COMMERCIAL BIAS at STANFORD and CORCEPT
Stanford University has replaced Dr. Alan Schatzberg as Principal Investigator on his NIH grant that studies psychotic depression. This step followed persistent questions from Senator Grassley about conflicts of interest and financial disclosure. Dr. Schatzberg’s drug mifepristone has been in NIH-supported clinical trials at Stanford and in FDA-monitored trials sponsored by Corcept, the company Dr. Schatzberg founded.
The University emphasized “We want to put to rest confusion about the integrity of the research involving mifepristone.” Questions did arise following NIH-supported publications from Stanford in 2001 and 2002. Neither one found significant evidence of efficacy, yet both were repeatedly touted by Dr. Schatzberg and his associates as positive. The 2001 report had no significant findings even after attempts to cherry-pick the data. In the 2002 report the data were so weak that Dr. Schatzberg elected to present no statistical analyses of outcome at all. We now know from Corcept’s three negative FDA-monitored Phase III trials that the early challenges to mifepristone’s efficacy had merit (see Abstract #63). As Dr. Schatzberg should know, wishful thinking and hand waving are no substitute for quality data that are rigorously analyzed. Dr. Schatzberg is accountable for the unwarranted positive tone of those early publications. His later promotional claims reveal a commercial bias that has no place in academic medicine.
Scientists are required to present both the positive and the negative aspects of their research “fully and honestly.” Here is one example of this code (see item 2). Here is another (see item 15). The standard does not change when commerce is involved. The standard applies in review articles as much as in original reports. Did the Stanford-Corcept group meet this standard? That is the issue Stanford now confronts.
In a 2003 textbook that he coauthored (Manual of Clinical Psychopharmacology), Dr. Schatzberg made a clearly biased claim. He stated “Two recent studies of … (mifepristone) … by our group have demonstrated efficacy in the treatment of psychotic depression.” He was referring to the 2001 and 2002 Stanford-NIH publications. Dr. Schatzberg went on to state that “The effects were more pronounced on the psychosis than on the depression, but both were significantly improved within 7 days.”
The claim of “demonstrated efficacy” is categorically false. It may be fraudulent. Neither study achieved any accepted evidence of efficacy. The second claim also is categorically false. No quantitative data on significant improvement of psychotic symptoms or depression severity exist in the two studies for drug over placebo. Lack of efficacy is what the investigative journalist Paul Jacobs exposed so well, with the consultation of independent statisticians, in the San Jose Mercury News July 10, 2006.
These false claims in a well-known textbook promoted a positive climate of opinion for Dr. Schatzberg’s drug in the period leading up to Corcept’s planned IPO. Through the textbook, Dr. Schatzberg also promoted positive professional expectations in advance of the marketing of his drug. Moreover, in this American Psychiatric Press publication Dr. Schatzberg did not disclose his large financial interest.
The pattern of exaggerating positive trends in the data while suppressing mention of negative analyses has become a trademark of Stanford-Corcept publications. Dr. Schatzberg made similar unwarranted claims in a 2003 journal article. In 2006 Dr. Schatzberg did likewise in another APA Press publication (The American Psychiatric Publishing Textbook of Mood Disorders). Once again, Dr. Schatzberg used an APA Press textbook to talk up his drug’s prospects. Once again, Dr. Schatzberg did not disclose his own financial interest.
In 2006, Corcept’s CEO (Dr. Joseph Belanoff) and the former Chief Medical Officer (Dr. Charles DeBattista) published a review article on use of mifepristone in neuropsychiatric disorders. In violation of the journal publisher’s policy, the article was sourced only to Stanford University. These current and past Corcept officers did not disclose their financial interest or their relationship to the corporation. They highlighted the use of mifepristone in psychotic depression. Referring to the 2001 Stanford-NIH trial, they claimed “all five patients showed a substantial improvement in depression.” This claim is categorically false. The question of fraud arises again.
These examples illustrate what I have termed commercial promotion and branding through academic outlets. In all, 13 scientific journals, 4 textbooks, and other media have been tainted by these and similar misrepresentations. These biased claims in reference to the Stanford-NIH trials were also featured in press releases and press interviews while Corcept was raising private and public capital.
This pattern of bias raises questions of ethics, and of possible fraud. One could make the case that the misrepresentations described here do not fall under the safe harbor provisions of US securities law. It is one thing for entrepreneurs to speculate giddily about the potential of their product if the available scientific data are presented accurately (“fully and honestly”). In that circumstance, caveat investor applies. But it is an altogether different matter when entrepreneurs misrepresent the available scientific data by emphasizing positive trends while suppressing the inconvenient, negative aspects of the data. That is what Corcept did in discussing the 2002 Stanford-NIH trial in its SEC filing March 19, 2004 leading up to the IPO. That is also what Dr. Schatzberg and his associates did in the examples given above.
Dr. Schatzberg is slated to become president of the American Psychiatric Association in 2009. The APA would do well to reconsider his fitness for that office. We would have expected Dr. Schatzberg, who is also President of the American Psychiatric Press, the publishing arm of the APA, to understand that he and his corporate associates should discuss their scientific data “fully and honestly,” while being transparent about their competing financial interests. As for Stanford University, these academic biases and systemic conflicts of interest signal the need for a fresh look at the academic-corporate boundary.
Thursday, August 07, 2008
Wednesday, August 06, 2008
FBI Raids Hospitals, Arrests CEO
Previous posts on Health Care Renewal have featured a rogues gallery of disgraced leaders of health care organizations. For example, we recently discussed a former hospital CEO who concealed that he had served time in the US Navy's brig. The Los Angeles Times just reported a story that suggests a new low in hospital leadership,
The list of the accused is striking.
The Associated Press (here, via the San Diego Union-Tribune) reported that two people, including one hospital CEO, were arrested during the raids.
We have often discussed how health care has come to be dominated more and more by ever larger organizations. Thus, the leadership of these organizations has increasing influence over health care, and hence on people's health and safety. Yet on this blog we have documented more and ever sleazier examples of ill-informed, incompetent, self-interested, and even corrupt leadership of health care organizations.
The story above is of allegations, indictments, and lawsuits. But if half of the allegations in it are true, it would represent a new low for hospital leadership.
Thus, I raise again a proposal for licensure of leaders of all organizations that affect health care, starting with hospitals, academic medical centers, and hospital systems; but also including managed care organizations and health care insurers; drug, biotechnology, and device companies; health information technology companies; etc, etc, etc. Such licensure could assure that leaders have some minimum level of knowledge about and exposure to health care; and that they must conform to some ethical standards. Licensure could be subject to removal under due process. Clearly, licensing health care organizational leaders would not solve all or most of health care's problems. But it would at least assure some minimum standard of leadership.
FBI agents served search warrants this morning on three hospitals as part of an investigation into alleged Medicare fraud involving homeless patients who were recruited from skid row.
Dr. Rudra Sabaratnam, an owner and the chief executive of City of Angels Medical Center, and Estill Mitts, an alleged patient recruiter, were indicted by a federal grand jury last week on 21 counts of healthcare fraud, money laundering and income tax evasion.
The men were arrested this morning as part of the federal government's criminal investigation, according to FBI spokeswoman Laura Eimiller.
''It's a scheme that ranged from street operatives to the CEO of a hospital,' said U.S. Atty. Thomas P. O'Brien, adding that he expects several more arrests in coming weeks.
At the same time, Los Angeles City Atty. Rocky Delgadillo announced civil litigation against the three hospitals and their operators in what officials said was a 'scheme to defraud the Medi-Cal and Medicare programs out of millions of dollars.'
Beginning at 8 a.m., agents working with the federal Department of Health and Human Services, the Internal Revenue Service and the California Department of Justice raided City of Angels Medical Center, Los Angeles Metropolitan Medical Center and Tustin Hospital and Medical Center.
The raids cap what law enforcement sources told The Times was a nearly two-year investigation of alleged medical fraud on skid row.
The city attorney's office alleged that the hospitals tried to fill empty beds in a bid to boost their finances.
The hospitals allegedly were aided by a patient recruiting operation on skid row that plucked homeless people from the streets and delivered them with fake medical conditions to the hospitals.
Metropolitan Medical Center in 2006 was accused by the Los Angeles Police Department of using ambulances to 'dump' five patients in one day onto the streets of the downtown skid row area against their will after their discharge from the hospital. At the time, officials at the hospital strongly denied any wrongdoing.
But the city attorney now alleges that those patients had been recruited 'by runners' who directed them to an assessment center on 7th Street, where their Medicare and Medi-Cal benefits eligibility was checked and a 'fabricated description of conditions' was prepared by non-doctors so they could be eligible for treatment. All five of the patients were admitted to Metropolitan Medical Center.
Each of the patients received $20 to $30 when they returned to the assessment center after spending one to three days in the hospital, according to the suit.
'Within the past four years, hundreds, if not thousands of other homeless persons in skid row have been recruited, hospitalized, treated and discharged in a manner substantially similar . . . as part of a long-running scheme to bilk the Medicare and Medi-Cal programs out of millions of dollars by causing unnecessary hospitalization for paid recruits,' the lawsuit alleges.
The list of the accused is striking.
Among those named in the suit are Pacific Health Care Corp.; Los Angeles Metropolitan Medical Center, its Chief Executive John Fenton and admitting physician Frederick Rundall; Tustin Hospital and Medical Center, its Chief Executive Daniel Davis, Chief Financial Officer Vincent Rubio and admitting physicians Kenneth Thaler and Al-Reza Tajik; and City of Angels Medical Center and its owner-operators Robert Borseau and Sabaratnam. Mitts, the owner and manager of Metropolitan Healthcare LLC and the president of the 7th Street Christian Day Center, which was until recently located on skid row, is also named in the suit.
City attorneys allege that the Tustin hospital was guaranteed 40 to 50 patients a month while City of Angels got 25 to 30 patients month. Metropolitan Medical Center received patients whenever beds were available, according to the suit. City attorneys allege the admitting Drs. Rundall, Thaler and Tajik did not see their patients until shortly before their discharge. City attorneys allege that for patient referrals, Mitts' group was paid $20,000 per month each from Metropolitan Medical Center and Tustin, while City of Angels paid between $400 to $1,000 a week to the recruiting group.
The suit also alleges that the Tustin hospital's chief financial officer personally received a $3,500-a-month kickback from Mitts' group to ensure that Tustin continued to take homeless patients from the skid row center.
The Associated Press (here, via the San Diego Union-Tribune) reported that two people, including one hospital CEO, were arrested during the raids.
FBI agents arrested Rudra Sabaratnam, 64, chief executive officer of City of Angels hospital, and Estill Mitts, 64, who operated the 7th Street Assessment Center, where people are screened for health needs, the U.S. attorney's office said in a statement.
A federal jury last week indicted both men. The 21-count indictment, which was unsealed Wednesday, charged them with conspiring to receive and take kickbacks for patient referrals and to commit health care fraud.
Sabaratnam also was charged with paying kickbacks while Mitts also was charged with money laundering and tax evasion.
If convicted, Sabaratnam could face 50 years in federal prison, and Mitts could face 140 years, authorities said.
We have often discussed how health care has come to be dominated more and more by ever larger organizations. Thus, the leadership of these organizations has increasing influence over health care, and hence on people's health and safety. Yet on this blog we have documented more and ever sleazier examples of ill-informed, incompetent, self-interested, and even corrupt leadership of health care organizations.
The story above is of allegations, indictments, and lawsuits. But if half of the allegations in it are true, it would represent a new low for hospital leadership.
Thus, I raise again a proposal for licensure of leaders of all organizations that affect health care, starting with hospitals, academic medical centers, and hospital systems; but also including managed care organizations and health care insurers; drug, biotechnology, and device companies; health information technology companies; etc, etc, etc. Such licensure could assure that leaders have some minimum level of knowledge about and exposure to health care; and that they must conform to some ethical standards. Licensure could be subject to removal under due process. Clearly, licensing health care organizational leaders would not solve all or most of health care's problems. But it would at least assure some minimum standard of leadership.
Courting Tobacco Money
We have posted about the controversies arising from recently revealed research agreements between Richmond, Virginia based Virginia Commonwealth University (VCU) and tobacco company Philip Morris. These were first publicly discussed in May in a New York Times article. As we posted here, the main issues were that the research agreements themselves were secret; the agreements apparently gave Philip Morris control over all publications arising from the research, since they defined all products of the work as proprietary information belonging to Philip Morris; and that research for hire on behalf of a tobacco company, given that tobacco products have known severe health risks and no health benefits, seems to go against the mission of a medical school and academic medical center. We also noted that the university administration's apparent lack of qualms about its relationship with Philip Morris might have been related to its president's role as a leader of a tobacco company. (He sits on the board of Universal Corp, a tobacco buyer, processor, and distributor.) We later observed how little attention this subject has gotten in Richmond's major news outlet. Most recently, we noted that some university leaders were willing to open a public dialogue about the issue, thus exhibiting more transparency under criticism than has been shown by many other organizations.
This week's Richmond (VA) Style Weekly reported that there were plans for even greater ties between VCU and Philip Morris,
Furthermore, it appeared that VCU leadership, not Philip Morris, initiated these plans,
We have previously discussed how medical school and academic medical center leaders often seem to care more about financial goals than the fulfillment of their clinical and academic missions. This can lead to pressure on faculty to raise research money from commercial sponsors, such as drug, biotechnology and device companies who have vested interests in having the research results favor their products. Medical schools and academic medical centers often seem so eager to get such money that they let the research sponsors control many aspects of the research, making it easier for them to manipulate the research to favor their products (see post here). Faculty pushed to work with commercial sponsors may be prone to become "key opinion leaders" who help the sponsors market their products.
All that is bad enough, but at least drug, biotechnology and device companies make products designed to treat, prevent, and sometimes even cure disease. In my humble opinion, medical school leaders fundamentally violate their institution's mission when they solicit money from a company whose products cause disease without providing any clinical benefits.
This week's Richmond (VA) Style Weekly reported that there were plans for even greater ties between VCU and Philip Morris,
Virginia Commonwealth University officials have repeatedly denied the existence of a proposal to create a women’s health center funded by Philip Morris USA, but a draft copy of the proposal shows the idea did — and in some iteration still does — exist.
A copy of a working paper titled 'Proposal to Create the VCU Center for Health Pregnancy and Neonatal Outcomes,' obtained by Style Weekly, shows plans for a center focused on treatment and research into preventing defects, early birth and mortality.
Furthermore, it appeared that VCU leadership, not Philip Morris, initiated these plans,
In part, the memo obtained by Style reveals a plan for how VCU could solicit money from Philip Morris.
The seven-page proposal includes various attachments and is detailed down to budget projections for such specifics as bus and cab fare for participants. It concludes with a subheading titled 'Why Philip Morris USA should support this initiative.' The rationale for the pitch? 'Philip Morris USA will be investing in the future of the Richmond community,' and 'giving new meaning to ‘being well-born’.'
Pam Lepley, a university spokeswoman, says she was unaware of the proposal until contacted about it last week. During a July 16 community forum held on the medical campus, Dr. Francis L. Macrina, the school’s vice president for research, repeatedly denied knowledge of the proposal, saying that no proposal has ever existed.
Lepley now says the proposal is a working paper developed by the dean of the medical school, Jerry Strauss, but adds that it was not specifically aimed at attracting the financial support of Philip Morris.
'This is a draft proposal that Jerry Strauss was working on for any number of potential philanthropic providers,' Lepley says, calling it a working proposal that remains internal to the school. 'This is an initiative of Jerry Strauss’.'
The Richmond-based tobacco company is the only private corporation mentioned in the proposal and the only entity mentioned that is not the university or one of various governmental service providers foreseen as partners.
The assertion that the proposal has yet to see the light may not be worth a pack of smokes, either.
'This was a proposal that the dean of medicine shopped with Philip Morris,' says a medical school faculty member, speaking on condition of anonymity. 'Since all this has broken, [Strauss] has said [in meetings] that Philip Morris did not accept it or they did not fund it.'
We have previously discussed how medical school and academic medical center leaders often seem to care more about financial goals than the fulfillment of their clinical and academic missions. This can lead to pressure on faculty to raise research money from commercial sponsors, such as drug, biotechnology and device companies who have vested interests in having the research results favor their products. Medical schools and academic medical centers often seem so eager to get such money that they let the research sponsors control many aspects of the research, making it easier for them to manipulate the research to favor their products (see post here). Faculty pushed to work with commercial sponsors may be prone to become "key opinion leaders" who help the sponsors market their products.
All that is bad enough, but at least drug, biotechnology and device companies make products designed to treat, prevent, and sometimes even cure disease. In my humble opinion, medical school leaders fundamentally violate their institution's mission when they solicit money from a company whose products cause disease without providing any clinical benefits.
Tuesday, August 05, 2008
BLOGSCAN - A Proposed Comparative Effectiveness Institute
On the Health Beat Blog, Maggie Mahar discussed a bill in the US Senate proposing the formation of a comparative effectiveness institute. It has one striking drawback. The board of the proposed institute, which would include representatives of "private payers; [and] pharmaceutical, device and technology companies." Both groups have financial interests favoring comparative effectiveness studies with particular groups. Private payers make more money when they can avoid paying for expensive tests, treatments, and other forms of care. They would prefer to see comparative effectiveness studies that find that more expensive tests, treatments, etc do not work so well. Pharmaceutical, biotechnology, and device companies would prefer to see comparative effectiveness studies that find their products work well. Because of these conflicts of interest, neither representatives of private payers nor representatives of pharmaceutical, biotechnology or device companies should be on the board of this institute.
Monday, August 04, 2008
What Influences Advocates of Providing "More, Not Less, Truthful Information" About Off-Label Drug Use?
Last week's New England Journal of Medicine included a letter [Troy DE, Gottlieb S. Pharmaceutical promotion and first amendment rights. N Engl J Med 2008; 359: 536. ] supporting pharmaceutical companies' rights to promote their products for uses not approved by the US Food and Drug Administration (FDA). The letter applauded "the robust, sound constitutional protection the U.S. Supreme Court affords truthful, nonmisleading commercial communication such as that embodied in reprints of scientific articles discussing off-label uses." It asserted "appropriate off-label use that informs proper patient care is fostered by more, not less, communication of truthful, nonmisleading information."
Policy discussions about issues such as this, I believe, would also benefit from the provision of "more, not less, communication of truthful, nonmisleading information."
The first author of this letter, Daniel E. Troy, identified his affiliation with the law firm Sidney Austin LLP, and disclosed that he "represents manufacturers who submitted comments to the Food and Drug Administration (FDA) on its draft reprint guidance."
Mr Troy did not disclose that he is the future general counsel of UK-based international pharmaceutical company GlaxoSmithKline. This appointment, effective September 2, 2008, was announced the week before the NEJM letter was published. (See this article in the Wall Street Journal.)
The second author, Dr Scott Gottlieb, did not disclose any potential conflicts of interest.
Thus, Dr Gottlieb did not reveal that he is on the board of directors of Molecular Insight Pharmaceuticals, a "a biopharmaceutical company specializing in the emerging field of molecular medicine." As a member of the board, Dr Gottlieb is expected to have "unyielding loyalty" to the stockholders and their financial interests.
I admit that as a strong advocate of free speech, I too have trouble with the idea that the FDA can restrict simple written or oral communication by a drug company's representatives about their products. (Gifts or payments to physicians as part of marketing efforts are very much another story.) So I do not have a big problem with the policy position Troy and Gottlieb took on this.
But I do believe that as advocates of more "truthful, nonmisleading information" they should disclose financial relationships that might influence the policy positions they are advocating. As it stands, without such disclosures, their letter to the NEJM amounted to stealth health policy advocacy, something we now see all to much of.
Policy discussions about issues such as this, I believe, would also benefit from the provision of "more, not less, communication of truthful, nonmisleading information."
The first author of this letter, Daniel E. Troy, identified his affiliation with the law firm Sidney Austin LLP, and disclosed that he "represents manufacturers who submitted comments to the Food and Drug Administration (FDA) on its draft reprint guidance."
Mr Troy did not disclose that he is the future general counsel of UK-based international pharmaceutical company GlaxoSmithKline. This appointment, effective September 2, 2008, was announced the week before the NEJM letter was published. (See this article in the Wall Street Journal.)
The second author, Dr Scott Gottlieb, did not disclose any potential conflicts of interest.
Thus, Dr Gottlieb did not reveal that he is on the board of directors of Molecular Insight Pharmaceuticals, a "a biopharmaceutical company specializing in the emerging field of molecular medicine." As a member of the board, Dr Gottlieb is expected to have "unyielding loyalty" to the stockholders and their financial interests.
I admit that as a strong advocate of free speech, I too have trouble with the idea that the FDA can restrict simple written or oral communication by a drug company's representatives about their products. (Gifts or payments to physicians as part of marketing efforts are very much another story.) So I do not have a big problem with the policy position Troy and Gottlieb took on this.
But I do believe that as advocates of more "truthful, nonmisleading information" they should disclose financial relationships that might influence the policy positions they are advocating. As it stands, without such disclosures, their letter to the NEJM amounted to stealth health policy advocacy, something we now see all to much of.
Friday, August 01, 2008
FOLLOW the MONEY
FOLLOW the MONEY
There is no sign of let-up in the scrutiny of Stanford University and Dr. Alan Schatzberg, who chairs the University’s department of psychiatry. Since Senator Grassley started asking questions last month, the explanations offered about Stanford’s management of this faculty member’s conflicts of interest vis à vis his NIH grants and his corporation (Corcept Therapeutics) have become non-viable. The story so far can be found here and here and here.
Senator Grassley was concerned that Stanford gave him lowball information about Dr. Schatzberg’s financial stake in Corcept, and no information about Dr. Schatzberg’s realized financial gains from selling Corcept stock. Inspection of Stanford’s answers to Sen. Grassley and of the University’s faculty disclosure forms reveals that they were not designed for transparency. Dr. Schatzberg’s realized gain of $109,000 in 2005 was not reported to Stanford and so was never reported to NIH as required or to Sen. Grassley in response to the senator’s request for information. As if these were not problems enough, the University’s claims that Dr. Schatzberg kept an appropriate distance from Stanford’s NIH-supported studies of his drug were challenged here and here.
Dr. Schatzberg’s faculty disclosure information released by Stanford is artfully opaque. The real story can only be pieced together from Corcept’s SEC filings, which, I remind readers, are not provided to the public in a spirit of disclosure but because they are required by law. Here are some revealing numbers aggregated from half a dozen or so documents on the SEC website.
Between 2000 and 2007, Dr. Schatzberg’s total compensation from Corcept, at a minimum, can be documented as $401,250. He received at least $52,500 for serving on the board of directors, and $348,750 for chairing Corcept’s Scientific Advisory Board (SAB). In addition, he realized income through selling shares worth $109,000. That adds up to more than $510,000.
While Dr. Schatzberg was earning almost $350,000 from Corcept for his work on the SAB, he was also being paid by NIH to do overlapping scientific work. Where was the boundary? The Stanford clinical trials of Dr. Schatzberg’s drug closely resembled Corcept’s trials in dosage, duration, and outcome measures. As the NIH-funded Principal Investigator at Stanford and as chair of the Corcept SAB, Dr. Schatzberg is accountable for the design of the trials conducted both at the University and by the corporation. To an exaggerated degree, the Stanford trials were touted as positive, whereas the Phase III trials conducted by Corcept were all negative. The scientific rationales put forth by Dr. Schatzberg through his NIH-supported studies of related clinical research questions were used by Corcept in raising capital and in pleading with the FDA for fast-track status. Many of the claims from these NIH-supported studies had a bearing on the potential market for Dr. Schatzberg’s drug – his expansive estimates of the prevalence of psychotic depression, for instance, and his unwarranted claim that his drug acted to “re-set” a key, depression-related, brain-hormone system on which his drug acts. There was even a revolving door for junior faculty between Stanford and the corporation. One junior faculty member worked on the Stanford studies, then went full-time to Corcept for about 2 years as its Chief Medical Officer, then returned to the Stanford faculty ranks. Now another former junior faculty member is Corcept’s CMO. Dr. Schatzberg has the power to influence the academic careers of these individuals. Hello! Is there a conflict of interest here? Does it seem that there really was no boundary?
There is no sign of let-up in the scrutiny of Stanford University and Dr. Alan Schatzberg, who chairs the University’s department of psychiatry. Since Senator Grassley started asking questions last month, the explanations offered about Stanford’s management of this faculty member’s conflicts of interest vis à vis his NIH grants and his corporation (Corcept Therapeutics) have become non-viable. The story so far can be found here and here and here.
Senator Grassley was concerned that Stanford gave him lowball information about Dr. Schatzberg’s financial stake in Corcept, and no information about Dr. Schatzberg’s realized financial gains from selling Corcept stock. Inspection of Stanford’s answers to Sen. Grassley and of the University’s faculty disclosure forms reveals that they were not designed for transparency. Dr. Schatzberg’s realized gain of $109,000 in 2005 was not reported to Stanford and so was never reported to NIH as required or to Sen. Grassley in response to the senator’s request for information. As if these were not problems enough, the University’s claims that Dr. Schatzberg kept an appropriate distance from Stanford’s NIH-supported studies of his drug were challenged here and here.
Dr. Schatzberg’s faculty disclosure information released by Stanford is artfully opaque. The real story can only be pieced together from Corcept’s SEC filings, which, I remind readers, are not provided to the public in a spirit of disclosure but because they are required by law. Here are some revealing numbers aggregated from half a dozen or so documents on the SEC website.
Between 2000 and 2007, Dr. Schatzberg’s total compensation from Corcept, at a minimum, can be documented as $401,250. He received at least $52,500 for serving on the board of directors, and $348,750 for chairing Corcept’s Scientific Advisory Board (SAB). In addition, he realized income through selling shares worth $109,000. That adds up to more than $510,000.
While Dr. Schatzberg was earning almost $350,000 from Corcept for his work on the SAB, he was also being paid by NIH to do overlapping scientific work. Where was the boundary? The Stanford clinical trials of Dr. Schatzberg’s drug closely resembled Corcept’s trials in dosage, duration, and outcome measures. As the NIH-funded Principal Investigator at Stanford and as chair of the Corcept SAB, Dr. Schatzberg is accountable for the design of the trials conducted both at the University and by the corporation. To an exaggerated degree, the Stanford trials were touted as positive, whereas the Phase III trials conducted by Corcept were all negative. The scientific rationales put forth by Dr. Schatzberg through his NIH-supported studies of related clinical research questions were used by Corcept in raising capital and in pleading with the FDA for fast-track status. Many of the claims from these NIH-supported studies had a bearing on the potential market for Dr. Schatzberg’s drug – his expansive estimates of the prevalence of psychotic depression, for instance, and his unwarranted claim that his drug acted to “re-set” a key, depression-related, brain-hormone system on which his drug acts. There was even a revolving door for junior faculty between Stanford and the corporation. One junior faculty member worked on the Stanford studies, then went full-time to Corcept for about 2 years as its Chief Medical Officer, then returned to the Stanford faculty ranks. Now another former junior faculty member is Corcept’s CMO. Dr. Schatzberg has the power to influence the academic careers of these individuals. Hello! Is there a conflict of interest here? Does it seem that there really was no boundary?
Then there is information in the SEC filings about stock held in the name of Dr. Schatzberg’s two children. In January 2002 Dr. Schatzberg was listed as the beneficial owner of 3,605,215 shares. This number included 360,000 shares held of record by each of his two children, over which Dr. Schatzberg had voting control. By December 31, 2004 the number of shares declared for each child had contracted to 300,000. A reasonable inference is that 60,000 shares may have been sold on behalf of each child at some time between early 2002 and the end of 2004. It may be that the original count of 360,000 shares per child was stated in error, but that seems unlikely. Corcept consummated its stock IPO in April 2004 at a price of $12.00 per share. When Dr. Schatzberg sold his own shares in 2005 he realized a price of $7.00 per share. We don’t know for sure what price any shares sold on behalf of Dr. Schatzberg’s children may have brought, because these are apparently not listed as insider trades. Up to the end of 2004 they could have fetched anything between $11.00 and around $5.50. If they fetched $7.00 then as much as $840,000 may have been realized for the Schatzberg family. The cost to Dr. Schatzberg for these 120,000 shares was $40.
So now we are looking at something between at least $510,000 and potentially around $1,350,000 realized by Dr. Schatzberg and his family from Corcept between 2000 and 2007. As I detailed before, Dr. Schatzberg also made 2 determined but unsuccessful runs at selling shares for $7-11 million during the corporation’s IPO attempts. Keep in mind that all of this would be OPM – other people’s money. And Dr. Schatzberg was already being paid by Stanford and NIH. What did Dr. Schatzberg contribute to the greater good in return for this corporate bonanza? You be the judge. To many appalled observers it looks like gaming the system.
This case bids fair to become a landmark that convinces NIH and the Universities to get real about academic-corporate boundaries. Senator Grassley issued a new round of questions to both Stanford and NIH yesterday. And as Ed Silverman reports this afternoon, Stanford has now replaced Dr. Schatzberg as Principal Investigator on the NIH grant.
Shut Up, They Explained (to Ezetimibe Critics)
One of our scouts alerted me to a remarkable editorial just published by Harrison, Brown and Raggi on the ezetimibe controversy [Harrison DG, Brown WV, Raggi P. Enhanced hype. Am J Cardiol 2008; 102: 368-369. Link here, requires subscription.]
We have posted before (as have many others,) about problems with the ENHANCE trial of ezetimibe (Zetia, by Schering-Plough, and one component of Vytorin, by Merck), and how the trial seemed to be designed and implemented so as to increase the likelihood of a favorable result for the sponsors' interests. Particularly controversial was the sponsors' decision to change the definition of the trial's outcome variable after the data was collected, (later reversed after it was publicized.) It also turned out that the supposedly "independent" panel responsible for that decision included a majority of members who had previous financial ties to Merck and/or Schering-Plough.
The ENHANCE trial was not meant to determine whether ezetimibe had any effects on clinical outcomes, that is, whether it made patients feel or function better, avoid morbid events, or live longer. Its focus was on whether the drug reduced the thickness of arterial walls in patients with very high cholesterol levels. The study failed to show even this effect.
Since no previous study had shown that ezetimibe leads to symptom reduction, functional improvement, prevention of morbidity, or extension of life, it was surprising that the American College of Cardiology and the American Heart Association rushed to the drug's defense, counseling physicians not to take patients off it. Why continue to give patients a drug that has never been shown to provide clinical benefit? In this post, we wondered whether this enthusiasm unsupported by clinical research evidence had to do with undisclosed conflicts of interest affecting the defenders of ezetimibe.
Since then, in the continuing absence of evidence about the benefits of ezetimibe, there has been continuing controversy over its use. Harrison, Brown and Raggi continued in this vein. They clearly sided with the American College of Cardiology's statement that physicians should not take patients off ezetimibe, which they contrasted with what they characterized as
So this editorial is noteworthy not because it defended ezetimibe, or belittled its critics, but because it seemed to question the right to criticize the established dogma.
Obviously, the authors of the editorial have no legal authority to censor those whose views offend them. But even veiled questioning of the right to express dissent are contrary to the core values of science and medicine. For science to advance, open discussion and criticism of methods, results and interpretations is vital. For physicians to take the best possible care of patients, they must have access to the best possible evidence from clinical research, even if that evidence offends the powers that be or those with vested interests.
A clue as to why the authors took such an extreme position may be found in the last sentence of their article,
Why would they be so worried as to raise the hyperbolic concern that the controversy over ENHANCE could cause ezetimibe, and even Merck and Schering-Plough to be "eliminated?" A quick Google search revealed disclosed that the authors collectively have multiple relevant financial relationships that they did not disclose.
The inconvenient truths that we censor or hide surely will return to afflict us.
ADDENDUM (3 August, 2008) - See also comments by anonymous blogger "PM" on Gooznews.
We have posted before (as have many others,) about problems with the ENHANCE trial of ezetimibe (Zetia, by Schering-Plough, and one component of Vytorin, by Merck), and how the trial seemed to be designed and implemented so as to increase the likelihood of a favorable result for the sponsors' interests. Particularly controversial was the sponsors' decision to change the definition of the trial's outcome variable after the data was collected, (later reversed after it was publicized.) It also turned out that the supposedly "independent" panel responsible for that decision included a majority of members who had previous financial ties to Merck and/or Schering-Plough.
The ENHANCE trial was not meant to determine whether ezetimibe had any effects on clinical outcomes, that is, whether it made patients feel or function better, avoid morbid events, or live longer. Its focus was on whether the drug reduced the thickness of arterial walls in patients with very high cholesterol levels. The study failed to show even this effect.
Since no previous study had shown that ezetimibe leads to symptom reduction, functional improvement, prevention of morbidity, or extension of life, it was surprising that the American College of Cardiology and the American Heart Association rushed to the drug's defense, counseling physicians not to take patients off it. Why continue to give patients a drug that has never been shown to provide clinical benefit? In this post, we wondered whether this enthusiasm unsupported by clinical research evidence had to do with undisclosed conflicts of interest affecting the defenders of ezetimibe.
Since then, in the continuing absence of evidence about the benefits of ezetimibe, there has been continuing controversy over its use. Harrison, Brown and Raggi continued in this vein. They clearly sided with the American College of Cardiology's statement that physicians should not take patients off ezetimibe, which they contrasted with what they characterized as
hysterical coverage from Web sites, news organizations, and cardiologists who seem to seek high visibility.So the "hype" and hysteria, according to Harrison, Brown and Raggi, were criticisms of attempts to manipulate the ENHANCE trial, and observations about the lack of clinical evidence supporting the use of ezetimibe. What made their article remarkable, however, was its suggestion that purveyors of "hype" and "hysteria" as defined by Harrison, Brown, and Raggi, should just shut up. First the three authors wrote,
Strong statements regarding guidelines or policy in the use of this drug by cardiologists (with little background in lipid research and atherosclerosis biology) are inappropriate and certainly premature.Then,
unsupported premature claims regarding a drug’s effectiveness or lack thereof should be conveyed properly, as in the case of the American College of Cardiology’s official statement. There seems to be a recent love affair with the issuance of headline-grabbing statements to the press, and this should be discouraged. When done in haste without proper study and thought, they appear to be self-aggrandizing, and at worse, they are very misleading.
So this editorial is noteworthy not because it defended ezetimibe, or belittled its critics, but because it seemed to question the right to criticize the established dogma.
Obviously, the authors of the editorial have no legal authority to censor those whose views offend them. But even veiled questioning of the right to express dissent are contrary to the core values of science and medicine. For science to advance, open discussion and criticism of methods, results and interpretations is vital. For physicians to take the best possible care of patients, they must have access to the best possible evidence from clinical research, even if that evidence offends the powers that be or those with vested interests.
A clue as to why the authors took such an extreme position may be found in the last sentence of their article,
In the case of ezetimibe, we are concerned that this drug or its makers will be eliminated on the basis of hyperbole, misinformation....
Why would they be so worried as to raise the hyperbolic concern that the controversy over ENHANCE could cause ezetimibe, and even Merck and Schering-Plough to be "eliminated?" A quick Google search revealed disclosed that the authors collectively have multiple relevant financial relationships that they did not disclose.
- Dr David G Harrison is on the scientific advisory board of Atherogenics, Inc.
- Dr W Virgil Brown, according to a financial disclosure statement provided by the National Lipid Association, on whose board he sits, "has advisory relationships" with AstraZeneca, Bristol-Myers Squibb, Merck, Merck Shering Plough, Pfizer, Reliant, Kos, Lilly; has "research relationships" with AstraZeneca, Lilly, Kos, Pfizer, Takeda; has "educational relationships" with Abbott, Lilly; and has "speakers' bureau relationships" with AstraZeneca, Bristol-Myers Squibb, Merck, Merck Shering Plough, Pfizer, Reliant, Kos, Lilly, Abbott, Takeda, Kos.
- Dr Paolo Raggi, according to disclosure statements provided by HDCN for a 2001 meeting, "received grant support and honoraria from Genzyme Therapeutics and is a stockholder in Pfizer Inc;" and according to disclosure statements provided by the Office of Continuing Education for Johns Hopkins University School of Medicine for a 2007 meeting, received an honorarium from Amgen, and received grants, consulting fees, and speakers' honoraria from Genzyme.
Perhaps the authors' financial identification with Merck and Merck Schering-Plough, and with the pharmaceutical and biotechnology industries in general lead to such exaggerated concern. In any case, the authors should have revealed these financial relationships, and allowed readers to decide whether they might have affected their views. Nonetheless, while conceivably such relationships could have somewhat explained the authors' partiality to censorship, it does not excuse it.
As documented on the FIRE web-site, it is now commonplace for academic administrators to try to silence those who disagree with the prevailing campus dogma. This impulse to censor those who provide inconvenient opinions or facts now seems to be extending to the scholarly medical literature. It is ironic that those calling for censorship simultaneously seem loathe to reveal their financial relationships with those with vested interests in maintaining the status quo.The inconvenient truths that we censor or hide surely will return to afflict us.
ADDENDUM (3 August, 2008) - See also comments by anonymous blogger "PM" on Gooznews.
Another "Rising Star" Health Care Executive Implodes
Add this to our series of failed health care leaders, from the South Florida Sun-Sentinel,
In a story in the Miami Herald, CEO Sacco was quoted, "we thought we had a rising star."
Not exactly.
I argued in a somewhat different context for developing a licensure process for leaders of health care organizations. Licensing doctors and health professionals has been going on for a long time. But now leaders of health care organizations, from hospitals to drug companies, have as much if not more influence over health care, and hence the health and safety of patients as do doctors. Yet there are no requirements that leaders of health care organizations have any particular educational background, knowledge, commitment to health care values, or, for that matter, that they have not committed crimes. Given the scope of bad leadership discussed on Health Care Renewal, maybe a licensing process for health care executives would at least ensure that they have not served time in the brig for theft.
ADDENDUM (5 August, 2008) - See related post entitled "Should More Hospital CEOs be Physicians?" by Maggie Mahar on the Health Beat Blog.
A top Memorial Regional Hospital administrator caught up in a fraud investigation in the Virgin Islands resigned this week after admitting he spent time in a military prison and lied about it.
Rodney E. Miller, 36, who came to the Hollywood hospital less than a year ago as chief operating officer and a rising star, never disclosed he spent time in a Navy brig on theft charges, Frank Sacco, chief executive of the South Broward Hospital District, said Thursday. Sacco said when he confronted the man he hoped would one day succeed him, Miller admitted his lie and quit the $370,000 job on the spot Tuesday.
Details of Miller's past emerged in a series of stories published this week by the Virgin Islands Daily News that outlined widespread alleged financial abuses by Miller and others at Schneider Regional Medical Center in the Virgin Islands. The newspaper, and an audit by the U.S. Inspector General's Office, found that more than $1 million was improperly diverted to Miller's personal accounts between 2002 and 2007. Also, he received $3.8 million in salary over several years while patients went without basic needs for a lack of money, the newspaper reported.
But it was Miller's failure to disclose a "bad conduct" discharge from the Navy that led to his departure from Memorial Regional, Sacco said. Miller stole another serviceman's credit cards in 1995 and went on a spending spree, then concocted an elaborate scheme to cover his tracks, the Daily News reported. He left the service in 1996 and his discharge, after appeals, became official in 2000.
The information, including terms of his 10-month prison sentence and allegations that he submitted fraudulent documents to investigators, came from Miller's service records, which are public under federal law. No one from Memorial Regional or an independent search firm ever verified Miller's service, Sacco said.
Miller served as Schneider's chief executive officer for five years before accepting the job as head of the adult hospital at Memorial Regional in October. The inspector general's report was finished two weeks before Miller was hired in Broward, but not released until Monday.
The audit, conducted jointly by the Inspectors General of the Virgin Islands and the U.S. Interior Department, details an "alarming depth of mismanagement" at the hospital by Miller, his top executives and the board charged with overseeing their operations. Miller received more than $1.3 million above his contracted pay scale.
Investigators were met with "secrecy and a deliberate concealment of financial records" that forced them to seek subpoenas, according to the audit.
In a story in the Miami Herald, CEO Sacco was quoted, "we thought we had a rising star."
Not exactly.
I argued in a somewhat different context for developing a licensure process for leaders of health care organizations. Licensing doctors and health professionals has been going on for a long time. But now leaders of health care organizations, from hospitals to drug companies, have as much if not more influence over health care, and hence the health and safety of patients as do doctors. Yet there are no requirements that leaders of health care organizations have any particular educational background, knowledge, commitment to health care values, or, for that matter, that they have not committed crimes. Given the scope of bad leadership discussed on Health Care Renewal, maybe a licensing process for health care executives would at least ensure that they have not served time in the brig for theft.
ADDENDUM (5 August, 2008) - See related post entitled "Should More Hospital CEOs be Physicians?" by Maggie Mahar on the Health Beat Blog.
Thursday, July 31, 2008
10 Years Later, An Eerie Echo of the Fall of AHERF
This week, as reported by Steve Twedt in the Pittsburgh Post-Gazette, accounting irregularities were found at the West Penn Allegheny Health System,
Although the AHERF bankruptcy appears to be the largest failure of a not-for-profit health care corporation in US history, its story has produced remarkably few echoes for doctors, other health care professionals, health care researchers, and health policy makers. I often use the fall of AHERF as major example in talks, at least the few talks I am allowed to give on such unpleasant subjects. Rarely have more than a few people in the audience heard of AHERF prior to my discussion of it. I only could locate one article in a medical or health care journal that discussed the case in detail, albeit incompletely since it was written before Abdelhak's guilty plea [Burns LR, Cacciamani J, Clement J, Aquino W. The fall of the house of AHERF: the Allegheny bankruptcy. Health Aff (Millwood) 2000; 19: 7-41.] I doubt the case is used for teaching in most medical or public health schools. The lack of discussion of such a significant case is a prime example of the anechoic effect.
Therefore, let me summarize some of important points not found above (see also this narrative, starting on page 5):
An independent review of West Penn Allegheny Health System finances has found that it overstated payments from vendors and patients by $73 million over the past two years, a move that is expected to result in substantial operating losses.
'This is significant,' said analyst Jeff Schaub of Fitch Ratings in New York, who spoke to WPAHS officials yesterday.
WPAHS President and Chief Executive Officer Dr. Christopher Olivia sent a system-wide e-mail yesterday morning assuring staff that the reductions 'have no direct implications on the System's pension plan' and that WPAHS has 'now adopted an industry 'best practice' accounting methodology to help ensure a mistake of this nature does not reoccur.'
Mr. Schaub said hospitals have to estimate revenues for patient services because payments generally don't match hospital charges, but in this case West Penn Allegheny used a flawed methodology to make those estimates.
While it's not unusual for those estimates to be off somewhat, a $73 million adjustment 'is not a trivial amount,' he said, particularly for a system that has relied on investment earnings to stay in the black.
Yesterday's announcement carries uneasy echoes of the 1998 financial meltdown of Allegheny General Hospital's former parent, Allegheny Health and Education Research Foundation, which aggressively expanded into the Philadelphia market only to end up in bankruptcy. Two years later, AGH merged with West Penn Hospital to create the West Penn Allegheny Health System.
In fact, last week, Moody's Investor Service issued a report on the 10 year anniversary of the fall of the house of AHERF (the Allegheny Health Education and Research Foundation). Per an article again by Steve Twedt in the Pittsburgh Post-Gazette, who also wrote a significant series in the same newspaper summarizing the collapse of AHERF,
From the distance of 10 years, the historic bankruptcy of Allegheny General Hospital's then-parent organization still offers valuable lessons for today's health-care industry, says a new report by Moody's Investor Service.
'AHERF left such a stain, such an indelible mark on hospital management teams, they realized that if one of the big systems can fail, no one is immune,' said Lisa Goldstein, leader of the Moody's health-care team that produced the report.
On July 21, 1998, Allegheny Health and Education Research Foundation (AHERF) defaulted, resulting in what is still the largest bankruptcy ever among the 560 Moody's-rated not-for-profit health-care entities. At the time, AHERF had $2 billion in revenue and $555 million in outstanding debt, according to the Moody's report.
Analyst Lisa Martin, who wrote the report, says industrywide forces converged with 'the organization's own management and governance failures' to cause the foundation's failure.
The external forces included Medicare reimbursement cuts -- still an issue a decade later -- and highly competitive markets in both Pittsburgh and Philadelphia.
But, she added, 'we believe its ultimate downfall was driven more by decisions of the organization itself -- weak governance, poorly executed strategies, lack of refined leadership, and absence of methodical execution.'
Although the AHERF bankruptcy appears to be the largest failure of a not-for-profit health care corporation in US history, its story has produced remarkably few echoes for doctors, other health care professionals, health care researchers, and health policy makers. I often use the fall of AHERF as major example in talks, at least the few talks I am allowed to give on such unpleasant subjects. Rarely have more than a few people in the audience heard of AHERF prior to my discussion of it. I only could locate one article in a medical or health care journal that discussed the case in detail, albeit incompletely since it was written before Abdelhak's guilty plea [Burns LR, Cacciamani J, Clement J, Aquino W. The fall of the house of AHERF: the Allegheny bankruptcy. Health Aff (Millwood) 2000; 19: 7-41.] I doubt the case is used for teaching in most medical or public health schools. The lack of discussion of such a significant case is a prime example of the anechoic effect.
Therefore, let me summarize some of important points not found above (see also this narrative, starting on page 5):
- AHERF, one of the largest health care systems of its day, was built by the poster-boy for health care imperial CEOs, Sherif Abdelhak.
- Abdelhak, who started as food services purchasing manager at Allegeheny General Hospital, was repeatedly hailed as a "visionary" (in the March, 1997, ACP Observer) a "genius," and the like. His plans to create a huge integrated health care system were part of the wave of the future. Abdelhak was even invited to give the prestigious John D Cooper lecture at the annual meeting of the American Association of Medical Colleges (AAMC), which was published in Academic Medicine [Abdelhak SS. How one academic health center is successfully facing the future. Acad Med 1996; 71: 329-336.] He proclaimed that "we will need to create new forms of organization that are more flexible, more adaptive, and more agile than ever before." And he announced that "my aim as chief executive has been to unleash the creativity and productive potential of every individual and to provide an environment that encourages teamwork"
- While Abdelhak was making these grandiose promises, he paid himself and his associates very well. For example, he received $1.2 million in the mid-1990s, more than three times the average then for a hospital system CEO. He lived in a hospital supplied mansion worth almost $900,000 in 1989. Five of AHERF's top executives were in the top 10 best paid hospital executives in Philadelphia.
- Although Abdelhak talked of teamwork, he warned the combined faculty of the new Allegheny University of the Health Sciences (AUHS): "Don’t cross me or you will live to regret it."
- As AHERF was hemorrhaging money, Abdelhak continued to pay himself and his cronies lavishly.
- After the AHERF bankruptcy, which was at the time the second largest bankruptcy recorded in the US, Abdelhak was charged with numerous felonies involving receiving charitable assets. In a plea bargain, he pleaded no contest to misusing charitable funds, a misdemeanor, and was sentenced to more than 11 months in county prison.
The story of AHERF is not merely that of an unlucky bankruptcy. It shows what can go wrong when health care adopts business practices such as jumping the latest management band-wagons and genuflecting before imperial CEOs.
Yet since the fall of AHERF, we are still hearing breathless stories about the latest wonderful plans to save health care (think about, for example, electronic medical records, pay for performance schemes, etc), and the brilliant CEOs (think about, for example, William McGuire, the former CEO of UnitedHealth) who will be our saviors.
We health care professionals need to stop falling for this hype and spin. Saving health care will take clear thinking and hard work by a lot of people. The "visionaries," if we let them, are likely to depart with a huge cache of money, leaving us and health care worse off. If it is just "not done" to talk about cases such as that of AHERF, and other examples of "recent unpleasantness," how will be learn not to fall for the propaganda?
Of course, it is those who benefit from the propaganda who do not want us catching on to their game.
If physicians, health professionals, health care researchers, and health policy makers do not learn the lessons of the fall of AHERF, they will be doomed to see its repetitions. What just happened to West Penn Allegheny Health Systems is only a small example of all the things that can go wrong.
Cancer Data Collection Outsourced, and Then Manipulated
I have a favorite quote about the impossibly complex bureaucratic structure of the American health care system from Oxymorons by JD Kleinke,(1) (which I used in my "Cautionary Tale" article in the European Journal of Internal Medicine[2]):
It seems impossible to keep track of all the administrative, managerial and bureaucratic organizations that now impact health care. All of them, however, seem greatly susceptible to mismanagement, and worse.
Here is the latest example, from the Baltimore Sun,
I am of course familiar with the concept of a state-wide cancer registry. I must say it did not previously occur to (even) me that states would out-source the operation of such registries, and if so, that they would not bother to supervise the companies entrusted with collecting and analyzing the data.
Macro International Inc, is a for-profit, apparently privately held company. (I cannot find it on the Edgar database.) It boasts that its"mission is to deliver high-quality, research-based solutions to complex problems, integrating objective information with the advisory and implementation tasks needed to improve real world performance." That wording is so full of buzz words and management/ bureaucratic-speak that I am not sure what it means. So I cannot accuse Macro International's performance of violating its own mission. But it certainly violated the values of public health and health care research.
So we have yet another example of how health care activities have been transferred from people and organizations which were supposed to be fulfilling a (in this case, public) health mission, to (in this case, for-profit) organizations which do not have an overt commitment to the mission, a governance structure designed to fulfill the mission, or effective oversight or regulation to ensure that they fulfill the mission.
So the result was mismanagement, and fabricated data. The latter had direct impact on health care research, and on individual patients.
To take back the future of health care, we will have to ensure that health care is carried out by people and organizations pledged to uphold its core values, and working transparently and accountably under explicit and enforceable codes of ethics.
References
1. J.D. Kleinke. Oxymorons: the myth of a US health care system, Jossey-Bass, San Francisco (2001).
2. Poses RM. A cautionary tale: the dysfunction of the American health care system. Eur J Int Med 2003; 14: 123-130.
Tens of thousands of well-meaning people work throughout the health care system, none of whom ever see a patient or deliver any actual medical care. They preside over an infinity of rules, regulations, forms, processes, contract outsourcing, financial brokering, benefit plan tinkering, analytical processes, incompatible data systems, and dead forests of paperwork. Health care administration in America is a tower of Babel that reaches to the moon....
It seems impossible to keep track of all the administrative, managerial and bureaucratic organizations that now impact health care. All of them, however, seem greatly susceptible to mismanagement, and worse.
Here is the latest example, from the Baltimore Sun,
A state contractor tampered with Maryland's cancer registry, a database used by researchers to track the disease's impact, counting hundreds of patients as having cancer when they did not, according to a legislative audit released yesterday.
The company, Macro International Inc., found in an internal investigation that data were deliberately altered between August 2004 and December of that year. The company fired the employee responsible for the cancer registry. State officials said that Macro employees apparently overreported the incidence of cancer to ensure that the database met standards set by a national certification association, which closely monitors registries to ensure that states have a complete count of cases.
The misinformation led researchers to send an estimated 400 women letters beginning in 2005 asking them to participate in a cervical cancer study when they did not have the disease. About 10 of those women called the state Family Health Administration, part of the state's Department of Health and Mental Hygiene - one of the first indications that the cancer registry was inaccurate.
Guy Garnett, a Macro vice president, declined to comment, citing company policy not to discuss client issues. The company completed the contract term, earning $1.9 million to manage the registry for 18 months through January. The state hired a new vendor, Westat, beginning in February.
In 2003, when Macro submitted the 2001 cancer database to the North American Association of Central Cancer Registries, it did not receive certification as required under its contract. Auditors faulted the state agency for not taking action, such as terminating the contract.
The next year, Macro did receive certification, but the auditors noted that information was later found to be erroneous. Auditors outlined several red flags that were not raised until years later.
First, the state agency did not review the 2002 data until August 2005, when it found they showed a 90 percent increase in cervical cancer cases and a 70 percent increase in melanoma cases from 1998 to 2002. At the time, auditors said, Macro could not provide an adequate explanation for the staggering rise in cancer incidence.
Around the same time, as part of the state health department's study of breast and cervical cancer diagnosis in Maryland women, about 2,300 patients in the cancer registry were asked to participate in the study. The Family Health Administration later worked with Macro to comb through medical histories, comparing original laboratory reports with data in the cancer registry, and determined that 400 of them did not have cancer. The study was suspended.
Then in May 2006, a former Macro employee informed the state agency that data were deliberately altered. Macro's investigation found that more than 13 percent of all cases in 2002 showed signs of tampering, according to the audit. Macro concluded that the changes were 'methodical and were made by one or more persons with broad access to the system,' the audit said.
I am of course familiar with the concept of a state-wide cancer registry. I must say it did not previously occur to (even) me that states would out-source the operation of such registries, and if so, that they would not bother to supervise the companies entrusted with collecting and analyzing the data.
Macro International Inc, is a for-profit, apparently privately held company. (I cannot find it on the Edgar database.) It boasts that its"mission is to deliver high-quality, research-based solutions to complex problems, integrating objective information with the advisory and implementation tasks needed to improve real world performance." That wording is so full of buzz words and management/ bureaucratic-speak that I am not sure what it means. So I cannot accuse Macro International's performance of violating its own mission. But it certainly violated the values of public health and health care research.
So we have yet another example of how health care activities have been transferred from people and organizations which were supposed to be fulfilling a (in this case, public) health mission, to (in this case, for-profit) organizations which do not have an overt commitment to the mission, a governance structure designed to fulfill the mission, or effective oversight or regulation to ensure that they fulfill the mission.
So the result was mismanagement, and fabricated data. The latter had direct impact on health care research, and on individual patients.
To take back the future of health care, we will have to ensure that health care is carried out by people and organizations pledged to uphold its core values, and working transparently and accountably under explicit and enforceable codes of ethics.
References
1. J.D. Kleinke. Oxymorons: the myth of a US health care system, Jossey-Bass, San Francisco (2001).
2. Poses RM. A cautionary tale: the dysfunction of the American health care system. Eur J Int Med 2003; 14: 123-130.
Tuesday, July 29, 2008
On a Clinical IT Abomination and a Health IT Leadership Gap
... If there ever was a reason for physicians, other clinicians and patients to oppose the use of Electronic Medical Records forced upon them by third parties, here it is. Assuming this story is accurate, it reflects what I believe will be an increasing trend towards control of the medical profession via computer:
I believe a much more aggressive response is needed from the medical profession, including organized medicine, besides "opting out" of abusive third party payer arrangements.
In a former role of Manager of Medical Programs for a regional transit authority, I've seen labor unions that were representing bus drivers and janitors act far more aggressively and wisely in representing their members against management whims than organized medicine represents physicians against payer and government whims.
If organized medicine were performing its role in representing the profession aggressively, considering the evidence that paper charts can perform as well as electronic records in many circumstances and that most clinical IT benefits accrue to payers and other third parties, then major concessions would have been demanded of the primary beneficiaries for physicians to adopt electronic medical records.
"Musn't be too aggressive or appear disgruntled" is one of the reasons I've heard from academic colleagues that this does not occur. Physicians must be "gentlemen" and "team players." ("Team player" in today's context often means "co-conspirator to mediocrity" or to even worse).
I ask "why?" [should physicians avoid appearing angry]. The directness and actual aggressiveness of the labor union representatives I saw in action was quite effective in improving the conditions for their members. Interestingly, the union people were aggressive when "in role" yet polite when I encountered them in other settings, such as the daily commute to work. The public would likely respond to legions of angry doctors like few other means of communication could muster.
In a similar vein, I have heard from numerous circles that it's best to advocate for informatics leadership of Health IT (such as EMR, CPOE etc.) without demonstrating emotion or 'disgruntledness.' That raises several questions:
On leadership of Health IT efforts: the sudden push by government towards universal HIT in recent years has often puzzled me. HIT rapidly moved from "experimental" status to godsend and panacea, although ample evidence was available that this was not the case. Enterprise EHR's seem to cost as much as entire new hospital wings. Yet ONC, AHRQ and other agencies seemed to start operating from the panacea assumption, largely since the internet hype that began at the end of the last decade.
The Office of the National Coordinator for Health IT (ONC) was established in 2004 to promote electronic health records in the United States. Regarding ONC, I've recently had some conversation with persons instrumental in the evolution of VistA, the Veteran Administration's EHR, and listened to presentations on VistA at a number of conferences.
It seems VistA is a very different universe from commercial HIT, one of strong collaboration and pride and creativity. This is likely due to its unique and relatively constrained purpose (care of veterans and family) and the non-profit nature of its history. You can get a good sense of this from the new book "Medical Informatics 20/20: Quality and Electronic Health Records through Collaboration, Open Solutions, and Innovation" (Amazon link here) written by key VistA personnel from that perspective. (Note: I use the book for teaching graduate students about the best ways to create and implement HIT and am cited in it for my views on social issues in HIT as at my website).
Commercial HIT is, on the other hand, highly corporatized, in the worst 2008 sense of the word. It is a highly competitive (need I say cutthroat) business, highly fragmented, proprietary, and anything but open. Commerical HIT is characterized by many stakeholders with widely varying agendas, forming an often dysfunctional "HIT ecosystem" (link) that largely excludes clinicians from meaningful decision making. The ecosystem is primarily centered on profit. It is an entirely different world than VistA.
In addition, hospital IS departments are usually woefully unprepared and incapable of meeting the challenges of clinical IT. IT is not a hospital core competence. Quite frankly, many of the IT leaders I've met in hospitals have been barely competent and in some cases downright abysmal where the needs and culture of practicing clinicians -- and sick patients -- are involved.
Physicians have been "resisting" health IT for 30+ years now. The diffusion of healthcare information technology after 30-plus years of effort and billions of dollars spent remains limited. As per the 2008 statistics in the NEJM article "Electronic Health Records in Ambulatory Care - A National Survey of Physicians", NEJM 359:50-60, just four percent of physicians in theU.S.
Yet those same physicians have to be restrained from using new therapeutic modalities and drugs where the benefit to patients is reasonably clear cut, even procedures and devices that are complex to perform or utilize.
Perhaps our society should take the 'resistance' to clinical IT as a phenomenon for serious consideration. One should perhaps ask themselves if they'd happily volunteer to receive a new therapy or drug that physicians have been 'resisting' for several decades.
Clinical IT is a world further characterized by issues such as these (thanks to Al Borges, MD and Health IT discussion site EMRUpdate.com for some of these links):
and many others of a similar nature.
This raises several questions:
These are very important questions. I do not know the answers. However, the decision makers in our government should ensure that they do.
-- SS
Association of American Physicians and Surgeons (AAPS)
August 2008 News
Innocent Caught in Dragnet
With a 19.7% increase in budget, and a 64-person increase in staff to a total of 1,495, the Office of Inspector General (OIG) is aggressively looking for fraud. The anti-fraud cash cow brings in $20 for $1 spent. To "find" fraud, the government gets creative, elevating ordinary billing disputes to fraud.
"The government overkills. It ruins their life. Doctors lose their career. They overbill Medicare, and it may have been sloppy," states attorney Patric Hooper. "But rather than pay back $100,000, they owe millions" (MCA 6/30/08).
One Pinellas County, Fla., physician was hauled off in handcuffs because of an ongoing dispute with UnitedHealth Care over E&M coding. What preceded the indictment was a refusal by the physician to use [healthcare IT] products sold by Ingenix, a United subsidiary. "It's clear from the documents that United filed the claim in retaliation," said the doctor's attorney. "I've never before encountered such a blatant attempt at coercion by a payer public or private" (ibid.).
Note that electronic medical record software, such as Amazing Charts, could make you liable for false claims, as through unintentional misuse of cut-and-paste functions or templates that automatically fill in blanks (ibid.).
Enforcement is being enhanced through use of anti-fraud "strike forces." The investigators are often retired policemen, and they do not treat physicians as "white collar" (MCA 6/30/08).
Some suggestions from Medicare Compliance Alert: Guard your NPI. Screen staff carefully, and watch out for "rogue employees" who might be identity thieves. Report business partners to the government; it can protect your own business. Have procedures in place to deal with search warrants. Be sure the information on your Medicare enrollment form is accurate; wrong information from a form filled in 20 years ago could result in a false claim (ibid.).
AAPS advice: consider opting out.
I believe a much more aggressive response is needed from the medical profession, including organized medicine, besides "opting out" of abusive third party payer arrangements.
In a former role of Manager of Medical Programs for a regional transit authority, I've seen labor unions that were representing bus drivers and janitors act far more aggressively and wisely in representing their members against management whims than organized medicine represents physicians against payer and government whims.
If organized medicine were performing its role in representing the profession aggressively, considering the evidence that paper charts can perform as well as electronic records in many circumstances and that most clinical IT benefits accrue to payers and other third parties, then major concessions would have been demanded of the primary beneficiaries for physicians to adopt electronic medical records.
"Musn't be too aggressive or appear disgruntled" is one of the reasons I've heard from academic colleagues that this does not occur. Physicians must be "gentlemen" and "team players." ("Team player" in today's context often means "co-conspirator to mediocrity" or to even worse).
I ask "why?" [should physicians avoid appearing angry]. The directness and actual aggressiveness of the labor union representatives I saw in action was quite effective in improving the conditions for their members. Interestingly, the union people were aggressive when "in role" yet polite when I encountered them in other settings, such as the daily commute to work. The public would likely respond to legions of angry doctors like few other means of communication could muster.
In a similar vein, I have heard from numerous circles that it's best to advocate for informatics leadership of Health IT (such as EMR, CPOE etc.) without demonstrating emotion or 'disgruntledness.' That raises several questions:
- Are physicians finding themselves marginalized and at the whim of IT managers, payers and other non clinical third parties because they have been just too angry and aggressive in demanding what was best for medicine and for themselves?
- Has there ever been any disagreement or conflict of such major proportions (and profitability) as healthcare that has been resolved purely through gentleman's dialog?
- Finally, are there lessons to be learned from these gentlemen who "petitioned for redress of grievances in the most humble of terms", only to be answered by even worse treatment?
On leadership of Health IT efforts: the sudden push by government towards universal HIT in recent years has often puzzled me. HIT rapidly moved from "experimental" status to godsend and panacea, although ample evidence was available that this was not the case. Enterprise EHR's seem to cost as much as entire new hospital wings. Yet ONC, AHRQ and other agencies seemed to start operating from the panacea assumption, largely since the internet hype that began at the end of the last decade.
The Office of the National Coordinator for Health IT (ONC) was established in 2004 to promote electronic health records in the United States. Regarding ONC, I've recently had some conversation with persons instrumental in the evolution of VistA, the Veteran Administration's EHR, and listened to presentations on VistA at a number of conferences.
It seems VistA is a very different universe from commercial HIT, one of strong collaboration and pride and creativity. This is likely due to its unique and relatively constrained purpose (care of veterans and family) and the non-profit nature of its history. You can get a good sense of this from the new book "Medical Informatics 20/20: Quality and Electronic Health Records through Collaboration, Open Solutions, and Innovation" (Amazon link here) written by key VistA personnel from that perspective. (Note: I use the book for teaching graduate students about the best ways to create and implement HIT and am cited in it for my views on social issues in HIT as at my website).
Commercial HIT is, on the other hand, highly corporatized, in the worst 2008 sense of the word. It is a highly competitive (need I say cutthroat) business, highly fragmented, proprietary, and anything but open. Commerical HIT is characterized by many stakeholders with widely varying agendas, forming an often dysfunctional "HIT ecosystem" (link) that largely excludes clinicians from meaningful decision making. The ecosystem is primarily centered on profit. It is an entirely different world than VistA.
In addition, hospital IS departments are usually woefully unprepared and incapable of meeting the challenges of clinical IT. IT is not a hospital core competence. Quite frankly, many of the IT leaders I've met in hospitals have been barely competent and in some cases downright abysmal where the needs and culture of practicing clinicians -- and sick patients -- are involved.
Physicians have been "resisting" health IT for 30+ years now. The diffusion of healthcare information technology after 30-plus years of effort and billions of dollars spent remains limited. As per the 2008 statistics in the NEJM article "Electronic Health Records in Ambulatory Care - A National Survey of Physicians", NEJM 359:50-60, just four percent of physicians in the
Yet those same physicians have to be restrained from using new therapeutic modalities and drugs where the benefit to patients is reasonably clear cut, even procedures and devices that are complex to perform or utilize.
Perhaps our society should take the 'resistance' to clinical IT as a phenomenon for serious consideration. One should perhaps ask themselves if they'd happily volunteer to receive a new therapy or drug that physicians have been 'resisting' for several decades.
Clinical IT is a world further characterized by issues such as these (thanks to Al Borges, MD and Health IT discussion site EMRUpdate.com for some of these links):
- "Oh no! Half of all current EMRs fail!", from 1/2007 Technology for Doctors (link to PDF)
- "Avoiding EMR meltdown: How to get your money's worth. About a third of practices that buy electronic medical records systems stop using them within a year. A little homework can help ensure you buy one that will work for you.", from 12/2006 AMNews (link)
- Quote: "The failure rates of EMR implementations are also consistently high at close to 50%", from Proceedings of the 11th International Symposium on Health Information Management Research – iSHIMR 2006 (link to PDF)
- Quote: "Industry experts estimate that failure rates of Electronic Medical Record (EMR) implementations range from 50–80%.", from 7/2006 A Commonsense Approach to EMRs (link to PDF)
- Kaiser Permanante HIT Meltdown (link)
- UK: Milton Keyne's Care Records System caused 'near meltdown' (link)
and many others of a similar nature.
This raises several questions:
- ONC was founded by our government. Where, exactly, was the government receiving its inputs on HIT pros and cons, drawbacks and challenges? The drawbacks have been known for a long time. Was the primary source of information from the pro-HIT optimists, opportunists and Pollyannas (per my HIT Ecosystem essay), lobbyists, and those whose experiences were largely positive in development of non commercial, large scale HIT (e.g., VA?) Could a term to describe what the administration has been told by the "HIT Ecosystem" members be this word?
- Was ONC founded on the premise that the commercial HIT 'ecosystem' operates like the VA, i.e., a world of collaboration and creativity? Could it be seeing commercial HIT through 'rose-colored glasses?'
- ONC seems to have focused on "technical" issues - standards, interoperability, etc. - at the expense of the social impediments and drawbacks to HIT. It seems the working assumption is that all that stands in the way of universal HIT, much like in the VA, is fine details of the technology and 'physician resistance.' Is ONC positioned to understand the commercial HIT sector and its issues, and in fact produce a candid and realistic "lessons learned" report as being called for in proposed House Energy and Commerce legislation?
These are very important questions. I do not know the answers. However, the decision makers in our government should ensure that they do.
-- SS
Friday, July 25, 2008
MANAGING CONFLICTS of INTEREST at STANFORD
MANAGING CONFLICTS OF INTEREST AT STANFORD
The case of Stanford University and Dr. Alan Schatzberg, chairman of Stanford’s department of psychiatry, continues to raise questions. You can see previous discussions here. The questions concern transparency at the academic-corporate boundary, reporting conflicts of interest to NIH, and Stanford’s “management” of a faculty member known to have a significant conflict. The conflict involves a company Dr. Schatzberg founded (Corcept Therapeutics), a drug called mifepristone that Corcept has in clinical trials for depression, and NIH-supported studies of the same drug at Stanford.
Stanford’s position is that Dr. Schatzberg “has not been involved in managing or conducting any human subjects research involving Mifepristone …” Dr. Schatzberg’s 2006 published disclaimer stated “…Dr Schatzberg played no direct role in the recruitment, assessment, or follow-up of subjects enrolled in this study. Dr Schatzberg was not directly involved in the analysis of data stemming from this research.” Stanford represented that this disclaimer applies also to earlier publications with Dr. Schatzberg as co-author.
This disclaimer is hardly credible, considering the responsibilities of NIH-funded Principal Investigators. I pointed out many of the inconsistencies before. Now there is new evidence that Dr. Schatzberg failed to maintain an arm’s-length relationship to the projects at Stanford.
In a 2008 review article, Dr. Schatzberg discussed the Stanford projects in ways that contradict the claim of an arm’s-length relationship. This article acknowledged Dr. Schatzberg’s NIH grant support at Stanford. Corcept Therapeutics was not acknowledged as a source of funding. The first concern is that, if Dr. Schatzberg’s relationship to the Stanford studies is as Stanford claimed, then he has no business publishing a NIH-supported review article that portrays his drug’s prospects in a favorable light. Hello! Is there a conflict of interest here? Review articles that assess a field and synthesize data form a crucial part of science that has to be off-limits to Dr. Schatzberg just as much as assessing patients in one of his clinical trials would be. His many favorable, even exaggerated, articles, reviews and commentaries since he founded Corcept should have come under this proscription. So much for Stanford’s “management” of the conflict. Dr. Schatzberg certainly had a role in managing the research supported by NIH at Stanford – he managed the climate of scientific opinion for his drug and he managed the tone of the NIH-supported publications from Stanford.
Second, Dr. Schatzberg made a claim of efficacy for his drug that differed from what was originally reported in an NIH-supported Stanford study. He claimed a 31% decrease of symptom ratings with a scale called the BPRS. The original report does not confirm that claim. From the published data tabulated in the report, the reduction of symptom severity was 20%. Readers can easily check that for themselves. So, in a current scientific review article Dr. Schatzberg deviated from the published record. He also inflated by half the efficacy estimate for his drug. Hello! Is there a conflict of interest here?
Third, this false claim indicates that Dr. Schatzberg performed and published his own reanalysis of the primary data from an NIH-funded Stanford study. He didn’t get the number 31% from the published article. Yet Stanford says he had no part in managing or conducting the research or in analyzing any data. So here we have an NIH-funded Principal Investigator, with a clear conflict of interest, who supposedly remains at arm’s length from the project, accessing the primary data files, running a new analysis himself, and publishing an exaggerated new efficacy result for his drug that does not match what he published previously as a co-author. That is inconsistent with Stanford’s defense of Dr. Schatzberg. Hello! Is there a conflict of interest here?
Fourth, in this review article Dr. Schatzberg presented the first data on mifepristone blood levels in a peer reviewed journal, along with an elaborate scientific argument for the importance of the blood level as a moderator of response. These blood level data came from Corcept’s clinical trials, but the target blood level stated by Dr. Schatzberg did not correspond to SEC filings and press releases from Corcept. The administrative issue here is how Stanford justifies the presentation and discussion of original scientific data by a Principal Investigator who is supposedly insulated from the scientific work of the project in order to avoid bias. Dr. Schatzberg’s discussion of the new data and his scientific arguments about blood levels form a crucial part of the scientific platform for his drug’s current prospects, and as such must be off limits, just as assessing patients in one of his clinical trials would be off limits under Stanford’s policy. Hello! Is there a conflict of interest here?
This current example undercuts the assertions by Stanford and Dr. Schatzberg that his conflicts of interest have been “managed” by the University. Dr. Schatzberg may not have assessed any patients in Stanford’s trials of mifepristone, but he has had the lead role in responding to scientific critiques, where he clearly was the manager. He also has had the lead role in selling the mifepristone story to the scientific community and in shaping the tone of the NIH-supported Stanford publications that Corcept relied on to raise capital. Hello! Is there a conflict of interest here? How does Stanford justify these academic-commercial boundary violations, and why does NIH not act on the known conflicts of interest? That was Senator Grassley’s question to Dr. Zerhouni today.
The case of Stanford University and Dr. Alan Schatzberg, chairman of Stanford’s department of psychiatry, continues to raise questions. You can see previous discussions here. The questions concern transparency at the academic-corporate boundary, reporting conflicts of interest to NIH, and Stanford’s “management” of a faculty member known to have a significant conflict. The conflict involves a company Dr. Schatzberg founded (Corcept Therapeutics), a drug called mifepristone that Corcept has in clinical trials for depression, and NIH-supported studies of the same drug at Stanford.
Stanford’s position is that Dr. Schatzberg “has not been involved in managing or conducting any human subjects research involving Mifepristone …” Dr. Schatzberg’s 2006 published disclaimer stated “…Dr Schatzberg played no direct role in the recruitment, assessment, or follow-up of subjects enrolled in this study. Dr Schatzberg was not directly involved in the analysis of data stemming from this research.” Stanford represented that this disclaimer applies also to earlier publications with Dr. Schatzberg as co-author.
This disclaimer is hardly credible, considering the responsibilities of NIH-funded Principal Investigators. I pointed out many of the inconsistencies before. Now there is new evidence that Dr. Schatzberg failed to maintain an arm’s-length relationship to the projects at Stanford.
In a 2008 review article, Dr. Schatzberg discussed the Stanford projects in ways that contradict the claim of an arm’s-length relationship. This article acknowledged Dr. Schatzberg’s NIH grant support at Stanford. Corcept Therapeutics was not acknowledged as a source of funding. The first concern is that, if Dr. Schatzberg’s relationship to the Stanford studies is as Stanford claimed, then he has no business publishing a NIH-supported review article that portrays his drug’s prospects in a favorable light. Hello! Is there a conflict of interest here? Review articles that assess a field and synthesize data form a crucial part of science that has to be off-limits to Dr. Schatzberg just as much as assessing patients in one of his clinical trials would be. His many favorable, even exaggerated, articles, reviews and commentaries since he founded Corcept should have come under this proscription. So much for Stanford’s “management” of the conflict. Dr. Schatzberg certainly had a role in managing the research supported by NIH at Stanford – he managed the climate of scientific opinion for his drug and he managed the tone of the NIH-supported publications from Stanford.
Second, Dr. Schatzberg made a claim of efficacy for his drug that differed from what was originally reported in an NIH-supported Stanford study. He claimed a 31% decrease of symptom ratings with a scale called the BPRS. The original report does not confirm that claim. From the published data tabulated in the report, the reduction of symptom severity was 20%. Readers can easily check that for themselves. So, in a current scientific review article Dr. Schatzberg deviated from the published record. He also inflated by half the efficacy estimate for his drug. Hello! Is there a conflict of interest here?
Third, this false claim indicates that Dr. Schatzberg performed and published his own reanalysis of the primary data from an NIH-funded Stanford study. He didn’t get the number 31% from the published article. Yet Stanford says he had no part in managing or conducting the research or in analyzing any data. So here we have an NIH-funded Principal Investigator, with a clear conflict of interest, who supposedly remains at arm’s length from the project, accessing the primary data files, running a new analysis himself, and publishing an exaggerated new efficacy result for his drug that does not match what he published previously as a co-author. That is inconsistent with Stanford’s defense of Dr. Schatzberg. Hello! Is there a conflict of interest here?
Fourth, in this review article Dr. Schatzberg presented the first data on mifepristone blood levels in a peer reviewed journal, along with an elaborate scientific argument for the importance of the blood level as a moderator of response. These blood level data came from Corcept’s clinical trials, but the target blood level stated by Dr. Schatzberg did not correspond to SEC filings and press releases from Corcept. The administrative issue here is how Stanford justifies the presentation and discussion of original scientific data by a Principal Investigator who is supposedly insulated from the scientific work of the project in order to avoid bias. Dr. Schatzberg’s discussion of the new data and his scientific arguments about blood levels form a crucial part of the scientific platform for his drug’s current prospects, and as such must be off limits, just as assessing patients in one of his clinical trials would be off limits under Stanford’s policy. Hello! Is there a conflict of interest here?
This current example undercuts the assertions by Stanford and Dr. Schatzberg that his conflicts of interest have been “managed” by the University. Dr. Schatzberg may not have assessed any patients in Stanford’s trials of mifepristone, but he has had the lead role in responding to scientific critiques, where he clearly was the manager. He also has had the lead role in selling the mifepristone story to the scientific community and in shaping the tone of the NIH-supported Stanford publications that Corcept relied on to raise capital. Hello! Is there a conflict of interest here? How does Stanford justify these academic-commercial boundary violations, and why does NIH not act on the known conflicts of interest? That was Senator Grassley’s question to Dr. Zerhouni today.
Thursday, July 24, 2008
Do we really have the societal wisdom to put all healthcare data online?
The following story on IT security is simply stunning in its layers of apparent ineptitude.
I further find at this link that this system administrator was once convicted in Kansas of aggravated robbery and served time.
Yet numerous constituents of the "Health IT Ecosystem" (a title I use to describe the complex HIT environment, link) espouse the value of national healthcare and genetics databases to be stored by commercial companies such as Google and Microsoft, and/or the Federal Government.
This raises the question: in 2008, do we really have the levels of societal wisdom necessary to put all health care data online?
-- SS
I further find at this link that this system administrator was once convicted in Kansas of aggravated robbery and served time.
Yet numerous constituents of the "Health IT Ecosystem" (a title I use to describe the complex HIT environment, link) espouse the value of national healthcare and genetics databases to be stored by commercial companies such as Google and Microsoft, and/or the Federal Government.
This raises the question: in 2008, do we really have the levels of societal wisdom necessary to put all health care data online?
-- SS
One admin's missing password leaves San Francisco in a lockdown state
By Michael Hatamoto , BetaNews
July 18, 2008, 5:00 PM
A former San Francisco city computer network administrator remains in a Bay Area jail after pleading not guilty to four charges of computer tampering. Meanwhile, the city's computer network is in limbo.
Prior to his arrest, Terry Childs, 43, of Pittsburg, California, managed to manipulate the city's computer system, creating a password that has effectively locked out all other city network administrators. As an employee in the San Francisco Department of Technology Information Services, he helped create a new network used for the San Francisco FiberWAN (wide-area network), his former defender said.
The FiberWAN network is responsible for controlling the city's e-mails, law enforcement records, payroll, and personal records. It controls 60 percent of the city's municipal data that also includes lawyer information and 311 information system.
In an interview today with the San Francisco Chronicle , Childs' attorney, Erin Crane, characterized his client as willing to cooperate, but may only turn over the password city officials need to operate their network after negotiations have concluded. Crane described Childs as more than the network's administrator -- indeed, as its architect.
Childs pleaded not guilty yesterday in San Francisco Superior Court, and is now being held in custody on $5 million bail. He will next face a bail hearing on Wednesday, July 23.
The public defender who initially defended Terry Childs, Mark Jacobs, removed himself from the case over suspected conflict of interest, after it was learned his own records were among those included in the files that Childs still holds hostage.
Specifically, Childs stopped authorized network users from accessing to parts of the network they should be authorized to use, and also enabled his own access to sections of the network to which he should have been restricted while he worked for the city, San Francisco district attorney spokespeople said.
Computer security experts have been quick to chastise the city for letting one person have access to the entire system, while recommending each person should only have access to a piece of the network. Aside from Childs, it's believed five or six people are expected to have accounts enabling universal access to everything in the network, though the identity or whereabouts of those individuals has not been made known.
In another mistake, the city apparently did not keep adequate system backups, which they could have used to restore the network and its passwords by now. Even so, it's unknown if there are any backups of the system and password, and if Childs also locked the administrator account from those backups.
There has been no data breach, no tampering with the system itself, and the only problem at the moment is that everyone is locked out, city officials confirmed.
San Francisco Mayor Gavin Newsom, city officials, and Cisco engineers are still trying to resolve network issues about five days after the initial incident. Earlier in the week, Mayor Newsom said it could take up to eight weeks to fully restore the network to working order, costing the city thousands of dollars in resources. But the eight week prediction is a worst-case scenario, in which an entirely new infrastructure would have to be built, and the current network dismantled.
During a press conference earlier in the week, Mayor Newsom described Childs as a "rogue employee" who became "a bit maniacal and full of himself."
The network restoration could happen much faster and easier with cooperation from Childs, who had said several times that he does not plan to help the city fix the network. After Childs' first court appearance, attorney Crane said this an entire issue was nothing but a misunderstanding, that the media and public had blown out of proportion.
Although the D.A. has not released the full criminal complaint against Childs, and what would have led him to do this, local Bay Area media outlets reported an alleged dispute between Childs and one of his managers. Unconfirmed reports indicate he was to be suspended on July 9 for alleged insubordination.
With little known details available out the case, the media, both professional admins and the general public have already formed their own opinion about the case, saying it's ludicrous that someone who has yet to hurt someone is being held on $5 million bail. Others, however, said effectively hijacking an entire city's computer network and holding it hostage is the wrong course of action, regardless of what grievances he has against his employers.
Even though Childs remains in police custody, he is still receiving paychecks from his $127,735 per year salary. Moving forward, the city of San Francisco hopes to work with Childs and his attorney to resolve the network issues in a timely matter, though specific talks are taking place behind closed
Attacking "Side Effects" with Logical Fallacies, Version 2
Side Effects by Alison Bass continues to generate controversy. As described by a reviewer in the New England Journal of Medicine,(1) the book
The reviewer concluded,
Ad Hominem
One of Galenberg's main arguments was that Side Effects treated as black and white a story that is really about shades of gray. Furthermore, he alleged that "its hyperbole and 'villains-versus-heroes' style do no justice to a pressing public health issue." From there, he tried to discredit two of its "heroes."
Bass actually used a number of pages to address the allegations of malpractice made against the "hero" psychiatrist. But the psychiatrist's role in the book was the early raising of the hypothesis that selective serotonin uptake inhibitor (SSRI) anti-depressants may lead to suicidal ideation. Whether that hypothesis is true, and whether or not other people sought to manipulate or suppress evidence relevant to it were the real questions Side Effects addressed. The psychiatrist's conduct with a particular patient are irrelevant to their answers.
Similarly, although Elliot Spitzer did oversee the lawsuit against GlaxoSmithKline, the manufacturer of Paxil, his conduct years later that lead to his resignation as Governor of New York had nothing to do with this lawsuit or the issues it raised. Furthermore, Side Effects focused on how his staff investigated the relevant facts and pursued the lawsuit. Spitzer's role on the ground was minimal.
Thus, a single paragraph in Galentberg's Health Affairs review employed the ad hominem fallacy twice. This fallacy may be defined one "in which a claim or argument is rejected on the basis of some irrelevant fact about the author of or the person presenting the claim or argument. Typically, this fallacy involves two steps. First, an attack against the character of person making the claim, her circumstances, or her actions is made (or the character, circumstances, or actions of the person reporting the claim). Second, this attack is taken to be evidence against the claim or argument the person in question is making (or presenting)."
Guilt By Association
Later, Galenberg wrote,
So,
Of course, anything written by anyone could be misinterpreted by someone else, or used in conjunction with yet more logical fallacies to provide erroneous support of an unrelated position. I submit that implying that Scientologists, not a group discussed or addressed in Side Effects, would be so involved was an attempt at asserting guilt by assocation. This may be defined as one "in which a person rejects a claim simply because it is pointed out that people she dislikes accept the claim."
Slippery Slope
Galenberg's worry noted above lead to a dire warning,
Galenberg did not explain how Bass' book, devoted as it was to the case of the marketing and research of single drug, could undermine all of psychiatric care. Thus, this appears to be a slippery slope, defined as a fallacy "in which a person asserts that some event must inevitably follow from another without any argument for the inevitability of the event in question."
Conclusion
What Galenberg's review did not do is meaningfully address the facts presented in the book, and Bass' main interpretation of them. Side Effects argued that clinical research evidence specifically about the safety of SSRIs for children and adolescents, not adults was suppressed and manipulated. In fact, there is now considerable evidence that SSRIs may have risks for children and adolescents that were not appreciated until recently, and may not be very efficacious for younger patients. For example, the systematic review by Whittington et al included published and unpublished data from randomized controlled trials of SSRIs in children and adolescents.(3) Its abstact concluded "published data suggest a favourable risk-benefit profile for some SSRIs; however addition of unpublished data indicates that risks could outweigh benefits of these drugs (except fluoxetine) to treat depression in children and young people. The systematic review of published trials by Fergusson et al concluded there was "an association between suicide attempts and the use of SSRIs."(4)
Galenberg concluded on the regretful note,
However, Galenberg never provided evidence or clear arguments that disputed the "underlying facts." Rather, this review, like the one by Herrmann, seemed at best to show the reviewer's distaste for Side Effects, rather than the source of that emotion.
Galenberg did allude in his review to his background,
He did not specify the companies for which he worked, the topic or purpose of the consultations, the nature of the lectures he gave, or the research he pursued. However, a quick search revealed that one of his colleagues in such research pursuits was Dr Martin Keller, one of the "villains," to use Galenberg's term, in Bass' book. (For example, see this article by Keller et al from 2007.[5]) The disclosures in that study included,
Thus, this seems to be yet another in our series of cases of confused defenses of financial entanglements among industry and academics. Such confusion seems likely to appear in arguments made by people who themselves may have relevant conflicts of interest. As Joe Collier said, " people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult."(6)
I would submit that Dr Gelenberg's review perhaps unintentionally supports the argument that physicians' and academics' financial entanglements with organizations with vested interests in promoting products, services, or ideologies should not merely be disclosed and managed, but should be materially reduced, if not eliminated.
References
1. Friedman RA. Side effects: a prosecutor, a whistleblower, and a bestselling antidepressant on trial. N Engl J Med 2008; 358: 2852. Link here.
2. Gelenberg AJ. Warning: Side Effects may include distorted vision. Health Aff 2008; 27: 1193-4. Link here.
3. Whittington CJ, Kendall T, Fonagy P, Cottrell D, Cotgrove A, Boddington E. Selective serotonin reuptake inhibitors in childhood depression: systematic review of published version unpublished data. Lancet 2004; 363: 1341-1345.
4. Kirsch I, Deacon BJ, Medina-Huedo TB, Scoboria A, Moore TJ, Johnson BT. Initial severity and antidepressant benefits: meta-analysis of data submitted to the Food and Drug Administration. PLoS Med 5(2): e45 . Link here.
5. Keller MB, Trivedi MH, Thase ME, Shelton RC, Kornstein SG, Nemeroff CB, Friedman ES, Gelenberg AJ et al. The prevention of recurrent episodes of depression with venlafaxine for two years (PREVENT) study: outcomes from the 2-year and combined maintenance phase. J Clin Psychiatr 2007; 68: 1246-1256. Link here.
6. Collier J. The price of independence. Br Med J 2006; 332: 1447-9. Link here.
used the case of Paxil to expose the unsavory and self-serving relationships among members of the pharmaceutical industry, psychiatrists, and members of the FDA.
The reviewer concluded,
Bass's riveting and well-researched account of these disturbing ties should be widely read by members of the medical profession, many of whom continue to believe, despite all evidence to the contrary, that they are immune to the influence of drug companies.We previously posted about how the book inspired one reviewer to unleash a series of logical fallacies in an apparent attempt to discredit Bass and Side Effects. Now a review by AJ Gelenberg has appeared in Health Affairs, the respected scholarly journal of health care and health policy research, which also employed its share of logical fallacies.(2)
Ad Hominem
One of Galenberg's main arguments was that Side Effects treated as black and white a story that is really about shades of gray. Furthermore, he alleged that "its hyperbole and 'villains-versus-heroes' style do no justice to a pressing public health issue." From there, he tried to discredit two of its "heroes."
One hero, a psychiatrist, admitted to a series of boundary violations with a patient that caused me to blanch. But no matter; he’s a good guy, and the author declares his intent to be pure. Another of her bigger-than-life heroes is Eliot Spitzer. The prepublication version of Bass’s book I read was written before Spitzer’s resignation as New York’s governor. I wonder if her heroes get redacted when their feet turn out to be made of clay.
Bass actually used a number of pages to address the allegations of malpractice made against the "hero" psychiatrist. But the psychiatrist's role in the book was the early raising of the hypothesis that selective serotonin uptake inhibitor (SSRI) anti-depressants may lead to suicidal ideation. Whether that hypothesis is true, and whether or not other people sought to manipulate or suppress evidence relevant to it were the real questions Side Effects addressed. The psychiatrist's conduct with a particular patient are irrelevant to their answers.
Similarly, although Elliot Spitzer did oversee the lawsuit against GlaxoSmithKline, the manufacturer of Paxil, his conduct years later that lead to his resignation as Governor of New York had nothing to do with this lawsuit or the issues it raised. Furthermore, Side Effects focused on how his staff investigated the relevant facts and pursued the lawsuit. Spitzer's role on the ground was minimal.
Thus, a single paragraph in Galentberg's Health Affairs review employed the ad hominem fallacy twice. This fallacy may be defined one "in which a claim or argument is rejected on the basis of some irrelevant fact about the author of or the person presenting the claim or argument. Typically, this fallacy involves two steps. First, an attack against the character of person making the claim, her circumstances, or her actions is made (or the character, circumstances, or actions of the person reporting the claim). Second, this attack is taken to be evidence against the claim or argument the person in question is making (or presenting)."
Guilt By Association
Later, Galenberg wrote,
I worry that Bass’s book can do harm with its broad-brush smear.
So,
Scientologists could find support for their cruel and misinformed agenda of laying waste an area of medical care that is tragically stigmatized.
Of course, anything written by anyone could be misinterpreted by someone else, or used in conjunction with yet more logical fallacies to provide erroneous support of an unrelated position. I submit that implying that Scientologists, not a group discussed or addressed in Side Effects, would be so involved was an attempt at asserting guilt by assocation. This may be defined as one "in which a person rejects a claim simply because it is pointed out that people she dislikes accept the claim."
Slippery Slope
Galenberg's worry noted above lead to a dire warning,
Worst of all, patients and their families could turn away from needed attention and further compound the neglect of psychiatric disorders.
Galenberg did not explain how Bass' book, devoted as it was to the case of the marketing and research of single drug, could undermine all of psychiatric care. Thus, this appears to be a slippery slope, defined as a fallacy "in which a person asserts that some event must inevitably follow from another without any argument for the inevitability of the event in question."
Conclusion
What Galenberg's review did not do is meaningfully address the facts presented in the book, and Bass' main interpretation of them. Side Effects argued that clinical research evidence specifically about the safety of SSRIs for children and adolescents, not adults was suppressed and manipulated. In fact, there is now considerable evidence that SSRIs may have risks for children and adolescents that were not appreciated until recently, and may not be very efficacious for younger patients. For example, the systematic review by Whittington et al included published and unpublished data from randomized controlled trials of SSRIs in children and adolescents.(3) Its abstact concluded "published data suggest a favourable risk-benefit profile for some SSRIs; however addition of unpublished data indicates that risks could outweigh benefits of these drugs (except fluoxetine) to treat depression in children and young people. The systematic review of published trials by Fergusson et al concluded there was "an association between suicide attempts and the use of SSRIs."(4)
Galenberg concluded on the regretful note,
I wish that Alison Bass had been more credible and responsible in presenting this dilemma and the underlying facts.
However, Galenberg never provided evidence or clear arguments that disputed the "underlying facts." Rather, this review, like the one by Herrmann, seemed at best to show the reviewer's distaste for Side Effects, rather than the source of that emotion.
Galenberg did allude in his review to his background,
I have consulted to the pharmaceutical industry, given lectures they have funded, and taken educational and research funds from them through my university.
He did not specify the companies for which he worked, the topic or purpose of the consultations, the nature of the lectures he gave, or the research he pursued. However, a quick search revealed that one of his colleagues in such research pursuits was Dr Martin Keller, one of the "villains," to use Galenberg's term, in Bass' book. (For example, see this article by Keller et al from 2007.[5]) The disclosures in that study included,
Dr. Gelenberg is a consultant to Eli Lilly, Pfizer, Best Practice, AstraZeneca, Wyeth, Cyberonics, Novartis, Forest, and GlaxoSmithKline; has stock options with Vela Pharmaceuticals; and has received research grants (to the University of Arizona) from Novartis.
Thus, this seems to be yet another in our series of cases of confused defenses of financial entanglements among industry and academics. Such confusion seems likely to appear in arguments made by people who themselves may have relevant conflicts of interest. As Joe Collier said, " people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult."(6)
I would submit that Dr Gelenberg's review perhaps unintentionally supports the argument that physicians' and academics' financial entanglements with organizations with vested interests in promoting products, services, or ideologies should not merely be disclosed and managed, but should be materially reduced, if not eliminated.
References
1. Friedman RA. Side effects: a prosecutor, a whistleblower, and a bestselling antidepressant on trial. N Engl J Med 2008; 358: 2852. Link here.
2. Gelenberg AJ. Warning: Side Effects may include distorted vision. Health Aff 2008; 27: 1193-4. Link here.
3. Whittington CJ, Kendall T, Fonagy P, Cottrell D, Cotgrove A, Boddington E. Selective serotonin reuptake inhibitors in childhood depression: systematic review of published version unpublished data. Lancet 2004; 363: 1341-1345.
4. Kirsch I, Deacon BJ, Medina-Huedo TB, Scoboria A, Moore TJ, Johnson BT. Initial severity and antidepressant benefits: meta-analysis of data submitted to the Food and Drug Administration. PLoS Med 5(2): e45 . Link here.
5. Keller MB, Trivedi MH, Thase ME, Shelton RC, Kornstein SG, Nemeroff CB, Friedman ES, Gelenberg AJ et al. The prevention of recurrent episodes of depression with venlafaxine for two years (PREVENT) study: outcomes from the 2-year and combined maintenance phase. J Clin Psychiatr 2007; 68: 1246-1256. Link here.
6. Collier J. The price of independence. Br Med J 2006; 332: 1447-9. Link here.
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