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NerveCenter Senate probe seeks industry payment data on individual academic researchers.

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NERVECENTER
Events, people, and issues in academic neurology
DECEMBER 2008
SENATE PROBE SEEKS INDUSTRY
PAYMENT DATA ON INDIVIDUAL
ACADEMIC RESEARCHERS
Image from http://bioguide.congress.gov
Contact Annals of Neurology, [email protected]
cate that the company and/or researchers may
have suppressed or obscured suicide risk data during clinical trials of the drug.
Leading depression researcher Charles
Nemeroff, former Chairman of the Department
of Psychiatry at Emory University, was the first big
name “outed” in what is expected by observers to
be a long and difficult investigation.
In early October, Nemeroff resigned from
Emory amid revelations that he had received over
$960,000 USD from GSK in 2006, yet reported
less than $35,000 to the school. Subsequent
investigations revealed payments totaling more
than $2.5 million from drug companies between
2000 and 2006, yet only a fraction was disclosed.
In a floor speech to the Senate in September,
Grassley told colleagues about the investigation of
individual researchers. “I don’t mean that they
actually hide the data,” he said, “but they make
these numbers so difficult to find that they might
as well be invisible.”
Image from http://www.senate.gov/~finance
Two Senate leaders have sent letters to almost two
dozen major universities seeking financial information on individual researchers involved in federally-funded studies. The letters include names
and request information on all reported payments
and honoraria from drug companies and medical
device manufacturers. The data is to be compared
with payments reported by the companies.
The initiative marks a widening of an investigation by Senators Charles Grassley (R-Iowa) and
Sen. Herb Kohl (D-Wisconsin)
Herb Kohl (D-Wisconsin) into potential financial
conflicts of interest (FCOI) between drug manufacturers and researchers receiving National
Institutes of Health (NIH) grants. Grassley is
ranking member of the Senate Finance
Committee, while Kohl chairs the Senate Special
Committee on Aging.
“As you know, institutions are required to
‘Prosecution by Media’
manage a grantee’s conflicts of interest. But I am
James C. Grotta, Chairman of the Department of
learning that this task is made difficult because
Neurology and Director of the Stroke Program at
physicians do not consistently report all the paythe University of Texas Medical School at
ments received from drug and device companies,”
Houston, believes the probe is motivated more by
Grassley states in the letters.
politics and public perception than by widespread
The information sought includes dates, payabuse, and laments the focus on individual
ment descriptions and amounts, and annual total
researchers.
income from the payment source - including all
Sen. Charles Grassley (R-Iowa)
“It’s unfair,” he says, “especially when some
speaking and advisory fees, Continuing Medical
very well-respected researchers have been targeted and careers have
Education (CME) work, honoraria, research support, travel and
been ruined.” Grotta, who is not being investigated, was one of the
other perquisites.
principal investigators in the landmark studies that resulted in the
The University of Texas, Columbia, Stanford, Brown, Harvard
1996 approval of tissue plasminogen activator (tPA) for acute stroke.
/ Massachusetts General Hospital, UCLA, and the University of
“It’s prosecution by the media without due process, and grandCincinnati are just a few of the schools to have received letters to
standing by members of congress looking for votes. Careers have
date.
been ruined, without any indication that they were doing anything
The investigation stems, in part, from revelations over the past
that others were not, to some degree or another, just because what
two years that some researchers involved in clinical trials of the antithey were doing was not atypical five or ten years ago,” he noted.
depressant paroxetine (Paxil/Seroxat) had received, and failed to
“To suddenly hold people accountable for continuing to accept
report, large payments from the manufacturer GlaxoSmithKline
speaking and consulting fees – something that was acceptable until
(GSK).
recently – does everyone a disservice. I honestly don’t think the
Post-approval reports of suicides among teens and young adults
problem is as big as it seems in the news. Exposure, yes, but influprompted the Food and Drug Administration (FDA) to order a
ence over findings or bias is another thing. Where do you draw the
“black box” warning in 2006. A major lawsuit filed against the
line? The line has never been clearly defined in the past, and sudcompany followed, and court documents released in October indiANNALS OF NEUROLOGY
DECEMBER 2008
A7
denly a congressman decides to draw one?”
Professor Arthur Caplan, Director of the University of
Pennsylvania’s Center for Bioethics noted that regardless of the
medium or method used, the message is clear.
“We’re entering into an era when reliance on an individual
researcher’s integrity will be replaced by a bureaucracy – integrity
just hasn’t worked, and more scandals are coming,” he said. “Some
kind of legislation will be passed, and academic researchers working
with NIH funds will be expected to fully disclose this information.
The loopholes are about to be closed.”
Toward Transparency
Several medical associations have already worked with Grassley’s
investigators, including the American Psychological Association and
American Academy of Cardiology, according to Norman Kahn,
Executive Vice-President and CEO of the Council of Medical
Specialty Societies.
“When all is said and done, they had good experiences with
Grassley’s staff, who listened and learned. And they received nice
letters concluding the investigations. This has been a wake-up call
to specialty societies. There’s already more transparency today, and
we’re heading toward even more.”
The CMSS board met Nov. 15 and approved new FCOI policy guidelines that will be available soon, noted Kahn, and the NIH
launched a model electronic FCOI compliance program on Oct. 10.
Universities are supposed to monitor conflicts when their
researchers receive NIH grants, and the NIH is supposed to monitor conflicts, at least involving payments exceeding $10,000 over a
12-month period, but until recently there has been little top-down
enforcement or oversight.
In 2007, Grassley and Kohl introduced S.2029, the “Physician
Payments Sunshine Act,” which would require drug companies to
disclose all payments to physicians. The information would be
made publicly available online by the US Department of Health
and Human Services. Congress has not yet taken up this reform legislation.
The proposed legislation builds on similar initiatives in
Minnesota, Vermont, Maine and West Virginia, and would apply to
manufacturers with $100 million or more in annual gross revenues.
Penalties for not reporting payments would range from $10,000 to
$100,000 per violation.
Recently, Eli Lilly, Merck and GSK have each promised to
make payment and advisory fees public on their respective websites.
GSK, implicated in the Nemeroff scandal, has vowed to cap all payments to medical academics at $150,000 a year.
“Starting today, the NIH could send a signal that business as
usual is over. The simple threat of losing prestigious and sizable
NIH grants would force accurate financial disclosure," Grassley
recently told the Wall Street Journal.
Wake-Up Call
Academic neurologists share some of the blame for the current
FCOI situation, according to . John C. Morris, the Friedman
Professor of Neurology and Director of the Alzheimer's Disease
Research Center at Washington University at St. Louis School of
Medicine.
A8
ANNALS OF NEUROLOGY
DECEMBER 2008
Sample Letter From Grassley and Kohl
October 16, 2008
Lee C. Bollinger
President
Columbia University
2960 Broadway
New York, NY 10027
Dear Mr. Bollinger:
The United States Senate Special Committee on Aging has jurisdiction over and a
duty to, among other things, the continuing study of all matters pertaining to problems
and opportunities of older people, including their health. The Committee on Finance has
jurisdiction over the Medicare and Medicaid programs and, accordingly, has a responsibility to the more than 80 million Americans who receive health care coverage under those
programs. As Chairman and Ranking Member of these Committees, respectively, we have a
duty to protect the health of Medicare and Medicaid beneficiaries and safeguard taxpayer dollars authorized and appropriated by Congress for those programs.
For the last several years, our Committees have been investigating various aspects of
the pharmaceutical and medical device industries, including consulting arrangements and
funding for Continuing Medical Education (CME). We have compiled evidence documenting the strong ties between these industries and physicians.
As part of our oversight responsibilities, we have been analyzing the policies and
practices that universities and hospitals have in place requiring their physicians to report
outside income. We have concluded that there is a lack of transparency in this area.
To help us better understand these relationships, we would appreciate your office
providing our Committees the following information detailing the outside income from
the following persons from January 1, 2003 to the present:
1. Martin B. Leon, MD;
12. Warren Sherman, MD;
2. Gregg W. Stone, MD;
13. Robert Sommer, MD;
3. Jeffrey W. Moses, MD;
14. Paul Teirstein, MD;
4. Mark A. Apfelbaum, MD; 15. Giora Weisz, MD;
5. Stephane Carlier, MD, PhD; 16. Gary Mintz, MD;
6. Michael B. Collins, MD;
17. Steven Wolff, MD;
7. Antonio Colombo, MD;
18. Alexandra Lansky, MD;
8. William A. Gray, MD;
19. Roxana Mehran, MD;
9. Ajay J. Kirtane, MD, SM;
20. George Dangas, MD;
10. Susheel K. Kodali, MD;
21. Manuela Negoita, MD; and
11. Edward M. Kreps, MD;
22. Victor Yick.
Because reporting practices vary widely from one institution to another, we would
appreciate you also placing this income into a chart, detailing compensation from outside
sources to the persons referenced above. For each payment to the persons mentioned
above from a company or organization, please provide the following information:
Name of payment source;
Date of payment;
Payment description (CME, honorarium, research support, etc.);
Amount of payment; and
Annual total from the payment source.
We would also appreciate a report of all funding provided to Columbia University
from the following companies and organizations from January 1, 2003 to the present:
a. Abbott Laboratories;
b. Medtronic Inc.;
c. Medinol;
d. Boston Scientific;
e. Johnson & Johnson; and
f. Cardiovascular Research Foundation.
Also, please explain the nature of the relationship between Columbia University and
the Cardiovascular Research Foundation (CRF). In response to this request, please provide
all pertinent documents and communications between the University and CRF. The time
span of this request covers January 1, 2003 to the present.
In cooperating with the Committees' review, no documents, records, data nor information related to these matters shall be destroyed, modified, removed or otherwise made
inaccessible to the Committees.
We look forward to hearing from you by no later than October 30, 2008.
Sincerely,
Herb Kohl
Chairman
Special Committee on Aging
Charles E. Grassley
Ranking Member
Committee on Finance
“It appears to me that we in academic neurology are probably
not as aware of the Grassley investigation as we should be,” he says.
“Until recently it has not been uncommon for us to do things for
[industry] to get extra funding for studies, or even for ourselves,
without being fully aware or appreciating how it might appear, especially in terms of public reaction to news reports. Even without any
bias at all on the part of researchers involved, it can appear improp-
er. The separation needs to be made very clear.”
In twenty years there has been an ongoing evolution in FCOI
policies at academic research institutions, according to Morris. “My
sense is that policies have become more sophisticated, but many of
us haven’t kept up – we’re probably less appreciative or aware of all
of the changes,” he notes.
Grotta, however, says that while the discussion might be necessary and overdue, he too believes Grassley’s approach is too heavyhanded. “The rules appear to have been changed without anyone
being told. Suddenly applying a new standard to academic-industry relationships, and implying that all of these are somehow wrong,
is not the right way to go about it. The discussion is a good one.
We should have rules and stick to them. But we can’t be arbitrary,
and this is a witch hunt,” he says.
“I believe the best benchmark is simply this: if you wouldn’t
want the information published on the front page of a major newspaper, don’t do it.”
Due Process Needed
Frank M. Longo, Professor and Chair of Neurology at Stanford
University School of Medicine, also finds fault in the approach
taken by Grassley and Kohl.
“I think it’s healthy for us to look at conflicts of interest and
FCOI policies, but it is just as important that it be done in a systematic way – not anecdotally or on an individual basis,” he says. “The
public’s perception is the reason we have to have strict policies that
are actively enforced. In the past, there were policies, but they probably weren’t enforced very well.”
Stanford adopted strict FCOI guidelines in October 2006, he
explains. Newer policies, like Stanford’s, make sense in the high
stakes world of drug and medical device developments, he adds.
“There are many areas in academic medical research with the
potential for conflict of interest. All of us neurologists have been to
talks where the speakers have received large amounts of money from
pharmaceutical companies, and one can’t help but wonder whether
this influences their views” he said.
The problem with naming individual researchers is that there is
no due process – the media picks up and reports the information,
according to Longo.
“It’s a news story, but it ruins careers before all of the facts are
in,” he says. “You can’t be anecdotal about this. There are rules, and
they have to be policed somehow, but this is a messianic approach
these politicians are taking. Remember, this was the status quo until
very recently. We need more discussion, not prosecution of highprofile individuals by default by politicians and the media before the
issue is placed in its proper context.”
A Simple Solution?
Art Caplan suggests a simple solution, dismissing any need for a system-wide overhaul and especially if it entails adding another layer of
bureaucracy. He says the major problem is the structure of the current system for reporting, and it can be easily addressed – with the
help of the Internal Revenue Service (IRS).
“Universities collect financial information on each faculty
member, and FCOI is assessed by the school, usually by committee.
But they don’t like to disclose the information, and they do not give
much to the NIH. Reporting to the NIH has been very weak, and
some are not disclosing the information,” he notes. “Further, major
drug companies are trying to head things off at the pass by volunteering to post FCOI data on websites for the public to see, but it’s
too late,” says Caplan.
“If we really want disclosure, we might as well simply correlate
researchers’ IRS forms with grants. It would be far more efficient
and would save a lot of paperwork. The government has the information anyway. When all is said and done, taking [additional] steps
to increase research transparency is redundant.” AN
Kurt Samson
Long Ago
in the Annals....
PERIPHERAL NERVE ISCHEMIA: PART 2. ACCUMULATION OF ORGANELLES
KORTHALS JK, KORTHALS MA, WISNIEWSKI HM
DECEMBER 1978
ABSTRACT
Following simultaneous ligation of the aorta and femoral artery in the cat, organelles accumulated in distal portions of the sciatic nerve
and in lower portions of the tibial and personeal nerves. The accumulations were located in the proximal and distal ends of the nerve infarction and delineated the borders of the necrotic area. Topographical analysis of the necrosis and organelle accumulations following ligation
of these main arteries showed the larger nerve fascicles to be more sensitive to ischemia than the smaller ones. The center of a nerve fascicle
was more sensitive than the periphery. The organelles accumulated in ischemic nerves during the first hours after arterial ligation, presumably as a result of lack of energy for fast axoplasmic transport. Later accumulations reflected mechanical block of axoplasmic transport due
to focal necrosis of the nerve. The content of organelle accumulations was similar to that found in lesions resulting from transection except
for the presence of 60 to 70 A filaments at the distal end of the infarction.Three children, two of them siblings, developed a progressive dystonic condition in the first decade of life. The symptoms and signs were milder in the mornings or after a daytime nap but worsened greatly later in the day. One patient became unable to walk by evening. Investigations in two patients revealed a reduced concentration of cerebrospinal fluid homovanillic acid. The two more severely affected patients showed dramatic and sustained improvement with levodopa therapy. The condition bears a clinical resemblance to some reported cases of juvenile Parkinson's disease but is probably a separate disorder.
ANNALS OF NEUROLOGY DECEMBER 2008
A9
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