Tuesday, December 12, 2017

Ex-Spy Chief Admits Role In 'Deep State' Intelligence War On Trump/ Zero Hedge

Wednesday, December 6, 2017

Turning over Public Health to Industry: the UK leaps ahead/ BMJ

from today's BMJ (British Medical Journal)


Tom Jefferson: The UK turns to Witty, Vallance, and Van Tam for leadership: revolving doors?


December 6, 20173Revolving doors are used to facilitate entry or exit into a building. The trick with using these doors is always to get your timing right. Too fast or too slow and you get stuck. 
The analogy seems apposite for a brace of recent announcements of important pharmaceutical industry figures taking over parts of UK operations in key aspects of healthcare planning and delivery. 
Andrew Witty, who left the helm of GSK in April, is going to head up the UK government’s Accelerated Access Review (AAR) programme. The AAR is said to be aimed at helping NHS patients “get quicker access to innovative new diagnostic tools, treatments, and medical technologies.”Meanwhile Patrick Vallance is leaving his post of head of research and development at GSK as part of a re-shuffle by the new CEO Emma Walmsley. Vallance is taking up a senior position in the UK government, as Chief Scientific Adviser. His job will be “improving the quality and use of scientific evidence in government as head of the Government Office for Science.”Last but not least, another academic with extensive ties to industry over influenza and pandemic planning (and another ex-employee of GSK, Roche and Aventis Pasteur MSD), Jonathan Van Tam has been appointed Deputy Chief Medical Officer responsible for emergency preparedness and pandemic planning. This is a similarly senior position which holds great power and will potentially involve committing huge quantities of taxpayers’ money to projects preparing for future emergencies, which may or may not come about. It is also a very delicate role as the amount of lobbying and corporate pressure applied on governments before the 2009 influenza pandemic shows. 
What are we to make of all this?The lowering of regulatory and HTA standards is in full swing and its main driver is the pharmaceutical industry. The general rhetoric of rushing drugs and devices through to needy patients willing to accept substantial risk rests on very thin evidence of benefit and unclear public support. 
Improving the quality of evidence is desperately needed as shown by the scores of examples of clinical trials that have been abandoned or distorted that have come to light in the last decade. Pandemic planning also requires some rethinking as the millions of pounds spent on a dubious pandemic with equally dubious fixes has shown. The close space of time of these “revolving doors” makes me wonder whether the government has objectively and properly overseen the decision making which has led to such important public positions being filled by senior industry figures. Can one walk away from leading industry, or rubbing shoulders with it, and perform an important public health function with impartiality? HM Government seems to think so, but if you are unsure (as I am) you may be given pause for thought. 
A career spent working in pharma usually means a commensurate share and farewell package. We are told that Andrew Witty is also engaged in a venture capital company, so his commercial life is still very much alive. We have not been told whether they have either sold their shares, or put them in a blind trust or in general how they are to behave when advising HM government on interventions such as drugs, biologics, or diagnostics which they helped develop and market.Professor Van Tam’s track record as an ex-employee of Roche, Aventis Pasteur MSD and SmithKline Beecham (now GSK) has been excluded from the official DH press release, which is interesting, but hardly confidence-building. He frequently attends events organised by the European Scientific Working Group on Influenza (ESWI), a well know industry-funded lobbying group. His predecessor in the CMO post, John Watson, was a founding member of ESWI. Van Tam has been a consistent supporter of pharmacological measures to address influenza and as head of the Pandemic Influenza Office at the UK Health Protection Agency in 2004-2007 bears responsibility for decisions which have been heavily criticised by the Public Accounts Committee. Van Tam went to the department of health from the University of Nottingham, the Chancellor of which is none other than Witty. 
In my view it is time that the government and the public took a close look at what is going on in the upper echelons of healthcare planning and delivery in this country and considered imposing a substantial time moratorium on hiring workers with close ties to industry. Should such senior appointments not be subject to parliamentary committee scrutiny? 
It’s no consolation but, doors seem to be spinning full time in the USA too, the latest being the appointment of the former boss of Eli Lilly to head the Department of Health and Social Services. 
EMA’s imminent move to Amsterdam from London may have been a factor in the UK appointments and may generate more revolving door activity with a rush of regulators unwilling to relocate, or the Government might be trying to reassure industry that it’s still in the driving seat. Another reason for watching events closely.  With so much movement the revolving door will eventually get stuck and cease to work the way it was intended.  What the decision makers seem to have forgotten is that the success of public health depends on the public having full trust and confidence in leadership. 
Tom JeffersonSenior Associate Tutor, University of Oxford. 

Monday, November 20, 2017

UN says Afghanistan produced 87% more opium than last year, for its biggest harvest ever. Expect a bigger supply and lower prices on the street.

In a report just issued (November 2017) by the United Nations Office on Drug Control, we learn that Afghanistan had a huge, bumper crop of opium in 2017.  Its biggest ever.  And if you read the details of the methods used to estimate the amount of opium produced, you will see that there is a large amount of guesswork, and the amount available for overseas distribution might be considerably greater than estimated.

https://www.unodc.org/documents/crop-monitoring/Afghanistan/Afghan_opium_survey_2017_cult_prod_web.pdf

Pages 7, 8

"Key Findings: 

Area under opium poppy cultivation increased by 63% since 2016, reaching a new record high... 

Opium poppy cultivation expanded to new regions and intensified where there was cultivation before…

Total eradication of opium poppy increased by 395 hectares but remained very low...

Potential opium yield and production increased in 2017 Potential opium production was estimated at 9,000 tons in 2017, an increase of 87% from its 2016 level (4,800 tons). The increase in production is mainly a result of an increase in area under opium poppy cultivation, while an increase in opium yield per hectare also contributed. In 2017, the average opium yield amounted to 27.3 kilograms per hectare, which was 15% higher than in 2016…" 

A graph of the area in hectares used to grow opium poppies in Afghanistan from 1994-present is on page 15 of the report.  As I noted previously, a US CIA/military presence in Afghanistan has historically corresponded to increased opium production.

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

Today, Nov 20, it was announced at a press conference that US and Afghan military forces have launched attacks on Taliban opium factories.

"U.S. Army General John Nicholson showed videos at a press conference of targeted aerial strikes against what he described as Taliban drug factories.  “Last night we conducted strikes in northern Helmand to hit the Taliban where it hurts, in their narcotics financing,” said Nicholson, flanked by Afghan Army Lieutenant General Mohammad Sharif Yaftali…"




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, 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.

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.

The office phone number is (207) 610-5885.
The office address is 210 Main Street, Ellsworth, Maine. 04605.  My office is on the 2nd floor.

Charges:  15 min brief (i.e., acute infection)           $  45
                 25 min  moderate                                    $  75
                 60 min  complex                                     $150
               120 min+ longterm, chronic, complex     $300


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