Asher Mullard

Mediator scandal rocks French medical community

A report into the events surrounding the Mediator affair has left French drug company Servier, regulators, industry, and the medical community reeling. Asher Mullard reports.

Drug withdrawal sends critical care specialists back to basics

Lilly has pulled its antisepsis drug Xigris (drotrecogin alfa) from markets worldwide because the results of the post-marketing PROWESS SHOCK trial did not show effi cacy. The move, which comes nearly 10 years after the drug was initially approved in the USA, brings a long controversial story to a close, but draws attention to the slow pace of progress for the treatment of sepsis. “This was an interesting saga for the fi eld of critical care. It really brought out the relationship between pharma and physicians”, says Anthony Suff redini, Associate Chief of the Critical Care Medicine Department at the US National Institutes of Health. Xigris, also known as activated protein C, took off to a bright start in 2000 when the phase 3 PROWESS trial was stopped early because of the drug’s high effi cacy (reducing the relative risk of death by 20% compared with placebo). Despite the early optimism, the anti-infl ammatory drug’s promise began to unravel at a 2001 US Food and Drug Administration (FDA) advisory meeting. Experts raised several concerns including worries over why Lilly changed the enrolment criteria half way through the trial. Faced with a lack of therapeutics on the one hand and insuffi cient clinical data on the other, ten panellists voted to approve the drug and ten voted to reject it. Regulators hedged their bets. The FDA approved the drug in 2001 for patients at high risk (but not low risk) of death, on the basis of a posthoc subgroup analysis of PROWESS. European regulators followed with a similar approval a year later. But subsequent fi ndings continued to divide the community. An analysis of the 3-month mortality rates in PROWESS did not fi nd a treatment eff ect. An FDA-mandated trial in patients at low risk of death was stopped early because of futility, and a subgroup analysis of high-risk patients who had inadvertently been enrolled into the trial was discouragingly negative. The drug also seemed to confer a higher risk of severe bleeding than originally noted.

The long Avandia endgame

1 year after drug regulators finished re-reviewing Avandias safety profile, the diabetes community is still left unsettled by the case. Asher Mullard reviews the lessons learned.

The art of losing

Find the secret to improve the quality of life by reading this the art of losing. This is a kind of book that you need now. Besides, it can be your favorite book to read after having this book. Do you ask why? Well, this is a book that has different characteristic with others. You may not need to know who the author is, how well-known the work is. As wise word, never judge the words from who speaks, but make the words as your good value to your life.

WHO heads back to the drug development drawing board

Disappointment over a long-awaited report on improving drug research and development for neglected diseases has driven WHO to create a new working group. Asher Mullard reports.

What does Pfizer's merger mean for drug development?

During the past 15 years, Pfizer has cumulatively spent US

Experimental Ebola drugs enter the limelight.

230 billion to buy up big drug developers including Warner–Lambert, Pharmacia, Wyeth, and Hospira. At the end of 2015, Pfi zer struck again, announcing plans to merge with Allergan, the maker of botox, in a

EU implicated in controversial counterfeiting bill

160 billion deal. The transaction, the biggest in the history of health care, is set to make Pfi zer the world’s largest drug company by sales. The main driver behind the deal, say analysts, was Pfizer’s desire to reduce its tax exposure. Whereas the company headquarters are currently in New York, NY, USA, Allergan is currently based in Dublin, Ireland. Pfi zer, as a result of the merger, will move its corporate headquarters to Ireland, where it will face a lower tax rate. Pfi zer’s current tax rate is around 25%, but will drop to below 20% after the deal closes, saving the company billions of dollars. In 2014, Pfizer made a similarly huge—but ultimately rebuffed—bid to buy UK-based AstraZeneca to achieve tax savings.