JUNE, 27 2012
MARY BOLAND
POST INDEPENDENT
GLENWOOD SPRINGS, CO
COLORADO (FiDA blog bold)
My husband has a full hip
joint replacement, the kind where they lop off the bone and replace it with a
metal rod and ball. Fortunately an easier procedure is now available where they
just recoat the ball in the hip joint. But we thank our lucky stars that his
metal hip joint is, so far, not causing any problems that we know of.
Many people who underwent
the same procedure as my husband have had major problems, requiring repeated
surgeries and causing long periods of, if not permanent, immobility.
And that is why I was
particularly interested to read an article In “Public Citizen Health Letter”
about the $350 billion medical device industry's “massive lobbying campaign to
weaken the already lax oversight of medical devices and to accelerate the
already too-quick review of high-risk medical products.”
The law setting the Federal
Drug Administration's user fees and regulation requirements for both new
medical device applications and ongoing oversight is up for renewal this year.
And already the members of Congress who have received the most campaign finance
help from the industry have introduced 14 bills aimed at easing regulation and
weakening measures intended to ensure patient safety.
That patient safety measures
need to be strengthened, not weakened, may be inferred from the substantial
increase in recalls in recent years. Recalls of devices posing high risk to
patients have doubled between 2007 and 2011, and recalls of devices posing
moderate risk have increased sevenfold.
And the growth of recalls cannot
be explained by any increase in the number of new medical devices, whose number
has been stable or declining in recent years.
Among recently recalled
devices are:
• Faulty implanted heart
defibrillators that incorrectly deliver dangerous electrical jolts to the
heart.
• Surgical clips that pop
off, causing patients to bleed to death internally.
• Artificial hips that shed
metal fragments into the bone and surrounding tissue, causing extreme pain and
restricting mobility.
• Infusion pumps that shut
down unexpectedly or dispense incorrect intravenous medicine doses.
In the face of this record,
the medical device industry spent $33.3 million on lobbying in 2007. In the
third and fourth quarters of 2011 there were at least 225 of these lobbyists
hard at work, including 107 who had previously worked for the federal
government.
Interestingly, one of the
bills introduced in Congress would weaken the financial conflict of interest
prohibition against individuals with industry interests serving on the FDA
advisory committee overseeing medical device approvals.
Members of a key House
health subcommittee with jurisdiction over medical devices have received
campaign contributions from the industry double those of the average House
member. And actual sponsors of the House bills seeking to weaken regulation and
oversight have received about three times more.
Public Citizen asserts that
in addition to allowing far too many dangerous devices to reach the market, the
FDA has inadequate post-market surveillance for adverse advents. The FDA
primarily depends on manufacturers and hospitals to report incidents of serious
injuries or deaths related to these devices. It is not in the manufacturers' or
hospitals' interest to do so.
Furthermore, Public Citizen
points out, the Republican-dominated Supreme Court held in 2008 that
manufacturers of FDA approved devices cannot be held liable for harms. Congress
should restore patients' rights to sue in such cases.
Public Citizen calls on
Congress to replace the current weak medical device regulatory regime with a
process that requires the same scrutiny as that given to new drugs,
particularly for moderate and high-risk devices that are permanently implanted
in the body.
The whole situation is just
one more sad example of our desperate need to amend the Constitution to
overturn the Supreme Court's disastrous Citizens United ruling that
corporations are people and the Constitution's free speech guarantee protects
their right to spend all the money they want to influence Congress.
Only then can we revamp our
election process to get campaign contributions out of the picture. And only
after that is done, could legislation possibly be enacted to end the “revolving
door” between industry regulators and lobbyists.
For further details, go
online to www.citizen.org/hrg.
And write your representatives and senators.
— “What Do We Really Want?”
appears on the second and fourth Thursdays of the month. Mary Boland is a
retired teacher and journalist, a proud grandmother, and a longtime resident of
Carbondale. Follow her on twitter@grannyboland.
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