Princess Health and Out for Two Weeks. Princessiccia
I'll be out of town with limited internet until September 27th. Feel free to leave comments, but I won't be able to moderate them until I return. Sorry for the inconvenience!
Politico
Doctors barred from discussing safety glitches in U.S.-funded software
Darius Tahir
09/11/15
http://www.politico.com/story/2015/09/doctors-barred-from-discussing-safety-glitches-in-us-funded-software-213553
President Barack Obama�s stimulus put taxpayers on the hook for $30 billion in electronic medical records, many of which have turned out to be technological disasters.
But don�t expect to hear about the problems from doctors or hospitals. Most of them are under gag orders not to discuss the specific failings of their systems � even though poor technology in hospitals can have lethal consequences.
A POLITICO investigation found that some of the biggest firms marketing electronic record systems inserted �gag clauses� in their taxpayer-subsidized contracts, effectively forbidding health care providers from talking about glitches that slow their work and potentially jeopardize patients.
POLITICO obtained 11 contracts through public record requests from hospitals and health systems in New York City, California, and Florida that use six of the biggest vendors of digital record systems. With one exception, each of the contracts contains a clause protecting potentially large swaths of information from public exposure. This is the first time the existence of the gag clauses has been conclusively documented.
... In their Commentary, Dr Koppel and Mr Kreda made clear the problems associated with applying the customs and traditions of business software contracting and sales (where �hold harmless� and �keep defects secret� clauses are commonplace) to health care information technology (HIT) as if they are the same. I believe that ignoring their differences has likely created an epidemic of violations of hospital governing body responsibilities and Joint Commission standards for health care organization leadership.
http://injury.findlaw.com/accident-injury-law/recklessness.html
Recklessness means the person knew (or should have known) that his or her action were likely to cause harm. Negligence means that the person acted in violation of a duty to someone else, with the breach of that duty causing harm to someone else.
Vendors say such restrictions target only breaches of intellectual property and are invoked rarely.
But doctors, researchers and members of Congress contend they stifle important discussions, including disclosures that problems exist. In some cases, they say, the software�s faults can have lethal results, misleading doctors and nurses who rely upon it for critical information in life-or-death situations.
Critics say the clauses � which POLITICO documented in contracts with Epic Systems, Cerner, Siemens (now part of Cerner), Allscripts, eClinicalWorks and Meditech � have kept researchers from understanding the scope of the failures.
... Sheldon Whitehouse (D-RI) asked a panel of witnesses [during a HELP committee hearing earlier this summer], including Allscripts CEO Paul Black: �Can anyone on this panel see a single reason why these contracts should have gag clauses in them?� No one ventured a reason.
After POLITICO disclosed its findings, an aide to HELP Chairman Lamar Alexander (R-Tenn.) said the committee would look at the issue, �exploring potentially harmful effects of these clauses � including how they could inhibit interoperability.�
... a comprehensive evaluation of the scientific literature has confirmed what many researchers suspected: The savings claimed by government agencies and vendors of health IT are little more than hype.
To conduct the study, faculty at McMaster University in Hamilton, Ontario, and its programs for assessment of technology in health�and other research centers, including in the U.S.�sifted through almost 36,000 studies of health IT. The studies included information about highly valued computerized alerts�when drugs are prescribed, for instance�to prevent drug interactions and dosage errors. From among those studies the researchers identified 31 that specifically examined the outcomes in light of the technology's cost-savings claims.
With a few isolated exceptions, the preponderance of evidence shows that the systems had not improved health or saved money.
... Take Cerner�s agreement with LA County�s Department of Health Services, signed in November 2012 and worth up to $370 million. It defines the vendor�s confidential information as �source code, prices, trade secrets, mask works, databases, designs and techniques, models, displays and manuals.� Such information can only be revealed with �prior written consent.� The protections cover the provider company, and its employees.
Such agreements, which are typical of the contracts examined by POLITICO, �contain broad protections for intellectual property and related confidentiality and non-disclosure language which can inhibit or discourage reporting of EHR adverse events,� said Elisabeth Belmont, corporate counsel at MaineHealth.
Belmont said she had also seen non-disparagement wordings that prohibit providers from disseminating negative information about the vendor or its software. POLITICO found no direct evidence of such clauses.
... The executive branch�the Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare and Medicaid Services are responsible for the subsidy program� has done little about the clauses, though providers and researchers have been grumbling about them since the 2011 Institute of Medicine report warning that �[t]hese types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT�related patient safety risks.�
...Agency officials say they deplore the clauses but lack the capacity to directly address the problem. �We strongly oppose �gag clauses� and other practices that prevent providers and other health IT customers and users from freely discussing problems and other aspects of their health IT,� an ONC spokesman said.
But, he continued, ONC cannot police them. The clauses take a variety of forms, and the extent to which vendors invoke them varies, making enforcement difficult � particularly for a small agency that doesn�t have investigative or police powers.
... Epic executives said they encourage open discussion. �With permission, we very frequently allow folks to share information around the software,� said Epic�s vice president for client success, Eric Helsher.
... a lot of problems may go under-reported. That offends [Dr. Bob] Wachter, who says the patient safety world �takes it as religion� that information be shared as widely as possible.
�These are worlds colliding. You can understand why a technology business would put restrictions on screenshots. But we�re not making widgets here, we�re taking care of sick people,� he said.
�At some level, I�d say, �How dare they?��
... In their Commentary, Dr Koppel and Mr Kreda made clear the problems associated with applying the customs and traditions of business software contracting and sales (where �hold harmless� and �keep defects secret� clauses are commonplace) to health care information technology (HIT) as if they are the same. I believe that ignoring their differences has likely created an epidemic of violations of hospital governing body responsibilities and Joint Commission standards for health care organization leadership.
Italy said on Wednesday it was seeking more than a billion euros in damages from multinational drug companies following a ruling by the country's antitrust authority that their policies had been detrimental to Italy's national health service.
The health ministry said in a statement it was requesting a total 1.2 billion euros ($1.6 billion) from Novartis and Roche for the damages incurred in 2012-2014, and was requesting 14 million euros from Pfizer.
It cited several recent antitrust rulings that the companies' repeated anti-competitive actions had caused the national health service 'considerable damage'.
Italy's state council, the highest administrative court, in February ruled that Pfizer had abused its dominant position relating to the glaucoma drug Xalatan 'with a clear and persistent intention to suppress competition'.
In a bid to widen access to vaccines, Doctors Without Borders is calling on Pfizer and GlaxoSmithKline to lower the prices for their pneumococcal vaccines to $5 per child in developing countries. The non-profit claims the drug makers are 'overcharging' donors and developing countries for vaccines that 'already earn them billions of dollars in wealthy countries.'
The non-profit, which regularly advocates for lower prices for medicines, maintains that, in general, the price to vaccinate a child against several diseases is now a 'colossal' 68 times more expensive than in 2001. In a new report, Doctors Without Borders attributes 45% of that increased cost to the price tags for pneumococcal vaccines sold by the drug makers. Pneumococcal disease, by the way, kills about 1 million children per year, mostly in poor and developing nations.
The non-profit maintains that the current price tag makes it difficult to supply the vaccine to large numbers of children, and the drug makers have already received $1 billion in incentives to manufacturer the vaccine for developing countries. 'We think it�s time for Glaxo and Pfizer to do their part to make vaccines more affordable for countries in the long term, because the discounts the companies are offering today are just not good enough,' says Malpani in a statement.
Moreover, Doctors Without Borders warns that pricing may eventually make it harder for a growing number of middle-income countries to afford vaccines. Over time, some of these countries will eventually �graduate� from the subsidized vaccine pricing established by Gavi and, when that happens, Doctors Without Borders estimates costs may rise up to six times what is the countries pay today.
The world's biggest vaccine by sales--Prevnar 13--just keeps getting bigger. And in doing so, the shot helped Pfizer notch 44% vaccines growth for the second quarter as the unit saw sales grow from $1.09 billion in last year's Q2 to $1.58 billion during the period this year.
For the quarter, the superstar pneumococcal disease-blocker notched a U.S. sales increase of 87% versus the same period last year, a jump Pfizer CEO Ian Read attributed to 'continued strong uptake' in U.S. adults.
Prevnar 13, which reeled in $4.29 billion in sales last year, is expected to grow to $5.83 billion in 2020 and remain atop the vaccines sales charts.
The company is also working 'country by country' to broaden the vaccine's reach in G7 countries....So there seems to be some evidence in support of the Doctors Without Borders claim that Pfizer could easily afford some small losses selling vaccines for use by poor children in less developed countries while it makes billions of dollars from vaccine sales in developed countries.
Pfizer has reached an agreement in principle to pay $400 million to settle a class-action securities lawsuit that alleged the drug maker illegally marketed several medicines and, subsequently, caused investors to lose money, according to a filing with the U.S. Securities and Exchange Commission.
The lawsuit alleged that, between January 2006 and January 2009, Pfizer marketed several drugs on an off-label basis. The medicines included the Bextra painkiller that was withdrawn from the market in 2005; the Geodon antipsychotic; the Zyvox antibiotic and the Lyrica epilepsy treatment.
The lawsuit, which was filed in federal court in 2010, alleged that the sales boost the drug maker received from the marketing prompted Pfizer executives to make 'false and misleading statements about Pfizer�s financial performance and sales practices [that] caused Pfizer stock to trade at artificially inflated prices.'
the drug maker revealed plans to pay $2.3 billion to resolve criminal and civil allegations that these drugs were marketed illegally.
The Competition and Markets Authority (CMA) has issued a statement of objections alleging the companies breached UK and EU law by raising the prices they charged for phenytoin sodium sold to the NHS.
The CMA says that for years industry giant Pfizer, which is listed in the US, and Flynn, a Stevenage-based company, between them sold the drug at a price up to 27 times higher than it had been previously priced.
Before September 2012, Pfizer manufactured and sold phenytoin sodium capsules to UK wholesalers and pharmacies under the brand name Epanutin.
Pfizer then sold the UK distribution rights for Epanutin to Flynn, which 'de-branded' the drug and started selling its version in September 2012. Pfizer continued to manufacture the drug, which it sold to Flynn at prices the CMA says were 'significantly higher' than those at which it had previously sold Epanutin.
The CMA claims Pfizer sold the drug at between 8 and 17 times its historic prices to Flynn, which then sold on phenytoin sodium at between 25 to 27 times more than the prices previously charged by Pfizer.
Before Flynn bought the rights for Epanutin, the NHS spent about �2.3m on phenytoin sodium capsules a year, according to the CMA. After the deal this spend rose to just over �50m in 2013 and more than �40m in 2014.
Pfizer, one of the world�s largest pharmaceutical groups, has said it will resist demands from investors and transparency campaigners that it disclose results from all historical drug trials.
Pfizer said it had a 'longstanding commitment to clinical trial transparency' and it already published data for trials from 2007. Requests for earlier data are considered on an individual basis. But it added: 'We don�t believe that further investment beyond this would offer value to patients, health services or to our shareholders.'This despite arguments above about the harms of research suppression. Given how much money Pfizer has spent on lawsuits, including one above about allegations of its management's deception of shareholders, one might think it would be worth it for management to make a little investment in transparency.
Pfizer failed to report hundreds of serious adverse drug reactions (ADRs) in the required timeframes according to Japan�s Ministry of Health, Labor and Welfare (MHLW) which has issued the US firm with a business improvement order.
Pfizer Inc. said Thursday that Chief Executive Ian Read�s total compensation rose 23% last year, lifted by an increase in pension value that offset a reduced annual bonus and equity award.
Mr. Read�s 2014 pay package totaled $23.3 million. The board raised the CEO�s salary to $1.83 million from $1.79 million but decreased his annual bonus by $400,000 and his equity award by nearly $1 million despite concluding that Mr. Read�s leadership during the year was 'outstanding.'It is not obvious that the rise in CEO pay is even remotely correlated to any rise in share-holder value. Moreover, there seems to be a total disconnect between the rewards given the CEO and the ethical record of the company he leads, especially since Pfizer, which calls itself "one of the world's premier pharmaceutical" corporations, announces its aspirations thus,
[Even though] Over the course of 2014, shares in the New York-based pharmaceutical company gained about 2% amid a 4% decrease in revenue.
we at Pfizer are committed to applying science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe, effective and affordable medicines and related health care services to the people who need them.
Humacyte Inc., a biotechnology company based in Research Triangle Park, has beefed up its board of directors by adding former U.S. Secretary of Health and Human Services Kathleen Sebelius and life sciences industry veteran Dale Sander.
The 11-year-old Humacyte develops novel human tissue-based investigational products that are being developed for potential commercialization for applications in regenerative medicine and vascular surgery. Sebelius adds a significant amount of heft to the company�s now eight-person board.
From 2009 to 2014, she served as the 21st Secretary of the HHS, leading the effort to pass and implement the Affordable Care Act. She�s also been named by Forbes as one of the 100 most powerful women in the world.
Prior to serving as secretary of HHS, Sebelius served as governor of Kansas, two terms as the Kansas insurance commissioner and four terms in the Kansas legislature.
'Secretary Sebelius is undoubtedly one of the most distinguished health care industry leaders of our time and we are honored to have her join our organization,' said Carrie Cox, chair and chief executive officer of Humacyte, in a statement. 'Her tenure in the public sector, and deep understanding of the rigors of the regulatory process and policy will provide unique perspective and insight to support our goals to improve care for Humacyte�s first application for patients with End Stage Renal Disease.'
government of the people, by the people, for the people, shall not perish from the earth.
The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.
What prompted her departure was the fallout over an article by William Peace, who at the time was a visiting professor in the humanities at Syracuse University. Mr. Peace wrote an essay for an issue of the journal, Atrium, that Ms. Dreger guest-edited. The essay is a frank account of a nurse who helped Mr. Peace regain his sexual function after he was paralyzed.
According to Ms. Dreger, Eric G. Neilson, vice president for medical affairs and dean of the university�s school of medicine, tried to censor the essay. The essay is straightforward in its description of sex, and includes multiple mentions of 'the dick police,' but the purpose is to illuminate what went on in the era prior to disability rights and studies.
As Mr. Peace writes, the unconventional approach of the unnamed nurse 'injected a compassionate eroticism that made me a better man.'
In her letter, Ms. Dreger writes that the university allowed the essay to be published online only after she and Mr. Peace threatened to talk publicly about what they saw as censorship. She writes that she was 'disgusted that the fear of bad publicity was apparently the only thing that could move this institution to stop censorship.'
Now the essay is out there, for all to see, 'dick police' and all. So what does Ms. Dreger want?
She asked the university to acknowledge that attempting to remove portions of the essay was a mistake and to promise not to do so in the future. 'They never acknowledged that the censorship was real,' Ms. Dreger said in an interview. 'I wanted a concrete acknowledgment and assurance that my work would not be subject to monitoring.' That, she said, would have been enough for her to remain.
The idea that institutions must acknowledge wrongdoing is central to Ms. Dreger's academic work.
The journal Atrium stopped publication after faculty objected to the new oversight committee, which [University spokesman Alan] Cubbage has described as 'an editorial board of faculty members and others, as is customary for academic journals.'
Dreger, who guest-edited the 'Bad Girls' issue [in which the controversial article first appeared], said that soon after publication, medical school administrators asked Atrium�s editors to remove the essay from the web, because the content was considered inflammatory and too damaging to the new Northwestern Medicine 'brand.' (Northwestern Memorial Health Care recently acquired Northwestern�s Feinberg School of Medicine faculty practice and merged with Cadence Health to operate under the Northwestern Medicine banner.) The editor, another faculty member, refused to single out one article for censorship and took down the journal�s web archive instead.
The controversy prompted the resignation of Kristi Kirschner, a former clinical professor humanities and bioethics at Feinberg, in 2014. Kirschner, now an adjunct professor of disability and human development at the University of Illinois at Chicago, told Inside Higher Ed earlier this summer that the alleged censorship had a 'chilling effect, antithetical to the idea of the university.'
A university spokesman declined to comment on Dreger�s case on Tuesday, saying it was a personnel issue. He also declined to answer general questions about censorship or the status of Atrium, which recently had its funding reduced, causing the journal to be canceled.
Atrium�s editor, Katie Watson, an assistant professor of bioethics and medical humanities, declined an interview but said the funding cut was not related to the 'Bad Girls' issue or censorship.
She referred additional questions to a post she wrote for Peace�s blog, Bad Cripple, in June, in which she said that she was disappointed with Peace for taking certain details of the case public, and in which she confirmed that a university content oversight committee meeting had been 'disheartening.'
"[T]he medical school required me to allow a vetting committee to review my editorial choices and veto them if they were perceived to conflict with other institutional interests," Watson wrote.
'As the settlement makes clear, the covered conduct in the settlement involved allegations focused on Dr. Charles Bennett, and grants for which Dr. Bennett was the principal investigator,' Northwestern officials said in a statement.
The statement was signed by Northwestern President Morton Schapiro, Provost Daniel Linzer, and Vice President for Medical Affairs and Dean of the Feinberg School of Medicine Eric Neilson.
[Michael] Henke confesses to wondering whether the many powerful enemies Bennett made in the pharmaceutical and biotechnology industries have struck back.
'We shouldn�t feed paranoia,' Henke said. 'However, given the exclusively positive experience when collaborating with his group, makes me wonder whether this litigation might follow some very particular other issues.'
According to the American Association of University Professors (1940):
'Academic freedom is essential to these purposes [the search for truth and its free exposition] and applies to both teaching and research. Freedom in research is fundamental to the advancement of truth.'
Cary Nelson, president of the AAUP and an English professor says that academic freedom:
'Gives both students and faculty the right to express their views � in speech, writing, and through electronic communication, both on and off campus � without fear of sanction, unless the manner of expression substantially impairs the rights of others or, in the case of faculty members, those views demonstrate that they are professionally ignorant, incompetent, or dishonest with regard to their discipline or fields of expertise.'
Even the American Society for Bioethics & Humanities, which is known for not taking positions on 'substantive moral and policy issues,' does take positions to support academic freedom and has done so in the past.
Since 1940, the notion of academic freedom has been a core tenet of university and faculty life. The idea was born in response to centralized governments telling researchers what they could and could not study and what they should and should not teach.
[Dr Danielle] Seaman had been in email communication with UNC�s Chief of Cardiothoracic Imaging beginning in 2011, when she expressed interest in a radiology position at the UNC School of Medicine, and the chief of the division encouraged her to apply, the case file describes. In 2012, Seaman was invited to visit the campus and toured the radiology department at UNC.
When Seaman expressed interest in the assistant professor position again in early 2015, however, the chief responded in an email by saying he had just received confirmation that 'lateral moves of faculty between Duke and UNC are not permitted' as per a 'guideline' set by the schools� deans.Both emails are included in the filing by Dr Seaman's lawyers.
In a later email, the chief also described to Seaman the reason the agreement was created�Duke had tried several years ago to recruit the entire bone marrow transplant team from UNC, and UNC was forced to pay them a large retention package to keep them.
'The general rule was that we didn�t recruit there and they didn�t recruit at Duke�it certainly was in the years I was in the administration,' said John Burness, former senior vice president for public affairs and government relations from 1991 to 2008. 'I don�t know if it�s ever been a formal agreement, but it�s certainly been a practice over a long period of time.'
Burness�now a visiting professor of the practice in the Sanford School of Public Policy�noted that he could not recall an instance in which a faculty member from UNC was recruited to Duke during Nannerl Keohane�s tenure as president of the University from 1993 to 2004. Keohane also confirmed that during her time as president the University avoided poaching of UNC faculty.
'The question of whether Duke and UNC [or N.C. State] should attempt to recruit faculty from the other campus was always somewhat delicate,' Keohane, now Laurance S. Rockefeller distinguished visiting professor of public affairs at Princeton University, wrote in an email.
Since the mid- 1970s, market-oriented scholars have challenged a broad range of legal principles previously assumed to sustain the trustworthiness of physicians and health systems. Doctrines shielding physicians from antitrust law, insulating them from insurers' and hospitals' influence over clinical practice, and reinforcing the precept of undivided clinical loyalty to patients came under attack as protection for the medical profession at consumers' expense. These scholars, including Clark Havighurst, Richard Epstein, and Mark Hall, urge contractual ordering of clinical standards of care; relationships among physicians, hospitals, and health care payers; and physicians' conflicting obligations to patients, payers, and other third parties.
For a decade or more, Clark Havighurst has been a philosophical thorn in the side of organized medicine, preaching a view of the health sphere that rejects decision making by professional self-regulation in favor of a system based on marketplace principles.Note that in retrospect, this article seemed to stake out Health Affair's position as an important organ to promote market fundamentalism in health care.