Why Did Tillott's Pharma Fund a Crohn's & Fish Oil Study?

(Below is some fish oil information from spring 2008 that I wrote but forgot to "publish")

Last week's health news included the headline "Omega-3 fatty acids don't work on Crohn's."

The headline was based on a study published in a JAMA article. However, the story in Reuters didn't mention that the study's funders have a signficant conflict of interest (as do the study's authors--but more on that later):

Funding/Support: This study was funded by Tillotts Pharma.

Role of the Sponsor: The trial was designed by the academic investigators in collaboration with representatives of Tillotts, and representatives of Tillotts reviewed and approved the final version of the manuscript.

source: Omega-3 free fatty acids for the maintenance of remission in Crohn disease: the EPIC Randomized Controlled Trials. JAMA. 2008 Apr 9;299(14):1690-7.

Tillotts Pharma is a Swiss Company which created Asacol and licenses it to Proctor & Gamble for North American sales.

 

The "Role of the Sponsor" implies some level of medical ghost writing--where Tillotts Pharma funds the study, uses the resulting data to write the article, and has the doctors sign off.

Why would Tillotts, a 100-person pharma company, fund an expensive study on fish oil and Crohn's disease?
I don't know the answer but here are some possibilities:

  • (nice, little conflict of interest)  Tillotts was investigating using a fish-oil like substance for a future medication and asked doctors to help out.
  • (maybe) The doctors approached Tillotts Pharma for a grant to study fish oils and Crohn's disease.
  • (not-so-nice intentions) Tillotts Pharma wants to discourage fish oil use.
    In the market, fish oil competes with Tillotts Pharma's Asacol and studies show that people prefer to take fish oil rather than drugs such as Asacol1. Also, 5-ASA drugs such as Asacol aren't that effective for maintaining remission for Crohn's patients2 [note: 5-ASA drugs are effective for ulcerative colitis].
  • (good) UCB Pharma, which owns 19% of Tillotts, funded the study to investigate fish-oil and IBD.
  • (also not-so-nice intentions) UCB Pharma, which also makes Dipentum (another 5-ASA drug), funded the study to steer more people to use their products.

 

So should you use fish oil? Listen to your gut. If you take Omega-3 supplements and they help you, it's probably worth (talking to your doctor!) and taking them . . . if nothing else, the JAMA study showed that people receiving fish oil had signifcantly lowered triglyceride levels--an average decrease of -21.5 mg/dL (or a 21.5 point lower cholesterol level).

Regarding conflict of interest, the article's authors disclosed these conflicts of interest--a list longer than the scientific references for the study:

Dr Feagan reported receiving grant and research support from Schering-Plough, Otsuka, Milllennium, Tillotts, Abbott, Protein Design Labs, Boehringer-Ingelheim, Novartis, Centocor, Berlex, Synta, Schering Canada, Elan/Biogen, UCB Pharma, BMS, Proctor & Gamble, and Napo Pharma; receiving consulting fees from Synta, Millennium, Schering Canada, Celltech, Centocor, Elan/Biogen, Janssen-Ortho, Protein Design Labs, ISIS, Teva Pharmaceuticals, Santarus, Schering-Plough, Bristol-Myers Squibb, Celgene, CombinatorRx Inc, UCB Pharma, Napo Pharma, Abbott, Proctor & Gamble, Osiris, Berlex, AstraZeneca, GeneLogic Inc, Cerimon Pharm, Tioga Pharm, Serono, Genentech, Tillotts Pharma AG, and CombinatoRx Inc; serving on the apeakers bureau of AstraZeneca; and serving on the scientific advisory board of Protein Design Labs, AstraZeneca, Elan/Biogen, Celltech, Synta, Schering Canada, Celgene, and Tillotts Pharma AG.

Dr Sandborn reported receiving grants or funding from Abbott Laboratories, Bristol-Meyers Squibb, Centocor, Chemocentryx, Elan Pharmaceuticals Inc, Otsuka American Pharmaceuticals Inc, PDL Biopharma, Procter & Gamble, Prometheus Laboratories, Salix Pharmaceuticals Inc, Schering-Plough, Serono, Shire Pharmaceuticals, Targacept Inc, Techlab Inc, Tillotts Pharma AG, and UCB Pharma (previously Celltech Therapeutics Ltd); receiving consulting fees from GlaxoSmithKline (previously Glaxo Wellcome), Abbott Laboratories (fees paid to the Mayo Clinic), ActoGeniX NV, AGI Therapeutics Inc, Ajinomoto Pharmaceuticals, Alba Therapeutics, Alizyme plc, Alza, Amgen Inc, Ardea Biosciences, Aspreva Pharmaceuticals, AstraZeneca, Atrix Laboratories Inc (acquired by QLT in 2004), Avidia Inc, Berlex, Bexel Pharmaceuticals Inc, BioBalance, Boehringer-Ingelheim Inc, Bristol Meyers Squibb, Celegene, Celltech (acquired by UCB Pharma in 2004) (fees paid to the Mayo Clinic), Centocor (fees paid to the Mayo Clinic), Cerimon Pharmaceutical Inc, Chemocentryx, CombinatoRx Inc, CoMentis, Corautus Genetics, Cosmo Technologies Ltd, CuraGen, Effective Pharmaceuticals Inc, Eisai Medical Research Inc, Elan Pharmaceuticals Inc, Enteromedics, Enzo Therapeutics Inc, Eurand, FlexPharm Ltd (previously named Enterotech), Genencor International, Genentech, H3 Pharma (name changed to Debiopharm SA in 2005), Hoffman LaRoche Inc (Roche), Hutchison Medipharma Ltd, Inflabloc Pharmaceuticas (previously named Pharmadigm Inc), Inotek Pharmaceutical, ISIS Pharmaceuticals, Jacobus Pharmaceutical Co, Johnson & Johnson Pharmaceutical Research & Development, LigoCyte Pharmaceuticals, McNeil Consumer and Specialty Pharmaceuticals, Medarex Inc, Merck Research Laboratories, Millennium Pharmaceuticals Inc, Nisshin Kyorin Pharmaceutical Co Ltd, Novartis, NPS Pharmaceuticals, Ocera Therapeutics Inc (previously named Renovia Inc), Ono Pharma USA, Otsuka American Pharmaceuticals Inc, PDL Biopharma (previously named Protein Design Labs) (fees paid to the Mayo Clinic), Pfizer, Procter & Gamble (fees paid to the Mayo Clinic), Prometheus Laboratories, Renovis Inc, Salix Pharmaceuticals Inc, Sangstat (acquired by Genzyme in 2003), Schering-Plough, Serono Inc, Shire Pharmaceuticals, Synta Pharmaceuticals, Targacept, Teva Pharmaceuticals, Therakos, Tioga Pharmaceuticals, UCB Pharma (fees paid to the Mayo Clinic), Vela Pharmaceuticals Inc, and ViaCell Inc; and receiving honoraria for speaking at continuing medical education events indirectly sponsored by Abbott Laboratories, Axcan Pharmaceuticals, AstraZeneca, Centocor, Elan Pharmaceuticals Inc, Falk Pharma, Otsuka American Pharmaceuticals Inc, PDL Biopharma, Procter & Gamble, Prometheus Laboratories, Salix Pharmaceuticals Inc, Schering-Plough, Shire Pharmaceuticals, and UCB Pharma.

Dr Mittmann reported receiving product development consultancy fees from Tillotts Pharma AG.

Dr Bar-Meir reported receiving consulting fees from Tillotts Pharma AG.

Dr Rostom reported receiving consulting fees from Novartis and Bayer and an unrestricted educational grant from ALBA Therapeutics. Mr Spleiss reported having employee equity ownership in Tillotts Pharma AG.

Dr Rutgeerts reported receiving consulting fees from Centocor, Schering-Plough, UCB Abbott, Elan-Biogen, PDL, Avidia, Bristol-Myers Squibb, Millennium, and Tillotts; lecture fees from Centocor, Schering-Plough, UCB, Abbott, and Elan-Biogen; and grant support from Centocor, Schering-Plough, Abbott, and UCB.

Drs D'Haens, Bradette, Cohen, Dallaire, Ponich, McDonald, Kiudelis, Hebuterne, Paré, Klvana, Niv, Ardizzone, Alexeeva, and Rostom were site investigators and were compensated for performing clinical measurements. No other financial disclosures were reported.

source: Omega-3 free fatty acids for the maintenance of remission in Crohn disease: the EPIC Randomized Controlled Trials. JAMA. 2008 Apr 9;299(14):1690-7.

 

1Erin D. Kennedy, MD, PhD, Theresa To, PhD, A. Hillary Steinhart, MD, Allan Detsky, MD, PhD, Hilary A. Llewellyn-Thomas, PhD, and Robin S. McLeod, MD. Do Patients Consider Postoperative Maintenance Therapy for Crohn's Disease Worthwhile? . Inflamm Bowel Dis. 2008 Feb;14(2):224-35.

2Laura E. Harrell, MD, Stephen B. Hanauer, MD. Mesalamine derivatives in the treatment of Crohn's disease. Gastroenterol Clin N Am 33 (2004) 303–317.