged on June 18, 2015 as part of the largest Medicare fraud case in history for submitting fraudulent claims for home health care and hospice services that were either not provided or deemed medically unnecessary.

The elaborate operation revolved around Muhammad Tariq, Shahid Tahir, and Manawar Javed—the owners of the home health care and hospice companies—paying kickbacks and bribes to physicians for referrals to their companies that included A Plus Hospice and Palliative Care, At Home Hospice, and At Home Network Inc.

While the reporting of this case focused on the apparent political leanings of the individuals involved, it also ignored any danger to non-terminal patients.


Discussion

The problem of fraudulant enrollment of non-terminal patients in hospice continues, despite our efforts over five years to make the problem more public.  The latest case involved a very big, very wealthy for-profit health care corporation which has had its share of troubles in the past.  Yet the latest case is as anechoic as earlier ones, including smaller cases this year.

These enrollments may be motivated by the desire for more money, but they put patients at risk.  Nonetheless, such abuses by hospices get little press coverage, seemingly are ignored by health care regulators and law enforcement, and are almost completely anechoic in the health care, medical and health policy literature.

If a measure of society is how it cares for the most vulnerable patients, the US laissez faire approach to for-profit hospices suggests a society in decline.

To repeat what I wrote the last time for-profit hospices were (barely) in the news for enrolling the wrong patients,...

 In my humble opinion, we should return control of direct patient care, especially of the most vulnerable patients, to health care professionals and if necessary small non-profit community organizations.  We ought to give strong consideration to banning corporate hospices, and banning all forms of the corporate practice of medicine and corporate health care "delivery."

Given how many insiders make so much money from the current version of laissez faire capitalism in health care, however, I would expect strong resistance should such apparently "radical," but actually conservative proposals actually get any mainstream attention.

But in an election season now often dominated by ridiculous hyperbole and outlandish statements, maybe such vitally (literally) important issues should start getting some attention.     

Thursday, July 14, 2016

Abort, Retry, Fail - Billionaire Bill Gates Opines, Sans Evidence, on ... the Efficacy of Hepatitis C Treatment?

If you needed advice about the technical characteristics of computer operating systems you probably would not go to your doctor for it.  So why would you seek the opinion of a software company mogul about the efficacy of pharmaceuticals?

Software Mogul Bill Gates on the Pricing and Efficacy of Antiviral Drugs for Hepatitis C 

Nonetheless, per Bloomberg, last week Bill Gates pontificated about drugs for the treatment of hepatitis C.  When apparently asked about the priorities of the Bill and Melinda Gates Foundation, Mr Gates said

market forces were working properly in hepatitis C, invoking Gilead Sciences Inc.’s treatments Sovaldi and Harvoni, which have been criticized by insurers and politicians as too expensive at $1,000 a pill or more for 12 weeks of treatment, before discounts and rebates.

While Gilead is the market leader, it’s now facing competition from Merck & Co. and AbbVie Inc., forcing prices lower.

'Curing hepatitis C, this is a phenomenal thing, and now you have multiple drug companies competing in terms of the quality and the price of that offering,' he said.

More broadly, Mr Gates defended the high prices of drugs in the US, partly because:

The drug companies are turning out miracles....

Not a Wonder Drug, According to the Clinical Research Evidence

Mr Gates, it seems, has not done a critical review of the data on the new antiviral treatments for hepatitis C.  In fact, starting in March, 2014, we have posted about the lack of good evidence from clinical research suggesting these drugs are in fact so wondrous.  The drugs are now touted as "cures," at least by the drug companies, (look here), and physicians are urged to do widespread screening to find patients with asymptomatic hepatitis C so they can benefit from early, albeit expensive treatment.

However, as we pointed out (e.g., here and here)
-  The best evidence available suggests that most patients with hepatitis C will not go on to have severe complications of the disease (cirrhosis, liver failure, liver cancer), and hence could not benefit much from treatment.
-  There is no evidence from randomized controlled trials that treatment prevents most of these severe complications
-  There is no clear evidence that "sustained virologic response," (SVR), the surrogate outcome measure promoted by the pharmaceutical industry, means cure. 
-  While the new drugs are advertised as having fewer adverse effects than older drugs, it is not clear that their benefits, whatever they may be, outweigh their harms.

Furthermore, health care professionals and researchers with heftier credentials in clinical epidemiology and evidence based medicine than mine have since published similar concerns.  These included
- a report from the German Institute for Quality and Efficiency in Health Care (the English summary is here)
- an article in JAMA Internal Medicine from the Institute for Clinical and Economic Review (1)
- a report from the Center for Evidence-Based Policy (link here)
- an article in Prescrire International (2)

These publications and your humble scribe noted that the clinical trials or other types of clinical research about new hepatitis C treatment published in the most prominent journals had numerous methodologic problems that all seemed likely to make the new drugs look better, perhaps intentionally.  (See posts herehere, and here.)

Why Do Rich People Who Run Foundations Tout Expensive Drugs?


Yet there is something about hepatitis C and the newer treatments of it that seems to inspire rich people who run foundations to sound like marketers for Gilead, sans evidence to support their viewpoints.  About one year ago, former US President Bill Clinton, now a leader of the well-publicized Clinton Foundation and of the now apparently independent Clinton Health Access Initiative, said something similar, as we posted here:

Clinton pointed to new hepatitis C drugs, Sovaldi and Harvoni, which are sold by Gilead Sciences for more than $80,000 for a 12-week program of treatment. Those medications often cure a disease that can cause liver disease and eventually lead to transplants or death, which are expensive, too. But the sticker price on the drug has caused a backlash by payers and patients.

'Who wants to let somebody's liver rot? Nobody,' Clinton said. 'Who's got $80,000 to spend? Not many. And if you're a small businessperson and you're in a small pool [of employer-based insurers], are you going to fire somebody who needs that treatment? These are all practical problems, and we can solve them.'

So what is going on here?  In a general sense, it may be that people who have become very rich, and have held very high level executive positions, start to believe they are expert on everything, especially in a country increasingly dominated by market fundamentalism/ neoliberalism in which money is touted as the ultimate measure of everything important.  But more specifically, Mr Gates may also be spending too much time with the top brass of his foundation, who may be all too used to hawking expensive drugs.

Former Pharmaceutical and Biotechnology Executives Running Supposedly Charitable Foundations

In particular, the current CEO of the Gates Foundation is Dr Susan Desmond-Hellmann.  When Dr Desmond-Hellmann's appointment as Chancellor of UCSF was announced in 2009, I suggested that she was a very unusual choice because of aspects of her track record in the pharmaceutical/ biotechnology business.  During her previous service as President of Drug Development at Genentech, Dr Desmond-Hellmann had defended the then sky high pricing of bevacizumab.  Of course, Dr Desmond-Hellmann, as a top executive, personally profited from such pricing.  In her last year at Genentech while the company was still independent, her total compensation was over $8,000,000.  As we discussed in 2014, while she was at UCSF, questions arose about her committment to public health when it was revealed she and her husband had large stock holdings in the tobacco company Altria.  Yet she continued to dismiss the importance of her many apparent conflicts of interest.

Also, in 2011, prior to the hiring of Dr Desmond-Hellmann, as we discussed here, a PLoS Medicine article by Stuckler et al(3) suggested a revolving door between the leadership of the Gates Foundation and of pharmaceutical and biotechnology companies,

Members of personnel also move between the Foundation and pharmaceutical companies. For example, in April 2010, a former Merck senior vice president, Richard Henriques, became the chief financial officer of the Gates Foundation. At least two other members of the Gates Foundation leadership have transferred from the leadership of GlaxoSmithKline to sit on the Foundation’s board of directors, including Kate James, the chief communications officer, and Tachi Yamada, until February 2011, the head of the Foundation’s global health program. Similar patterns were observed with the other foundations studied.


Foundations Promoting the Biotechnology and Pharmaceutical Agenda

Dr Desmond-Helmann has continued to use her bully pulpit at the Gates Foundation to promote high-tech medicine that uses the newest, most expensive drugs.  For example, in an interview in December, 2015 in the Washington Post, she promoted "precision public health" which would emphasize the supposed "innovation, that speed, that ability to use big data" characteristic of precision medicine brought to public health.  However, "precision medicine" has so far not been proven to fulfill its promise to benefit patients.

In addition, in May, 2016, a Wall Street Journal article noted that she has led the Gates Foundation to invest in commercial biotechnology firms,

Dr. Desmond-Hellmann cited a $52 million investment by the foundation in CureVac, a German biopharmaceutical company, as the type of partnership that could produce new tools against epidemics. CureVac is developing vaccine technologies based on messenger RNA that would instruct the body to produce its own defenses against infections. The funding, which the foundation announced in 2015, is for construction of a manufacturing facility; the foundation said it would provide additional funding to develop vaccines for several infectious diseases.

Are these investments the best way to provide better global health care?  An aside in the Bloomberg article suggests they may be more about making money.

The foundation reported in May that it had received an unexpected boost to its endowment when a stake in a small biotechnology firm, Anacor Pharmaceuticals Inc., sold for $86.7 million -- about 17 times the fund’s original investment. While the foundation had invested in Anacor to encourage the company’s work in neglected diseases, Anacor shares took off after its toenail fungus drug was approved.

I am sure that toenail fungus is not a major public health problem anywhere, much less in the developing world.

The tragedy here is that the Gates Foundation, which appears to be the largest private foundation in the US (and the world), has a huge impact on global health, and yet its leadership is squandering its moral authority in the pursuit of the pharmaceutical/ biotechnology agenda.  A review of a new book out about the foundation in November, 2015 in the Intercept noted that the book's author

spends much more time discussing whether the Gates Foundation is protecting the patents of pharmaceutical companies and whether it is making common cause with Monsanto to spread genetically modified crops in Africa

In January, 2016, the  Global Policy Forum put out a report that, per a Guardian article,  accused

organisations like the Bill and Melinda Gates Foundation, the Rockefeller Foundation and others are promoting solutions to global problems that may undermine the UN and other international organisations, says the report by the independent Global Policy Forum, which monitors the work of UN bodies and global policymaking.

Futhermore, the report asserted,

 Through their multiple channels of influence, the Rockefeller and Gates foundations have been very successful in promoting their market-based and bio-medical approaches towards global health challenges in the research and health policy community – and beyond.

More specifically, an article in the Independent accused the foundation of having a

ideological commitment to promote neoliberal economic policies and corporate globalisation


The report, per the Guardian, also accused the foundation of conflicts of interest,

The report also questions why the Gates foundation invests heavily in companies like Monsanto and Bayer. 'In addition to its grant-making activities, the Gates foundation has recently stepped up its support for the biotechnological industry directly.'

Also, similar to the PLoS Medicine article cited above(3)

'There is a revolving door between the Gates foundation and pharmaceutical corporations. Many of the foundation’s staff had held positions at pharmaceutical companies,' the report adds.

More dramatically, per the Independent,

the Gates Foundation 'often appears to be a massive, vertically integrated multinational corporation, controlling every step in a supply chain that reaches from its Seattle-based boardroom … to millions of end-users in the villages of African and south Asia.'

Furthermore, per the Intercept book review article, the larger problem is that the Gate Foundation and its CEO are largely unaccountable,

Bill and Melinda Gates answer to no electorate, board, or shareholders; they are accountable mainly to themselves. What’s more, the many millions of dollars the foundation has bestowed on nonprofits and news organizations has led to a natural reluctance on their part to criticize it. There’s even a name for it: the 'Bill Chill'  effect.

I would note parenthetically the foundation's board of trustees only includes Bill and Melinda Gates, Mr Gates' father, and Mr Warren Buffet.  Most large foundations have considerably larger boards of trustees, with at least some diversity in family membership and backgrounds.

In an interview with the Financial Times in March, 2016, Dr Desmond-Hellmann made a hash of addressing the accountability issue:

Accountability is another concern. To whom do these multibillion-dollar foundations answer?

For once, Dr Desmond-Hellmann’s confident responses falter. In reply to a suggestion that trans­parency is not the same thing as accountability — putting everything online means you can see what the foundation is doing, but does not mean that it is being held to account — she seems uncharacteristically stuck for words.

'The way that people can hold us accountable is to look at what we achieved as a foundation through our collaborations,' she says, quickly regaining her poise.


So even the foundation's CEO cannot say to whom, and how she is accountable.


Conclusions

So maybe Bill Gates' seemingly ill-informed apologia for the extremely high drug prices charged in the US, and his lack of understanding of the evidence about the efficacy, or lack thereof, of some of these high priced drugs is a small humorous story that indicates just the tip of the iceberg.  It appears that in our current market fundamentalist, neoliberal world, foundations may be more about promoting the commercial interests of their board members and officers than about improving the lot of humanity.  Yet for the most part they may succeed in obfuscating what they are doing through the haze of marketing and public relations.

True health care reform would first make transparent the web of institutional and individual conflicts of interest that seems to tie together nearly all big health care organizations, and open discussion of how to make health care organizations better serve health care rather than the narrow financial interest of their top leaders.

Graphic Interlude

A "blue screen of death"



 References

1. Ollendorf DA, Tice JA et al. The comparative clinical effectiveness and value of simeprevir and sofosbuvir in chronic hepatitis C viral infection. JAMA Intern Med 2014. Link here.
2. Sofosbuvir (Sovaldi), active against hepatitis C virus, but evaluation is incomplete. Prescrire Int 2015; 24: 5- 10. Link here.
3.  Stuckler D, Basu S, McKee M. Global health philanthropy and institutional relationships: how should conflicts of interest be addressed? PLoS Med 8(4): e1001020.  doi:10.1371/journal.pmed.1001020.  Link here.

Wednesday, July 13, 2016

Two recent stories of EHR un-exceptionalism, and a connection to prior HC Renewal posts including my own experiences

The following stories recently appeared in the press about the "un-exceptionalism" (or, I might more accurately state, the negative exceptionalism) of today's EHR technology.

Regarding each organization mentioned, I have had personal experience that, in retrospect, aligns with views I expressed about the organizations years ago.

First:

EHR safety goes to court
By Lisa Schencker
June 25, 2016
http://www.modernhealthcare.com/article/20160625/MAGAZINE/306259982

One patient's blood pressure plummeted dangerously after he was allegedly discharged with the wrong medications. In another instance, a physician couldn't place a pharmacy order for a newborn to receive vitamin K, which is given to babies to prevent serious bleeding.

On several other occasions, patients weren't accurately tracked, creating potential problems getting drugs to them.

Each of these alleged mishaps occurred at PinnacleHealth, a three-hospital system based in Harrisburg, Pa. PinnacleHealth blames each of the mishaps on its electronic health records vendor, Siemens; Cerner Corp. purchased Siemens' health IT business in February 2015.

The relationship between healthcare system and vendor devolved into this dueling lawsuit:

The incidents came to light as part of a breach-of-contract lawsuit Cerner filed against PinnacleHealth last year after the system, which had used Siemens as a vendor for 20 years, sharply curtailed its relationship and entered into a contract with a competing EHR vendor, Epic Systems Corp. PinnacleHealth related the incidents in its counterclaim; the counterclaim was filed in March of this year in state court in Pennsylvania, where it is seeking damages for Cerner's alleged fraud and breach of contract.

(I am cited in the article with respect to hold harmless clause-related issues not relevant to this blog posting.)

Cerner Corp. purchased Siemens' HIT business in Feb. 2015.  Prior to that, Siemens was an independent vendor of an EHR suite known as Soarian, deployed at PinnacleHealth as early as 2008.

See for instance http://news.usa.siemens.biz/press-release/customer-solutions/soarian-plan-care-assists-clinicians-developing-and-deploying-goal-

Soarian Plan of Care Assists Clinicians in Developing and Deploying Goal-Oriented Plans of Care
Monday, February 25, 2008

Siemens (http://www.usa.siemens.com/healthcareit) today announced that PinnacleHealth, a 750-bed, non-profit hospital and healthcare system serving Central Pennsylvania, and CentraState Healthcare System, a 272-bed, non-profit medical facility located in Freehold, N.J., have each signed on to serve as beta sites for Soarian® Plan of Care, a solution designed to support inter-disciplinary care teams in defining and helping to manage patient problems, interventions and expected outcomes, to provide care in order to achieve desired outcomes and to generate new knowledge at the point of care.

Notwithstanding my warnings on this blog and elsewhere that hospitals should NEVER be "beta testing sites" for experimental HIT software used on live patients without informed consent, that the relationship devolved to dueling lawsuits involving safety is not a surprise to me.

Relating to my own experiences as posted previously on this blog:

On August 20, 2009 I posted "Why Siemens Healthcare Fails" (http://hcrenewal.blogspot.com/2009/08/why-siemens-healthcare-fails.html).  In that post I noted regarding a job posting by Siemens for a "physician consultant" on HIT implementation:

... This [Siemens] job description might better be described as "glorified salesperson." It might be a good exit route for a "techie doc" (usually, someone who knows just enough about HIT to be destructive) who hates the current practice environment. It might also be good for managers who don't want knowledgeable experts pointing out their bad decisions and mismanagement, but I think a global company like Siemens should be setting its sights higher in such a crucial area as electronic medical records and clinical IT consultants.

I would not want such a physician advising or supporting complex HIT projects at my organization.

I also recalled my own Siemens face time:

... I spent time at Siemens Healthcare headquarters in Erlangen in 2000, and was offered gracious hospitality and a position overseeing the Soarian cardiology suite [as a result of my work in development of an extensive cardiology information system as CMIO at Christiana Care in Delaware from 1996-8]. The people I met in Erlangen then seemed extremely competent and informatics-savvy, but I turned the offer down through no fault of Siemens. I'd received a near-simultaneous offer (FAXed to my hotel in Erlangen, in fact) from pharma that involved a much stronger management role.

I understand through conversations over the past few years with current and ex-Siemens personnel that most of the Siemens personnel I'd met in Germany in 2000 are no longer with the company. I was told they'd performed suboptimally after the acquisition/merger with Shared Medical Systems (SMS) in Malvern, PA. (I do not find that credible, and would find it far easier to accept that the problems were on the American side, but that is a personal opinion.)

I'd informed my German hosts in 2000 that they'd better be very, very careful about acquisition of an American HIT company due to my experiences with a number of such companies, which I found highly political and highly ignorant of EHR quality issues.

Then, in my Feb. 2016 post "Plaintiff's Lawyers Are The Cause of EHR Problems?" (http://hcrenewal.blogspot.com/2016/02/himss-2016-presentation-plaintiffs.html) I recounted further experience with Siemens:

... an anecdote regarding the health IT Industry in the U.S.: the cardiology information system I developed, linked to above in the 2nd bullet point, was seen in 2000 by German engineers at Siemens Healthcare Erlangen as exemplary, and they offered me a position to further develop it, that I declined due to a simultaneous superior offer from Merck Research Labs.  However, in 2007 when I again spoke to Siemens, this time to Americans at the former Shared Medical Systems in Malvern, PA that had been acquired by Siemens, they found a system that actually produced clear, detailed outputs in a critical care area and was in use at the time in a major healthcare system in the region "impractical" - and never followed up with me.  Pearls before....)

 Finally, Siemens seems to have ignored a well-qualified informatics internal expert on explicit EHR safety warnings, as in my Feb. 8, 2010 post "A Lawsuit Over Healthcare IT Whistleblowing and Wrongful Discharge: Malin v. Siemens Healthcare" (http://hcrenewal.blogspot.com/2010/02/lawsuit-over-health-it-whistleblowing.html):

  • Siemens Medical's physician internal consultants (skilled anesthesiologists/informatics specialists), apparently in writing and including a remediation plan, opined that an IT system developed for critical care had numerous severe flaws, of sufficient seriousness that in their opinion the systems could harm or even kill patients if deployed;
  • These were warnings of defects and flaws in IT in the worst possible medical environment, critical care with the sickest and most vulnerable of patients, not some ambulatory clinic or primary care office;
  • Allegations were raised that the warnings were ignored, with at least one of the physicians, Dr. Malin, who was strongly concerned and vocal about the risks then being told his position was being eliminated. [It is not a surprise to note this rings alarm bells about the possibility of wrongful discharge based on retaliation and/or "greasing the skids" to eliminate potential whistleblowers or "non-team players" who could delay release of the software and affect revenue - ed.];
  • The company possibly ignored the remediation plans of their own clinician/informatics experts;
  • There were allegations of company misrepresentations about the new system to the FDA;
  • There were allegations of decision making on these issues by non-clinician IT managers lacking healthcare or healthcare informatics expertise.
  • A wrongful discharge complaint and then lawsuit were filed by Dr. Malin on the basis of violation of the whistleblower protection provisions of the Sarbanes-Oxley Act of 2002 (SOX), 18 U.S.C. § 1514A ("Civil action to protect against retaliation in fraud cases - Whistleblower Protection for Employees of Publicly Traded Companies");
  • The suit was dismissed on the apparent technicality that Siemens Medical in the U.S. is not subject to the provision in the SOX Act as is the publicly-traded corporate parent, Siemens AG; from document #4, pg 15:
... Health Services is a wholly-owned subsidiary of Siemens Med ... Siemens Med is a wholly-owned subsidiary of Siemens Corporation, which is indirectly owned, through two intervening layers, by Siemens AG, a German company that is publicly traded as defined by § 1514A of SOX ... Of these entities, only Siemens AG is a publicly-traded company. While both Health Services and Siemens Med are incorporated in Delaware and located in Malvern, Pennsylvania, they are separately incorporated entities.
  • Siemens Medical in their response to the suit denied the most severe allegations regarding the IT defects, but this issue was not followed up upon due to the lawsuit's dismissal on SOX issues despite the obvious potential public hazards the allegations of IT defects could represent;
  • In fact a US District Judge in the case, Peter J. Messitte, in the period after allowing Malin to prove the validity of SOX towards his case, opined that "No other discovery will be permitted, including but not limited to the alleged safety problems of Defendants’ product", document 4 above, Judge Messitte opinion, US District Court Maryland, pg. 25. [While perhaps understandable from a legal perspective, injured or dead patients don't really care about what legal precedents got them into the injured or dead state - ed.]
  • Siemens Medical admitted in their responses to the suit that some of the software in question, actually put in use in hospitals, was in fact "beta" software, i.e., experimental (per Item 38 in 'Siemens Answer to Complaint' document).

There's that "beta-software" issue again.

So, the acquirer (Cerner) of a product of an American Siemens HIT subsidiary that appeared to have what I consider defective HIT talent management practices (as exemplified by the aforementioned JD); bizarre views about successful, high-quality EHR software (seen by their German counterparts a few years prior as exceptional); and that appears to have not been very happy about its own employee warning explicitly of beta ICU software being so bad it could kill patients is now embroiled in litigation regarding safety by a former customer.

None of this is surprising to me at all.  Incompetence can only go so far in healthcare before things blow up.

An unanswered question, of course, is whether patients were harmed or killed as a result of Siemens software, including its beta tests on unsuspecting patients.

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

Here is a second story of EHR un-exceptionalism with a personal twist, this article in the Journal of the American Medical Informatics Association (JAMIA):
Comparison of accuracy of physical examination findings in initial progress notes between paper charts and a newly implemented electronic health record, June 28, 2016
http://jamia.oxfordjournals.org/content/early/2016/06/28/jamia.ocw067

Introduction There have been several concerns about the quality of documentation in electronic health records (EHRs) when compared to paper charts. This study compares the accuracy of physical examination findings documentation between the two in initial progress notes.

Methodology Initial progress notes from patients with 5 specific diagnoses with invariable physical findings admitted to Beaumont Hospital, Royal Oak [Michigan, near Detroit -ed.], between August 2011 and July 2013 were randomly selected for this study. A total of 500 progress notes were retrospectively reviewed. The paper chart arm consisted of progress notes completed prior to the transition to an EHR on July 1, 2012. The remaining charts were placed in the EHR arm. The primary endpoints were accuracy, inaccuracy, and omission of information. Secondary endpoints were time of initiation of progress note, word count, number of systems documented, and accuracy based on level of training.

Results The rate of inaccurate documentation was significantly higher in the EHRs compared to the paper charts (24.4% vs 4.4%). However, expected physical examination findings were more likely to be omitted in the paper notes compared to EHRs (41.2% vs 17.6%). Resident physicians had a smaller number of inaccuracies (5.3% vs 17.3%) and omissions (16.8% vs 33.9%) compared to attending physicians.

Conclusions During the initial phase of implementation of an EHR, inaccuracies were more common in progress notes in the EHR compared to the paper charts. Residents had a lower rate of inaccuracies and omissions compared to attending physicians. Further research is needed to identify training methods and incentives that can reduce inaccuracies in EHRs during initial implementation.

Apparently not covered in the article was the issue of patient harms that might have occurred (and could still occur) due to the "significantly higher rate of inaccurate documentation" in the EHR.   

"Beaumont Hospital" caught my eye, as I had interviewed for the CMIO role there in 2007 or early 2008.  My experiences are memorialized in an anonymized post at my Drexel informatics site which I reproduce in part here (the full essay is at http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=an_expert_says):
Sure, the experts think you shouldn't ride a bicycle into the eye of a hurricane, but we have our own theory

A medical informaticist who formerly held a “Director of Informatics” role a number of years ago in a very large hospital system, and who left the role due to a toxic management environment and lack of authority commensurate with responsibility, was seeking applied Chief Medical Informatics Officer (CMIO) positions once again.  ... He makes the following observations after completing two full rounds of interviews at a prestigious hospital system similar in size to his erstwhile employer, in a very competitive environment, that recently experienced a decline in its clinical quality stats. The organization feels the quality stats themselves were inaccurate, in part due to lack of good healthcare IT.

From what the informaticist was able to gather, their leadership was displeased. Board members were seasoned executives from a heavy-manufacturing industry that is extremely dependent on information technology and concurrent supply chain data. These executives apparently recommended that the organization move quickly on implementing EHRs.

The organization is thus planning to implement EHRs for thousands of physicians, most of whom are not employed by the hospital but are independent private practitioners, and likely to be skeptical or concerned about time impact and “grading” that could affect their livelihoods.  The hospital leaders also wanted to create integrated systems drawing on EHR data to automate quality reporting to regulatory agencies, as well as to support ongoing, funded clinical drug and device trials.

The informaticist was interviewed by the usual mix of clinician eager adopters, clinician skeptics, knowledgeable executives, skeptical executives who knew little about clinical IT, IT personnel who seemed overconfident given the enormity of the tasks at hand, and those who were clearly frightened by the prospect of being held accountable for a project of this magnitude. In the end, the informaticist did not get the position due to the organizational leaders being adamant the incumbent CMIO needed to also practice medicine.  The informaticist had explained on the first round that he believed a leadership role in a project of such magnitude and challenge called for the highest levels of executive presence and freedom from distraction, thus he did not intend to practice medicine (he had not practiced in his former Director of Informatics role for the same reasons).

He’d thought this issue had been settled after the first round of interviews, leading to the invitation for round two. This line of questioning was revisited, however, in round two in a group interview setting. The group interview was attended by a number of people with whom he’d already discussed this issue via individual meetings in round one. This suggested his time was being wasted and was rather annoying, especially considering that the informaticist had flown cross-country not once but twice to an organization not in consensus about a very basic hiring requirement
... It is not as if the organization had a doctor shortage, or that such a role would have ample free time where the incumbent would be idly sitting at their desk unless this time was absorbed seeing patients in the clinic. 

The stated reason for the organization’s wanting the CMIO to practice medicine was “to have credibility with the doctors.”  The informaticist explained that he’d found this not to be the case, that physicians being put “under the gun” of using EHR’s were generally more concerned that the CMIO had the executive authority to best represent their interests and understood medicine from training and practice at some point, not necessarily concurrently with the CMIO role.  Interestingly, there is no empirical research on this point, so the issue was the informaticist’s experience vs. the hospital’s ‘second-guessing’ a seasoned expert.

Ironically, the informaticist was told during his interviews that a CMIO they'd hired a few years ago had left, in part due to being overextended.  He was also told that some of the clinical IT problems he'd solved as a CMIO in the past Director of Informatics position were problems this organization had not been able to solve during the same time frame.

... Regarding underestimation, this organization appeared to have little idea of the difficulties they were getting into

... The informaticist had observed another indication that this organization ‘didn't know what they didn't know.’  He was informed that the organization had selected their EHR vendor prior to seeking a medical informatics expert. This implies they really did not understand what a medical informatics specialist does and can do, which is far more than being a tactical "EHR implementation assistant." ... The informaticist had been there, and had done that in his past role. He found it unrewarding then and actually had decided not to take the risk again, rejecting the new position, even before the organization decided they wanted an (effectively) part-time CMIO who also saw patients.

It was clear this organization, who the informaticist tried to “take to school” based on hard-earned expertise and extensive references on social issues in health informatics (e.g. on this website), felt they were the experts on what was best regarding CMIO background.   This may have been a dysfunctionality satirist Scott Adams once described like this:

Ignoring the Advice of Experts Without Good Reason
Example: Sure, the experts think you shouldn't ride a bicycle into the eye of a hurricane, but I have my own theory.

As I recall, an informatics physician much younger than I and with less experience was hired.  I do not know his fate.  However, I believe that my expertise at that time in EHR issues, and my no-nonsense stance on EHR safety and excellent management, might have averted or minimized the "inaccuracy" problems.

Therefore, it is also no surprise to me that the organization now relates the EHRs were causing significant charting inaccuracies.  It would also not surprise me if close calls and harm occurred. They apparently rode their bicycle into that hurricane, and doing so will usually produce a less than optimal outcome.

In summary, two recent articles on EHR-related lawsuits and operational problems, in my own personal experience, have potentially relevant "backstories" that may help provide context.  Those backstories relate primarily to what I've called "HIT amateurism" (e.g., faulty expertise evaluation) as well as HIT mismanagement (e.g., ignoring explicit internal warnings of dangers.)  I believe my experiences, and that of other such as Dr. Malin, are symptomatic of widespread health IT industry dysfunction.

I also believe that if this industry is ever to learn from its mistakes, it will only occur in the courtroom.  Being that the defense side is usually fierce, however, I am not sanguine needed learning will occur any time in the near future.

-- SS

Friday, July 08, 2016

Physicians go flatline on EHR enthusiasm

In a new study, physicians' enthusiasm levels for EHR's seem to resemble this EKG:




Do physicians really experience a satisfaction 'J-curve' with EHRs?
Max Green 
July 6, 2016 
http://www.beckershospitalreview.com/healthcare-information-technology/do-physicians-really-experience-a-satisfaction-j-curve-with-ehrs.html 

There's a school of thought about EHR adoption that suggests physicians experience an initial decrease in their positive perceptions of the technology, but over time those levels creep back up and ultimately surpass their pre-implementation perceptions. But does that J-curve actually exists for EHRs? A new study in the Journal of the American Medical Informatics Association says no. 

That "school of thought" must be from U.B.H. (Univ. of Blind Hyperenthusiasts) and O.U. (Ostrich University).

"[W]e did not find evidence for a J-curve pattern with respect to positive perceptions eventually exceeding baseline measures," the authors concluded. "Some measures followed a U-curve (returned to baseline), or flatlined, while most followed an L-curve (fell and remained below baseline)."

Translation: doctors hate the technology in its present form.

The study is based on a prospective longitudinal survey of Ann Arbor-based University of Michigan Health System physicians over the course of two years, from when they dropped their homegrown CareWeb EHR, for Epic's. Although all physicians received training on the new system and the system "invested substantial resources developing customized content," according to the paper, the only significant increase over baseline perception after two years of the new EHR was for documenting while in the exam room with patients. 

Surely, that accomplishment is worth the investment of hundreds of millions of dollars ...

"Future research is warranted to determine if positive perceptions eventually surpass baseline, and what interventions can help physicians use EHRs more effectively," the authors concluded.

The answer is "likely not."

In fact, the results of the new study are not surprising considering the not-so-glowing reviews of EHRs forwarded on to HHS in Jan. 2015 by the list of medical societies below (see link to the letter at my Jan. 28, 2015 post "Meaningful Use Not So Meaningful: Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing" at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html):


American Medical Association
AMDA – The Society for Post-Acute and Long-Term Care Medicine
American Academy of Allergy, Asthma and Immunology
American Academy of Dermatology Association
American Academy of Facial Plastic
American Academy of Family Physicians
American Academy of Home Care Medicine American Academy of Neurology
American Academy of Ophthalmology
American Academy of Otolaryngology—Head and Neck Surgery
American Academy of Physical Medicine and Rehabilitation
American Association of Clinical Endocrinologists
American Association of Neurological Surgeons
American Association of Orthopaedic Surgeons
American College of Allergy, Asthma and Immunology
American College of Emergency Physicians
American College of Osteopathic Surgeons
American College of Physicians
American College of Surgeons
American Congress of Obstetricians and Gynecologists
American Osteopathic Association
American Society for Radiology and Oncology
American Society of Anesthesiologists
American Society of Cataract and Refractive Surgery and Reconstructive Surgery
American Society of Clinical Oncology
American Society of Nephrology
College of Healthcare Information Management Executives
Congress of Neurological Surgeons
Heart Rhythm Society
Joint Council on Allergy, Asthma and Immunology
Medical Group Management Association
National Association of Spine Specialists
Renal Physicians Association
Society for Cardiovascular Angiography and Interventions
Society for Vascular Surgery

But, as the EHR pollyannas say, it'll all be better in ver. 2.0.

-- SS

Thursday, July 07, 2016

Bad Apple or Bad Orchard? - A Narrative of Alleged Individual Research Misconduct that Sidestepped the Pharmaceutical Corporate Context

Tales of medical research misconduct seem increasingly prevalent in the media, and are getting increasing attention.    They often may present a simple narrative, like this recent story in the New York Times, "An NYU Study Gone Wrong, and a Top Researcher Dismissed."

The Narrative Arc

A Renowned Researcher

The researcher in question was one Dr Alexander Neumeister.  Oddly enough, the article provided very little information about his background, but made it clear he was at New York University, and was a "top researcher."

The Potentially Ground-Breaking Studies

The NY Times article noted that the studies were of "an experimental, mind-altering drug."  In particular,

In one of the shuttered studies, people with a diagnosis of post-traumatic stress caused by childhood abuse took a relatively untested drug intended to mimic the effects of marijuana, to see if it relieved symptoms.

The study was ground-breaking, in that

It’s a critical time for two important but still controversial areas of psychiatry: the search for a blood test or other biological sign of post-traumatic stress disorder, which has so far come up empty, and the use of recreational drugs like ecstasy and marijuana to treat it.

The drug was not identified, but the article noted that it was

a drug intended to produce some of marijuana's effects, made by Pfizer

and was thus like the drug in "a French trial," that caused six patients to be "hospitalized with severe neurologic problems."

The study was apparently a small short-term randomized controlled trial

Some participants took the drug over a seven-day period; others took a placebo pill. The N.Y.U. team performed scans on each person to see whether brain activation patterns correlated with symptom relief.

The study called for recruiting 50 people with a PTSD diagnosis, according to study documents.

Research Misconduct Discovered

Initially, apparently,

Dr. Charles Marmar, the chairman of the psychiatry department at N.Y.U., said that people working with Dr. Neumeister had reported concerns about the lab’s compliance with research standards.

This led to

The federal inspection, from July 16 to Aug. 5 last year, found that the research team had failed to assess at least three subjects 24 hours after they had taken the experimental drug, contrary to study protocol, according to the F.D.A. letter. In several instances, the agency found, Dr. Neumeister had falsified documents by signing a fellow investigator’s name on reports. 'However, in fact, you or another study employee actually conducted these study procedures,' not the colleague, the F.D.A. concluded.

In summary

The violations 'jeopardize subject safety and welfare, and raise concerns about the validity and integrity of the data collected at your site,' the F.D.A. said in a letter
Note that the article did not explain why the FDA was called upon to investigate this problem.



Aggrieved Research Subjects

The article focused on one Ms Diane Ruffcorn, who "writes a popular Facebook blog on trauma,"

'I think their intent was good, and they were considerate to me,' said one of those subjects, Diane Ruffcorn, 40, of Seattle, who said she was sexually abused as a child. 'But what concerned me, I was given this drug, and all these tests, and then it was goodbye, I was on my own. There was no follow-up.'

After the trial, she was concerned because

Ms. Ruffcorn said she had several odd symptoms after the trial, including a hyper, wired sensation that occurred without the usual memories of abuse.  For months, she tried to find out whether those reactions were tied to the experimental drug, but because the study was shut down and the data belonged to Pfizer, the N.Y.U. doctors could not tell her whether she had taken the drug or placebo.

However,

Earlier this month, after much persistence, she found out that she’d taken the placebo. 'It was a big relief,' she said.

Note that the article did not explain why Pfizer owned the data, and would not reveal it. 

The Researcher Punished

The researcher did not agree that things were so bad,

Georges Lederman, a lawyer for Dr. Neumeister, said there may have been protocol violations, 'but N.Y.U. has taken the position that those violations were more egregious than we believe they actually were.' The issues could have been easily remedied, he said, and noted that they did not cause the sponsor of the research, the pharmaceutical giant Pfizer, to shut it down.

Note that the article did not explain why Pfizer was empowered to shut such a study down.

In any case,

Dr. Neumeister and N.Y.U. continue to disagree over the seriousness of the research violations, both sides said. But the university has tossed out all of the data as unreliable, and tracked down the study participants to check on their health, Dr. Marmar said.

And apparently Dr Neumeister quit, or was fired, although the article only said NYU "parted ways with a top researcher."

Summary

So, in summary, the story was that a prominent researcher was doing cutting edge research at a big university, but people onsite noted some problems, the government was called in to investigate, the investigation found problems, the research was stopped, and the researcher lost his job.  However, while the article mentioned that Pfizer sponsored the study, Pfizer had control of the study's data, and Pfizer had the power to shut the study down, the article did not comment on whether the involvement of Pfizer could have had any relationship to the narrative of alleged individual researcher misconduct.

Research Misconduct as a Problem with Bad Apples

Thus, in my humble opinion, this story followed the usual narrative arc of research misconduct stories: an individual scientist over-reaches, possibly in pursuit of fame and money, is discovered and punished, and things get back to normal.  The implication is that research misconduct is a bad-apple problem, although fueled by a hyper competitive research environment.  For example, last week the (UK) Times Higher Education Suppplement published an article entitled, "Is There a Problem with Research Integrity," that opened,

For many academics today, research is not about pushing intellectual boundaries. It is not about investigating a fascinating issue so much as it is about churning out publications, demonstrating impact and generating revenue in order to meet the performance targets upon which institutional reputation and individual careers depend.

The temptation to cut corners is immense. Tricks include getting your name on a paper that you contributed little towards, or “salami-slicing” the same research across several publications. More seriously, some researchers falsify – misrepresent – their data, or even fabricate them entirely. Some universities tacitly encourage such behaviour and the boundary between academic integrity and malpractice is becoming blurred.

The current case seems to be on of attempted falsification, misrepresentation of research data.

Notice the use of the pronoun "you," emphasizing that research misconduct is about individual misconduct.  Similarly, tha THE article included commentaries by various individuals.  One was by a "research integrity expert," who began,

Having positive and preferably spectacular research findings is wonderful. It helps you to get a publication in a journal with a high impact factor, which will be cited often and may attract a lot of media attention. This is not only a pleasant ego boost but may also be instrumental in getting your next grant or strengthening your academic position. So, in an ever more competitive and metrics-driven scientific environment, it is tempting to make such results occur by any means necessary.

All this is true as far as it goes.  But in my humble opinion, the usual research misconduct narrative is vastly oversimplified, as is the case reported by the New York Times.

We have been writing for years about massive problems with manipulation of clinical research to increase the likelihood that the results would satisfy vested interests, and suppression of research whose results remain unsatisfactory after such manipulation.  The vested interests are most commonly pharmaceutical, biotechnology or device companies and those working with them.  Such suppression and manipulation may make treatments that do not work look efficacious, and treatments that are dangerous look safe, and may lead to excess costs, and worse, harms to patients.  This kind of research misconduct may be facilitated by individual researchers seeking fame and fortune, but is hardly an individual sport.

Focusing on individual research misconduct thus leaves the larger problem of vested interests dominating clinical research anechoic.

Looking carefully at the NYU/ Neumeister case as reported, and a little research on the web suggests that there may be more involved than just the conduct of one researcher.  But that could only be confirmed, or refuted, by investigation beyond what this humble blogger can do.

A Pharmaceutical Company Sponsored, Likely Pharmaceutical Company Designed, Phase II Drug Study Gone Wrong

The NY Times article acknowledged, almost parenthetically, that the study on which the article was focused was sponsored by Pfizer, although it first did so in the context of Dr Neumeister's lawyer arguing that the problems with the study were not that serious:

[he] noted that they did not cause the sponsor of the research, the pharmaceutical giant Pfizer, to shut it down.

Later, the article stated,

Pfizer said that N.Y.U. was responsible for conducting the trial,

but noted

the company had previously tested the same drug, known as an F.A.A.H. inhibitor, for osteoarthritic pain, without significant side effects. 'The safety profile we observed does not preclude future development of our compound,' a Pfizer spokesman said by email.

So this was not a case of a company funding a study merely to advance medical science.  The implication was that the company was testing its own compound in hopes of seeking approval from the US Food and Drug Administration. That must be why it was the FDA that investigated the research misconduct, particularly to the extent that the conduct of the research violated a "protocol" to which the FDA was apprently privy.

More evidence that the study was under the control of Pfizer, rather than of Dr Neumeister, could be inferred from the problems Ms Ruffcorn had in determining whether she had taken the drug or placebo.

For months, she tried to find out whether those reactions were tied to the experimental drug, but because the study was shut down and the data belonged to Pfizer, the N.Y.U. doctors could not tell her whether she’d taken the drug or a placebo.

Note that the "data belonged to Pfizer," not to NYU or Dr Neumeister.

In fact, in perhaps the only critical look given to this story, in a post on Neuroskeptic

I believe the compound in question is PF-04457845.

I believe this because ClinicalTrials.gov lists a trial of PF-04457845 for PTSD, a trial which was recently terminated. NYU was one of the research sites. I also think that this trial is the fateful one, as it matches the NYT’s description of that study. Interestingly, ClinicalTrials.gov says that the trial was stopped 'based on Pfizer portfolio prioritization and not due to safety and/or efficacy concern or change in benefit:risk assessment of PF-04457845'.

So given that the study was a small randomized controlled trials of patients, not of healthy volunteers, it appeared to be a Pfizer sponsored, Pfizer designed, Pfizer controlled Phase II study being done in the hope of eventually marketing PF-04457845.

As noted in an article about agreements between academia and industry on the conduct of randomized controlled trials(1),

Many randomized clinical trials (RCTs) are designed and sponsored by for-profit companies. Companies typically contract academic investigators to identify, recruit, and manage patients. Clinical research under these circumstances is a business transaction that bears the potential for conflicts of interest, including those regarding the publication of trial results

It also appears that Pfizer was spending a more than tiny sum on this work.   A Politico article from 2014 revealed that Dr Neumeister at that time had a $1.7 million grant from Pfizer, presumably for this particular study.  Thus this drug trial was likely providing NYU with more than negligible monetary support, most likely including salary support for Dr Neumeister.

Dr Neumeister apparently has had some previous involvement with pharmaceutical companies, and with Pfizer specifically.  A search of the ProPublica Dollars for Docs 2009-13 database revealed that Dr Neumeister received consulting, travel funds and a more than $227,000 grant from Eli Lilly.  Dr Neumeister apparently is currently on the advisory board for Fiorello Pharmaceuticals.  In a 2015 article in the Journal of Clinical Psychiatry(2), Dr Neumeister acknowledged that he "has received consulting fees from Pfizer."

Conclusion

So it seems that in this case a study which may not have been conducted according to research standards was likely a pharmaceutical sponsored, designed, and controlled Phase II trial done as part of an effort to seek approval for a new drug.  Hence this case was not only about allegations of individual research misconduct, but about yet more problems with the implementation of commercially controlled human experiments designed to ultimately further marketing as well as science.  Yet none of the public discussion so far of this case was about whether Pfizer had any responsibilities to assure the quality of the research in which it was so involved, much less whether interactions between the company, the university which was being funded by the company, and the researcher employed by the university but whose salary was probably partially underwritten by the company might have affected how the study was implemented.

There may be many problems with individual misconduct affecting clinical research.  But failure to consider how this research is now mainly conducted within a commercial milieu seems to be missing the elephant in the room.  If we cannot plainly discuss research misconduct as part of the larger picture of health care dysfunction, we will not be able to do much about it.  True health care reform would help end the taboo on discussion about how powerful organizations and their wealthy and powerful leaders distort health care.  

ADDENDUM (11 July, 2016) - This post was re-published on the Naked Capitalism blog

References

1. Kasenda B, von Elm E, You JJ, Blumie A et al. Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials. PLoS Med 13(6): e1002046. doi:10.1371/journal.pmed.1002046. Link here.

2.  Mota N, Sumner JA, Lowe SR, Neumeister A et al. The rs1049353 Polymorphism in the CNR1 Gene Interacts With Childhood Abuse to Predict Posttraumatic Threat Symptoms. J Clin Psychiatr 2015; 76(12):e1622–e1623. Link here.