Başka bir renk deneyin:
Başka bir font büyüklüğü deneyin: 60% 70% 80% 90%


 


VURDUM DUYMAZLAR

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:
  1. Çeşitli komisyonlarda ve etik kurullarda  çalışan ve ilaç sanayii ile çok ciddi çıkar ilişkisi olanlar hakkında yetkililerden çıt çıkmıyor. Sükut ikrardan mı geelmekte?
  2. 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…
  3. 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…)
  4. 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 [email protected]
     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--
     [email protected]
           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 [email protected]
     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.