A Type of Rx Drug Tweet FDA Did Not Consider in its Recent Guidance
I couldn't sleep last night. For some reason I became obsessed with trying to figure out a way that pharma companies can create Rx branded tweets that satisfy FDA's recent "Industry Guidance for Internet/Social Media Platforms with Character Space Limitations — Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices."Is it possible?In a comment to the FDA on Regulation.gov, I described a Tweet that may pass muster with the FDA.Here's my comment:"The draft guidance does not mention Tweets accompanied by images, which is perhaps a way to present ISI along with benef...
Source: Pharma Marketing Blog - June 20, 2014 Category: Pharma Commentators Tags: #fdasm Drug Safety Guidance side effects space limitation Twitter Source Type: blogs
Abdominal aortic aneurysm
is a life threatening condition as it has a chance to rupture as the size increases. Non-surgical management of a large abdominal aortic aneurysm is by:
1. Injection of thrombin into the aneurysm sac
2. Insertion of a stent graft into the aneurysm through the femoral route
3. High dose atorvastatin
4. Dual anti-platelet therapy
Correct answer: 2. Insertion of an aortic stent graft
Large abdominal aortic aneurysms are conventionally treated by open surgery with placement of a graft after resecting the aneurysmal segment. But very often persons with large abdominal aortic aneurysms are in the older age group with associate...
Source: Cardiophile MD - April 19, 2014 Category: Cardiology Authors: Johnson Francis Tags: Cardiology MCQ DM / DNB Cardiology Entrance Source Type: blogs
MKSAP: 59-year-old woman with type 2 diabetes mellitus and hyperlipidemia
Test your medicine knowledge with the MKSAP challenge, in partnership with the American College of Physicians.
A 59-year-old woman is evaluated during a routine follow-up visit. She was recently diagnosed with type 2 diabetes mellitus and hyperlipidemia. She feels well. Medications are metformin, atorvastatin, and aspirin.
Physical examination findings and vital signs are normal. BMI is 27.
Laboratory studies reveal a serum creatinine level of 0.9 mg/dL (79.6 µmol/L), an estimated glomerular filtration rate of >60 mL/min/1.73 m2, and normal urinalysis results.
Which of the following is the most appropriate diagnostic...
Source: Kevin, M.D. - Medical Weblog - March 22, 2014 Category: Family Physicians Tags: Conditions Diabetes Endocrinology Nephrology Source Type: blogs
OTC Generic Lipitor? Will Consumers Monitor Their Own Cholesterol Levels?
Since Lipitor has come off patent, Pfizer has been facing very serious competition from the manufacturers of generic copies of its former cash-cow (see: Pfizer Lipitor Sales Are Threatened by Ranbaxy Generic Copy). But the company continues to try to breathe new life into the product by now proposing an OTC version (see: Lipitor Down, But Not Out: Pfizer Plans an OTC Version). Here are some of the details:
I've been following Lipitor's "demise" ever since Pfizer vowed the drug would maintain a 40% share of the total U.S. atorvastatin market. In May 2012, we all thought Pfizer Threw In the Lipi...
Source: Lab Soft News - March 8, 2014 Category: Pathologists Authors: Bruce Friedman Tags: Clinical Lab Industry News Clinical Lab Testing Laboratory Industry Trends Medical Consumerism Source Type: blogs
Pharmaceutical Companies Drastically Cut Speaker Payments for Doctors
A number of large pharmaceutical companies have greatly reduced payments to healthcare professionals for promotional speeches. ProPublica reports that GlaxoSmithKline and Pfizer have dropped their speaking payments by over 60% from 2011 to 2012. Eli Lilly reduced their spending by 55%, from $47.9 million in 2011 to $21.6 million in 2012. During the same period, Novartis reduced their spending from $24.8 million to $14.8 million.
ProPublica states that the sharp drop in payments coincides with the large settlement figures pharmaceutical companies have forked over to the government for their marketing practices, including ...
Source: Policy and Medicine - March 7, 2014 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
As Full Disclosure Nears, Doctors’ Pay for Drug Talks Plummets
Some of the nation’s largest pharmaceutical companies have slashed payments to health professionals for promotional speeches amid heightened public scrutiny of such spending, a new ProPublica analysis shows.Eli Lilly and Co.’s payments to speakers dropped by 55 percent, from $47.9 million in 2011 to $21.6 million in 2012.Pfizer’s speaking payments fell 62 percent over the same period, from nearly $22 million to $8.3 million.And Novartis, the largest U.S. drug maker as measured by 2012 sales, spent 40 percent less on speakers that year than it did between October 2010 and September 2011, reducing payments from $24.8 m...
Source: PharmaGossip - March 4, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Lipitor Down, But Not Out: Pfizer Plans an OTC Version. Will It Benefit or Harm Consumers?
(Source: Pharma Marketing Blog)
Source: Pharma Marketing Blog - March 3, 2014 Category: Pharma Commentators Tags: generics Lipitor OTC Pfizer Source Type: blogs
Pfizer Starts Testing For Over-The-Counter Lipitor
Looking backward to improve its future, Pfizer will once again try to gain FDA approval to market its blockbuster drug, atorvastatin (Lipitor), over-the-counter (OTC). Peter Loftus reports in the Wall Street Journal that the company has started a clinical study to support the application for low-dose atorvastatin (10 mg). … Click here to read the full post on Forbes. (Source: CardioBrief)
Source: CardioBrief - March 3, 2014 Category: Cardiology Authors: Larry Husten Tags: Policy & Ethics Prevention, Epidemiology & Outcomes atorvastatin cholesterol Lipitor over-the-counter statins Source Type: blogs
Packaging Defect Leads Merck To Recall All Lots of Liptruzet In US
Merck said today that it was recalling all lots of Liptruzet, its combination of the cholesterol-lowering drugs ezetimibe and atorvastatin, in the US. The company said the recall was due to a packaging defect which could potentially allow air and moisture to affect the quality of the drug, though the company said “the likelihood of the packaging defects decreasing the effectiveness of Liptruzet on a patient’s lipid profile or negatively impacting the safety of the product is remote.” To date there have been no adverse events or product complaints reported to the company. Merck is recalling the drug More...
Source: CardioBrief - January 14, 2014 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes atorvastatin ezetimibe Liptruzet Merck Source Type: blogs
No Needle, but the Damage was Done - A New Example of Suppression of Research about Adverse Effects of Prescription Narcotic Analgesics
This story feels personal, since as a physician who trained starting in the 1970s, figuring out how to manage patients who desperately wanted narcotics, whether to relieve pain, relieve addiction, or relieve financial distress has been a constant challenge.Background - Treating Pain while Avoiding "the Needle and the Damage Done"Almost as soon as I started clinical training in medical school I came up against the problem of narcotics. In the 1970s, narcotic addiction was a pressing problem that threw a dismal shadow over society.. In the hospital and emergency room we daily saw overdoses and the complicat...
Source: Health Care Renewal - December 26, 2013 Category: Health Medicine and Bioethics Commentators Tags: conflicts of interest deception Janssen Johnson and Johnson key opinion leaders narcotics suppression of medical research Source Type: blogs
Merry Christmas Big Pharma, from PharmaGossip and Sid Wolfe
Escalating criminal and civil violations: pharma has corporate integrity? Not reallySidney M Wolfe looks at the system that should, but does not, deter drug companies from breaking the lawAre criminal and civil penalties of hundreds of millions of dollars an important deterrent to law breaking by international drug companies?Further, would external monitoring in the form of US government mandated corporate integrity agreements (CIA)1 to prevent recurrences of such illegal activities, lasting five years after being signed, be an additional deterrent? Yes in both cases, but only if the size of the penalties outweig...
Source: PharmaGossip - December 24, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
As Pfizer Readies New Business Units, Amy Schulman Exits
Just a few months after Pfizer tapped general counsel Amy Schulman to head one of three so-called innovative business units that are supposed to take shape in January and widen her executive portfolio, the drugmaker disclosed this morning that she is leaving, according to a brief statement.
Replacing as head of the the vaccines, oncology and consumer healthcare business will be Albert Bourla, who has spent 20 years at Pfizer, most recently as president and general manager of what the drugmaker calls its established products business unit.
For the past five years, Schulman was a rising star at Pfizer. She was hired by forme...
Source: Pharmalot - December 17, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Are There Tiny Glass Shards in Your Pills?
A major pharmaceutical company recalls generic Lipitor.Contributor: Lisa ShereePublished: Dec 10, 2013 (Source: Most Recent Health Wellness - Associated Content)
Source: Most Recent Health Wellness - Associated Content - December 11, 2013 Category: Other Conditions Source Type: blogs
How Manipulated Clinical Evidence Could Distort Guidelines - the Case of Statins for Primary Prevention
This study excluded many patient for whom the statins were not contraindicated or warned against: uncontrolled hypertension; type 1 or type 2 diabetes mellitus on insulin or with a HgBA1C at least 10%; and body weight more than 50% "desirable limit for height." (Based on the official contraindications and warnings for commonly used statins, e.g., see contraindications for Lipitor here, active liver disease, pregnancy for likely to become pregnant, nursing mothers, hypersensitivity to the medicine; and warnings: use of cyclosprine or strong CYP3A4 inhibitors, uncontrolled hypothyroidism, renal impairment.) Thus ...
Source: Health Care Renewal - December 3, 2013 Category: Health Medicine and Bioethics Commentators Tags: American College of Cardiology American Heart Association clinical trials conflicts of interest evidence-based medicine guidelines manipulating clinical research review articles Source Type: blogs
Statins - John P. A. Ioannidis writes
The American College of Cardiology/American Heart Association (ACC/AHA) guidelines on assessment of cardiovascular risk1 and on treatment of blood cholesterol, which included recommendations for primary prevention with statins,2 came under intense criticism immediately with their release. Main concerns focused on flawed methods (problems with the risk calculation),3 ethics (conflicts of interest),4 and inferences (too many people offered treatment).The ACC and the AHA are among the most experienced organizations in medicine that develop guidelines. Their processes are meticulous, including transparent r...
Source: PharmaGossip - December 3, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
