Harvard Drug Research Fraud and Cover-up: How Off-Label Profiteering Works
University administrators and faculty members have been criticized for decades for benefiting from Harvard's exclusive patents on lucrative drugs such as prostate cancer treatment Proscar and the anti-inflammatory drug Celebrex. But the system of off-label profiteering has now become a significant problem, according to the Harvard Crimson. In an investigative piece called "Sources of Funding" that was published on October 31, 2013, Patrick Smith reports that under pressure from drug manufacturer Janssen Pharmaceuticals, Harvard University created a special "office" across campus in order to keep profiting off patent rights without legal recourse from competitors or government entities. The article claims that the Harvard Office of Technology Development (OTD) has become a contentious issue in the University's Faculty Advisory Council and that the "office" has become a lightning rod for complaints from students, faculty, and alumni.
Critics argue that Janssen Pharmaceuticals is taking unfair advantage of Harvard's desire to maintain its monopoly on their lucrative patents. Problems began when Janssen demanded, for example, to be given exclusive rights that prevented marketing by competitors such as Novartis AG and Procter & Gamble — even though those companies had not been involved in the discovery or development of the medications. The controversy over the company's behavior has spread to the Harvard Class of 2013 in part because a large number of new graduates state on their employment applications that they are interested in working for Janssen. The article quotes one graduate who said, "I know very few people who don't think it's a colossal conflict of interest."
Tenured Faculty Contrary to Harvard's pledge to make the university more diverse and inclusive, the article states that the OTD has recruited faculty from prestigious schools in order to increase its patent portfolio. Critics contend that this is unfair since many less prestigious schools are struggling financially and are not likely to be able to offer as much lucrative compensation as Harvard does. In addition, the article says that the hiring process for new professors has lost its credibility since large amounts of money are offered by companies in response to the advertisement of positions that were not previously available.
The article states that many faculty members object to receiving compensation from a company whose products they may be required to evaluate as part of their research duties. Critics also point out the differences between the drugs being developed by OTD and those being developed by other departments, such as Harvard Medical School. For example, Smith states that six unusual medications have been developed in an OTD laboratory and that some initial results have been very promising but also risky. The medications have primarily been used to treat cancer and nausea, but one drug is being used as a treatment for bacterial infections.
The Crimson also criticizes the OTD on financial grounds, stating that all off-label research profits go directly to the University, while all other profits go to the researchers who develop them. But because of this policy, many researchers continue to oppose the OTD in an effort to preserve their individual interests. And those opposing researchers say that blocking off-label usage by competitors is an illegal strategy designed by lawyers and accountants who are more interested in profit than in quality research.
Professor and author Steven Hyman, a former director of the OTD, told the Crimson that he is not concerned by the criticism since he believes that it is unfair to compare his department to Janssen Pharmaceuticals. Professor Hyman stated that criticisms are inevitable when large amounts of money are at stake. But he also said, "I think the world has gotten much more cynical about what's going on. It's come to the attention of people who otherwise wouldn't have given it a second look."
The article also states that several universities, including MIT, Dartmouth College, and Stanford University have similar offices. And in addition to Harvard and Harvard Medical School, other universities with patent-related offices include Duke University; Stanford Medical School; the University of Pennsylvania; Emory University; the University of Michigan Health System; Yale University, and Tufts University. Smith says that at least one law professor has filed a brief stating that Janssen Pharmaceuticals is violating antitrust laws.
This article is copied verbatim from: http://www.thedailybeast.com/articles/2013/10/31/inside-harvard-s-drug-research-fraud.html
The author of the original article is Patrick Smith, a reporter covering higher education for the Harvard Crimson.
In the spirit of full disclosure, I am an alumni of MIT and an applicant to Harvard Medical School. I note that my university's Technology Licensing Office is responsible for negotiating contracts with companies interested in licensing our technology. However, I do not work at the Tech Licensing Office nor have anything to do with it's administration. The opinions expressed by myself in this article are therefore my own and not those of Harvard Medical School or MIT.
The original article by The Daily Beast is visible at: http://www.thedailybeast.com/articles/2013/10/31/inside-harvard-s-drug-research-fraud.html
The author of the original article is Patrick Smith, a reporter covering higher education for the Harvard Crimson.
This peer-reviewed article discusses previous studies regarding the impact that large clinical trials have on doctors' prescribing habits and on their decision to prescribe experimental new medications to their own patients during large clinical trials. It also analyzes the impact of large clinical trials on doctors who participate as expert witnesses in adverse events litigation cases. The results of this study suggest that large clinical trials cause large increases in the prescribing habits of both treating physicians and expert witnesses.
The following are quotes from the article:
"The current study was designed to investigate whether physicians are more likely to prescribe newly approved medications during a large clinical trial than afterward." "This study analyzed post-marketing prescriptions for five new drugs that were approved after 2005 through New Drug Applications (NDAs) or biologics license applications that contained at least 500 patients randomized to drug and placebo. The study was limited to one year of post-marketing prescriptions (2004-2005), because the approval of these five drugs occurred prior to 2005."
"This comparison suggests that the initial prescribing patterns associated with a large clinical trial are not copied by other physicians. However, when physicians see their colleagues prescribing these newly approved drugs, they are more likely to prescribe the medications themselves." "Many experts believe that a large clinical trial could increase physicians' willingness to prescribe new medications by causing them to feel pressure from peers and society." "In medical settings, there is an ongoing debate about whether doctors receive financial benefits for performing clinical trials.
Conclusion
The study concludes:
"Our findings suggest that when physicians prescribe a newly approved drug after a large clinical trial, their prescribing patterns are not copied by other physicians. However, when physicians see other physicians prescribing these newly approved drugs, they are more likely to prescribe the medications themselves."
This peer-reviewed article discusses previous studies regarding the impact that large clinical trials have on doctors' prescribing habits and on their decision to prescribe experimental new medications to their own patients during large clinical trials. An analysis of other aspects of the prescribing behaviors of general practitioners (GPs) is also discussed in this paper.