“Incorrect statements by Novo Nordisk” ―Peter C. Gøtzsche| cc @FedeMedicaC @ENDOCRINO_COL

Moses AlanNovo Nordisk replies to BMJ investigation on incretins and pancreatic damage. 

 Re: Novo Nordisk replies to BMJ investigation on incretins and pancreatic damage.

Peter C Gøtzsche
Nordic Cochrane Centre
16 August 2013

“Incorrect statements by Novo Nordisk

Alan Moses, global chief medical officer at Novo Nordisk, states that “Novo Nordisk has always put patients first” and that “All available data held by Novo Nordisk on pancreatic effects of liraglutide have been shared with the regulatory agencies and are publicly available” (1). Both statements are wrong. As for always putting patients first (2):

– Novo Nordisk refused to provide inactive placebo to an independent researcher who had no other option than to do the study without placebo, which was criticised as a great weakness when the study was published.

– After hormone replacement therapy was found to be harmful, Novo Nordisk hired a German PR firm that sent letters to doctors downplaying the harms.

– In 2011, Novo Nordisk agreed to pay $25 million to resolve its civil liability arising from the illegal promotion of its haemophilia drug, NovoSeven. The US Justice Department suit alleged that Novo: improperly paid influential US Army physicians to use and promote NovoSeven; provided illegal incentives to researchers; and engaged in a “fraudulent scheme to use kickbacks and off-label promotion” to boost sales. In 2005, Novo Nordisk published a heavily manipulated trial in 301 severely bleeding trauma patients in a little-known journal that purported to show that NovoSeven worked. The statistician was from Novo Nordisk and the data analysis was seriously flawed; what the study really showed was that the drug didn’t work.

– In 2006, Novo Nordisk paid doctor’s assistants and a pharmacy chain in USA to switch diabetic patients to the company’s high-priced new insulin products.

– In 2012, a paper in the BMJ described that Novo Nordisk had recruited nearly 360 000 patients for questionable ‘studies’. Most studies were performed in middle or low income countries, even though the patients may have difficulty affording the more expensive insulin while in contrast, their doctors were paid for their assistance to the company. In India, the new insulin was nine times more expensive than the cheapest human insulin. Some of Novo Nordisk’s ‘results’ were published, but with selected subanalyses with positive outcomes, and with co-authors or writing support from the company.

As for liraglutide, it is false to say that all Novo Nordisk’s data are publicly available. Through freedom of information requests, Deborah Cohen found out that important safety data on liraglutide, both from humans and monkeys, are not in the public domain (3,4). It would probably not be possible today to get access to such data because the European Medicines Agency, due to the current cases in the European Court instigated by AbbVie and InterMune, has blocked the release of regulatory data. Diabetologist Victor Montori from the Mayo Clinic has stated that “There is a compelling biological rationale linking GLP-1 based treatments with pancreatitis and pancreatic cancer.” I agree, but Novo Nordisk interfered with a convincing study academic researchers had published on Gastroenterology’s website that reported an increased risk of pancreatitis and pancreatic cancer in patients with diabetes treated with two glucagon-like peptide-1 drugs (2).

1 Moses A. Novo Nordisk replies to BMJ investigation on incretins. BMJ 2013;347:f4386.

2 Gøtzsche PC. Deadly medicines and organised crime: How big pharma has corrupted health care. London: Radcliffe Publications, 2013 (to appear on 29 August).

3 Cohen D. Has pancreatic damage from glucagon suppressing diabetes drugs been underplayed? BMJ 2013;346:f3680.

4 Cohen D. Pressure mounts for companies to hand over data on antidiabetes drugs linked to pancreatic harm. BMJ 2013;346:f3900.

Competing interests: No competing interests”

 “I endorse the comments posted by Peter C Gøtzsche.”

Novo Nordisk replies to BMJ investigation on incretins and pancreatic damage.
Re: Let’s start this discussion again. 

22 August 2014
Jorge H Ramirez
Professor of Pharmacology
Universidad del Valle Cll 4B 36-00 Univalle sede San. Fdo. Edificio 116.

 Novo Nordisk: No answers yet.

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