Nursefriendly.com: Big Pharmaceuticals

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Thursday, May 5, 2011

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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Tuesday, April 26, 2011

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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Monday, April 18, 2011

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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Saturday, April 16, 2011

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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Friday, April 1, 2011

Study Finds Conflicts of Interest Among Medical Panelists - NYTimes.com

Doctors with private financial conflicts of interest dominated some of the panels that wrote guidelines on cardiovascular health in recent years, according to a medical journal study released on Monday.

Enlarge This Image

Penn Medicine

Dr. James N. Kirkpatrick, the study's senior author.

Enlarge This Image

University of Miami Health System

Dr. Ralph L. Sacco, president of the American Heart Association.

The guideline panels are the select groups of experts who are assigned to evaluate science independently and issue their advice to other doctors on what to do in clinical practice. The guidelines influence medical care, product choice, insurance coverage, government policy and malpractice cases.
The study, published in the Archives of Internal Medicine, found that conflicts of interest were reported by 56 percent of 498 people who helped write 17 guidelines for the American Heart Association and American College of Cardiology, from 2003 through 2008.

via nytimes.com

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Thursday, March 31, 2011

Conflicts Of Interest In Guideline Development: A Dirty Little Secret Gets Aired Again | The Health Care Blog

An Archives of Internal Medicine article (Conflicts of Interest in Cardiovascular Clinical Practice Guidelines) is getting a lot of notice today. In essence, many of the physicians who develop guideline that influence practice patterns and payment decisions have conflicts. The authors recommend only allowing those without conflicts to write the guidelines.

This isn’t a new issue. In 2006 I wrote a piece (Another dirty little secret is out in the open) and am reposting it below because it’s timely:

A year ago in Time to deal with medicine’s dirty little secrets?, I wrote about a variety of practices that are relatively well-known in the health care field but would be shocking to outsiders. Industry often takes the blame for “aggressive marketing tactics,” and no doubt some of that is deserved. But physicians are also culpable.

via thehealthcareblog.com

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Tuesday, March 29, 2011

Drug Shortages Distress Hospitals - WSJ.com

A shortage of injectable generic drugs for cancer and other serious diseases is putting pressure on hospitals, which are sometimes having to scramble to locate the medicines or search for alternative treatments.

The supply of these drugs has tightened in recent years as the generic-drug industry has consolidated, with many of the drugs now made by just one or two companies. In many cases patents have long expired and the original brand-name drug is no longer being produced.

Federal regulators have also stepped up enforcement of quality standards, limiting the ability of large manufacturers to ramp up production.

The drugs—typically used in hospitals and outpatient clinics—often require complex manufacturing processes with long lead times. Because factories produce many kinds of medicines, companies say they can't easily make more of one without creating a shortage in another.

via online.wsj.com

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Friday, March 11, 2011

FDA takes over Johnson & Johnson's Tylenol plants - Mar. 10, 2011

The government is taking over three Tylenol plants following a blizzard of drug recalls and a Food and Drug Administration criminal investigation into safety issues at the factories.
The FDA and the Justice Department on Thursday took action against McNeil PPC and two of its executives -- its vice president of quality and its vice president of operations for over-the-counter products -- for failing to comply with federally-mandated manufacturing practice.

McNeil, a division of Johnson & Johnson (JNJ, Fortune 500), said it had agreed to put its plants -- one in Las Piedras, Puerto Rico, one in Fort Washington, Pa. and one in Lancaster, Pa., under FDA supervision.

The agreement, known as a "consent decree," is subject to approval by a federal judge in Pennsylvania.

via money.cnn.com

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Wednesday, February 23, 2011

Drug maker cited for not reporting side effects - Health - Health care - msnbc.com

U.S. health regulators have warned Sanofi-Aventis SA's U.S. unit for failing to submit reports of possible serious side effects in a timely manner.

In a January 28 letter made public on Tuesday, the Food and Drug Administration said an early response from the drugmaker and its "promised corrective actions are inadequate to address the deficiencies."

"We remain concerned that your .... adverse drug experience reporting system has not been fully validated, and may have resulted in inaccurate assessment and untimely submission of 15-day alerts," FDA said.

via msnbc.msn.com

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Tuesday, February 15, 2011

Obama budget targets brand name medicines, Health.Yahoo.net

Big pharmaceutical companies could face increased competition from generic drugmakers under two proposals put forth by the Obama administration on Monday despite earlier savings extracted from drugmakers as part of last year's healthcare law.

President Barack Obama, as part of his 2012 budget proposal, called for cutting the number of years drugmakers could exclusively market brand-name biologic drugs to 7 years from 12.

He also set his sights on ending controversial "pay-for-delay" deals that affect traditional, chemical drugs by giving the U.S. Federal Trade Commission power to block them. Under such pacts, brand-name and generic drugmakers settle patent challenges with payoffs that delay lower-cost rivals from reaching the market.

The proposals face a tough challenge of getting through the divided Congress, but could alter the landscape for consumers' access to cheaper medicines.

They quickly drew industry protests.

via health.yahoo.net

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Thursday, May 5, 2011

Clinical Trial Deaths And Compensation In India // Pharmalot

Tuesday, April 26, 2011

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

Monday, April 18, 2011

FDA orders safety studies for some asthma drugs | Reuters

Saturday, April 16, 2011

Big Pharma backs deal to boost flu pandemic readiness | Reuters

Friday, April 1, 2011

Study Finds Conflicts of Interest Among Medical Panelists - NYTimes.com

Penn Medicine

University of Miami Health System

Thursday, March 31, 2011

Conflicts Of Interest In Guideline Development: A Dirty Little Secret Gets Aired Again | The Health Care Blog

Tuesday, March 29, 2011

Drug Shortages Distress Hospitals - WSJ.com

Friday, March 11, 2011

FDA takes over Johnson & Johnson's Tylenol plants - Mar. 10, 2011

Wednesday, February 23, 2011

Drug maker cited for not reporting side effects - Health - Health care - msnbc.com

Tuesday, February 15, 2011

Obama budget targets brand name medicines, Health.Yahoo.net

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