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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Despite Years of "Educational" DTC Ads, 82% of Americans Unaware of Dangers of High Cholesterol

Despite Years of "Educational" DTC Ads, 82% of Americans Unaware of Dangers of High Cholesterol | Pharmaguy's Insights Into Drug Industry News | Scoop.it

People who have high cholesterol may understand they need to manage their condition, but many aren’t sure how to do that, nor do they feel confident they can, according to a new survey from the American Heart Association.

 

The survey was conducted as part of Check.Change.Control.Cholesterol™, the association’s new initiative to help people better understand and manage their overall risk for cardiovascular disease, especially as it relates to cholesterol. Participants included nearly 800 people from across the country with either a history of cardiovascular disease (e.g. heart attack, stroke) or at least one major cardiovascular disease risk factor, (e.g. high blood pressure, high cholesterol or diabetes).

 

High cholesterol is a known risk factor for heart disease and stroke, causing about 2.6 million deaths each year. Yet, nearly half (47 percent) of survey respondents with a known history of or at least one risk factor for heart disease or stroke, had not had their cholesterol checked within the past year. Respondents with high cholesterol reported more recent testing, although 21 percent of them had not had their cholesterol checked in the past year.

 

Among other survey findings:

 

  • Most people with high cholesterol said they understood the importance of managing their cholesterol, being confused, discouraged and uncertain about their ability to do so.
  •  82 percent of all respondents identified a link between cholesterol and risk for heart disease and stroke.
  • Overall, people with a history of cardiovascular had lower perceptions of their real medical risk of cardiovascular disease.
  • Patients with a history of cardiovascular disease are at high risk for having another cardiovascular disease event, but among these patients, only 29 percent recognized they were high risk for another cardiovascular disease event.
  • Primary care providers were the healthcare professionals who participants talked about cholesterol with most often, and were more likely the ones to first diagnose high cholesterol.
  • The most common treatment recommendation given by healthcare providers were medication (79 percent), exercise (78 percent) and diet modifications (70 percent).
  • Patients with high cholesterol felt they were least informed about what should be their target body weight, the differences between the types of cholesterol (LDL vs HDL) and goals for cholesterol management.
Pharma Guy's insight:

OK, I understand you can't blame this all on the failure of direct-to-consumer advertising, but the industry's claim that such ads help educate people seems to take a big hit based on this American Heart Association survey.

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New, Pricey Biotech Cholesterol Drugs Aren't Selling.

New, Pricey Biotech Cholesterol Drugs Aren't Selling. | Pharmaguy's Insights Into Drug Industry News | Scoop.it

It looked like a surefire way to make billions.

 

A year ago, two new drugs that used a novel mechanism to drive down cholesterol levels came on the market, and were promptly crowned as blockbusters in waiting. Analysts estimated sales at more than $3 billion a year.

 

But the two drugs have been commercial flops, in part due to a complicated reimbursement system that has frustrated doctors, confused patients, and left the biotech industry worried about the implications for other high-priced drugs in the pipeline.

 

“These launches so far are close to, if not the biggest, wastes of development and commercial investment in recent industry history,” said Geoffrey Porges, a biotech analyst at Leerink.

 

The companies behind the drugs — Amgen and the partnership of Sanofi and Regeneron — are spending hundreds of millions to promote their products but have reaped a mere fraction of that in revenue. “You don’t need to be in finance to know that that’s not a sustainable business proposition,” Porges said.

 

The problem boils down to doctors who are reluctant to write prescriptions, insurers who are unwilling to pay for them, and drug companies that have failed to understand a fast-changing marketplace.

 

Docs won’t prescribe pricey new cholesterol meds unless they lower heart risks.

 

The failures could send a chill through the still-booming biotech business, which relies on the idea that the risky, expensive process of developing new drugs can one day pay off big.

 

Cardiologists say the drugs could save lives. An estimated 15 percent of the roughly 74 million Americans with high cholesterol have alarmingly high LDL levels despite taking other drugs. Many would be candidates for the new treatments.

 

[But cardiologists may be biased. See my insights.]

 

And yet the new therapies have only been prescribed about 120,000 times, according to data from QuintilesIMS, grossing just above $150 million combined in the past year.

Pharma Guy's insight:

Dr. Robert Eckel, former American Heart Association (AHA) president and co-author of certain cholesterol-related AHA guidelines, received nearly $33K in industry payments in 2014. Over $14K came from drug maker Sanofi Aventis.. Express Scripts’ Chief Medical Officer Dr. Steve Miller wrote in July 2015 that the company’s new cholesterol-lowering drug, Praluent, and other “PCSK9-inhibitors” like it, could cost U.S. payers and patients more than $100 billion per year if not managed properly. More here: http://sco.lt/8fqEmf

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Labor Union Calls Out AHA for Links to #Pharma

Labor Union Calls Out AHA for Links to #Pharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A UNITE HERE report [available here: http://bit.ly/AHAcontributions] has uncovered that the American Heart Association (AHA), its leadership, and authors of its guidelines accept large contributions from the pharmaceutical industry. As volunteers for the organization raise money in Heart Walks across the country, the labor union is calling on the AHA to take concrete steps to minimize the industry’s influence.


Dr. Robert Eckel, former AHA president and co-author of certain cholesterol-related AHA guidelines, received nearly $33K in industry payments in 2014. Over $14K came from drug maker Sanofi Aventis.. Express Scripts’ Chief Medical Officer Dr. Steve Miller wrote in July 2015 that the company’s new cholesterol-lowering drug, Praluent, and other “PCSK9-inhibitors” like it, could cost U.S. payers and patients more than $100 billion per year if not managed properly.


The AHA received over $15 million from pharmaceutical, medical device, and health-insurance companies in the 2013-14 fiscal year, including nearly $3.3 million from Pfizer.


Among other recommendations, UNITE HERE calls on the AHA to convene a panel of independent experts who do not receive income from pharmaceutical industries to review the 2013 ACC/AHA cholesterol guidelines and risk calculator.

Pharma Guy's insight:

Unite Here also launched a campaign against the funding of CME courses by "Big Pharma". Read "Las Vegas Chefs Against Pharma Funding of Continuing Medical Education". 


You might also be interested in reading "IMPROVE-IT heart drug trial balderdash."

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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 | Scoop.it

 

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’"; http://sco.lt/8GzPDV).

 

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”; http://sco.lt/7J3xyr). 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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AHA Cholesterol Guidelines Panel Vice Chair Finally Discloses Receiving $ from #Pharma

AHA Cholesterol Guidelines Panel Vice Chair Finally Discloses Receiving $ from #Pharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In 2013, the American Heart Association issued new guidelines for treating cholesterol, causing a stir that more patients may wind up being treated with medicines. As part of that process, the expert panel members who oversaw the document disclosed their financial ties to drug makers. But one large payment was not divulged.

The panel vice chair did not disclose nearly $110,000 in research grants received from Eli Lilly for running tests for an experimental cholesterol treatment. 


Robinson said the decision not to disclose the Lilly payments was, essentially, a timing issue. She began work on the Lilly study shortly after the AHA panel completed the guideline recommendations and submitted them for publication. This submission also occurred before she received any payments from the drug maker.


“The Eli Lilly study started after the guideline recommendations were completed, so it was not on my radar to report,” she wrote. She added that the funds were paid to the university to cover the cost of the research she was conducting, which is a standard price. “They are not direct payments to me,” she added.


The AHA further explained that Robinson abstained from voting on the recommendations because of her financial ties to several other drug makers, which had been disclosed.


One labor union, which first reported the failure to disclose the Lilly payment and is critical of financial ties between industry and the AHA, worries such relationships can raise health care costs. “The AHA should prohibit its authors and leadership from accepting industry payments,” said Arthur Phillips, a research analyst at Unite Here.


However, industry and some researchers argue completely severing ties is not practical, because they say the most qualified experts often have relationships with drug makers.

Pharma Guy's insight:

So, the drug industry has all of the most qualified physicians on its payroll? Thereby making conflict-of-interest inevitable?

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