Posts Tagged ‘Dimebon’

Pfizer writes off $725 million – were they a victim of scientific fraud?

January 20, 2014

Whether it is just error or bad judgement or fraud we will never know. Perhaps all three.

NewsObserver: In 2008, Pfizer paid $725 million for the rights to a Russian cold medicine called Dimebon. The pharmaceutical giant thought the drug could help ameliorate the symptoms of Alzheimer’s. Several clinical trials showed the medicine had no more impact than a placebo. Pfizer has largely abandoned the project.

Earlier this week came the news that Pfizer have now written off the entire $725 million.

The last flickering hope that Medivation’s Dimebon could help Alzheimer’s disease patients has just been extinguished. The biotech announced this morning that a 12-month study of the drug failed to register significant improvements for patients, mirroring two shorter Phase III studies in which Dimebon failed to outperform a sugar pill. Pfizer took the opportunity to bow out of its partnership, writing off its $225 million upfront and $500 million milestone program for what proved to be another embarrassing pipeline failure.

In 2008, Dimebon looked like an odds-on success, with positive data from a Russian study and 10 years of sales experience to underscore its safety. But Medivation was shaken to the core when its first late-stage study ended in failure, with an additional pratfall for Huntington’s disease to cap the disaster.

In the end, Dimebon’s failure helped tarnish the reputation of Russian drug studies while raising severe doubts about Medivation.

It is not only Pfizer which has been forced to make costly write-offs. Not long ago  GlaxoSmithKline was forced to shut down Sirtris Pharmaceuticals which it had acquired in 2008 for $720 million:

Xconomy:

Glaxo paid $720 million to acquire Sirtris in April 2008, to get ahold of technology that generated lots of breathless media coverage as a modern-day fountain of youth. The company sought to make drugs that act on sirtuins, a class of proteins that scientists believe play a role in aging, programmed cell death, and other key cell processes.

Even though the company is closing the Sirtris site, Stubbee says Glaxo remains confident in the drug candidates it got from that acquisition. ….

…. Sirtuins are known to be active when the body is in a calorie-restricted state, which scientists have shown contributes to longer lifespan. The idea at Sirtris was to make small-molecule chemical compounds that activated sirtuins as a way of fighting diseases that develop as people age—including Type 2 diabetes and cancer. ….. The research into the biological role of sirtuins, from Sirtris co-founder David Sinclair, has attracted its share of skeptics. Just last week, Sinclair, a researcher at Harvard Medical School, sought to buttress his early work with a new article in Science that says resveratrol and related compounds can activate sirtuins. One critic, quoted by the Boston Globe last week, said the role of one sirtuin called SIRT1 in aging, “is still as clear as mud.”

GSK is putting a brave face on all of this.

But for many medical and biotech researchers, the path to fame and fortune is by starting a start-up with some new compound or technique and by “leveraging the promise”. For pharma and biotechnology start-ups the objective is to be bought up by one of the majors for as exorbitant an amount as can be managed. And it seems that one way to inflate the value is by making preliminary data and trials show very optimistic results. Negative results never see the light of day and the positive aspects are exaggerated and at worst manipulated.

The ten-fold growth of retractions in medicine related fields since 1975 is mainly due to misconduct according to this report in Nature where “fraud or suspected fraud was responsible for 43% of the retractions”.

For Big Pharma this is simply a consequence of having “outsourced” part of their research. They can afford a few failures it could be thought. Of course the final cost is eventually borne by the consumers but some start-ups make a killing along the way.

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