Some more offerings in our fourth effort in these pages to get rid of this damned dander. It's still up! Here in the DOG Patch, D is for Dander, and the dander, in spite of smatterings of good new lately, has still got itself up.
Vive le Québec! Nodbody's taking sides in Canadian separatism, if it's still brewing north of the border. But a certain sense of fairness surely prevails, and we have to give them a rousing "jolly good" (whoops) among Canadian physicians. At least in the one province. As reported by the WaPo, a large group of doctors there have produced a petition (interesting to read here) asking that their proposed recent salary increases be rolled back. They're concerned about the sorry state of care and salary support throughout their province and nation. Pretty astonishing. It remains for those of us suffering from DTs (dander-toting) to investigate how it's being received in places like Ontario, or even moreso, Alberta and Saskatchewan. It's also intriguing that the signatories include almost half subspecialists--not just a bunch of lefty primary-care types. Ah, but there are 700 or so signatories here. And Quebec has over 17,000 physicians. 'Nuff said. Let's take back that explanation point above. Make it a question mark, and nonetheless hats-off to those young and resident physicians who signed the petition.
Should Textbook Authors Declare Conflict of Interest? Have to admit, this hadn't exactly been uppermost in our minds--I've no recollection that we at HCRenewal ever really discussed it at meetings--but now a scholarly journal has reported out some fascinating findings on COI among the authors of Harrison's venerable textbook of internal medicine, and several others. (Hell, some of us even knew Dr. Harrison: what would he say, and does it even matter?) In any case, this was reported recently in one of the STAT newsletters. They found an important piece in the journal AJOB Empirical Bioethics about potential COI problems with over a quarter of authors on patents, and almost a third on up to 800,000 dollars per author in pharmaceutical company payments. Seems that journal editors, especially in the top tier, do better than this in requiring declarations from submitting authors. After all, quite a few years ago the editors all got together and created a COI policy that many of us know first-hand when we try to publish. But tetbook editors seem to have, still, a sort of noblesse oblige about their solicited authors. When Harrison's successors anoint a certain individual as her resident expert on a given disorder, it's almost as though that expert is automatically considered above reproach. Or, is it the case, for example in the instance of McGraw-Hill and Harrison's, that the publishers haven't gotten to the same point of transparency as the journal editors did years ago? Either way, it needs to change.
Two Trump HHS Secretaries: the Doc and the Pharma Exec. Who's Choosing Wiselier? In that order. Dr. Price first, and now Mr. Azar. What does it mean when, pitting them head-to-head for decision-making and general comportment, the latter looks a damn sight better than the former? Says something about the ethics of a lot of physicians in our country, and especially so about those those who choose to run for elective office. On the one side we have Dr. Price, the orthopedist whose wife (herself a physician and state representative) inquired a few months ago whether HIV patients could be quarantined. And who himself did everything he could to weaken Obamacare, according to Politico and others. Comes now Azar, and remarkably, he's made some very adequate middle-of-the-road decisions. First that comes to mind: backing away from the radioactive attempts in Idaho (see an earlier DOG Patch Report on this) to gut the Affordable Care Act by skewering its structuring of insurance. It's all technical and full of legalese, but the eight-page letter Azar had Seema Verma write to Governor "Butch" Otter is a master stroke. And long. And canny. (Shows why Azar is where he is--wonder whether any ultra-right plants from the White House are in HHS as they are in the VA, undermining their own secretary. Time will tell.) In essence, despite its Vermoid verbosity, we can boil it down to this: Verma says, and by proxy Azar says to old Butch, and in part we quote: "As you know ... ACA is failing to deliver quality health care options to the American people and has damaged health insurance markets across the nation." This must have felt good to read for those in Idaho afflicted with Trumpist ideology. But Butch, (s)he goes on to say, the law is the law. We're going to enforce it.
Addressing threats to health care's core values, especially those stemming from concentration and abuse of power - and now larger threats to the democracy needed to advance health and welfare. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.
Showing posts with label Canada. Show all posts
Showing posts with label Canada. Show all posts
Saturday, March 10, 2018
Wednesday, June 11, 2014
Canada: Province-wide electronic medical record computer system 'glitch' causing patients to be turned away from care
This story describes a very bad scenario for sick Canadians. I offer just a few pithy comments, as not much more than that is needed:
Province-wide. Stunning. A very big argument against centralization of EHR resources.
I wonder when someone in the Canadian government is going to issue that now-famous slogan "but patient safety has not been compromised"...
More than 200 physician clinics are blind, deaf and dumb? Wonder what happens to acute patients on days like that.
Paper never goes on strike. Perhaps elimination of paper completely is not such a good idea?
No comment.
It's just a "glitch", sir or madam. Stop complaining. (http://hcrenewal.blogspot.com/search/label/glitch)
At Health Matters Medical Clinic, staff confirmed they too were dealing with no access to patients’ records on TELUS’s Wolf system.
Seems to be this TELUS: https://www.telushealth.com/health-solutions/electronic-health-records-%28ehr%29. Sounds like a monopoly to me.
On that page:
How ironic.
Data technicians were in a meeting? Sounds like a fantastic way to respond to a Province-wide medical emergency.
Paper never goes on strike.
That's just great for patient-physician relations.
"Wolf" is a somewhat humorous name considering these problems. As in, a predatory EHR ... one wonders just how much better the others are.
I wonder if any patients will suffer the ultimate consequence. (Hint to Canadians: never become too dependent on the Government. Stuff like this happens.)
Held medical hostage to bad health IT. How horrible.
Perhaps they're busy, in meetings discussing how to fix the problem.
-- SS
http://medicinehatnews.com/news/local-news/2014/06/10/system-failure-has-docs-patients-upset/
System failure has docs, patients upset
By Gillian Slade on June 10, 2014
Many patients were turned away from their doctor’s office Monday because a province-wide electronic medical record computer system had collapsed.
Province-wide. Stunning. A very big argument against centralization of EHR resources.
“This is the third straight week of issues with the TELUS Wolf system,” said Dr. Donovan Nunweiler at Southlands Medical Clinic. “We feel we were encouraged by government to switch to Wolf and now it’s not working.”
I wonder when someone in the Canadian government is going to issue that now-famous slogan "but patient safety has not been compromised"...
A year ago 202 physician clinics across Alberta using TELUS Wolf were unable to access patient records for most of the day.
More than 200 physician clinics are blind, deaf and dumb? Wonder what happens to acute patients on days like that.
On Monday patients arrived only to be told the electronic patient files were not accessible making it impossible to see test results, past medical history and medications.
Paper never goes on strike. Perhaps elimination of paper completely is not such a good idea?
“This is affecting me big time and affecting my income,” said Ken Hoeppner, a patient at HealthWORX Medical clinic, who had waited 15 days for his appointment. “Every time government touches something they wreck it. Our health care used to be good here before Alberta Health Services took over.”
No comment.
At HealthWORX, office manager Carel Liebenberg said the office was doing what it could to reschedule people. One patient had driven three hours to be there for his appointment early Monday.
It's just a "glitch", sir or madam. Stop complaining. (http://hcrenewal.blogspot.com/search/label/glitch)
At Health Matters Medical Clinic, staff confirmed they too were dealing with no access to patients’ records on TELUS’s Wolf system.
Originally to encourage physicians to move to electronic medical records, the government gave a monetary incentive. Alberta Health selected TELUS Health Solutions Wolf EMR after a request for proposals in 2008.
There was a requirement for the service to be available 99.9 per cent of the time between 6 a.m. and midnight with financial penalties for failure to do so.
“There is no longer any government support,” said Nunweiler. “We (Southlands Medical Clinic) pay $2,000 a month for this. Who is going to hold TELUS accountable now? The government has abandoned us. Cost and issues switching patient data, when systems are not compatible, prevents us from going somewhere else.”
Seems to be this TELUS: https://www.telushealth.com/health-solutions/electronic-health-records-%28ehr%29. Sounds like a monopoly to me.
On that page:
TELUS Electronic Health Records (EHR) provides a better way to share, access and consolidate information.
Without quick, secure access to complete and reliable information, healthcare provision can be inefficient, preventing patients from receiving the best care possible.
How ironic.
Liebenberg reached TELUS at 9 a.m. Monday.
“They said they had just become aware of the issue and that their data technicians were in a meeting discussing the problem,” said Liebenberg. “Last week the system was extremely slow, taking 15 minutes for a physician to simply renew a prescription.”
Data technicians were in a meeting? Sounds like a fantastic way to respond to a Province-wide medical emergency.
Nunweiler said he’d made notes on paper as he struggled to manage the snail’s pace of the system last week. Monday he would be adding to those notes and envisaged several hours at night entering the data to make it current.
Paper never goes on strike.
Liebenberg said the need to re-schedule appointments reflects badly on the clinic and some patients don’t understand it’s a system failure beyond the clinic’s.
That's just great for patient-physician relations.
Dr. Franz Yonker said HealthWORX had been using JonokeMed but the government endorsed TELUS Wolf and physicians were encouraged to switch.
“I think this is really bad for a government-backed system,” said Yonker.
"Wolf" is a somewhat humorous name considering these problems. As in, a predatory EHR ... one wonders just how much better the others are.
Becky Nelson arrived for her appointment to refill prescriptions and was concerned about how long it would take to get another appointment.
“The government needs to get this on track. We are suffering the consequences,” said Nelson.
I wonder if any patients will suffer the ultimate consequence. (Hint to Canadians: never become too dependent on the Government. Stuff like this happens.)
Donna Schneider brought her mother Vernie Ferguson in for results of some tests. Ferguson said she was not at all well.
“There is nowhere else to go and get my test results,” said Ferguson.
Held medical hostage to bad health IT. How horrible.
The News requested an interview with TELUS but there was no response on Monday afternoon.
The News requested information from Alberta Health but that was not available on Monday.
Perhaps they're busy, in meetings discussing how to fix the problem.
-- SS
Monday, October 01, 2012
Ontario must rethink health care ... including costs of health IT
Hat tip to a commenter for the link below to a Toronto newspaper opinion piece on Canadian healthcare rationing and the costs of health IT.
The line:
could have been written by me.
(In fact, I've written exactly such lines about the "National Programme for IT in the HHS" a/k/a the HITECH Act, regarding the waste of precious healthcare resources such as at my Jan. 2010 post "Electronic Medical Records and Going For Broke: Jackson Health System's Financial Future Appears Grim".)
This from the Toronto Sun:
I presume they're referring to the scandal such as I wrote of in May 2009 at my post "Canadian Health IT Ripoff ... Is Anyone in the U.S. Paying Attention?"
(Addendum Oct. 1, 2012: per the commenter, also see this July 2012 Toronto Sun story: eHealth Needs Surgery and this quote: "Auditor General Jim McCarter, in his clinical dissection of Ontario electronic health records woe in 2009, said $1 billion had been spent by over 10 years by two different governments, without getting full value for those dollars. He’s since been more specific about the numbers, saying “hundreds of millions of dollars” were likely wasted.")
From my aforementioned Jan. 2010 post:
Add "and for the not so poor" to that list.
But in the U.S. let's go merrily ahead and spend a trillion dollars for health IT, even if it's bad health it (BHIT), which there currently is no reason for manufacturers to stop producing (e.g., complete lack of regulation).
No problem, right?
-- SS
The line:
"While billion-dollar scandals like eHealth make these stories all the more frustrating for Ontarians, because of the appalling waste of scarce health-care dollars, the truth is governments across Canada, not just the Dalton McGuinty government in Ontario, are struggling with the same issues"
could have been written by me.
(In fact, I've written exactly such lines about the "National Programme for IT in the HHS" a/k/a the HITECH Act, regarding the waste of precious healthcare resources such as at my Jan. 2010 post "Electronic Medical Records and Going For Broke: Jackson Health System's Financial Future Appears Grim".)
This from the Toronto Sun:
Ontario must rethink health care
Toronto Sun
Saturday, September 29, 2012, 6:20 PM
The simple truth is Ontario’s health care system is running out of our money to pay for our health care.
That’s why we keep hearing about cases of patients being denied necessary surgery — particularly when it has to be done in the U.S. — and life-prolonging medications.
In the Sun’s news section today, Queen’s Park columnist Christina Blizzard tells the story of Erika Crawford, 17, whose family plans to go ahead with life-saving surgery in the U.S. to prevent her death from Ehlers-Danlos Syndrome, even though OHIP has callously refused to fund the expensive procedure.
Recently, Blizzard wrote about the plight of three-year-old Liam Reid, whose parents went ahead with eye-saving treatment available only in Detroit, with no guarantee OHIP will pay for that.
Over the summer, Blizzard wrote about 67-year-old Percy Bedard, denied OHIP funding for a life-prolonging drug for his prostate cancer because the health ministry doesn’t believe it’s cost effective.
The truth is that as time goes on, there are going to be more and more stories like this.
While billion-dollar scandals like eHealth make these stories all the more frustrating for Ontarians, because of the appalling waste of scarce health-care dollars, the truth is governments across Canada, not just the Dalton McGuinty government in Ontario, are struggling with the same issues.
I presume they're referring to the scandal such as I wrote of in May 2009 at my post "Canadian Health IT Ripoff ... Is Anyone in the U.S. Paying Attention?"
(Addendum Oct. 1, 2012: per the commenter, also see this July 2012 Toronto Sun story: eHealth Needs Surgery and this quote: "Auditor General Jim McCarter, in his clinical dissection of Ontario electronic health records woe in 2009, said $1 billion had been spent by over 10 years by two different governments, without getting full value for those dollars. He’s since been more specific about the numbers, saying “hundreds of millions of dollars” were likely wasted.")
From my aforementioned Jan. 2010 post:
... I have written on numerous occasions that health IT in its present form, often poorly designed and implemented under current IT leadership structures, is often a waste of precious healthcare resources. The resources might be better spent on essentials such as patient care for the poor or improved human staffing, until this experimental technology is perfected.
Add "and for the not so poor" to that list.
Since there isn’t enough money to give everyone the care they need, politicians and health bureaucrats routinely deny medically necessary services and treatments to save money.
This often means choosing between who will live and who will die, and who will suffer and who will lead a normal life.
To be sure, this review process has always been in place, particularly for out-of-province treatments and for funding new medications, since no publicly funded health care system can possibly provide every service to everyone.
But as the health care budget creeps towards eating up half of all spending in Ontario, these decisions are only going to become more frequent, and harder.
But in the U.S. let's go merrily ahead and spend a trillion dollars for health IT, even if it's bad health it (BHIT), which there currently is no reason for manufacturers to stop producing (e.g., complete lack of regulation).
No problem, right?
-- SS
Wednesday, May 17, 2006
A Former Editor Cites Foucault
A while back, we posted about the firing of the editors of the Canadian Medical Association Journal (CMAJ), noting this seemingly unfortunate example of a power struggle within a medical organization. However, the firing of Dr Hoey has generally been presented in terms of abuse of power as a violation of editorial independence.
For example, in 2005, Hoey wrote an unsigned editorial in CMAJ that started with the premise, "freedom from interference in editorial decisions stands at the heart of the credibility of any reputable journal." He then announced "we have a transgression to report," and then went on to recount how "a CMA [Canadian Medical Association] executive objected strenuously to a news article we were preparing on behind-the-counter access to levonorgestrel (Plan B)."(1) Similarly, the editor of the British Medical Journal responded to Hoey's firing, "this is a sorry tale that shows how little the CMA (its officers and - since there is no sign of a concerted outcry from them - its members) understands what it means to be the custodian of an international academic medical journal."(2)
There has been much more discussion of the firing of Hoey and then the departure of many other CMAJ editors. The New England Journal of Medicine ran a commentary in March.(3) Last week, it ran another, this time written by Dr Hoey, himself.(4) Would this more clearly delineate what happened?
Hoey's article, however, took an unusual stance. He chided "owners [who] may wish to limit to limit the scope of their journal, to restrict its editorial perspective to matters of bedside medicine and the narrower interests (as perceived by the usually nonphysician publishers) of their physician readership." He then denied this "vision." Instead, he proclaimed, "for Foucault, medicine is a political act."
That is where he lost me, decisively. The Foucault he cited, assuredly is Michel Foucault, one of the "postmodern vanguard," authorities repeatedly cited to justify the fashionable post-modern concepts that have swept through the academic humanities and social sciences. Foucault is cited:
But perhaps Hoey's citation of Foucault was a mistake, or misinterpretation. After citing Foucault, Hoey admonished journal editors not to discuss or even divulge editorial decisions to their publishers, for that would "gut the editorial independence of a journal." However, the editor's outlook and assurance should include "an eager propensity to poke a stick into something or somebody." That proclamation suggests that Hoey's reliance on Foucault was not some mistake. Characterizing an ideal journal editor as an undisciplined trouble-maker fits Foucault's fascination with "limit experiences."(12) Yet editors whose main joy is in poking sticks into something or somebody without restraint or accountability will only add to concentration and abuse of power.
Thus, it still seems like our original characterization of the dispute at CMAJ was apt, "A classic power struggle within medicine's increasingly less-hallowed halls. Here it seems drearily familiar." That's too bad.
References
1. CMAJ. The editorial autonomy of CMAJ. Can Med Assoc J 2006; 174: 9.
2. Godlee F. A big mistake. Brit Med J 2006; 332:
3. Shuchman M, Redelmeier DA. Politics and independence - the collapse of the Canadian Medical Association Journal. N Engl J Med 2006; 354:1337-1339.
4. Hoey J. Editorial independence and the Canadian Medical Association Journal. N Engl J Med 2006; 354: 1982-3.
5. Hicks SR. Explaining Postmodernism: Skepticism and Socialism from Rousseau to Foucault. Tempe: Scholargy Publishing, 2004. P. 2. (Link here)
6. Hicks, P. 14.
7. Farber DA, Sherry S. Beyond All Reason: the Radical Assault on Truth in American Law. New York: Oxford University Press, 1977. P. 24. (Link here)
8. Farber, Sherry. P. 106.
9. Farber, Sherry, P. 29
10. Lilla M. The Reckless Mind: Intellectuals in Politics. New York: New York Review of Books, 2001. P. 150. (Link here.)
11. Lilla. P. 154.
12. Lilla. P. 150.
For example, in 2005, Hoey wrote an unsigned editorial in CMAJ that started with the premise, "freedom from interference in editorial decisions stands at the heart of the credibility of any reputable journal." He then announced "we have a transgression to report," and then went on to recount how "a CMA [Canadian Medical Association] executive objected strenuously to a news article we were preparing on behind-the-counter access to levonorgestrel (Plan B)."(1) Similarly, the editor of the British Medical Journal responded to Hoey's firing, "this is a sorry tale that shows how little the CMA (its officers and - since there is no sign of a concerted outcry from them - its members) understands what it means to be the custodian of an international academic medical journal."(2)
There has been much more discussion of the firing of Hoey and then the departure of many other CMAJ editors. The New England Journal of Medicine ran a commentary in March.(3) Last week, it ran another, this time written by Dr Hoey, himself.(4) Would this more clearly delineate what happened?
Hoey's article, however, took an unusual stance. He chided "owners [who] may wish to limit to limit the scope of their journal, to restrict its editorial perspective to matters of bedside medicine and the narrower interests (as perceived by the usually nonphysician publishers) of their physician readership." He then denied this "vision." Instead, he proclaimed, "for Foucault, medicine is a political act."
That is where he lost me, decisively. The Foucault he cited, assuredly is Michel Foucault, one of the "postmodern vanguard," authorities repeatedly cited to justify the fashionable post-modern concepts that have swept through the academic humanities and social sciences. Foucault is cited:
- For his hostility to the Enlightenment. For example, he wrote, "it is meaningless to speak in the name of -or against - Reason, Truth, or Knowledge."(5) Hicks explained, "Postmodernism rejects the entire Enlightenment project. It holds that the modernist premises of the Enlightenment were untenable from the beginning and that their cultural manifestations have now reached their nadir. While the modern world continues to speak of reason, freedom, and progress, its pathologies tell another story. The postmodern critique of these pathologies is offered as the death knell of modernism: 'The deepest strata of Western culture' have been exposed, Foucault argues, and are 'once more stirring under our feet.'"(6)
- To support the self-contradictory and ultimately meaningless assertion that there is no external reality, that reality is "socially constructed." "Foucault at times suggested that underlying what counts as objective knowledge is a power relation, one category of people benefiting at the expense of another category of people. The radicals thus see the social construction of reality...."(7)
- To support totalitarianism. "As part of the attack on the Enlightenment, the critique of truth suffers from a tendency to reinforce pre-enlightenment despotism. The Enlightenment replaced individual and institutional power with more objective measures of validity, and it is no surprise that the rejection of objectivity collapses back into power as a means for defining absolute truth."(8) Foucault's belief that "liberal democracies are actually more oppressive than medieval despots or even modern totalitarians,"(9) was consistent with his occasional embrace of totalitarian rulers. In 1971, he said, "when the proletariat takes power, it may be quite possible that the proletariat will exert toward the classes over which it has triumphed a violent, dictatorial, and even bloody power. I can't see what objection could possibly be made to this."(10) Similarly, he extolled the 1978 Iranian revolution, "exulting in the 'intoxication' of revolution and the violent expression of 'collective will,' and praised its leaders 'political spirituality,' which he thought reflected a health 'religion of combat and sacrifice.'"(11)
But perhaps Hoey's citation of Foucault was a mistake, or misinterpretation. After citing Foucault, Hoey admonished journal editors not to discuss or even divulge editorial decisions to their publishers, for that would "gut the editorial independence of a journal." However, the editor's outlook and assurance should include "an eager propensity to poke a stick into something or somebody." That proclamation suggests that Hoey's reliance on Foucault was not some mistake. Characterizing an ideal journal editor as an undisciplined trouble-maker fits Foucault's fascination with "limit experiences."(12) Yet editors whose main joy is in poking sticks into something or somebody without restraint or accountability will only add to concentration and abuse of power.
Thus, it still seems like our original characterization of the dispute at CMAJ was apt, "A classic power struggle within medicine's increasingly less-hallowed halls. Here it seems drearily familiar." That's too bad.
References
1. CMAJ. The editorial autonomy of CMAJ. Can Med Assoc J 2006; 174: 9.
2. Godlee F. A big mistake. Brit Med J 2006; 332:
3. Shuchman M, Redelmeier DA. Politics and independence - the collapse of the Canadian Medical Association Journal. N Engl J Med 2006; 354:1337-1339.
4. Hoey J. Editorial independence and the Canadian Medical Association Journal. N Engl J Med 2006; 354: 1982-3.
5. Hicks SR. Explaining Postmodernism: Skepticism and Socialism from Rousseau to Foucault. Tempe: Scholargy Publishing, 2004. P. 2. (Link here)
6. Hicks, P. 14.
7. Farber DA, Sherry S. Beyond All Reason: the Radical Assault on Truth in American Law. New York: Oxford University Press, 1977. P. 24. (Link here)
8. Farber, Sherry. P. 106.
9. Farber, Sherry, P. 29
10. Lilla M. The Reckless Mind: Intellectuals in Politics. New York: New York Review of Books, 2001. P. 150. (Link here.)
11. Lilla. P. 154.
12. Lilla. P. 150.
Friday, March 10, 2006
Consequences of SFBC International's Clinical Trials: 20 People Get Tuberculosis
We have posted before about the troubles of contract research firm SFBC International We started by posting about allegations that private, for-profit clinical research firms, including SFBC International, supervised by for-profit institutional review boards (IRBs), were doing sloppy and shoddy work. We then noted allegations that SFBC International had tried to threaten or intimidate research subjects who talked to reporters about such poor research practices. Furthermore, we discussed how a review commissioned by the company found that a top executive, Jerry Seifer, SFBC International's Vice President for Legal Affairs, threatened participants in clinical studies who had talked to the press with deportation. Seifer, it turns out, had been the subject of past regulatory sanctions by federal regulators. In addition, study participants in a trial of an immunosuppressant drug carried out by the firm's Canadian subsidiary, SFBC Anapharm, acquired tuberculosis after exposure to another participant with active disease, despite their complaints to Anapharm staff. Most recently, we noted that Seifer had resigned, and the company's stock price had fallen.
There is an update on the human consequences of SFBC International's (mis)management of clinical trials. 20 people have contracted latent tuberculosis after being exposed to a patient with active TB during a trial of an immunosuppressant agent at SFBC International's SFBC Anapharm Canadian testing facility, according to CTV. Bloomberg News noted that 11 were employees of the company, while the remainder were patients in the study. CTV suggested that all would have to undergo nine months of therapy (presumably to suppress their latent TB and lower the likelihood it would become active in the future.) An investigation by Health Canada is ongoing. Bloomberg news could not get officials of SFBC International nor of Isotechnika, which made the trial drug, to comment.
CTV interviewed Professor Trudo Lemmens of the University of Toronto, who summed up the major issues.
Sadly, this case provides yet another reminder about how skeptical we must be about much of the clinical research now going on that is financed, and now often performed and supervised by loosely regulated corporations. And that is coming from a proud supporter of evidence-based medicine who has long advocated for clinical research, and who put my money where my mouth is by signing up as a trial subject. This sort of story really hurts.
There is an update on the human consequences of SFBC International's (mis)management of clinical trials. 20 people have contracted latent tuberculosis after being exposed to a patient with active TB during a trial of an immunosuppressant agent at SFBC International's SFBC Anapharm Canadian testing facility, according to CTV. Bloomberg News noted that 11 were employees of the company, while the remainder were patients in the study. CTV suggested that all would have to undergo nine months of therapy (presumably to suppress their latent TB and lower the likelihood it would become active in the future.) An investigation by Health Canada is ongoing. Bloomberg news could not get officials of SFBC International nor of Isotechnika, which made the trial drug, to comment.
CTV interviewed Professor Trudo Lemmens of the University of Toronto, who summed up the major issues.
The pharmaceutical industries want to have drugs on the market and they want to have them on the market quickly.Lemmens also noted that commercial ethics board may not do a good job policing such trials.
So they contract research organizations to do the human subject research for them. These companies are paid for the outcome, which is to have the trials done as quickly as possible, and so they have significant financial incentives to recruit human subjects and research them very quickly.
While many may be doing a good job, it's possible in the current regulatory system to shop for the most convenient, the fastest and the perhaps most lenient research ethics boards which imposes the least restrictions on your clinical trial.In response to this case he suggested,
The current Quebec situation underscores the need for the creation of a watchdog to oversee the industry, as well as stronger federal and provincial regulations to establish guidelines and requirements for research ethics boards, Lemmens said.It sounds like parallel solutions are needed in other countries.
Sadly, this case provides yet another reminder about how skeptical we must be about much of the clinical research now going on that is financed, and now often performed and supervised by loosely regulated corporations. And that is coming from a proud supporter of evidence-based medicine who has long advocated for clinical research, and who put my money where my mouth is by signing up as a trial subject. This sort of story really hurts.
Sunday, March 05, 2006
CMA Journal Slides Down Razor Blade
The Saturday, 4 March '06 Toronto Globe and Mail tells of recent difficulties at the once-venerable Canadian Medical Association Journal.
Not a pretty sight, but one that readers of this blog -- and folks like Dr. Jerry Kassirer, CMAJ ed board member and formerly editor of the New England Journal -- have become sadly inured to.
The bare facts of the controversy are difficult to fully capture here. Apparently, according to journalist Gloria Galloway's Globe and Mail piece, the publisher, one Mr. Graham Morris, fired the editor, Dr. John Hoey, for committing the sin of editorial freedom: scheduling an editorial that looked into certain pharmacists' alleged practice of grilling women seeking the morning-after pill.
Apparently the pharmacists' organization was sufficiently unhappy about the piece (and how did they know about it?) to pressure the publisher for withdrawal. And apparently he acceded. Then, another issue erupted, over practice-privatization, and a critical piece from the editors was overlain by another, less critical one.
It became a trifecta, finally, when the new Acting Editor, Stephen Choi, felt compelled to resign in protest over the Association's rejection of "an editorial governance plan that called for the CMA to accept the independence of the editor-in-chief."
There are lots of ways to read this controversy, and it's best to keep our powder dry until we learn more. But that last step in the trifecta, the CMA's refusal to assure editorial autonomy, may in some ways amount to the likely key in understanding what's going on. A classic power struggle within medicine's increasingly less-hallowed halls. Here it seems drearily familiar. To quote the late great Jack Webb: "The story you are about to see is true; the names have been changed to protect the innocent."
Not a pretty sight, but one that readers of this blog -- and folks like Dr. Jerry Kassirer, CMAJ ed board member and formerly editor of the New England Journal -- have become sadly inured to.
The bare facts of the controversy are difficult to fully capture here. Apparently, according to journalist Gloria Galloway's Globe and Mail piece, the publisher, one Mr. Graham Morris, fired the editor, Dr. John Hoey, for committing the sin of editorial freedom: scheduling an editorial that looked into certain pharmacists' alleged practice of grilling women seeking the morning-after pill.
Apparently the pharmacists' organization was sufficiently unhappy about the piece (and how did they know about it?) to pressure the publisher for withdrawal. And apparently he acceded. Then, another issue erupted, over practice-privatization, and a critical piece from the editors was overlain by another, less critical one.
It became a trifecta, finally, when the new Acting Editor, Stephen Choi, felt compelled to resign in protest over the Association's rejection of "an editorial governance plan that called for the CMA to accept the independence of the editor-in-chief."
There are lots of ways to read this controversy, and it's best to keep our powder dry until we learn more. But that last step in the trifecta, the CMA's refusal to assure editorial autonomy, may in some ways amount to the likely key in understanding what's going on. A classic power struggle within medicine's increasingly less-hallowed halls. Here it seems drearily familiar. To quote the late great Jack Webb: "The story you are about to see is true; the names have been changed to protect the innocent."
Thursday, June 09, 2005
Canadian Ban on Private Health Insurance Struck Down
The Globe and Mail reported that the Canadian Supreme Court has just struck down as unconstitutional a law in Quebec that makes private health care insurance illegal. Dr. Albert Schumacher, the President of the Canadian Medical Association, said, "this is indeed a historic ruling that could substantially change the very foundation of medicare as we know it."
The court found "in sum, the prohibition on obtaining private health insurance is not constitutional where the public system fails to deliver reasonable services."
Health Care Renewal has frequently discussed the excesses of the for-profit and private not-for-profit organizations that comprise a major chunk of the US health care system, so Canada's impending leap into a multi-centric health care system may not be an unalloyed success. However, throwing caution about commenting about another nation's politics aside, I can't help but think that putting a little more control of health care into the hands of individual Canadians may not be entirely a bad thing. Maybe some of our friends north of here will comment more knowledgeably.
The court found "in sum, the prohibition on obtaining private health insurance is not constitutional where the public system fails to deliver reasonable services."
Health Care Renewal has frequently discussed the excesses of the for-profit and private not-for-profit organizations that comprise a major chunk of the US health care system, so Canada's impending leap into a multi-centric health care system may not be an unalloyed success. However, throwing caution about commenting about another nation's politics aside, I can't help but think that putting a little more control of health care into the hands of individual Canadians may not be entirely a bad thing. Maybe some of our friends north of here will comment more knowledgeably.
Wednesday, March 02, 2005
A Health Care System "Better Suited to a Monty Python Movie"
In the US, advocates for a single-payer health care financing system have long cited the Canadian model. And many of these advocates have implied that changing the US health care financing system would cure most of the country's health care ills.
To illustrate that a single-payer financing system has not solved all of Canada's health care problems, see this story in the Globe and Mail.
In Ontario, hospitals often have to guess what the government will set as their budgets, then run for most of the fiscal year based on the guess, only to find out at the end of the year that their guess was wrong. The provincial government may then blame the hospital for running a deficit based on a budget the hospital had never actually seen. So that's one reason why the head of the Ontario Hospital Assocation called for a new system, claiming the current one "would be better suited to a Monty Python movie."
This is just a reminder that organization and governance of health care may be even more important than financing. But in the US, financing receives much more attention.
To illustrate that a single-payer financing system has not solved all of Canada's health care problems, see this story in the Globe and Mail.
In Ontario, hospitals often have to guess what the government will set as their budgets, then run for most of the fiscal year based on the guess, only to find out at the end of the year that their guess was wrong. The provincial government may then blame the hospital for running a deficit based on a budget the hospital had never actually seen. So that's one reason why the head of the Ontario Hospital Assocation called for a new system, claiming the current one "would be better suited to a Monty Python movie."
This is just a reminder that organization and governance of health care may be even more important than financing. But in the US, financing receives much more attention.
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