You can't take research like that serious with these kinds of conflicts of interest.
First of all, it was sponsered by the pharmaceutical companies, second of all, every doctor participating in that study has been on their payroll in the past with bonuses, working for them as consultants, research grants, fees, sponsorships, etc.
"Conflict of interest
Guarantor of the article: Gary R. Lichtenstein, MD.
Specific author contributions: Design and conduct of clinical trials contributing data to these pooled analyses: Gary R. Lichtenstein, Paul Rutgeerts, William J. Sandborn, Bruce E. Sands, and Robert H. Diamond; data collection and analysis: Robert H. Diamond, Linda Tang, Jennifer Montello, and Freddy Cornillie; and all authors provided critical content review and final approval of this manuscript.
Financial support: Funding for the clinical trials contributing data to these pooled analyses was provided by Janssen Research & Development, a Johnson & Johnson (J&J) pharmaceutical company.
Potential competing interests: Dr Lichtenstein has received research grants and/or has served as a consultant for Abbott Corporation, Alaven, Bristol-Myers Squibb, Janssen, Elan, Ferring, Meda Pharmaceuticals, Merck/Schering-Plough, Millennium Pharmaceuticals, Pfizer Pharmaceuticals, Proctor and Gamble, Prometheus Laboratories, Salix Pharmaceuticals, Santarus, Shire Pharmaceuticals, UCB, Warner Chilcotte, and Wyeth. Professor Rutgeerts has received research support from Janssen, Merck/Schering-Plough, UCB, and Abbott Laboratories, as well as consulting and/or speaking honoraria from Janssen, Merck/Schering-Plough, UCB, Abbott Laboratories, Elan-Biogen, NovImmune, Italfarmako, Bristol-Myers Squibb, Millennium Pharmaceuticals, Tillots, Glaxo SmithKline, and ChemoCentryx. Dr Sandborn has received has received consulting fees and research support from Abbott Laboratories, Janssen, and UCB Pharma, as well as consulting fees from Merck/Schering-Plough. Dr Sands has received consulting fees from Abbott Immunology, Axcan Pharma, Avaxia Biologics, Bristol-Myers Squibb, Elan Pharmaceuticals, Emmi Solutions, Janssen, Glaxo Wellcome SmithKline, Millennium Pharmaceuticals/Takeda, Novartis Pharmaceuticals, Pfizer, Prometheus Laboratories, and owns common stock in Avaxia Biologics, a company that is not publicly traded. Professor Colombel has received consulting fees and has participated in continuing medical education events supported by unrestricted educational grants from Janssen and Merck/Schering-Plough. Dr Diamond and Linda Tang are employed by Janssen Research & Development, a J&J pharmaceutical company. Jennifer Montello is an employee of J&J. Freddy Cornillie is an employee of Janssen Biologics BV, a J&J pharmaceutical company."
The FDA says something completely different:
A. Clinical Trials
Lymphoma had been observed with infliximab or etanercept use in previous clinical
trials (5 reports in the literature). Of the approximately 2000 patients exposed to
either agent, 7 developed lymphoma as follows: 4 with infliximab for RA, 2 with
infliximab for CD, and 1 with etanercept for RA. The investigators did not consider
the occurrence of lymphoma to be associated with the use of infliximab or etanercept.
B. Post-Licensure Reports
• Etanercept: Eighteen cases of lymphoma occurring after the initiation of etanercept
therapy were reported to the Food and Drug Administration between May, 1999 and
December, 2000. The symptoms that led to the diagnosis of lymphoma occurred
within 2 and 52 weeks (median 8 weeks) of the first etanercept dose. The median
patient age was 64 years. The majority of patients were female (61%), and the most
common indication for use was RA (83%). Most patients on etanercept were reported
to be currently on methotrexate or to have a history of methotrexate use (72%) or any
immunosuppressive drug, including methotrexate (78%).
• Infliximab: Ten cases of lymphoma occurring after initiation of infliximab treatment
were reported to the FDA between March 1999 and December 2000. The lymphomas
occurred between 2 and 44 weeks of the first infliximab dose (median 3 weeks). The
median age for infliximab cases was 62 years. The majority of the patients were male
(60%), and the most common treatment indication was CD (60%).
Reviewer comment: In patients with RA, estimated odds ratios for developing
lymphoma range from 2 to 26. Active disease, advanced patient age, prolonged use
of immunomodulatory drugs (most notably methotrexate), poor functional class, and
widespread joint involvement may be associated with a greater odds ratio. For
patients on either etanercept or infliximab therapy, the observed reporting rate of
approximately 9 cases of lymphoma per 100,000 patient-years approximates the
estimated incidence rate of lymphoma in the general population and is lower than
that for patients with RA. However, underreporting is a major limitation of passive
surveillance. The relationships among lymphoma, disorders of immune function
including RA and CD, and immunomodulatory therapy including TNF-α antagonist
therapy remain poorly defined.
The fact that this medication has received a black box warning by the FDA means it's one of the most dangerous drugs on the market, calling it safe is very deceiving.
Post Edited (Ganwei) : 6/25/2012 1:14:27 AM (GMT-6)