1 Boring Old Man

Gaining perspective on a history you lived through might be the hardest thing of all. How you saw it then and how it looks to you and to others now create a ciphered dreamscape not so easily parsed. Was Janis Joplin a symbol of freedom and liberation or an early slave to a coming opioid epidemic? When you’re passed on the highway by a roaring motorcycle cavalcade, is it the marauding Hell’s Angels or a bunch of Orthopedic Surgeons out for a weekend spin on their gajillion dollar Harleys? It’s the stuff in between, the story of the transition, that often holds the key to understanding. That’s certainly true in a psychotherapy that aims to find how some childhood situation morphs into a rigid maladaptive character trait that wreaks havoc with an adult life. There was such a transition in the world of psychopharmacology that I basically slept through [mid 1980s through the mid 2000s] and I’m still at trying to fill it in – it’s slow going.

Within a year of the introduction of chlorpromazine, a National Academy of Sciences grant led to a conference, chaired by Ralph Gerard and Jonathan Cole, aimed at establishing the appropriate evaluative methods for the new pharmacotherapies… There was a recognition that rating scales and randomized controlled trials were needed…[see Recommendations for reporting studies of psychiatric drugs]

… further funds were forthcoming from Congress — more than could be utilized by the center. In addition, following the success of chlorpromazine, pharmaceutical companies flooded the market with copycat drugs and approached investigators to test them. These events led Cole to set up in 1959 a clinical committee chaired by Henry Brill to assemble interested clinicians in order to standardize evaluative methods in clinical studies and to avoid duplication of research efforts." Brill recruited … to serve on a steering group for what became The Early Clinical Drug Evaluation Unit [ECDEU]. The unit’s task was to study the safety of new drugs, to find their appropriate dose ranges, and to look for appropriate clinical niches. It was hoped that federal funding would confer independence on the investigators.

One of the major undertakings of the ECDEU group was the development of standardized clinical trial protocols, agreed methods of coding information, and rating scales such as Hollister and John Overall’s Brief Psychiatric Raring Scale [BPRS]. The global assessment scales, which have been a mainstay of clinical trials ever since, were developed by ECDEU. In collaboration with the NIMH, a centralized computerized system [BLIPS] was set up to collate information. These efforts were aimed in part at controlling the potential excesses of the pharmaceutical industry. But there was also a hope that clinical trials could be channeled along development routes that would yield objective and reliable data that could benefit both clinicians and pharmaceutical companies.

In collaboration with The George Washington University Biometric Laboratory, the ECDEU Standard Reporting System has been made available to any investigator interested in conducting clinical trials, whether federally grant supported or not. To utilize these services, the investigator is requested to:

1. Submit a Research Plan Report and agree to send the study data to the Biometric Laboratory.
2. Collect sufficient information about the subjects in his study so that the data can be entered into the ECDEU data bank. This means, essentially, that a core of data must be collected for each patient…

In return, he receives a sufficient number of assessment scales to conduct his research. Once the trial is completed, the forms are returned to the Biometric Laboratory for processing and data analyses, the results of which are sent to the investigator in the form of a standard data package. The rating scales and data processing services are provided at no charge – our sole "remuneration" being the opportunity to add the investigator’s data to the data bank. It should be stressed that an investigator’s data and/or results are never published or disseminated to others without his permission.

The operational criteria embodied in DSM-III were born into a world different from the one in which they were conceived. Richard Nixon’s election in 1968 might have led to a demise of disinterested research in any event, but the administration also faced a health budget that was burgeoning alarmingly. The Vietnam War had led to an economic crisis in 1968, aggravated several years later by the oil crisis. The government began to cut back on funding for the National institutes of Health. Sensing the change, Jonathan Cole left the Psychopharmacology Research Center [PRC] and returned to clinical practice. The NIMH research budget declined by $5 million from 1969 to 1976. Grants from ECDEU came to an end in 1975. By 1980 state funds for research had dried up. Independent clinical research was over, although since "science" at the NIMH was untouched few realized it…

In 1977, Jimmy Carter established a presidential commission on mental health. This recommended greater attention to the psychiatric needs of children and minorities, support for research and in particular for epidemiology, the development of a specific plan for treating the chronically mentally ill, and the establishment of methods for monitoring the performance of the mental health services. These initiatives were embodied in the Mental Health Systems Act, which was signed into law shortly before Carter left office. This Canute-like bill faced a strong adverse tide. Two months later, the new Reagan government recommended an interruption of all mental health grant programs in research and training. This Republican administration had come into office committed to lowering taxes, deregulation, decreasing federal control, and increasing the states’ authority. The new act was dismantled. Federal care and social security support for the chronically mentally ill went into a sharp decline, and the continuing increase in health care budgets provided the matrix for the birth of managed care…

By the mid-1970s the ECDEU program was failing. Funds had dried up. Out of the ashes of ECDEU arose a superficially similar body, the New Clinical Drug Evaluation Unit [NECDEU], but one with a very different character. This was a marketplace where companies hired clinical investigators. Previously researchers had told industry what needed to be done, but now companies did not have to approach investigators to design their trials for them, compile the statistics, or write the papers. The formulas for clinical trials that the ECDEU investigators had put together to contain the pharmaceutical industry became a petard on which psychiatry was hoist. Armed with off-the-shelf protocols, companies sought out those researchers who were prepared to do the work that suited a commercial agenda. A process had begun that led to the analysis of trial results within the company and thereafter to the writing up of the results by company personnel. Senior clinical investigators now might be used as figureheads on papers or for presentations at academic meetings, but the clinical presence was increasingly becoming ornamental rather than substantial. They were merely figureheads for studies conducted by relatively untrained nonmedical personnel and in some cases the patients did not exist…

Wikipedia: The Journal of Psychopharmacology is a monthly peer-reviewed scientific journal published by Sage Publications on behalf of the British Association for Psychopharmacology. It was established in 1987 and is a member of the Committee on Publication Ethics. The editors-in-chief are David Nutt [Imperial College London] and Pierre Blier [University of Ottawa]. The journal covers all aspects of psychopharmacology.

While it is possible that medicine actually needs the British Association of Psychopharmacology to issue guidelines about the off-label use of psychotropic agents in children and adolescents, it is at least equally possible that there’s another agenda driving this editorial in their Journal of Psychopharmacology…

BAP Position Statement: Off-label prescribing of psychotropic medication to children and adolescents

by Aditya N Sharma, Celso Arango, David Coghill, Paul Gringras, David J Nutt, Peter Pratt, Allan H Young, and Chris Hollis

Journal of Psychopharmacology. 2016, 30[5]:416 –421.

[full text online]

The off-label use of medicines for children and adolescents remains a common and important issue for prescribing practice across child and adolescent psychiatry, paediatrics and primary care. This editorial focusses on psychotropic drug treatment, which plays an essential part in the comprehensive management of a range of child and adolescent psychiatric disorders. Despite a growing evidence base for drug treatment in child and adolescent psychiatric disorders, much psychotropic medication continues to be prescribed off-label [i.e. outside the limits of the marketing authorisation or product license]. The reasons for and implications of off-label prescribing, including the potential clinical benefits/risks and medico-legal implications, are often poorly understood by both patients and prescribers. An important unintended consequence of the uncertainties and confusion surrounding the status of off-label prescribing for children and adolescents may be that effective drug treatments are being withheld or underused. This BAP Position Statement aims to clarify these issues, challenge some of the myths surrounding off-label prescribing for children and adolescents and offer practical guidance for prescribers.

Declaration of Conflicting Interests

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr Shaniui, Professor Gringnis, Mr Pratt, and Professor Hollis have no conflicts of interest.

Dr Arango has been a consultant to or has received honoraria or grants from Abbot, AMGEN, AstraZeneca, Bristol-Myers Squibb, Caja Navarra, CIBERSAM, Funddacion Alicia Koplowitz, Forum, Institutu de Salud Carlos III, Janssen Cilag, Lundbeck, Merck, Ministerio de Cicncia c Itmovacion, Ministerio de Sanidad, Ministerio de Economla y Competitividad, Muiua Madrikna, Otsuka, Pfizer, Roche, Servier, Shire, Schering Plough and Takeda.

Professor Coghill has been a consultant to or has received honoraria or grants from Novartis, Sandov, Shire, Eli Lilly, Vifor Pharma and Glaxo Smith Kline. He has also received royalties from Oxford University Press.

Professor Nutt has ownership or part ownership in Equasy Enterprises and Chaperon, with interests in the area of psychopharmacology. He has acted as a consultant for Lundbeck, Nalpharm, Shire, MSI arid Actelion. He has acted as an expert witness for Separator and received research grant income from Lundbeck. He has also accepted paid speaking engagements in industry supported symposia for Lundbeck, Otsuka, Lilly, RMS, Janssen, Glaxo Smith Kline, Pfizer, AstraZeneca, Pharma and Servier.

Professor Young has been a consultant to or has received honoraria or grants from AstraZeneca, Lundbeck, Eli Lilly, Janssen, Servier. Sunovion, Cyberonics and Wyeth.

Neuroscience-based Nomenclature (NbN) for Journal of Psychopharmacology

by David J Nutt and Pierre Blier

Journal of Psychopharmacology. 2016, Vol. 30[5]:413– 415.

[full text online]

WEB SITE: Watch Video

As of May 2016, the Journal of Psychopharmacology will fully adopt Neuroscience-based Nomenclature [NbN] for all publications and correspondence. In this, we join many other leading journals in our field, including European Neuropsychopharmacology, Biological Psychiatry, CNS Spectrums, European Psychiatry, International Journal of Neuropsychopharmacology, Journal of Clinical Psychopharmacology, Neuropsychopharmacology, Pharmacopsychiatry, World Journal of Biological Psychiatry and others that will also recommend the use of NbN. This decision has been ratified by the British Association for Psychopharmacology [BAP] council.

For the Journal of Psychopharmacology and the BAP, this step marks the output of a process that we have been involved in developing with the European College of Neuropsychopharmacology [ECNP]. Part of the impetus to this initiative came from an editorial in Journal of Psychopharmacology back in 2009. Most of the vital background data collecting and organisation of the knowledge base has been done by a BAP member, Dr Sue Wilson.

Under the leadership of the ECNP in 2008, a taskforce for psychotropic nomenclature composed of representatives from five international organisations: the ECNP, American College of Neuropsychopharmacology, Asian College of Neuropsychopharmacology, International College of Neuropsychopharmacology and International Union of Basic and Clinical Pharmacology. The group tasked itself ‘to examine ways of improving the current nomenclature in psychopharmacology’. Specifically, the new nomenclature was to [a] be based on contemporary scientific knowledge, [b] help clinicians to make informed choices when working out the next ‘pharmacological step’, [c] provide a system that does not conflict with the use of medications and [d] be future proof to accommodate new types of compounds. An initial proposal was discussed in the scientific community and accordingly revised. It is this revised system that Journal of Psychopharmacology will use…

Califf: FDA can’t isolate itself from industry, despite ‘touchy’ issues

Califf said the FDA has to work with industry so it doesn’t fall behind on changes in medical science.

STAT

By Sheila Kaplan

April 19, 2016

The new Food and Drug Administration chief says the agency has to work with industry groups so it can keep up with the latest developments in medical science — because otherwise, even the agency’s best experts will fall behind. In a wide-ranging talk Tuesday to the Alliance for a Stronger FDA, a group devoted to increasing the agency’s funding, FDA Commissioner Robert Califf revisited the big issue critics raised before his confirmation nearly two months ago: the need for the agency to stay independent of the industry group it regulates.

At the time, some Democratic critics worried that he was too close to the pharmaceutical industry, and Califf eventually convinced most of them that he would stay independent. On Tuesday, however, Califf insisted that in order to stay up to date on breakthroughs in science and technology, the FDA must work with those who are developing the innovations. “We have to be able to interface effectively with people that we regulate, which is extraordinarily touchy territory,” Califf said. “Getting this right is not something I can do; it needs to be a consensus of the community we work in.” “We have to keep our sanctity of regulation, but we have to be fluent with the outside industry, as the knowledge changes so rapidly,” he said.

Califf was confirmed by an overwhelming Senate majority on February 24, five months after President Obama nominated him. It was a long haul, in part because some opponents did not like research he conducted or oversaw at Duke, much of which was funded by pharmaceutical firms. But today, in front of 80 people from patient advocacy groups, corporations, and trade groups, Califf insisted that the FDA’s relationship with industry is a practical reality…

That the FDA has to work with industry and keep up with scientific advances goes without saying. I don’t think that’s the question on the table here. The issue is more "Does the FDA work for industry?" If you’re not acquainted with what I’m talking about, this would be a good time to take a look at the approval process for Zoloft in 1990 where the FDA head strong-armed a New Drug Approval [NDA]…

… or the Supplemental New Drug Approval [sNDA] for Rexulti as an adjunct in Treatment Resistant Depression last year where the FDA medical reviewer stretched the standards:

I’ve been impressed that the majority of the FDA New Drug Approval [NDA] Medical Reviews I’ve read [which is most of the psychiatric drugs from Prozac forward] were on the mark. Their standards [proof of safety and two positive studies] are by mandate and will do. My complaints are about the political interference in more than a few decisions [examples above], the lack of vigorous post-marketing review, vigilance in monitoring advertising, and something else big. It’s hard to talk about the advertising part because Direct-to-Consumer advertising should be banned in any form, so it gets complicated what the FDA should take on. But I would say that accuracy would best describe the FDA’s domain of vigilance.

“We want a happier, more satisfied group of employees who can progress in their professions,” he said. For starters, he added, “we’re working on the parking issue.”

em·pir·i·cal  /ëm-pir-i-kãl/
adjective: empirical
based on, concerned with, or verifiable by observation or experience rather than theory or pure logic…

Era 3 for Medicine and Health Care

by Donald M. Berwick MD

JAMA. 2016 315[13]:1329-1330.

Constant conflict roils the health care landscape, including issues related to the Affordable Care Act, electronic health records, payment changes, and consolidation of hospitals and health plans. The morale of physicians and other clinicians is in jeopardy. One foundational cause of the discord is an epic collision of 2 eras with incompatible beliefs.

Era 1
Era 1 was the ascendancy of the profession, with roots millennia deep—back to Hippocrates. Its norms include these: the profession of medicine is noble; it has special knowledge, inaccessible to laity; it is beneficent; and it will self-regulate. In return, society conceded to the medical profession a privilege most other work groups do not get: the authority to judge the quality of its own work. However, the idealism of era 1 was shaken when researchers examining the system of care found problems, such as enormous unexplained variation in practice, rates of injury from errors in care high enough to make health care a public health menace, indignities, injustice related to race and social class, and profiteering. They also reported that some of the soaring costs of care were wasteful — not producing better outcomes. These findings made a pure reliance on trusted professionalism seem naive. If medical professionals were scientific, why was there so much variation? If they were beneficent, how could they permit so much harm? If they self-regulate, how could they waste so much?

Era 2
The inconsistency helped birth era 2, which dominates the present. Exponents of era 1 believe in professional trust and prerogative; those of era 2 believe in accountability, scrutiny, measurement, incentives, and markets. The machinery of era 2 is the manipulation of contingencies: rewards, punishments, and pay for performance. The collision of norms from these 2 eras—between the romance of professional autonomy on the one hand, and the various tools of external accountability on the other—leads to discomfort and self-protective reactions. Physicians, other clinicians, and many health care managers feel angry, misunderstood, and over controlled. Payers, governments, and consumer groups feel suspicious, resisted, and often helpless. Champions of era 1 circle the wagons to defend professional prerogatives. Champions of era 2 invest in more and more ravenous inspection and control…

But I absolutely can’t argue with Dr. Berwick’s point about the pollyanna idealism and the dark side of Era 1. I wouldn’t even argue that it was those other doctors who didn’t do it right. Medical Care isn’t the Wild West. It’s an essential profession that needs oversight and discipline – not cowboys and entrepreneurs. And I realize that because of my own experience, what I see in modern medical practice and in treatment guidelines is the pollyanna idealism and the dark side of Era 2. But unfortunately, there’s plenty to see.

The UK should bid adieu to the EU

Boston Globe

By John R. Bolton

April 19, 2016

Americans generally still see the EU as an economic union. Until relatively recently, many still called it “the Common Market,” though Europeans themselves had long ago discarded that outmoded term. In economic theory, a continental free-trade zone is hard to argue against; indeed, its commercial appeal was what initially persuaded the UK and others to join. But the EU is not now, hasn’t been for years, and for many never was, intended to be “merely” a free-trade area.

Instead, from its inception, the EU [and predecessors like the European Coal and Steel Community] was always primarily about reconfiguring political power. EU acolytes believe that the very concept of the nation-state brought war and misery to Europe for centuries. Their answer was straightforward: Eliminate European nation-states, a goal embodied in the 1957 Treaty of Rome’s pledge of “ever closer union.” Although Brits generally understood this phrase as merely aspirational, it was gospel for the EU’s altar boys.

Brexit, therefore, highlights for America a central issue in the international sphere: “Who governs?” [As the title of Robert Dahl’s classic study asked.] Today, the United States stands on the slippery slope of “sovereignty sharing,” a concept central to what its EU devotees call “the European project.” At the turn of the millennium, the consensus in academia held that the global nature of so many problems [climate change, for example] meant it was only a matter of time before national sovereignty would be relegated to museums. Although this supranational euphoria has subsided somewhat, Britain’s referendum would constitute a true counterrevolution.

Americans, therefore, should hardly be surprised so many Britons resent distant and unaccountable EU governance. On this side of the Atlantic, we readily understand that sovereignty resides constitutionally in “we, the people,” not in the federal government. At a time of dwindling confidence that we have control over our own government, the idea of sharing sovereignty internationally, thereby diluting it even further, is decidedly as unattractive here as in Britain.

Britain’s debate is full of specious charges and countercharges, such as the argument that Brexit would endanger British and European security. This is false. Europe’s security rests with NATO, not the EU, and NATO has one thing the EU never will: the United States. Nor will Britain simply be cast adrift if it leaves the EU. Economic common sense will persuade all concerned to mitigate the consequences of the split and maintain the benefits of free economic intercourse. If European states, upset with Brexit, try “beggar thy neighbor” policies in response, they will deserve what they get.

What I learned living in the UK for three years is that two things were not to ever be understood by yours truly – British Politics and Cricket. And since I was there, they’ve added the European Union to the mix, so now I double-dog don’t understand. So Obama is headed to London, and he wants the UK to stay in the EU whereas John Bolton, despised by me from his Bush UN Ambassador days as a noted neoconservative opposed to the UN, is fanning Brexit [BRitish EXIT] flames on the side of the Queen. Who can sort this out? Well, the British people will soon have the chance to vote. The "INs" are in the lead, but the polls have gone back and forth.

Brussels thrown into chaos as Dutch people plan SECOND referendum on hated trade deal

EUROPE’S elite were facing the wrath of the Dutch people once more tonight as support surged for a SECOND referendum on a controversial EU deal in a matter of weeks.

Express

by Nick Gutteridge

April 16, 2016

The Dutch people are plotting a second EU referendum

Brussels bureaucrats are facing the humiliating prospect of having to justify their flagship TTIP trans-Atlantic trade deal to the Dutch public less than a month after being sent packing over a land grab plot with Ukraine. Anger has been growing across Europe over the hated commercial stitch-up with America, which opponents say will only benefit big business and pave the way for the privatisation of public services including our NHS. And now, much like with the Ukraine treaty, the Dutch public is leading the way in opposing a deal which has already been rubber stamped behind doors by unelected eurocrats. 

More than 100,000 people have signed a petition ordering the Dutch government to hold referendum on the issue in the last few days alone. If it reaches 300,000, humiliated ministers will have no choice but to prepare a public vote.

Such a move would be another crushing blow for the beleaguered EU, which is coming apart at the seams amid an unprecedented outburst of people power. Spurred on by new online movements pro-democracy campaigners are finally fighting back against the Brussels machine, with the historic Dutch referendum earlier this month signalling a landmark victory for freedom and the right to self-determination. Now the rebellious Dutch have TTIP – which stands for the TransAtlantic Trade and Investment Partnership – firmly in their sights…

Two years ago, I had some communication with Trudo Lemmens, a Canadian Law Professor who pointed me to the [weak] legal basis they had rolled out to defend this right-they-really-didn’t-have. It came from a self-serving reading of some trade agreements [see except where necessary to protect the public…, spellbound…, non-negotiable…, tomorrow…]. But in communication with Lemmens, he mentioned that there were some Trade Agreements up ahead that might actually turn that right-they-really-didn’t-have into a right-they-really-did-have and throw a monkey wrench into our hopes for a rational Data Transparency plan – particularly since it’s the EMA [European Medicines Agency] that’s been so rational about this issue. It’s TTIP he was referring to. And now it’s upon us, coming up for a vote by the Council of the European Union on May 26th.

What is TTIP? And six reasons why the answer should scare you

Have you heard about TTIP? If your answer is no, don’t get too worried; you’re not meant to have

The Independent

by Lee Williams

6 October 2015

The Transatlantic Trade and Investment Partnership is a series of trade negotiations being carried out mostly in secret between the EU and US. As a bi-lateral trade agreement, TTIP is about reducing the regulatory barriers to trade for big business, things like food safety law, environmental legislation, banking regulations and the sovereign powers of individual nations. It is, as John Hilary, Executive Director of campaign group War on Want, said: “An assault on European and US societies by transnational corporations.”

Since before TTIP negotiations began last February, the process has been secretive and undemocratic. This secrecy is on-going, with nearly all information on negotiations coming from leaked documents and Freedom of Information requests. But worryingly, the covert nature of the talks may well be the least of our problems. Here are six other reasons why we should be scared of TTIP, very scared indeed:

1. The NHS
   Public services, especially the NHS, are in the firing line. One of the main aims of TTIP is to open up Europe’s public health, education and water services to US companies. This could essentially mean the privatisation of the NHS. The European Commission has claimed that public services will be kept out of TTIP. However, according to the Huffington Post, the UK Trade Minister Lord Livingston has admitted that talks about the NHS were still on the table.
2. Food and environmental safety
   TTIP’s ‘regulatory convergence’ agenda will seek to bring EU standards on food safety and the environment closer to those of the US. But US regulations are much less strict, with 70 per cent of all processed foods sold in US supermarkets now containing genetically modified ingredients. By contrast, the EU allows virtually no GM foods. The US also has far laxer restrictions on the use of pesticides. It also uses growth hormones in its beef which are restricted in Europe due to links to cancer. US farmers have tried to have these restrictions lifted repeatedly in the past through the World Trade Organisation and it is likely that they will use TTIP to do so again. The same goes for the environment, where the EU’s REACH regulations are far tougher on potentially toxic substances. In Europe a company has to prove a substance is safe before it can be used; in the US the opposite is true: any substance can be used until it is proven unsafe. As an example, the EU currently bans 1,200 substances from use in cosmetics; the US just 12.
3. Banking regulations
   TTIP cuts both ways. The UK, under the influence of the all-powerful City of London, is thought to be seeking a loosening of US banking regulations. America’s financial rules are tougher than ours. They were put into place after the financial crisis to directly curb the powers of bankers and avoid a similar crisis happening again. TTIP, it is feared, will remove those restrictions, effectively handing all those powers back to the bankers.
4. Privacy
   Remember ACTA (the Anti-Counterfeiting Trade Agreement)? It was thrown out by a massive majority in the European Parliament in 2012 after a huge public backlash against what was rightly seen as an attack on individual privacy where internet service providers would be required to monitor people’s online activity.  Well, it’s feared that TTIP could be bringing back ACTA’s central elements, proving that if the democratic approach doesn’t work, there’s always the back door. An easing of data privacy laws and a restriction of public access to pharmaceutical companies’ clinical trials are also thought to be on the cards.
5. Jobs
   The EU has admitted that TTIP will probably cause unemployment as jobs switch to the US, where labour standards and trade union rights are lower. It has even advised EU members to draw on European support funds to compensate for the expected unemployment. Examples from other similar bi-lateral trade agreements around the world support the case for job losses.  The North American Free Trade Agreement (NAFTA) between the US, Canada and Mexico caused the loss of one million US jobs over 12 years, instead of the hundreds of thousands of extra that were promised.
6. Democracy
   TTIP’s biggest threat to society is its inherent assault on democracy. One of the main aims of TTIP is the introduction of Investor-State Dispute Settlements (ISDS), which allow companies to sue governments if those governments’ policies cause a loss of profits. In effect it means unelected transnational corporations can dictate the policies of democratically elected governments.

   ISDSs are already in place in other bi-lateral trade agreements around the world and have led to such injustices as in Germany where Swedish energy company Vattenfall is suing the German government for billions of dollars over its decision to phase out nuclear power plants in the wake of the Fukushima disaster in Japan. Here we see a public health policy put into place by a democratically elected government being threatened by an energy giant because of a potential loss of profit. Nothing could be more cynically anti-democratic.

   There are around 500 similar cases of businesses versus nations going on around the world at the moment and they are all taking place before ‘arbitration tribunals’ made up of corporate lawyers appointed on an ad hoc basis, which according to War on Want’s John Hilary, are “little more than kangaroo courts” with “a vested interest in ruling in favour of business.”

So I don’t know about you, but I’m scared. I would vote against TTIP, except… hang on a minute… I can’t. Like you, I have no say whatsoever in whether TTIP goes through or not.  All I can do is tell as many people about it as possible, as I hope, will you. We may be forced to accept an attack on democracy but we can at least fight against the conspiracy of silence.

hat tip to berit bryn jensen…  

European Parliament’s vote turns health into a trade secret

Trade Secrets Directive opens the way for shady TTIP negotiations

epha

14 April 2016

Brussels, 14 April 2016. The European Parliament approved today a new Directive on Trade Secrets, a position that would signal that trade secrets outweigh the public interest. The impact will be negative for health, by declaring information on safety of medicines commercially confidential and to be kept secret from patients, regulators and the public. The Trade Secrets Law would gag journalists and whistle-blowers, undermining freedom of expression and preventing vital information reaching the media and public. With regard to public health, the new rules would erect a barrier to public access to data on the safety and efficacy of medicines.

As a result, Europe could soon be stripped of its hard-won global leader position on clinical trials transparency. The proposals for the Trade Secrets Directive are clearly intended to increase commercial confidentiality in the interest of drug makers who seek to keep clinical trials results secret, and would weaken patient safety protection and halt further research and independent analyses. The worrying lack of legal guarantees preventing companies from abusing the concept of trade secrets opens the way for unethical repetition of clinical trials on people, and the injection of public resources spent on therapies that are no better than existing treatments, do not work, or do more harm than good.

“This vote weakens recent efforts by European Institutions to increase sharing and transparency of essential health data. Clinical trials data transparency is key for patient safety, for access to affordable medicines, for public health research and innovation.” stated Nina Renshaw, Secretary General of the European Public Health Alliance. “Today’s vote is clearly designed to undermine the Clinical Trials Regulation, on which the ink is barely dry, which was huge progress for patient safety and access to medicines, but has always been opposed by the pharmaceutical industry which prefers to conduct trials in secrecy. It also seems to be aiming at smoothing the way for the pharmaceutical industry in the EU-US TTIP negotiations, and would lower transparency requirements in the EU to be closer in line with much weaker rules in the US.”

Today’s vote creates dangerous uncertainty around the issue of trade secrets, particularly for medicines. It opens the way for pharmaceutical companies to use and abuse this Trade Secrets Directive, leaving only rulings from the European Court of Justice to determine the outcome and judgement of future litigations on a case-by-case basis. The Council of the EU will vote on this Directive on 26 May -a vote that will likely be in line with the Parliament’s stance…

Trade Secrets Directive Clears European Parliament Despite Concerns

Intellectual Property Watch

by Dugie Standeford

14/04/2016

Rejecting calls for a vote to be delayed until the European Commission proposes tougher whistle-blower protections, the European Parliament on 14 April approved by 503-131 new rules giving companies redress for theft or misuse of trade secrets. Debate on the trade secrets directive showed sharp divisions among lawmakers, heightened by the recent “Panama Papers” and other leaks, over whether the legislation will help businesses safeguard their innovative ideas or lead to increased corporate secrecy…

Test-Retest Reliability of a Computerized Adaptive Depression Screener

by David Beiser, Milkie Vu, and Robert Gibbons

Psychiatric Services. Published online: April 15, 2016

Objective: Computerized adaptive testing [CAT] provides improved precision and decreased test burden compared with traditional, fixed-length tests. Concerns have been raised regarding reliability of CAT-based measurements because the items administered vary both between and within individuals over time. The study measured test-retest reliability of the CAT Depression Inventory [CAT-DI] for assessment of depression in a screening setting where most scores fall in the normal range.

Methods: A random sample of adults [N=101] at an academic emergency department [ED] was screened twice with the CAT-DI during their visit. Test-retest scores, bias, and reliability were assessed.

Results: Fourteen percent of patients scored in the mild range for depression, 4% in the moderate range, and 3% in the severe range. Test-retest scores were without significant bias and had excellent reliability [r=.92].

Conclusions: The CAT-DI provided reliable screening results among ED patients. Concerns about whether changes in item presentation during repeat testing would affect test-retest reliability were not supported.

Patients who had a critical illness, were age 17 or younger, were non–English speaking, were without decisional capacity, or had a behavioral health–related chief complaint were excluded. After written consent was obtained, the CAT-DI was administered twice by research assistants using tablet computers. The second test was administered within one to three minutes following the end of the first test.

Depression is associated with increased mortality, adverse health outcomes, and increased overall treatment-related costs. The emergency department [ED] is an important safety net for patients with behavioral health problems and thus may be an ideal setting to diagnose and initiate treatment for patients with depression. Current estimates suggest that between 8% and 32% of ED patients present with depression. However, conducting the detailed assessments of depression severity required to initiate treatment is often infeasible in the ED because of high patient volumes and limited access to behavioral health expertise. Therefore, any strategy that reduces the burden of empirically based assessment of depression has the potential to improve outcomes…

So based on this 93 second assessment [average time to take a CAT-DI test on a computer tablet], we’re going to prescribe an antidepressant medication? See, I can’t even talk about this without getting sarcastic. Let me start over. There’s a whole line of thinking that conceptualizes depression as if it’s an epidemic medical disease. The logic begins with some allusion to the prevalence in the population and the notion that it is rapidly increasing, then progresses to some kind of estimate of the cost in lost productivity and things like over-use of medical services etc. The end point of this logic train is that we need early detection, rapid treatment [antidepressants], and better drugs than the ones we currently have.

I hope this article comes to us as an anachronism past it’s prime. It started in 2002 when Dr. Gibbons, a statistician at the University of Chicago, got an NIMH Grant to develop computerized screening instruments [what!…]. That same year, Dr. David Kupfer et al published A Research Agenda for the DSM-V, laying out a plan for a biologically-based medical psychiatry, the dream of many since the 1980 DSM-III. And 2002 was also the year Tom Insel was appointed head of the NIMH [Psychiatry as a Clinical Neuroscience Discipline]. Robert Gibbons part in this story has been a dogged determination to undermine the Black Box warning on the antidepressants and an equally persistent campaign to advance this screening instrument. The CAT-DI tools were developed with NIMH funds and then turned into a for-profit enterprise in concert with David Kupfer, his wife Elizabeth Frank, and others on the sly [When is Disclosure Not Disclosure?]. So there’s an attempt to capitalize on this screening instrument.

If this article is about evaluating the test-retest reliability of his CAT-DI instrument, and using the ER patients was a way to get a spread out cohort for that test, it didn’t come out so well. Only 2/5 in the severe range and 2/5 in the moderate range were reliable – that’s 4/10 in the ranges that mattered:

But beyond being a weak test [… Not Ready for Prime Time], the gross improprieties in its development, and the obvious profit motives involved, I wonder about the whole idea of screening people for depression. The questions asked on any such instrument that would register significant depression aren’t subtle. If a person is answering them honestly enough to generate a high score, they’re not trying to hide being depressed, so it’s going to show to anyone who is engaged and looking. 

The ever-sensible British Neuroscientist we know as Neuroskeptic has a particularly sensible blog post up [How To Avoid Neurohype], tied to his equally sensible Daily Dot commentary [Why we’re living in an era of neuroscience hype].

In my view, it’s this sense of “hard” vs. “soft” truth that lies at the root of the craze for neurobullshit. We seem prone to a mind-brain dualism, thinking that the mind is something soft, malleable, and mysterious, whereas the brain is a hard, biological thing open to scientific probing. Therefore, we feel that if we can reframe a “mind” problem as a “brain” problem, then by doing so we’re already halfway to finding a solution. [In fact, the hard/soft, brain/mind fallacy dates back to Greek philosophy, and is known as Cartesian Dualism.]

Really, the human brain is no harder or easier to understand than the human mind, because they are ultimately the same thing. So, while it is possible in principle to reframe a “mind” issue as a “brain” issue, it’s often not useful to do so… Why is there so much neurobullshit around today? I think the answer is that neuroscience really has made great advances in the past few decades, and these advances have been very visible…

Ultimately, modern neurohype is driven by the appeal of “hard” or scientific approaches to problems, combined with the modern buzz surrounding brain science. The result is that neuroscience [or something resembling it] has become a selling point — a shiny new coat of paint, both for products and for ideas. Today, while we really do know more about the brain than ever before, our understanding is still very limited. Neuroscience is not yet advanced enough to tell us the answer to life, the universe, and everything.

I had left general psychiatry for a particularly specialized niche, and on returning twenty-five years later, there was a distinct change in the way patients presented. It was a surprise that took some getting used to. Some announced their diagnosis [bipolar, ocd, dissociative disorder]. Many presented their emotional complaint as if it were a disease [depression, anxiety]. And I was supposed to do something with that pronouncement with no further information, as if "I have depression" lead to some specific treatment. Even harder for me was "My antidepressant isn’t working anymore,!" "My depression is coming back," or "I have a chemical imbalance."  I had no illusion that I was going to do in-depth case studies in a general charity clinic, but I didn’t anticipate hearing something equivalent to "I found a new mole." And often, taking a real history was hard work. "What’s that got to do with…?"

Many of the patients, even here in the Appalachian Mountains, had adopted this medical model [in the scorned usage]. At first I thought it was something learned from their doctors or the tv ads, but it was more than that. It was something they had maybe initially picked up that way, but it was maintained by many because… [don’t know the because]. And it’s in the culture now "My neighbor, see she’s bipolar and…". The responsibility for improvement was jettisoned to some external locus of control – a new variant of an old psychological defense mechanism. It was enough of a change that I had to relearn how to interview certain people to get the necessary information. There are a lot of things you can do to help people even in the direst of circumstances, but you can’t do them if you don’t know what they are. And you can’t know that without their allowing you to join in a "look around."

So "Therefore, we feel that if we can reframe a ‘mind’ problem as a ‘brain’ problem, then by doing so we’re already halfway to finding a solution" is not just what neuroscientists or some psychiatrists do. Patients do it too. Sometimes it’s a burden handed to patients by their psychiatrists or GPs. And sometimes it’s a thing that patients pick up and carry to extremes – going on a search for an elusive chemical cure instead of making changes in their lives or situations that would make for a more fulfilling visit to our planet. And occasionally, it becomes a place where patients can hide for a very long time to their detriment.