Tag Archives: FDA

The week: the News in health

Posted on March 2, 2012 | Leave a comment

The U.S. spent about $7,000 per capita in 2008 on health care. Peer countries, like Japan and the U.K., spend about half that amount and achieve equally good results, as measured, for example, by life expectancy at birth. Continue reading →

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Posted in Weekly news

Tagged FDA, Food and Drug Administration

Memory loss and statins

Posted on February 29, 2012 | Leave a comment

Cognitive (brain-related) impairment, such as memory loss, forgetfulness and confusion, has been reported by some statin users and people being treated with statins may have an increased risk of raised blood sugar levels and the development of Type 2 diabetes. Now there are more reasons for patients to be worried about taking statins. Continue reading →

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Posted in Focus on patients, Health information

Tagged FDA, Statin

It’s Friday ! Here is what happened in healthcare news this week

Posted on February 24, 2012 | Leave a comment

The FDA is concerned enough about heart problems from Qnexa that they are considering requiring studies – but the studies might come after the drug hits the market and people begin taking it. With two other diet drugs, Contrave and Arena, also in the pipeline for FDA approval, the FDA plans to have advisers discuss the possibility of requiring heart-risk studies for all weight-loss drugs. Continue reading →

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Posted in Weekly news

Tagged FDA, Food and Drug Administration, Johnson

Pradaxa: Case study on DTC marketing moratorium ?

Posted on January 16, 2012 | 2 Comments

In the first quarter of 2011, the FDA received 40,151 domestic reports of serious, disabling or fatal injury associated with drug therapy. The total represented a 3% increase over the previous calendar quarter, and a 19.5% increase over the first quarter of 2010. Continue reading →

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Posted in FDA, Focus on patients

Tagged FDA, Pradaxa

Drug companies cannot hope for blockbuster drugs anymore.

Posted on December 22, 2011 | 4 Comments

Blockbuster drugs. They are, to this day, an addiction for big pharma. A blockbuster can produce a huge ROI and fund the development of new drugs and new marketing programs but today the deck is stacked against blockbuster drugs.

The healthcare environment today is one in which cost containment is a key element. A lot of blockbuster drugs are going to come off patent including,Zyprexa, Cymbalta and Viagra. Insurers, before adding new and improved brands, are asking for clinical proof that new products outperform generics. In addition the FDA is taking a harder look at all NDA’s and in most cases is asking for more clinical studies before approval cutting down on the time the drug is on the market and this the ROI for these products. Continue reading →

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Posted in Business of the drug industry

Tagged Atorvastatin, Blockbusters, FDA, Food and Drug Administration, Long Tail, Marketing, Pharmaceutical drug, Pharmaceutical industry, Zyprexa

Summary of healthcare news

Posted on November 11, 2011 | 2 Comments

Despite the challenges for pharma in social media, the industry accounted for 4 percent of the $25.8 billion spent on overall US online advertising last year, according to new estimates from eMarketer. eMarketer also predicts that healthcare and pharma advertisers will see double digit growth over the next few years, rising from U.S. $1.03 billion in 2010 to $1.86 billion in 2015. Continue reading →

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Posted in Weekly news mash-up

Tagged Abbott Laboratories, FDA, Food and Drug Administration, Health care, Merck, Merck & Co, Phil Baumann, United States

The future of healthcare is visible but requires new ways of thinking

Posted on November 10, 2011 | 6 Comments

An editorial in today’s Times asks “WHY can’t Americans tap into the ingenuity that put men on the moon, created the Internet and sequenced the human genome to revitalize our economy and consumer health?” The editorial says that “we are in the early phases of the next big technology-driven revolution, which I call “consumer health.” When fully unleashed, it could radically cut health care costs and become a huge global growth market.” The answers are both complicated and simple but at their core they require a new way of thinking about marketing and health. Continue reading →

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Posted in Contrarians POV

Tagged Bill Gates, Consumer, Facebook, FDA, Food and Drug Administration, iPad, Pharmaceutical industry, United States

More bad news on medical devices

Posted on October 26, 2011 | 1 Comment

U.S. reviewers said a Medtronic Inc device was effective for treating a common heart rhythm disorder, but they raised concerns about its safety. Medtronic’s Cardiac Ablation System is designed to treat persistent atrial fibrillation, a major cause of strokes. But, in documents released on Tuesday, Food and Drug Administration staff expressed concerns about the high rate of stroke found in patients treated with the device. Yet medical device makers continue to fight any more regulatory oversight rules by the FDA. Clearly patient safety is not as important as sales. Continue reading →

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Posted in Medical Devices

Tagged Atrial fibrillation, Clinical trial, FDA, Food & Drug Administration, Medical Devices, Medtronic, New York Times, Patient

Why medical devices need more scrutiny

Posted on October 1, 2011 | 4 Comments

An article this morning in the Times on faulty metal hip implants is enough to get readers depressed and angry. Imagine if you had gone through the pain and inconvenience of getting a metal hip implant only to learn later that the device has been recalled and that it could lead to more complications ? Sure some people are going to be angry and sue but what about the others who are going to have the quality of their lives upended ? What about the people who may get permanently depressed because of damage to their bodies ? Isn’t the FDA supposed to protect consumers ? Continue reading →

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Posted in Medical Devices

Tagged DePuy, England, FDA, Food & Drug Administration, Hip replacement, Insulin pump, Medical device, Medtronic

Medtronic: Investors first, patients second

Posted on August 24, 2011 | 1 Comment

The new chief executive of Medtronic, who took over the company in June, said Medtronic remained committed to returning cash to shareholders and to exploring smaller acquisitions. In his strategy vision, however, there was no mention of focusing on patients or providing evidence based medical devices for better patient outcomes. Is it any wonder then that Medtronic doesn’t want the FDA to add new regulations for testing and approving medical devices ? Continue reading →

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Posted in Medical Device business

Tagged Business, FDA, Food & Drug Administration, Healthcare, Medical device, Medtronic, Patient, United States