Is ASCO abiding by IOM ethics guidelines?

June 4, 2010

Op-Ed The Healthcare Channel

The Wall Street Journal’s Ron Winslow posted a blog essay about the extraordinary embargo confusion caused by the ASCO press corps. The story received considerable favorable reviews by healthcare journalists commenting on Twitter, etc. In previous years, other journalists from large national news companies have expressed similar frustration with the annual ASCO meeting. CNBC’s Mike Huckman was actually removed from the convention hall one year for allegedly setting up his cameras and reporting from within the conference hall.

Why is the ASCO meeting so secretive and opaque? True science is supposed to be freely disseminated in a transparent fashion. Oppressive rules of embargo for the media, and the banning of cameras during the meeting, are antithetical to a true “scientific meeting”.

Smaller freelance journalists and “new media” outlets have to overcome even greater hurdles with ASCO than the larger organizations such as WSJ and CNBC. For example, The Healthcare Channel is accepted as legitimate “news media” by organizations with the  highest standards in the land, ranging from the U.S. Senate media office to the White House press office. Every major journal, including the NEJM, JAMA, Lancet, Circulation, Annals of Internal medicine, etc grant The HCC media access, yet ASCO’s Journal of Clinical Oncology does not.

The ASCO press office does not acknowledge The HCC as being legitimate news. Arbitrary reason have been given by ASCO, such as “The HCC does not provide editorial content”, whatever that means. In fact, “editorial content” like the O’Reilly Factor is precisely the type of media that is NOT accepted as “news” by the White House, etc.

The HCC has reported numerous times over the last several years how the ASCO meeting has been conducted in questionable ways.  In 2007, The HCC reported on the favorable attention a “late breaking” breast cancer trial received and questioned the influence of the large sponsor Genentech. In 2008, The HCC discussed the controversial way that ASCO released its abstracts. This reporting has undoubtedly dis-ingratiated The HCC with the lobbying staff of ASCO.

In 2009, the IOM issued ethical guidelines for how large medical societies that take money from the drug and device industry, such as ASCO, should handle their annual meetings. The HCC interviewed one of the authors, Dr. Eric Campbell of Harvard. A similar guidelines was published in JAMA. The HCC interviewed one its authors, Dr. David Wofsy of UCSF.

The 2010 ASCO meeting should be held to these ethical guidelines. Per the video interviews above, will the 2010 ASCO meeting:

• Ban all satellite educational symposium that serve as marketing meetings for the drug companies?
• Ban all branded gift items such as pens and bags?
• Ban the acceptance of any drug industry cash from any ASCO official?
• Ban the acceptance of any drug industry cash from any member of a “guidelines committee”?
• Restrict total ASCO funding from the drug industry to less than 25% of the total revenue?
• Ban the selling of ASCO member email and addresses to drug marketers?

Exclusive: Is a California medical school going broke?

December 12, 2009

The nationwide recession, likely to be reclassified as a depression when all is said and done, has hit California more severely than most other regions given that housing was so crucial to its economy. Major cuts in spending have been made by the State government. Even before the bubble burst in 2007 and 2008, the University of California System was struggling.

Now, it seems that one of the best medical schools in California, UCSF, is running a budget deficit in excess of $100 Million, closer to $200 Million, according to our sources. If true, this is not information that UCSF wants the public to know. In 2007, the newly hired Dean of UCSF medical school, David Kessler, former Dean of Yale medical school and former Commissioner of the FDA, began looking at the internal books of UCSF. According to Kessler, he was fired after he discovered problems on the university balance sheet that conflicted with public statements from UCSF and he reported these as a whistleblower.

Senator Charles Grassley has been investigating this situation and whether Dr. Kessler was indeed retaliated against for being a whistleblower. The HCC has obtained the most recent (second) letter from the Senate Finance Oversight Committee (see below). According to the letter, UCSF has now hired an outside independent accounting firm, PricewaterhouseCoopers, to validate its own internal audits. Previously, a private accounting firm, KPMG, was unable to confirm the findings of the UCSF internal audit despite statements from university officials to the contrary.

If it is true that UCSF is in serious fiscal trouble and resorting to illegal means to cover it up, then the implications might expand beyond UCSF to other California medical schools. The factors that led to the UCSF deficit were undoubtedly tied to the overall budgetary problems the State has been dealing with for much of this decade. Therefore, the entire University of California system is possibly in similar peril. This may be obvious given the recent announcements of tuitions increases that led to student protests and arrests. However, the full extent of the budget deficits may be underappreciated.

December 7, 2009

Via Electronic Transmission

Mark G. Yudof

President

University of California System

1111 Franklin Street

Oakland, CA 94607

Dear Mr. Yudof:

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 am committed to ensuring that NIH and universities receiving NIH monies properly fulfill their mission to advance the public’s welfare and make 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.

I am writing to you about allegations of financial discrepancies within the Medical School at the University of California at San Francisco (Medical School) (UCSF/University).  Based upon the materials that I have obtained and reviewed to date, as well as the interviews conducted, it appears that these allegations were raised by Dr. David Kessler, former Dean of the Medical School, and former Commissioner of the Food and Drug Administration.  Some of these same concerns were reported also in the press.

The Medical School at UCSF receives hundreds of millions of taxpayer dollars every year from various federal agencies.  If there is any question about the integrity of the finances at UCSF, I am worried that similar problems regarding taxpayer dollars may also exist at other campuses within the UC System, such as UC Davis, UC Berkeley, and UCLA.

In response to my concerns and after discussions with outside counsel, the UC System agreed to engage PricewaterhouseCoopers (PwC) to conduct a limited financial review and to provide a written opinion of the UCSF’s internal controls related to its compliance with selected federal requirements. The selected compliance requirements would include: activities allowed or not allowed, allowable costs/cost principles, cash management, period of availability, and reporting.  PwC will apply criteria established by the Office of Management and Budget (OMB) in the Compliance Supplement (Appendix B to OMB Circular No. A-133) in assessing the University’s compliance. [ATTACHMENT A]  I am glad that the UC System has taken this issue seriously and is committed, like me, to keeping financial safeguards in place to ensure that taxpayer dollars are used in accordance with applicable law.

In addition to the above, my staff investigators also identified a number of troubling matters related to UCSF. These matters include, what appear to be UCSF:

· Appearing to provide misleading statements to the California State Senate; and

· Providing less than accurate statements to the media.

I. BACKGROUND

In March 2003, UCSF began recruiting a candidate to become the Dean of the Medical School at UCSF.  As part of this process, UCSF’s Vice Dean of Administration and Finance Jaclyne Boyden faxed the candidate a letter including several charts depicting the financial condition of the Medical School (the Boyden Letter). After joining the faculty in September 2003, the new Dean, raised concerns about the financial information in the Boyden Letter.  Based upon the information available to me, UCSF responded by forming a group called the Washington Committee to review the Boyden Letter information.

To further address the concerns about financial integrity, UCSF hired KPMG in 2007. KPMG was charged with preparing independent reports concerning both the Boyden Letter and the work done by the Washington Committee.

II. UCSF PROVIDING WHAT APPEARS TO BE MISLEADING STATEMENTS TO THE CALIFORNIA STATE SENATE

The conclusions reached by KPMG appear to be materially different from statements that UCSF Chancellor J. Michael Bishop made to the California State Senate.  In a letter to California State Senator Abel Maldonado and signed by Chancellor Bishop on March 7, 2008, Chancellor Bishop made what appear to be several inaccurate and/or misleading claims about KPMG’s work.[4] Specifically, Chancellor Bishop made the following statements to the California State Senate regarding the UCSF’S finances:

· Gift and endowment income in the Boyden letter can be tied back to the General Ledger, as has been verified by KPMG. (Emphasis added)

· The actual revenue ‘numbers’ in the Boyden Letter have been verified by the Washington Committee and KPMG as substantially accurate….  [ATTACHMENT B] (Emphasis added)

However, it appears that these representations directly contradict the conclusions reached by KPMG. More specifically, KPMG determined the following with regard to its review of the Boyden Letter:

· UCSF was not able to provide a documented process/methodology used to create the “Sources of funds” Schedule.  Therefore, recomputation of the “Sources of funds” Schedule was not repeatable and could not be reconciled to the General Ledger. (Emphasis added)

· [The Boyden Letter] identifies items that should be separately identified and used in computing the figures, but the “Letter” did not identify the specific associated fund number(s). Due to the lack of a fully documented process/methodology, KPMG could not generate a line by line item reconciliation of the ‘Sources of funds’ Schedule to UCSF’s General Ledger. [ATTACHMENT C] (Emphasis added)

Furthermore, KPMG’s analysis of the Washington Committee review concluded:

· The methodology used by UCSF to create the “Actual Financial Sources and Uses Schedules” was not sufficiently documented to be repeatable, or to allow a third-party to accurately recreate the figures contained within the “Actual Financial Sources and Uses Schedules.”[3] [ATTACHMENT D] (Emphasis added)

Interestingly, KPMG had not seen the Chancellor’s letter to California Senator Maldonado until I gave them a copy.  After reviewing that letter, KPMG provided the following comments:

· With respect to the schedule in the Boyden letter, KPMG could not reconcile any category of revenue back to the General Ledger, including gifts and endowment income.  (Emphasis added)

· KPMG did not address the accuracy of the figures contained in the Boyden Letter because UCSF was not able to provide a documented process/methodology used to create the “Sources of Funds” Schedule.  Therefore, computation of the “Sources of Funds” Schedule was not repeatable and the figures contained therein could not be reconciled to the General Ledger.  [ATTACHMENT E] (Emphasis added)

In light of this information, please provide any documents/information that can explain the discrepancies highlighted above.

III.

UCSF PROVIDING LESS THAN ACCURATE STATEMENTS TO THE MEDIA

I also found it very troubling that UCSF appeared to promote the belief that KPMG substantiated the claims of the Washington Report; however this was not the case.  On January 15, 2008, UCSF released to the media the “Washington Report” and KPMG’s review of the Washington Committee Report.

To begin, the “Washington Report” was a 36 page document, with nine attachments [ATTACHMENT F] However, KPMG’s review of the Washington Committee was limited to an analysis of a single page.  In conversations with my staff, KPMG said that it was unaware of the fact that a 36 page document with attachments was prepared at all. On the contrary, KPMG was under the impression that a much more limited document was prepared.  Furthermore, my staff investigators contacted a faculty member at UCSF who was on the committee that was charged with writing the Washington Report.  That faculty member told my investigators that s/he had never seen the completed Washington Report; rather s/he only saw the single page that was analyzed by KPMG.

Furthermore, when shown all 36 pages of the “Washington Report” that UCSF released, KPMG responded:

KPMG did not receive a copy of the “Washington Report” when it began its engagement             in July 2007.  UCSF provided KPMG with certain documents, including Excel     spreadsheets, some of which appear to include information contained in attachments to       the “Washington Report”. (Emphasis added)

A few weeks after releasing its version of the Washington Report, UCSF put out an Executive Summary regarding KPMG’s analysis of the Washington Report.  [ATTACHMENT G]  UCSF’s summary stated, “Principle Conclusion: the findings of the Work Group were substantiated.”  (Emphasis added)

Again, KPMG disputes UCSF’s principle conclusion. In addition KPMG added that it did not review or comment on UCSF’s Executive Summary of KPMG before UCSF put out its conclusion that was inconsistent with the material in my possession.  When asked to comment on UCSF’s summary of its report, KPMG responded, “KPMG does not believe that this conclusion substantiates the key findings of the Washington Report.” (Emphasis added)

In light of this information, please provide any documents/information that can explain the discrepancies set forth above.

I thank you again for your continued cooperation and I would appreciate receiving the information requested in this letter by December 21, 2009.  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_Downey@finance-rep.senate.gov.

Sincerely,

Charles E. Grassley

Ranking Member

Committee on Finance

Attachments

Steven Cummings, MD: The denosumab FREEDOM trial

Dr. Steven Cummings, director of the San Francisco Coordinating Center and faculty of UCSF, and principle investigator of the Amgen FREEDOM trial, discusses the results of the trial. FREEDOM looked at 8,500 postmenopausal patients and followed them for three years. The outcome measures were fracture rates in different areas (vertebral, nonvertebral, hip). The study showed a strong efficacy for twice-yearly subcutaneous injected denosumab with minimal adverse events (infection being the main concern). There were no reports of ONJ as has been reported with high doses of bisphosonates.