Big Pharma's Nigerian Nightmare

What was the deal yesterday with the drug business and things of Nigerian origin? Two stories yesterday both involved Nigerians with angry lawers accusing companies -- Novartis and Pfizer -- of misdeeds.

First,  Peter Rost broke a nice scoop on a former senior data analyst at Novartis who claims the company submitted flawed data to the FDA: Nigerian-native David Olagunju alleges in a suit that he was fired for "disclosing and refusing to participate in illegal and unethical activities regarding the testing and reporting of human drug study results concerning Tasigna (ANM), Novartis' new cancer drug."

Guess what? Novartis recently announced that its Tasigna approval application was being delayed by the FDA. (Ed Silverman at Pharmalot carries a different take here.)

Second, the WSJ reported Nigerian lawyers withdrew their case against Pfizer in favor of what they claim will be a refiled case with stronger evidence in the Nigerian meningitis flap. Briefly, the Nigerian government has accused Pfizer of using a meningitis outbreak to test Trovan, an experimental drug, on 100 children.  11 kids died as a result, the Nigerians claim. Pfizer denies the claim.

The meningitis case is interesting in a "Life Imitates Art" type of way. Movie fans will remember that it sounds a lot like the premise of The Constant Gardener. I mention this because the drug industry at one time had an informal whispering campaign to discredit the movie. GSK vp Mike Pucci  used the movie as an example of how pop culture had turned against the industry in his talks at pharma conferences, in which he urged the biz to get its shit together and make a stronger case to the public.

More interestingly, the industry-friendly DrugWonks once excoriated the movie as a bunch of improbable  lies.  DrugWonks is technically correct: The movie takes place in Kenya, but the Pfizer suit is about Nigeria; the disease in the movie is  tuberculosis, but the disease in Nigeria is meningitis; a bunch of people are killed by the drug in the movie, but only 11 are killed in Nigeria... so that's lots of differences!

Comments

[Sunil S Chiplunkar]

The need of the hour is high standards of Corporate governance and collaborative working. Today in the era of instant information one cannot afford to have damages since damage control is that much more difficult. Thus, it is important to have high standards of corporate governance and collaborative working, for eg. if a third party CRO and another consultancy firm like Accenture were involved in such clinical research projects, the collaborations would have created a system of checks and controls and prevented any disasters and tensions. Let us not forget we are operating in a globalized world - silos are out!

[Sunil S Chiplunkar]

The need of the hour is high standards of Corporate governance and collaborative working. Today in the era of instant information one cannot afford to have damages since damage control is that much more difficult. Thus, it is important to have high standards of corporate governance and collaborative working, for eg. if a third party CRO and another consultancy firm like Accenture were involved in such clinical research projects, the collaborations would have created a system of checks and controls and prevented any disasters and tensions. Let us not forget we are operating in a globalized world - silos are out!