More than sixty thousand Canadians per year and climbing get knee replacement surgery.
A U.S study published last week in the British Medical Journal finds that a good number of patients south of the border may be getting new knees before they need them.
The study by researchers in the U.S. and the Netherlands looked at just under 4,500 patients with osteoarthritis of the knee and those at high risk of arthritis. They looked at the impact of knee replacement surgery on patients and the cost of the surgery to the system. Overall, each patient benefited somewhat from the surgery with better quality of life. For patients with moderate arthritis, the improvement was modest; for those with severe arthritis, it was substantial. When they looked at the cost of the surgery plus hospital charges, they found that knee replacements were cost effective only in patients with bad arthritis. The authors concluded that knee replacement surgery should be restricted to more severely affected patients.
This is a U.S. study. So you may be wondering how relevant the conclusions are for Canada. One Canadian orthopedic surgeon told me the study is spot on. Money is wasted on people who shouldn't have knee replacements and, many patients end up worse following surgery. Far too many need a second operation to fix problems that were caused by the original replacement, such as stiffness and instability of the knee – often due to surgery that should not have taken place.
The Canadian Institute for Health Information tracks the rising number of repeat surgeries that are being done on Canadians who have new knees put in at a relatively young age. Surgeons who fix botched replacements surgery say the original surgeon replaced the knee even though the arthritis wasn't bad enough. Perhaps the patient complained of a lot of pain and the surgeon replaced the knee without knowing if replacing the knee would fix the pain. They say patients aren't being properly informed of the risks of surgery, and aren't being prepared for what they must do to recover from the operation. The provinces and the federal government have been more focused on wait times. Studies like this one have put outcomes and money wasted on the radar screen.
Sunnybrook's Holland Musculoskeletal Program has developed an award-winning model of patient care. The Holland Program has centralized management and triage of all referrals for joint replacement surgery. Instead of an orthopedic surgeon handling referrals, that job goes to an advanced practice physiotherapist or APP. APPs have additional training in assessing patients with arthritis. They triage patients and refer them to the orthopedic surgeon only when there is objective evidence that that the patient needs a new knee.
The APPs and the surgeons assess the patient's function, and use measurable criteria to score patients. Twenty-eight per cent of the patients the APPs see do not need surgery. Those patients get education on how to manage their arthritis. Patients can demand to see the surgeon, but that seldom takes place because APPs are good at what they do.
At first, the orthopedic surgeons there were a bit skittish about the new approach because they were used to seeing the own referrals. Some were frankly afraid they'd lose business. Now, they love it when APPs assess and screen patients. Before, they had to sift out the patients who needed new knees from those who didn't, and they had to deal with patients who were disappointed that they weren't getting surgery. Now, they have confidence that when the APPs say a patient needs a new knee, they need a new knee. Like me, family doctors are just guessing who needs surgery; the APP knows.
Fewer patients needing surgery means patients get seen faster and discharged faster. In my book, that's potential a win for every stakeholder.
To me, the bottom line is that patients should not demand a new knee. Instead, they should demand an assessment of their arthritis that is both thorough and objective. You'll know it's both if you are asked a lot of questions about how you function at home, and if you are watched by the health professional as you walk and do other standardized testing.
For my money, an APP is well qualified to assess you and to decide if you need surgery now, or if it can wait. Studies have shown that compared to physicians, APPs are just as good and maybe even better in diagnostic accuracy and the effectiveness of their treatment advice. APPs have also been shown to spend healthcare dollars as wisely and maybe even more wisely. Currently, APPs have started to take hold in Ontario. I think we need to see them right across Canada.
Above all, do not be disappointed if you are advised that you don't need a new knee today. There is always tomorrow.
How safe is your medical device? Even regulators may not really know
White Coat Black Art ·
Dennis
Fegan with his grandchildren. Fegan's Vagus Nerve Stimulator was
implanted to control seizures caused by epilepsy, but it instead stopped
his heart. (Catherine Modlin/Submitted by Jeanne Lenzer)
Listen to the full episode26:30
The medical world has caught a severe case of the tech bug.
Cutting-edge
medical devices are joining pacemakers, lenses and artificial hips and
knees implanted inside millions of patients, and for the most part,
they're improving the lives of patients.
But in her book The Danger Within Us: America's Untested, Unregulated Medical Device Industry and One Man's Battle to Survive It, Jeanne Lenzer details
disturbing stories of recalls, hacking, injuries and even deaths
related to medical devices that go largely untested and unregulated.
She told White Coat, Black Art host Dr.
Brian Goldman that to find the root of this unregulated market in the
U.S., one has to go back to 1976 when the Food and Drug Administration
(FDA) took control of the medical device industry.
"At that
point there were already a lot of devices on the market and in people's
bodies; everything from pacemakers to nerve stimulators and spine
implants. So what the FDA did was they said: 'OK, you guys are already
all on the market, we will grandfather you in,'" said Lenzer, who has
written for BMJ, (formerly the British Medical Journal) New York Times
Magazine, The New Republic and other outlets.
Author
and journalist Jeanne Lenzer's new book The Danger Within Us chronicles
the untested, unregulated medical device industry. (Submitted by Jeanne Lenzer)
"To
make matters worse, they told companies: 'Now if you want to add new
devices you can simply say that your device is similar or substantially
equivalent to a device that's already on the market.'"
This
approval method means many devices on the market have never been tested
on humans, and some have not been proven clinically safe or effective.
Moreover,
Lenzer said, it's extremely hard to discover (let alone track) how many
devices have been sold or implanted into patients.
"The FDA
doesn't require manufacturers to tell them how many people are even
implanted with their devices. It's a black hole," Lenzer said.
The
surgeon who took his hip out described what he saw as an "automotive
crank case full of dirty oil." The tissues had turned to black mush.- Jeanne Lenzer
For example, the DePuy metal-on-metal hip implant ended up poisoning some patients, leading to a recall and lawsuits against the maker.
The metal hips parts grated on one other, releasing chromium and cobalt, causing metallosis.Lenzer described the case of a U.S. surgeon who had to have his own metal-on-metal implant removed.
"The
surgeon who took his hip out described what he saw as an 'automotive
crank case full of dirty oil.' The tissues had turned to black mush,"
Lenzer said, adding that cobalt poisoning can also cause thyroid
disorder, heart failure and brain problems.
If the U.S had a
mandatory registry for devices the way Japan, Australian and other
countries do, patients who had devices implanted at U.S. hospitals might
have been saved from needing a heart transplant after the device
poisoned its host.
Jeanne Lenzer's new book details the unregulated medical device industry. (Submitted by Jeanne Lenzer)
Dr.
David Urbach, surgeon-in-chief at Toronto's Women's College Hospital,
says that Canada is also in need of better tracking of medical devices. In a study published last year, he and his colleagues poured over 10 years of medical device records filed with Health Canada.
"We
weren't able to find the rate of recalls mostly because we weren't able
to determine how many devices are out there," he said, echoing
the situation in the U.S.
Seizure-control device stopped patient's heart
The patient at the heart of Lenzer's book is a man named Dennis Fegan, a former firefighter from Texas.
Fegan had hard-to-treat epilepsy and a Vagus Nerve Stimulator (VNS) implanted in 2000 to help control his seizures.
But
by 2006, he was repeatedly collapsing and losing consciousness. In July
of that year he ended up in an ER after his parents found him passed
out in his home.
According to Lenzer, doctors discovered that the VNS wasn't stopping Fegan's seizures: it was stopping his heart.
"His heart was stopping so long, he was passing out and having seizures from a lack of oxygen to the brain." Lenzer said.
Doctors deactivated his VNS, but Fegan was never able to sue the manufacturer, Cyberonics, because a U.S Supreme Court ruling prevents patients from taking device-makers to court over FDA-approved devices.
The VNS had
only been conditionally approved by the FDA because of "a high rate of
deaths among the test subjects" — a fact that wasn't required to be told
to patients, said Lenzer.
Can
you imagine if patients were told, "Gee, we've got this new device, it
might maybe help you. But it also might kill you.... Would you like to
try it?" I mean this is sheer insanity.- Jeanne Lenzer
It was later approved for treating depression, even though studies showed it wasn't effective for the condition.
It was one of several devices approved against the advice of FDA scientists in what's come to be known as Device-gate,Lenzer said.
"The
FDA scientists unanimously rejected a number of devices, saying these
are unsafe, they shouldn't go on the market and they didn't want to
approve them. When suddenly a phone call was made by ... a congressman
to FDA managers, and FDA managers overruled their own
scientists," she said.
The medical device industry is currently
estimated at close to $200-billion a year in Canadian funds. Lenzer says
profits, and the industry's close relationship with the FDA, seem to
take priority over patient safety.
While Canada has not seen a scandal the liked of Device-gate, Urbach says there is a lot of room for improvement in our system.
Dr. David Urbach says he removes gastric bands every week at Women's College Hospital in Toronto. (Michael Wong/Women’s College Hospital)
As
in the U.S., many devices on the Canadian market have not been tested
in humans or have been assumed to be safe because they are modifications
of existing devices.
"I don't think we really know these
products for certain are safe and effective. There may be unknown risks
to all of these medical devices," he said — even though these risks are
likely to be "small."
Urbach says many doctors aren't aware that Health Canada relies on citizens to file reports about devices and adverse events.
He
says the manufacturers have a "huge incentive to innovate, create new
products and put them out on the market," and the public assumes that
the newest technology must be the best, even if that's not always the
case.
Giving patients a voice
So what's a patient to do?
Lenzer said patients are finding their voice in advocacy groups set up to hold companies to account.
Both Lenzer and Urbach advise patients to ask questions about any device, to check existing databases for additional information and to question the need for the device in the first place.
Urbach suggests
asking questions like, "Is this absolutely necessary? Are there other
alternatives? What's the consequence of not having this particular
device used?" are questions Urbach suggests.
Lenzer says part of the solution has to come from lawmakers.
"We
really need to make the kind of policy and political and health-care
changes that will make a difference for patients,' she said, adding that
she herself has an intra-ocular lens implant following removal of a
cataract.
"Part of my frustration that led me to write this book
is that it's disappointing to see devices that are useful tarred by the
fact that there are many devices that are causing harm. I want to
separate them out so we can all be more secure that ... we know more
about our devices before they're put in our bodies."
Skip Arthroscopy for Degenerative Knee Disease, Report Says
Marcia Frellick
May 12, 2017
Knee
arthroscopy is not cost-effective and is strongly discouraged for
patients with degenerative knee disease, say authors of a
meta-analysis-based practice guideline published May 10 in the BMJ.
The
authors include in the definition of degenerative knee disease patients
with knee pain, especially those more than 35 years old, with or
without X-rays showing osteoarthritis, meniscus tears, locking or
catching of the knee, and acute or subacute onset of symptoms.
However,
some experts disagree with the report's conclusions. David C. Johnson,
MD, an orthopedic surgeon with MedStar Orthopaedic Institute at MedStar
Washington Hospital Center in Washington, DC, who says he has completed
about 5000 of the surgeries since 1978, said the report will not change
his practice.
The report was prompted most recently by a randomized controlled trial published in the BMJ
in June 2016, which concluded that, among patients with a degenerative
medial meniscus tear, knee arthroscopy was not more beneficial than
physical therapy.
The current report is based on two systematic reviews: one
on the benefit of knee arthroscopy compared with nonsurgical care,
which included data from 13 randomized trials for benefit outcomes (1668
patients) and 12 more observational studies for complications (more
than 1.8 million patients.)
A second team did a systematic review to address what level of change on a given scale is important to individual patients.
"[F]urther research is unlikely to alter this recommendation," they write.
Lead
author Reed A. C. Siemieniuk, MD, from the Department of Health
Research Methods,
Evidence, and Impact at McMaster University in
Hamilton, Ontario, Canada, told Medscape Medical News the
recommendation is strong enough that insurers should consider
withholding payment for the surgeries, and that there should be
financial incentives for not performing them, as they cost $3 billion a
year in the United States alone.
He said the procedure is
ingrained in medical school education and is commonly done for many
reasons, "and financial incentives are certainly one of them."
The
report notes that knee arthroscopy is performed more than 2 million
times a year worldwide. And most guidelines continue to support
arthroscopy for groups including those with torn meniscus, sudden onset
of pain or swelling, or mild to moderate difficulties with knee
movement.
The problem, Dr Siemieniuk says, is that most people affected would fit into those 3 categories.
"We
think the burden of proof rests squarely on the shoulders of people who
would suggest that this does help anybody in the long term," Dr
Siemieniuk said.
Among reasons the report is trustworthy, he says, are that
authors did not have financial conflicts of interest, the literature
was rigorously studied, and patients were consulted, including those who
did and did not have the surgery.
"Really,
there's almost no long-term benefit at all and there are risks with
[the surgery]. We weren't able to find any evidence to support its use,"
he said.
Surgeons Evaluate Cases Individually
Although
Dr Johnson encourages his colleagues to read the report and take it to
heart, he says he does not agree with the conclusions.
"Doctors
in the trenches," he said, know that risks and kinds of tears must be
stratified, and some people will not do well with arthroscopy, but
others will, and those decisions must be made individually.
He offered an example: "If you have a knee that doesn't have any
arthritis, X-rays are normal, and there is a clear vertical tear which
is an acute tear or a complex tear...those people will do better."
Good
candidates are also those with a complex tear, with vertical and
horizontal tears, and when the meniscus has been degenerating for a
period of time and now with a twisting injury a fragment has broken off
and that fragment is giving the patient difficulty when they did not
have difficulty before.
"Those
people will do well in the vast majority cases," he said. "And it may
last 3 years. But 3 years is a long time for somebody who's having knee
pain. They get a reprieve."
He
points out the report targets people older than 35 years and adds,
"people over 35 are still very active, and in my book are young, and it
would be bad to withhold a treatment that would benefit them even if the
chance of benefit is 75% or 65%. Most patients would choose that."
Physicians need to examine each patient to see what is causing the problem, Dr Johnson explains.
"You
stratify your decision base to consider each and every one separately,
and not bunch them all together and make a blanket statement that I'll
never operate on anybody who has any kind of arthritis," he said.
The authors also point out risks associated with the surgery; Dr Johnson says those are "overblown."
"In 5000 cases, I have had zero infections. I've never had to go back into a knee to wash out an infection."
He said he has had five deep-vein thrombosis (DVT) cases that needed treatment, all of whom came in with clotting disorders.
"If
you count five DVTs, that's about the rate of DVTs in the general
population even without surgery, so when I hear that you shouldn't do
something because of risk of infection or DVTs, I find that overblown,
at least in my population."
He
points out, and the report confirms, that the American Academy of
Orthopaedic Surgeons is against doing arthroscopy for patients with
osteoarthritis, "but if you have a degenerative knee with meniscus tear,
they're going to support doing arthroscopy. They're going to support
doing arthroscopy for patients who have mechanical symptoms, and they're
going to support patients with evidence of osteoarthritis with a
meniscal tear that is symptomatic, and they'll support patients without
evidence of osteoarthritis who had a meniscal tear that was symptomatic.
"All of these were denied by the BMJ."
The authors have disclosed no relevant financial relationships. BMJ. 2017;357:j1982. Full text For more news, join us on Facebook and Twitter
Surgery won’t help degenerative knee problems, experts say
By
Marilynn Larkin Reuters
Dr. Ben Shaffer leads a team as they perform arthroscopic
surgery on a knee at Sibley Memorial Hospital on March 3, 2010, in
Washington, DC.
(Photo by Jahi Chikwendiu/The Washington Post via Getty Images)
AA
Surgery won’t cure chronic knee pain, “locking,” “clicking,” a
torn meniscus, or other problems related to knee arthritis, according to
a panel of international experts.
Every year, more than two
million people with degenerative knee problems have arthroscopic
surgery, in which a surgeon inserts a tiny camera into the knee and uses
small instruments to try to fix what’s wrong.
But guidelines published Wednesday in the British Medical Journal recommend against the procedure for just about everyone with knee arthritis. READ MORE: Long wait times for surgery? Depends on where you live
“It does more harm than good,” Dr. Reed Siemieniuk, chair of the guideline panel, told Reuters Health by email.
“Most
patients experience improvement after arthroscopy, but in many cases,
this is probably wrongly attributed to the surgery itself rather than to
the natural course of the disease, a placebo effect, or (other)
interventions like painkillers and exercise.”
In
addition, the procedure is costly – up to $3 billion annually in the
U.S. alone – and there’s a risk of rare but serious adverse effects such
as blood clots or infection, said Siemieniuk, who works in the
department of Health Research Methods, Evidence and Impact at McMaster
University in Hamilton, Ontario, Canada.
The
panel, made up of surgeons, physical therapists, clinicians and
patients, analyzed data from 13 randomized controlled trials – the gold
standard way to test medical procedures – involving a total of 1,668
patients. The trials compared knee arthroscopy to conservative
treatments such as exercise and painkillers.
The panelists also
reviewed 12 less-rigorous studies of close to two million patients that
looked at complications from the procedure.
After considering the
balance of benefits, harms and burdens of knee arthroscopy, as well as
the quality of the evidence for each outcome, the panel made a “strong
recommendation against arthroscopy.”
WATCH: In what ways could Canada’s heathcare system improve?
The evidence shows a less than 15 per cent probability of “small or
very small improvement in short-term pain and function” from the
procedure, and improvements would likely last less than a year, the
panelists noted.
They thought it was more important to avoid
postoperative limitations such as pain, swelling and restricted
activity, and the risk of adverse effects.
“Chronic knee pain can
be incredibly frustrating to live with – both for the person
experiencing the pain and for their doctors,” Siemieniuk said.
“The
problem is that none of the current options cure the pain. Most people
will continue to live with some pain even with weight loss, physical
therapy, and painkillers. Knee replacement surgery also has important
limitations and should be delayed as long as possible. So it’s no
surprise that many placed their hopes in arthroscopic knee surgery.”
Still, he said, “We believe that no one or almost no one would want this surgery if they understand the evidence.”
If
you have chronic knee pain, “double down on efforts for things we know
work – for example, weight loss and physical therapy,” he advised.
“Also,
talk to your healthcare provider (doctor, physical therapist) about
strategies to reduce the physical stress on the knee that exacerbates
the pain,” he added.
Dr. Joseph Bosco, vice-chair at NYU Langone
Orthopedics in New York City, told Reuters Health, “In general I agree
with the findings and support most of the conclusions.”
“The only
issue is that in the study with the strongest evidence, the operative
group did not do physical therapy,” he said by email. “That is not
consistent with how we treat our patients. Almost all patients get
physical therapy following knee arthroscopies.”
“Cortisone
injections, physical therapy and anti-inflammatory medications work as
well or better than surgery for most degenerative meniscal tears,” said
Bosco, who was not involved in developing the guidelines.
However,
he added, a small group of people “who (also) have mechanical symptoms,
localized pain, and acute onset of pain will benefit, so a blanket
recommendation against all surgery for degenerative meniscal tears is
not appropriate.”
Sickening, gruelling or frightful: how doctors measure pain
Suffering is difficult to describe and impossible to see. So how can doctors tell how much it hurts?
by John Walsh
One
night in May, my wife sat up in bed and said, “I’ve got this awful pain
just here.” She prodded her abdomen and made a face. “It feels like
something’s really wrong.” Woozily noting that it was 2am, I asked what
kind of pain it was. “Like something’s biting into me and won’t stop,”
she said.
“Hold on,” I said blearily, “help is at hand.” I brought her
a couple of ibuprofen with some water, which she downed, clutching my
hand and waiting for the ache to subside.
An hour later, she was sitting up in bed again, in
real distress. “It’s worse now,” she said, “really nasty. Can you phone
the doctor?” Miraculously, the family doctor answered the phone at 3am,
listened to her recital of symptoms and concluded, “It might be your
appendix. Have you had yours taken out?” No, she hadn’t. “It could be
appendicitis,” he surmised, “but if it was dangerous you’d be in much
worse pain than you’re in. Go to the hospital in the morning, but for
now, take some paracetamol and try to sleep.”
Barely half an hour later, the balloon went up. She was
awakened for the third time, but now with a pain so savage and
uncontainable it made her howl. The time for murmured assurances and
spousal procrastination was over. I rang a local minicab, struggled into
my clothes, bundled her into a dressing gown, and we sped to St Mary’s
Paddington at just before 4am.
The flurry of action made the pain subside, if only through
distraction, and we sat for hours while doctors brought forms to be
filled, took her blood pressure and ran tests. A registrar poked a
needle into my wife’s wrist and said, “Does that hurt? Does that? How
about that?” before concluding: “Impressive. You have a very high pain
threshold.”
The pain was from pancreatitis, brought on by rogue
gallstones that had escaped from her gall bladder and made their way,
like fleeing convicts, to a refuge in her pancreas, causing agony. She
was given a course of antibiotics and, a month later, had an operation
to remove her gall bladder.
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“It’s
keyhole surgery,” said the surgeon breezily, “so you’ll be back to
normal very soon. Some people feel well enough to take the bus home
after the operation.” His optimism was misplaced. My wife came home the
following day filled with painkillers. When they wore off, she writhed
with suffering. After three days she rang the specialist, only to be
told: “It’s not the operation that’s causing discomfort – it’s the air
that was pumped inside you to separate the organs before surgery.” Once
the operation had proved a success, the surgeons had apparently lost
interest in the fallout.
During that period of convalescence, as I watched her
grimace and clench her teeth and let slip little cries of anguish until a
long regimen of combined ibuprofen and codeine finally conquered the
pain, several questions came into my head. Chief among them was: “Can
anyone in the medical profession talk about pain with any authority?”
From the family doctor to the surgeon, their remarks and suggestions
seemed tentative, generalised, unknowing – and potentially dangerous:
Was it right for the doctor to tell my wife that her level of pain
didn’t sound like appendicitis when the doctor didn’t know whether she
had a high or low pain threshold?
Should he have advised her to stay in bed and risk her appendix
exploding into peritonitis? How could surgeons predict that patients
would feel only “discomfort” after such an operation when she felt agony
– an agony that was aggravated by fear that the operation had been a
failure?
I also wondered if there were any agreed words that would
help a doctor understand the pain felt by a patient. I thought of my
father, a GP in the 1960s with an NHS practice in south London, who used
to marvel at the colourful pain symptoms he heard: “It’s like I’ve been
attacked with a stapler”; “Like having rabbits running up and down my
spine”; “It’s like someone’s opened a cocktail umbrella in my penis …”
Few of them, he told me, corresponded to the symptoms listed in a
medical textbook. So how should he proceed? By guesswork and aspirin?
There seemed to be a chasm of understanding in human
discussions of pain. I wanted to find out how the medical profession
apprehends pain – the language it uses for something that’s invisible to
the naked eye, that can’t be measured except by asking for the
sufferer’s subjective description, and that can be treated only by the
use of opium derivatives that go back to the middle ages. When investigating pain, the basic
procedure for clinics everywhere is to give a patient the McGill pain
questionnaire. Developed in the 1970s by two scientists, Dr Ronald
Melzack and Dr Warren Torgerson, both of McGill University in Montreal,
it is still the main tool for measuring pain in clinics worldwide.
Melzack and his colleague Dr Patrick Wall of St Thomas’ Hospital in London had already galvanised the field of pain research in 1965 with their seminal “gate control theory”,
a ground-breaking explanation of how psychology can affect the body’s
perception of pain. In 1984, the pair went on to write Wall and
Melzack’s Textbook of Pain, the most comprehensive reference work in
pain medicine. It has gone through five editions and is currently more
than 1,000 pages long.
In the early 1970s, Melzack began to list the words patients
used to describe their pain and classified them into three categories:
sensory (which included heat, pressure, “throbbing” or “pounding”
sensations), affective (which related to emotional effects, such as
“tiring”, “sickening”, “gruelling” or “frightful”) and lastly evaluative
(evocative of an experience – from “annoying” and “troublesome” to
“horrible”, “unbearable” and “excruciating”).
You don’t have to be a linguistic genius to see there are
shortcomings in this range of terms. For one thing, some words in the
affective and evaluative categories seem interchangeable – there’s no
difference between “frightful” in the former and “horrible” in the
latter, or between “tiring” and “annoying” – and all the words share an
unfortunate quality of sounding like a duchess complaining about a ball
that didn’t meet her standards.
But Melzack’s grid of suffering formed the basis of what became the McGill pain questionnaire.
The patient listens as a list of “pain descriptors” is read out and has
to say whether each word describes their pain – and, if so, to rate the
intensity of the feeling. The clinicians then look at the questionnaire
and put check marks in the appropriate places. This gives the clinician
a number, or a percentage figure, to work with in assessing, later,
whether a treatment has brought the patient’s pain down (or up).
A more recent variant is the National Initiative on Pain
Control’s pain quality assessment scale (PQAS), in which patients are
asked to indicate, on a scale of 1 to 10, how “intense” – or “sharp”,
“hot”, “dull”, “cold”, “sensitive”, “tender”, “itchy”, etc – their pain
has been over the past week.
The trouble with this approach is the imprecision of that
scale of 1 to 10, where a 10 would be “the most intense pain sensation
imaginable”. How does a patient “imagine” the worst pain ever and give
their own pain a number? Some men may find it hard to imagine anything
more agonising than toothache or a tennis injury. Women who have
experienced childbirth may, after that experience, rate everything else
as a 3 or 4.
I asked some friends what they thought the worst physical
pain might be. Inevitably, they just described nasty things that had
happened to them. One man nominated gout. He recalled lying on a sofa,
with his gouty foot resting on a pillow, when a visiting aunt passed by;
the chiffon scarf she was wearing slipped from her neck and lightly
touched his foot. It was “unbearable agony”.
A brother-in-law nominated post-root-canal toothache –
unlike muscular or back pain, he said, it couldn’t be alleviated by
shifting your posture. It was “relentless”. A male friend confided that a
haemorrhoidectomy had left him with irritable bowel syndrome, in which a
daily spasm made him feel “as if somebody had shoved a stirrup pump up
my arse and was pumping furiously”. The pain was, he said, “boundless,
as if it wouldn’t stop until I exploded”. A woman friend recalled the
moment the hem of her husband’s trouser leg snagged on her big toe,
ripping the nail clean off. She used a musical analogy to explain the
effect: “I’d been through childbirth, I’d broken my leg – and I recalled
them both as low moaning noises, like cellos; the ripped-off nail was
excruciating, a great, high, deafening shriek of psychopathic violins,
like nothing I’d heard – or felt – before.”
It seems a shame that these eloquent descriptions are
reduced by the McGill questionnaire to words like “throbbing” or
“sharp”, but its function is simply to give pain a number – a number
that will, with luck, be decreased after treatment, when the patient is
reassessed.
This procedure doesn’t impress Professor Stephen McMahon of
the London Pain Consortium, an organisation formed in 2002 to promote
internationally competitive research into pain. “There are lots of
problems that come with trying to measure pain,” he says. “I think the
obsession with numbers is an oversimplification. Pain is not
unidimensional. It doesn’t just come with scale – a lot or a little – it
comes with other baggage: how threatening it is, how emotionally
disturbing, how it affects your ability to concentrate. The measuring
obsession probably comes from the regulators who think that, to
understand drugs, you have to show efficacy. And the American Food and
Drug Administration don’t like quality-of-life assessments; they like
hard numbers. So we’re thrown back on giving it a number and scoring it.
It’s a bit of a wasted exercise because it’s only one dimension of pain
that we’re capturing.”
Illustration: Matthew Richardson
Pain can be either acute or chronic, and
the words do not (as some people think) mean “bad” and “very bad”.
“Acute” pain means a temporary or one-off feeling of discomfort, which
is usually treated with drugs; “chronic” pain persists over time and has
to be lived with as a malevolent everyday companion. But because
patients build up a resistance to drugs, other forms of treatment must
be found for it.
The Pain Management and Neuromodulation Centre at Guy’s and
St Thomas’ Hospital in central London is the biggest pain centre in
Europe. Heading the team there is Dr Adnan Al-Kaisy, who studied
medicine at the University of Basrah, Iraq, and later worked in
anaesthetics at specialist centres in England, the US and Canada.
“I’d say that 55 to 60% of our patients suffer from lower
back pain,” he says. “The reason is, simply, that we don’t pay attention
to the demands life makes on us, the way we sit, stand, walk and so on.
We sit for hours in front of a computer, with the body putting heavy
pressure on small joints in the back.” Al-Kaisy reckons that in the UK
the incidence of chronic lower back pain has increased substantially in
the last 15 to 20 years, and that “the cost in lost working days is
about £6 to 7 billion”.
Elsewhere the clinic treats those suffering from severe
chronic headaches and injuries from accidents that affect the nervous
system.
Do they still use the McGill questionnaire? “Unfortunately
yes,” says Al-Kaisy. “It’s a subjective measurement. But pain can be
magnified by a domestic argument or trouble at work, so we try to find
out about the patient’s life – their sleeping patterns, their ability to
walk and stand, their appetite. It’s not just the patient’s condition,
it’s also their environment.”
The challenge is to transform this information into
scientific data. “We’re working with Professor Raymond Lee, chair of
Biomechanics at London South Bank University, to see if there can be
objective measurement of a patient’s disability due to pain,” he says.
“They’re trying to develop a tool, rather like an accelerometer, which
will give an accurate impression of how active or disabled they are, and
tell us the cause of their pain from the way they sit or stand. We’re
really keen to get away from just asking the patient how bad their pain
is.”
Some patients arrive with pains that are far worse than
backache and require special treatment. Al-Kaisy describes one patient –
let us call him Carter – who suffered from a terrible condition called ilioinguinal neuralgia,
a disorder that produces a severe burning and stabbing pain in the
groin. “He’d had an operation in the testicular area, and the inguinal
nerve had been cut. The pain was excruciating: when he came to us, he
was on four or five different medications, opiates with very high
dosages, anticonvulsive medication, opioid patches, paracetamol and
ibuprofen on top of that. His life was turned upside down, his job was
on the line.” The utterly stricken Carter was to become one of
Al-Kaisy’s big successes.
Since 2010, Guy’s and St Thomas’ has offered a residential
programme for adults whose chronic pain hasn’t responded to treatment at
other clinics. The patients come in for four weeks, away from their
normal environment, and are seen by a motley crew of psychologists,
physiotherapists, occupational health specialists and nursing physicians
who between them devise a programme to teach them strategies for
managing their pain.
Many of these strategies come under the heading of
“neuromodulation”, a term you hear a lot in pain management circles. In
simple terms, it means distracting the brain from constantly brooding on
the pain signals it is getting from the body’s periphery. Sometimes the
distraction is a cunningly deployed electric shock.
“We were the first centre in the world to pioneer spinal
cord stimulation,” says Al-Kaisy. “In pain occasions, overactive nerves
send impulses from the periphery to the spinal cord and from there to
the brain, which starts to register pain. We try to send small bolts of
electricity to the spinal cord by inserting a wire in the epidural area.
It’s only one or two volts, so the patient feels just a tingling
sensation over where the pain is, instead of feeling the actual pain.
After two weeks, we give the patient an internal power battery with a
remote control, so he can switch it on whenever he feels pain and carry
on with his life. It’s essentially a pacemaker that suppresses the
hyperexcitability of nerves by delivering subthreshold stimulation. The
patient feels nothing except his pain going down. It’s not invasive – we
usually send patients home the same day.”
When Carter, suffering from agonising pain in the groin, had
failed to respond to any other treatments, Al-Kaisy tried his new
combination of therapies. “We gave him something called a dorsal root
ganglion stimulation. It’s like a small junction-box, placed just
underneath one of the bones of the spine. It makes the spine
hyperexcited, and sends impulses to the spinal cord and the brain. I
pioneered a new technique to put a small wire into the ganglion,
connected to an external power battery. Over 10 days the intensity of
pain went down by 70% – by the patient’s own assessment. He wrote me a
very nice email saying I had changed his life, that the pain had just
stopped completely, and that he was coming back to normality. He said
his job was saved, as was his marriage, and he wanted to go back to
playing sport. I told him, ‘Take it easy. You mustn’t start climbing the
Himalayas just yet.’” Al-Kaisy beams. “This is a remarkable outcome.
You cannot get it from any other therapies.” The greatest recent breakthrough in
assessing pain, according to Professor Irene Tracey, head of the
University of Oxford’s Nuffield Department of Clinical Neurosciences,
has been the understanding that chronic pain is a thing in its own
right. She explains: “We always thought of it as acute pain that just
goes on and on – and if chronic pain is just a continuation of acute
pain, let’s fix the thing that caused the acute and the chronic should
go away. That has spectacularly failed. Now we think of chronic pain as a
shift to another place, with different mechanisms, such as changes in
genetic expression, chemical release, neurophysiology and wiring. We’ve
got all these completely new ways of thinking about chronic pain. That’s
the paradigm shift in the pain field.”
Tracey has been called the “Queen of Pain” by some media
commentators. She was, until recently, the Nuffield Professor of
anaesthetic science and is an expert in neuroimaging techniques that
explore the brain’s responses to pain. Despite her nickname, in person
she is far from alarming: a bright-eyed, enthusiastic, welcoming and
hectically fluent woman of 50, she talks about pain at a personal level.
She has no problem defining the “ultimate pain” that scores 10 on the
McGill questionnaire: “I’ve been through childbirth three times, and my
10 is a very different 10 from before I had kids. I’ve got a whole new
calibration on that scale.” But how does she explain the ultimate pain
to people who haven’t experienced childbirth? “I say, ‘Imagine you’ve
slammed your hand in a car door – that’s 10.’”
She uses a personal example to explain the way perception
and circumstance can alter the way we experience pain, as well as the
phenomenon of “hedonic flipping”, which can convert pain from an
unpleasant sensation into something you don’t mind. “I did the London
Marathon this year. It needs a lot of training and running and your
muscles ache, and next day you’re really in pain, but it’s a nice pain.
I’m no masochist, but I associate the muscle pain with thoughts like, ‘I
did something healthy with my body,’ ‘I’m training,’ and ‘It’s all
going well.’”
I ask her why there seems to be a gap between doctors’ and
patients’ apprehension of pain. “It’s very hard to understand, because
the system goes wrong from the point of injury, along the nerve that’s
taken the signal into the spinal cord, which sends signals to the brain,
which sends signals back, and it all unravels with terrible
consequential changes. So my patient may be saying, ‘I’ve got this
excruciating pain here,’ and I’m trying to see where it’s coming from,
and there’s a mismatch here because you can’t see any damage or any
oozing blood. So we say, ‘Oh come now, you’re obviously exaggerating, it
can’t be as bad as that.’ That’s wrong – it’s a cultural bias we grew
up with, without realising.”
Recently, she says, there has been a breakthrough in
understanding about how the brain is involved in pain. Neuroimaging, she
explains, helps to connect the subjective pain with the objective
perception of it. “It fills that space between what you can see and
what’s being reported. We can plug that gap and explain why the patient
is in pain even though you can’t see it on your x-ray or whatever.
You’re helping to bring truth and validity to these poor people who are
in pain but not believed.”
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But
you can’t simply “see” pain glowing and throbbing on the screen in
front of you. “Brain imaging has taught us about the networks of the
brain and how they work,” she says. “It’s not a pain-measuring device.
It’s a tool that gives you fantastic insight into the anatomy, the
physiology and the neurochemistry of your body and can tell us why you
have pain, and where we should go in and try to fix it.”
Some of the ways in, she says, are remarkably direct and
mechanical – like Al-Kaisy’s spinal cord stimulation wire. “There are
now devices you can attach to your head and allow you to manipulate bits
of the brain. You can wear them like bathing caps. They’re portable,
ethically allowed brain-stimulation devices. They’re easy for patients
to use and evidence is coming, in clinical trials, that they are good
for strokes and rehabilitation. There’s a parallel with the games
industry, where they’re making devices you can put on your head so kids
can use thought to move balls around. The games industry is, for fun,
driving this idea that when you use your brain, you generate electrical
activities. They’re developing the technology really fast, and we can
use it in medical applications.”
Illustration: Matthew Richardson
Pain has become a huge area of medical
research in the US, for a simple reason. Chronic pain affects over 100
million Americans and costs the country more than half a trillion
dollars a year in lost working hours, which is why it has become a
magnet for funding by big business and government.
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Researchers
at the Human Pain Research Laboratory at Stanford University,
California, are working to gain a better understanding of individual
responses to pain so that treatments can be more targeted. The
laboratory has several study initiatives on the go – into migraine,
fibromyalgia, facial pain and other conditions – but its largest is into
back pain. It has been endowed with a $10m grant from the National
Institutes of Health
to study non-drug alternative treatments for lower back pain. The
specific treatments are mindfulness, acupuncture, cognitive behavioural
therapy and real-time neural feedback.
They plan to inspect the pain tolerance of 400 people over
five years of study, ranging from pain-free volunteers to the most
wretched chronic sufferers who have been to other specialists but found
no relief. The idea is to find people’s mid-range tolerance (they’re
asked to rate their pain while they are experiencing it), to establish a
usable baseline. They then are given the non-invasive treatments – such
as mindfulness and acupuncture – and are subjected afterwards to the
same pain stimuli, to see how their pain tolerance has changed from
their baseline reading. MRI scanning is used on the patients in both
laboratory sessions, so that clinicians can see and draw inferences from
the visible differences in blood flow to different parts of the brain.
A remarkable feature of the assessment process is that
patients are also given scores for psychological states: a scale
measures their level of depression, anxiety, anger, physical
functioning, pain behaviour and how much pain interferes with their
lives. This should allow physicians to use the information to target
specific treatments. All these findings are stored in an “informatics
platform” called Choir, which stands for the Collaborative Health
Outcomes Information Registry. It has files on 15,000 patients, 54,000
unique clinic visits and 40,000 follow-up meetings.
The big chief at the Human Pain Research Laboratory is Dr
Sean Mackey, Redlich professor of anaesthesiology, perioperative and
pain medicine, neurosciences and neurology at Stanford. His background
is in bioengineering, and under his governance the Stanford Pain Management Center
has twice been designated a centre of excellence by the American Pain
Society. A tall, genial, easy-going man, he is sometimes approached by
legal firms who want him to appear in court to state definitively
whether their client is or is not in chronic pain (and therefore
justified in claiming absentee benefit). His response is surprising.
“In 2008, I was asked by a law firm to speak in an
industrial injury case in Arizona. This poor guy got hot burning asphalt
sprayed on his arm at work; he had a claim of burning neuropathic pain.
The plaintiff’s side brought in a cognitive scientist, who scanned his
brain and said there was conclusive evidence that he had chronic pain.
The defence asked me to comment, and I said, ‘That’s hogwash, we cannot
use this technology for that purpose.’
“Shortly afterwards, I gave a talk on pain, neuroimaging and
the law, explaining why you can’t do this – because there’s too much
individual variability in pain, and the technology isn’t sensor-specific
enough. But I concluded by saying, ‘If you were to do this, you’d use
modern machine-learning approaches, like those used for satellite
reconnaissance to determine whether a satellite is seeing a tank or a
civilian truck.’ Some of my students said, ‘Can you give us some money
to try this?’ I said, ‘Yes, but it can’t be done.’ But they designed the
experiment – and discovered that, using brain imagery, they could
predict with 80% accuracy whether someone was feeling heat pain or not.”
Mackey finally published a paper about the experiment. So
did his findings influence any court decisions? “No. I get asked by
attorneys, and I always say, ‘There is no place for this in the
courtroom in 2016 and there won’t be in 2020. People want to push us
into saying this is an objective biomarker for detecting that someone’s
in pain. But the research is in carefully controlled laboratory
conditions. You cannot generalise about the population as a whole. I
told the attorneys, ‘This is too much of a leap.’ I don’t think there’s a
lot of clinical utility in having a pain-o-meter in a court or in most
clinical situations.”
Mackey explains the latest thinking about what pain actually
is. “Now we understand that pain is a balance between ascending
information coming from our bodies and descending inhibitory systems
from our brains. We call the ascending information “nociception” – from
the Latin nocere, to harm or hurt – meaning the response of the
sensory nervous system to potentially harmful stimuli coming from our
periphery, sending signals to the spinal cord and hitting the brain with
the perception of pain. The descending systems are inhibitory, or
filtering, neurons, which exist to filter out information that’s not
important, to “turn down” the ascending signals of hurt. The main
purpose of pain is to be the great motivator, to tell you to pay
attention, to focus. When the pain lab was started, we had no way of
addressing these two dynamic systems, and now we can.”
Mackey is immensely proud of his massive CHOIR database –
which records people’s pain tolerance levels and how they are affected
by treatment – and has made it freely available to other pain clinics as
a “community source platform”, collaborating with academic medical
centres nationwide “so that a rising tide elevates all boats”. But he is
also humble enough to admit that science cannot tell us which are the
sites of the body’s worst pains.
“Back pain is the most reported pain at 28%, but I know
there’s a higher density of nerve fibres in the hands, face, genitals
and feet than in other areas,” Mackey says, “and there are conditions
where the sufferer has committed suicide to get away from the pain.
Things like post-herpetic neuralgia, that burning nerve pain that occurs
after an outbreak of shingles and is horrific; another is cluster
headaches – some patients have thought about taking a drill to their
heads to make it stop.”
Like Irene Tracey, Mackey is enthusiastic about the rise of
transcranial magnetic stimulation (“Imagine hooking a nine-volt battery
across your scalp”) but, when asked about his particular successes, he
talks about simple solutions. “Early on in my career, I used to be very
focused on the peripheral, the apparent site of the pain. I was doing
interventions, and some people would get better but a lot wouldn’t. So I
started listening to their fears and anxieties and working on those,
and became very brain-focused. I noticed that if you have a nerve
trapped in your knee, your whole leg could be on fire, but if you apply a
local anaesthetic there, it could abolish it.
“This young woman came to me with a terrible burning
sensation in her hand. It was always swollen; she couldn’t stand anyone
touching it because it felt like a blowtorch.” Mackey noticed that she
had a post-operative scar from prior surgery for carpal-tunnel syndrome.
Speculating that this was at the root of her problem, he injected
botulinum toxin, a muscle relaxant, at the site of the scar. “A week
later, she came up and gave me this huge hug and said, ‘I was able to
pick up my child for the first time in two years. I haven’t been able to
since she was born.’ All the swelling was gone. It taught me that it’s
not all about the body part, and not all about the brain. It’s about
both.” Main illustration by Matthew Richardson This is an edited version of an article that appears on Mosaic. It is republished here under a Creative Commons licence. • Follow the Long Read on Twitter at @gdnlongread, or sign up to the long read weekly email here.
http://www.ted.com
Our medical systems are broken. Doctors are capable of extraordinary
(and expensive) treatments, but they are losing their core focus:
actually treating people. Doctor and writer Atul Gawande suggests we
take a step back and look at new ways to do medicine -- with fewer
cowboys and more pit crews.
An analysis of old studies suggests LSD may have a role to play in treating alcoholism.
The
powerful hallucinogen LSD (lysergic acid diethylamide) has potential as
a treatment for alcoholism, according to a retrospective analysis of
studies published in the late 1960s and early 1970s.
The study1,
by neuroscientist Teri Krebs and clinical psychologist Pål-Ørjan
Johansen of the Norwegian University of Science and Technology in
Trondheim, is the first-ever quantitative meta-analysis of
LSD–alcoholism clinical trials. The researchers sifted through thousands
of records to collect data from randomized, double-blind trials that
compared one dose of LSD to a placebo.
Of 536 participants in six
trials, 59% of people receiving LSD reported lower levels of alcohol
misuse, compared to 38% of people who received a placebo. “We were
surprised that the effect was so clear and consistent,” says Krebs. She
says that the problem with most studies done at that time was that there
were too few participants, which limited statistical power. “But when
you combine the data in a meta-analysis, we have more than 500 patients
and there is definitely an effect,” she says. In general, the reported
benefits lasted three to six months. Their findings are published today
in the Journal of Psychopharmacology.
Psychedelics were promoted
by psychiatrists in the 1950s as having a range of medical uses — to
treat conditions such as schizophrenia, for example — before political
pressures in the United States and elsewhere largely ended the work.
“Alcoholism was considered one of the most promising clinical
applications for LSD,” says Johansen. Alcoholics Anonymous co-founder
Bill Wilson is said to have espoused the benefits of LSD in the book
Pass It On: The Story of Bill Wilson and How the AA Message Reached the
World.
In the last decade or so, however, a new generation of
researchers have been interested in harnessing the therapeutic benefits
of illicit drugs — such as 3,4-methylenedioxymethamphetamine (MDMA or
ecstasy) for post-traumatic stress disorder, ayahuasca for drug and
alcohol dependency, and psilocybin, the active ingredient in
hallucinogenic mushrooms, for smoking cessation.
The snow globe of perception?
How
psychedelics exert such effects, especially after a single dose,
remains unclear. LSD and its chemical cousins share structural
similarities with the neurotransmitter serotonin, which is linked to
many aspects of mood, memory and pleasure. These psychedelics also bind
the same receptor sites in the brain as serotonin, but there the
similarity may end — studies have shown that the hallucinogens elicit
chemical cascades different from other compounds that bind at the same
receptor2. To complicate matters further, LSD also acts at other receptors3.
For
the moment, studying human behavioural responses rather than brain
chemistry may be more helpful in understanding how the drugs work. Robin
Carhart-Harris, a psychopharmacologist at Imperial College London who
has researched how psilocybin could treat depression, says that
psychedelics must work at both biological and psychological levels.
“Psychedelics probably work in addiction by making the brain function
more chaotically for a period — a bit like shaking up a snow globe —
weakening reinforced brain connections and dynamics,” he says.
Roland
Griffiths, a behavioural biologist at the Johns Hopkins University
School of Medicine in Baltimore, Maryland, is investigating the
influence of psilocybin on smoking cessation, and says that psychedelics
sometimes give rise to distinctive, insightful experiences that can
produce enduring positive changes in attitude, mood and behaviour.
“This
is impressive and important work,” says Matthew Johnson, a psychiatrist
also at Johns Hopkins University who is now running a small trial
looking at the effectiveness of psilocybin to treat nicotine addiction.
“Although this meta-analysis does not replace the need to test the
approach in new, well-designed and rigorous clinical trials, it puts
some more muscle behind the interpretation that the older literature
shows hints that psychedelic therapy might really help addiction.”
However,
Ken Checinski, a consultant addiction psychiatrist and independent
researcher based in London, says that although the results are exciting,
no pharmacological treatment should be seen as a magic bullet and that
modern therapeutic techniques have improved. “The included LSD trials
pre-date the use of psychological techniques such as motivational
interviewing and cognitive behaviour therapy,” he says.
