Are anticoagulants underused in Ontario?

In writing the following post, I came upon the paper How Can We Avoid a Stroke Crisis in Europe? If you do nothing more, read this paper. You found my blog because you were searching for information on anticoagulants, heart rhythm problems and risk of stroke. Read the linked paper. You may find it answers many of your questions.

When done, if you want to know more, read the rest of my post. There are also more links of interest.

Cheers,
Rockinon -- a patient with ongoing heart problems
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Are anticoagulants underused in Ontario? This is the question I asked myself upon learning that a friend in constant heart flutter was not taking an anticoagulant to lessen his chances of suffering a debilitating stroke.

I found an article in The American Journal of Medicine looking at this very question. I learned there are clear guidelines for managing atrial fibrillation and atrial flutter with recommendations for anticoagulation based on a patient's overall stroke risk. I also learned that the guidelines are not always being followed.

In a study of more than 170,000 patients in the States, less than 50% of high-risk patients were given anticoagulant therapy. The study concluded that the anticoagulation guidelines are not being routinely followed in clinical practice. The study did not conclude this was resulting in harm to untreated patients but decided another study, one looking at treatment outcomes, was warranted.

I can understand doctors being hesitant to immediately give anticoagulants to all patients with high CHADS₂ scores. Although I am now taking an anticoagulant daily, it was a tough call for my doctors.

I have microbleeding in the brain, discovered during an MRI scan. For a very good discussion of the significance of cerebral microbleeds read the article Cerebral microbleeds: a new dilemma in stroke medicine posted in the Journal of the Royal Society of Medicine. In my case, as in all cases, doctors must weight the risks vs. the benefits of various treatments. All too often the answer is a trade-off.

Clearly, a slightly elevated CHADS₂ score is not always enough to convince doctors anticoagulants are the best response. They see the risk/benefit ratio as not favouring the immediate use of a blood thinner (an inaccurate name for anticoagulants.) I don't envy doctors. They find themselves forced to choose between a rock and a hard place every day.

So, should more Ontario patients be on anticoagulants to protect them against stroke? It is hard to say for certain but the answer may well be yes. The Canadian doctors, like their American counterparts, may be too conservative, too timid. In steering their patients down a path that avoids the complications resulting from the use of blood thinners, their patients may be on the road to a stroke.

If you have a heart arrhythmia and are not on a blood thinner, you should ask your doctor why not. There may be good reasons for not giving you anticoagulant therapy but you should know what they are. To get a handle on your risk of a stroke, here is a link to a CHA₂DS₂-VASc Score calculator.

To better understand your risk of bleeding, here is a link to a HAS-BLED calculator. Taken together these two calculators point to the difficult decisions forced upon your doctor.

Lastly, not all abnormal heart rhythms are created equal. All arrhythmias do not result in equal risk of stroke. And atrial flutter, when occurring alone, does not carry the same increased risk of stroke as atrial fibrillation. That said, atrial flutter is often accompanied by periods of atrial fibrillation.

So, should my friend be taking an anticoagulant to lessen his risk of stroke? Maybe. He was on a blood thinner but stopped taking his medication on his own. Possibly his doctor senses his patient's fears and this tips the scales against recommending anticoagulants in the doctor's mind.

But atrial flutter is not benign. It is associated with an increase in overall mortality. According to a  posting on Patient.co.uk, persistent atrial flutter when left untreated can become chronic atrial fibrillation (AF). Even after treatment, I had my atrial flutter eradicated by undergoing an ablation procedure, I continue to take the powerful arrhythmia fighting drug sotalol to help insure my flutter does not return. I also continue to take Pradaxa, a blood thinner, twice a day.

Lastly, I wonder if the perceived dramatic increase in cost of anticoagulant therapy in recent years has influenced doctors, especially in the States. The old drug of choice, coumadin, is relatively inexpensive and safe. Unfortunately, it is also a fair amount of trouble. Regular blood work is necessary to insure the dosage is effective. The bothersome constant need for monitoring is one reason many patients quietly stop taking coumadin without consulting their doctors.

Newer drugs, like Pradaxa (dabigatran), cost more but do not require the expensive regular blood work. Some studies, such as one in Denmark, have found treatment with dabigatran only costs about 10% more than coumadin, with the increased cost of the medication the main driver of the added Pradaxa expense. I take Pradaxa to protect me against stroke while minimizing my chances of suffering a cranial bleed.

Minimizing the occurrence of strokes is a win-win situation. Both patients and society benefit from anticoagulant therapy in high-risk AF populations. A French study found the mean cost of a severe stroke was €34,809, and the risk of a severe stroke is what accompanies AF. The mean cost of a mild stroke in the study was €10,530. Clearly, dabigatran saves society money by preventing severe strokes in AF patients.

So, why do doctors shy away from prescribing blood thinners when the cost is not exorbitant and the benefits appear to be clear? One study pointed to a misplaced fear of bleeding, especially cranial bleeding. The fear of bleeding seems to trump the fear of stroke among medical professionals.

And so, in seeking treatment for heart rhythm problems there is one risk that is often overlooked: The risk that one's doctor has a personal aversion, an unsubstantiated fear, of the side-effects of the what should be one of the drugs of choice -- an anticoagulant.

NASA claims no ties to research paper

National Post: Tuesday, March 18, 2014

It was quite the story: A NASA-funded study predicted the end of the civilized world as we know it. The controversial report calculated that our global civilization is headed for annihilation. The sky may not be falling now but come back in a few decades and bring a hard hat.

The Independent: Sun., Mar. 3, 2014

The story, published by The Independent and The Guardian in Britain, was picked up by The Huffington Post and immediately went viral. The story was repeated by media outlets around the world. Even NASA entered the fray with a comment. This was not unexpected as scores of media outlets around the globe reported on the NASA-funded and oh-so-damning report.

Did the NASA statement contain any surprises? In a word, yes. For one thing, NASA called the media reports "erroneous." The soon-to-be released study "was not solicited, directed or reviewed by NASA. It is an independent study . . . ," NASA claimed.

NASA was in damage-control mode, distancing itself from the story. A Google search found a link to the scholarly paper. The authors write, "This work was partially funded through NASA/GSFC grant NNX12AD03A."

The National Socio-Environmental Synthesis Center (SESYNC), one of the sponsors of the paper, reports:

" [Safa] Motesharrei [one of the authors of the paper] received minor support from NASA to develop a coupled earth system model. Some of this funding was spent on the mathematical development of the HANDY model."

The paper is not only connected to NASA by some minor funding, one of the report's authors, Eugenia Kalnay, was branch head at NASA Goddard Space Flight Center prior to heading off to the University of Maryland.

The media reports may have overstated the NASA connection but the NASA press release underplays the connection the space agency has to this University of Maryland paper. The respected-research-patina conveyed by an association with NASA is certainly there. The reason for NASA's backpedaling is clear.

The study in question found that the ongoing economic stratification of society -- think of the one percenters and the rich-get-richer world endorsed by right wing capitalist Kevin O'Leary on CBC -- makes the collapse of civilization almost unavoidable. Major policy changes to reduce inequality are desperately needed, according to the authors.

I find one of the most interesting features about this story is not how far and fast it spread but the limits to growth it encountered. Even the Club of Rome might find this interesting. I could find no evidence that Sun Media, Canada's right wing newspaper chain, featured the story at all.

Does U.S. educated reporter hate Canadian health care system?

The headline screams "Crohn's research at Robarts hits world stage." Is the headline true? Yes. Is it the whole story? Not by a long shot.

Dr. Brian Feagan is the director of Robarts Clinical Trials at the Robarts Research Institute in London, Ontario. Last year Feagan was among those awarded the 2013 Scientific Achievement Award by the Crohn’s & Colitis Foundation of America (CCFA). Feagan has long been known for, as they say, pushing the needle forward in the quest for cures to these diseases.

The man is amazing. A quick Google search shows he has been at the forefront of inflammatory bowel disease research since late in the last century at least. His latest work is, not surprisingly, a continuation and a validation of research which has attracted global interest for years. He is a longtime player on the world health care stage.

Londoners should be proud of medical scientists like Feagan and proud of the work being done at the Robarts Research Institute. Researchers like Feagan and their studies are among the reasons I have the institute on my short list for an annual charitable donation. Because of the work done there, I am increasing my donation this year.

If you have been reading the series of articles run by The London Free Press and carried by Sun Media across the chain, you would think that Canadians are receiving second rate health care when compared to what is available south of the border in the States. The story tells readers "many provinces won't pay" for an aggressive approach for treating Crohn's disease.

A quick Google search turned up this online post by a woman in Salt Lake City, Utah:

In November, my new gastroenterologist . . . started me on Humira. It's a biological medication to decrease inflammation that has been successful to treat some people's Crohn's disease. . . .

The insurance denied the claim when the the pharmacy tried to get payment, because after a couple of refills at a local pharmacy, it's only covered when it comes from a "specialty pharmacy," called Acredo. After three hours either talking with people at Acredo, the specialty pharmacy, or having my doctor's office or the University pharmacy techs talk with people at Acredo and the insurance company, I left without the medication.

The patient ended her tirade saying, "Sigh. I wish private enterprise wouldn't get between patients and treatment"

Yes, some provinces resist paying for aggressive and expensive treatments for Crohn's disease as the first line approach -- but so do many private insurance plans around the globe. These are often plans that the patients thought were excellent until they were denied coverage for a drug like Humira.

I will leave the last word to Beth, the lady with Crohn's disease that I quoted out of Salt Lake City.

"I shouldn't be surprised [at the denial of coverage], since Anthem Blue Cross is beholden to stockholders before patients. Private business, in my opinion, is NOT always the best way to get things done, especially when it comes to health issues."

The Free Press article wasn't wrong. It wasn't error filled. But it wasn't balanced either.

Where are the editors?

The Globe and Mail needs to hire some editors. They are running way too thin. A recent story was trying to be hip and cool by making reference to "Llewyn Davis, the vagrant folk singer imagined by the Cohen brothers, who opened a show for Elvis Presley."

The problem is that the movie making brothers are the Coens. No 'h'. And the movie, Inside Llewyn Davis, shows Davis appearing on stage immediately before Bob Dylan. Not Elvis Presley.

It just makes one want to scream: "Aaauuugghh!"

When the James Bond film franchise hit the 50-year mark, Heather Hiscox on CBC went on and on about her favourite Bond film, Goldfinger, in which Bond stops Auric Goldfinger from stealing gold stored in Fort Knox. She goes on and on about the amazing planned theft. Trouble is Goldfinger never planned to steal the gold. Too bulky. Too heavy. He was going to explode a dirty bomb in Fort Knox. This would contaminate the gold and leave it worthless.

When newspapers and high-paid news anchors cannot get facts right, facts so easily checked, how are we to be certain  they are getting their facts right about a situation like the one unfolding in Ukraine.

That's Ukraine and not the Ukraine. When I worked at The London Free Press an editor put me straight.

What the world can learn from India concerning health care

Today I read an interesting article in the Harvard Business Review on what is being done right in India when it comes to keeping health care costs in check. It makes an interesting counterpoint to the stories being run by the local paper. The London Free Press seems to have hate on for the Canadian single-payer health care system. The writers at the paper deliver criticism in spades, not that our system doesn't at times deserve it, but the paper fails to offer many detailed solutions.

If you are interested in the rising cost of health care,  read: India's Secret to Low-Cost Health Care. The article makes a number of interesting claims, but two that really stood out are:

1. The health care available in Indian hospitals is cheaper even when you adjust for wages: For example, even if Indian heart hospitals paid their doctors and staff U.S.-level salaries, their costs for open-heart surgery would still be one-fifth of those in the U.S.
2. When it comes to innovations in health care delivery, these Indian hospitals have surpassed the efforts of other top institutions around the world.

Plus ça change, plus c'est la même chose.

The idea that "the more things change, the more they stay the same" is a common one around the world. No doubt because it's true.

The late Horace Judson was a famous and well respected journalist. His most famous book was Eighth Day of Creation, a history of molecular biology. Published way back in 1996, I believe this book is still in print. Of course, the fact that his daughter Olivia Judson is the well known evolutionary biologist and popular writer also keeps his name current.

While reading a review of Horace Judson's book on heroin addiction, published in 1974, I was struck by how little the world has moved forward in the intervening forty years.

The reviewer, Gerald McLaughlin, Associate Professor of Law at Fordham University School of Law, wrote:

Apart from government moneys being spent on drug law enforcement, apart from the countless government research grants given academics every year, entire industries have begun to grow up around the drug cure business - methadone clinics staffed by private physicians have become booming business, drug analysis and urinalysis centers have sprung up to serve their needs, and private drug research firms have been created. Like the fabled "military-industrial" complex of the Eisenhower years, a "drug abuse-industrial complex" has been created. Once created, it is hard to dismantle. To put it another way, with so much money at stake, there is an incentive not to let the problem die or at least there is an incentive to push for one's own special treatment modality. The law enforcers want to keep their funds, so they push for new law enforcement programs to end the heroin traffic; the methadone maintenance advocates push for more money for more centres; sociologists and psychologists request further grants to test this or that theory of addiction. Quite often some of these diverse elements or the "drug abuse-industrial complex" lobby against new alternatives simply to prevent money from being siphoned off to fund new programs or approaches. Fiscal preservation is an age-old vice of man.

Of course, some things do change. I must add that in the years following the publication of Judson's book, Heroin Addiction in Britain - What Americans can learn from the English experience, the British government turned more and more towards the American model. The Brits even appointed a drug czar in 1998. 

The changes failed.

Kalydeco: What is the whole story?

The other night I caught a little foreign film in which the woman protagonist was one difficult lady to love. She had a young niece who was also damn difficult. Thrown into the mix was a boyfriend who had his own little, and so little, quirks. The movie ended on an upbeat note but with such a convoluted story it was difficult to know how all would play out in the end.

Sun Media is using the story to attack Ontario Liberals.

Now take the news. Everyday we read, hear and watch stories reported in the media. They are usually good tales with strong, neat story lines. Maybe too neat. I often have the feeling there is more to these stories than we are being told. Life is depicted by the media more as bad fiction than rich reality.

Take the story of the young Ontario girl taking the very expensive Kalydeco (ivacaftor) to treat a rare form of cystic fibrosis (CF). Sun Media reports it costs $348,000 annually in Canada for this unique drug. This is completely out of the financial reach of most people. At this point, the Ontario government is refusing to assist this young girl and her family as they struggle to cope with this massive expense.

The government has stated that it would like to help and to this end it and a number of other Canadian provinces are in negotiations with Vertex, the maker of the drug. At this point, the company and the provincial drug consortium in Ontario are at loggerheads over the price of the drug which is perceived by many to be outrageously expensive.

The kicker in this is that the genetic variation of CF the drug treats is rare. It is so rare that only about 20 people in the province would be helped by taking Kalydeco. The entire cost to the province would be less than $8 million.

Read the story at news.com.au.

What has the mainstream media left unsaid? Well to start, it is not just bureaucrats in Ontario balking when confronting the high cost of the Vertex drug. Health care bureaucrats around the world have choked when confronting the high cost.

A story similar to the one being played out in Ontario made headlines across Australia. Ellie Haikalis has the type of cystic fibrosis controlled by Kalydeco. Unfortunately, her family cannot afford the treatment and the Australian government refused to assist them.

Her mother, Rachelle, told the media  she and her husband had discussed selling their home but realized that even taking that drastic action would not raise the money demanded by the drug maker.

Almost thirty concerned American doctors banned together to pen a letter to Vertex. They wrote:

It is at best unseemly for Vertex to charge our patient's insurance plans (including strapped state medical assistance plans), $294,000 annually for two pills a day . . . This action could appear to be leveraging pain and suffering into huge financial gain for speculators, some of whom were your top executives who reportedly made millions of dollars in a single day (Boston Globe, May 29).

The dispute over the cost of Kalydeco is just one skirmish in a larger, ongoing war being fought in numerous countries scattered across the globe. But the Kalydeco story on its own is a good one. Many see the price charged for this drug as "unconscionable."

Read the fine Milwaukee-Wisconsin Journal Sentinel story.

A story in Medpage Today, Cystic Fibrosis: Charity and Industry Partner for Profit, points out Vertex developed ivacaftor (Kalydeco) "with the help of a $75 million investment from the Cystic Fibrosis Foundation -- as well as a hefty investment from taxpayers through grants from the National Institute of Health which underwrote the cost of early research."

It isn't just Yanks who have some skin in this game. There are Canadians at the table too, such as Lap-Chee Tsui and John R. Riordan of the Hospital for Sick Children in Toronto. The two research scientists, along with Francis Collins of the University of Michigan, led a team isolating the gene responsible for cystic fibrosis. Medical breakthroughs do not occur in a research vacuum.

On the upside, the drug cost isn't out of sight for everyone. Ian Smith, Vertex executive vice president and chief financial officer, exercised stock options to gross more than $60 million in one day, according to the Milwaukee-Wisconsin Journal Sentinel.

If Smith had the type of CF in question, he could live to be a hundred and never experience any difficulty in paying for his supply of Kalydeco thanks to his after tax profits from just that one day.

Of course, Smith does not have CF. The millionaire has no reason to worry. He can breath easy.