Suspect surrogate end points
Clofibrate reduced cholesterol in persons at risk for heart disease. Lower cholesterol is associated with a lower risk for heart disease. Unfortunately, patients who took clofibrate were more likely to die.
Encainide reduces the number premature heart beats (PVCs) is persons who have had heart attacks. PVCs are strongly associated with a higher risk of death after a heart attack. Unfortunately, patients who took encainide after heart attacks were much more likely to die. It is estimated that encainide caused thousands of excess deaths.
Rosiglatazone lowers the glycohemoglobin level in persons ...
Source: PharmaGossip - May 2, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
The FDA, Surrogate Endpoints, And Blood Pressure Drugs
In recent years the FDA has come under increasing fire for approving drugs on the basis of surrogate endpoints without any evidence of greater clinical benefit. The most famous example of this is the diabetes drug rosiglitazone. Despite strong evidence demonstrating that it was effective at lower blood glucose levels– the surrogate endpoint– serious questions emerged about the cardiovascular safety of the drug, eventually leading to its near withdrawal from the market in the US (and full withdrawal in Europe). Questions have also been raised about the long term health effects of drugs targeting a More… (Source: CardioBrief)
Source: CardioBrief - April 22, 2013 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes FDA food and drug administration Surrogate endpoint Source Type: blogs
#187: Beet this: More evidence of BP-lowering effects of dietary nitrate; amiodarone-cancer link reemerges in observational study; ACE inhibitor, beta-blocker may thwart cardiotoxicity from chemotherapy; will new FDA meeting on Avandia prompt withdrawal?
Beet this: More evidence of BP-lowering effects of dietary nitrate; amiodarone-cancer link reemerges in observational study; ACE inhibitor, beta-blocker may thwart cardiotoxicity from chemotherapy; will new FDA meeting on Avandia prompt withdrawal o (Source: Blogs@theHeart.org)
Source: Blogs@theHeart.org - April 19, 2013 Category: Cardiology Authors: theheart.org Tags: This week in cardiology from heartwire Source Type: blogs
Drug companies' hold on healthcare slammed
A research paper published in the European Journal of Clinical Investigation this month claims that patients worldwide are being deceived into taking drugs they don't need, don't work and put lives at risk.
Co-author of the paper, Dr Emmanuel Stamatakis - Associate Professor at the University of Sydney said it was ''entirely illogical'' to rely on the pharmaceutical industry to fund medical research.
The Crete-born professor, who is also a senior research associate at University College, London, told Neos Kosmos that whilst industry funding of research was necessary, the model of funding used needs to be radically overhaul...
Source: PharmaGossip - April 16, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
FDA Schedules Another 2 Day Avandia Advisory Panel
Once again the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) will be the subject of a 2 day FDA hearing. According to a meeting announcement scheduled to be published in the Federal Register on Monday, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet on June 5 and June 6 to ”discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial.” … Click here to read the full story on Forbes. &#...
Source: CardioBrief - April 12, 2013 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes Avandia diabetes FDA food and drug administration GlaxoSmithKline GSK Rosiglitazone Source Type: blogs
FDA reviewing heart risks of Avandia
WASHINGTON (AP) — The Food and Drug Administration will hold a meeting in June to reassess the safety of GlaxoSmithKline's former blockbuster diabetes drug Avandia.
Avandia was severely restricted in 2010 due to concerns about its impact on the heart.
Regulators announced the highly unusual move in a government notice Friday. The FDA will ask a panel of outside experts to review a new analysis of the key study about Avandia's heart risks.
A spokeswoman for Glaxo said the drug company commissioned researchers at Duke University to reanalyze the study, and submitted the results to the FDA last year.
The FDA first appro...
Source: PharmaGossip - April 12, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Today's shock!- Drug companies 'put profits over lives'
Patients are being deceived into taking drugs they do not need, that do not work and even put lives at risk, according to a scathing review of the influence big drug companies have on healthcare.
Drug companies "masterfully influenced" medicine, a joint review between Australian, British and US researchers has found, describing how the enormous profit involved in making and selling drugs gave the industry power to influence every stage of the health system.
"As a result of these interferences, the benefits of drugs and other products are often exaggerated and their potential harms are downplayed," their research publishe...
Source: PharmaGossip - April 10, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Shock of the Day - Drug companies 'put profits over lives'
Patients are being deceived into taking drugs they do not need, that do not work and even put lives at risk, according to a scathing review of the influence big drug companies have on healthcare.
Drug companies "masterfully influenced" medicine, a joint review between Australian, British and US researchers has found, describing how the enormous profit involved in making and selling drugs gave the industry power to influence every stage of the health system.
"As a result of these interferences, the benefits of drugs and other products are often exaggerated and their potential harms are downplayed," their research publishe...
Source: PharmaGossip - April 8, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Victoza, Januvia, and Other Diabetes Drugs Under FDA Scrutiny: Marketing's "Ethical Concerns"
"Facing growing evidence that some of America's top-selling diabetes medicines could lead to pancreatic disease, federal regulators [see FDA notice here] on Thursday opened an unusual review of drugs from Merck & Co., Bristol-Myers Squibb Co. and other pharmaceutical makers," reports the Wall Street Journal (here).Some of the "evidence" may have come from Public Citizen in a petition it filed in 2010 with the Food and Drug Administration (FDA). That petition called on the agency to "immediately remove from the market the increasingly prescribed diabetes drug Victoza because it puts patients at higher risk of thyroid ca...
Source: Pharma Marketing Blog - March 15, 2013 Category: Pharma Commentators Tags: Drug Safety Victoza FDA Avandia Januvia Paula Deen Ethics diabetes Source Type: blogs
March Diabetes News Snippet Post
Here are all the news items posted in March: Jennysaid... People taking Byetta, Victoza, Januvia, and Onglyza had less heart failure than those not on these drugs. http://www.sciencedaily.com/releases/2013/03/130310164109.htmHowever, it is likely this is because Avandia and Actos CAUSE heart failure, rather than that these other drugs prevent it. People are rarely put on both families of drugs at once. It may also be because these GLP-1 related drugs are mostly prescribed to affluent, younger people with diabetes and good health insurance, while poorer people are put on the cheap sulfonylurea drugs which are now known to ...
Source: Diabetes Update - March 11, 2013 Category: Diabetes Authors: Jenny Source Type: blogs
Roche Peels Back The Curtain On Clinical Trial Data
In response to enormous criticism over its handling of Tamiflu clinical trial data, Roche announced a new plan to increase access to such information and its approach mimics steps begun recently by GlaxoSmithKline. Specifically, Roche will work with an “independent” group of “recognized experts” to evaluate and approve requests to access patient-level data and will also support the release of case study reports for all of its licensed medicines.
The move comes after Roche found itself in a heated row with researchers at the Cochrane Collaboration, who two years ago complained they were repeatedly st...
Source: Pharmalot - February 26, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Avandia BMJ Clinical Trials Cochrane Collaboration GlaxoSmithKline Phrma Roche Tamiflu Source Type: blogs
Is Evidence-Based Medicine Only an Illusion?
By Kristina Fiore, Staff Writer, MedPage Today
Published: February 23, 2013
In a system where half of all clinical trials never see the light of publication, doctors are merely "imagining that we're practicing evidence-based medicine," says Ben Goldacre, MBBS, a British physician and science journalist.
Goldacre is among the most vocal critics of drugmakers who refuse to hand over complete clinical trial data, making it impossible for doctors and patients to get the full picture on most of the medicines widely used today. He decries the industry's behavior in his new book, Bad Pharma, which in itself is a review of the e...
Source: PharmaGossip - February 24, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Glaxo Sued By Maryland AG Over Avandia Risks
So $3 billion may be a large sum of money, but this does not make everything go away. Having paid that much last year to the US federal government to resolve a bushel of civil and criminal charges, some of which pertained to the Avandia diabetes pill, GlaxoSmithKline now faces a fresh lawsuit from the Maryland attorney general, who claims the state overpaid by at least $38 million for purchasing the controvresial drug.
In the lawsuit, Glaxo is charged with misleading various state programs, including the State Employee Prescription Drug Plan, the State Retiree Prescription Drug Plan and the Medical Assistance Program, abo...
Source: Pharmalot - February 22, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Avandia Diabetes GlaxoSmithKline Source Type: blogs
