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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Another Reason for Seniors to Skip Zostavax Vaccine for Shingles: Serious Side Effects Claim Attorneys

Another Reason for Seniors to Skip Zostavax Vaccine for Shingles: Serious Side Effects Claim Attorneys | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Merck & Co. could have a growing Zostavax problem on its hands. After several plaintiffs filed lawsuits claiming the drugmaker’s shingles vaccine caused serious injury and death, attorneys say more cases are on the way.

 

Plaintiffs have sued in state and federal courts in Pennsylvania alleging that Merck’s Zostavax—used to prevent shingles, the painful complication of varicella infection—caused serious side effects, including death.

 

“I think Merck has failed terribly … to warn about the very serious side effects and the failure of the vaccine to do what they claim it does,” attorney Marc Bern told FiercePharma.

 

Bern, founding partner at Marc J. Bern & Partners, said his firm has “thousands of complaints” yet to be filed in Philadelphia, with the injuries running “the gamut from contracting shingles as a result of the vaccine all the way to serious personal injuries such as blindness in one eye, individuals who have serious paralysis in their extremities, brain damage, all the way to death.”

 

In a statement, Merck said it “stands behind the demonstrated safety and efficacy” of the shot, which is licensed in 50 countries.

 

Further Reading:

Pharma Guy's insight:

Seniors have bee avoiding getting vaccinated for shingles even though the Affordable Care Act requires private insurers to cover Zostavax without co-pays for people older than 60 (read “Early Shortages, Delayed Marketing, High Prices, Other Health Priorities, Among Reasons Why Seniors Skip Shingles Vaccine”; http://sco.lt/4wT9NZ Perhaps the side effects mentioned in this article is a bigger reason.

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Merck Uses Humor & Fear to Promote Zostavax Shingles Vaccine

Merck Uses Humor & Fear to Promote Zostavax Shingles Vaccine | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Are you the type of consumer motivated by fear? Or are you more likely to take action based on advice from a humorous celeb? Doesn't matter--Merck & Co., in a push to boost vaccine sales before new competition arrives, has a shingles commercial for you.

 

The company is currently airing two ad types that couldn't be more different from one another. In one--dubbed "Surprise Door Knock"--NFL analyst and former quarterback Terry Bradshaw barges into the home of a trio of adults to explain with gusto the nasty effects of shingles and caution them to ask their doctors for more info.

 

"We all in?" he asks, as they pile their hands atop each other's with a rousing chorus of "yes!" "Good--'cause if not, we're gonna watch highlights of my career 12 hours straight. I know--talk about pain!" he says with a laugh.

 

Merck's other currently running spots are much more serious and somber. "Day #7 with Shingles" and "Day #18 with Shingles" each depict a sufferer trying to go about his daily life. One struggles through a dismal day at the office thanks to shingles pain, and the other gives up on a game of golf because of it, while a colleague and friend go one-on-one with the camera to express their concerns.

 

The one thing the ads all have in common? Graphic depictions of the condition, which can cause unsightly rashes and blistering of the skin. And, of course, pain.

 

Merck has good reason to want to reach a broad spectrum of adults with its awareness push. Fellow vaccine behemoth GlaxoSmithKline has a shingles candidate, Shingrix, coming up the pipeline, and when it's finally ready to roll, the British company expects it to be a "major market disrupter" for Merck's Zostavax.

 

Pharma Guy's insight:

I updated my "Gallery of Scary Pharma Industry Advertising" PPT on Slideshare to include these ads (see  http://bit.ly/ScaryPharmaAds).

 

Which brand name is more memorable:  Zostavax or Shingrix? It seems to me that consumers are not likely to remember either name - not that it matters much if there is not much difference in effectiveness. 

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Early Shortages, Delayed Marketing, High Prices, Other Health Priorities, Among Reasons Why Seniors Skip Shingles Vaccine

Early Shortages, Delayed Marketing, High Prices, Other Health Priorities, Among Reasons Why Seniors Skip Shingles Vaccine | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Seniors have been particularly slow to take advantage of the shingles vaccine. The Food and Drug Administration approved it a decade ago, and the C.D.C. recommends it for those over 60, including those who’ve already had shingles.

 

Coverage has climbed steadily, but in 2014 had still reached only 31 percent of those over 65. As with nearly all of these vaccines, older whites were more likely to have been vaccinated than blacks, Hispanics or Asians.

 

Seniors and their caregivers should request vaccinations; the C.D.C. publishes guidelines and a quiz that explain which ones are recommended. Zostavax, the current shingles vaccine, reduces the risk of the disease in adults over 60 by half, and the incidence of postherpetic neuralgia by two-thirds.

 

(Quick primer: Shingles results from the same virus that causes chickenpox, which nearly all older Americans have had. The virus typically remains dormant for decades, but the odds of its reactivation rise steeply after 50 as the immune system weakens. The lifetime risk of shingles is one in three, rising to one in two for those over 85.)

 

The vaccine’s underuse can be blamed, in part, on supply shortages in its early years until about 2012. The manufacturer, Merck, and the C.D.C. didn’t increase media campaigns until vaccine supplies were sufficient; such campaigns had just started when Ms. Abate became ill. It’s not surprising that she was only vaguely aware of Zostavax.

 

Cost remains a barrier to getting Zostavax and some other adult vaccines.

 

In a study published this past summer, researchers reported that nearly 40 percent of the time, patients over 50 who requested a prescription for Zostavax at a pharmacy chain chose not to receive the vaccine; out-of-pocket costs were most frequently the reason.

 

The Affordable Care Act requires private insurers to cover Zostavax without co-pays for people older than 60, and many cover it for policyholders over 50. But Medicare beneficiaries find that, unlike the flu and pneumococcal vaccines, which are covered under Part B and often administered in physicians’ offices, Zostavax and Tdap are covered under Part D.

 

Physicians can’t easily bill for Part D reimbursement, so they often send patients to pharmacies, which can. But because Part D involves a welter of different plans and formularies, some requiring patients to pay for the vaccine and then seek reimbursement, the cost and co-pays can discourage use. Zostavax, at about $200 a dose, is the most expensive adult vaccine.

 

This landscape could change drastically in a year or so. In October, the pharmaceutical giant GlaxoSmithKline submitted a new shingles vaccine for F.D.A. approval.

 

International studies indicate that the newcomer, Shingrix, is far more effective than the current vaccine, reducing the incidence of shingles by 90 percent. Moreover, the effectiveness doesn’t appear to decrease among older age groups, as Zostavax’s does.

 

Shingrix has its own drawbacks. For one, it requires a second injected dose several months after the first; some people won’t follow up. The manufacturer has yet to set a price, and unless Congress changes the law, any new vaccine will face the same Part D billing complications.

 

But if the F.D.A. approves it, and the C.D.C. recommends its use (which triggers insurance coverage), Shingrix may also prevent a lot of shingles cases — but only if older adults are actually vaccinated.

 

They don’t have a great track record.

Pharma Guy's insight:

Meanwhile, Merck is now ramping up its promotion of Zostavax in anticipation of the entrance of GSK’s Shingrix to the market (read “Merck Uses Humor & Fear to Promote Zostavax Shingles Vaccine”; http://sco.lt/6IjHSD). Shingrix appears to be much more effective and GSK expects it to be a "major market disrupter" for Merck's Zostavax.

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