Clinical Trial Deaths And Compensation In India // Pharmalot

An investigation by India’s health ministry has found that drugmakers running clinical trials in the country have not compensated survivors of most volunteers who died during their studies. Of 671 deaths that were reported last year, there is evidence that compensation was given in just three cases, The Business Standard writes.

And so, the health ministry has asked 44 drugmakers to explain why they have not provided compensation, which is mandatory under the current law. Among those queried were Eli Lilly, Novartis, Pfizer, Bayer, Merck, Johnson & Johnson and Sanofi-Aventis. For instance, data compiled by the ministry show there were 152 deaths reported during Sanofi trials and 138 took place in Bayer trials.

A Novartis spokesperson tells the paper that its clinical trial investigator insisted any deaths were not caused by a medication, but instead due to the progression of underlying diseases. And compensation is not required in such cases. Other drugmakers offered a similar argument. Ministry officials also say that most deaths, which were attributed to cancer or cardiovascular and cerebrovascular disorders, seemed to have occurred due to the advanced stage of illness among volunteers.

via pharmalot.com

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How academic physicians turn into drug company shills, KevinMD.com

by Carl Elliott

These days many thought leaders find themselves on shaky ground. The past few years have not been good for business. Some of the most prominent thought leaders have been exposed and censured by Grassley. Others have seen public opinion turning against them and gone underground. As more states institute Sunshine laws, anyone considering an industry consultancy must weigh the money and status boost against the potential downside of public exposure.

Still, the thought-leader business has proved more resilient than many people predicted. Most of the thought leaders investigated by Grassley have managed to retain their academic positions, even in the face of withering criticism. A resistance movement has even formed. Led by Dr. Thomas Stossel of Harvard University, the Association of Clinical Researchers and Educators (ACRE) has defiantly opposed attempts to cut back industry payments to doctors.

Many former thought leaders simply confess disillusionment. “There is a feeling that you want to be where the action is, and even if it’s not real action, at least industry gives you the feeling that things are happening,” Healy says. “They give you the feeling that you’re up on the wave.” After a while, however, the thrill of consulting begins to wear thin. There are just too many airports, too many hotels, too many fancy dinners. Eventually they all look the same. Healy says, “You’ve got a choice between the boredoms of perpetually surfing—where the first two waves are fun, but eight hours later, Jesus Christ—or do you return to the tedium of the beach?”

via kevinmd.com

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FDA orders safety studies for some asthma drugs | Reuters

U.S. health regulators have ordered drugmakers to conduct clinical trials involving a total of 53,000 patients to test the safety of a controversial class of inhaled asthma drugs that are already on the market.

The trials are being required to demonstrate the safety of medicines known as long-acting beta-agonists (LABAs) when used in combination with inhaled steroids, another class of asthma drugs, the U.S. Food and Drug Administration said on Friday.

LABAs to be studied are AstraZeneca's Symbicort, GlaxoSmithKline's Advair Diskus, Merck & Co's Dulera, and Novartis AG's Foradil.

via reuters.com

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Big Pharma backs deal to boost flu pandemic readiness | Reuters

Virus samples will be shared globally in exchange for vaccines produced from them under a landmark deal to improve preparedness for a flu pandemic, diplomats at the World Health Organization said on Saturday.

In a statement to Reuters, the International Federation of Pharmaceutical Manufacturers and Associations, which represents 26 research-based drugmakers, welcomed the plan and confirmed the commitments its members had undertaken as part of it.

Negotiators ended an all-night session with a draft agreement accepted by all countries, including the United States, the last to join the consensus, diplomats said.

via reuters.com

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