Gün geçmesin ki bilim dünyası yeni bir ilaç skandalı ile çalkalanmasın. Bundan 10-15 sene önce saygın bir sektör olan ilaç sektörü neden itibarını kaybetti ve en itimad edilmez sektörlerden birisi haline gelmeye başladı?... Kar.. kar.. kar... daha fazla kar.. Yeni molekül keşiflerinin 1990 lardan sonra durma noktasına gelmesi, milyonlarca dolar harcanarak yeni keşfedilen ilaçların çoğunun piyasaya çıkmadan veya piyasaya çıktıktan bir-kaç sene sonra ciddi yan etkileri sebebi ile yasaklanması sebebi ile özellikle çok uluslu şirketler zora düşmüş ve hissedarlarını tatmin için bazıları etik dışı, değişik stratejiler seçmek zorunda kalmıştır. Yeni ilaç keşfedilememesinin kısa bir süre sonra jenerik ilaç firmalarını da etkilemesi kaçınılmazdır. Bu durumda ne olacak?
1. Araştırmalara devam
2. Mevcut ilaçları kombine ederek yeni ilaç yaratmak
3. Mevcut ilaçların endikasyonlarını genişletmek
4. Eldeki ilaçlar için yeni hastalıklar icat etmek.
Her nekadar ilaç firmaları araştırmalarına devam etmekteyse de, araştırmalarında büyük değişikler olmaya başladı. Roche ve Novartis gibi büyük firmaların bazıları konvansiyonel ilaç araştırmalarını hemen hemen tamamen durdurdular ve araştırmalarını biyo-teknoloji veya high-tec ilaçlara kaydırdılar. Diğer çok uluslularda bu yönde çalışmalara başladılar. Konvansiyonel ilaç araştırmaları ise Çin ve Hindistan gibi ülkelere kaymakta, Türkiye gibi ülkeler ise herzaman olduğu gibi yan gelip yatmakta...
Merck, Schering, Pf,zer gibi firmalar ise eski ayları kırpıp kırpıp yıldız yapma peşinde. Antihipertansif-diüretik, statin-statin, antiallerjik-antiallerjik, analjezik-analjezik gibi eldeki ilaçların sabit doz kombinasyonlarını yaparak ve bunlara patent-veri koruması alarak patenti dolmuş ilaçlarının piyasada kalmasını sağlıyolar. Maalesef bu kombinasyonların çoğu tek bir ilaca üstünlük göstermemekte, hatta toksik etki göstermekte. Bazı kombinasyonların ise, NSAID-proton pompası inhibitörleri, NSAID-opioid, NSAID-triptan kombinasyonları gibi, pazardan ciddi pay alacak gibi görünmekte. Bu konuda da ulusal ilaç firmalarımız havalarını almakta...
İlaç pazarını büyütmenin diğer bir yolu da doğru-yanlış yeni endikasyonlar yaratmak. Örneğin antiepileptiklerin migren dahil çeşitli ağrılı durumlarda kullanılması, Statinlerin, NSAID lerin Alzhaimerde kullanımları gibi. Bu güne kadar yeni endikasyon ile kullanılan ilaçların tedaviye getirdiği artı bir değer olmamıştır. Örneğin, Topamax’ın migren proflaksiisne getirdiği tek yenilik, tedavinin astronomik boyuta ulaşmasıdır. Yıllardır migren proflaksisisnde kullanılan ve çok ucuz olan propranolola herhangi bir üstünlük sağlamamıştır... Antipisikotiklerin demansta kullanımı fayda yerine zarar getirmiş ve ölümlere sebep olmuştur... SSRI lerin çocuklarda kullanımının nelere sebep olduğu ve hangi sahtekarlıklarla pazarlandığı bir önceki yazımızda uzun boylu anlatılmıştı.
Pazarı genişletmek için ilaç firmaları tarafından yeni hastalık icat edilmesi ise bu konudaki en aşağılık sömürü sistemidir. Bunlardan bazıları ciddi bilimsel kuruluşlar tarafından lanetlenmişler isede yinede bazı firmaların bazı sahtekar yandaşları bunları hastaların kanını emerek desteklemektedirler... Bu konuya daha öncek yazılarımızda uzun uzun değinmiştik. Arzu edenler, metabolik sendrom, kadın seksüel disfonksiyonu, erkek osteoporozu gibi “Acı İlaç” arşivinden bulabilirler.
Bütün bu oyunlar oynanırken, bir taraftan sanayi-akademi-bürokrat işbirliği sağlanırken, diğer taraftan sanayi-politikacı-basın işbirliğinden faydalanılabilinilmektedir. Örneğin, ABD başkanı Bush babasının ve kardeşinin yönetimde olduğu bir firmanın ilaçlarını sattırabilmek için tüm Amerikalıların akıl hastalığı yönünden taranmasını istemiştir (BMJ 328:1458, 2004; www.whitehouse.gov/infocus/newfreedom/toc-2004.html). Bunun karşılğı bazı ilaç firmaları başkanlık seçimlerine önemli destek vermişlerdir. Örneğin, Lilly ilaç firması 2000 seçimlerinde %80’i BUSH’un seçim kampanyasına olmak üzere 1.6 milyon dolar harcamıştır. Bush’un emri üzerine ilaç satışlarını artırmak için çeşitli programlar başlatılmıştır. Bunlardan birisi “TEXAS” projesidir.Texas projesinde (ilaç firmaları ve Robert Wood Jhonson fonu tarafından desteklenmekte) klasik ilaçlarla tedavi yerine ilaç firmalarının etkileri ile algoritmalar değiştirlmiş, yeni antedepressanlar ve antipsikotikler kullanılmaya başlanmıştır. BMJ’ e göre politikacı-ilaç sanayii işbirliği akıl hastalıklarının tedavisinde faydası şüpheli, ölümcül yan etkilere sahip, pahalı ilaçların kullanılmasına yol açmıştır ( Bu konuda detaylı bilgi isteyenler lütfen ekteki akılalmaz dosyayı okusunlar). Texas algoritmasında ilk tercih atipik antipiskotik olarak yer alan olanzapin (ZYPREXA) 2003 yılında tüm dünyada 4.2 milyar dolar hasılat yapmıştır. ABD de ZYPREXA’nın % 70 inin devlet tarafından (medicare ve medicaid) ödenmiştir (G. Harris, New York Times).
Bir önceki yazımızda Harvard Tıp Fakültesi satılık çocuk psikiyatristlerinin ilaç firmalarından aldıkları para karşılığı nasıl hastalık yarattıklarını anlatmıştık. Joseph Biederman’ın çabaları sayesinde çocuklarda bipolar bozukluk tanısı %4000 artıyor, ilaç firmaları milyarlarca dolar kazanıyor ve milyonlarca çocukta gereksiz ciddi yan etkileri olan ilaçları kullanmaya başlıyorlar. Sonuç: çocuklarda intiharlar, cinayetler, suç oranında artış…. New York Times’a göre ,bu son olaylar psikiyatrik endüstrinin nekadar “dishonest” (lügata göre: dürüst olmayan, sahtekâr, yalancı. namussuz, sahtekâr, serefsiz. namussuz,sahtekar. namussuz. s. dürüst olmayan, sahtekâr, yalancı. namussuz. sahtekâr, hileli, aldatıcı; karaktersiz; namussuz, şerefsiz, dürüst olmayan) olduğunu ortaya çıkarttı. İsim yapmış sözde bilim adamlarının ilaç sanayii ile olan ekonomik bağları bunların dürüstlüğünü, güvenilirliği ve kişilik bütünlüklerini yerle bir ederek, bu satılmışların ilaç pazarlayıcı (drug pusher, sokaklarda uyuşturucu pazarlayanlar için kullanılan bir terim), hastalık yaratıcı ve zavallı hastaları sömüren yaratıklar haline getirmiştir.
Özellikle psikiyatrik endüstri son 15 senedir devamlı tekrarlayan bilimsel sahtekarlıklar, ekonomik yolsuzluk ve entellektüel ahlaksızlığa dayanmakta ve çocuklarda şeker hastalığı, obesite, intihar ve vahşi davranışlara sebep olan tehlikeli ilaçlar yaygın şekilde kullandırılmaya başlanmıştır. Dr. Biedermanlar gibiler bipolar bozukluk ve dikkat eksikliği gibi ne olduğu tam olarak bilinmeyen hastalıklara, bazılarına FDA’in onay vermediği, ilaçları pompalamakta ve bunun karşılığı belirli ilaç firmalarından milyonlarca (1.6 milyon dolar) almışlar. Biederman 4 yaş gibi çok küçük çocuklarda bile santral sinir sistemini ciddi olarak etkileyecek ilaçları kullanmaktan çekinmemiştir. Son projelerinden birisi 4-6 yaş arasındaki çocuklarda Astra Zeneca’nın Seroquel’ini deneyerek beyinlerinde neler olduğunu !!?? araştırmak… Dürüst bilim adamları ve yazarlar bunun Nazi Almanyasındaki araştırmalardan farkı olmadığını ileri sürmektedirler (Human medical experimentation in the United States: The shocking true history of modern medicine and psychiatry (1833-1965); Top Psychiatric Researcher Dr. Biederman Caught Lying about $1.6 Million in Drug Money; Performed Medical Experiments on Children; http://www.cchr.org/)
Umarız bu yazılarımız bizdeki vurdum duymaz akademisyen, meslek örgütleri, bürokrat ve sanayii mensuplarını biraz uyandırır???
Ekli dosya: TEXAS projesi ve sahtekarlıklar, 66 sayfa
Not:
- Çeşitli komisyonlarda ve etik kurullarda çalışan ve ilaç sanayii ile çok ciddi çıkar ilişkisi olanlar hakkında yetkililerden çıt çıkmıyor. Sükut ikrardan mı geelmekte?
- Son birkaç gündür eczacıların 3 kuruşluk karları ile nasıl ilaç harcamalarının sübvansiye edilmeye çalışıldığını (!) hep beraber gördük. Son 5-6 senedir eczacısı, sanayicisi, hastası kendilerinden birşeyler verdi ama bir kurum hep karlı çıktı… Bunlar kimler acaba? Fortune 500 deki en fazla net satış yapan listesine bakarsanız bunların kimler olduğunu anlarsınız…
- Eczane iskontoları dolayısı ile devletin 400 milyon YTL kazandığı açıklanmakta ve bu iskonto alınmaz ise devletin zarar edeceği söylenmekte. Söyleye söyleye dilimizde tüy bitti.. Halen her sene akılsız ilaç kullanımı dolayısı ile 2-3 milyar doları çöpe atıyoruz ve akılsızlığımızın ceremesini eczacıların çekmesini istiyoruz. Size küçük bir örnek… Bilindiği gibi NSAID lerin effervessan, saşe gibi farmasötik formları geri ödenmemekte ama bazı liquid jeller ödenmekte . Mesela diyelim!.. 20 adet 200 mg ibuprofen ihtiva eden NUROFEN (Aİ) 1.85 YTL, 20 adet 200 mg ibuprofen ihtiva eden ADVİL LİQUI-GELS (Wyeth) 5.33 YTL… Hasta neden boşu boşuna aşırı katkı ödüyor, bunun avantajı nedir? (İlgili firma dahil, herkese cevap hakkı vereceğimize söz veririz…)
- ABD Senato tutanakları : Doktorlara ilaç firmaları tarafından para ödenmesi
Congressional Record: June 23, 2008 (Senate)]
[Page S5956-S5958]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]
[DOCID:cr23jn08-118]
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.
.
[Congressional Record: June 4, 2008 (Senate)]
[Page S5029-S5033]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]
[DOCID:cr04jn08-168]
PAYMENTS TO PHYSICIANS
Mr. GRASSLEY. Mr. President, starting last year, I started looking at
the financial relationships between physicians and drug companies. I
first began this inquiry by examining payments from Astra Zeneca to Dr.
Melissa DelBello, a professor of psychiatry at the University of
Cincinnati.
In 2002, Dr. DelBello published a study that found that Seroquel
worked for kids with bipolar disorder. The study was paid for by Astra
Zeneca, and the following year that company paid Dr. DelBello around
$100,000 for speaking fees and honoraria. In 2004, Astra Zeneca paid
Dr. DelBello over $80,000.
Today, I would like to talk about three physicians at Harvard Medical
School--Drs. Joseph Biederman, Thomas Spencer, and Timothy Wilens. They
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.
Out of concern about the relationship between this money and their
research, I asked Harvard and Mass General Hospital last October to
send me the conflict of interest forms that these doctors had submitted
to their institutions. Universities often require faculty to fill these
forms out so that we can know if the doctors have a conflict of
interest.
The forms I received were from the year 2000 to the present.
Basically, these forms were a mess. My staff had a hard time figuring
out which companies the doctors were consulting for and how much money
they were making. But by looking at them, anyone would be led to
believe that these doctors were not taking much money. Over the last 7
years, it looked like they had taken a couple hundred thousand dollars.
But last March, Harvard and Mass General asked these doctors to take
a second look at the money they had received from the drug companies.
And this is when things got interesting. Dr. Biederman suddenly
admitted to over $1.6 million dollars from the drug companies. And Dr.
Spencer also admitted to over $1 million. Meanwhile, Dr. Wilens also
reported over $1.6 million in payments from the drug companies.
The question you might ask is: Why weren't Harvard and Mass General
watching over these doctors? The answer is simple: They trusted these
physicians to honestly report this money.
Based on reports from just a handful of drug companies, we know that
even these millions do not account for all of the money. In a few
cases, the doctors disclosed more money than the drug companies
reported. But in most cases, the doctors reported less money.
For instance, Eli Lilly has reported to me that they paid tens of
thousands of dollars to Dr. Biederman that he still has not accounted
for. And the same goes for Drs. Spencer and Wilens.
What makes all of this even more interesting is that Drs. Biederman
and Wilens were awarded grants from the National Institutes of Health
to study the drug Strattera.
Obviously, if a researcher is taking money from a drug company while
also receiving Federal dollars to research that company's product, then
there is a conflict of interest. That is why I am asking the National
Institutes of Health to take a closer look at the grants they give to
researchers. Every year, the NIH hands out almost $24 billion in
grants. But nobody is watching
[[Page S5030]]
to ensure that the conflicts of interest are being monitored.
That is why Senator Kohl and I introduced the Physician Payments
Sunshine Act. This bill will require companies to report payments that
they make to doctors. As it stands right now, universities have to
trust their faculty to report this money. And we can see that this
trust is causing the universities to run afoul of NIH regulations. This
is one reason why industry groups such as PhRMA and Advamed, as well as
the American Association of Medical Colleges, have all endorsed my
bill. Creating one national reporting system, rather than relying on a
hodge-podge of state systems and some voluntary reporting systems, is
the right thing to do.
Before closing, I would like to say that Harvard and Mass General
have been extremely cooperative in this investigation, as have Eli
Lilly, Astra Zeneca and other companies. I ask unanimous consent that
my letters to Harvard, Mass General, and the NIH be printed 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 4, 2008.
Elias A. Zerhouni, M.D.
Director, National Institutes of Health,
Bethesda, Maryland.
Dear Director Zerhouni: As a senior member of the United
States Senate and the Ranking Member of the Committee on
Finance (Committee), I have a duty under the Constitution to
conduct oversight into the actions of executive branch
agencies, including the activities of the National Institutes
of Health (NIH/Agency). In this capacity, I must ensure that
NIH properly fulfills its mission to advance the public's
welfare and makes responsible use of the public funding
provided for medical studies. This research often forms the
basis for action taken by the Medicare and Medicaid programs.
Over the past number of years, I have become increasingly
concerned about the lack of oversight regarding conflicts of
interest relating to the almost $24 billion in annual
extramural funds that are distributed by the NIH. In that
regard, I would like to take this opportunity to notify you
about five problems that have come to my attention on this
matter.
First, it appears that three researchers failed to report
in a timely, complete and accurate manner their outside
income to Harvard University (Harvard) and Massachusetts
General Hospital (MGH). By not reporting this income, it
seems that they are placing Harvard and MGH in jeopardy of
violating NIH regulations on conflicts of interest. I am
attaching that letter for your review and consideration.
Second, I am requesting an update about a letter I sent you
last October on problems with conflicts of interest and NIH
extramural funding regarding Dr. Melissa DelBello at the
University of Cincinnati (University). In that letter, I
notified you that Dr. DelBello receives grants from the NIH,
however, she was failing to report her outside income to her
University.
Third, the Inspector General for the Department of Health
and Human Services Office (HHS OIG) released a disturbing
report last January which found that NIH provided almost no
oversight of its extramural funds. But your staff seemed to
show little interest in this report. In fact, Norka Ruiz
Bravo, the NIH deputy director of extramural programs was
quoted in The New York Times saying, ``For us to try to
manage directly the conflict-of-interest of an NIH
investigator would be not only inappropriate but pretty much
impossible.''
Fourth, I am dismayed to have read of funding provided to
several researchers from the Foundation for Lung Cancer:
Early Detection, Prevention & Treatment (Foundation). Dr.
Claudia Henschke and Dr. David Yankelevitz are two of the
Foundation's board members. As reported by The New York
Times, the Foundation was funded almost entirely with monies
from tobacco companies, and this funding was never fully
disclosed. Monies from the Foundation were then used to
support a study that appeared in The New England Journal of
Medicine (NEJM) back in 2006 regarding the use of computer
tomography screening to detect lung cancer. The NEJM
disclosure states that the study was supported also by NIH
grants held by Drs. Henschke and Yankelevitz.
Regarding the lack of transparency by Dr. Henschke and Dr.
Yankelevitz, National Cancer Institute Director John
Niederhuber told the Cancer Letter, ``[W]e must always be
transparent regarding any and all matters, real or perceived,
which might call our scientific work into question.''
The NEJM later published a clarification regarding its
earlier article and a correction revealing that Dr. Henschke
also received royalties for methods to assess tumors with
imaging technology. There is no evidence that the
Foundation's tobacco money or Dr. Henschke's royalties
influenced her research. But I am concerned that the funding
source and royalties may have not been disclosed when the NIH
decided to fund Dr. Henschke.
Fifth, I sent you a letter on April 15, outlining my
concerns about a report on the National Institute of
Environmental Health Sciences (NIEHS). That report found 45
cases at the NIEHS where extramural grants had not receiving
sufficient peer review scores but were still funded. This
finding is yet another example that the NIH provides little
oversight for its extramural program.
Dr. Zerhouni, you faced similar scandals back in 2003 when
it came to light that many NIH intramural researchers enjoyed
lucrative arrangements with pharmaceutical companies. It took
you some time, but you eventually brought some transparency,
reform and integrity back to NIH. As you told Congress during
one hearing, ``I have reached the conclusion that drastic
changes are needed as a result of an intensive review by NIH
of our ethics program, which included internal fact-finding
as well as an external review by the Blue Ribbon Panel.''
NIH oversight of the extramural program is lax and leaves
people with nothing more than questions--$24 billion worth of
questions, to be exact. I am interested in understanding how
you will address this issue. American taxpayers deserve
nothing less.
In the interim, I ask you to respond to the following
requests for information and documents. In responding to each
request, first repeat the enumerated question followed by the
appropriate response. Your responses should encompass the
period of January 1, 2000 to April 1, 2008. I would
appreciate receiving responses to the following questions by
no later than June 18, 2008:
1. Please explain what actions the NIH has or will initiate
to provide better oversight and transparency for its
extramural funding program.
2. Please explain how often the NIH has investigated and/or
taken action regarding a physician's failure to report a
``significant financial interest,'' as defined by NIH
regulation. For each investigation, please provide the
following information:
a. Name of the Doctor(s) involved;
b. Date investigation began and the date ended;
c. Specific allegations which triggered investigation;
d. Findings of the investigation; and
e. Actions taken by the NIH, if any.
3. Since receiving notice that the University of Cincinnati
was provided incomplete information from Dr. DelBello
regarding her outside income, what steps has/will NIH take to
address this issue? Please be specific.
4. Please provide a list of all NIH grants received by Dr.
DelBello. For each grant, please provide the following:
a. Name of grant;
b. Topic of grant; and
c. Amount of funding for grant.
5. Please provide a list of any other interactions that Dr.
DelBello has had with the NIH to include membership on
advisory boards, peer review on grants, or the like.
6. Since reports appeared in the press regarding the
undisclosed funding of the Foundation for Lung Cancer: Early
Detection, Prevention & Treatment, what steps has/will NIH
take to address this issue? Please provide all external and
internal communications regarding this issue.
7. Please provide a list off all NIH grants received by Dr.
Claudia Henschke. For each grant, please provide the
following:
a. Name of grant;
b. Topic of grant; and
c. Amount of funding for grant.
8. Please provide a list of any other interactions that Dr.
Henschke has had with the NIH to include membership on
advisory boards, peer review on grants, or the like.
9. Please provide a list off all NIH grants received by Dr.
David Yankelevitz. For each grant, please provide the
following:
a. Name of grant;
b. Topic of grant; and
c. Amount of funding for grant.
10. Please provide a list of any other interactions that
Dr. Yankelevitz has had with the NIH to include membership on
advisory boards, peer review on grants, or the like.
11. Please provide a list off all NIH grants received by
Dr. Joseph Biederman. For each grant, please provide the
following:
a. Name of grant;
b. Topic of grant; and
c. Amount of funding for grant.
12. Please provide a list of any other interactions that
Dr. Biederman has had with the NIH to include membership on
advisory boards, peer review on grants, or the like.
13. Please provide a list off all NIH grants received by
Dr. Timothy Wilens. For each grant, please provide the
following:
a. Name of grant;
b. Topic of grant; and
c. Amount of funding for grant.
14. Please provide a list of any other interactions that
Dr. Wilens has had with the NIH to include membership on
advisory boards, peer review on grants, or the like.
I request your prompt attention to this matter and your
continued cooperation. I also request that the response to
this letter contain your personal signature. If you have any
questions please contact my Committee staff, Paul Thacker at
(202) 224-4515. Any formal correspondence should be sent
electronically in PDF searchable format to brian--
Sincerely,
Charles E. Grassley,
Ranking Member.
[[Page S5031]]
____
U.S. Senate,
Committee on Finance,
Washington, DC, June 4, 2008.
Dr. Drew Gilpin Faust,
President, Harvard University,
Massachusetts Hall, Cambridge, MA.
Dr. Peter L. Slavin,
President, Massachusetts General Hospital (Partners
Healthcare), Boston, MA.
Dear Drs. Faust and Slavin: 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 Medicare and Medicaid beneficiaries and safeguard taxpayer
dollars appropriated for these programs. The actions taken by
thought leaders, like those at Harvard Medical School who are
discussed throughout this letter, 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 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. In these letters, I
asked questions about the conflict of interest disclosure
forms signed by some of their faculty. Universities require
doctors to report their related outside income, but I am
concerned that these requirements are disregarded sometimes.
I have also been taking a keen interest in the almost $24
billion annually appropriated to the National Institutes of
Health to fund grants at various institutions such as yours.
As you know, institutions are required to manage a grantee's
conflicts of interest. But 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 writing to try and assess the implementation of
financial disclosure policies of Harvard University (Harvard)
and Massachusetts General Hospital (MGH/Partners), (the
Institutions). In response to my letters of June 29, October
25, and October 26, 2007, your Institutions provided me with
the financial disclosure reports that Drs. Joseph Biederman,
Thomas Spencer, and Timothy Wilens (Physicians) filed during
the period of January 2000 through June 2007.
My staff investigators carefully reviewed each of the
Physicians' disclosure forms and detailed the payments
disclosed. I then asked that your Institutions confirm the
accuracy of the information. In March 2008, your Institutions
then requested additional information from the Physicians
pursuant to my inquiry. That information was subsequently
provided to me.
In their second disclosures to your Institutions, the
Physicians revealed different information than they had
disclosed initially to your respective Institutions. On April
29, 2008, I received notification from Harvard Medical
School's Dean for Faculty and Research Integrity that he has
referred the cases of these Physicians to the Standing
Committee on Conflicts of Interest and Commitment (``Standing
Committee''). The Chief Academic Officer (CAO), Partners
HealthCare System, also wrote me that Partners will look to
the Standing Committee to conduct the initial factual review
of potential non-compliance that are contained in both the
Harvard Medical School Policy and the Partners Policy. In
addition, the CAO stated that, in addition to the Standing
Committee's review process, Partners will conduct its own
independent review of conflicts of interest disclosures these
Physicians submitted separately to Partners in connection
with publicly funded research and other aspects of Partners
Policy. I look forward to being updated on these reviews in
the near future.
In addition, I contacted executives at several major
pharmaceutical companies and asked them to list the payments
that they made to Drs. Biederman, Spencer, and Wilens during
the years 2000 through 2007. These companies voluntarily and
cooperatively reported additional payments that the
Physicians do not appear to have disclosed to your
Institutions.
Because these disclosures do not match, I am attaching a
chart intended to provide a few examples of the data that
have been reported me. This chart contains three columns:
payments disclosed in the forms the physicians filed at your
Institutions, payments revealed in March 2008, and amounts
reported by some drug companies.
I would appreciate further information to see if the
problems I have found with these three Physicians are
systemic within your Institutions.
INSTITUTIONAL AND NIH POLICIES
Both Harvard and MGH/Partners have established an income de
minimus limit. This policy forbids researchers working at
your Institutions from conducting clinical trials with a drug
or technology if they receive payments over $20,000 from the
company that manufactures that drug or technology. Prior to
2004, the income de minimus limit established by your
institutions was $10,000.
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'' that 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.
Based upon information available to me, it appears that
each of the Physicians identified above received grants to
conduct studies involving atomoxetine, a drug that sells
under the brand name Strattera. For example:
In 2000, the NIH awarded Dr. Biederman a grant to study
atomoxetine in children. At that time, Dr. Biederman
disclosed that he received less than $10,000 in payments from
Eli Lilly & Company (Eli Lilly). But Eli Lilly reported that
it paid Dr. Biederman more than $14,000 for advisory services
that year--a difference of at least $4,000.
In 2004, the NIH awarded Dr. Wilens a 5-year grant to study
atomoxetine. In his second disclosure to your Institutions,
Dr. Wilens revealed that he received $7,500 from Eli Lilly in
2004. But Eli Lilly reported to me that it paid Dr. Wilens
$27,500 for advisory services and speaking fees in 2004--a
difference of about $20,000.
It is my understanding that Dr. Wilens' NIH-funded study of
atomoxetine is still ongoing. According to Eli Lilly, it paid
Dr. Wilens almost $65,000 during the period January 2004
through June 2007. However, as of March 2008, and based upon
the documents provided to us to date, Dr. Wilens disclosed
payments of about half of the amount reported by Eli Lilly
for this period. Dr. Wilens also did three other studies of
atomoxetine in 2006 and 2007.
I have also found several instances where these Physicians
apparently received income above your institutions' income de
minimus limit. For instance, in 2003, Dr. Spencer conducted a
study of atomoxetine in adolescents. At the time, he
disclosed no significant financial interests related to this
study. But Eli Lilly reported paying Dr. Spencer over $25,000
that year.
In 2001, Dr. Biederman disclosed plans to begin a study
sponsored by Cephalon, Inc. At the time; Dr. Biederman
disclosed that he had no financial relationship with the
sponsor of this study. Yet, on his conflict of interest
disclosure, he acknowledged receiving research support and
speaking fees from Cephalon, Inc., but did not provide any
information on the amounts paid. In March 2008, Dr. Biederman
revealed that Cephalon, Inc. paid him $13,000 in 2001.
In 2005, Dr. Biederman began another clinical trial
sponsored by Cephalon, Inc., which was scheduled to start in
September 2005 and end in September 2006. Initially, Dr.
Biederman disclosed that he had no financial relationship
with the sponsor of this study. But in March 2008, Dr.
Biederman revealed that Cephalon, Inc. paid him $11,000 for
honoraria in 2005 and an additional $24,750 in 2006.
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. 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. Indeed at this
time there are several pharmaceutical and device companies
that are looking favorably upon the Physician Payments
Sunshine Bill and for that I am gratified.
Accordingly, I request that your respective institutions
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 the Physicians,
please confirm that the Physicians reported to Harvard and
MGH/Partners' designated official ``the existence of [his]
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
Harvard and MGH/Partners ensured ``that the interest has been
managed, reduced, or eliminated?'' Please provide an
individual response for each grant that each doctor received
from January 2000 to the present, and provide any
documentation to support each claim.
3. Please report on the status of the Harvard Standing
Committee and additional Partners reviews of the
discrepancies in disclosures by Drs. Biederman, Spencer and
Wilens, including what action, if any, will be considered.
4. For Drs. Biederman, Spencer, and Wilens, please report
whether a determination can be made as to whether or not any
doctor 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.
[[Page S5032]]
5. Please provide a total dollar figure for all NIH monies
annually received by Harvard and MGH/Partners, respectively.
This request covers the period of 2000 through 2007.
6. Please provide a list of all NIH grants received by
Harvard and MGH/Partners. This request covers the period of
2000 through 2007. For each grant please provide the
following:
a. Primary Investigator;
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 June
18, 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. BIEDERMAN AND RELATED INFORMATION REPORTED BY PHARMACEUTICAL COMPANIES
----------------------------------------------------------------------------------------------------------------
Payments Amount
Year Company Disclosure filed with revealed in company
institution March 2008 Reported
----------------------------------------------------------------------------------------------------------------
2000................................ GlaxoSmithKline........ Not reported........... $2,000 $3,328
Eli Lilly & Company.... <$10,000............... 3,500 14,105
Pfizer Inc............. Not reported........... 7,000 7,000
2001................................ Cephalon............... No amount provided..... 13,000 n/a
GlaxoSmithKline........ No amount provided..... 5,500 4,428
Eli Lilly & Company.... No amount provided..... 6,000 14,339
Johnson & Johnson...... Not reported........... 3,500 58,169
Medical Education Not reported........... 21,000 n/a
Systems.
Pfizer Inc............. No amount provided..... 5,625 5,625
2002................................ Bristol-Myers Squibb... No amount provided..... 2,000 2,000
Cephalon............... No amount provided..... 3,000 n/a
Colwood................ Not reported........... 14,000 n/a
Eli Lilly & Company.... No amount provided..... 11,000 2,289
Johnson & Johnson...... Not reported........... Not 706
reported
Pfizer Inc............. No amount provided..... 4,000 2,000
2003................................ Bristol-Myers Squibb... No amount provided..... 500 250
Cephalon............... <10,000................ 4,000 n/a
Eli Lilly & Company.... <10,000................ 8,250 18,347
Johnson & Johnson...... <10,000................ 2,000 2,889
Medlearning............ Not reported........... 26,500 n/a
Pfizer Inc............. <10,000................ 1,000 1,000
2004................................ Bristol-Myers Squibb... No amount provided..... 6, 266 6,266
Cephalon............... Not reported........... 4,000 n/a
Eli Lilly & Company.... No amount provided..... 8,000 15,686
Johnson & Johnson...... Not reported........... Not 902
reported
Medlearning............ Not reported........... 26,000 n/a
Pfizer Inc............. Not reported........... 3,000 4,000
2005................................ Cephalon............... Not reported........... 11,000 n/a
Eli Lilly & Company.... <20,000................ 12,500 7,500
Johnson & Johnson...... Not reported........... Not 962
reported
Pfizer Inc............. Not reported........... 3,000 3,000
Medlearning............ Not reported........... 34,000 n/a
2006................................ Cephalon............... Not reported........... 24,750 n/a
Johnson & Johnson...... Not reported........... Not 750
reported
Primedia............... Not reported........... 56,000 n/a
2007................................ Primedia............... Not reported........... 30,000 n/a
----------------------------------------------------------------------------------------------------------------
Note 1: Dr. Biederman revealed in March 2008 that his outside income totaled about $1.6 million during the
period January 2000 through June 2007. Information reported by the pharmaceutical companies indicate that they
made additional payments that are not reflected in Dr. Biederman's disclosures.
Note 2: 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 n/a (not
available) reflects that a company was not contacted.
SELECTED DISCLOSURES BY DR. SPENCER AND RELATED INFORMATION REPORTED BY PHARMACEUTICAL COMPANIES
----------------------------------------------------------------------------------------------------------------
Payments Amount
Year Company Disclosure filed with revealed in company
institution March 2008 reported
----------------------------------------------------------------------------------------------------------------
2000................................ GlaxoSmithKline........ Not reported........... $3,000 $1,500
Eli Lilly & Company.... Not reported........... 12,345 11,463
2001................................ GlaxoSmithKline........ Not reported........... 4,000 1,000
Eli Lilly & Company.... Not reported........... 8,500 10,859
Strategic Implications. Not reported........... 16,800 n/a
2002................................ GlaxoSmithKline........ Not reported........... 3,000 3,369
Eli Lilly & Company.... Not reported........... 14,000 14,016
Strategic Implications. Not reported........... 29,000 n/a
2003................................ Eli Lilly & Company.... Not reported........... 6.000 25,500
Johnson & Johnson...... Not reported........... 1,250 0
Thomson Physicians Not reported........... 46,500 n/a
World.
2004................................ Eli Lilly & Company.... Not reported........... Not 23,000
reported
Pfizer Inc............. Not reported........... 3,500 3,500
2005................................ Eli Lilly & Company.... <$20,000............... 6,000 7,500
Johnson & Johnson...... Not reported........... 1,500 227
Medlearning............ Not reported........... 28,250 n/a
2006................................ Eli Lilly & Company.... No amount provided..... 15,688 8,188
Johnson & Johnson...... Not reported........... 5,500 0
Primedia............... Not reported........... 44,000 n/a
2007................................ Eli Lilly & Company.... No amount provided..... 6,000 16,188
----------------------------------------------------------------------------------------------------------------
Note 1: Dr. Spencer revealed in March 2008 that his outside income totaled about $1 million during the period
January 2000 through June 2007. Information reported by the pharmaceutical companies indicate that they made
additional payments that are not reflected in Dr. Spencer's disclosures.
Note 2: 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 n/a (not
available) reflects that a company was not contacted.
SELECTED DISCLOSURES BY DR. WILENS AND RELATED INFORMATION REPORTED BY PHARMACEUTICAL COMPANIES
----------------------------------------------------------------------------------------------------------------
Payments Amount
Year Company Disclosure filed with revealed in company
institution March 2008 reported
----------------------------------------------------------------------------------------------------------------
2000................................ GlaxoSmithKline........ Not reported........... $5,250 $12,009
Eli Lilly & Company.... Not reported........... 2,000 2,057
Pfizer Inc............. Not reported........... 1,250 2,250
TVG.................... Not reported........... 11,000 n/a
2001................................ GlaxoSmithKline........ <$10,000............... n/a 2,269
Eli Lilly & Company.... No amount provided..... 3,952 952
J.B. Ashtin............ Not reported........... 14,500 n/a
2002................................ GlaxoSmithKline........ Not reported........... 7,500 10,764
Eli Lilly & Company.... Not reported........... 4,500 3,000
Pfizer Inc............. Not reported........... 1,500 1,500
Phase 5................ Not reported........... 20,000 n/a
[[Page S5033]]
2003................................ Eli Lilly & Company.... Not reported........... 12,000 0
Phase 5................ Not reported........... 90,500 n/a
TVG.................... Not reported........... 31,000 n/a
Medlearning............ Not reported........... 24,000 n/a
2004................................ Eli Lilly & Company.... Not reported........... 7,500 27,500
Phase 5................ Not reported........... 84,250 n/a
Medlearning............ Not reported........... 46,000 n/a
2005................................ Eli Lilly & Company.... <20,000................ 9,500 9,500
Promedix............... Not reported........... 70,000 n/a
Advanced Health Media.. Not reported........... 37,750 n/a
2006................................ Eli Lilly and Physician No amount provided..... 5,963 12,798
World (Lilly).
Advanced Health Media.. Not reported........... 56,000 n/a
Primedia............... Not reported........... 32,000 n/a
2007................................ Eli Lilly & Company.... Not reported........... 9,000 14,969
Veritas................ Not reported........... 25,388 n/a
----------------------------------------------------------------------------------------------------------------
Note 1: Dr. Wilens revealed in March 2008 that his outside income totaled about $1.6 million during the period
January 2000 through June 2007. Information reported by the pharmaceutical companies indicate that they made
additional payments that are not reflected in Dr. Spencer's disclosures.
Note 2: 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 n/a (not
available) reflects that a company was not contacted.