The Mystery of the Northwestern Settlement - the Plot Thickens

A few weeks ago, we wrote about this curious case.<br /><br /><b>How the Case Stood </b><br /><br />Northwester University, a prominent research university, settled charges it had mismanaged US government grant funds.  While it did not admit guilt, and specifically exonerated the faculty leader on whose watch the mismanagement allegedly occurred, the settlement and most of its coverage strongly suggested wrongdoing by the faculty member in charge of the scientific conduct of the grants, Professor Charles L Bennett.  While the alleged financial mismanagement was of funds in the mere millions, a relatively small amount as federal fraud cases go, and there were no allegations of anything harmful to patients, or of any research misconduct, the investigation involved multiple federal agencies, including the Federal Bureau of Investigation.  The settlement of charges of financial mismanagement, not research misconduct,  included unfavorable references to Dr Bennett, who as Principal Investigator should have been in charge of the scientific conduct of the grants, but not of their financial management.  Much bigger cases of alleged fraud, involving hundreds of millions of dollars, and potentially harm to patients due to overuse of dangerous drugs or devices, have not involved the FBI, and not included any disparagement of individuals who could have authorized, directed, or implemented the alleged misbehavior.<br /><br />None of the initial press coverage noted the peculiarity of these aspects of the case, nor provided any explanations for them.       <br /><br />Days later, the Cancer Letter published a long article in this case, which is now <a href="http://www.cancerletter.com/articles/20130809">available without a subscription</a>.  This article includes even more curiosities that raise even more questions.<br /><br /><b>Dr Bennett Found Irregularities, Sangoleye Pleaded Guilty, Nobody Noticed </b><br /><br />In the original media coverage, Dr Bennett was accused based on complaints by a whistle blower.  For example, in an <a href="http://www.suntimes.com/news/21623742-418/northwestern-to-pay-nearly-3-million-to-settle-cancer-research-fraud-suit.html">article</a> in the Chicago Sun-Times,<br /><br /><blockquote class="tr_bq"> A <i>whistleblower suit filed under seal in 2009 by former Lurie Cancer Center worker Melissa Theis </i>first alleged the wrongdoing by Bennett. </blockquote><br /><br />However, the story in the Cancer Letter suggests Dr Bennett had tried to blow the whistle himself.  First,<br /><br /><blockquote class="tr_bq">Bennett said the allegations that he spent NCI money on dinners and vacations were inaccurate. He said he had encountered administrative irregularities at Northwestern and <i>reported them to compliance officials.</i></blockquote><br />In addition,<br /><br />'I <i>reported administrative issues by Northwestern University with my grants to the university compliance officer</i> in 2006, just prior to my long-term bout with cancer that was diagnosed there,' Bennett said to The Cancer Letter. 'I have never had a single administrative discussion about the matter with anyone.'<br /><br />Specifically,<br /><br /><blockquote class="tr_bq">Bennett’s statement about lax administration of grants at Northwestern appears to be bolstered by <i>an aspect of the scandal that has escaped media attention </i>even as multiple news stories in Chicago and national outlets focused on the settlement.<br /><br />The Cancer Letter has learned that <b><i>days before the settlement with Northwestern was announced, a former research administrator at the Division of Hematology and Oncology at the university’s medical school pled guilty to felony charges stemming from administration of Bennett’s NCI grants.</i></b><br /><br />According to documents filed in the U.S. District Court for the Northern District of Illinois, <i>Feyifunmi Sangoleye, the rogue administrator, set up an elaborate scheme to divert $86,000 to her personal accounts.</i>The proceeds financed a wedding and a honeymoon in Europe, court documents say.</blockquote><br />The article later included more detail,<br /><br /><blockquote class="tr_bq">Bennett said that he <i>saw irregularities in the actions of the research administrator </i>who handled his Research for Adverse Drug Events and Reports and that he has <i>alerted the administration of the Division of Hematology and Oncology.</i><br /><br /><b><i>That same administrator, Sangoleye, pled guilty to larceny and theft, admitting to having embezzled NCI funds from Bennett’s program</i></b> into a checking account created in the name of a fictitious contractor.<br /><br />According to court documents, <i>Sangoleye created a vendor code for a fictitious entity she called ATSDATA.</i><br /><br />Then she <i>created 10 false invoices</i> from that entity and <i>paid them with Northwestern’s checks.</i><br /><br />The checks were <i>sent to the ATSDATA post office box, which Sangoleye had rented, and placed into a bank account she created.</i><br /><br />Between June 29, 2007, and July 29, 2008, ATSDATA received eight Northwestern checks that added up to $86,000. '<i>Sangoleye converted the proceeds of the ATSDATA checks to her own use and to the use of another' individual,</i> the plea agreement states.<br /><br />'I knew nothing about ATSDATA,' Bennett said in response to questions from The Cancer Letter. '<i>The administrator told me that ATSDATA was the billing address for the University of Illinois Survey Research Laboratory</i>, a formal subcontractor. I did not know that the Survey Research Lab had any particular billing name.<i> I have documented this to Jonathan Licht [chief of Northwestern’s Division of Hematology/Oncology] in 2008.</i>'</blockquote>So in summary, Dr Bennett, who was responsible for the scientific integrity but not the financial management of his grants, reported financial irregularities to Northwestern managers.  These reports lead to a guilty plea by a former Northwestern manager who admitted embezzling money.  However, this guilty plea was anechoic.  It did not appear in any media accounts.  The settlement negotiated between Northwestern University and the government did not acknowledge it.    <br /><br /><br />According to the Cancer Letter, Northwestern managers did not want to discuss the crimes of Sangoleye when the Cancer Letter brought it up,<br /><br /><blockquote class="tr_bq"><i> Northwestern officials declined to discuss Sangoleye, </i>saying only that she had been employed by the university as a research administrator from February 2006 through August 2009.</blockquote><br />The Cancer Letter suggested why the university might have had an interest in keeping the Sangoleye crimes and its settlement of the allegations about Dr Bennett apart.<br /><br /><blockquote class="tr_bq">Legal experts say that <i>the final plea agreement between Sangoleye and the government would have weakened Northwestern’s position in negotiating the settlement</i>. The final version of the plea agreement with Sangoleye was filed on July 25, just five days prior to the announcement of the government’s $3 million settlement with Northwestern.</blockquote>Northwestern University might have had an interest in keeping the Sangoleye criminal case and its civil case separate.  However, the government did not obviously have such an interest.<br /><br /><b><i>Why did the government not address Sangoleye's crimes in the settlement it made with Northwestern University?</i></b><br /><br /><b>The Ambiguities of the Named Whistle Blower's Work</b><br /><br />As we noted in our <a href="http://hcrenewal.blogspot.com/2013/08/the-mystery-of-northwestern-settlement.html">earlier post</a> on this case, the role of the named whistle blower, Melissa Theis, was unclear, especially vis a vis Dr Bennett.  Although Dr Bennett as Principal Investigator of some of the grants involved ought not to have had any direct control of the financial management of the grants, Ms Theis apparently worked in some financial management capacity.  Yet Ms Theis apparently blew the whistle on the university, and on Dr Bennett for alleged financial, not research mismanagement. <br /><br />The Cancer Letter raised new doubts about Ms Theis' role,<br /><br /><blockquote class="tr_bq">Several observers were <i>surprised to see that the relator, Theis, was never employed by the cancer center</i>.<br /><br />According to her 2009 suit, Theis came to Northwestern as a temp two years earlier, in 2007, serving as a <i>purchasing coordinator for the Division of Hematology and Oncology. The division, which is separate from the cancer center, administered all but one of the grants in question, the NIH database shows.</i><br /><br />After a year, in 2008, Theis was <i>hired as a fulltime employee of the Northwestern Medical Faculty Foundation. The foundation, which runs the medical practice, is also separate from the cancer center.</i> She left Northwestern in October 2008.<br /><br />'Theis specifically noted that <i>invoices were submitted for consultants and services that were never included in the initial grant budget,</i>' the complaint states. 'Invoices were submitted for consultants and services that were significantly in excess of the amount budgeted for the grant, and many of the consultants and vendors failed to provide detailed information about the actual services rendered.'</blockquote><br />Again, in the usual practice, such invoices might have been requested by a grant investigator, but the requests would have to have been vetted and then the invoices would have to have been generated by managers, not scientists or physicians.  <br /><br /><b><i>Who really administered these grants, and why did the settlement minimize the responsibility of university managers while apparently blaming scientists for bad financial management?</i></b><br /><br /><b>Dr Bennett's Supporters and Enemies</b><br /><br />In our <a href="http://hcrenewal.blogspot.com/2013/08/the-mystery-of-northwestern-settlement.html">first post</a> on this case, we had contrasted how the settlement and media coverage of it appeared to heap blame upon Dr Bennett alone, while not attaching any responsibility to his academic supervisor on one hand, or any university managers on the other.  We noted that Dr Bennett, after having been a consultant for Amgen,  had become known as a "pharmascold," a skeptic of pharmaceutical industry practices, and the author of research that suggested one Amgen product was more hazardous than had been previously thought.  His supervisor, on the other hand, had multiple ongoing financial ties to the pharmaceutical industry.<br /><br />The Cancer Letter suggested others were trying to connect related dots. First, in general,<br /><br /><blockquote class="tr_bq">Making enemies is an exhaustively studied side effect of probing the safety of cancer drugs, and during much of the period in question, <i>Bennett was producing more than his standard quota of foes.</i></blockquote><br />In particular,<br /><br /><blockquote class="tr_bq">Now, researchers who worked with Bennett on the ESA issues are puzzled by his legal problems. <br /><br />'<i>Charlie has been an important voice in raising concerns regarding the use of erythropoietin in patients with cancer,'</i> said Anthony Blau, co-director, Institute for Stem Cell and Regenerative Medicine at the University of Washington. 'In particular, his 2008 metaanalysis, published in JAMA, heightened awareness of the issue and helped to reduce the indiscriminate use of erythropoietin in cancer patients.'<br /><br />Blau is a co-author on the <a href="http://jama.jamanetwork.com/article.aspx?articleid=181533">JAMA paper</a> [as noted in our <a href="http://hcrenewal.blogspot.com/2013/08/the-mystery-of-northwestern-settlement.html">previous post</a>.] <br /><br />'<i>This doesn’t really fit in his picture,</i>' said Michael Henke, a radiation oncologist in Freiburg, Germany, who was the first to stumble across potential problems stemming from overuse of ESAs.<br /><br />'You might recall, we got in contact in 2003 when our group communicated potential dismal effects of erythropoietin on cancer patients—a story not really appreciated these days because of economic interests,'  Henke said referring to the pioneering paper in The Lancet. Henke was the senior author on the JAMA paper.<br /><br />'However, Dr. Bennett and we consistently gathered additional data that were finally reported as a meta-analysis in 2008. Consequently, erythropoietin prescriptions dramatically decreased, eventually prolonging or even saving lives of cancer patients.'<br /><br />'While collaborating, I did learn him <i>as extraordinarily active, alert-eyed colleague who strictly adhered to serious scientific conduct and to the wellbeing of patients</i>.'<br /><br />Henke confesses to <i>wondering whether the many powerful enemies Bennett made in the pharmaceutical and biotechnology industries have struck back.</i><br /><br />'We shouldn’t feed paranoia,' Henke said.  'However, given the exclusively positive experience when collaborating with his group, makes me <i>wonder whether this litigation might follow some very particular other issues</i>.'</blockquote><br /><b><i>Did Dr Bennett's transformation from a consultant to to a fierce scientific skeptic of the pharmaceutical industry influence the handling of this case, and its media coverage?</i></b><br /><br /><b>Summary</b><br /><br />The coverage by the Cancer Letter underscores our previous concerns, so I will simply repeat the summary from my last post.<br /><br />The settlement by Northwestern University, which was mainly about allegations made against Dr Charles L Bennett, who was not a party to the settlement, was very different that the vast majority of the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">march of legal settlements</a> whose continuation we have frequently discussed.<br /><br />The settlement and its media coverage raised important questions whose answers would be important to the assessment of  our current regulatory and legal response to misbehavior by and within large health care organizations.  Health Care Renewal is about raising such issues by commenting on public information, media reports, and research.  I hope those with capacity to investigate will consider these questions.  Inquiring minds want to know.<br /><br /><div class="separator" style="clear: both; text-align: center;"></div><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhTN3CIxmIM6GicEB51I-Ob3VrzUm8FD4oH4c689NVpFCg9z4d7CjFHCs-xail6Kkz-rNhZ1TwUo05OfwWOZClh2E-YeFEGZin13pIgwRIAyHLGtb2uOYm3pXbLJoImDMJf99kwTf2E3Rn7/s1600/SherlockHolmes(RMP082013).jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="196" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhTN3CIxmIM6GicEB51I-Ob3VrzUm8FD4oH4c689NVpFCg9z4d7CjFHCs-xail6Kkz-rNhZ1TwUo05OfwWOZClh2E-YeFEGZin13pIgwRIAyHLGtb2uOYm3pXbLJoImDMJf99kwTf2E3Rn7/s200/SherlockHolmes(RMP082013).jpg" width="200" /></a></div><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiaaBoxJHP1a-4vKQJ-K2QCLeGONuSncMwrZHXm7QlxGpToMSQWfUA8Ynap9x8URrARsYJvEwIE4wUL38ETuPSGQAODJIraz8M9hHw7lu_7KrAzT5KfEXQDC6dkNt7kKVIZcW3iFPoSAwIc/s1600/SherlockHolmes(RMP082013).jpg" imageanchor="1"><br /></a></div>ADDENDUM (27 August, 2013) - See also <a href="http://brodyhooked.blogspot.com/2013/08/the-fate-of-scientist-who-reveals-drug.html">comments</a> by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog. <br /><br /><br />Roy M. Poses MD in Health Care Renewal  <br /><br />

The Mystery of the Northwestern Settlement - the Plot Thickens

A few weeks ago, we wrote about this curious case.How the Case Stood Northwester University, a prominent research university, settled charges it had mismanaged US government grant funds.  While it did…

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The Dangers of Big Corporate Health Care: Deceptive Marketing of Cancer Treatments

A series of articles over the last few months, culminating in an <a href="http://www.reuters.com/article/2013/03/06/us-usa-cancer-ctca-idUSBRE9250L820130306">investigative report </a>by Reuters, provided the newest example of what can go wrong when corporations provide direct care to vulnerable patients.  In this case, the vulnerable patients had cancer, and the corporation that provided them care was the Cancer Treatment Centers of America (CTCA).  I will try to go through the case chronologically.<br /><br />As Rueters reported, CTCA "was founded in 1988 by Richard J. Stephenson, who has been chairman ever since."<br /><br /><b>The Founder's Checkered Past</b><br /><br /><u>A Misdemeanor </u><br /><br />As Reuters noted,<br /><br /><blockquote class="tr_bq">A graduate of Northwestern University Law School, Stephenson started out as an investment banker. In 1966 he became a trustee of Americans Building Constitutionally, an organization that helped wealthy individuals set up not-for-profit corporations and personal trusts to avoid paying federal income and inheritance taxes.<br /><br /><span id="midArticle_9"></span>In 1969, <i>a California state court found the group's top official and six others guilty of grand theft or conspiring to commit grand theft. Stephenson had pleaded no contest to false advertising, a misdemeanor</i>, and testified for the state, according to media reports at the time.</blockquote><br /><u>Allegations of Use of Unproven Cancer Treatments</u><br /><br />Stephenson seemingly stayed out of trouble until 1975, but<br /><br /><blockquote class="tr_bq"><span id="articleText">Stephenson ventured into healthcare in 1975, when he and partners bought Zion-Benton Hospital in Zion, Illinois, renaming it American International Hospital. By the late 1980s, American International was <i>facing financial problems and its 'reputation had been severely damaged' by local press reports about its use of unproven cancer treatments</i>, according to a 2004 court opinion on a successful petition by a former CTCA president seeking an increased valuation for his share of the company.</span></blockquote><br /><b>CTCA: No More Unsubstantiated Claims</b><br /><br />Apparently around the time American International Hospital starting having major troubles, Stephenson branched out,<br /><br /><blockquote class="tr_bq"><span id="articleText">In 1988, Stephenson founded CTCA. He was motivated, said CEO Bonner, by the difficulty he had identifying and obtaining the best therapies for his mother after she developed bladder cancer. She died in 1982.</span></blockquote><br /><span id="articleText">By 1996, CTCA got into trouble too,</span><br /><span id="articleText"></span><br /><span id="articleText"> </span><br /><blockquote class="tr_bq"><span id="articleText">Cancer Treatment Centers of America got in trouble with regulators in 1996, when the Federal Trade Commission accused it of, among other things, <i>presenting survival claims it couldn't support.</i> The company <i>entered into a consent decree with the FTC and, without admitting any of the allegations, agreed not to make unsubstantiated outcomes claims.</i></span></blockquote><br /><b><span id="articleText">"Unscientific Therapies" </span></b><br /><span id="articleText"><br /></span><span id="articleText">As far as I can tell, all was then quiet until 2012.  Late that year, a Forbes columnist <a href="http://www.forbes.com/sites/stevensalzberg/2012/12/31/making-a-profit-from-offering-ineffective-therapies-to-cancer-patients/">wrote</a>,</span><br /><blockquote class="tr_bq"><span id="articleText"> </span>Alongside standard, science-based cancer therapies, CTCA also offers an array of questionable, unscientific therapies, which it proudly labels as part of its 'integrative cancer treatment.'  <a href="http://www.cancercenter.com/cancer-treatments.cfm">CTCA advertises many such treatments</a>, including: <br /><div style="padding-left: 30px;">* Acupuncture<br /> * Acupressure<br /> * Chiropractic<br /> * <a href="http://www.cancercenter.com/complementary-alternative-medicine/naturopathic-medicine.cfm">Naturopathy</a><br /> * <a href="http://www.cancercenter.com/complementary-alternative-medicine/naturopathic-medicine.cfm">Homeopathy</a><br /> * Mind-Body medicine (including Reiki and Qi Gong)</div><br /><i>None of the treatments in this list has any scientific support showing that they provide a benefit to cancer patients.</i>  Some of them carry a real risk of harm, as I’ve written about previously.</blockquote><br />He further charged,<br /><br /><blockquote class="tr_bq">CTCA makes <i>multiple unsupported, unscientific claims for its alternative treatments</i>, such as:<br /> <ul><li>'<a href="http://www.cancercenter.com/brain-cancer/naturopathic-medicine.cfm">Naturopathic medicine can help</a> reduce these [cancer-related] symptoms, strengthen the immune system and support the healing process throughout your brain cancer treatment.'</li><li>'<a href="http://www.cancercenter.com/complementary-alternative-medicine/acupuncture.cfm">Acupuncture may help</a> to alleviate [cancer] treatment-related side effects, such as nausea and vomiting.'</li><li>'<a href="http://www.cancercenter.com/leukemia/chiropractic-care.cfm">When used during your leukemia treatment</a>, our chiropractic care services can help correct bone, muscle and joint problems and restore nerve function.' </li></ul>These are just a few examples. These claims, and CTCA’s marketing of the therapies involved, present a huge ethical problem. </blockquote><br /><b>Manipulated Survival Statistics</b><br /><br />Then, in March 2012, the Reuters investigative reporters <a href="http://www.reuters.com/article/2013/03/06/us-usa-cancer-ctca-idUSBRE9250L820130306">charged</a> that CTCA manipulated its survival statistics to make its results look better.<br /><br /><blockquote class="tr_bq">CTCA reports on its website that the percentage of its patients who are alive after six months, a year, 18 months and longer regularly tops national figures. For instance, 60 percent of its non-small-cell lung cancer patients are alive at six months, CTCA says, compared to 38 percent nationally. And 64 percent of its prostate cancer patients are alive at three years, versus 38 percent nationally.<br /><br /><span id="midArticle_13"></span>Such claims are misleading, according to nine experts in cancer and medical statistics whom Reuters asked to review CTCA's survival numbers and its statistical methodology.<br /><span id="midArticle_14"></span><br />The experts were unanimous that <i>CTCA's patients are different from the patients the company compares them to, in a way that skews their survival data</i>. It has relatively few elderly patients, even though cancer is a disease of the aged. It has almost none who are uninsured or covered by Medicaid - patients who tend to die sooner if they develop cancer and who are comparatively numerous in national statistics.<br /><span id="midArticle_15"></span><br />Carolyn Holmes, a former CTCA oncology information specialist in Tulsa, Oklahoma, said she and others <i>routinely tried to turn away people who 'were the wrong demographic' because they were less likely to have an insurance policy that CTCA preferred</i>. Holmes said she would try to 'let those people down easy.'<br /><br /><span id="midArticle_0"></span>Equally significant, CTCA includes in its outcomes data only those patients 'who received treatment at CTCA for the duration of their illness' - patients who have the ability to travel to CTCA locations from the get-go, without seeking local treatment first. That means excluding, for example, those who have exhausted treatment options closer to home and arrive at a CTCA facility with advanced disease.<br /><br /><span id="midArticle_1"></span><i>Accepting only selected patients and calculating survival outcomes from only some of them 'is a huge bias and gives an enormous advantage to CTCA,</i>' said biostatistician Donald Berry of MD Anderson Cancer Center in Houston.</blockquote><br />Furthermore,<br /><br /><span id="articleText"></span><br /><br /><br /><blockquote class="tr_bq"><i>CTCA also appears to exclude the vast majority of its patients when it calculates survival data. In survival results from 2004 to 2008 posted on its website, CTCA reported 61 patients with advanced prostate cancer, 97 with advanced breast cancer, 434 with advanced lung cancer, and 165 with advanced colon or rectal cancer. These are the four most common solid tumors. In the same period, CTCA treated thousands of patients at its Zion facility alone</i>, according to filings with state regulators.<br /><br /><span id="midArticle_8"></span>'We agree that some of our sample sizes' are small 'and have always stated this as a limitation of our study,' said Xiong, the consultant to CTCA.<br /><br /><span id="midArticle_9"></span>'I'd have some concerns about why and <i>wonder if some cherry-picking was going on</i>,' said Spectrum Health's Campbell.<br /><br /><span id="midArticle_10"></span>Moreover, while the standard reporting period for cancer survival is five years after diagnosis, CTCA on its website doesn't go that far; for the four most common tumors, it<i> reports survival up to four years at most.</i> And as Reuters found, the company's advantage often diminishes as the five-year mark approaches </blockquote>  <br /><b>The Founder's Checkered Present</b><br /><br />By the way, also in the last few months, watchdog groups have asked for an investigation of CTCA's founder for possible deceptive actions that might have violated US election laws.  In December, 2012, the Washington Post <a href="http://www.washingtonpost.com/politics/freedomworks-tea-party-group-nearly-falls-apart-in-fight-between-old-and-new-guard/2012/12/25/dd095b68-4545-11e2-8061-253bccfc7532_story.html">reported </a><br /><br /><blockquote class="tr_bq">In the weeks before the election, more than $12 million in donations was funneled through two Tennessee corporations to the FreedomWorks super PAC after negotiations with [CTCA Founder Richard J] Stephenson over a preelection gift of the same size, according to three current and former employees with knowledge of the arrangement.<br /></blockquote>Then,<br /><br /><blockquote class="tr_bq"> Two watchdog groups last week asked the Federal Election Commission and the Justice Department to investigate the donations from the two Tennessee companies. The groups, Democracy 21 and the Campaign Legal Center, say <i>the arrangement could violate federal laws that prohibit attempting to hide the true source of a political contribution by giving it under another name</i>.</blockquote><br /><br /><b>Summary</b><br /><br />In summary, there are now charges in the media that Cancer Treatment Centers of America manipulated its survival data to makes its advertised results appear better, while it also advertises unproven complementary and alternative medicine treatments  as effective.  In the past the company had signed a consent decree not to make (presumably any more) unsubstantiated claims.  Meanwhile, the company's founder, who has a past history of a no contest plea to false advertising, and who had previously run a hospital system also charged with making unsupported survival claims, has been accused of hiding political donations.<br /><br />Thus this organization, run by someone who has his own history of deception, has been found to make exaggerated and/or unsubstantiated advertising claims of several types and at different times.  These claims could attract vulnerable patients who perhaps could get better care elsewhere, possibly leading to excess morbidity and even early mortality.  <br /><br />So Cancer Treatment Centers of America seems to be the latest reason to worry about the laissez faire US system which allows lightly regulated for-profit corporations to provide direct "care" to our most vulnerable patients.   We have recently discussed how a for-profit hospital chain may have been over treating some patients and under treating others, possibly risking patients' health to increase revenues (look <a href="http://hcrenewal.blogspot.com/2012/08/paging-doctor-ebdita-how-private-equity.html">here</a>);  how for-profit hospice corporations by enrolling patients who do not actually have terminal illness for palliative care only  could be denying potentially curative treatment to curable patients (look<a href="http://hcrenewal.blogspot.com/search/label/hospices"> here</a>); and how for-profit mental health clinics and drug treatment centers could be providing shoddy, and potentially dangerous care to boost revenues (look <a href="http://hcrenewal.blogspot.com/2012/07/private-equity-vs-patient-care-bainful.html">here</a> and <a href="http://hcrenewal.blogspot.com/2013/03/deadly-over-doses-and-private-equity.html">here</a>). <br /><br />We will see if the newest part of the pattern of news reports about CTCA and its founder, coupled with reports about other for-profit health care corporations that provide direct care to vulnerable patients provoke any official action.  However, the pattern is substantial enough so that it should make all health care professionals and all patients  reconsider whether ever to trust a for-profit hospital system, hospital, clinic or other site providing direct health care to patients.<br /><br />On a policy level, as I have said before,....   In my humble opinion, before the health care bubble bursts, we need to challenge the notion that direct health care should ever be provided, or that medicine ought to be practiced by for-profit corporations. Before market fundamentalism became so prominent, many states prohibited the corporate practice of medicine, and the American Medical Association <a href="http://hcrenewal.blogspot.com/2007/12/relman-in-jama-on-threats-to-physicians.html">forbade the commercialization of medicine.</a><br /><br /> It is time to heed that wisdom. I submit that we will not be able to have good quality, accessible health care at an affordable price until we restore physicians as independent, ethical health care professionals, and until we restore small, independent, community responsible, non-profit hospitals as the locus for inpatient care.<br />

The Dangers of Big Corporate Health Care: Deceptive Marketing of Cancer Treatments

A series of articles over the last few months, culminating in an investigative report by Reuters, provided the newest example of what can go wrong when corporations provide direct care to vulnerable p…

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Rendering Unto Caesar - What the Abramson Family Cancer Research Institute vs Thompson Says About the Loss of the Academic Medical Mission

A case, <a href="http://www.nytimes.com/2012/02/06/health/cancer-center-in-lawsuit-says-a-doctor-appropriated-a-discovery.html">reported</a> by the New York Times as involving an intellectual property dispute, should create a lot of cognitive dissonance about the state of the academic medical mission.<br /><br /><strong>Litigation Involving the Abramson Family Cancer Research Institute and Dr Craig B Thompson</strong><br /><br />Here is how the Times outlined the story:<br /><blockquote><em>The president of Memorial Sloan-Kettering Cancer Center</em> in New York is in a <em>billion-dollar dispute</em> with his former workplace, a<em> cancer institute at the University of Pennsylvania</em>, over <em>accusations that he walked away with groundbreaking research</em> and used it to help <em>start a valuable biotechnology company</em>. <br /><br />In a lawsuit, the <em>Leonard and Madlyn Abramson Family Cancer Research Institute at Penn described its former scientific director, Dr. Craig B. Thompson, as 'an unscrupulous doctor'</em> who 'chose to abscond with the fruits of the Abramson largess.' </blockquote><br />In particular,<br /><blockquote>In the suit, the Abramson cancer institute, which has received more than $100 million from the philanthropist Leonard Abramson and his family, says that <em>Dr. Thompson concealed his role in starting Agios, which has attracted investors with a potentially new way to treat cancer. The institute says Dr. Thompson’s actions deprived it of proceeds that could support future research, causing it damages that could exceed $1 billion</em>.</blockquote><br />So presumably the Abramson Institute is alleging that Thompson took its intellectual property and put it into Agios, and the Institute therefore wants compensation. Note that the Institute does not appear to be alleging either that Thompson was supposed to be its employee, but actually was working for Agios at the time he was supposed to be working for the institute; or that Thompson hid a a conflict of interest created by his financial relationship with Agios that could have affected how he fulfilled his professional responsibilities there. <br /><br />Note further that certain other parties declared that they are not part of this dispute. These included Dr Thompson's current employer:<br /><blockquote><em>Sloan-Kettering declined to comment, saying it was not a party to the lawsuit</em>....</blockquote><br />These also included the University of Pennsylvania:<br /><blockquote>Susan E. Phillips, senior vice president for Penn Medicine, said that <em>the suit had been filed not by the university but by the research institute, a separate entity. </em>She said the university was investigating the accusations. </blockquote><br />The nature of this dispute ought to generate several kinds of cognitive dissonance.<br /><br /><strong>Protecting Intellectual Property vs Upholding the Academic Mission at the University of Pennsylvania</strong><br /><br />On <a href="http://www.afcri.upenn.edu/aboutus/ourhistory.html">one of its web pages</a>, the Abramson Family Cancer Research Institute describes its history:<br /><blockquote>The Abramson Cancer center of the University of Pennsylvania provides each patient with <em>exemplary care though a comprehensive team approach, personalized service, education and outreach, and nationally recognized cancer research programs</em>.</blockquote><br />The web page describes the institute as simply part of the larger University of Pennsylvania cancer center, which came to be named for the Abramson family:<br /><blockquote><em>Penn's Cancer Center was renamed in 2002 as the Abramson Cancer Center of the University of Pennsylvania,</em> recognizing the Abramson family's $100 million commitment to support comprehensive cancer research and care.</blockquote><br />Thus it seems that the Abramson institute is simply a piece of a traditional academic medical center.<br /><br />The academic mission is traditionally described as the creation and teaching of knowledge. Thus, if an academic institution creates new knowledge, its should then disseminate it, not own it. Of course, in the US, since the Bayh-Dole act was passed, academic institutions were given the ability to patent their discoveries, and began to protect and sequester the knowledge they contained, rather than disseminating it.<br /><br />In this case, however, one part of a large university and a large academic medical center seems to be concentrating entirely on its right of ownership of intellectual property, not the traditional academic mission. The fact that this dispute has lead to litigation suggests that the academic organization is now intent on protecting, rather than disseminating knowledge. The dispute appears to be between a commercial research company and its allegedly errant former hired manager.<br /><br /><strong>The Abramson Institute: Part or Independent of the Academic Medical Center?  </strong><br /><br />A little more digging suggests that the nature of the Abramson institute is not as clear as is described in its web-page. A GuideStar search revealed that the institute is actually legally independent from the university. It filed its own 990 form (latest version, covering 2009-2010, <a href="http://www.guidestar.org/FinDocuments/2010/232/929/2010-232929823-074d3257-9.pdf">here</a>.)<br /><br />The filing did list various entities, including the Clinical Care Associates of the University of Pennsylvania Health System, and the Trustees of the University of Pennsylvania as "related tax-exempt organizations."<br /><br />However, this filing should create cognitive dissonance about what the underlying nature of the Institute? Is it part of the University of Pennsylvania and its medical center, or is independent but cooperating?<br /><br />This dissonance is only enhanced by the ambiguous response of the University of Pennsylvania to the lawsuit. If the Institute is part of the University, then the University ought to be party to the lawsuit, it would seem.<br /><br />This filing with the US government did underline the Institute's commitment to disseminating research. A description of its tax "exempt purposes" included:<br /><blockquote>Education - scientists at the Institute actively <em>share their discoveries with the research community, physicians, and students.</em></blockquote><br />As above, this statement of purpose appears not to fit with the filing of a lawsuit to obtain damages due to the alleged taking of intellectual property. If this really were the Institute's mission, would not they want the intellectual property liberated so it could be actively shared? The cognitive dissonance about the mission of the Institute and of the University versus the protection and sequestration of intellectual property is thus increased.<br /><br /><strong>Upholding the Academic Mission vs Staying Uninvolved at Memorial Sloan-Kettering Cancer Center</strong><br /><br />As an aside, note that Dr Thompson is now not just working for Agios. In fact, he has been President of the Memorial Sloan-Kettering Cancer Center since 2010 (look <a href="http://www.mskcc.org/news/magazine/october-2010/craig-thompson-named-president-msk">here</a>). Just like the Abramson Cancer Center, Sloan-Kettering is an academic medical center with the traditional mission of teaching, research, and patient care. Here is its <a href="http://www.mskcc.org/about">mission statement</a>:<br /><blockquote>As one of the world's premier cancer centers, Memorial Sloan-Kettering Cancer Center is committed to <em>exceptional patient care, leading-edge research, and superb educational programs.</em></blockquote><br />So one would think that people there ought to be concerned by allegations that its current president took intellectual property without authorization, and that he is "an unscrupulous doctor." If these allegations were to be proven false, they seemingly would represent a major, unwarranted slur on its and his reputation. If they were to be proven true, they would indicate that current leadership might not have the character to uphold the mission. Either outcome would be serious and have serious implications. However, at the moment, this noted academic medical institution has expressed neither outrage about possibly false accusations nor resolve to investigate the matter and then weed out any leaders not devoted to the mission.<br /><br />Thus, the apparent intention of the leadership of Memorial Sloan-Kettering to stay uninvolved with this case ought to generate more cognitive dissonance. <br /><br /><br /><strong>Summary</strong><br /><br />The cognitive dissonances evoked by the case of the Abramson Institute vs Dr Thompson ought to inspire questions about what our academic medical institutions have become.  While they proclaim their devotion to research and teaching to improve health and health care, and advance science, they may increasingly act like commercial research organizations whose main goal is to generate increased revenue from products and services, and in this case, from intellectual property.  <br /><br />It is hard to see how this emphasis on holding onto rather than disseminating new knowledge will be good in the long run for science, learning, or patient care.<br /><br />We are now a good 30+ years into our ill-fated American experiment about the effects of turning medicine commercial and making health care a commodity. So far, it has yielded the highest costs in the world, but declining access, mediocre quality, and demoralized professionals.  Squabbling among top researchers and leading academic medical institutions over the ownership of intellectual property for the sake of revenue, not dissemination, is the latest symbol of the decline of our health care.<br /><br />I can only hope that all the parties involved suddenly remember that they are supposed to be creating and disseminating knowledge, not just getting rich. 

Rendering Unto Caesar - What the Abramson Family Cancer Research Institute vs Thompson Says About the Loss of the Academic Medical Mission

A case, reported by the New York Times as involving an intellectual property dispute, should create a lot of cognitive dissonance about the state of the academic medical mission.Litigation Involving t…

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What the November, 2009, Breast Cancer Screening Argument Obscured

In November, 2009, a rancorous argument about screening mammography for women aged 40-49 was touched off by the publication of updated guidelines(1), supported by a systematic literature review(2) by the US Preventive Services Task Force (USPSTF).  The guidelines suggested that yearly mammographic screening for women in that age group should <em>not be automatic</em>, but <em>a decision made for individual patients after discussion between the patients and their doctors.</em>  This was based on a critical review of the best available data which suggested that the benefits of screening acrue to only a few patients.  1904 women would have to start screening and continue for multiple rounds to prevent one cancer death over 11-20 years of follow-up.  These benefits had to be balanced against a number of potential risks, including the risks of treatment of cancers that might never behave malignantly, and the at least theoretical risk of generating new cancers through radiation exposure from mammography.  <br /><br />These seemingly reasonable recommendations generated heated responses.  The debate, to be charitable, seemed to be at its core about how one should weigh benefits and harms in making individual and health policy decisions.  Since different people value different outcomes differently, I was not sure at the time how to make a meaningful contribution to this debate, or whether the debate had to do with the issues we usually discuss on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>.<br /><br />I should note that the USPSTF guidelines never said "do not screen" women under age 50, or that the government should not pay for such screening.  They did say "<em><strong>the decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take pateint context into account, including the patient's values regarding specific benefits and harms</strong></em>."  It is hard to see how anyone could argue with that as an expression empowering patients' choices and values.  (For further discussion about how the recommendations were actually modest and reasonable, see Partridge and Winer.)(3)<br /><br />Now that the dust has settled, it may be useful to reflect further on this.  Doing so suggests that the rancorous US debate mainly obscured rather than illuminated the major issues regarding mammography screening, particularly about our lack of clear evidence from clinical research needed to make the best individual and  policy decisions about mammography. <br /><br />It seems to me that the main questions one must answer to make an individual or policy decision about screening mammography are:<br /><br /><strong>Does it improve longevity? </strong><br /><br />This is not the same as asking whether mammography reduces mortality from breast cancer.  It is theoretically possible that while decreasing mortality due to breast cancer, screening and its downstream consequences increases mortality from other causes.  At least in theory, screening may detect small tumors that would never grow or metastasize.  Treating such tumors could sometimes lead to premature death due to complications of surgery, radiation, or chemotherapy.  Furthermore, screening also involves periodically exposing large numbers of women to radiation, which may sometimes cause new tumors.  So reducing breast cancer mortality does not automatically mean that overall longevity would be improved.<br /><br />There have been eight major trials of breast cancer screening which included women younger than 50. (See reference 2.)  None demonstrated a statistically significant increase in overall survival (that is, an increase unlikely to have been due to chance alone) due to screening.<br /><br /><strong>Does it reduce suffering, improve functioning or generally improve quality of life?</strong><br /><br />To my knowledge, no major trial attempted to answer this question.  No such data is mentioned in the USPSTF systematic review.<br /><br /><strong>Do the above benefits outweigh all its potential harms and risks?</strong><br /><br />So we cannot answer this question, because the benefits that might be most meaningful to patients (overall survival, symptom reduction, functional improvement, overall quality of life improvement) have not been clearly measured.<br /><br /><strong>A Lack of Relevant Evidence</strong><br /><br />So the USPSTF guidelines, like other relevant guidelines, were based on the evidence that is available.  Since the evidence did not directly answer the most important questions, the guideline writers were left doing the best they could with evidence that only indirectly addressed the main issues.  No wonder they ended up unable to make a clear recommendation, and leaving the decisions to individual discussions, and individual discussions that would necessarily hinge on guesses about the unknown.  <br /><br />One would think that a big point of discussion about breast cancer screening would be why after eight trials enrolling a total of about 350,000 patients reported over 20 years we still cannot answer the big clinical questions.  A related point for discussion in the US is why only one, and the earliest trial was conducted here.  If we here in the US think breast cancer screening is such a major concern (and we should think so), why have we been unable to mount a single important trial of it since the HIP trial conducted more than 30 years ago?<br /><br />Instead, the rancorous debate in the US included...<br /><br /><strong>Anecdotes, Some Irrelevant</strong><br /><br />The press found a number of women who said they would not be alive were it not for screening mammography before age 50.  With all due respect, one cannot tell whether an individual whose tumor was found on screening mammography would still have been diagnosed early enough for succesful treatment in the absence of screening mammography.  (And also with all due respect, we have no idea whether there also are cases of women who died as a result of treatments of tumors that never would have progressed, or cases of women who died of tumors caused by radiation from multiple mammograms.)  Reasoning from single cases when people, diseases, and treatment results vary so much is likely to mislead.  <br /><br />It is somewhat ironic that some of the cases cited were of women who had breast cancer diagnosed before age 40, even though the debate was supposedly about screening from ages 40-49.  For example, in an inflammatory article that suggested that some "oncologists" might want the USPSTF sent to the prison at Guantanamo Bay, Washington Post editorialist Dana Milbank cited cancer activist Nancy Brinker, who mentioned her sister "whose breast cancer was found with a mammogram at age 37," (and apparently who tragically is no longer alive).(4)  <br /><br /><strong>Going Well Beyond the Evidence</strong><br /><br />As noted above, no trial has shown that screening mammography for women under 50 increases overall longevity.  We all hope it does, but so far, there is no clear evidence that it does.  <br /><br />Yet multiple media reports included assertions that screening mammography saves lives.   For example, the breast cancer activist mentioned above said, "mammography saves lives," apparently including mammography under age 50.(4)  An op-ed column by Dr Alan Kaye, chairman of radiology at Bridgeport Hospital, asserted "large, multinational research studies have shown that mammography saves lives in all age groups covered by the current guidelines."(5)  I would challenge him to show me a single such study that found a statistically significant increase in overall survival for patients under 50.  A Texas radiologist stated, "I diagnosed a 40-year old woman with breast cancer last week.  If she had waited 10 years, with pre-menopause breast cancer she would have been dead."(6)  Unfortunately, since she was just diagnosed, how can he be certain that she will survive any given amount of time?  How could he know that the cancer might not have become manifest, absent that single mammogram, later while still treatable?  <br /><br />I do not want to be too hard on patients who do not appreciate that the outcomes of testing and treatment for breast cancer are not certain.  However, one would hope that physicians would be able to deal with this uncertainty.<br /><br /><strong>Conflicted Opinions</strong><br /><br />Some of the more strident discourse came from those who may have had financial vested interests in promoting screening mammography.  Fugh-Berman and Bell pointed out numerous "fact-free emotionally charged statements" made by people who appeared to "reading from the same script-book."(7)  They identified that many of the loudest critics of the USPSTF guidelines were affiliated with not-for-profit organizations with impressive names, but also with substantial financial support from corporations that make products used in mammography.  Also, some had personal financial relationships with such corporations.  <br /><br />An op-ed article by former US Food and Drug Agency (FDA) commissioner Dr Andrew von Eschenbach and Ms Nancy Desmond distorted the USPSTF guidelines to mean "most women should delay screening until they are 50," and claimed that was based on cost concerns, not clinical evidence.(8).  Desmond is the CEO of and von Eschenbach is now a senior advisor to the Center for Health Transformation.  The Center's <a href="http://www.healthtransformation.net/cs/our_members">members</a> include numerous pharmaceutical and device manufacturing corporations, including several that make mammography equipment (e.g., GE Healthcare and Siemens).<br /><br /><strong>Summary</strong><br /><br />Cancer, especially breast cancer, has major emotional connotations, and can be a difficult issue to deal with from many people.  The conflicting emotions cancer brings out in many patients may understandably affect their physicians, as well as friends and family.  Nonetheless, physicians, other health policy professionals, and health policy experts can serve patients better if they do not allow the patients' understandable affective responses cloud their understanding of the clinical and scientific issues.  <br /><br />Yet the late 2009 debate in the US about screening mammography included many responses in which emotion seemed to overwhelm reason.  It may also be that some such responses came from people who had vested interests, or whose employers had vested interests that supported the emotional, rather than the reasoned approach.  Meanwhile, no one seemed to acknowledge that a big reason we are still debating this topic is that we have not made the effort or expended the resources to do good trials of sufficient size to answer the questions that need answering.  Of course, such trials might provide answers that would upset some people, or threaten others' incomes.  (As one news article pointed out, mammography is now a $5 billion a year industry in the US.)(6)<br /><br />So my end of annus horribilis 2009 message on Health Care Renewal is to better serve our patients, from 2010 onward we health care professionals need  to try harder to put evidence and logic ahead of our own emotions, and certainly ahead of our financial self-interest.  <br /><br />Note that numerous bloggers have taken on this topic, so see posts on <a href="http://scienceblogs.com/insolence/2009/11/really_rethinking_breast_cancer_screenin.php">Respectful Insolence</a>, <a href="http://www.gooznews.com/node/3173">GoozNews</a>,  <a href="http://healthcareorganizationalethics.blogspot.com/2009/11/death-panel-plots-and-mammogram.html">Health Care Organizational Ethics</a>, and the <a href="http://www.evidenceinmedicine.org/2009/11/uspstf-mammography-and-grading-recommendations.html">Evidence in Medicine blog</a>.<br /><strong><span style="font-size: x-small;">References</span></strong><br /><br /><span style="font-size: x-small;">1. US Preventive Services Task Force. Screening for breast cancer: U.S. Preventive Services Task Force recommendation statement.  Ann Intern Med 2009; 151: 716-726. [link </span><a href="http://www.annals.org/content/151/10/716.full"><span style="font-size: x-small;">here</span></a><span style="font-size: x-small;">]</span><br /><span style="font-size: x-small;">2. Nelson HD, Tyne K, Naik A et al. Screening for breast cancer: an update for the U.S. Preventive Services Task Force.   Ann Intern Med 2009; 151: 727-737.  [link </span><a href="http://www.annals.org/content/151/10/727.full"><span style="font-size: x-small;">here</span></a><span style="font-size: x-small;">]</span><br /><span style="font-size: x-small;">3. Partridge AH, Winer EP. On mammography - more agreement than disagreement.  N Engl J Med 2009; 361: 2499-2501. [link </span><a href="http://content.nejm.org/cgi/content/short/361/26/2499"><span style="font-size: x-small;">here</span></a><span style="font-size: x-small;">]</span><br /><span style="font-size: x-small;">4. Milbank D. Feeling farther from the finish.  Washington Post, Nov 24, 2009.  [link </span><a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/11/23/AR2009112303145.html"><span style="font-size: x-small;">here</span></a><span style="font-size: x-small;">]  </span><br /><span style="font-size: x-small;">5. Kaye A. An alarming retreat on early detection.  Hartford Courant, Nov 25, 2009 [link </span><a href="http://www.courant.com/news/opinion/editorials/hc-kaye-healthcare1125.artnov25,0,2479096.story"><span style="font-size: x-small;">here</span></a><span style="font-size: x-small;">]</span><br /><span style="font-size: x-small;">6.  Jacobson SJ. Dallas-area clinics ignore proposed rules, still push for mammograms. Dallas News, Nov 27, 2009.  [link </span><a href="http://www.dallasnews.com/sharedcontent/dws/dn/latestnews/stories/112709dnmetmammograms.3f4c9cb.html"><span style="font-size: x-small;">here</span></a><span style="font-size: x-small;">]</span><br /><span style="font-size: x-small;">7. Fugh-Berman A, Bell A. Mammography and the corporate breast.  Bioethics Forum, Nov 24, 2009.  [link </span><a href="http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=4194"><span style="font-size: x-small;">here</span></a><span style="font-size: x-small;">]</span><br /><span style="font-size: x-small;">8. von Eschenbach A, Desmond N. Government panels can't put price on human life. Associated Press, Nov 24, 2009.  [link </span><a href="http://www.healthtransformation.net/cs/opeds_news?pressrelease.id=3509"><span style="font-size: x-small;">here</span></a><span style="font-size: x-small;">]</span>

What the November, 2009, Breast Cancer Screening Argument Obscured

In November, 2009, a rancorous argument about screening mammography for women aged 40-49 was touched off by the publication of updated guidelines(1), supported by a systematic literature review(2) by …

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Spun Silly: Academic Medical Center Cancer Treatment Advertising in the Era of Hype and Flim-Flam

Over the weekend, the New York Times <a href="http://www.nytimes.com/2009/12/19/health/19cancerads.html">reported</a> on how prestigious academic medical centers advertise cancer care.  Here are some examples,<br /><br /><strong>Prostate Cancer Surgery at Mount Sinai</strong><br /><blockquote>A print advertisement for prostate cancer surgery at Mount Sinai Medical Center in Manhattan is typical of the way many elite research and teaching hospitals <em>sell hope to the public</em>. <br /><br />'Our newest prostate specialist, Dr. David Samadi, has pioneered a minimally invasive approach that allows him to retain <em><strong>the highest cancer cure rates with the lowest risk of side effects</strong></em>,' says the ad.<br /><br />Highest cure rates. Lowest risk. What evidence does the medical center have to back up such superlatives?<br /><br />The ad’s claims are based on the successful results of Dr. Samadi’s operations and testimonials from his patients, said Jane Zimmerman, Mount Sinai’s chief marketing officer. <br /></blockquote>However, the article noted that the hospital could provide no studies that showed that its or Dr Samadi's results were superior to those of other hospitals or other surgeons.<br /><blockquote>... the ad with the superlative prostate cancer claims ... was later revised to say that Dr. Samadi’s approach gives 'high rates of success coupled with lowered risks of side effects.' Ms. Zimmerman said Dr. Samadi was not available to be interviewed. <br /></blockquote>Also,the people who concocted the advertisement said it was not really meant to tell prospective patients that the surgeon had better results than all others:<br /><blockquote>But marketing executives defend their approach, saying cancer treatment ads tend to play more heavily on emotion than on medical statistics because <em><strong>the ads are not intended to inform people who already have the disease. They are meant to make an impression on future patients</strong></em>, who may decide on treatments years after they have seen an ad, or to sway influential people who might advise a future patient. <br /><br /><em><strong>'This isn’t retail advertising,'</strong></em> said Ellis Verdi, president of the DeVito/Verdi Agency in Manhattan.<br /><br />The agency produced the Mount Sinai ad, which ran in The New York Times, and has created cancer ads for other hospital clients. <em><strong>'This is reputation advertising,'</strong></em> Mr. Verdi said. 'There is a very big difference.'<br /></blockquote><br />But the advertisement said that the hospital's prostate cancer specialist had the highest survival and lowest adverse event rates.  How would a patient with prostate cancer realize that the advertisement was only meant to enhance the hospital's reputation, but not meant to speak to him?   <br /><br /><strong>Radiation for Brain Tumors at Massachusetts General Hospital</strong><br /><blockquote>'We gave Nick <em><strong>something he couldn’t find anywhere else in the Northeast. Life without cancer</strong></em>.'<br /><br />That was the text of a print ad last year by the Massachusetts General Hospital Cancer Center in Boston, promoting its $50 million center for proton beam therapy, a kind of high-energy radiation to treat brain tumors and other cancers. <br /><br />The hospital was the only medical center in the region with a proton therapy center, the ad said, enabling doctors there to successfully treat the brain tumor of a young man named Nick. <br /><br />The<em><strong> ad’s concept was that Nick had a greater chance of survival because the precise proton beam could destroy malignant brain tissue while leaving surrounding healthy brain tissue intact</strong></em>, said Jodie Justofin, the marketing director at Mass General’s cancer center.<br /><br />Dr. Thomas F. DeLaney, the medical director of the Francis H. Burr Proton Therapy Center at Mass General, said he had no involvement in the ad and did not have any information about Nick. <br /></blockquote><br />However, the article also noted that "no rigorous studies have shown that proton beam therapy has higher brain-cancer cure rates than other treatment methods, said Dr. [John D] Birkmeyer of Michigan [a professor at the University of Michigan and cancer outcomes researcher]. 'The ad might be accurate that they are the only hospital in the Northeast with this particular widget,' he said. 'But it could be misleading that the availability of this particular widget gave this patient better odds of survival.'"<br /><br />Again, the advertisement said that the patient got "life without cancer," something he could not get anywhere else in the Northeast.  How would a patient with a brain tumor realize that the advertisement was merely based on a "concept," rather than scientific evidence that his  or her only hope for "life without cancer" could come from proton beam therapy at the Massachusetts General Hospital?<br /><br /><strong>Surgery for Cervical Cancer at Memorial Sloan-Kettering Cancer Center</strong><br /><blockquote><em><strong>'Cancer, You said I’d never bear children,'</strong></em> reads the handwritten letter, held out by a pretty, healthy-looking woman, as a toddler peeks from behind the paper. <em><strong>'My daughter says you’re wrong.'</strong></em><br /><br />That recent print ad from Memorial Sloan-Kettering Cancer Center in Manhattan tells the story of Michelle Rogala, a patient with cervical cancer. <br /><br />Ms. Rogala’s hospital in New Jersey could offer her only a hysterectomy, an operation that would have left her unable to have children. Instead, she went to Memorial Sloan-Kettering, where she entered a clinical trial that was studying less invasive surgery. Ms. Rogala now has a little girl named Maddie. <br /><br />Ellen Miller-Sonet, vice president for marketing at Memorial Sloan-Kettering, said consumers seeing the ads realizes that these were individual stories. 'They know that no two people are the same,' she said. <br /></blockquote>However, Ms Rogala told the NY Times, "hers had indeed been a special case. She had early-stage cervical cancer, she said, making her eligible for a novel operation that has now become a standard treatment at the center. After her operation, doctors told her she would need fertility treatments to conceive. But she said she turned out to be one of the few patients in the study who did not need radiation — which can cause fertility problems. She later became pregnant without medical intervention."<br /><br />Again, why "consumers," much less patients with cervical cancer, would realize that the advertisement was just an "individual story," not a promise that the hospital's treatment of cervical cancer would not prevent future pregnancies, was entirely obscure.<br /><br /><strong>Summary</strong><br /><br />The three advertisements described in the NY Times article had some features in common. All seemed to promise exceptional results. None were based on clear scientific evidence. All seemed to have been products of marketers and advertising agencies working without input from the physicians who actually provide the treatments they were advertising. All the marketers defended their work by saying that the advertisements did not actually mean what they appeared to mean.<br /><br />My most obvious comment is that hospitals, even the most prestigious teaching hospitals, now seem to be willing to market their services like the used car salespeople seen on late night television.  Such advertisements, of course, are unseemly and undignified coming from such august institutions.  Worse, they seem to promise more than what these or any hospitals can be proved to deliver, and the only defense of the marketers who produced the advertisements were that they did not mean what they seemed to mean.<br /><br />This shows the sad, and ultimately deceptive and unethical effects of turning the leadership of our best medical institutions over to businesspeople with little knowledge or understanding of the values of  health care.<br /><br />It also shows what has happened to health care in an age of hype, scam, sham, spin and flim-flam.  It all seems part of what Frank Rich just <a href="http://www.nytimes.com/2009/12/20/opinion/20rich.html">wrote</a> about in the NY Times:<br /><blockquote>If there’s been a consistent narrative to this year and every other in this decade, it’s that most of us, Bernanke included, have been <em>so easily bamboozled</em>. The men who <em>played us for suckers</em>, whether at Citigroup or Fannie Mae, at the White House or Ted Haggard’s megachurch, are the real movers and shakers of this century’s history so far. That’s why the obvious person of the year is Tiger Woods. His <em>sham</em> beatific image, questioned by almost no one until it collapsed, is nothing if not the farcical <em>reductio ad absurdum of the decade’s flimflams</em>, from the cancerous (the subprime mortgage) to the inane (balloon boy).<br /><br />What makes the golfing superstar’s tale compelling, after all, is not that he’s another celebrity in trouble or another fallen athletic 'role model' in a decade lousy with them. His scandal has nothing to tell us about race, and nothing new to say about hypocrisy. The conflict between Tiger’s picture-perfect family life and his marathon womanizing is the oldest of morality tales.<br /><br />What’s striking instead is the exceptional, Enron-sized gap between this golfer’s public image as a paragon of businesslike discipline and focus and the maniacally reckless life we now know he led. What’s equally striking, if not shocking, is that the American establishment and news media — all of it, not just golf writers or celebrity tabloids — fell for the Woods myth as hard as any fan and actively helped sustain and enhance it.<br /><br />People wanted to believe what they wanted to believe. Tiger’s off-the-links elusiveness was no more questioned than Enron’s impenetrable balance sheets, with their 'special-purpose entities' named after 'Star Wars' characters. Fortune magazine named Enron as America’s 'most innovative company' six years in a row. In the January issue of Golf Digest, still on the stands, some of the best and most hardheaded writers in America offer 'tips Obama can take from Tiger,' who is typically characterized as so without human frailties that he 'never does anything that would make him look ridiculous.'<br /></blockquote>I would note that the health care precursor to all this was how the former CEO of the Allegheny Health Education and Research Foundation (AHERF), the biggest health care system in Pennsylvania in the 1990s, was hailed as a visionary in the medical press and scholarly literature, which later ignored AHERF's bankruptcy and its former CEOs criminal conviction (see post <a href="http://hcrenewal.blogspot.com/2007/04/that-recent-unpleasantness-fall-of.html">here</a>.)  So my one disagreement with Mr Rich is that the problems are much older than the 21st century.<br />Rich concluded,<br /><blockquote>after a decade of being <em>spun silly</em>, Americans can’t be blamed for being cynical about any leader trying to sell anything. As we say goodbye to the year of Tiger Woods, it is the country, sad to say, that is left mired in a sand trap with no obvious way out. <br /></blockquote><br />The way out of our sand trap in health care, of course, is to refuse to be spun any more. We need to stop believing the hype propogated by all the clever marketers, and all the self-interested CEOs who hire them.<br /><br />Meanwhile, I would suggest to any cancer patient who failed to get the wonderful results promised by some slick hospital advertisement, there may be some lawyers who with whom you ought to speak.

Spun Silly: Academic Medical Center Cancer Treatment Advertising in the Era of Hype and Flim-Flam

Over the weekend, the New York Times reported on how prestigious academic medical centers advertise cancer care.  Here are some examples,Prostate Cancer Surgery at Mount SinaiA print advertisement for…

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