[Congressional Record Volume 154, Number 104 (Monday, June 23, 2008)]
[Senate]
[Pages S5956-S5958]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PAYMENTS TO PHYSICIANS
Mr. GRASSLEY. Madam President, I started looking at the financial
relationships between physicians and drug companies several years ago.
I first began this inquiry by examining payments to individuals who
served on FDA's Advisory Boards. More recently, I began looking at
payments from drug companies to professors at our nation's medical
schools and more specifically at the payments from Astra Zeneca to a
professor of psychiatry at the University of Cincinnati.
I then moved on to look at several psychiatrists at Harvard and Mass
General Hospital. These physicians are some of the top psychiatrists in
the country, and their research is some of the most important in the
field. They have also taken millions of dollars from the drug companies
and failed to report those payments accurately to Harvard and Mass
General.
For instance, in 2000 the National Institutes of Health awarded one
Harvard physician a grant to study atomoxetine in children. At that
time, this physician disclosed that he received less than $10,000 in
payments from Eli Lilly which makes Straterra, a brand name of
atomoxetine. But Eli Lilly reported that it paid this same physician
more than $14,000 for advisory services that year--a difference of at
least $4,000.
I would now like to report what I have found out about another
researcher--Dr. Alan Schatzberg at Stanford. In the late nineties, Dr.
Schatzberg helped to start a company called Corcept Therapeutics--Dr.
Schatzberg is a copatent owner on a drug developed by Corcept. That
company applied to the Food and Drug Administration for approval to
market Mifepristone for psychotic depression.
Dr. Schatzberg is a well-known psychiatrist and has received several
grants from the National Institutes of Health to study Mifepristone.
While Dr. Schatzberg has reported some of his income from Corcept
Therapeutics to Stanford, he did not report a profit of $109,179 from
the sale of 15,597 shares of Corcept stock on August 15, 2005 because
he was not required to do that under Stanford's rules.
But if it is not required by Stanford, I submit to you that it should
be. Why? Because in his Stanford disclosures, Dr. Schatzberg only had
to report whether he had more than $100,000 of stock in Corcept
Therapeutics. However, his filings with the U.S. Securities and
Exchange Commission show that he has control of 2,738,749 shares of
Corcept stock worth over $6 million.
In addition, in 2002 Dr. Schatzberg did not report any income from
Johnson & Johnson, but the company reported to me that it paid Dr.
Schatzberg $22,000 that year. And in 2004, Dr. Schatzberg reported
receiving between $10,000-$50,000 from Eli Lilly. But Eli Lilly
reported to me that they paid Dr. Schaztberg over $52,000 that year.
Before closing, I would like to say that Stanford has been very
cooperative in this investigation, as have been many of the drug
companies. I ask unanimous consent to have my letter to Stanford
printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
U.S. Senate,
Committee on Finance,
Washington, DC, June 23, 2008.
Dr. John L. Hennessy,
President, Stanford University, Office of the President,
Stanford, CA
Dear Dr. Hennessy: First, I would like to thank you again
for working with me to lower student tuition at Stanford
University (Stanford/University). It was a great leap forward
in the effort to help students afford a quality education.
Next, I would like to bring several other issues to your
attention regarding Stanford, its conflict of interest
policies, and a particular faculty member at your University.
As you know, the United States Senate Committee on Finance
(Committee) has jurisdiction over the Medicare and Medicaid
programs and, accordingly, a responsibility to the more than
80 million Americans who receive health care coverage under
these programs. As Ranking Member of the Committee, I have a
duty to protect the health of
[[Page S5957]]
Medicare and Medicaid beneficiaries and safeguard taxpayer
dollars appropriated for these programs. The actions taken by
thought leaders, like those at Stanford, often have a
profound impact upon the decisions made by taxpayer funded
programs like Medicare and Medicaid and the way that patients
are treated and taxpayer funds expended.
Moreover, and as has been detailed in several studies and
news reports, funding by pharmaceutical companies can
influence scientific studies, continuing medical education,
and the prescribing patterns of doctors. Because I am
concerned that there has been little transparency on this
matter, I have sent letters to almost two dozen research
universities across the United States regarding about 30
physicians. In these letters, I asked questions about the
conflict of interest disclosure forms signed by some of their
faculty. As you know universities like Stanford require
doctors to report their related outside income. But I am
concerned that these requirements are sometimes disregarded.
I have also been taking a keen interest in the almost $24
billion annually appropriated to the National Institutes of
Health (NIH) to fund grants at various institutions such as
Stanford. Institutions are required to manage a grantee's
conflicts of interest. However, I am learning that this task
is made difficult because physicians do not consistently
report all the payments received from drug companies.
To bring some greater transparency to this issue, Senator
Kohl and I introduced the Physician Payments Sunshine Act
(Act). This Act will require drug companies to report
publicly any payments that they make to doctors, within
certain parameters.
I am also writing to assess the implementation of financial
disclosure policies at Stanford University. In response to my
letter of October 25, 2007, Stanford provided me with copies
of the financial disclosure reports that Dr. Alan Schatzberg
filed during the period of January 2000 through June 2007.
My staff investigators carefully reviewed each of Dr.
Schatzberg's disclosure forms and detailed the payments
disclosed. Subsequently, I asked that Stanford confirm the
accuracy of the information. In March 2008, Stanford's Vice
Provost and Dean of Research provided clarifications and
additional information from Dr. Schatzberg pursuant to my
inquiry.
In addition to obtaining information from Stanford, I also
contacted executives at several major pharmaceutical and
device companies and asked them to list the payments that
they made to Dr. Schatzberg during the years 2000 through
2007. These companies voluntarily and cooperatively reported
additional payments that do not appear to have been disclosed
to Stanford by Dr. Schatzberg. For instance, in 2002 Dr.
Schatzberg did not report any income from Johnson & Johnson,
but the company reported to me that it paid Dr. Schatzberg
$22,000 that year. And in 2004, Dr. Schatzberg reported
receiving between $10,000-$50,000 from Eli Lilly. But Eli
Lilly reported to me that they paid Dr. Schatzberg over
$52,000 that year.
Because these disclosures do not match, I am attaching a
chart intended to provide to Stanford a few examples of the
data reported to me. This chart contains columns showing the
payments disclosed in the forms Dr. Schatzberg filed with
Stanford and the amounts reported by several drug and device
companies.
The lack of consistency between what Dr. Schatzberg
reported to Stanford and what several drug companies reported
to me seems to follow a pattern of behavior. More
specifically, I have uncovered inconsistent reporting
patterns at the University of Cincinnati, and at Harvard
University and Mass General Hospital.
Institutional and NIH Policies
Let me now turn to another matter that is of concern.
Stanford requires every faculty member to make an annual
disclosure related to both conflict of commitment (where no
financial information is requested), and conflict of
interest. As noted to me in your letter dated March 14, 2008,
``It is our obligation to avoid bias in research, including
that conducted with federal funds.''
Based upon the information provided to me to date, Stanford
has a zero dollar threshold for disclosures for research
involving human subjects. Faculty members are required to
disclose a range of amounts received from outside
relationships that are related to a faculty member's research
activities (such as participation on advisory boards or
boards of directors, or consulting). In most instances, the
University's standard for a significant financial interest is
whether the faculty member received $10,000 or more in
income, holds $10,000 or more in equity for publicly traded
companies, or has any equity in the company in the event the
company is privately held.
Further, federal regulations place several requirements on
a university/hospital when its researchers apply for NIH
grants. These regulations are intended to ensure a level of
objectivity in publicly funded research, and state in
pertinent part that NIH investigators must disclose to their
institution any ``significant financial interest'' may appear
to affect the results of a study. NIH interprets
``significant financial interest'' to mean at least $10,000
in value or 5 percent ownership in a single entity.
Again based upon the information provided to me, it appears
that Stanford takes failures to report outside income quite
seriously. As noted in your correspondence dated March 14,
2008, ``It is our obligation to avoid bias in research,
including that conducted with federal funds.'' You then
described a Stanford investigation conducted in 2006
regarding a researcher who failed to report gifts, meals and
trips from a device company. That faculty member was later
terminated.
Based upon information available to me, it appears that Dr.
Schatzberg received numerous NIH grants to conduct studies
involving Mifepristone for treating depression. Corcept
Therapeutics, a publicly traded company, has applied to the
Food and Drug Administration for approval to market
Mifepristone for psychotic depression. These grants funded
studies during the years 2000 through 2007 that examined the
treatment of psychotic major depression using Mifepristone.
During these years, Dr. Schatzberg, consistent with
Stanford's conflict policy, disclosed to Stanford a financial
relationship with Corcept Therapeutics (Corcept) including
stock ownership of over $100,000 and payments for activities
including its Board of Directors, Advisory Board Membership,
consulting, licensing agreements, and royalties. According to
his disclosures, these payments were between $50,000 to
$100,000 in the years 2003 through 2005, and between $10,000
to $50,000 in the years 2001, 2002, 2006, and 2007.
However, it appears based upon the information available,
Dr. Schatzberg did not and was not required to report a
profit of $109,179 from the sale of 15,597 shares of Corcept
stock on August 15, 2005. This transaction is found in his
publicly available filings with the U.S. Securities and
Exchange Commission (SEC). Earlier that year, Dr. Schatzberg
began enrolling an estimated 100 patients for a clinical
trial, sponsored by the NIH, to evaluate Mifepristone to
treat psychotic depression.
Further, while Dr. Schatzberg appropriately disclosed to
Stanford that his stock shares were valued at over $100,000,
I am not certain that this number captures the stocks' true
value. Dr. Schatzberg carries an equity interest in Corcept
with over 2 million shares of stock. For instance, as of
January 31, 2008, he reported to the SEC that he held
2,438,749 shares of Corcept stock, with sole voting power
for 2,738,749 shares. On June 12, 2008, Corcept stock
closed at $2.24 a share, meaning that his stock is
potentially worth over $6 million. Obviously, $6 million
is a dramatically higher number than $100,000 and I am
concerned that Stanford may not have been able to
adequately monitor the degree of Dr. Schatzberg's
conflicts of interest with its current disclosure policies
and submit to you that these policies should be re-
examined.
In light of the information set forth above, I ask your
continued cooperation in examining conflicts of interest. In
my opinion, institutions across the United States must be
able to rely on the representations of its faculty to ensure
the integrity of medicine, academia, and the grant-making
process. And the NIH must rely on strong institutional
conflict of interest policies to ensure the integrity of the
grant making process. At the same time, should the Physician
Payments Sunshine Act become law, institutions like yours
will be able to access a database that will set forth the
payments made to all doctors, including your faculty members.
Accordingly, I request that Stanford respond to the
following questions and requests for information. For each
response, please repeat the enumerated request and follow
with the appropriate answer.
1. For each of the NIH grants received by Dr. Schatzberg,
please confirm that he reported to Stanford University's
designated official ``the existence of [a] conflicting
interest.'' Please provide separate responses for each grant
received for the period from January 1, 2000 to the present,
and provide any supporting documentation for each grant
identified.
2. For each grant identified above, please explain how
Stanford ensured ``that the interest has been managed,
reduced, or eliminated.'' Please provide an individual
response for each grant that Dr. Schatzberg received from
January 2000 to the present, and provide any documentation
supporting each claim.
3. Did Dr. Schatzberg violate any federal or Stanford
policies by not revealing his stock sale in 2005? If not, why
not?
4. Is Stanford considering any changes in its disclosure
policies to more fully capture the degree of a conflict when
a faculty member owns shares in a company that are in excess
of $100,000?
5. Please report on the status of any possible reviews of
research misconduct and/or discrepancies in disclosures by
Dr. Schatzberg, including what action if any will be
considered.
6. Please report if a determination can be made as to
whether or not Dr. Schatzberg violated guidelines governing
clinical trials and the need to report conflicts of interest
to an institutional review board (IRB). Please respond by
naming each clinical trial for which the doctor was the
principal investigator, along with confirmation that
conflicts of interest were reported, if possible.
7. Please provide a total dollar figure for all NIH monies
received annually by Stanford University. This request covers
the period of 2000 through 2007.
8. Please provide a list of all NIH grants received by
Stanford University. This request covers the period of 2000
through 2007. For each grant please provide the following:
a. Primary Investigator;
[[Page S5958]]
b. Grant Title;
c. Grant number;
d. Brief description; and
e. Amount of Award.
Thank you again for your continued cooperation and
assistance in this matter. As you know, in cooperating with
the Committee's review, no documents, records, data or
information related to these matters shall be destroyed,
modified, removed or otherwise made inaccessible to the
Committee.
I look forward to hearing from you by no later than July
xx, 2008. All documents responsive to this request should be
sent electronically in PDF format to Brian_Downey@finance-
rep.senate.gov. If you have any questions, please do not
hesitate to contact Paul Thacker at (202) 224-4515.
Sincerely,
Charles E. Grassley,
Ranking Member.
SELECTED DISCLOSURES BY DR. SCHATZBERG AND RELATED INFORMATION REPORTED
BY PHARMACEUTICAL COMPANIES AND DEVICE MANUFACTURERS
------------------------------------------------------------------------
Disclosure filed Amount company
Year Company with Institution reported
------------------------------------------------------------------------
2000............ Bristol Myers No amount provided $1,000
Squibb.
Eli Lilly......... No amount provided $10,070
2001............ Bristol Myers No amount provided $4,147
Squibb.
Corcept >$10,000<$50,000 a n/a
Therapeutics.
Eli Lilly......... No amount provided $10,788
2002............ Bristol-Myers Not reported...... $2,134
Squibb.
Corcept >$100,000 b....... n/a
Therapeutics.
Corcept <$10,000 c........ n/a
Therapeutics.
Corcept <$10,000 d........ n/a
Therapeutics.
Eli Lilly......... No amount provided $19,788
Johnson & Johnson. Not reported...... $22,000
2003............ Bristol-Myers No amount provided $4,000
Squibb.
Corcept <$10,000 e........ n/a
Therapeutics.
Corcept >$10,000<$50,000 f n/a
Therapeutics.
Corcept >$100,000 g....... n/a
Therapeutics.
Corcept <$10,000 h........ nfa
Therapeutics.
Corcept <$10,000 i........ n/a
Therapeutics.
Eli Lilly......... No amount provided $18,157.34
j.
2004............ Bristol-Myers <$10,000.......... $0.00
Squibb.
Corcept >$10,000<$50,000a. n/a
Therapeutics.
Corcept >$100,000 g....... n/a
Therapeutics.
Eli Lilly......... >$10,000<$50,000 k $52,134
Pfizer............ Not reported...... $2,500
2005............ Bristol-Myers <$10,000.......... $0
Squibb.
Corcept >$10,000<$50,000 a n/a
Therapeutics.
Corcept >$100,000 g....... na
Therapeutics.
Eli Lilly......... >$10,000-<$50,000. $9,500
Pfizer............ No amount provided $2,000
2006............ Bristol-Myers Not reported...... l $6,000
Squibb.
Corcept <$10,000 h........ n/a
Therapeutics.
Corcept >$10,000<$50,000.. n/a
Therapeutics.
Corcept >$100,000 g....... n/a
Therapeutics.
Eli Lilly......... >$10,000<$50,000 m $20,500
Pfizer............ Not reported...... $300
2007............ Eli Lilly......... Not reported...... $10,063
------------------------------------------------------------------------
a Physician disclosed payment for Advisory Board Membership, Board of
Directors, and consulting.
b Physician disclosed payment for equity.
c Physician disclosed payment for serving as a Director, consultant.
d Physician disclosed payment for royalties.
e Physician disclosed payment for serving as a Advisory Board Member.
f Physician disclosed payment for consulting.
g Physician disclosed stock ownership.
h Physician disclosed payment for licensing agreement.
i Physician disclosed payment for serving as Director, Board of
Directors.
j Physician disclosed payment of <$10,000 for consulting, and did not
provide amounts received for research, grants and gift funding.
k Physician disclosed payment of <$10,000 for Advisory Board Membership,
and >$10,000<$50,000 for honoraria for papers or lectures, and
consulting.
l Bristol-Myers Squibb stated that Stanford intended to pay Dr.
Schatzberg $6,000 for conducting an annual course for which the
company provides a grant.
m Physician disclosed payment for serving as a Advisory Board Member and
consulting.
Note 1: When a Physician named a company in a disclosure but did not
provide an amount, the text reads ``no amount reported.'' When a
Physician did not list the company in the disclosure, the column reads
``not reported.'' The Committee contacted several companies for
payment information and the notation nla (not available) reflects that
a company was not contacted.
Note 2: The Committee was not able to estimate the total amount of
payments disclosed by Dr. Schatzberg during the period January 2000
through June 2007 due to the fact that some amounts were not provided
and in other instances ranges were used. Information reported by the
pharmaceutical companies indicate that they made additional payments
that are not reflected in his disclosures.
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