Pharmaguy's Insights Into Drug Industry News
187.1K views | +30 today
Follow
Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
Curated by Pharma Guy
Your new post is loading...
Your new post is loading...
Scooped by Pharma Guy
Scoop.it!

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.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Statin Side Effects: More Than Half the Time Doctors Don't Take Patient Complaints Seriously

Statin Side Effects: More Than Half the Time Doctors Don't Take Patient Complaints Seriously | Pharmaguy's Insights Into Drug Industry News | Scoop.it
The science on statins and sexual function is inconclusive, but it does appear that taking a statin can affect a person’s sex life, in both positive and negative ways.


2008 report from the University of California, San Diego, tells a different story. Researchers looked at statin use and sexual function in 1,000 men and women, half of whom were given a statin and half of whom took a placebo. Over all, men on statins were about twice as likely as those taking placebos to report that their ability to achieve orgasm had become “somewhat worse” or “much worse.”


Dr. Beatrice Golomb, a professor at the University of California, San Diego, medical school, who helped conduct that study, says doctors don’t always take patients seriously when they talk about side effects, sexual or otherwise. In other research, Dr. Golomb found that when patients complained about the most commonly recognized side effects of statins, their doctors denied the possibility of a connection more than half the time.

Pharma Guy's insight:


So much for "patient empowerment" and "patient centricity!" 


What about diabetes as a side effect?


New York Times OpEd piece published by a well-known cardiologist who said Americans are being "over-dosed" with statins to treat high cholesterol (see "We're overdosing on cholesterol-lowering statins says Top(ol) cardiologist").


"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."

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

DTC Makes My Job Harder, Says Doc

DTC Makes My Job Harder, Says Doc | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Direct-to-consumer advertising is the biggest barrier to practicing medicine today, cardiologist Harmony Reynolds, MD, said in response to one of 10 questions MedPage Today is asking thought


1. What's the biggest barrier to practicing medicine today?

Direct-to-consumer advertising. These ads often frighten people about medication side effects without providing the right information about why a medication may be needed and why taking a small risk of side effects may be worthwhile. I don't think companies realize all of the effects these ads have. They make my job harder.

Pharma Guy's insight:


OK. One physician does not a consensus make. Her specialty is coronary artery disease and she seems to like prescribing high doses of statins. Ads for statins actually mention why they are needed and they don't overplay the risks, which are minimal.  So I am not sure why these DTC ads would be a barrier to Dr. Reynolds' practice of medicine.


In any case, drugs ads tend to understate the risks. About 40% of violations in drug ads cited by the FDA between 2004 and 2013 relate to "risk minimization." That's twice the percentage of violations relating to "overstated efficacy" (see chart here: Do TV DTC Ads Overstate Rx Drug Risks?).

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Side Effects of Major Statins Compared. Guess Which Company Has the Worst?

Statins have been linked with cardiovascular problems as well as amnesia and mental decline. But neurological side effects are not turning up as frequently in postmarketing safety data. And muscle-related side effects, which are also commonly linked to the drugs, show up more often in three Merck products than in the rest of the class.


That's the word from healthcare informatics company Advera Health Analytics. The firm sifted through FDA postmarketing safety reports, and compiled data on side effects for companies producing statin drugs. Advera's report found that Merck's ZocorMevacor and Vytorin were associated with more muscle-related side effects than other drugs in the class such as Pfizer's ($PFECaduet, AbbVie's ($ABBVSimcor and AstraZeneca's ($AZN) blockbuster Crestor.


For example, Zocor had 4275 reports of myalgia, 632 reports of myopathy, and 3552 cases of rhabdomyolysis, a condition commonly linked to statins that involves the breakdown of muscle tissue. In comparison, Caduet had 59 reports of myalgia, 5 reports of myopathy and 12 reports of rhabdomyolysis in postmarketing data. And AbbVie's Simcor was linked to 365 reports of myalgia.


Still, Merck is standing by its drugs, saying that reports submitted under the voluntary reporting system "often have incomplete medical and drug histories and unsubstantiated diagnoses," the company told FiercePharma in a statement.

Pharma Guy's insight:

One potential side effect to keep an eye on is Type 2 diabetes... Lipitor was linked to 7,061 reports of Type 2 diabetes mellitus in Advera's report, and Crestor was tied to 557 reports of the disease. Those numbers could come as bad news to AstraZeneca, which will face U.S. generics for Crestor in May 2016 and is already dealing with competition from off-patent Lipitor.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

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

more...
No comment yet.