I have long maintained that the FDA REMS programs mainly serve the purpose of big drug companies looking to avoid class-action litigation, while they limit access to drugs and create additional administrative tasks for clinicians.
I have seen your recent comments on providing REMS programs for opioids. Since you are the director of OND, I was hoping to give you some feedback on these programs, and to alert you to the adverse effect on patient care that they can have.
I am a clinical hematologist and oncologist. I have to contend with many drugs under these programs, including Promacta, Nplate, Thalomid, Tysabri, and Revlimid. Looks like opioids are next on the list.
I recently had a health journalist interview me about the new guidelines for mammography under 50.
You may recall a storm of controversy was touched off in December 2009, when the US Preventive Services Task Force recommended that mammography begin at 50. Sarah Palin went so far as to compare these recommendations to "death panels" under health care reform. The controversy died down, and health care reform legislation was rewritten to ensure access to mammographic screening.
Let the gushing begin. The new son-of-Plavix, Brilinta, beat Plavix in a randomized trial, published this week.
Plavix is a leading blood thinner given to patients after a heart attack or stent procedure. Only problem is that it's set to go off patent in 2011, leaving AstraZeneca needing to fill a $6 billion/year revenue hole.
Looks like Brilinta is all but inevitable. The incremental benefit is 1.9%, leaving insurance pharmacy benefit managers having to scratch their heads over whether a 1.9% benefit is worth billions of dollars in incremental drug spending.
(reproduced from Medscape.com original link: http://www.medscape.com/viewarticle/703926) June 4 2009 (Orlando Florida) — It has been nearly 10 years in coming but at last there is a positive result with a vaccine approach to follicular lymphoma. Two other phase 3 clinical trials have failed but the one that succeeded was reported during a plenary session here at the American Society of Clinical Oncology (ASCO) 45th Annual Meeting.
According to American Heart Association more than 1.2 million patients in the U.S. go through cardiac angiograms every year and out of which 1 to 2% of cases results in complications and nearly 25 people die every year with this process. A new study published in the New England Journal of Medicine (NEJM) however has revealed that noninvasive CT scans are almost as precise at imaging coronary artery blockages as against traditional angiography and are much safer for the patients.
A new research publication reveals that lack of vitamin D can double the risk of getting cardiovascular disease like stroke and heart failure. Dr. James H. O'Keefe director of preventive cardiology at the Mid America Heart Institute in Kansas City is the lead author of a paper published in the Dec. 9 issue of the Journal of the American College of Cardiology. Dr. O’Keefe opined that lack of vitamin D can add to known major risk factors like high blood pressure diabetes and stiffening of the left ventricle of the heart and blood-vessels.
Named after German physician Alois Alzheimer who first mentioned about this disease in the year 1906 Alzheimer's Disease is a brain disorder which progressively destroys the ability to remember motivation imagine and study. With the progress of this disease people with Alzheimer's are unable to recognize themselves and the world around them. Alzheimer’s Disease is sometimes also accompanied by depression anxiety and paranoia symptoms. It is anticipated that every 70 seconds someone in the United States develops Alzheimer's disease.
Scientists have warned US Congress about the possible risks involved while using mobile phones. They informed Congress that regular use of mobile phones could lead to brain cancer. There has been an on-going debate around the world about the possible impact of magnetic field emitted by cell phones and its effect on human beings. Particularly children are thought to be at a greater risk though conclusive data remains years away.
A class of drugs commonly utilized to lower cholesterol may have a future in preventing blood clots in patients with breast lung colon and other solid-organ cancers. Research conducted by a team at the Albert Einstein Medical Center in Philadelphia has shown that cancer patients taking statins had a decreased incidence of clots compared with patients not using the medications. But experts have added caution noting that the results which were due to be presented at the American College of Chest Physicians' annual meeting in Philadelphia are not yet ready for the general public.