Friday, September 15, 2017

Apparently Ebola, like Tuberculosis or Lyme bacteria and many known viruses, can remain in your body for years after infection


Ebola Virus RNA detection in Semen More than Two Years after Resolution of Acute Ebola Virus Infection 
Abstract 
Among 149 men who survived Ebola virus disease (EVD) and donated semen 260–1016 days after EVD onset, Ebola virus (EBOV) ribonucleic acid (RNA) was detected in 13 (9%). Of 137 men who donated semen 2 years after EVD onset, 11 (8%) had an EBOV RNA-positive specimen. The mechanism underlying the persistence of EBOV RNA in semen is unclear, and it is unclear whether the detection of viral RNA represents the presence of infectious virus."


As case reports have emerged of Ebola virus persisting in the eyes and genitourinary tract, people began to wonder if there were 'privileged sites' that allowed the Ebola virus to remain intact but dormant in people who had had earlier infections. Now there is additional strong evidence this occurs.

 Ebola RNA was detected in semen in 8% of 137 men who survived an Ebola infection--two years later.  Presumably, like the organisms which cause Lyme Disease, TB, chickenpox and other infections, people may develop recurrent illness if their immune system fails to control persisting, live organisms.

While the presence of RNA is not absolute evidence that live, infectious Ebola virus remains in the bodies of recovered victims, as culture of the virus would be, it is hard to imagine any other scenario to explain this finding.  Especially since shedding of Ebola virus was known to possibly continue for months after an infection, even prior to the 2014 Ebola epidemic.


Do drug companies spend the most money to promote the most useless drugs?/ CMAJ


Drug companies spent the most money to promote the most useless drugs, according to the following study in the Canadian Medical Association Journal:

The relation between promotional spending on drugs and their therapeutic gain: a cohort analysis
Joel Lexchin MSc MD
Abstract
Background: Whether drug promotion helps or hinders appropriate prescribing by physicians is debated. This study examines the most heavily promoted drugs and the therapeutic value of those drugs to help determine whether doctors should be using promo- tional material to inform themselves about drugs.
Methods: Lists were constructed of the 50 most heavily promoted drugs (amount of money spent on journal advertisements and vis- its by sales representatives) and the 50 top-selling drugs (by dollar value) for 2013, 2014 and 2015. Therapeutic gain was determined by examining ratings from the Patented Medicine Prices Review Board and the French drug bulletin Prescrire International and was categorized as major, moderate or little to none. For each of the 3 years, the number of drugs in the 3 therapeutic categories for drugs in both groups was compared. The amount and proportion of money spent on promotion for drugs in each of the 3 therapeutic categories for the 3 years was also determined.
Results: Therapeutic ratings were available for 42 of 79 of the most heavily promoted drugs over the 3 years and for 40 of 61 of the top-selling drugs. Nearly all the money spent on promotion in each of the 3 years went to drugs with little to no therapeutic gain. The distribution of therapeutic gain for drugs in both groups was statistically significantly different only in 2013 (p = 0.04).
Interpretation: Most of the money spent on promotion went to drugs that offer little to no therapeutic gain. This result calls into ques- tion whether doctors should read journal advertisements or see sales representatives to acquire information about important medical therapies. 


Correspondence to: Joel Lexchin, jlexchin@yorku.ca CMAJ Open 2017. DOI:10.9778/cmajo.20170089 

Tuesday, August 22, 2017

Pharma industry ‘getting away with murder’ abroad/ STAT

Chilling report from STATon how Big Pharma is suing governments and overturning patent laws around the world to raise the price of its meds:
By BROOK K. BAKER and KATRINA GEDDES
AUGUST 21, 2017

Seven months after President Trump accused the pharmaceutical industry of “getting away with murder,” he is busy lining the pockets of large pharmaceutical companies worldwide by giving them more power to charge higher prices overseas. Their price monopolies are likely to be extended under a draft executive order promising “greater intellectual property protection” in multilateral and bilateral trade agreements. The North American Free Trade Agreement, for example, has already been pegged to harmonize foreign intellectual property standards to reflect those found in the United States. Canada, it seems, will be the first target of U.S. indoctrination.
The Canadian government has been repeatedly excoriated for its failure to parrot U.S. intellectual property laws, receiving numerous reprimands in congressional hearings and Office of the United States Trade Representative reports for daring to define its own standards of patentability. While the U.S. vehemently defends its own sovereignty and singularity, it seems like it cannot tolerate these principles in other nations.
That was certainly the view held by U.S. pharmaceutical giant Eli Lilly when, in November 2012, it filed an investor-state arbitration claim against the Canadian government for overturning two of its pharmaceutical patents. As McGill University’s E. Richard Gold recently described in STAT, disgruntled with its losses, Eli Lilly sued the Canadian government for $500 million for its “radical departure” from U.S. intellectual property standards. Five years later, the company has spent more than $12 million trying to educate the Canadian government on what is, and what is not, an acceptable margin of change in its domestic law.
The company’s strategy to mold Canadian law in its image ultimately prevailed. In June, the Canadian Supreme Court delivered a stunning decision, overturning decades of Canadian precedent to arrive at the same standard of patentability demanded by Eli Lilly and applied in the U.S.
The U.S. Chamber of Commerce gleefully praised the decision, while Canadian academics lamented the boon to foreign patent holders at the expense of local startups. The Canadian Supreme Court had pre-empted NAFTA’s renegotiation, which had identified Canada’s patentability standards as a “serious problem” that would need to be addressed.
The chilling effect of investor-state arbitration on national sovereignty is not new, and the Eli Lilly case is only one in a long line of throw-downs by deep-pocketed corporations anxious to wring more profits out of foreign markets.
The Australian government spent six years (and millions of taxpayer dollars) defending its plain packaging laws from tobacco giant Phillip Morris in a dispute so decidedly comical it even made the desks of late-night comedy shows. That a sovereign nation could not pass laws designed to protect the health of its citizens without being slapped with a billion-dollar lawsuit seems so determinedly ridiculous that one has to wonder how these disputes continue to arise. But they do — in the shadows of corporate boardrooms, behind the closed doors of arbitral proceedings, and on the fringes of mainstream media.
Here’s another example. The Colombian government had sought to supply its citizens with an affordable generic version of Gleevec, a cancer drug made by Novartis. Worried about losing profits on its $15,000 pill, Novartis threatened the Colombian government with an investor-state dispute, and the Colombian government had no choice but to accede.  Similarly, the threat of an $800 million investor-state dispute was used by Gilead Sciences to force the Ukrainian government to deregister a generic drug that was competing with sofosbuvir (Sovaldi), Gilead’s $84,000 hepatitis C medication.
The increasing use of investor-state litigation by big pharmaceutical companies to bully sovereign nations into withdrawing public health measures reflects the broad and dangerous reach of investor-state arbitration. And the strategy isn’t limited to this industry.
Wealthy foreign companies can bring investor-state claims against anygovernment measure that adversely affects corporate profits, including the closure of nuclear power plants, a ban on mining that was contaminating water, or the closure of a poisonous metal smelter.
National governments are increasingly confronting a shrinking domestic policy space, hemmed in by the chilling effect of closed-door arbitration that prioritizes profits over public health. As long as international trade agreements permit investor-state disputes, Eli Lilly, Phillip Morris, Novartis, and other companies will continue to bully sovereign nations into serving their bottom line.
As we continue to witness the private arbitration of public interests, we must ask ourselves whether Trump will continue abetting pharmaceutical companies at “getting away with murder.”
Brook K. Baker is a professor of law at Northeastern University in Boston and senior policy analyst for Health GAP (Global Access Project). Katrina Geddes is a research fellow at Global Access in Action at Harvard Law School.

Saturday, August 12, 2017

I am opening a private internal medicine practice September 1 in Ellsworth, Maine

I hope to see patients with challenging disorders, those who wish to reduce their medications and/or use diet and lifestyle changes to improve health (especially diabetes and hypertension), and those with illnesses occurring after tick bites, fibromyalgia-related, or a consequence of military service or anthrax vaccine.  I will also treat the range of illnesses seen in primary care internal medicine, and I love to work with patients to achieve optimal wellness.

Throughout my career, I have had patients referred to me who were not helped by standard western medicine. While I cannot help everyone, I often take a unique look at the illness, and have a broader palette of measures to use than most doctors. My use of supplements and vitamins also informs my approach to wellness.

I believe everyone deserves great healthcare, so have made my charges considerably lower than standard rates. I also offer sliding scale fees for low income patients.  However, in order to make this practice work, I cannot accept any insurance plans, and patients must pay for my services when services are rendered.

Appointments may be made at (207) 522-5229.
The office phone number will be (207) 610-5885.

The office address is 210 Main Street, Ellsworth, Maine. 04605.  My office is on the 2nd floor.

Sunday, July 23, 2017

WHO DREAMS UP US FOREIGN POLICY? In Syria, there is no answer that makes sense. Has our foreign policy been privatized?

from  What the demise of the CIA’s anti-Assad program means

Washington Post Opinion by David Ignatius
July 20, 2017


"What did the CIA’s covert assistance program for Syrian rebels accomplish? Bizarrely, the biggest consequence may be that it helped trigger the Russian military intervention in 2015 that rescued President Bashar al-Assad — achieving the opposite of what the program intended. 
Syria adds another chapter to the star-crossed history of CIA paramilitary action. These efforts begin with the worthy objective of giving presidents policy options short of all-out war. But they often end with an untidy mess, in which rebels feel they have been “seduced and abandoned” by the promise of U.S. support that disappears when the political winds change..." x
... Run from secret operations centers in Turkey and Jordan, the program pumped many hundreds of millions of dollars to many dozens of militia groups. One knowledgeable official estimates that the CIA-backed fighters may have killed or wounded 100,000 Syrian soldiers and their allies over the past four years.  
"... The United States didn’t have a political strategy to match the CIA’s covert campaign. “There was no ‘there’ there, in terms of a clearly articulated national security objective and an accompanying strategy,” said Fred Hof, a former State Department official who has followed the Syria story closely."
... Contrast the sad demise of the CIA’s anti-Assad program in western Syria with the rampaging campaign against the Islamic State in the east. What’s the difference? In the east, motivated, well-organized Syrian fighters are backed by U.S. warriors on the ground and planes in the sky. In this game, halfway is not the place to be. 

Thursday, June 22, 2017

Evidence based medicine manifesto for better healthcare/ BMJ

Here is a very good start at diagnosing inherent problems in the medical research enterprise, and suggestions for correcting them.--Meryl

BMJ 2017357 doi: https://doi.org/10.1136/bmj.j2973 (Published 20 June 2017)
  • Carl Heneghan, director1,
  • Kamal R Mahtani, deputy director1,
  • Ben Goldacre, director EBM DataLab1,
  • Fiona Godlee, editor in chief2,
  • Helen Macdonald, head of education2,
  • Duncan Jarvies, multimedia editor2
    1. A response to systematic bias, wastage, error, and fraud in research underpinning patient care
      Informed decision making requires clinicians and patients to identify and integrate relevant evidence. But with the questionable integrity of much of today’s evidence, the lack of research answering questions that matter to patients, and the lack of evidence to inform shared decision how are they expected to do this?
      Too many research studies are poorly designed or executed. Too much of the resulting research evidence is withheld or disseminated piecemeal.1 As the volume of clinical research activity has grown2 the quality of evidence has often worsened,3 which has compromised the ability of all health professionals to provide affordable, effective, high value care for patients.”
      The BMJ and the University of Oxford’s Centre for Evidence Based Medicine have collaborated on Evidence Live, a yearly conference designed to “develop, disseminate, and implement better evidence for better healthcare.” Through this work and other projects, we know of substantial problems but also progress and solutions spanning the breadth of the evidence ecosystem, from basic research to implementation in clinical practice.
      The EBM manifesto offered here grew from that awareness. It is an open invitation for others to contribute to and join a movement towards better evidence by providing a roadmap for how to achieve the listed priorities and to share the lessons from achievements already made. Its aim is to complement and unite existing efforts as well as create new ones.

      Why can’t we trust the evidence?

      Serious systematic bias, error, and waste of medical research are also well documented (box 1).4 Most published research is misleading to at least some degree, impairing the implementation and uptake of research findings into practice. Lack of uptake into practice is compounded by poorly managed commercial and academic vested interests15; bias in the research agenda (often because of the failure to take account of the patient perspective in research questions and outcomes)1617; poorly designed trials with a lack of transparency and independent scrutiny that fail to follow their protocol18 or stop early19; ghost authorship20; publication and reporting biases5721; and results that are overinterpreted or misused,22 contain uncorrected errors,14 or hide undetected fraud.923

      Box 1: Problems with current evidence

      • A landmark review suggested that results from half of all trials are never published, and that positive trials are twice as likely to be published as results from negative trials5
      • The cost of clinical drug trials rose fivefold in one decade and is hindering the development of new medicines6
      • 85% of research spending currently goes to waste 4
      • In a study of systematic reviews, 86% of 92 Cochrane reviews did not include data from the main harm outcome 7
      • A systematic review of 39 studies found no robust studies evaluating shared decision making strategies8
      • From 2009 to 2014 the drug industry received fines totalling $13bn (£10bn; €12bn) for criminal behaviour and civil infringements—few systematic changes have occurred to prevent such problems occurring again9
      • “Despite repeated calls to prohibit or limit conflicts of interests among authors and sponsors of clinical guidelines, the problem persists”10
      • One third (34%) of scientists report questionable research practices, including data mining for statistically significant effects, selective reporting of outcomes, switching outcomes, publication bias, protocol deviations, and concealing conflicts of interest11
      • A 2012 survey of 9036 BMJ authors and reviewers found that of the 2782 (31%) who replied, 13% had witnessed or had firsthand knowledge of UK based scientists or doctors inappropriately adjusting, altering, or fabricating data during their research for the purpose of publication12
      • 8% of authors from 630 articles admitted they had lied in their authorship statements13
      Poor evidence leads to poor clinical decisions. A host of organisations has sprung up to help clinicians interpret published evidence and offer advice on how they should act. These too are beset with problems such as production of untrustworthy guidelines,10 regulatory failings,23 and delays in the withdrawal of harmful drugs.24 Collectively these failings contribute to escalating costs of treatment,25 medical excess (including the related concepts of medicalisation, overdiagnosis, and overtreatment)26 and avoidable harm.24

      Developing more trustworthy evidence: the EBM manifesto

      The steps required to develop trustworthy evidence (box 2) have been refined through a series of activities with stakeholders, including seminars, round table discussions, online consultations, and direct feedback. Tackling the problems will take time, resources, and effort. The evidence based medicine community should take responsibility for this. However, it is a vast project that is being led, and will be led, by disparate groups around the world. We hope to focus attention on the tools and strategies most effective at delivering change, so that we can all work together to improve healthcare using better quality evidence. The manifesto document and priorities are a living document and will evolve over time to advocate for trusted evidence for better healthcare. If you want to have your say and join the discussion then visit (http://evidencelive.org/manifesto/).

      Box 2: EBM manifesto for better health

      • Expand the role of patients, health professionals, and policy makers in research
      • Increase the systematic use of existing evidence
      • Make research evidence relevant, replicable, and accessible to end users
      • Reduce questionable research practices, bias, and conflicts of interests
      • Ensure drug and device regulation is robust, transparent, and independent
      • Produce better usable clinical guidelines
      • Support innovation, quality improvement, and safety through the better use of real world data
      • Educate professionals, policy makers, and the public in evidence based healthcare to make an informed choice
      • Encourage the next generation of leaders in evidence based medicine

      Tuesday, May 30, 2017

      Zimbabwe's historic anthrax epizootic: new analysis

      A paper has been published here and, while in draft form, discussed at length here, which reanalyzes the features of Zimbabwe's anthrax epizootic, which began in 1978 and slowly tailed off after 1980.

      The authors include an MD and geography specialists from the University of Nevada, Reno.  The first author, James M. Wilson, MD, has founded a center to investigate and forecast epidemics.  From his bio:
      Director, Nevada State Infectious Disease Forecast Station @ the University of Nevada-Reno.This is the first operational infectious disease forecast station in the United States that operates at the state level. 
      The group has done a great job collecting information about weather (temperature, rainfall), soils, outbreak locations, possible means of spread, and number of animals and humans affected, as well as the movement of the epidemic over time.  The group has pulled together the detail needed to create maps and tables that convey how the epidemic evolved chronologically.

      The authors have [as I believe I did in 1992] put to rest a number of unsupported theories as to the nature of the epidemic, and confirmed that the geographic "hops" anthrax made are not explained by natural occurrences.  The authors confirm that anthrax cases extended to the borders of Zimbabwe, but remained confined within Zimbabwe's boundaries. Adjoining countries experienced no similar epizootic.

      The authors agree that the vast majority of human cases were associated with exposure to anthrax-contaminated animals, hides or meat.

      Of interest, a number of anonymous commenters were extremely critical of Wilson's paper as it was in progress.  Their arguments were mostly specious, and I would be able to knock each down if it was useful to do so; I did knock down a few, then stopped sparring with anonymous critics.  If the critics were serious, presumably they would have used their names.  What was interesting was the concerted attack on Wilson, some 38 years since the onset of the epizootic, to deny the event could have been due to biological warfare.  Yet there is no other explanation, consistent with the facts, that has ever been put forward.

      Wilson's paper also makes clear that the 2015 report on this epizootic, by Stephan P. Velsko from Lawrence Livermore National Laboratory (LLNL), self-published by LLNL, is not worth the paper it is printed on. Velsko ditched the facts and built a house of cards based on his own inferences about the epidemic, providing an example of the extreme lengths a so-called scientific exercise can be taken to turn the scientific method on its head. I criticized his work here.

      Wilson reported that I had been living in Zimbabwe at the time of the epizootic.  Actually, I was living in the US.  I travelled to Zimbabwe to study the epizootic in 1992, and did a poster presentation on the epizootic in Nairobi at the International Society for Infectious Diseases in July 1992, making the argument that the many unique features of this epizootic could only be explained as an act of biological warfare.  Margarete Isaakson, a South African infectious disease scientist with likely connections to Project Coast, and an interest in Ebola, screamed at me in Nairobi for daring to present such rubbish. I believe this was because I came too close to her area of expertise.

      Nothing has changed since Zimbabwe's tragic epizootic.  Biowarfare is a horrible mode of warfare that has not been eradicated, identifying it is controversial, and developing the scientific tools that allow one to definitively identify when an act of offensive biowarefare has been used, shifts the balance of power from the perpetrators to the investigators and to those who were attacked.  That seems a very fair power shift, but it isn't to everyone's liking. (What makes biological warfare especially attractive is the ability to hide that it actually occurred, and who caused it.) Scientific studies that remove this advantage are, unsurprisingly, being attacked.

      The attacks, mostly spurious, that Wilson has received for his paper tell us there are still many people who would keep the whole subject under wraps.

      Finally, despite a 2010 paper by Fasanella et al. that flies can transmit anthrax spores in the lab (and several similar earlier papers going back decades have found the same thing), the problem is the flies' failure to transmit enough spores or viable vegetative forms to cause illness in livestock, because on the order of one million spores is required to achieve an infectious dose. It is much more likely that flies could transmit anthrax to rodents, for whom several orders of magnitude fewer organisms are required.  But in nature, they do not seem to do this, either.  So much for the fly theory.

      While I am pleased this subject is getting the careful attention it deserves, I wonder why it is getting it now?

      Wednesday, May 24, 2017

      COMMENTARY Death By A Thousand Clicks: Leading Boston Doctors Decry Electronic Medical Records/ WBUR

      By 
      It happens every day, in exam rooms across the country, something that would have been unthinkable 20 years ago: Doctors and nurses turn away from their patients and focus their attention elsewhere — on their computer screens.
      By the time the doctor can finally turn back to her patient, she will have spent close to half of the appointment serving not the needs of her patient, but of the electronic medical record.
      Electronic medical records, or EMRs, were supposed to improve the quality, safety and efficiency of health care, and provide instant access to vital patient information.
      Instead, EMRs have become the bane of doctors and nurses everywhere. They are the medical equivalent of texting while driving, sucking the soul out of the practice of medicine while failing to improve care.
      To fix them, hospital administrators and clinicians need to work together to demand better products from EMR manufacturers and to urge government to relax several provisions of the HITECH Act, the 2009 law that spawned many of the problems with EMRs.
      How did technology that has increased efficiency in every other industry become such a drag on health care? For starters, people who take care of patients did not design or choose these systems. They were foisted upon us.
      Doctors and nurses know that good diagnosis and treatment requires listening attentively to their patients. They spend years learning to parse the clues that patients offer, both the physiological and personal, in order to provide the right care.
      To do this well takes time and undivided attention.
      Making sense of a patient’s blood panel means knowing the patient’s work and eating habits, and where he or she may have traveled. We need to know if the patient is experiencing a traumatic life event, like the death of a parent or domestic abuse, in order to interpret an elevated blood pressure.
      Instead of making this easier, most EMRs create extra work. A lot of extra work, thanks to endless prompts with multiple choice answers that hardly ever fit the facts and that demand click after click to get anything done.
      Want to order a simple test? That requires getting through multiple prompts. Need to write a prescription -- an exercise that used to take less than 15 seconds? Another set of clicks.
      Typing, filing, mailing results and placing referrals all used to be done by assistants. Now, EMRs put that burden on clinicians, and we must do it during office visits, or “encounters,” as EMRs call them. And when the wrong button is clicked, the wrong test or drug is ordered, or it does not go through at all, delaying medical care.
      It’s death by a thousand clicks, and it happens every day.
      We are frustrated by EMRs because they pull us away from our patients. We are driven mad by the fact that EMRs in different locations do not talk to each other. And we think it’s just wrong that much of the EMR’s busywork is about optimizing billing for the hospital.
      Who is to blame? Start with EMR manufacturers, who lobbied Congress to require every hospital and doctor’s office to install an EMR system; hospital administrators who bought technology that conveniently pushed billing duties onto doctors and nurses; and federal regulators, who imposed on EMRs numerous quality metric requirements that do nothing to improve care.
      We do not want to go backward. We believe that computing is essential to the future of medicine. We simply want all EMRs to live up to their promise of improving care and making patient information readily available.
      Thousands of doctors in Boston and across the country are expressing the same frustration, through gritted teeth, between exasperated sighs, and in resignation letters. EMRs are driving too many health care providers to hang up their scrubs and white coats in search of work that is less infuriating and more fulfilling.
      As we continue to debate how our country will finance an equitable health care system for all, we need a long-term strategy to address this crisis in health care delivery.
      The public and private institutions of this city have long and illustrious histories of leadership in health care. Now is the time to embrace that tradition and do something about EMRs. We plan to hold town hall meetings to give providers, patients and community members a chance to discuss how to address the problems of EMRs. We invite executives and administrators from all our hospital systems to participate.
      The sound of medicine is not the click of a mouse. It is the human voice. Let’s bring it back, for the sake of our patients’ health and our own sanity.