The Official Medtipster Blog

www.Medtipster.com Source: Boston Globe – 1.24.2011

It’s a common scenario: A 60-year-old woman is told she has high cholesterol but has no other risk factors for heart disease like high blood pressure, diabetes, or a smoking habit. Should she take a statin to lower her cholesterol?

Many doctors say, why not? But a review study by the Cochrane Collaboration, a nonprofit research organization, suggests otherwise. The review, which analyzed 14 trials involving the use of statins to prevent heart disease in low-risk patients, found only “limited evidence” that the drugs provide significant benefits, especially in women, and urged that “caution should be taken when prescribing statins” to prevent heart disease.

The cholesterol-lowering drugs – which include atorvastatin (Lipitor), rosuvastatin (Crestor), and simvastatin (Zocor) – have clearly been shown to reduce heart attacks, strokes, and deaths in higher risk patients such as those with diabetes or established heart disease. And they have minimal side effects.

In fact, the American Heart Association recommends that low-risk patients with high cholesterol consider taking a statin if lifestyle changes, such as increased exercise or weight loss, don’t work to bring cholesterol levels down.

But the Cochrane review study – written by British researchers – calls that practice into question, highlighting “shortcomings” in studies that found clear benefits in anyone who took statins to lower high cholesterol levels.

“The potential adverse effects of statins among people at low risk of [cardiovascular disease] CVD are poorly reported and unclear,” the authors wrote.

Other experts, though, disagree. “I think they make grand pronouncements that are wrong,” says Dr. Chris Cannon, a cardiologist at Brigham and Women’s Hospital who participated in another recent review study of statin use in low-risk patients published in the November issue of Lancet. (Cannon has accepted research grants from statin manufacturers and served on an advisory board for Bristol-Myers Squibb, which makes the statin Pravachol.)

The Lancet study found that high-risk and low-risk patients who take statins to lower their cholesterol can reduce their risk of having a heart attack, stroke, or heart procedure by 25 percent.

In absolute risk terms, statin users who don’t have heart disease would lower their yearly risk of having heart complications from 1.8 percent to 1.4 percent. Those who have already been diagnosed with heart disease would lower their yearly risk from 5.6 percent to 4.5 percent – and those with type 2 diabetes from about 5 percent to about 4 percent.

The lower your heart disease risk, the smaller the benefits you’ll receive from statins. That means the risk of side effects will play a greater role in determining whether you should take the drug. The Cochrane report found that statins didn’t increase the risk of cancer and posed a small risk of rhabdomyolysis, a serious condition involving the breakdown of muscles.

The biggest side effect, severe muscle soreness, occurs in about 3 to 5 percent of users, though some research indicates the incidence may be higher in women and for those who take higher doses or more potent statins.

www.Medtipster.com Source: Dow Jones Newswires – Philadelphia Bureau, 1.5.2011

Drug-store clinics, supported by hospital systems and insurers, are girding to play a broader role in delivering medical care as the U.S. health system faces a growing doctor shortage.

Where retail clinics met skepticism from the medical community a few years ago, industry leaders see them gaining acceptance and taking on greater responsibility, complementing rather than replacing primary physicians.

Retail clinics operated by national pharmacy chains CVS Caremark Corp. (CVS) and Walgreen Co. (WAG), which together represent two-thirds of the market, are forming partnerships with health systems and have expanded the scope of services offered, moving beyond flu shots and sore-throat care into screenings and monitoring of chronic conditions.

“From a quality perspective and an affordability (perspective) we present a good solution,” said Dr. Andrew Sussman, associate chief medical officer of CVS Caremark and president of its MinuteClinic business. “We are at a unique and in some ways defining moment.”

Clinics see their role growing as millions more people gain insurance coverage under the U.S. health overhaul in 2014, intensifying a national physician shortage also heightened by an aging and increasingly diabetic population.

The health-system partnerships, in turn, are expected to help drive expansion of a decade-old U.S. retail clinic industry that peaked at 1,211 as of December, according to consultant Tom Charland of Merchant Medicine LLC, who tracks the industry in his ConvUrgentCare Report.

“We are predicting much greater clinic expansion in 2011 vs. 2010, largely because of these partnerships,” Charland said.

Merchant Medicine estimates the industry added 28 clinics net this year, a 2.4% increase. Wal-Mart Stores Inc. (WMT), which house independently owned clinics, led that growth, more than doubling the sites in its stores to add 63 clinics, Merchant Medicine said.

MinuteClinic and Take Care Clinic chains, though, both have seen double-digit percentage growth in patient visits this year. Although MinuteClinic closed a few locations in 2010, it expects to add 100 clinics a year to reach about 1,000 by 2015, roughly double the current number.

Drop-in clinics, generally staffed by nurse practitioners, say they don’t aim to become a “medical home” for patients, although a significant percentage of those visiting them–more than half of those using MinuteClinic and 40% at Walgreen’s Take Care Clinic–lack a primary physician.

“We are increasingly playing a role as an advocate and navigator for these patients,” said Peter Hotz, vice president for Walgreen’s health and wellness division.

Walgreen wouldn’t say whether its clinics are profitable, although Hotz said they should contribute to revenue and earnings as they grow. CVS expects MinuteClinic to be break-even by the end of 2011. Neither company breaks out the financial figures for its clinics.

CVS Caremark sees MinuteClinic, which added monitoring of diabetes, hypertension and cholesterol in 2010, as a partner with health systems in a “medical home network,” Sussman said. The company has entered collaborations with hospital systems in several states and is in talks with others.

Ohio’s Cleveland Clinic academic medical center has called its relationship with MinuteClinic “a true continuity of care model,” and the two organizations are working to integrate electronic medical records systems to facilitate sharing of patient information.

For Walgreens, which operates 359 Take Care Clinics plus 370 worksite health centers, the expanded retail clinic role fits a strategy to make its pharmacies “health-care destinations,” Hotz said. The clinics recently formed a collaboration with the Ochsner Health System in New Orleans and are developing other potential partnerships.

Insurers appear to support an expanded role for clinics. Roughly 70% of visits at MinuteClinics and Take Care Clinics are covered by commercial or government insurance.

“Most insurers cover all of our services, including chronic-condition monitoring. Payers have expanded coverage as our range of services has expanded,” CVS Caremark spokeswoman Carolyn Castel said.

While WellPoint Inc. (WLP), the largest U.S. managed-care company by members, prefers patients use primary care doctors as their medical homes, “we also recognize that not every market has an adequate supply of primary care physicians to fill this role and that not every member desires such an intimate relationship with a (physician),” spokeswoman Jill Becher said.

Although WellPoint doesn’t cover the comprehensive chronic-condition monitoring that some retail clinics have started to offer, it does contract with all the major clinics and as of March it will cover an additional 24 services offered by nurse practitioners at retail clinics, including conducting lipid panels, glucose monitoring and testing for tuberculosis and HIV.