1 Boring Old Man

Vanessa’s Law Honours Memory Of Tory MP Terence Young’s Late Daughter

Huffington Post

By The Canadian Press

12/06/2013

The Conservative government has introduced new legislation aimed at protecting consumers from unsafe medications and reducing adverse drug reactions. The Protecting Canadians from Unsafe Drugs Act is known as Vanessa’s Law in honour of the late daughter of Conservative MP Terence Young. The 15-year-old died of a heart attack 13 years ago while on a prescription drug for a stomach ailment. The medication was later deemed unsafe and pulled from the market.

Young, MP for Oakville, has been fighting ever since for a more stringent Canadian drug-monitoring system. Under the new legislation, the government now has the power to initiate mandatory recalls for unsafe drugs and to demand reports from health-care institutions on adverse drug reactions. The bill also allows the government to impose tough new penalties for unsafe products, including jail time and new fines of up to $5 million a day instead of the current $5,000.

Drug companies must also revise labelling to provide details on health risks, and to do further testing on medications when they are shown to pose dangers to some consumers, especially children.

Minister Ambrose announces a Transparency and Openness Framework

Health Canada posts Diane-35 Safety Review Summary and works with partners on a prescriber checklist as first step

CNW

from Health Canada

04/08/2014

The Honourable Rona Ambrose, Minister of Health, today delivered on a commitment to begin transparently publishing drug safety reviews. The Minister committed to providing Canadians with access to Health Canada drug safety reviews with the posting of a summary of the safety review of the acne treatment Diane-35. This is the first summary safety review to be made public.

Once a drug is on the Canadian market, Health Canada continues to monitor the safety of health products to identify and assess potential harms. As a result, departmental safety reviews are conducted when a safety issue is identified for a product on the Canadian market. The posting of summary safety reviews will provide Canadians with plain-language descriptions of Health Canada’s findings and decisions, so patients can make informed decisions and continue to have confidence in the health products they use. The full reports will be made available through a link on Health Canada’s website; however they are subject to redactions of personal and confidential information.

The posting of summary safety reviews is the first in a series of measures that Health Canada is taking to be more transparent and open with Canadians about regulatory decisions. As part of Health Canada’s Regulatory Transparency and Openness Framework, the department has committed to providing Canadians with credible and timely information. This easy to understand information will allow them to make well-informed decisions concerning their health and that of their families. Canadians will also have the chance to provide Health Canada with feedback on the Framework.

Health Canada has also made available today a practical new tool to assist in the safe prescribing of Diane-35 and to better inform healthcare professionals and patients of its risks. In consultation with the Canadian Pharmacists Association, the Canadian Dermatology Association, and the Institute for Safe Medication Practices, Health Canada has developed a checklist to guide healthcare professionals through the decision to prescribe Diane-35. The checklist will reinforce existing warnings and precautions for this drug.

Today’s announcements build on the Government’s Patient Safety agenda, including Legislation that was introduced in December 2013, known as the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law).

House of Commons adopts government strengthened patient safety legislation

Amended Vanessa’s Law advances transparency commitments

Digital Journal

by Canada NewsWire

June 16, 2014

The Government of Canada welcomes amendments that would strengthen transparency in the proposed patient safety legislation Vanessa’s Law [Bill C-17]. Since introduction in December 2013, Vanessa’s Law has received broad support from members of Parliament, stakeholders and healthcare groups in recognition of the important drug safety improvements that it would deliver, should it become law.

The amendments to Bill C-17 were introduced by Member of Parliament, Terrence Young and adopted by the House of Commons Standing Committee on Health on June 12. The Bill has now passed Third Reading in the House of Commons and moves to the Senate for consideration. The amendments include the requirement that both positive and negative decisions about drug authorizations be disclosed on a public website; and that clinical trial information be disclosed on a public registry. The amendments also better define the scope of confidential business information [CBI] and allow the Minister to disclose CBI about a product if the Minister believes the product may pose a serious risk to Canadians.

The amendments to Bill C-17 would enable Health Canada to continue strengthening its Regulatory Transparency and Openness Framework that was announced in April of this year by the Minister. The Framework commits Health Canada to a set of concrete initiatives that would make easy to understand regulatory health and safety information more available to Canadians. With this information, Canadians can make well-informed decisions concerning their health and that of their families.

Quick Facts

• Vanessa’s Law [Bill C-17] would give the Minister of Health new tools to better respond to drug safety issues, such as the power to recall unsafe drugs, impose stiff financial penalties, and require mandatory adverse reaction reporting by healthcare facilities.
• The amendments to the Bill would enhance transparency concerning Health Canada’s regulatory decisions, information regarding clinical trials, and the scope of confidential business information and disclosure.
• If passed, Vanessa’s Law would provide new tools to make pharmaceutical drugs, biologics and medical devices safer for Canadians.

Quotes

• Vanessa’s Law would enable us to take drug safety to a new level. With the amendments brought forward by my colleague Terence Young, it would now also provide Canadian patients and safety experts with information they have long been calling for. I will also personally ensure that Health Canada continues to find ways to be more open and more transparent with Canadians each and every year. I’ve made that commitment. We will be looking at further steps to ensure that crucial drug safety information is made available to Canadians."
  Rona Ambrose – Minister of Health
• "Once implemented, Vanessa’s Law will save innumerable of lives a year in Canada, and prevent tens of thousands of injuries. It is difficult to overstate the importance of this Bill to patient safety. This is a generational change. Vanessa would be very pleased to know that her loss of life has led to the government of Canada acting to prevent others from suffering her fate."
  Terence Young – Member of Parliament

Unless I’ve misread this story, it’s aiming towards being a model for us all. The details of the Data Transparency scheme aren’t completely apparent, but the progression of their march is encouraging and with a track record like this, one would predict that even if they falter on the details, they’ll get things right sooner or later [if I’m wrong about that, I hope some of our neighbors in Canada will let me know]. I particularly like the idea of posting the public summaries. I hope the specifics live up to my optimism…

Chair: So you are arguing in favour of full release of information. What impact do you think that would have on the pharmaceutical industry?

Tracey Brown: When you say full release of information, I should just clarify that. It is helpful to think of this at four levels. One is the registration of trials; that is level 1. That has been a problem, certainly historically, although there have been some improvements since the 2007 FDA regulations and other interventions. We do not even have the contents list, if you like, of what has been done, never mind being able to track down some of the results. That is something that reviewers who are looking across a whole range of studies really struggle with; they spend a lot of time just trying to find out what has actually been done but been left in a cupboard somewhere. Registration is about knowing what the trial is for and registering the protocols.

The second level of information, which is what AllTrials is calling for, is the basic summary of the clinical study report. That says what was actually found, what the primary outcomes were and what the protocols were. We would like to see as much information there as possible, but that certainly gives you some indication of what research has been done and how it has been undertaken.

The area for quite a lot of discussion at the moment is what I would call level 3, which is the full clinical study report. That contains in many cases quite a lot. It is a very large report-quite often, it even runs to thousands of pages-and it may contain quite a lot of individual patient data, things that might be tracked to individual patients or other things that constitute reasons why people might be concerned. There is a discussion about the release of those. I just note that we are seeing their release by the European Medicines Agency already for those drugs that they have them for.

Then there is the fourth level, which is individual patient data. A lot of very productive discussion is going on about how to establish good protocols for sharing that among the research community-for example, setting out the same requirements for secondary research as you would for primary research, looking at the same data…

Pamela Nash: Ms Brown, just to be clear, is the aim of the AllTrials campaign to have all four levels published?

Tracey Brown: No, the aim of the AllTrials campaign is to ensure that levels 1 and 2 are published. Levels 1 and 2 do not have a huge amount of practical implication. It’s just a shocker that they are not published already. Levels 3 and 4-level 4 particularly has a certain practical implication, depending on the organisation. The requirements of level 3 – what would be an equivalent to a clinical study report; there are such things, but for an academic, for example-just need to be ironed out and worked on. It is not a huge barrier to publishing that information. There is quite important information at level 3 about serious adverse events, for example, that may need to be shared, but that just takes a little more work and thinking about.

We are really pleased that, in signing up to AllTrials, GlaxoSmithKline, for example, committed to publishing a lot of their level 3 data. Obviously, we are going to look at what they encounter in doing that. That is an ongoing discussion with them. A lot of the people who have signed up to AllTrials are committed to that, too, but what we want to do is just to get past the idea that secrecy is okay. That is really the ultimate aim ofAllTrials. It is just to find out what people have done and what they have found, at a very basic level, and then we can go on to look at some of the implications of sharing that…

I don’t trust PHARMA, period. Besides the string of regular misbehavior with Clinical Trial Data reaching back over the last two decades, there’s been an aggressive campaign to undermine Data Transparency in the recent past:

• the leaked memo [in the shadows…]
• their Trade Commission letter [see an ill-gotten fortune…]
• the AbbVie/InterMune suit
• the PhRMA/EFPIA conference in Brussels [see a deal-breaker?…]
• the article [Intellectual Property Protections Are Vital to Continuing Innovation in the Biopharmaceutical Industry]
• the EMA U Turn [see a crushing setback… and some further information…]

• the a priori protocol with all legitimate ammendments;
• the raw data tables abstracted before the blind is broken [with the unblinding key];
• access to the original CRFs to check the AEs;

Evidence based medicine: a movement in crisis?

by Trisha Greenhalgh, Jeremy Howick, Neal Maskrey, for the Evidence Based Medicine Renaissance Group

British Medical Journal. 2014 348:g3725

It is more than 20 years since the evidence based medicine working group announced a “new paradigm” for teaching and practising clinical medicine. Tradition, anecdote, and theoretical reasoning from basic sciences would be replaced by evidence from high quality randomised controlled trials and observational studies, in combination with clinical expertise and the needs and wishes of patients. Evidence based medicine quickly became an energetic intellectual community committed to making clinical practice more scientific and empirically grounded and thereby achieving safer, more consistent, and more cost effective care. Achievements included establishing the Cochrane Collaboration to collate and summarise evidence from clinical trials; setting methodological and publication standards for primary and secondary research; building national and international infrastructures for developing and updating clinical practice guidelines; developing resources and courses for teaching critical appraisal; and building the knowledge base for implementation and knowledge translation.

From the outset, critics were concerned that the emphasis on experimental evidence could devalue basic sciences and the tacit knowledge that accumulates with clinical experience; they also questioned whether findings from average results in clinical studies could inform decisions about real patients, who seldom fit the textbook description of disease and differ from those included in research trials. But others argued that evidence based medicine, if practised knowledgably and compassionately, could accommodate basic scientific principles, the subtleties of clinical judgment, and the patient’s clinical and personal idiosyncrasies…

One of my pet peeves is reading an article that is either pro or con about something, but rather than starting with the conclusion and explaining the reasons, the author pretends neutrality and slides his/her argument in at the end as if it has been forced on him/her by the weight of evidence. I feel gamed by such an argument style. Hitler used it in Mein Kampf. Dr. Insel just did it with Are Children Overmedicated? [see fore·told…]. So when I have an opinion, I try to say it up front in case you have a similar affliction. In this case, I’ve supplied an image to let you know how I feel about the notion of Evidence·Based·Medicine. I don’t like it. It feels like a trap. It is a trap.

1. The idea generalizes a small, short-term experiment on carefully selected subjects as a paradigm for large, heterogeneous group who may take the medication for years [as if such a transformation is scientifically justified – which it rarely is].
2. It is built on the phantasy that is similar to the notion that building a model airplane that flies is the last step before going into production for jumbo jets.
3. It opens a portal for companies with only conflicts of interest to easily insert their products into mainstream medicine effortlessly.
4. following from number 2., it virtually guarantees corruption [as has been shown repeatedly in a variety of venues].
5. While one motive of Evidence·Based·Medicine is to discourage sloppy "shooting from the hip," it replaces that with an even more dangerous sloppy dependence on rote and thoughtless practice.
6. It has been regularly used to withhold services and treatment, denigrate anything subjective in medicine, and justify practices that are supported by trivial statistics rather than clinical effectiveness.
7. It discourages the time honored method of evaluating medications by their performance in wide clinical practice.
8. The people setting the guidelines have been not only often compromised, but also largely non-practitioners.
9. It was itself an idealistic and naive experiment that failed its own clinical trial.

Much progress has been made and lives have been saved through the systematic collation, synthesis, and application of high quality empirical evidence. However, evidence based medicine has not resolved the problems it set out to address [especially evidence biases and the hidden hand of vested interests], which have become subtler and harder to detect. Furthermore, contemporary healthcare’s complex economic, political, technological and commercial context has tended to steer the evidence based agenda towards populations, statistics, risk, and spurious certainty. Despite lip service to shared decision making, patients can be left confused and even tyrannised when their clinical management is inappropriately driven by algorithmic protocols, top-down directives and population targets.

Such problems have led some to argue for the rejection of evidence based medicine as a failed model. Instead we argue for a return to the movement’s founding principles — to individualise evidence and share decisions through meaningful conversations in the context of a humanistic and professional clinician-patient relationship. To deliver this agenda, evidence based medicine’s many stakeholders — patients, clinicians, educators, producers and publishers of evidence, policy makers, research funders, and researchers from a range of academic disciplines — must work together. Many of the ideas in this paper are not new, and a number of cross sector campaigns with similar goals have already begun. We hope that our call for a campaign for real evidence based medicine will open up debate and invite readers to contribute [for example, by posting rapid responses on bmj.com]. 

No, I haven’t gone over to the dark side, but I still have no reason not to like this new APA President yet. I wonder how long the honeymoon will last. He’s in an odd position, following people who are brain crazed [Schatzberg, Lieberman] or not particularly effective [Oldham, Jeste] in a land long slumbering under the spell of PHARMA, Tom Insel’s unrealistic fantasies, and the neo-Kraepelinian DSM-whatevers. But he does get through a paragraph without saying words like brain, biomarkers, genome, proteonomics, neuroimaging, connectopathies, etc. Whether or not he will try to lead psychiatry out of its biomedical stupor into the healthier and reality-based eclecticism that fits the patients we actually see [or he even wants to] remains to be seen. We’ll certainly be watching.

What his predecessors have failed to notice is that a growing number of psychiatrists refuse to operate in the world created for them by Managed Care and insurance reimbursment, and that’s not all about money. Many make less by staying off the grid, myself included. A lot of it has to do with being unwilling to have practice dictated by excel spreadsheets in the offices of bureaucrats, the marketing departments of a corrupt industry, or the moguls of the APA and NIMH. Many avoid the APA like a plague. And many who still work in that system would be glad for a chance to change it into something more compatible with the real reasons they chose this specialty in the first place.

European Ombudsman reaction to EMA’s 12 June 2014 statement issued after its Management Board meeting

13 Jun, 2014

The European Ombudsman, Emily O’Reilly, notes the statement EMA published after its management board meeting on 12 June. As EMA now intends to finalise a revised wording for its proactive clinical trial data policy, the Ombudsman cannot yet comment in detail on what may emerge. However, the Ombudsman notes that she shares the grave concerns expressed by members of the scientific community about EMA’s draft disclosure policy. In her view, it was defective on three fronts:

It allowed data only to be seen on-screen using an interface, thereby preventing researchers from downloading the data. According to EMA’s 12 June statement this point seems to be subject to change by "giving the possibility to download, save and print trial data for academic and non-commercial research purposes". If implemented, the Ombudsman would welcome this change.

• It imposed broad legal conditions on the access to and use of such data.
• It only allowed limited access to clinical trial data by redacting significant information.

The Ombudsman welcomes the fact that the Management Board of EMA seems to have responded to the concerns of the scientific community concerning on-screen access. The Ombudsman is unaware whether the Management Board has suggested any changes relating to the other two concerns. The change to the draft policy requested by the Management Board will now require EMA to make changes to the draft Terms of Use. The Ombudsman will carefully examine the Terms of Use when they are modified to reflect the outcome of the Management Board meeting. The Ombudsman will also, in that context, examine how EMA intends to redact the documents. The Ombudsman also notes EMA’s assertion that its new policy is without prejudice to the right to request public access to documents.

In 2012, subsequent to a request to release clinical study reports relating to two medicines [Humira and Esbriet], EMA decided to release these clinical study reports with only limited redactions. It recently agreed, as part of a compromise deal with a pharmaceutical company, to make more extensive redactions to the Humira documents. The Ombudsman is currently carrying out an inquiry to determine the legality of those additional redactions. The Ombudsman remains puzzled as to why EMA abandoned its original draft disclosure policy from 2012 and substituted it with a different draft policy, more in line with the pharmaceutical industry’s wishes.

EMA’s double U-turn on its peeping tom policy for data release?

British Medical Journal Blogs

by Tom Jefferson and Peter Doshi

13 Jun, 2014

Yesterday’s announcement that the EMA Management Board may have adopted a less obstructive policy to releasing clinical trial data comes hard on the heels of widespread coverage [see here, here, here, and here] and protests [by the EU Ombudsman, us, us again, Trudo Lemmens, the ISDB/AIM/ Nordic Cochrane Centre/ Medicines in Europe Forum, German IQWiG, and AllTrials]. All this, plus a Twitter #screenonly campaign, reveals enormous discontent with the agency’s last minute announcement of “view on screen only” access to clinical study reports [CSRs], new “redaction principles,” and new legal “terms of use.” In two responses, EMA executive director Guido Rasi defended the agency’s draft policy, explaining that the EMA’s latest draft policy represented “absolutely no change in direction.”

Yesterday’s press release from the EMA announces “more user-friendly amendments proposed by EMA executive director Guido Rasi, that will not only allow the Agency to proactively publish clinical trial data that are submitted as part of marketing authorisation applications, but also give the possibility to download, save, and print the trial data for academic and non-commercial research purposes.” This appears, on the face of it, to be another major change by the agency, effectively doing away with the peeping tom policy proposal to look, but not touch the material. However, we urge those who are about to rush to the nearest off-licence and purchase some champagne, to bide their time, and wait until we see the fine print of the policy.

Firstly, even if the “view on screen only” policy has been removed, serious concerns remain about the EMA’s redaction and terms of use policies. Secondly, we’ve had surprises sprung on us before. Things looked good before the EMA’s sudden “u-turn” in the middle of May. Last week, Rasi told AllTrials that “the issue of the usefulness of on-screen access to data was discussed with academics during the whole consultation process and we do not accept that this is a superficial or useless gesture.” Yet the peeping tom clause came as a surprise to those attending the EMA’s 16 May meeting with academics. Furthermore, many of the researchers who had formally contributed to earlier EMA committee work in 2013 do not appear to have been invited to this final meeting, for reasons as yet unexplained. [A letter, co-signed by Peter Doshi, was sent to Rasi requesting an explanation].

On this basis, we feel that Ronald Reagan’s old maxim “trust but verify” is more appropriate than celebrations.

Yeah, I’m still stuck on the things that lead up to the EMA U Turn, a house that PHARMA built like so many others. I tried sitting down this afternoon and pretending I’m an AbbVie executive, and then detached from that identification and looked at what I was worried about during my moments as a pretend PHARMA mogul. Neal Ryan was very clear about his company’s worry [see a deal-breaker?…] – that some "Pakistani" would figure out how they make Humira [a monoclonal antibody that attacks Tumor Necrosis Factor] and begin brewing up cheap batches in the Himalayas. The racism in that comment aside, the point is well taken [they’re pretty stingy with the formula for Coca Cola too]. That is a legitimate concern for a company, the true meaning of trade secrets.

In light of discussions at the Board, the wording of the policy, including practical arrangements for academic and non-commercial research users, will now be finalised with a view to its adoption by the Board through written procedure by mid-July 2014, and will be effective from 1 October 2014. Importantly, the Agency will ensure that the policy will not prejudice citizens’ rights under existing access to documents legislation and the new clinical trials regulation.

So the compromise is fairly clear. Give us the protocol, the data we want from the outcome variables, and the CRFs to look at the AEs, and keep the how-to-make-it secrets to yourself. If that could be done and could he trusted, it’s a compromise I could live with. But keeping everything secret just to preserve trade secrets won’t do. Too many companies have cheated too regularly and too destructively to even consider continuing to do that. Actually, it looks like the EMA gave them that point – "academic and non-commercial research users" [not competitors] – which is, in fact, the second part of their venerated Article 39 [3]:

3. Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.

First off, I realize I’m stuck in a loop. I can’t seem to get away from the European Medicines Agency’s U Turn on Data Transparency. So I guess I’ll be stuck here until I’m not – because that didn’t just happen – it was orchestrated and we know who did it and a bit about how. In some further information… we were told by Peter Doshi and the BMJ about the bargaining by AbbVie and InterMune. In in the shadows… we saw how the PhRMA and EFPIA schemed in a concerted attack on Data Transparency aimed at the EMA. And now from from Trudo Lemmens, we’re shown a letter from PhRMA to the Chair of the US Trade Policy Committee lobbying the US to support their position. I pulled a few representative paragraphs:

May 10, 2013 Mr. Douglas Bell Chair, Trade Policy Staff Committee Executive Office of the President 600 17 th Street, N.W. Washington, D.C. 20508 Re: Request for Comments Concerning the Proposed Transatlantic Trade and Investment Partnership, 78 Fed. Reg. 19566 [Apr. 1, 2013] [page 2] Another issue of concern to the industry is the EMA’s current and proposed data disclosure policies. The biopharmaceutical industry is firmly committed to enhancing the public health through responsible reporting and publication of clinical research and safety information. Companies publish their research, collaborate with academic researchers, and disclose clinical trial information at the time of patient registration, drug approval, and for medicines whose research programs have been discontinued. However, disclosure of companies’ non-public data submitted in clinical and pre-clinical dossiers and patient-level data sets risks damaging public health and patient welfare. PhRMA and its members urge the U.S. government to engage with the EU in every available venue to ensure responsible data sharing that protects patient privacy, maintains the integrity of the regulatory review process, and preserves incentives for biomedical research by adequately shielding confidential commercial information from inappropriate disclosure. The EMA’s current and proposed data disclosure policies jeopardize these principles… [page 12] The EMA’s current practices, in addition to its proposed policies to proactively disclose companies’ non-public data submitted in clinical and pre-clinical dossiers and patient-level data sets, risk damaging public health and patient welfare. Government disclosure of companies’ unprocessed, non-contextualized raw data and technical analysis provides little benefit to practicing healthcare professionals and their patients. On the contrary, disclosure of such clinical trial data, including confidential commercial information, threatens patient privacy by facilitating patient re-identification from anonymized patient-level data sets; encourages second guessing of the EMA’s expert regulatory decisions, thereby undermining patient trust in the safety and effectiveness of approved medicines; and harms incentives to invest in biomedical research. The primary beneficiaries of such non-public information are competitors who wish to free-ride off of the investments of the innovators. Further, failing to protect confidential commercial information contained in regulatory submissions is inconsistent with the EU’s treaty obligations contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights [TRIPS]. In order to benefit public health in the long run, data disclosure policies must preserve patient privacy, respect the integrity of regulatory systems, and maintain incentives to invest in innovative medical research, consistent with 21 C.F.R. §§ 312.130; 312.45(c); 314.430; 601.51(c) and Article 39(3) of TRIPS. For these reasons, PhRMA and its members urge the U.S. Government to engage with the EU in every available venue to resolve this issue…

I formatted this for the blog last night, and highlighted parts of it. When I got back to it after work today, I found myself highlighting the rest of it. So I just gave up and let it stand as it is. It’s all infuriating. Data Transparency doesn’t compromise subject’s privacy. It doesn’t reveal confidential commercial information. In fact, this whole business about CSR‘s is a ruse. We don’t care about their carefully crafted CSR narratives. All we really want is the a priori protocol; the IPDs for the numeric and categorical results; and access to the CRFs to check the IPDs and look at the raw comments on AEs. It’s no harder to spin a CSR than a published paper [if these acronyms put you off, see in the details…, achilles’ heel…, and the wrong compromise… and this figure]:

3. Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.

Back in July of last year, we were treated to a leaked memo from PhRMA and EFPIA outlining a broad strategy to fight the EMA Data Transparency initiatives [a closing argument…]. It was reported in the Guardian [Big pharma mobilising patients in battle over drugs trials data] and is shown here as a reminder [read the details]:

Notice that they mention "… a series of meetings in Brussels, organised jointly by PhRMA and EFPIA, in the week of August 26 to advance these strands." That was that incendiary presentation by AbbVie’s lawyer, Neal Parker [see a deal-breaker?…]. You remember, that one where there was smoke coming out of the regulator’s ears [see Industry and drug regulators disagree on which data should remain confidential].

Well, it looks like they got the job done anyway from the way the EMA took its U Turn. Lets hope the resultant outcry really does reverse some of the damage done. But my point is that all of this was to be behind the scenes. It was only fortuitous that we got to hear about them in action at all. And from what we know now, there was still a hell of a lot that went on in the shadows that we still don’t know about.

Are Children Overmedicated?

Director’s Blog: NIMH

By Thomas Insel

June 6, 2014

A recent symposium at the Carter Center featured a report by the Centers for Disease Control and Prevention [CDC] that as many as 10,000 toddlers may be receiving psychostimulant medication, like methylphenidate [Ritalin]. The media reports of this, like many past reports, decried the overmedication of children. The numbers are notable. The latest estimate from the National Center for Health Statistics reports that 7.5 percent of U.S. children between ages 6 and 17 were taking medication for “emotional or behavioral difficulties” in 2011-2012.  The CDC reports a five-fold increase in the number of children under 18 on psychostimulants from 1988-1994 to 2007–2010, with the most recent rate of 4.2 percent. The same report estimates that 1.3 percent of children are on antidepressants. The rate of antipsychotic prescriptions for children has increased six-fold over this same period, according to a study of office visits within the National Ambulatory Medical Care Survey. In children under age 5, psychotropic prescription rates peaked at 1.45 percent in 2002-2005 and declined to 1.00 percent from 2006-2009.

Taken together, what do these numbers mean? A common interpretation: children with behavioral or emotional problems are being overmedicated by psychiatrists too busy to provide therapy, at the request of parents too busy to provide a healthy home environment. A corollary of this interpretation is to blame schools too busy to provide recess or activities for fidgety boys. And usually the blame extends to the pharmaceutical companies that market medications in pursuit of profits.

While blaming psychiatrists, parents, schools, or drug companies might seem legitimate, some of the facts just don’t fit. First, most of the prescriptions for stimulant drugs and antidepressants are not from psychiatrists. In fact, outside of a few major cities, families in much of the nation have very limited access to child psychiatrists. Blaming parents is easy, but as Judith Warner argues in her book, We’ve Got Issues, most parents resist medication rather than request it. Schools in many parts of the country have reduced unstructured time, but the increase in medication is now seen in toddlers, years before children begin school. And drug companies, while frequently maligned, have reduced, not increased, their marketing budgets in the US.

If psychiatrists, parents, schools, or drug companies are not the culprit, who is? The answer is potentially more complicated and more worrisome. Is it possible that the increased use of medication is not the problem but a symptom? What if more children were struggling with severe psychiatric problems and actually the problem was not over-treatment but increased need? Surely, if we discovered more children were being treated for diabetes or immune problems, we wouldn’t blame the providers or the parents. We’d be asking what drives the increase in incidence. And, there actually are large increases in the incidence of Type I diabetes and food allergies.

Skepticism regarding increased rates of emotional and behavioral difficulties as opposed to increases in other medical disorders can be attributed in part to the absence of biomarkers or laboratory tests for psychiatric diagnosis comparable to glucose tolerance tests for diabetes or anaphylactic reactions for allergies. Absent these kinds of consistent, objective measures for mental disorders, we cannot distinguish between a true increase in the number of children affected or simply changing values or trends in diagnosis. Clearly context matters. What one parent might consider hyperactivity, another parent might consider healthy exuberance.  What physicians once called attention deficit hyperactivity disorder [ADHD], often now elicits a diagnosis of childhood bipolar disorder, leading to a 40-fold increase in prevalence from 1994-1995 to 2002-2003.

No question, in a field without biomarkers, there is a risk of over-diagnosis. No question, subjective diagnosis could invite unnecessary treatment and over-medication. But what if the increased use of medication reflected more children with severe developmental problems and more families in crisis? What if the bigger problem is not over-medication but under-treatment? Hearing that 7.5 percent of children are on medication [4.2 percent on psychostimulants] seems stunning, but knowing that 11 percent of children have a diagnosis of ADHD raises a possibility of under-treatment.

In fact, evidence from nationally representative surveys of youth in the U.S. challenges recent concerns regarding widespread overmedication and misuse of medications, at least in adolescents. Among those with current mental disorders, only 14.2 percent of youth reported psychotropic medication use, and the majority who had been prescribed medications had a mental disorder with severe consequences, functional impairment, suicidality, or associated behavioral or developmental difficulties. In light of the evidence that about 1 in every 12 youth suffer from a severe developmental, behavioral or emotional disorder, under-treatment remains a serious problem.

Of course, the problem may be both over-treatment and under-treatment. It is possible that children with issues that would be resolved by psychotherapy alone are receiving medication.  It seems very likely, given the data in adolescents, that many who would benefit from medication and psychotherapy are receiving neither intervention. It is also worth considering that the rates of childhood mental disorders could be stable, but that more children are getting the treatment they need and, for many, detection and intervention is at an early age. If it is your child suffering acutely from anxiety, autism, anorexia, or depression, the problem is certainly not over-treatment. The CDC report showed that parents of more than one-half of those children who used a prescribed medication for emotional or behavioral difficulties had reported that this medication helped the child "a lot.” What I hear from families in crisis is lack of access, poor quality care, and a desperate need for answers. In the media reports on over-medicating children, this perspective is missing. The possibility that there is a real increase in the number of children suffering with severe emotional problems, just as there is a real increase in the number of children with diabetes and food allergies, is not even considered. Shouldn’t we be asking why so many children, at younger ages, are being seen for emotional and behavioral problems?

It’s funny. I don’t really see Tom Insel as a cause of what happened in psychiatry, but rather a product. He was something of a whiz kid finishing college at 17. He went straight from residency [1976-1979] to the NIMH and was in some kind of lab somewhere until becoming an administrator in 1994 [and ever since]. He has championed the neuroscience version of psychiatry since it came into view, and never wavered. He has never practiced psychiatry, or for that matter, any kind of medicine. From the dates, I would guess he did psychiatry training during the years when an internship in general medicine wasn’t required, though I don’t know that. He has moved from theory to theory about how brain disease causes mental illness, and in that he has never wavered either. He has micromanaged the directions of the NIMH rather than following some balanced sampling generated from the scientific community at large.

"What Freeman Dyson said about the importance of tools for new directions in science is critically important for NIMH. Biomarkers, new therapies, and preventive strategies for brain disorders, especially for the “connectopathies” that we call mental disorders, will require better tools. NIMH will be co-leading the BRAIN Initiative with our sister institute, the National Institute for Neurological Disorders and Stroke (NINDS). Whether you are a scientist working on synapses or a family member challenged by a mental disorder, the BRAIN Initiative represents a bold commitment by the NIH, offering hope for the development of better tools to enhance our understanding of the brain in health and disease."