An open letter from the
Chairman of TMTA
Open
letter to
Marguerite Pridgen, Office of Federal Financial Management, Office
of Management and Budget,
Room 6025, New Executive Office Building, Washington, D.C. 20503
Re:
Buy American requirements of the ARRA
As is the case with other industrial sectors, the
medical technology industries of the United States and Canada
benefit greatly from being part of the world’s largest trading
relationship. The integrated nature of the economies of both of our
countries is vital to all of us. This is even more so in the case of
our industry. Not only do the jobs of millions of Americans and
Canadians depend on this reality, so do the health and wellbeing of
hundreds of thousands of our respective citizens.
For these reasons, TMTA member companies and their US
suppliers and customers have grown alarmed at the confusion and
uncertainty surrounding implementation of the ARRA. Again, as is the
case with other industries, the situation in the medical technology
industry is resulting in unwarranted delays in project start-ups,
cancellation of contracts and new orders, delayed shipments, and
consequently the serious erosion of long-standing cross-border
supply relationships. Business transactions are also being severed
for projects outside ARRA coverage because of the uncertainties
arising out of the upcoming legislation.
Our industry is specifically concerned about the following points:
Use of the insufficiently defined term “manufactured”
is already resulting in differing and/or conflicting interpretations
from various procurement agencies and/or US contractors.
Also of great concern to our industry is the
legislation’s use of the term “substantial transformation”. Such a
term can indeed only lead to confusion since many medical technology
products are the result of cooperation between companies which ship
components to each other several times across our respective borders
before a “finished” product is completed.
As your letter points out, ours is truly a
continental economy. Not only have our two countries enjoyed open
and transparent access to each other’s procurement markets for many
years, our respective industries they have literally grown
around this reality. To rip that out now would not only endanger
the survival of our respective industrial sectors, it may even set
medical technology back several years as doctors, hospitals and
medical suppliers are forced to scramble to find new alternatives
for long-established therapies and healing processes.
We, at TMTA, think that the Buy
American provisions contained in the ARRA may have many
unintended consequences, consequences that most companies can ill
afford in these trying economic times. We are especially concerned
that a retaliatory backlash in Canada and other countries could
inflict serious harm to American and Canadian manufacturers alike.
As you point out in your letter, if Canada and the United States,
the world’s two largest trading partners, cannot avoid imposing
restrictions on our bilateral trade, then it is difficult to see how
the global economy can avoid falling into a vicious circle of
protectionism.
For these reasons, we ask the American Administration
to not impose Buy American requirements
on sub-national procurement contracts, or on grants and other
financial assistance awards and cooperative arrangements with
private entities
funded by the ARRA.
Just as you do, we take heart in the fact that the
ARRA does offer provisions for waiving regulatory restrictions in
case where it is determined that applying Buy American constraints
would be inconsistent with the public interest. Clearly, the loss of
US jobs and the disruption of a highly competitive manufacturing
base in North America are not in the public interest, either of
Canada or of the United States.
Neither
does threatening the health and wellbeing of hundreds of thousands
of people. For these reasons, we join you in urging Congress to use
this waiver in exempting state and other sub-national entities from
Buy American provisions attached to ARRA funding.
TMTA is committed to open and reciprocal access to
procurement markets in both Canada and the United States and will
partner with the CME and any federal agency towards that end. There
is no doubt that the present economic downturn does indeed present
enormous problems for our industry. But we believe that, if handled
well, the situation can offer Americans and Canadian a significant
opportunity to improve upon existing trade agreements. We too are
encouraged by the willingness of the Canadian and Provincial
Governments to propose the negotiation of a more open procurement
agreement between our two countries covering federal,
state/provincial, and local authorities.
American jobs are being lost by Buy American
as Canadian companies see business in the United States disappear.
More jobs will be lost if our two countries do not act quickly to
keep our procurement markets open and enhance new business
opportunities in these troubling times.
Sincerely,
Christian Dubé, Chairman, Trillium Medical Technology Association
Reprint of an article
from Newsweek Magazine
Bench to bedside
Academia slows the search for cures
Now that president Obama has almost all of his top
science picks in place – from the Department of Energy to the FDA –
the lack of an appointee for the director of the National Institutes
of Health is standing out like a creationist at an evolution
conference. I hope the delay means Obama has grasped the need for,
and the difficulty of finding, a powerful director who can get
beyond the rhetoric about moving discoveries out of the lab and make
it a reality. That hasn’t happened yet, six years after a
much-ballyhooed NIH “road map” declared such bench-ot-bedside
research a priority and vowed to reward risk-taking, innovative
studies, not the same old incremental research that has produced too
few cures.
NIH has its work cut out for it, for the forces within academic
medicine that (inadvertently) conspire to impede research aimed at a
clinical payoff show little sign of abating. One reason is the
profit motive, which is supposed to induce pharma and biotech to
invest in the decades-long process of discovering, developing and
testing new compounds. It often does. But when a promising discovery
offers a low profit potential, patients can lose out. A stark
example is the work of Donald Stein, how at Emory University, who in
the 1960s noticed that female rats recovered from head and brain
injuries more quickly and completely than male rats. He hypothesized
that the pregnancy hormone progesterone might be the reason. But
progesterone is not easily patentable. Nature already owns the
patent, as it were, so industry too a pass. “Pharma didn’t see a
profit potential, so our only hope was to get NIH to fund the
large-scale clinical trials” says Stein. Unfortunately, he has
little luck getting NIH support for his work (more on that later)
until 2001, when he received $2.2 million for early human research,
and in October a large trial testing progesterone on thousands of
patients with brain injuries will be launched at 17 medical centers.
For those of you keeping score at home, that would be 40 years after
Stein made his serendipitous discovery.
The desire for academic advancement, perversely, can also impede
bench-to-bedside research. “In order to get promoted , a scientist
must publish in prestigious journals”, note Bruce Bloom, president
of Partnerships for Cures, a philanthropy that supports research.
“The incentive is to publish and secure grants instead of to create
better treatments and cures”. And what do top journals want?
“Fascinating new scientific knowledge, [not] mundane treatment
discoveries,” he says. Case in point: in research supported by
Partnerships for Cures, scientists led by David Teachey of
Children’s Hospital of Philadelphia discovered that rapamycin, an
immune-suppressing drug, can vanquish the symptoms of a rate and
sometimes fatal children’s disease calls ALPS, which causes the body
to attack its own blood cells. When Teachey developed a mouse model
to test the treatment, he published it in the top hematology
journal, Blood, in 2006. But the 2009 discovery that rapamycin cure
kids with APLS? In the 13th ranked journal. The hardcore
science was already known, so top journals weren’t interested in
something as trivial as curing kids. “It would be nice if this sort
of work were more valued in academia and top journals,” Teachey
says. Berish Rubin of Fordham University couldn’t agree more. He
discovered a treatment for a rare, often fatal genetic disease,
familial dysautonomia. Given the choice of publishing in a top
journal, which would have taken months, or in a lesser one
immediately, he went with the latter. “Do I regret it?” Rubin asks.
“Part of me does, because I’m used to publishing in more highly
ranked journals, and it’s hurt me in getting NIH grants. But we had
to weigh that against getting the information out and saving
children’s lives.”
Not all scientists put career second. One researcher recently
discovered a genetic mutation common in European Jews. He has enough
to publish in a lower-tier journal but is holding out for a top one,
which means identifying the pathway by which the mutation leads to
the disease. Result: at least two more years before genetic
counselors know about the mutation and can test would-be parents and
fetuses for it.
With these forces in play, NIH has to push back even harder to make
translational research a priority. When Stein applied for NIH
funding in the 1980s and 1990s, “people didn’t believe a pregnancy
hormone could help patients recover from brain injury’” he says.
“People said it was too simple.” And when he, too, tried to publish
in top journals, the papers were rejected in large part because all
he was reporting was success in treating people, not the mechanism
or physiological pathway that constitutes the sexy science that wins
plaudits. Teachey could not get NIH funding either. Reviewers said
the work was too translational – and this was after the NIH road map
professed love for translational research. It will take an NIH
director of almost mythical proportions to turn around this ship.
Written by Sharon Begley, regular science columnist for Newsweek
Magazine.
Position statement from MEDEC
As cases of H1N1 virus continue to increase around the globe, the
World Health Organization has raised the influenza pandemic alert to
level 6. As a worldwide pandemic creates a surge in demand,
the Canadian health sector needs to be proactive in determining the
need for influenza medical supplies and equipment. As well, Canadian
health officials need to work collaboratively with industry to
establish volume and timing for these supplies. In light of the
growing pandemic threat, MEDEC, Canada’s Medical Technology
Companies, has revised its position and has released a Pandemic
Planning Position Paper that we would like to share with you.
Medec’s position with regards to the pandemic
Limited global manufacturing capacity requires Canadian health
officials to be proactive in determining their need for pandemic
influenza medical supplies and equipment.
Pandemic influenza medical supply and equipment lists need to be
revisited to identify the type of products needed in Canada to deal
with the current and future situation.
Canadian health officialsneed to collaborate with industry to
develop guidelines on the provision of service for medical equipment
during a pandemic influenza outbreak.
Canadian health officials need to work collaboratively with industry
to establish volume and timing for pandemic influenza medical
equipment and supplies stockpiles.
Canadian health officials need to develop warehousing options and
stock rotation plans to deal with the pandemic medical equipment and
supplies inventory.
Depending on medical supply, equipment and servicing needs, there
may be an incremental cost associated with providing health
officials with pandemic requirements.
Business continuity plans need to be developed by MEDEC members in
preparation for an increased pandemic outbreak.
The goal of MEDEC companies during the current influenza alert phase
will be to effectively manage the surge of requests without
disrupting supplies to customers for regular activity.
The issues involved
Canadian federal and provincial governments and health care
organizations were encouraged to create pandemic influenza plans two
and three years ago. Some did, others did not. In most cases the
plans were written based on a worst case scenario that 35% of the
population would be affected, placing a surge demand on the acute
care system to deal with the sick.
Canadian pandemic influenza efforts were primarily focused on
stockpiling vaccines, anti-virals and personal protective equipment
to deal with the outbreak. Servicing of medical equipment critical
to pandemic influenza response may not be included in the
preparedness plans of government and health care organization plans.
In the past two years, pandemic influenza has not been a priority
for most countries. The World Health Organization has the IP at
level 6. This will have triggered many pandemic plans into
operational mode and stockpiles will become an active issue again.
Medical device and supply companies have limited manufacturing
capacity to deal with a global surge demand for products required to
respond to a pandemic influenza outbreak.
The majority of medical supplies and equipment needed for a pandemic
are manufactured internationally, or require the importing of raw
materials, raising concerns about being able to respond to pandemic
requests should borders be closed. Companies providing service to
needed medical technology will need to be consulted to determine
service level requirements and capacity.
Health officials around the world are now monitoring the current
H1N1 influenza outbreak and communicating with health care
organizations and the public. A pandemic influenza outbreak expected
to be a global threat will place a global surge demand on the need
for specific medical supplies and equipment. To protect their
citizens, many countries have built a stockpile of medical equipment
and supplies to deal with a pandemic influenza outbreak. Those
stockpiles are being reviewed. Different parts of Canada and
different health care organizations are at different stages in terms
of being prepared for an outbreak.
* This text replaces MEDEC’s previous position statement, “Pandemic
Influenza Planning and the Medical Device Industry, Spring 2006”.
For more information:
Stephen Dibert
President & CEO
MEDEC - Canada's Medical Technology Companies
MEDEC - Les sociétés canadiennes de technologies médicales
405 The West Mall, Suite #900, Toronto, ON M9C 5J1
t. 416.620.1915 x226
f. 416.620.1595
www.medec.org
Opinion: Steven Lewis takes aim at the medical profession
Spare the Policy, Spoil the Profession
Steven Lewis
The jig is up: Canada's publicly financed healthcare system does not
reliably deliver safe, high-quality, efficient care - and this after
doubling spending in the past decade. Patient friendly it isn't; the
convenience of providers comes first. Need primary care after 5:00
p.m.? Go to emergency. Got four complaints? Make four appointments.
Every serious analysis comes to the same conclusion: the system
needs a major refit to improve access, quality and value for money.
Yet, we remain a nation of demonstration projects, taking two steps
backward for every step forward. Of the many obstacles to
transformative change, one looms larger than all the others:
organized medicine. For the better part of 40 years, organized
medicine has more often than not stood in the way of efforts to
re-engineer healthcare. It has pursued its own interests with
brilliant success and passed them off as the public interest. It has
secured more money, the right to saturate one jurisdiction or
specialty with doctors and neglect others, largely autonomous and
unaccountable practice, and separate and unequal access to the
councils of state and the boardrooms of health organizations. Don't
blame organized medicine for the way it behaves; blame us, meaning
the citizenry and the governments we elect. We're the enablers.
Spoiling a
noble profession
Predictably, the system suffers: the documented
shortcomings in safety, access and quality speak for themselves.
More surprisingly, doctors are suffering too. Their own surveys
unearth a litany of miseries, fantasies about leaving practice
within a couple of years (they don't, even when they say they will),
overwork, ennui. So, if it's not working for us, and it's not
working for them, why does nothing change?
We owe the doctors of Canada a serious apology for
spoiling a noble profession. By kowtowing to organized medicine, we
end up with collective agreements and policies that entrench the
status quo and keep Canadian healthcare in the dark ages. Doctors
who have nothing to do with medical politics nonetheless bear the
consequences of the positions taken by their representatives. The
culture of self-centredness and privilege erodes idealism and
produces generations of cynics who chafe under the rules of the game
but lack the will to change them. Here are the main errors for which
we need to atone:
First, we have erred in how we pay most doctors, and
for letting medical politics determine what and who are worth more
and worth less. Allowing organized medicine to divide up the pie has
distorted care patterns, undercompensated many doctors, obscenely
enriched others and pitted group against group. The doctors who use
their hands out-earn those who use their brains. The ophthalmologist
who does 20 cataract procedures in a day earns more than the one who
figures out 20 complex eye disorders in a week. The dermatologist's
pay leaves the rheumatologist's in the dust. We stand by in learned
helplessness as the medical associations concoct a reward system
that produces 10 times as many pediatricians as geriatricians, a
steady abandonment of primary care and a generation of doctors
practising at the low end of their capacities.
Most doctors have no clue about the effectivenss of what they
deliver
Second, we should apologize for letting doctors
practice in the 21st century with the tools of Bob Cratchit.
Governments sign collective agreements that condone quill pen
medicine - we're at the bottom of the G7 pack in the adoption of the
electronic medical record. Quality improvement (QI) tools and
techniques are optional. There is no obligation to undergo practice
profiling and recertification. Most doctors have no clue about the
quality and effectiveness of what they deliver - and those who think
they do are almost certainly wrong. The inevitable results: medical
practice harms 10% of patients in hospitals; there is routine
prescribing of dangerous dosages and drug combinations to the
elderly; there is widespread failure to diagnose and effectively
manage the most common and straightforward chronic diseases; primary
healthcare patients get all of the evidence-based care they need
only about half the time; and the list goes on.
Research shows that the longer doctors practice, the
more they decline. We would never neglect the career development of
our pilots, car mechanics or workers in fast-food restaurants the
way we have neglected the professional competence of doctors. And
instead of organized medicine imploring governments and health
organizations to analyze patients' anonymized data, feed back the
results and help doctors with QI, the Canadian Medical Association
president makes ominous speeches about privacy.
Third, it's been a mistake to leave unchallenged the
attribution of access problems to shortages of doctors and to
inflate medical school enrolments by two thirds in response.
Instead, we should have mandated strategies that could dramatically
improve access right now, such as advanced access scheduling.
Millions of Canadians can't get to see their family doctor the same
week they call for an appointment, while everyone in England can and
does in 48 hours. Do the process re-engineering, optimize the
division of labour among the professions and then assess whether
there are shortages - and if so, of what? And recognize that
expanding enrolments in medical school won't solve the shortage of
specialists in the disciplines that internal medical politics has
consigned to the bottom of the income ladder.
Fourth, we have erred in adopting organized
medicine's view that all doctors' problems, dissatisfactions and
anxieties are soluble in cash. When doctors tell us they can't be on
call 24/7, 365 days a year in rural areas, we empathize and come to
the table to help find a solution. Nurse practitioners? No thanks.
Group-based practice? Can't sell it to the members. How about a
hundred thousand bucks extra? Sounds good! So we inflate doctors'
incomes to do the same things that sap their energy, ruin their home
life and keep them on a treadmill to depression, substance abuse and
burnout. Shame on us.
Fifth, we've blundered in letting medicine dwell in
splendid isolation atop the heap of the health professions. We allow
the guild to keep competent others out of the sandbox: nurse
practitioners are threatening; let's go for physician assistants.
The pharmacist who knows more than the doctor about pharmacotherapy
remains a diffident subordinate instead of a true partner. The other
guilds follow medicine's lead, and we wonder why interprofessional
collaborative practice goes nowhere. If being separate and unequal
made doctors happy and the system better, fine. But the job
satisfaction survey data show the unhappy consequences of letting
organized medicine get in the way of its own members' well-being.
Sixth, we owe a
mea culpa
for letting organized medicine's media grandstanding, government
baiting, hyperbole and fear mongering go unchallenged. Because we do
not hold organized medicine to a higher standard of discourse and
accountability, its rhetoric becomes bolder and it comes to believe
its own propaganda, that every misdeed or wait list is everyone's
fault but doctors'. We've turned organized medicine into expert
blackmailers: more money, more machinery, a bonus here, a new
medical school there. Attend a committee meeting? Pay us. Become
true partners in the hard job of running the system? Nah, we like
being independent contractors, not integrated team players. Staff
the emergency room? Pay us fee-for-service, an hourly rate on top of
that, a shift bonus on top of that. Set up shop in the poor part of
town where the need is greatest and unmet? Charter of Rights!
Freedom! We fed the beast and stood by as medical altruism and
decency became entombed in a hard shell of self-serving cynicism. No
one wins.
We've given
organized medicine too much power
Our biggest mistake is failing to demand more of both
organized medicine and individual doctors. We admit only superior
students into medical school. We put them through intensive training
(but not much education in citizenship and how systems work). We
then turn a blind eye to huge variations in practice and never
evaluate them seriously. And because this is a proven recipe for
substandard quality, we let organized medicine persuade us that the
remedy is to pay extra for mere competence - participating in
chronic disease management collaboratives and following the
occasional clinical practice guideline. This is our fault and our
folly.
Lord Acton would have expected as much: power
corrupts, and we have given organized medicine too much power. The
dysfunction is intergenerational: we have not sufficiently protected
and nurtured opportunities for new generations to chart a different
path. We have given medicine autonomy without accountability and
increased its allowance while its grades declined and it acted out
at the table. Small wonder that practice is anarchic and error
abounds. We didn't bring organized medicine up right, and we have
only ourselves to blame for its values and behaviour.
Apology is a precursor to reconciliation and
recovery. We need to recognize our mistakes and become the partners
organized medicine deserves to restore its dignity as a profession
that advances the public interest and justice for its members.
Collectively, physicians are worse than the sum of their parts, and
that harms all of them, and us. Our mistake has been to give
organized medicine what it wants. It is time to give it what it
needs, and to help it understand the difference.
About the Author
Steven Lewis is a Saskatoon-based health policy consultant
and part-time academic who thinks the health care system needs to
get a lot better a lot faster.
An open letter to Ontario medical technology entrepreneurs
Calling all medical technology entrepreneurs!
Many of us in the medical technology field are concerned
about a troubling situation that is emerging in
Ontario.
GPOs (Group Purchasing Organizations) set up by the Ontario
Health department are increasingly cutting small or
medium-sized enterprises right out of the loop.
Yes, international corporations have always challenged
smaller Canadian manufacturers with bundling programs and
other special “deals and incentives”. But in the past
several years, GPOs have united with these corporations to
further push
Ontario manufacturers off the
playing field. Some of us are even finding ourselves being
physically shut out of hospitals regardless of the quality
or price advantages we offer. With the introduction of the
LHINs, the
Ontario
government is pushing our provincial hospitals to embrace
these GPOs regardless of the impact to our Medical
Manufacturing Industry.
Are GPOs on your radar yet? Has your business been
affected? Has
the situation begun to impact your bottom line?
Are your sales suffering from a lack of access to
Ontario
hospitals? If not, are you, like us, concerned that present
market conditions are just the lull before the storm?
Are you also aware of the fact that a parallel situation
occurred in the
USA?
Did you know that American GPOs had to be forced to play
fair by the concerted action of their federal and state
governments? Did you know that those same GPOs being handcuffed in the
US
are now banding with our Ontario GPOs to form an even more
powerful marketing force? Do you realize that
as this cross-border alliance takes effect, more and more
cheap medical products will flow in from the US and Mexico?
Do you care?
We care! We care a lot! And we’re not going to take this
situation lying down. We’ve been alerting the
Ontario
government to this situation since July 2007. We’ve written
letters, sent emails, made phone calls, had meeting after
meeting. So far, all that’s happened is that we’ve been
“handled” by various levels of the bureaucracy. Smooth
bureaucrats have dished out lots of lovely words but done
nothing to correct the situation. Their spin doctors have
spun us around so much that we’re dizzy from the experience!
Since
it is becoming painfully obvious that the
Ontario
government has no intention to play fair, we’re now planning
to escalate our battle onto its next level.
We’re preparing to take our case to the public and spill the
news on the kickbacks and the backroom deals that are
blocking us from fair market access. We intend to blow the
lid off those forces that are preventing us from marketing
our innovative, cost effective, high quality products to
provincial hospitals which are supported by our tax dollars.
To achieve this, we aim to form a coalition of province-wide
manufacturers ready to stand up for their survival. Can we
count on you? Have you had enough? Are you ready to stand up
and be counted? At this point, all we require of you is that
you answer our short questionnaire and email it back to us
by the end of this month.
Are you ready to make a difference? It should take no more
than 3 minutes to record and send us your answers by May 29,
2008.
Responses will be
tallied and compiled to make our point. Once that is done,
we will approach the
Ontario
government one last time to state our case. If their
response continues to be as evasive and unproductive as it
has been, we will then come back to you to rally your
support for another, even more forceful step. And so on. And
so on. Until we get results. After all, while it would be
unfortunate for
Ontario
to loose its auto industry, it could prove fatal for
Ontarians to loose their medical technology industry.
Very sincerely,
Christian Dube
Chairman
Trillium Medical Technology Association
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