Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Vascepa: Amarin's Yellow Brick Road to the American Heart Association

Vascepa: Amarin's Yellow Brick Road to the American Heart Association | Pharmaguy's Insights Into Drug Industry News |


A decision by the American Heart Association to invite the Amarin chief executive to chair its annual gala, which will have a “Wizard of Oz” theme, is causing a flap worthy of the Wicked Witch.


Why? Amarin itself is controversial for the aggressive approach it’s taken toward promoting its prescription fish oil pill for lowering high triglycerides levels. The company filed a lawsuit two years ago against the Food and Drug Administration after the agency rejected its bid to market the pill for people with slightly lower levels, which is an unapproved use (read “Amarin Wins Off-Label Case Against FDA; Vows to Promote Viscera Off Label "’ASAP’";


The lawsuit caused a sensation amid mounting pharmaceutical industry complaints that the FDA squelches free speech (read “FDA May Soon Be Replaced by Judicial Off-Label Activism”; The agency subsequently settled the case, allowing Amarin to promote its Vascepa pill for this unapproved use to physicians. But some believe that, by tapping Amarin’s John Thero, the AHA appears to be unwisely endorsing the company’s tactics and its drug.


Dr. Harlan Krumholz, a Yale University cardiologist, tweeted:


“One wonders if American Heart Assoc might have been able find chair for their ball w/less baggage an effective evidence-based med.”


Meanwhile, in a March 21 press release announcing the gala, AHA senior vice president Kathy Kauffman gushed that Amarin and its CEO “bring passion and great leadership to the Heart & Stroke Ball.” Moreover, the press release was jointly released by the drug maker and the AHA, a move that an AHA spokesperson admitted was a mistake in comments to CardioBrief, which first reported about the gala.


In fact, as CardioBrief pointed out, Amarin contributed $60,000 to the AHA during its 2016 fiscal year, although in fairness, the drug maker was one of approximately 50 companies that donated more than $29 million to the organization. One patient advocate suggested the praise in the news release and the corporate contribution gave the impression of an improper relationship.


So what does the AHA have to say for itself? More…


Further Reading:

Pharma Guy's insight:

File this under “If they only had a brain.”

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Omega3 drugs Recruit Pawn Stars & Fish for DTC Campaigns

Omega3 drugs Recruit Pawn Stars & Fish for DTC Campaigns | Pharmaguy's Insights Into Drug Industry News |
Celebrity endorsement, copay cards and online edutainment are some of the ways marketers are dueling for attention in the prescription omega3 space.

Amarin is poised to announce a celebrity tie-in with cable-TV star Rick Harrison (host of the showPawn Stars) as part of an integrated campaign to boost awareness of its one-year-old Vascepa brand. And AstraZeneca, whose prescription omega-3 drug Epanova is a relative newcomer, recently launched an unbranded, digital edutainment effort. 

Amarin's partnership with Harrison, who was diagnosed with the condition, works the correlation between knowing trig-treatment facts and not being hoodwinked in his own pawn shop.

“If I hadn't checked with my doctor, I would have made the mistake many make, thinking dietary supplement omega-3s are actually over-the-counter drugs,” Harrison says in a video on the related site, adding that Pawn Stars teaches that “knowing what's valuable and authentic is important to success.” 

Meanwhile, in a campaign that takes its cue from the aquatic theme of DTC advertising done by GlaxoSmithKline's Lovaza—but also departs from it—AZ posted three videos as part of an unbranded consumer effort called “Take it From a Fish.” The videos, dubbed “Love,” “Diet” and “Tri,” take the viewer into the seafood section of the grocery store as two talking fish carry on a casual conversation about healthy eating habits.

Pharma Guy's insight:

Doesn't Harrison often ask his dad about "what's valuable and authentic" on the Pawn Stars show?

As far as I am concerned, these Rx drugs are "me-too" versions of existing over-the-counter dietary supplements, no  matter what Harrison might say about Vascepa

Read my take on the comments made by Harrison: 

Did Pawn Star Rick Harrison Ask His Daddy About the Value of Vascepa Omega-3 Fish Oil?
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Amarin Takes FDA to Court Fishing for Right to Promote Off-Label Use of Vascepa

Amarin Takes FDA to Court Fishing for Right to Promote Off-Label Use of Vascepa | Pharmaguy's Insights Into Drug Industry News |
A small drug maker called Amarin has filed a lawsuit against the FDA to argue that its right to distribute information about unapproved uses of a medicine is protected by the First Amendment.

Amarin wants to be able to provide doctors with clinical trial data that does not directly pertain to the approved uses of its Vascepa prescription fish-oil pill, the lawsuit states. The FDA endorsed drug to treat people with very high levels of triglycerides, a type of fat in the blood that can lead to heart disease.

Specifically, Amarin seeks to provide doctors with data about the effectiveness of its drug to treat people with slightly lower triglyceride levels. But last month, the FDA rejected an Amarin bid to market its pill to that patient population and denied its plan to add the data to the Vascepa product labeling.

Yet the drug maker believes it has a constitutional right to distribute the information, even though such a move would be considered to be off-label promotion by the FDA. And so, Amarin is asking a federal court in New York to “declare [that] it may engage in its proposed speech about Vascepa.”

Even though doctors are free to prescribe medicines for any use, the FDA has long argued that off-label promotion may be evidence that a drug maker intended or attempted to sell misbranded medicines. The agency also maintains that off-label promotion effectively skirts the drug approval process.

One consumer advocate agrees. “If companies can go directly to physicians with studies they believe support other uses, they would be no motivation to seek FDA approval for those purposes,” says Michael Carome, the director of Public Citizen Health Research Group.

In its lawsuit, Amarin counters that FDA regulations are not only onerous, but prevent doctors from obtaining information from the “most knowledgeable sources – the drug manufacturers.” The lawsuit was joined by four physicians who, the suit says, prescribe Vascepa off-label to people with varying levels of triglycerides.

Pharma Guy's insight:

Cable-TV star Rick Harrison (host of the show Pawn Stars) is a celebrity spokesperson for Vascepa. Here's his official announcement made via his @GoldSilverPawn Twitter account, which has over 155,000 followers: 

"Excited to share my story of lowering my very high #triglycerides through the new Lower My Trigs campaign: #spon"

If Amarin wins this case, Ricky can use fewer characters in his tweets by shortening "very high #triglycerides" to just "high #triglycerides".

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