VURDUM DUYMAZLAR

klinik farmakoloji dosyası
Acı İlaç

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... read 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; ). 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; 

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

     ed 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 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 ed several companies for

 payment information and the notation nla (not available) reflects that

 a company was not ed.

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 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 ed 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 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 ed several companies for payment information and the notation n/a (not

 available) reflects that a company was not ed.

 

 

        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 ed several companies for payment information and the notation n/a (not

 available) reflects that a company was not ed.

 

 

         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 ed several companies for payment information and the notation n/a (not

 available) reflects that a company was not ed.