Healthy Skepticism Library item: 13152
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Faunce T.
Australia's medical device industry needs stricter regulation
The Age 2008 Mar 13
http://www.theage.com.au/news/opinion/hip-bones-and-hip-pockets/2008/03/12/1205126007207.html?page=fullpage#contentSwap1
Full text:
REVELATIONS that US investigations into kickbacks paid to senior
surgeons by giant US medical device companies Stryker and Zimmer may
extend to Australia should be deeply troubling for patients, health
institution managers and policy makers in this country.
It is undoubtedly true that many genuine evidence-based health
innovations in medical device technology arise from research undertaken
by clinicians who receive appropriate remuneration, including royalties.
Yet the US Senate Special Committee on Ageing has received evidence that
last year Zimmer paid $US86 million and Stryker $US40 million directly
to surgeons to encourage loyal use of their artificial hip and knee
devices. Indeed, last year Zimmer and three other large medical device
companies paid $US311 million to settle an investigation by the US
Justice Department into no-work consultancy deals with surgeons in
return for exclusive use of the paying company’s products.
Comments by a spokeswoman, reported in The Age, that the Stryker company
was “unaware if its links to Australian doctors would be examined by US
investigators” seem either disingenuous or unduly optimistic given that
Stryker recently informed investors in a US Securities and Exchange
Commission filing that the US Justice Department’s criminal division was
investigating the company for possible violations of the Foreign Corrupt
Practices Act, which prohibits US companies from paying bribes overseas.
The Australian Orthopedic Association’s Guidelines for Interactions with
Medical Device Suppliers 2006 prohibits such surgeons from direct
benefits for implanting prostheses. Such prohibited benefits include
shares, options, research support and support for travel. The guidelines
state that “under no circumstance” should a member “enter into an
agreement which links the number of implants used clinically with
personal or institutional remuneration or material benefit”.
The guidelines require members to disclose to patients such potential
conflicts of interest and to prohibit product endorsements.
Consultancies are permitted only if “covered by a legally binding
contract which explicitly defines the expectations of the commercial
organisation” and is “subject to an annual report”. These guidelines
confirm that patient safety and wellbeing must not only be, but appear
as, the chief priority.
One problem, however, is that multinational device corporations are
adept at framing kickbacks as legitimate donations or invitations to
bona fide scientific meetings. Another is that despite increasing
interest in “full financial informed consent”, few surgeons have the
time or inclination to adequately disclose any financial involvement in
the device they are about to implant.
Furthermore, a decade of systematic underfunding of Australian public
hospitals by the pro-privatisation former federal government has forced
hospitals to seek funds from industry sources. So, too, has the
government’s push for patents and research grants involving “linkage”
between medical academia and industry.
With the Rudd Government having established a Health and Hospitals
Reform Commission, and with health-care reform being one of the main
points of interest for the imminent 2020 Summit, it is time for an
urgent review of our national regulatory system in this area.
Why, in Australia, do we never see medical device or pharmaceutical
companies paying millions of dollars to government regulators after
actions have proven a prima facie case for collusion, kickbacks and
other forms of pro-monopolistic or corrupt practices? Is it that such
companies, routinely involved in such nefarious payments in the US and
Europe, are somehow more transparent and honest in this nation?
A more likely answer is the reluctance and/or inability of the
Australian Competition and Consumer Commission to investigate corruption
and anti-competitive practices in these industries. Reform of such a
watchdog organisation should be a priority for an Australian government
seeking value for health-care expenditure. This could include so-called
qui tam payments under which whistleblowers get a percentage of the
amount recovered from a successful large-scale anti-corruption action by
a government regulator. Similarly, we have a world-class Pharmaceutical
Benefits Advisory Committee that evaluates scientific evidence for the
objectively demonstrated therapeutic significance of new products and
passes on recommendations for a price negotiation.
This system is not as finely tuned for cost-effectiveness evaluations of
new medical devices, with the Medical Services Advisory Committee having
less evidence to work with and fewer opportunities for hard bargaining
over the price offered by industry. Yet the advantages of each state
pooling the buying power of the equivalent of Health Purchasing Victoria
are manifest: there would be much greater leverage over industry to
justify price.
Meanwhile, nanotechnology will soon revolutionise both the ubiquity and
cost of medical devices in the health-care sector. Regulatory reforms
should also include encouragement for multidisciplinary, collaborative
and integrated projects that not only acquire and publish crucial data
about the risks of such next-generation medical devices, but channel
that data into regulatory structures where experts make objective
assessments of the comparative “health innovation” value of such
products to the community.
The alternative, characteristic of the US health-care system, sees huge
managed care corporations controlling pools of doctors required by
employment contracts, or enticed by kickbacks, to exclusively use
products chiefly as a service to corporate shareholders.
