By Joseph Walker
David Kandzari, an Atlanta cardiologist, also has worked as a
consultant to makers of medical devices. He received at least
$100,000 from them in five years, according to corporate and
government data.
Another organization he works with, the Food and Drug
Administration, doesn't appear to mind. In October, the FDA put Dr.
Kandzari on a panel reviewing a medical device made by Boston
Scientific Corp., one of the companies he has advised.
The FDA didn't disclose the connection. It was among numerous
financial ties the FDA hasn't disclosed between medical-device
makers and the doctors and other experts who review devices for it,
a Wall Street Journal analysis of corporate, state and federal data
shows.
In panels evaluating devices involved in cardiology, orthopedics
and gynecology from 2012 through 2014, a third of 122 members had
received compensation--such as money, research grants or travel and
food--from medical-device companies, an examination of databases
shows.
Nearly 10% of the FDA advisers received something of value from
the specific company whose product they were evaluating.
The FDA disclosed roughly 1% of these corporate connections.
The situation concerns critics. "Undisclosed conflicts raise
questions about the decision-making capacity of the committees and
whether the public can have confidence in their recommendations,"
said Joseph Ross, an associate professor at Yale School of
Medicine.
The FDA follows the committees' advice in a large majority of
instances, on prescription drugs as well as on medical devices. On
devices, it has convened more than 20 meetings this year for
recommendations on whether to approve novel products or put new
regulations on older ones.
The issue arose most recently in July regarding a panel
evaluating surgical tools called power morcellators that cut up
uterine fibroid growths. A gynecologist stepped down from the panel
not long after the Journal inquired about payments he had received
from a maker of the devices, a connection the FDA hadn't
disclosed.
The FDA said under current law and policy, it discloses
advisers' financial interests only when it has determined the
experts need a waiver in order to serve.
In making this determination, it has discretion. Having done
paid work for a medical-device company doesn't disqualify a doctor
or scientist from sitting on an advisory panel, nor require public
disclosure, as long as the work wasn't related to the specific
topic or product the panel focuses on, FDA officials said.
Current consulting work that is directly related to a panel
topic is typically a disqualifying conflict, as is ownership of a
large amount of the device maker's stock, said FDA Associate
Commissioner Jill Hartzler Warner. Still, if the FDA believes the
individual's expertise can't be found elsewhere, it can issue a
waiver.
It posts such waivers on its website. The agency said it can't
reveal any other financial ties or potential conflicts because what
its scientific advisers tell it is confidential.
"Our challenge and our goal is to retain public confidence in
the advisory-committee process and at the same time to obtain the
very best advice," Ms. Hartzler Warner said.
"If you have a financial interest with a sponsor or a related
firm, but it's not related to the product at the meeting, it's not
disqualifying," she said. "The firms are often large and diverse,
and whatever position the FDA takes, it won't affect the
relationship between the firm and the" expert adviser.
Doctors said their consulting work doesn't affect their panel
decisions. "I've never sat there on a panel and thought, 'I wonder
what my friends at companies X, Y and Z would say.' I just don't
view it that way," Dr. Kandzari said.
In the panel in October, he voted to approve a heart device from
Boston Scientific, a firm that has paid him between $5,700 and
$8,190 in consulting fees and expenses for food, travel and lodging
since 2011, according to company data. The consulting didn't
concern the kind of device the October panel evaluated, so it posed
no conflict, he said.
Dr. Kandzari confirmed he has consulted for various device
makers. He questioned the accuracy of payment data posted by
companies, saying, among other things, that some payments were
actually made to his employer.
As for Boston Scientific, it said that device makers "are not
consulted, or engaged in any way in the selection of panel
members."
The FDA said broader disclosure could discourage people from
sitting on advisory panels. The agency already has a challenge
getting highly qualified experts to sign on, Ms. Hartzler Warner
said. Edward Y. Cheng, an orthopedic surgeon at the University of
Minnesota Medical School and Cancer Center, said doctors have a
strong financial disincentive to serve because they must take time
away from their practices.
Among ties not disclosed by the FDA were $6,666 in consulting
fees Dr. Cheng received from a maker of all-metal hip implants a
year before he sat on a panel evaluating the safety of that type of
hip. Dr. Cheng said the work was unrelated to all-metal hips.
Dr. Cheng said it is the FDA's job to gauge whether a conflict
exists but added: "if I personally thought a conflict existed that
would affect my ability to remain unbiased, I would decline to
participate." The FDA said it doesn't comment on individual panel
advisers or their finances.
There is no central way for the public to learn of ties between
panel members and makers of medical devices or drugs, which pay
hundreds of millions of dollars a year to physicians in consulting,
speaking and other fees, according to data from the Centers for
Medicare and Medicaid Services. Concerns that such ties could
affect doctors' medical decisions have led to calls for greater
transparency.
Many large drug and device companies post their payments to
doctors online, often as part of legal settlements over fraud
allegations. Some states, including Massachusetts and Vermont, post
payments to physicians in their areas.
Doctors often must disclose potential conflicts when writing for
scientific journals or giving presentations at medical meetings.
The federal government this year launched a database called Open
Payments, which so far has five months of 2013 data on company
payments to doctors and teaching hospitals. The Journal used all
these sources as well as archives maintained by PharmaShine, a
service of Obsidian Healthcare Disclosure Services LLC.
No database reveals doctors' and medical scientists'
stockholdings, so any search can give only a partial picture of
financial ties.
The Journal's tally of payments to members of panels on
cardiology, orthopedic and gynecology devices in 2014 found that
64% received no value from device makers in the past five years.
The rest did, varying from less than $15 for food and beverage to
more than $500,000 in research funding.
Of doctors who received something from companies, 32% got less
than $500 in value and 26% received $10,000 of value or
greater.
Before advisory-panel meetings, the FDA asks potential members
to report all financial ties, including consulting fees, research
grants and stock, in companies with business before the panel and
their competitors. In general, if the value of current interests
exceeds $50,000, a person will be excluded, said an FDA guidance
document.
If the agency decides a payment isn't truly a conflict, it can
issue what is called a "502 authorization" letting the person
serve, said Ms. Hartzler Warner.
The 502 authorizations, unlike waivers, aren't publicly
disclosed.
The FDA declined to say how many 502 authorizations it issues
annually.
"The problem with the FDA's policy is you don't know how they
use their discretion," said Celia Wexler, a lobbyist for the Union
of Concerned Scientists, a group that opposes political
interference in scientific and regulatory matters.
"It's very difficult for us to know to what extent the FDA
probes, and the extent to which panel members take the disclosure
requirements seriously."
Shortly before the July panel on morcellator surgical
devices--which reviewed concerns they could spread hidden uterine
cancers--the Journal discovered that panel member Andrew Brill had
received nearly $100,000 in consulting fees in 2013 from Johnson
& Johnson, then the largest maker of morcellators. The
information was on a J&J-run public database, which also shows
that another J&J unit paid $6,000 to Dr. Brill in 2013.
Dr. Brill resigned from the panel just before it met. The FDA
said he recused himself because of his financial interests with
companies. It declined to discuss why it initially appointed him to
the panel. Dr. Brill declined to comment.
Documents posted on the website of the American Association of
Gynecologic Laparoscopists show Dr. Brill also had ties to another
morcellator maker, Karl Storz GmbH of Germany, for which he was a
consultant and speaker in 2012.
Another corporate connection the FDA didn't disclose: Dr. Brill
sat on a panel examining risks of surgical mesh products, which are
used to support internal organs and treat urinary incontinence, in
2011--a year when he received $82,600 from J&J subsidiaries,
including one that makes surgical mesh. The information is on
J&J's website.
J&J declined to comment. It pulled its morcellators from the
market earlier this year. Karl Storz didn't respond to requests for
comment.
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Keith Isaacson, a doctor who served on the morcellator panel,
had received nearly $12,000 in consulting fees from a J&J
subsidiary in 2013, the Journal reported in July. Further review of
databases shows that Dr. Isaacson also got $9,500 from J&J from
2010 through 2012 for consulting, food and education and training;
and that he received $148,400 in consulting fees and other
compensation from Karl Storz from 2009 through 2013. The
information came from websites of J&J, a Massachusetts health
agency and Open Payments.
At the panel's meeting, Dr. Isaacson expressed doubt about data
showing that women getting surgery for fibroids have a 1 in 350
chance of having malignant tumors that morcellators could spread, a
panel transcript shows. He noted a recent study that found the risk
was closer to 1 in 7,450.
Dr. Isaacson declined to comment. The FDA wouldn't discuss the
payments or why it placed Dr. Isaacson on the panel in view of
these corporate ties.
Dr. Kandzari, the cardiologist who served on an October FDA
panel evaluating a heart device, is the director of interventional
cardiology and chief scientific officer at Piedmont Heart Institute
in Atlanta. He has published many medical-journal articles. He said
his consulting for device companies is aimed at helping firms
design more-efficient clinical trials.
One FDA panel Dr. Kandzari sat on last year considered a
pacemaker and a defibrillator made by Medtronic Inc. That is a
company from which Dr. Kandzari received between $76,600 and
$130,600 for consulting work, teaching, travel, lodging and meals
from 2010 through 2013, according to company and federal databases.
A panel transcript shows he abstained from voting on whether to
approve expanded use of the devices because he wasn't sure whether
the benefits outweighed the risks.
Dr. Kandzari said his past consulting for Boston Scientific, the
maker of the device that was being evaluated at the October panel,
had concerned an arterial stent. The October panel focused on a
different Boston Scientific product: a plug that seals a heart
appendage to cut the risk of strokes caused by clots.
That plug, called the Watchman, had been backed by previous FDA
panels but was being reviewed again because a study showed patients
receiving it had more strokes caused by blood clots than patients
getting the blood thinner warfarin.
While the panel in October deemed the device safe, a narrow
majority that included Dr. Kandzari judged it not as effective as
warfarin. Still, he voted yes in a 6-5 panel vote concluding its
benefits outweighed its risks, tantamount to a recommendation of
marketing approval.
Dr. Kandzari said despite his concerns that "stroke was not
necessarily reduced with this technology," he believed it should be
available for patients who are at high risk of complications from
warfarin.
Following the advisers' vote, Boston Scientific told analysts it
expected the Watchman to win FDA approval in the first half of 2015
and eventually reach $500 million in yearly sales.
Andrea Fuller contributed to this article.
Write to Joseph Walker at joseph.walker@wsj.com
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