Study: Gardasil doesn’t cause autoimmune conditions

BY Allison Cerra

PASADENA, Calif. — A human papillomavirus vaccine created by drug maker Merck does not cause autoimmune conditions after young women are inoculated, according to a new Kaiser Permanente study.

Researchers used electronic health records to conduct an observational safety study of 189,629 females ages 9 to 26 years in California who were followed for six months after receiving each dose of Gardasil, the quadrivalent HPV vaccine, from 2006 to 2008. The study looked for autoimmune conditions — such as immune thrombocytopenia, autoimmune hemolytic anemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, Type 1 diabetes, Hashimoto’s disease, Graves’ disease, multiple sclerosis, acute disseminated encephalomyelitis, other demyelinating diseases of the central nervous system, vaccine-associated demyelination, Guillain-Barre syndrome, neuromyelitis optica, optic neuritis and uveitis — since autoimmune reactions have been a long-standing concern surrounding vaccination and many parents withhold the vaccine from their children because of perceived safety concerns, the researchers noted.


"This kind of safety information may help parents with vaccination decisions," said study lead author Chun Chao, a research scientist at the Kaiser Permanente Department of Research & Evaluation in Pasadena, Calif. "These findings offer some assurance that among a large and generalizable female population, no safety signal for autoimmune conditions was found following HPV4 vaccination in routine clinical use."

The study, funded by Merck, appears in the Journal of Internal Medicine.

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FDA approves actinic keratosis treatment

BY Alaric DeArment

PARSIPPANY, N.J. — The Food and Drug Administration has approved a topical treatment made by Leo Pharma for a skin condition that can lead to cancer, the drug maker said Wednesday.

Leo announced the FDA approval of Picato (ingenol mebutate) gel in the 0.015%/0.05% strength for actinic keratosis, also known as AK, which is a precancerous condition resulting from cumulative sun exposure that has the potential to lead to squamous cell carcinoma.

"Since there is no way to predict which actinic keratosis will advance to skin cancer, early detection and treatment of lesions are critical," said Mark Lebwohl of the Department of Dermatology at New York’s Mount Sinai Medical Center and an investigator of a late-stage clinical trial of the drug. "What makes this new solution particularly exciting is the two- or three-day course of treatment."

According to the American Academy of Dermatology, 1-in-5 Americans will develop skin cancer in their lifetimes, and studies have shown that about 65% of cases of squamous cell carcinoma begin as untreated actinic keratosis.

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Walgreens signs 500,000 and counting to its Prescription Savings Club

BY Michael Johnsen

DEERFIELD, Ill. — In its battle with Express Scripts, Walgreens is not only seeking to retain that prescription base payer by payer, but also patient by patient, as evidenced by the more than 500,000 customers who have taken advantage of Walgreens’ Prescription Savings Club since Jan. 1, according to company officials.

And while Walgreens has discounted that pre-existing savings program this month, the $25 in savings is not the primary reason patients are signing on in record numbers — it’s choice. “Being a patient [at Walgreens] for more than 15 years, I was very upset that Express Scripts wouldn’t cover my prescriptions," noted Walgreens pharmacy patient Janet Paz, who frequents a Walgreens in Lowell, Mass. "To me, it’s more than a pharmacy, it’s a friendship. When my pharmacist took the time to tell me about the Prescription Savings Club, we discovered that I could actually save on medications including one that my plan doesn’t even cover," she added.

The PSC card promotion is part of a comprehensive national effort by Walgreens to help patients who are covered by an Express Scripts pharmacy network continue using Walgreens when possible or make a smooth transition to another community pharmacy, the pharmacy operator stated. That program had been priced at $20 for individual and $35 for family, but for January Walgreens discounted that program to $5 for individual and $10 for family. According to Walgreens, the PSC program offers savings on more than 8,000 brand-name and all generic medications. For more than 400 generic medications, Walgreens offers a three-month supply for less than $1 a week.

“We have heard from hundreds of thousands of patients that they want to preserve their relationship with Walgreens, and this is reflected by the incredible number of PSC members we have signed up this month," said Michael Polzin, Walgreens spokesman. "We know patients are feeling disrupted by the prospect of losing the access we provide, including 24-hour service and having the medication they need in stock, so we are pleased that so many of them have found a cost competitive solution in the form of our PSC card.”

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