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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Cleveland Clinic Cardiologist Nissen Likens Anti-Statin “Internet Cult” to Anti-Vaxxers

Cleveland Clinic Cardiologist Nissen Likens Anti-Statin “Internet Cult” to Anti-Vaxxers | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Researchers studied over 28,000 patients in Massachusetts and found three in 10 stopped taking statins after experiencing side effects, which were presumed to be due to the drugs. Some 8.5% of them had a cardiovascular event, such as a heart attack or stroke, within four years -- versus 7.6% of those who continued taking statins.

 

"That's a very significant number," said Cleveland Clinic cardiologist Dr. Steven Nissen, who was not involved in the study but penned an accompanying editorial in the same journal.

 

One expert questioned whether his findings had much to do with statins at all.

"We don't know what (else) was different about the groups," said Dr. Rita Redberg, a professor of medicine at University of California, San Francisco. Redberg was not involved in Turchin's research. "People that take medicines and are adherent do better than people that don't."

 

For example, those who take medications consistently might also eat better or exercise more, Redberg added. So a "small difference" between the groups "isn't that revealing," she said.

 

Nissen said that statins have developed a "bad reputation with the public," largely due to websites that peddle scary and unscientific claims about statins.

 

"We have a large number of people in the public that have been convinced by this internet cult that statins are bad for you," said Nissen, who compared the trend to discussions surrounding vaccines and climate change. "How did we get into this kind of a mess?"

 

These claims, Nissen said, could actually increase reported side effects. The more patients are aware -- and perhaps fearful -- of statins and their side effects, the more likely they are to report those side effects. This phenomenon is known as the "nocebo effect," the opposite of the placebo effect.

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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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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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Sanofi's Heart Felt - True Patient Stories, But a Boring Documentary!

Sanofi's Heart Felt - True Patient Stories, But a Boring Documentary! | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Take a look at the trailer for Heart Felt—an eye-opening documentary by Academy Award® winner Cynthia Wade and brought to you by Sanofi and Regeneron.


True Stories of Life in the Shadow of High LDL Cholesterol

This documentary film captures the stories of people across five different countries engaged in a fight against the same common enemy—LDL cholesterol (LDL-C). It shows their struggles, reveals their fears, and tells true stories of courage—taking a condition that too often goes unnoticed and making it felt.

Pharma Guy's insight:


C'mon Sanofi! Did you really need an award-winning documentary filmmaker to produce a feature-length movie about cholesterol that looks and sounds like dozens of other similar movies/commercials I've seen created by nameless ad agencies?

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Cheap Generic Statins Save Money and Lives

Cheap Generic Statins Save Money and Lives | Pharmaguy's Insights Into Drug Industry News | Scoop.it
A new study finds patients who had a lower co-payment for a generic statin were not only more likely to take their medicine, but they were also more likely to experience fewer deaths due to heart attack or stroke than those taking a brand-name statin.


The study examined more than 90,100 Medicare beneficiaries who were 65 years or older with prescription drug coverage between 2006 and 2008, and who began taking a statin. Of those, more than 83,700 were on a generic and nearly 6,400 took a brand-name drug. Most patients in both groups were taking simvastatin, which was sold as Zocor as a brand-name medicine.


“The results weren’t surprising to us,” says Joshua Gagne, an assistant professor of medicine at Brigham and Women’s Hospital and Harvard Medical School. “We know that when drugs cost more, patients are less likely to use them. And with statins, they are chronically used. And if they are not used, the patient is not likely to realize a benefit. But I don’t think any study connected the dots in this way before.”


-----------------ADDENDUM----------------

It seems that hypercholesterolemia ("high cholesterol") is the medical conditiondu jour of us baby boomers. According to the authors, "among baby boomers, hypercholesterolemia was more common (73.5% vs 33.8%; P .001), and medication use for hypercholesterolemia was more than 10 times greater(25.9% vs 1.5%; P .001)."

In other words, we all have high cholesterol! Of course, the line that separates "normal" from "high" cholesterol has moved significantly downward from one generation to the next, thanks in part to the push by the drug industry to sell more cholesterol-lowering drugs.

Coincidently (?), baby boomers were also more likely to have diabetes. I inserted a ? there because I recall a New York Times OpEd piece by a well-known cardiologist who said Americans are being "over-dosed" with statins to treat high cholesterol: "It is only with the more potent statins -- Zocor (now known as simvastatin), Lipitor (atorvastatin) and Crestor (rosuvastatin) -- particularly at higher doses, that the risk of diabetes shows up," said Dr. Topol. "The cause and effect was unequivocal because the multiple large trials of the more potent statins had a consistent excess of diabetes." I'm weening myself off statins because of a history of diabetes in my family (see "Bad News for Potent Cholesterol Drug Users, but Not Me!").

Pharma Guy's insight:


Hmmm... There's a link between drug cost and adherence? Every presentation from pharma I've heard focuses on behavioral characteristics of the patient -- i.e., blame the patient! Read, for example, Effective Pharma Adherence Programs Start With The Patient

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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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Amgen Wants to Own Your Protected Health Information in Exchange for Copay Card

Amgen Wants to Own Your Protected Health Information in Exchange for Copay Card | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Amgen is the Rumpelstiltskin of the drug industry.

As reported by MedPage Today/CardioBrief, "Doctors, pharmacists, patients and others are now starting to learn that in order to receive financial assistance from Amgen for its expensive new cholesterol drug Repatha, patients are being required to surrender rights to their personal information, including their personal health information."

Not even HIPAA-protected health information is off limits.

"The agreement specifically states that by agreeing to the terms [of Amgen's privacy policy] patients may lose federal HIPAA protection," notes CardioBrief.

Patients must agree that they "understand that Amgen may use [their] personal information, including [their] personal health information, for 10 years once [they] accept this Authorization ..." 

What other nasty things must poor people agree to in order to get a copay card?


Find out here.

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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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FDA to Amarin: Chill Out, Dude! Don't Sue Us! You Have Free Speech.

Last month, a small drug maker called Amarin caused a stir by filing 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.


Now, in an unusual move that appears designed to blunt the impact of the lawsuit, the FDA has written a letter to Amarin saying the types of materials the drug maker would like to distribute to doctors actually would not be a problem. And the FDA suggests that Amarin might have known this if the drug maker had discussed the issue before filing its lawsuit.


As it turns out, the FDA says that Amarin never approached the agency about the issue.In her letter, FDA official Janet Woodcock makes a point of writing that Amarin “did not ask for our views before filing” its lawsuit “as other pharmaceutical companies sometimes do.” A spokesman for Amarin says  the drug maker would not comment.


Moreover, Woodcock also reiterated FDA plans to release a so-called industry guidance for governing the dissemination of off-label information. In effect, the letter amounted to a pre-emptive move that might slow the progress of the lawsuit, according to regulatory experts.


Adds Peter Pitts, a former FDA associate commissioner for external affairs, who now does policy consulting for the pharmaceutical industry: “Amarin got some bad regulatory advice. The FDA has loudly signaled that it is going to act with increased regulatory discretion on off-label communications. This was either missed or ignored by Amarin.


“… A meeting with the agency would have addressed their concerns. [As for the FDA], “exercising regulatory discretion is a smart move as it takes the matter out of the hands of a judge. A free speech ruling would make things much more difficult for the agency. The FDA opted for strategic retreat rather than face a potential sledgehammer legal decision.”

Pharma Guy's insight:


Also, FDA said in a footnote to the letter: "FDA has long taken the position that firms can respond to unsolicited requests for information about FDA-regulated medical products by providing truthful, non-misleading, and non-promotional scientific or medical information that is responsive

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