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Taking a shot: Flu vaccinations up at retail

BY Michael Johnsen

As many as 111 million Americans had gotten a flu shot by mid-November, representing 36% of the 305 million Americans older than 6 months of age, the Centers for Disease Control and Prevention reported in early December. The number of people getting vaccinated is up slightly from last year, the CDC reported, most notably among children and seniors.

Additionally, more influenza vaccines are being administered in a retail setting. While 55% of people are still getting their vaccinations in a doctor’s office or other medical setting, 21% of adults have been vaccinated in a retail setting and 16% in a workplace setting.

In 2010, of people who had gotten a flu shot, 58% did so before November, 23% were inoculated in November and 19% had their flu shots administered between December and May.

“This is the second year of our universal influenza vaccination recommendation,” reported Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases for the CDC, adding that the number of people who have gotten their flu shot to date is outpacing last year’s rate by about 3.5 percentage points during the same period in 2010.

Approximately 36% of adults had been vaccinated through Dec. 5, versus 34% in 2010; and 37% of children had been vaccinated through Dec. 5, versus 31% in 2010.

 

FAST FACTS

  • Flu is contagious up to one day before symptoms develop and between five days and seven days after symptoms subside.

  • Everyone 6 months and older should get a flu vaccine each year. Those at greater risk for serious complications if they get the flu include seniors, toddlers, pregnant women and people with certain health conditions, including asthma, diabetes or heart disease.

  • The best way to prevent the flu is by getting a flu vaccine each year.

  • The nasal-spray flu vaccine — a vaccine made with live, weakened flu viruses that is given as a nasal spray — is approved for use in healthy people 2 to 49 years of age who are not pregnant.

  • There are three “flu shots” this year: an intramuscular shot approved in people 6 months and older, a high-dose vaccine for seniors and for the first time this season, an intradermal vaccine for use in adults between the ages of 18 and 64 years.

Click here for data on the 2011-12 flu season.

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Heart disease, hypertension, high cholesterol still extremely prevalent

BY Alaric DeArment

Of all the diseases labeled “silent killers,” heart disease is the one that gets that epithet most often. According to the National Center for Health Statistics, since 1900, there has been only one year in which heart disease wasn’t the deadliest disease in the country: 1918, the year of the great influenza pandemic, when 450,000 Americans died.

That trend has not gone away. According to the Centers for Disease Control and Prevention, 1-in-6 adults in the United States, or 16.3% of the adult population, has high cholesterol, defined as 240 mg of cholesterol per deciliter of blood. The condition disproportionately affects women, with 16.9% of women in the United States having high cholesterol, compared with 15.6% of men, while middle-aged and older adults also are disproportionately likely to have it.

The numbers are even higher for hypertension. According to the CDC, high blood pressure affects 33% of adults ages 20 years and older, causing more than 20,000 deaths per year. The condition is especially prevalent in nursing homes, with 53% of residents having it — for a total of 790,300 — according to a CDC study from 2004.

To view the charts listing the Top 20 hypertension and cholesterol-lowering drugs, click here.

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Lipitor foreshadows approaching patent cliff for other leading drugs

BY Alaric DeArment

For the past several years, drug industry experts have spoken in terms of the “patent cliff,” the period when the patents covering several blockbuster drugs are set to expire, thus leaving their manufacturers with a big, gaping hole in their revenues as those drugs face competition from generics.

Of all the drugs on the patent cliff, Pfizer’s cholesterol medication Lipitor (atorvastatin calcium) is by far the best known, not to mention the drug with the highest revenues of any drug in history, with more than $7 billion in 2010 sales in the United States alone. When Lipitor’s patent expired on Nov. 30, 2011, thus opening the drug to competition from Ranbaxy Labs’ generic version, it provided some insight of where the market for cardiovascular drugs is heading.

According to a report released in December by market research firm Decision Resources, expiration of patents covering blockbuster drugs that treat dyslipidemia, and subsequent competition from generics, will decrease the size of the market by nearly $6 billion in the United States, the United Kingdom, Germany, France, Italy, Spain and Japan through 2020. Patent expirations, according to the report, will result in a decrease of nearly $19 billion in sales between 2010 and 2020; the market had sales of $29 billion in 2010. Other drugs facing patent expiration include Merck’s Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin), Abbott’s Niaspan (niacin extended-release), and AstraZeneca’s and Shionogi’s Crestor (rosuvastatin calcium), which had sales of $3.8 billion in 2010, according to IMS Health.

A similar phenomenon is occurring in the market for drugs to treat high blood pressure. According to a November Decision Resources report, the size of that market will decline from about $26 billion in 2010 to $20.5 billion in 2020 in the same seven countries named in the dyslipidemia report. The decline also is thanks to the loss of patent protection for drugs to treat the condition, particularly Novartis’ Diovan (valsartan/hydrochlorothiazide). According to IMS Health, Diovan will lose patent protection this year, and Decision Resources expected it to face a decline of more than $1 billion in major markets once generic versions enter the market. The drug had global sales of more than $6 billion in 2010, according to Novartis.

The increasing difficulty of achieving blockbuster sales on drugs targeted toward primary-care disease states, such as cholesterol and hypertension, is spurring many companies to pursue specialty drugs instead. “Emerging agents will find it difficult to penetrate the highly genericized hypertension market because of competition from inexpensive and efficacious generic anti-hypertension drugs,” Decision Resources analyst Taskin Ahmed said. But this doesn’t mean development hasn’t continued.

According to a report released last year by the Pharmaceutical Research and Manufacturers of America, 299 drugs are in clinical development or under review by the Food and Drug Administration for heart disease, including 43 for lipid disorders and 27 for hypertension. Of the drugs for hypertension, four were in, or had completed, phase-3 clinical trials, whereas 10 lipid disorder drugs were in, or had completed, the trials.

Of course, Pfizer isn’t letting go of Lipitor just yet. It’s hoping to get FDA approval to launch an OTC version of the drug — though the record of FDA approvals for OTC statins has so far been unsuccessful — and it has entered deals with PBMs and specialty pharmacy provider Diplomat Specialty Pharmacy to try and ensure that patients keep using the branded version of the drug.

Regardless, the market for heart health drugs has evolved considerably in recent years and is likely to continue evolving, especially as it becomes increasingly dominated by generics.

To view the charts listing the Top 20 hypertension and cholesterol-lowering drugs, click here.

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