New AAFP President to Focus on Administrative Burden
Michael Munger, MD, recently assumed the role of president of the American Academy of Family Physicians (AAFP). During his opening speech, he spoke about the progress being made in moving toward a value-based care approach and the angst many members feel about the increasing administrative burden on their practices.
Prior to his role as president, Munger served on the board for three years. During those three years, he noted that a recurring theme in conversations with other family physicians was what can be done about the overload of administrative work that is taking time away from meeting with patients.
“You all lov...
Source: Policy and Medicine - September 27, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
AbbVie Found Liable for Misrepresentation in AndroGel Case
In July 2017, a Chicago jury found AbbVie Inc. guilty of fraudulently misrepresenting the risks of its testosterone replacement drug AndroGel. The federal jury ordered the company to pay $150 million in punitive damages.
Allegations
The verdict comes in a case where Jesse Mitchell blamed the drug for a heart attack he had in 2012 after four years of taking AndroGel. Mitchell, who used AndroGel from 2008 to 2012, alleged that AbbVie knew or should have known the drug could cause cardiovascular disease, strokes and other serious injuries, but failed to adequately warn consumers and doctors. He was 49 at the time of his hea...
Source: Policy and Medicine - August 7, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Insurance Company Files Large RICO Class Action Targeting Low-Testosterone Therapies: Claims Manufacturers Invented “Low-T” and Duped Payors Into Paying Billions
Insurer Medical Mutual of Ohio has sued Abbvie, Abbott Laboratories, Solvay, Eli Lilly, Auxilium, Actavis, and a host of subsidiaries over each company’s respective “low testosterone” disease awareness activities and promotion of testosterone replacement therapy (TRT) drugs. “These TRT drugs were marketed as part of a decade-long deceptive marketing scheme to transform the male aging process into a curable disease state,” argues the complaint. Medical Mutual of Ohio brought the case on behalf of any payors who paid all or a portion of the cost of AndroGel, Testim, Testopel, Axiron, Androderm, and Fortesta Gel—T...
Source: Policy and Medicine - November 24, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
RICO: Offering Co-Pay Coupons Does Not Constitute A Racketeering “Enterprise,” Rules Federal Court
Pharmaceutical manufacturer co-payment coupons have come under a lot of scrutiny recently. HHS-OIG recently warned these coupons may violate the anti-kickback statute if they encourage the purchase of Medicare Part D drugs. Manufacturers seem to be safe, however, from co-pay challenges under RICO—the federal Racketeer Influenced and Corrupt Organizations Act which was originally enacted to combat organized crime. Last week, a Federal Court judge dismissed an insurance company’s claim that they overpaid for drugs in which Abbott Laboratories and Abbvie allegedly committed mail and wire fraud by offering co-pay cou...
Source: Policy and Medicine - October 14, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Public Citizen Petitions FDA to Add a Black Box Warning to Low-T Drug Labeling
(Source: Pharma Marketing Blog)
Source: Pharma Marketing Blog - February 25, 2014 Category: Pharma Commentators Tags: Androgel Black Box Warning Low T Wolfe Source Type: blogs
Public Citizen Petitions FDA for a Black Box Warning on Testosterone
Products
WASHINGTON - February 25 - Public Citizen today called on the U.S. Food and Drug Administration (FDA) to immediately add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs available in the U.S.The urgent petition is based on growing evidence of the risks of heart attacks and other cardiovascular dangers from many individual randomized studies going back as far as 2010 and a recently published overall analysis (meta-analysis) of 27 studies going back as far as 20 years. Although 13 of these studies, funded by the drug ind...
Source: PharmaGossip - February 25, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Low T' and the peril of medicating grumpy old men
Could you have low testosterone?That's the question Abbott Laboratories (now AbbVie) has been urging men to consider with its "Is It Low T?" awareness campaign, a highly effective effort to change how doctors and the public think about managing aging in men.Since 2008, this massive marketing endeavor has targeted middle-aged men who have put on some weight, sometimes feel grumpy or get sleepy after meals, encouraging them to have their testosterone levels tested and to consider treatment if levels are low. It has helped persuade legions of men to take a drug that may not help and may actually do harm for a condit...
Source: PharmaGossip - February 15, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
"Selling That New-Man Feeling" - NYT Quotes Pharmaguy on Low-T Marketing
Occasionally, mainstream media reporters call me for my opinion on the marketing of drugs.Several days ago I received a call from Nastasha Singer, a New York Times reporter. She interviewed me for a story published today in the Business section of the Sunday Times about the marketing of testosterone drugs. The title of that story is "Selling That New-Man Feeling." I've written several posts about the marketing of "Low-T"here on Pharma Marketing Blog (here, here, and here) and interviewed Adriane Fugh-Berman, MD, Associate Professor at Georgetown University Medical Center and Director of PharmedOut (...
Source: Pharma Marketing Blog - November 24, 2013 Category: Pharma Commentators Source Type: blogs
Can 'Low T' Drugs Cause The Big 'H,' As In Heart Attack?
Maybe a little ‘Low T’ is something men can live with. How so? For the past several years, elixirs for boosting testosterone levels have been widely touted for curing low sex drives amid controversy over their benefits and research suggesting the malady is less common that advertising suggests. Now, though, a new study finds that the drugs raised the risk of a heart attack, stroke or death by 29 percent.
The study, which was published in the Journal of the American Medical Association, reviewed data from more than 8,700 men who underwent an angiography at one of 76 cardiac catheterization labs in the US Veterans Affair...
Source: Pharmalot - November 6, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
DTC Ad Spending Is Rising So Far This Year, But Will It Continue?
For those keeping track of direct-to-consumer advertising of prescriptions – and we know that many do – newly released data indicates a slight uptick in promotional spending in recent months. Through the first half of this year, DTC advertising totaled $1.82 billion, a slight 1.2 percent rise over the same period a year earlier, according to DTC Perspectives, an industry consulting firm that cited Kantar Media data.
Why? “The reasons for stabilization are new brands doing heavy DTC,” writes Bob Ehrlich, a former Warner-Lambert executive who runs DTC Perspectives, in his blog. He cites new spending for two drugs –...
Source: Pharmalot - October 2, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
David Healy vs AbbVie - A good medicine is a chemical plus good information
http://davidhealy.org/abbvie/
How to AbbVie: Step 1.
If you are taking, or know anyone who is on:
HumiraDepakote (another AbbVie drug, for which the company was fined $1.3 Billion for mismarketing).Kaletra (for HIV/AIDs)Androgrel for low TestosteroneLupron used for prostate cancer, breast cancer and endometriosisEsbriet
Report any events happening on these drugs to RxISK.org by clicking on the name of the drug. This will take you to the research pages for the drug. The drug name will be automatically entered when you click on Report a Drug Side Effect from the research pages. An exception...
Source: PharmaGossip - July 15, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
FDA MedWatch Safety and Adverse Event Reporting Program Expands Patient Resources
Earlier this month, the Food and Drug Administration (FDA) celebrated the
20th anniversary
of its
MedWatch program, which provides important safety information associated with FDA-regulated products, with a new form that will encourage more consumer participation.
Under MedWatch, health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated products. Reporting to FDA such "adverse events" as unexpected, serious side effects, accidental exposure, and product quality issues can prompt the agency to act—and it can also ...
Source: Policy and Medicine - July 10, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
Pay-to-Delay: Not Necessarily Illegal, But Not Long For The World
The Supreme Court has another ruling that affects the drug industry: FTC v. Actavis took up the question of "pay to delay", the practice of paying generic companies to go away and not challenge a branded drug. Actavis was in the process of bringing a version of Solvay's AndroGel to market, claiming that the Solvay patent was invalid. They won that case, and the FDA approved their generic version, but Solvay turned around and paid them (and Paddock, another generic firm) to not bring any such drug to the market.
The Federal Trade Commission (FTC) filed suit, alleging that re- spondents violated §5 of the Federal Trade Com...
Source: In the Pipeline - June 17, 2013 Category: Chemists Tags: Regulatory Affairs Source Type: blogs
The Testosterone Trap
Should the Modern Man Be Taking Testosterone?
Is It Low T? .com
By now you've likely seen the commercials. Fit-looking middle-age men telling you how they put on weight, had less energy, and were no longer the sexual tigers they were in their twenties -- until, that is, they started rubbing testosterone gel on their shoulder, upper arm, or abdomen.
Now they feel more like the men they used to be.
The commercials don't mention a 2009 study in the New England Journal of Medicine wherein a group of men on testosterone replacement therapy had more than four times the number of cardiovascular problems -- so many that the s...
Source: PharmaGossip - May 2, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Your Aging Problem: Is It [LowT]? Take this Quiz and Find Out. Or Just Chalk It Up to Clever Marketing. Adriane Fugh-Berman, MD, Explains
Have you noticed a recent deterioration in your ability to play sports? Are you falling asleep after dinner?Those are just two of the questions in the "Is it Low T?" symptom quiz "Supported by AbbVie," the pharma company that markets Androgel -- testosterone replacement therapy -- for the treatment of androgen deficiency, a condition that AbbVie marketers have renamed "LowT." (click on image for enlarged view)"If you answered 'yes' to questions 1 or 7, or to at least three of the other questions," says AbbVie, "your symptoms may be caused by Low T."Jeez! I answered "Yes" to 7 out of 10 of these questions? What about you? ...
Source: Pharma Marketing Blog - April 26, 2013 Category: Pharma Commentators Tags: Symptom Quiz AbbVie Low T testosterone Androgel Source Type: blogs
