Latest Example of the Rigged Health Care System: BTG Pleaded Guilty to "Misbranding" for Marketing a Device Never Proven to Do Any Good

Just before the US Presidential election, yet another story of how the health care system is rigged slipped just barely into public view.   The only media report with any detail about it came from the Corporate Crime Reporter on November 7, 2016.

The Selling of an Unproven Invasive Device

The basics were:

Pennsylvania-based medical device manufacturer Biocompatibles Inc., a subsidiary of BTG plc, pled guilty to misbranding its embolic device LC Bead and will pay more than $36 million to resolve criminal and civil liability arising out of its illegal conduct.

So,

Biocompatibles pled guilty to a misdemeanor charge in connection with the company’s misbranding of LC Bead, in violation of the Food, Drug and Cosmetic Act.

LC Bead was cleared by the U.S. Food and Drug Administration (FDA) as an embolization device that can be placed in blood vessels to block or reduce blood flow to certain types of tumors and arteriovenous malformations.

LC Bead has never been cleared or approved by FDA as a drug-device combination product or for use as a drug-delivery device or 'drug-eluting' bead.

In fact, while

The FDA sought assurances in 2004 that Biocompatibles would not use FDA clearance for the device for embolization to market the device for drug delivery, according to a statement of offense to which the company agreed.

Biocompatibles told the FDA that 'under no circumstance' would the company use the embolization clearance to market the device for drug delivery.

However, two years later, Biocompatibles began marketing LC Bead for drug delivery through the company it hired to carry out its sales and distribution in the United States.

The distribution company told its sales representatives that LC Bead was '[a] drug-delivery device' and trained its sales representatives to 'aggressively penetrate the chemoembolization market.'

Sales representatives subsequently told health care providers that the device increased the level of chemotherapy delivered to a liver tumor and resulted in “better tumor response rates,...”

Furthermore,

In December 2009, Biocompatibles filed an application with FDA for approval of LC Bead as a drug-eluting bead combination product. However, FDA informed the company that it was not accepting the application because clinical studies did not provide adequate evidence of a therapeutic benefit.

Summary

So to summarize, this device was approved for a specific use (embolization). The company was admonished not to market the device for drug delivery, as there was no evidence that it was safe and effective for this use. The company promised not to market it for drug delivery, but allegedly did exactly that, and rather aggressively. Since there was no evidence that the device was effective or safe in that application, patients were implanted with devices that at best may have been useless, or even directly harmful, and all implanted patients were at risk of the usual complications from such devices.

The penalty to the company appeared substantial, until it is compared with the company's revenue, which was 447.5 million pounds sterling last year (look here).  

However, despite the fact that the company did what it promised the FDA it would not do, and the likelihood that patients may have been harmed by these actions, it was only charged with "misbranding." Note that at least it did actually admit to misbranding, as it pleaded guilty to this charge. Yet despite the apparent egregiousness of all this, no individual at the company who may have enabled, authorized, directed, or implemented these dishonest and likely dangerous behaviors suffered any negative consequences.

Health care professionals who lie to patients about the risks of the procedures they perform on them are liable to lose malpractice suits, if not face criminal lawsuits. People at big companies that act analogously face... usually nothing adverse.  Thus they exhibit impunity.

Thus the system appears to be rigged to favor of leadership and management of large companies, as opposed to health professionals, and particularly as opposed to patients.  For years now we have discussed stories like this, which include allegations of severe misbehavior by large health care companies affirmed by legal settlements, but which only involve paltry financial penalties to the companies, and almost never any negative consequences to any humans. Furthermore, as in this case, these stories are often relatively anechoic, noted often only briefly in the media, and have inspired no real action by the US government. 

  

This adds to the evidence suggesting that US health care, at least, is rigged to benefit its top insiders and cronies, and as such, is part of a larger rigged system.  We have previously discussed how market fundamentalism (or neoliberalism) led to deregulation, which enabled deception, fraud, bribery, and intimidation to become standard business practices, and allowed increasing concentration of power by large corporations. Managerialism allowed the top leaders of these corporations and their insider cronies to amass increasing power and money. Everyone else, other employees, stockholders of public corporations, customers, vendors and suppliers, and the public at large lost out.   In health care, these changes led to an increasingly costly system which produced increasingly bad results for patients and the public. 

We have called for years for what we sometimes term "true health care reform" to derig the system.  Little has changed, while perceptions that the system is rigged have become more common.  Failure up to now of the "establishment" do do anything about the rigging of the system leads to cynicism, and the search for quick and dirty solutions. 

Trumping the Evidence - The Donald Denies Asbestos Related Disease, Post-Traumatic Stress Disorder, Chronic Traumatic Encephalopathy but Asserted Vaccines Cause Autism

One of the main causes of health care dysfunction identified by demoralized health care professionals in our 2003 qualitative study was threats to evidence-based medicine, and by extension, evidence-based public health and health policy.(1) Since then, we have frequently discussed threats such as manipulation and suppression of clinical research to further vested interests, and distortion of research dissemination, such as ghost written articles, often enabled by individual and institutional conflicts of interest.

These and other causes of health care dysfunction which we discuss, however, have hardly been the stuff of political debates. In particular, US presidential campaigns often feature very bland discussions of health care, when they feature them at all. These discussions, furthermore, usually are limited to health insurance, but rarely challenge the unusual American system which relies on for-profit health care insurance.

So Health Care Renewal usually does not provide much content relevant to political campaigns.

The 2016 presidential election season has not been usual. True, one campaign, that of Hillary Clinton, has featured the detailed, but relatively bland policy points that we usually see.

Her opponent, Donald Trump, is very different. He is known for wide ranging unscripted comments. In particular (barely) reported instances, his comments have included apparent attacks on the clinical or public health research evidence base. (I used the word "appearent" since nothing Mr Trump writes or says is ever that clear.)

Denied Asbestos Related Disease

The best reported example is the oldest. A Mother Jones article from June, 2016, noted that in Mr Trump's presumably ghost-written book, Art of the Comeback, he wrote that asbestos is "100 percent safe, once applied," and it "got a bad rap." He also claimed that

the movement against asbestos was led by the mob, because it was often mob-related companies that would do the asbestos removal.

It is possible that these comments arose from Mr Trump's resentment of the costs of asbestos removal from his many real estate holdings.

Nonetheless, the evidence that asbestos is a major health hazard is old, but quite clear. (See summaries by The National Cancer Institute, the Agency for Toxic Substances and Disease Registry, the Occupational Safety and Health Adminstration.) Asbestos can cause asbestosis, which may lead to severe respiratory insufficiency, lung cancer, and mesothelioma. The application of asbestos can be very hazardous, but once applied it can still endanger not only those who remove it, but firefighters, other first responders, etc.

Ridiculed the Concept of Post-Traumatic Stress Disorder (PTSD)

On October 3, 2016, the Washington Post reported,

Donald Trump told a group of military veterans on Monday that some members of the military develop mental health issues because they are not 'strong' and 'can't handle it.

'When you talk about the mental health problems, when people come back from war and combat, they see things that maybe a lot of the folks in this room have seen many times over. And you're strong and you can handle it, but a lot of people can't handle it,' the Republican presidential nominee told an audience of military veterans at an event in Northern Virginia on Monday morning.

Allowing for Mr Trump's famously chronically garbled syntax, he appeared to say that PTSD is not a mental illness, but simply a manifestation of weakness. However, there seems to be no data to support this assertion, rather the contrary seems more likely to be true (for example, see the links in this article.)

Scoffed at Chronic Traumatic Encephalopathy (CTE)

In a story apparently only reported in the sports sections of the media (for example, here in USA Today on October 12, 2016), Mr Trump appeared to dismiss the dangers of concussions,

Trump likewise demonstrated a poor grasp of concussions and lashed out at the NFL when he commented on a woman who passed out in the crowd.

From the speech:

'That woman was out cold, and now she’s coming back. We don’t go by these new, and very much softer, NFL rules. Concussions..’oh, oh! Got a little ding on the head. No, no, you can’t play for the rest of the season.’ Our people are tough.'

This isn’t the first time Trump has ridiculed the NFL for its increased awareness of brain injuries. At a rally in Iowa earlier this year, he made similar comments.

Via Mic:

'Football’s become soft. Football has become soft,' GOP presidential candidate Donald Trump said (twice) at a rally in Iowa on Sunday.

'But football’s become soft like our country has become soft,' he added to cheers and nods. 'It’s true. It’s true.'

'What used to be considered a great tackle, a violent head-on [tackle]. … You used to see these tackles and it was incredible to watch, right?' Trump said.

Rather than being a "little ding on the head," there is pretty convincing evidence that concussions can lead to real neurological problems. See the website of the Boston University CTE (chronic traumatic encephalopathy) Center, which provides this summary,

Chronic Traumatic Encephalopathy (CTE) is a progressive degenerative disease of the brain found in athletes (and others) with a history of repetitive brain trauma, including symptomatic concussions as well as asymptomatic subconcussive hits to the head. CTE has been known to affect boxers since the 1920s. However, recent reports have been published of neuropathologically confirmed CTE in retired professional football players and other athletes who have a history of repetitive brain trauma. This trauma triggers progressive degeneration of the brain tissue, including the build-up of an abnormal protein called tau. These changes in the brain can begin months, years, or even decades after the last brain trauma or end of active athletic involvement. The brain degeneration is associated with memory loss, confusion, impaired judgment, impulse control problems, aggression, depression, and, eventually, progressive dementia.

The Center's personnel wrote a 2009 review article(2), available here, which supplies considerably more detail.

Asserted Vaccines Cause Autism

A September, 20, 2016, Huffington Post article noted that Mr Trump has been a proponent of the theory that vaccines cause autism at least since 2012,

The Republican nominee is a full-blown proponent of the notion that vaccines cause autism, a theory that researchers have studied and rejected over and over after a medical journal helped launch the notion with a 1998 article since retracted.

Lots of autism and vaccine response. Stop these massive doses immediately. Go back to single, spread out shots! What do we have to lose.
— Donald J. Trump (@realDonaldTrump) October 22, 2012

I am being proven right about massive vaccinations—the doctors lied. Save our children & their future.
— Donald J. Trump (@realDonaldTrump) September 3, 2014

Again, at best, the link between vaccines and autism is very controversial at best.  Most reviews suggest that the evidence supporting any relationship is very limited, for example, see the 2003 review by Wilson et al(3) and the 2016 review by Taylor et al.(4)

The Republican Party Platform Which Trump Presumably Approved Asserted that Pornography is a Public Health Hazard

At least partially related is this story, as reported by CNN in July, 2016,

The Republican Party will declare internet pornography a 'public health crisis' under an amendment added to the draft party platform Monday at preliminary meetings in Cleveland.

North Carolina delegate Mary Frances Forrester successfully proposed the amendment in a subcommittee of the platform committee Monday morning.

'The internet must not become a safe haven for predators,' the provision states. 'Pornography, with its harmful effects, especially on children, has become a public health crisis that is destroying the life of millions....'

It appears that this provision conflates adult and child pornography.  There seems to be no good evidence that adult pornography creates health risks.

(Note: there is some irony in this story, as Mr Trump has appeared, albeit fully dressed, in several softcore porn videos, see stories here and here.  He also nominally wrote a racy novel, which was actually ghost written, see story here.  Also, his current wife also has appeared in one "lad mag" photo shoot sans clothes, see story here.)  

Comments

We have been discussing threats to the clinical and public health evidence base for a while.  We are used to discussing distortions of the evidence base that serve to support vested interests.

However, I cannot recall casual attacks on specific parts of the evidence base by apparently woefully uninformed political candidates.  It is not unusual for candidates for public office to talk about health care, public health, and related policies.  It is unusual for them to make assertions about specific evidence about particular diseases, and their risk factors and causation.

It is disturbing when one candidate for the most powerful political office in the US repeatedly disregards the best clinical and public health evidence, and offers ill considered opinions about public health that could potentially harm patients.

But Mr Donald Trump is a very unusual candidate.  Perhaps this is why Scientific American, which "is not in the business of endorsing political candidates," took a strong position against what Mr Trump has been saying about science.

'If it disagrees with experiment it is wrong.'
—Richard Feynman

Four years ago in these pages, writer Shawn Otto warned our readers of the danger of a growing antiscience current in American politics. 'By turning public opinion away from the antiauthoritarian principles of the nation's founders,' Otto wrote, 'the new science denialism is creating an existential crisis like few the country has faced before.'

Otto wrote those words in the heat of a presidential election race that now seems quaint by comparison to the one the nation now finds itself in. As if to prove his point, one of the two major party candidates for the highest office in the land has repeatedly and resoundingly demonstrated a disregard, if not outright contempt, for science. Donald Trump also has shown an authoritarian tendency to base policy arguments on questionable assertions of fact and a cult of personality.

Americans have long prided themselves on their ability to see the world for what it is, as opposed to what someone says it is or what most people happen to believe. In one of the most powerful lines in American literature, Huck Finn says: 'It warn't so. I tried it.' A respect for evidence is not just a part of the national character. It goes to the heart of the country's particular brand of democratic government. When the founding fathers, including Benjamin Franklin, scientist and inventor, wrote arguably the most important line in the Declaration of Independence—'We hold these truths to be self-evident'—they were asserting the fledgling nation's grounding in the primacy of reason based on evidence.

While this election may have effects that go way beyond science, particularly the integrity of the clinical and public health evidence base, those concerned about these issues need to take heed now before the voting is finished.  

References

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

2. McKee AC, Cantu Rc, Nowinski CJ et al. Chronic Traumatic Encephalopathy in Athletes: Progressive Tauopathy following Repetitive Head Injury. J Neuropathol Exp Neurol. 2009 July ; 68(7): 709–735. doi:10.1097/NEN.0b013e3181a9d503.

3. Wilson K, Mills E, Ross C et al. Association of Autistic Spectrum Disorder and the Measles, Mumps, and Rubella Vaccine: A Systematic Review of Current Epidemiological Evidence. Arch Pediatr Adolesc Med. 2003;157(7):628-634. doi:10.1001/archpedi.157.7.628. Link here.

4. Taylor LE, Swerdfeger AL, Eslick GD. Vaccines are not associated with autism: An evidence-based meta-analysis of case-control and cohort studies. Vaccine 2016; 32: 3623–3629. Link here.

Legal Settlements to Remind Us How Our Health Care System Became Rigged: by GSK, Novartis, CVS

Amidst the sound and fury of the US election season, almost under the radar sneak legal settlements demonstrating continuing bad behavior by big health care organizations, and the continuing lack of accountablity of these organizations' leaders.

We note three cases involving unethical practices leading to overuse of pharmaceuticals that appeared in the last two months, in chronological and alphabetical order.


GlaxoSmithKline Settles Charges of Bribing Chinese Doctors

A summary from Stat by Ed Silverman on September 30, 2016,

GlaxoSmithKline on Friday agreed to pay $20 million to settle charges of violating the Foreign Corrupt Practices Act for what authorities called a pay-to-prescribe scheme in China. In doing so, Glaxo becomes the latest global drug maker to face such accusations as part of a long-running probe by US authorities into companies that paid bribes overseas in order to boost sales of their medicines.

The settlement is an outgrowth of the bribery scandal that rocked Glaxo and resulted in a $490 million fine two years ago after a Chinese court found the company guilty of bribing doctors, hospital officials, and other non-governmental personnel. The former head of the Glaxo unit in China also pleaded guilty to bribery-related charges and was given a three-year suspended sentence.

As part of the scheme, Glaxo employees allegedly funneled kickbacks through trade groups and travel agencies that planned events. Between 2010 and June 2013, Glaxo spent nearly $225 million on planning and travel services. But after reviewing a sample of invoices, authorities found about 44 percent were inflated and approximately 12 percent were for events that did not occur, according to an SEC order.

In 2010, Glaxo hired a Chinese company to develop a project to provide clinics with tools to store and administer vaccines that required refrigeration. Instead, the project was used to give laptops and other electronic devices as gifts to clinics that were believed to have the potential to market still other Glaxo drugs. In all, the drug maker spent about $2.3 million doing this.

Articles in the Wall Street Journal and Reuters stated the bribes were explicitly meant to boost sales of drugs.  However, I am not able to find any information in the few media reports or the US Securities and Exchange Commission order about which products were so promoted.  It appears likely, however, that these alleged practices led to overuse of drugs that at best did patients no good and at worst caused direct harm. 

Although proceedings in China resulted in punishment of a GSK official there, the US proceedings did not subject any individual to negative consequences for enabling, authorizing, directing or implementing any bribes.

Note that our posts on previous misadventures by GSK can be found here.

Novartis Settles Charges of Illegally Promoting Skin Cream for Infants in the US

Again, as summarized by Ed Silverman in Stat on October 5, 2016,

Novartis has agreed to pay $35 million to settle charges of illegally promoting a prescription skin cream for use with infants and toddlers. The deal marks the second time in the past year the drug maker has struck a deal with US authorities to resolve allegations of improperly marketing its medicines.

The agreement, announced on Wednesday, stems from a whistleblower lawsuit filed by a former Novartis sales representative, who accused the company of deliberately trying to widen the market for Elidel by encouraging prescriptions for children younger than 24 months, even though the medicine was not approved for that patient population. At one point, regulators issued a warning about the risk of cancer in small children.

'We were instructed that Elidel was so safe it could be put on up to 80 percent of a baby’s body. And we were never told that it might cause cancer,' said Donald Galmines, 44, the former rep, in a statement. He added that he was trained to invite doctors and their families or staffs to dinners at expensive restaurants, even though during the course of the meal, Elidel might not even be brought up.

The illegal marketing occurred between 2002 and 2009,...

So this case involved allegations of deceptive marketing.  In particular, the deception was potentially dangerous to infant patients, since it appears that the drug promoted was unduly dangerous.

In this settlement, however, the company got to explicitly deny wrongdoing.

Novartis denied the allegations in the settlement agreement.

Novartis has had considerable recent legal trouble involving unethical behavior.

The settlement comes amid a difficult stretch for Novartis. The drug maker last year paid $390 million to settle charges of paying kickbacks to boost sales of two other drugs. And the company is facing a trial stemming from yet another whistleblower lawsuit filed by a different former sales rep, who similarly alleged Novartis illegally marketed medicines.

Those cases gained considerable attention because US Attorney Preet Bharara, who is based in New York, claimed Novartis is a repeat offender when he announced the government had joined the lawsuits in 2013. He was referring to a 2010 case in which the company paid $422.5 million for allegedly marketing six drugs off-label and paying kickbacks to health care professionals.

The United States is not the only venue where Novartis has encountered such charges. Last March, the drug maker agreed to pay $25 million to settle charges that it violated the Foreign Corrupt Practices Act by making illegal payments to health care providers in China. Employees gave money, gifts, vacations, and entertainment to health care professionals between 2009 and 2011, according to US authorities.

Furthermore, an even more extensive list of previous Novartis misadventures can be found in our post here.

Despite all that, however, the settlement did not subject any individual to negative consequences for enabling, authorizing, directing or implementing the allegedly illegal promotion.

Omnicare Settles Charges of Accepting Kickback to Help Illegally Promote Depakote

Finally, as yet again best summarized by Ed Silverman on StatNews on October 17, 2016,

Omnicare, which is the nation’s largest nursing home pharmacy, agreed on Monday to pay more than $28 million to resolve charges of seeking kickbacks from Abbott Laboratories in exchange for boosting prescriptions for a medicine that the drug maker had promoted illegally.

As part of the scheme, Omnicare disguised the kickbacks from Abbott as grants and educational funding, and took rebates from the drug maker based on the amount of Depakote that was prescribed for each nursing home resident. In addition, Abbott paid for Omnicare management meetings at a Florida resort and offered tickets to sporting events, according to the US Department of Justice.

The arrangement between Omnicare and Abbott began after the drug maker launched a new initiative in 1997 to boost prescriptions for the drug, which is approved for treating seizures, bipolar mania, and migraines, but not uncontrollable behavior due to dementia. The following year, Omnicare began soliciting kickbacks from Abbott and the scheme lasted about three years, according to court documents.

The settlement is the latest in a long-running probe by the feds into Omnicare, which is now owned by CVS, and the interplay between nursing home pharmacies and drug makers.

In 2012, Abbott reached a $1.5 billion global civil and criminal settlement that resolved, among other things, alleged kickbacks paid to nursing home pharmacies. At the time of the agreement, the feds noted that Abbott promoted Depakote for controlling behavioral disturbances in dementia patients, even though the US Food and Drug Administration never approved the pill for this particular use.

'Kickbacks to entities making drug recommendations compromise their independence and undermine their role in protecting nursing home residents from the use of unnecessary drugs,' said Benjamin Mizer, the principal deputy assistant attorney general in the Justice Department’s Civil Division,...

So it appears that at best the kickbacks led to prescription of drugs that did patients little good, and may have caused adverse effects.  

An article in the Cincinnati Business Courier noted that CVS, of which Omnicare is now a subsidiary, avoided admitting any responsibility for the alleged acceptance of kickbacks,

CVS 'agreed to settle this matter to avoid the expense and uncertainty of protracted litigation,' spokesman Mike DeAngelis said of the suit against Omnicare. 'The activities, which were alleged to have violated anti-kickback laws, all occurred prior to CVS Health’s acquisition of Omnicare. These matters involved Omnicare only, and no allegations were made against any of CVS Health’s other businesses, including CVS Pharmacy and CVS Caremark. CVS Health is committed to the highest standards of ethics and business practices, and there was no admission of wrongdoing.'

An Associated Press article noted Omnicare's previous track record,

Omnicare has spent hundreds of millions of dollars resolving kickback litigation in recent years. In 2014, it agreed to pay more than $124 million to settle lawsuits alleging it gave kickbacks to some facilities so they would keep the company as their drug provider for elderly Medicare and Medicaid recipients.

In 2009, Omnicare said it would pay $98 million to settle allegations that it solicited or paid a variety of kickbacks. That included an accusation that it received kickbacks from Johnson & Johnson for recommending that doctors prescribe to nursing home patients the antipsychotic Risperdal, which can hasten death in elderly people with dementia.

Furthermore, an extensive list of parent company CVS' misadventures can be found in this post.


Despite all that, again, the settlement did not subject any individual to negative consequences for enabling, authorizing, directing or implementing the alleged acceptance of kickbacks.

Summary

Three settlements in two months by three major health care corporations involved allegations of unethical behaviors that were meant to increase prescribing of various pharmaceuticals, whether or not patients needed them, or were more likely to be harmed by them.  Despite the unsavory nature of the behaviors, and the likelihood of patient harms, the companies involved had to pay fines that were tiny relative to their multi-billion dollar revenues.  The companies did not have to admit responsibility, and company managers and leaders did not suffer any negative consequences for enabling, authorizing, directing or implementing the bad behavior.  Thus they exhibited impunity.

These cases are just the latest in a long march of legal settlements to remind us of the continuing bad behavior of large health care organizations, and the continuing impunity of their managers and leaders.

This adds to the evidence suggesting that US health care, at least, is rigged to benefit its top insiders and cronies, and as such, is part of a larger rigged system.  We have previously discussed how market fundamentalism (or neoliberalism) led to deregulation, which enabled deception, fraud, bribery, and intimidation to become standard business practices, and allowed increasing concentration of power by large corporations. Managerialism allowed the top leaders of these corporations and their insider cronies to amass increasing power and money. Everyone else, other employees, stockholders of public corporations, customers, vendors and suppliers, and the public at large lost out. In health care, these changes led to an increasingly costly system which produced increasingly bad results for patients and the public.

We have called for years for what we sometimes term "true health care reform" to derig the system.  Little has changed, while perceptions that the system is rigged have become more common.

Unfortunately, perceptions of a rigged system may not always inspire honest reform. Instead, they can enable the rise of demagogues and would be dictators who promise only they can solve the problem. This appears to have happened in the US. Now honest people who want to unrig the system must first prevent an even worse result, authoritarianism or frank dictatorship.  Never has Benjamin Franklin's warning that we only have "a republic, if you can keep it" been more salient.

However, should we be successful in fending off despotism, the original problems that led the system to be rigged will remain, and new men on white horses may appear, unless we truly reform the system. 

So let us not forget how we got here in the first place.  And should we successfully preserve our republic, let us remember the need for wholesale, real health care reform that would make health care leaders accountable for what their organizations do, particularly when these organizations misbehave.

Petitions for Research Integrity and Against Corruption Available for Signature

Recently, two petitions relevant to the goals of Health Care Renewal have become available. 

US Petition to "Stop False Reporting of Drug Benefits & Harms by Making FDA & NIH Work Together"

Health Care Renewal blogger Dr Bernard Carroll, along with Dr Mickey Nardo, who blogs on 1BoringOldMan, and Emeritus Professor John H Noble Jr have authored a petition to improve the reporting of clinical research in the US, and hence combat the manipulation of clinical research, a topic we often discuss.

Its essence is:

We now petition Congress to require the FDA and NIH to coordinate their monitoring and sharing of key information through ClinicalTrials.gov. Working together, the two agencies could enable stakeholders to verify whether purported scientific claims are faithful to the a priori protocols and plans of analysis originally registered with the FDA. Publication of analyses for which such fidelity cannot be verified shall be prohibited unless the deviations are positively identified (as in openly declared unplanned, secondary analyses). This prohibition shall include scientific claims for on-label or off-label uses made in medical journals, archival conference abstracts, continuing education materials, brochures distributed by sales representatives, direct-to-consumer advertising, and press releases issued by companies or their academic partners. It shall extend to FDA Phase 2, Phase 3, and Phase 4 clinical trials. By acting on this petition, Congress will create a mechanism for stakeholders independently to verify whether inferences about clinical use suggested by the unregulated corporate statistical analyses can be trusted.

The full petition is available online, and is sponsored by the Science and Evidence Council of the Right Care Alliance.

Transparency International Declaration Against Corruption

Transparency International is sponsoring a declaration, valid globally, against corruption.  We often discuss health care corruption, despite the apparent taboo against doing so.  As we just noted, this comes as Transparency International is launching a major initiative against health care corruption.

Its essence is:

I will not pay bribes
I will not seek bribes
I will work with others to campaign against corruption
I will speak out against corruption and report on abuse
I will only support candidates for public office who say no to corruption and demonstrate transparency, integrity and accountability.

It is available for signature here.  

ONC to Boost Oversight over EHR Usability, Patient Safety Woes

ONC (The Office of the National Coordinator for Health Information Technology at HHS, https://www.healthit.gov/newsroom/about-onc) is reportedly getting more authority to oversee HIT quality.

Some initial observations:

(1) More government control of yet another healthcare domain may be a double-edged sword, BUT:

(2) Something had to be done about HIT, and this initiative could have a good outcome if not overwhelmed too much by corporate and inter-party politics (in our current environment, that is far from assured), and

(3) It validates what we have been writing about on this blog since 2004, and elsewhere on my part since about 1998.

I am also bolding passages I find of most interest.  Emphases mine:

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

Health Analytics

By Jennifer Bresnick 

October 14, 2016

http://healthitanalytics.com/news/onc-boosts-oversight-to-fix-ehr-usability-patient-safety-woes 

The ONC will now have more authority to look into EHR usability problems that may produce patient safety risks, thanks to a rule that increases oversight capabilities.

The nation’s quality improvement and payment activities aren’t the only things receiving a federal overhaul this week: the electronic health records that will support clinicians as they implement MACRA and move towards a patient-centered, value-based care environment are also getting some renewed attention.

In conjunction with the publication of the MACRA final rule, the ONC has announced enhanced oversight for the Certified EHR Technology (CEHRT) program, which aims to address some of the usability, patient safety, and workflow design flaws endemic in the current generation of health IT tools.

What have we written about for years here?  Problems including but not limited to:

• EHR usability
• Patient safety
• Workflow design flaws

I hope my efforts and those of other "HIT iconoclasts" (a term that was often used pejoratively) has helped spur recongition of these problems and the resultant action.

The “ONC Health IT Certification Program: Enhanced Oversight and Accountability” rule will give the ONC more authority to regulate the design and functionality of certified tools, which form the backbone of most organizations’ health IT infrastructure.  The final rule will be officially published in the Federal Register on October 19, 2016.

A transparent, direct, and more stringent review process may help to reduce the continuous litany of complaints about convoluted workflows, lost hours of productivity, insufficient interoperability capabilities, and frustrating inconsistencies that often prompt users to develop dangerous and unauthorized workarounds.

What else have we written about for years here?  Problems including but not limited to:

• lost hours (person-years, really) of clinician productivity,
• insufficient interoperability (although my emphasis has been that we musst have basic operability before interoperability)
• Ill-conceived, ill-implemented, discombobulated user interfaces that force dangerous workarounds (e.g., my 2009 ten-part series "Are Health IT Designers, Testers and Purchasers Trying to Harm Patients?" at http://tinyurl.com/hostileuserexper).

(Such EHR problems as the six items above led to the 2011 death of my own mother.)

An increased focus on design and user experience may also help to reduce opportunities for providers to make data integrity mistakes that make big data analytics such a difficult proposition for many stakeholders – and put patient safety at risk due to inadequate communication, lost data, or incorrect inputs.

I add "IT-based data integrity mistakes" as well.

EHRs are consistently found at the top of patient safety hazard lists from organizations like the ECRI Institute.  The ONC itself has repeatedly acknowledged the danger of inefficient and poorly designed health IT tools, most recently releasing a pair of reports in June that outlined the many dangers of inadequate EHRs, clinical decision support systems, and big data analytics technologies.

I recall this 2010 statement from ONC Chair Blumenthal.  From my May 3, 2010 post "David Blumenthal on health IT safety: nothing to see here, move along" at http://hcrenewal.blogspot.com/2010/05/david-blumenthal-on-health-it-safety.html:

... http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented

Blumenthal said that although an advisory committee concluded that more information was necessary, he called the evidence of the reports “anecdotal and fragmented” at best ... [Blumenthal's] department is confident that its mission remains unchanged in trying to push all healthcare establishments to adopt EMRs as a standard practice. "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's could impede patient safety," he said.

I opined that "Perhaps I'm a bit behind these postmodern times, but I once believed the perhaps now old-fashioned and obsolete view that a scientist would not base a conclusion of medical safety in national dissemination of drug, device, or whatever on some analysis of anecdotal data, whether 'preliminary' or final."

(Just sixteen days after that post, on May 19, 2010, an EHR-related medication reconciliation failure caused my mother to suffer severe injuries, that led to her crippling and death.)

I was right, ONC was dead wrong, and I'm sure ONC hates me for that reason.  From a blog post here:

... Edmund Burke correctly predicted the outcome of the French revolution. He also provided the reasons why it would end in bloodshed. He was vilified, hated and condemned for telling the truth, and when he was proven right, he was hated even more for being right ... The more one tells an ugly truth the more that person is hated. This is because people want a glittering lie to be true. In this we will ignore facts and instead turn to emotion.

Back to the article:

“More transparency and accountability in health IT is good for consumers, physicians, and hospitals,” said National Coordinator Vindell Washington, MD, MHCM, in a press release marking the publication of the oversight rule. “Today’s final rule strengthens the program by ensuring that certified health IT helps clinicians and individuals use and exchange electronic health information safely and reliably.” 

Correction:  transparency and accountability, without the "more"; as currently there is little to none.

The ONC’s actions may go some way towards appeasing the large number of industry stakeholders who have been calling for increased health IT oversight since the start of the physician burnout epidemic, largely blamed on the shortcomings of EHR technology.

"Appeasing" is the wrong word.  You appease dictators who do not have the people's best interests at heart.  I would use the word "meeting the intelligent demands of ..."

“We recognize that certified health IT often does not operate in a vacuum,” wrote Elise Sweeney Anthony, JD, Director of the ONC Office of Policy in an accompanying blog post.  “In order for ONC to properly evaluate certified health IT, we may have to look at whether certified health IT may fail to perform as it should when it interacts with uncertified capabilities within the product or with other technology.”

Way too much emphasis on the "Certified" label, which by definition has little meaning, considering the new measures this article described.

The rule allows the ONC to take “necessary action” when CEHRT tools currently in use pose risks to patient safety, and provides an appeal process for the developers of products that come under scrutiny.  ONC will also authorize and oversee accredited testing laboratories (ONC-ATLs) to respond more rapidly to performance issues. 

It will be interesting to see how this plays out.  Again, in the current political mess in this country, I am not highly optimistic.

The agency is also planning to make the results of their surveillance public in an effort to increase transparency and accountability across the industry.

There's transparency, and then there's "transparency."  Wonder which one will predominate?

... "We certainly are leveraging all the opportunities that we have at ONC and our partners at the Office for Civil Rights and other agencies to see that we're protecting consumers and that data is going to flow," said former National Coordinator Karen DeSalvo to the Subcommittee on Information Technology in March of 2016. “There are areas where we know there may be some opportunity like information blocking where we would need some additional support."

Meanwhile, I understand the OCR denies patients rights to their EHR audit trails, which are, in fact, the only way to independently verify if a fraud or tort is being committed upon them i.e., by record alteration....

... But the ONC’s oversight plans may not go far enough, according to Ben Moscovitch, Manager of the Health Information Technology Initiative at the Pew Charitable Trusts.  Since the rule only focuses on catching flaws in EHRs already being used by providers, the agency is missing an opportunity to engage in some preventative care of their own.

“While it's important to check for safety issues in EHRs that are already in use, there is still more we can do to improve EHR safety,” Moscovitch said in an emailed statement. “For one, we need to test EHRs before they go to market, to detect and address possible flaws ahead of time.  “Electronic health records can have some inadvertent flaws, and some that can cause harm. What this rule does is focus on catching potential issues in EHRs that are already in use, but we should also be working to identify and address these hazards before EHRs hit the market,” he asserted. “That means testing them earlier in the process to catch individual issues

I strongly agree.  That is called pre-market surveillance.

... In addition, we need to create a collaborative for EHR safety, bringing stakeholders together to identify common problems and disseminate best practices.”

In fact, we need robust post-market surveillance and need to disseminate not just best practices, but (as I've written many times over the past ~18 years), disseminate worst practices  - lessons learned - to be avoided.  And not be shy or P.C. about publishing the nasty things that sometimes happen in the HIT ecosystem.

The ONC also points out that non-certified products are not on the review agenda – unless the agency needs to examine whether or not they interfere with the function of CEHRT tools.  For providers using a mixture of certified and non-certified technologies, this limitation may be problematic when attempting to remedy workflow issues or patient safety concerns.

Another wrinkle.

I wish ONC luck.  They'll need it.

I'd offer my help, but as mentioned above, they were spouting industry propaganda at a time when doing otherwise might have prevented a very ugly occurrence involving my late mother.  That's just going to take quite a bit more time to forgive.

-- SS

Transparency International Once Again Takes on Health Care Corruption

I am happy to report that Transparency International is making a big new push against health care corruption.

Health Care Corruption as a Taboo Topic

Transparency International (TI) defines corruption as

Abuse of entrusted power for private gain

In 2006, TI published a report on health care corruption, which asserted that corruption is widespread throughout the world, serious, and causes severe harm to patients and society.

the scale of corruption is vast in both rich and poor countries.

Also,

Corruption might mean the difference between life and death for those in need of urgent care. It is invariably the poor in society who are affected most by corruption because they often cannot afford bribes or private health care. But corruption in the richest parts of the world also has its costs.

The report did not get much attention.  Since then, health care corruption has been nearly a taboo topic in the US.  When health care corruption is discussed in English speaking developed countries, it is almost always in terms of a problem that affects benighted less developed countries.  On Health Care Renewal, we have repeatedly asserted that health care corruption is a big problem in all countries, including the US, but the topic remains anechoic.

Yet somehow, a substantial minority of US citizens, 43%, seemed to believe that corruption is an important problem in US health care, according to a TI survey published in 2013 (look here).  But that survey was largely ignored in the media and health care and medical scholarly literature in the developed world, and when it was discussed, it was again in terms of results in less developed countries.  Health Care Renewal was practically the only source of coverage in the US of the survey's results.

The Transparency International Pharmaceuticals & Healthcare Programme


In June, 2016, Transparency International showed it was back in the fight against health care corruption.  At that time, it published a report on corruption in the pharmaceutical sector.  We discussed it here.  Unfortunately, that report also got little notice in the media or in the medical or health care literature.

This report was actually one of the first efforts from a new Transparency International initaitive to address health care corruption, entitled the Transparency International Pharmaceuticals & Healthcare Programme.  Its mission statement begins [italics added by me]:

Every day, all around the world, people suffer and die due to corruption in the pharmaceutical and healthcare sector. Our vision is a world where less corruption leads to improved global health and healthcare outcomes, leaving no one behind.

Building on twenty years of experience in this and other sectors, Transparency International’s Pharmaceuticals & Healthcare Programme is taking up the challenge of understanding, identifying and combatting corruption in this vital sector. The Programme wants to achieve genuine change in the pharmaceutical and healthcare sector through reducing corruption and promoting transparency, integrity and accountability.

On its new website is its next major report, Diagnosing Health Care Corruption. Its introduction updates the 2006 report, and begins with:

Every day, all around the world, people suffer and die due to corruption in the healthcare sector. It disproportionally affects vulnerable groups, who do not have the knowledge, money or connections to access the care or products they need. While corruption can occur in every area of a health system, corruption from the highest levels will trickle down to effect healthcare received by patients at local health care facilities.

There are several broad effects of corruption in healthcare. Distorted policy, legislative andclinical priorities; a loss of money from health systems; denied or delayed access to health care services and treatment; and a loss of trust in national health facilities, personnel and to a wider extent national governance as a whole.

However, the specific cost of corruption is almost impossible to measure. Like other forms of white-collar crime corruption is inherently hidden from sight and even when some forms of corruption are discovered it is hard to quantify their impact.

The report was motivated by the finding that:

individuals in the healthcare sector do not always understand what corruption is and how it may undermine their work. Conversely, anti-corruption specialists do not always understand and appreciate the complexity of the health care system. This map – a project that will be kept updated – attempts to bridge that gap by providing for the first time, a comprehensive and accessible guide to a health system and the types of corruption that may occur.

The report discussed how corruption affects eight different aspects of the health care system:
- health system governance
- health system regulation
- research and development
- marketing
- procurement
- product distribution and storage
- financial and workforce management
-delivery of healthcare services

For each aspect, it discusses specific types of corruption, 37 in all.  An interactive map of the eight aspects of the health care system and 37 types of corruption affecting them starts on the main page of the website.

In the future, the Pharmaceuticals & Healthcare Programme

activities will be prioritised around five areas in health systems: research & development; manufacturing; procurement and distribution; marketing; and service delivery. These were identified following extensive stakeholder engagement and the programme’s foundational research.

The Pharmaceuticals & Healthcare Programme will target global, national and local interventions. Ongoing research and the lessons drawn from regional and national projects will be used to influence global policy to produce structural change within the health sector; promote global best practice standards to strengthen transparency and accountability; and support national and local interventions and solutions.

Comments

Transparency International's re-engagement with the problem of health care corruption argues for the importance and magnitude of this problem.  I hope its new report is not as anechoic as Transparency International's previous efforts were, that it helps to end the taboo on even discussing health care corruption, much less addressing it.  I dare to hope that the new initiative might actually lead to some action to reduce health care corruption. 

As I have said before, and now once more with feeling... if we really want to reform health care, in the little time we may have before our health care bubble bursts, we will need to take strong action against health care corruption.  Such action will really disturb the insiders within large health care organizations who have gotten rich from their organizations' misbehavior, and thus taking such action will require some courage.  Yet such action cannot begin until we acknowledge and freely discuss the problem.  The first step against health care corruption is to be able to say or write the words, health care corruption.

Ransomware and incompetence in backups leads to medical data loss...but the thieves were honest thieves!

"An honest thief!" said Caledon Hockley of Jack Dawson, after planting the Heart of the Ocean diamond necklace in Jack's pocket.  https://www.youtube.com/watch?v=G5UEwCHUHjg

The headline of this posting may sound absolutely insane, but it is factual.

But don't worry, your precious medical data is far safer than it ever was on that 5,000-year-old invention, papyrus.

Marin patients’ medical data lost after cyber attack
By Richard Halstead, Marin Independent Journal   
September 30, 2016
http://www.mercurynews.com/2016/09/30/marin-patients-medical-data-lost-after-cyber-attack/

The Marin Healthcare District and Prima Medical Foundation are notifying more than 5,000 patients that some of their medical data was lost due to a glitch that followed a ransomware attack in August.

There's that all-purpose euphemism again, "glitch", which in this case is a euphemism for negligence.  See blog query link  http://hcrenewal.blogspot.com/search/label/glitch for more on "glitches."

Prima Medical Foundation supports the Prima Medical Group, many of whose doctors work closely with Marin General Hospital.

I covered the wondrous EHR at Marin General Hospital at my May 17, 2013 post "Marin General Hospital nurses warn that new computer system is causing errors, call for time out" at http://hcrenewal.blogspot.com/2013/05/marin-general-hospital-nurses-warn-that.html, and my May 20, 2013 post "Marin General Hospital's Nurses are Afraid a Defective EMR Implementation Will Harm or Kill Patients .. CEO Cites Defective HHS Paper and Red Herrings As Excuse Why He Knowingly Allows This To Continue" at http://hcrenewal.blogspot.com/2013/05/marin-general-hospitals-nurses-are.html.

The computer records of Marin Medical Practice Concepts, a Novato company that provides medical billing and electronic medical records services to many Marin physicians, were hacked on July 26. As a result, some Marin doctors were unable to access their patients’ medical records for more than a week.

More than a week with no records is, needless to say, putting patients at great risk.

Responding to questions from the Independent Journal on Aug. 4, Lynn Mitchell, CEO of Marin Medical Practice Concepts, confirmed the malware attack. In her email, Mitchell wrote, “Ransom was paid. For security reasons we will not be releasing the amount or denomination paid.”

That really inspires confidence.

Typically in such ransomware attacks, a sophisticated computer virus finds its way into a victim’s system when an unsuspecting employee opens an email attachment. The virus encrypts the system’s data and attackers essentially hold the data hostage until the owners of the information pay a ransom, typically in an untraceable digital currency such as Bitcoin.

A virus "finds its way" into a victim's system?

Let me rephrase into the politically incorrect, but factually correct, "due to incompetence in computer security. evil people are able to infiltrate the virus into a life-critical EHR system."

The Marin Healthcare District and Prima Medical Foundation issued nearly identical press releases on Wednesday, stating, “The third-party forensic firm hired to investigate this incident found no evidence that patient personal, financial, or health information was accessed, viewed, or transferred.

I guess they never considered that such evidence could have been removed by the hackers, who obviously had just a bot more IT expertise than the average high schooler.

But, of course, the thieves were honest thieves who would NEVER steal valuable medical charts for profit on the black market...

Here's what I consider the very worst part of this incident:

“However, during the restoration process, one of MMPC’s backup systems failed, causing information to be lost that was collected at the district’s nine medical care centers between July 11, 2016 and July 26, 2016.”

I note that a "backup system failing" causing data loss is a "never" event.  Incompetence...

The release went on to say: “This information includes vital signs, limited clinical history, documentation of physical examinations, and any record of the communication between patients and their physician during a visit in that 15 day period. Results of diagnostic tests were not lost and patients do not need to be re-tested.”

But patient safety was not compromised...

Jamie Maites, a spokeswoman for Marin General Hospital, said, “The ransom unlocked the data; however, at the time of the incident, we were in the middle of a system upgrade. The data loss occurred at the time of the system restore due to a faulty backup system — not due to the malware.”

Well, that's certainly reassuring.

Maites said Marin General’s systems were unaffected by either the ransomware or the failed backup systems. The patients being notified are patients of physician practices that are part of the Marin Healthcare District Medical Care Centers and Prima Medical Foundation.

The hackers were generous in sparing the hospital.

In a statement, Lee Domanico, chief executive of the Marin Healthcare District, said, “Our community can rest assured that the Marin Healthcare District will continue to work side by side with our vendors to ensure that all of our data is protected with today’s most advanced technology to reinforce their security systems against the most aggressive threats.”

Lee Domanico is the same CEO who I cited in my aforementioned posts who in 2013, after dire nurse warnings, brilliantly assured the board that the hospital was safe, despite "glitches" in the new system and that "I'm confident that in spite of the implementation issues, we have a system today that is safer for patients than our old paper system, and it will get even safer as we gain experience with it and work to fix some of the glitches we've experienced."

In a similar statement, Dr. Robert Newbury, chief executive of the Prima Medical Foundation, said, “It is unfortunate that these types of cyber-attacks have become so common.”

I would more precisely state that it is unfortunate that health IT leaders are so incompetent that they cannot secure their own life-critical systems.

... According to a report issued by the Attorney General’s Office in February, in the past four years the attorney general has received reports on 657 data breaches affecting a total of more than 49 million records of Californians.  The report said that malware and hacking present the greatest threat, accounting for 54 percent of the breaches. The report added that health care, which accounted for 16 percent of breaches, is starting to see an increase in hacking breaches as the sector transitions to electronic medical records. And it said that the “most vulnerable information in health care was medical information, such as patient records, and Social Security numbers.”

I really have to ask if the (increasingly elusive) benefits of EHRs warrant this level of security risk - let alone the known risks of bad health IT aside from security issues.

-- SS