May 26, 2019vioxx

Quantum Leap

Spotless ECGs from ERT

March 14, 2011

It would be hard to find a firm handling more electrocardiogram (ECG) data than ERT. The company handles 9 million ECG data points annually. Not long ago, the firm decided to do something about industry-standard ECG data error rates in the neighborhood of 80-90 percent. That's no typo. The typical error rates reflect the difficulties that all life science companies encounter—grossly antiquated methods of hand transcribing heart data to a piece of paper or an electronic system. New Process The resolution of even minor gaffes is costly, running perhaps $10 to $35 per error. On a human level, the correction can involve a few emails, phone calls or even a personal visit to a clinical site. ERT wondered if the ECG error rate could be slashed by 85 percent. To find out, the Philadelphia-based firm (with 650 employees and $141 million in 2010 revenues) sat down and tried to rethink everything.…more...

Can Pharmacovigilance Scale?

Data-Mining 12 Million Lives

January 20, 2009

Twenty six patients. Eleven patients. Three patients. Despite the billions spent on clinical research, regulatory decisions often boil down to adverse events in a handful of patients. There are widely divergent…more...

Litigation Avoidance

How to Not Get Sued

January 13, 2009

Next time you write an email at work, imagine an aggressive prosecutor looking over your shoulder, ready to take your words out of context. His main aim: To besmirch you and…more...

Litigation Into Perpetuity?

Drug Safety: A Lawyer’s View

March 05, 2008

When will the drug safety wars end? How will they end? A new president? A Supreme Court decision? We thought Tom Lamb might know. He’s an attorney based in Wilmington, North…more...

Harvard Prof On Stats Shifts

Pssst! Need To Change An End Point?

February 07, 2008

Not long ago, on a bleak winter morning when the U.S. Congress and the New York governor and the Connecticut attorney general and the second most important medical journal were trashing the industry, we banged out an email to Scott Evans. He’s a senior research scientist in Harvard University’s School of Public Health. He teaches biostatistics there,…more...

The V-Word

Merck’s Win, Industry’s Loss

November 26, 2007

Earlier this month, after months of negotiations, Merck announced a large but manageable $4.85 billion settlement of an unknown number of Vioxx plaintiffs who can prove they took the drug and suffered strokes or heart attacks. Those plaintiffs still have to approve the deal. But it appears to be a watershed win for Merck, which had tenaciously…more...

Three Ticking Clocks

Bayer Halts Trasylol Sales

November 07, 2007

In another significant win for medical journal editors in their new role as regulators, Bayer suspended sales of anti-clotting drug Trasylol (aprotinin), which had been implicated in kidney failure, cardiovascular problems and mortality risk. The drug had approximately $135 million in 2007 sales. We have no special knowledge of Trasylol. All we can say is that for…more...

‘Enough--This Is The Label’

RAPS: CDER’s Kweder, Part II

October 01, 2007

At the annual conference of the Regulatory Affairs Professionals Society (RAPS), held in Boston last week, the FDA’s Sandra Kweder (deputy director of the Office of New Drugs in CDER) gave a well-attended talk packed with sugary rhetoric. Such statements could be taken as indicating that nothing will change in the agency’s stance toward the industry. But…more...

New FDA Review Process

RAPS: Kweder of CDER, Part I

The FDA’s Sandra Kweder talks about Vioxx, a consultant’s study of its process, and how that process is about to be standardized across all sections of CDER. A report from the 2007 RAPS conference for regulatory affairs pros.

Quintiles Safety Spinoff

iGuard Post-Marketing Database

A Quintiles offshoot has created an online drug-safety hub which simultaneously offers nifty color-coded warnings to consumers about their prescriptions and a potentially valuable post-marketing research tool for the industry.

Avandia, etrials, FDA on e-CRFs

News Briefs

News for Tuesday, May 22.

Thinking Beyond The Label

FDA On Drug Safety

A senior FDA official tells the Post-Approval Summit what the agency is going to do and would like to do in the post-Vioxx era.

Legal Prowess, PR Fumble

Merck’s Deeper Peril

An article in the Harvard Business Review in February 2007 outlines the mistakes of companies that do not engage the media, and offers a prescription for regaining a good public image.

Zyprexa Documents Case

Lilly Judge Spanks NYT

A federal judge is irritated with the media and orders a lawyer and physician to return secret documents that have already been widely posted on the web.

Pharma's Reputational Rehab

On Winning Hearts And Minds

Our sense is that ordinary Americans could still be persuaded that the drug industry serves an important role in taking basic scientific research and delivering it to a local pharmacy or loved one. But the industry needs to produce its scientists and specify how its products improve life, save money and prevent surgery.

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