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Novo Nordisk Shares Fall After Delay in Approval

February 11, 2013 by Leave a Comment

The company said Sunday that the Food and Drug Administration requested information from a study that looks at cardiovascular health before it can finish reviewing Tresiba and Ryzodeg.

Novo Nordisk said it was surprised and disappointed by the decision. The company plans to provide the requested data, but it probably will not be able to do that this year.

The F.D.A. also told the drugmaker it could not approve the drugs until the company resolved some manufacturing violations the agency outlined in a recent warning letter. The Dec. 12 letter said an inspection of the company’s drug-making factory in Denmark found significant violations of good manufacturing practices.

The letter accused the company of not establishing or following appropriate written procedures for preventing contamination of sterile drug products.

Diabetes is a chronic condition in which the body either does not make enough insulin to break down the sugar in foods or uses insulin inefficiently. It can cause early death or serious complications like blindness, a stroke, kidney disease or heart disease when blood sugar climbs too high and damages organs and blood vessels.

Demand for drugs that treat diabetes is climbing as rising instances of obesity are causing an explosion of diabetes cases globally.

Tresiba and Ryzodeg have already received approval in Europe, Japan and Mexico. Both drugs use the insulin degludec, which can last more than 42 hours and helps diabetics control their blood sugar levels beyond the 24-hour period offered by current products on the market.

In November, an F.D.A. panel had voted 8-4 in favor of approval for degludec. The panelists also voted unanimously that the drugmaker should be required to conduct a definitive cardiovascular study of the drug due to concern about possible heart safety side effects.

But the panelists recommended that the trial should be conducted after the drug is approved, Novo Nordisk said in a statement.

Shares of Novo Nordisk fell 13 percent Monday in Copenhagen, to 930 kroner, or $167.

Article source: http://www.nytimes.com/2013/02/12/business/global/novo-nordisk-shares-fall-after-delay-in-approval.html?partner=rss&emc=rss

Filed Under: Global Business Tagged With: , ,

Economix Blog: Lose Weight for Your Country

January 7, 2013 by Leave a Comment

CATHERINE RAMPELL

CATHERINE RAMPELL

Dollars to doughnuts.

Last week there was a lot of fanfare over a new study showing that overweight people have less risk of dying than people of normal weight. Lovers of butter cookies and Popeyes the world over surely rejoiced at the news. But at the annual meeting of the American Economic Association over the weekend in San Diego, health economists I spoke with expressed dismay over the study’s fiscal implications.

“The study looked at quantity of life, not quality of life, and that’s a very important distinction,” noted Dana Goldman, director of the University of Southern California’s Leonard D. Schaeffer Center for Health Policy and Economics.

A higher body mass index — a standard measure for determining whether people are overweight or obese — is associated with a number of chronic illnesses, including diabetes, heart disease and hypertension. These chronic illnesses are expensive to treat. If, as it now turns out, overweight people are living longer in addition to racking up more chronic illnesses, that means Medicare is on the hook for paying for more expensive people for more years. (I should note that Americans in the two highest obesity categories — B.M.I. of 35 and up — had a higher mortality rate than everyone else. Research suggests, though, that the obese still cost the government more over the course of their lifetimes because their annual expenses are so high.)

In other words, your spare tire might help you live longer, but it is also accelerating the country’s debt problems.

Professor Goldman said the study underscored the fiscal imperative to get more Americans to a normal weight, whether through financial nudges to eat better, like a soda tax, or some sort of biomedical intervention, like an F.D.A.-approved pill that would reduce obesity. Right now, he said, the incentive system for medical practitioners does not encourage treatment of obesity as a disease itself — only the complications that later result from obesity.

He gave as an example a doctor he knows who has an obese patient taking expensive drugs for various health problems related to being overweight. The doctor told Professor Goldman: “The best thing I could do for this patient would be to take him for a walk. But I don’t get paid for that.”

Article source: http://economix.blogs.nytimes.com/2013/01/07/lose-weight-for-your-country/?partner=rss&emc=rss

Filed Under: Economy News Tagged With: , ,

Unboxed: Stand-Up Desks Gaining Favor in the Workplace

December 1, 2012 by Leave a Comment

THE health studies that conclude that people should sit less, and get up and move around more, have always struck me as fitting into the “well, duh” category.

But a closer look at the accumulating research on sitting reveals something more intriguing, and disturbing: the health hazards of sitting for long stretches are significant even for people who are quite active when they’re not sitting down. That point was reiterated recently in two studies, published in The British Journal of Sports Medicine and in Diabetologia, a journal of the European Association for the Study of Diabetes.

Suppose you stick to a five-times-a-week gym regimen, as I do, and have put in a lifetime of hard cardio exercise, and have a resting heart rate that’s a significant fraction below the norm. That doesn’t inoculate you, apparently, from the perils of sitting.

The research comes more from observing the health results of people’s behavior than from discovering the biological and genetic triggers that may be associated with extended sitting. Still, scientists have determined that after an hour or more of sitting, the production of enzymes that burn fat in the body declines by as much as 90 percent. Extended sitting, they add, slows the body’s metabolism of glucose and lowers the levels of good (HDL) cholesterol in the blood. Those are risk factors toward developing heart disease and Type 2 diabetes.

“The science is still evolving, but we believe that sitting is harmful in itself,” says Dr. Toni Yancey, a professor of health services at the University of California, Los Angeles.

Yet many of us still spend long hours each day sitting in front of a computer.

The good news is that when creative capitalism is working as it should, problems open the door to opportunity. New knowledge spreads, attitudes shift, consumer demand emerges and companies and entrepreneurs develop new products. That process is under way, addressing what might be called the sitting crisis. The results have been workstations that allow modern information workers to stand, even walk, while toiling at a keyboard.

Dr. Yancey goes further. She has a treadmill desk in the office and works on her recumbent bike at home.

If there is a movement toward ergonomic diversity and upright work in the information age, it will also be a return to the past. Today, the diligent worker tends to be defined as a person who puts in long hours crouched in front of a screen. But in the 19th and early 20th centuries, office workers, like clerks, accountants and managers, mostly stood. Sitting was slacking. And if you stand at work today, you join a distinguished lineage — Leonardo da Vinci, Ben Franklin, Winston Churchill, Vladimir Nabokov and, according to a recent profile in The New York Times, Philip Roth.

DR. JAMES A. LEVINE of the Mayo Clinic is a leading researcher in the field of inactivity studies. When he began his research 15 years ago, he says, it was seen as a novelty.

“But it’s totally mainstream now,” he says. “There’s been an explosion of research in this area, because the health care cost implications are so enormous.”

Steelcase, the big maker of office furniture, has seen a similar trend in the emerging marketplace for adjustable workstations, which allow workers to sit or stand during the day, and for workstations with a treadmill underneath for walking. (Its treadmill model was inspired by Dr. Levine, who built his own and shared his research with Steelcase.)

The company offered its first models of height-adjustable desks in 2004. In the last five years, sales of its lines of adjustable desks and the treadmill desk have surged fivefold, to more than $40 million. Its models for stand-up work range from about $1,600 to more than $4,000 for a desk that includes an actual treadmill. Corporate customers include Chevron, Intel, Allstate, Boeing, Apple and Google.

“It started out very small, but it’s not a niche market anymore,” says Allan Smith, vice president for product marketing at Steelcase.

The Steelcase offerings are the Mercedes-Benzes and Cadillacs of upright workstations, but there are plenty of Chevys as well, especially from small, entrepreneurial companies.

In 2009, Daniel Sharkey was laid off as a plant manager of a tool-and-die factory, after nearly 30 years with the company. A garage tinkerer, Mr. Sharkey had designed his own adjustable desk for standing. On a whim, he called it the kangaroo desk, because “it holds things, and goes up and down.” He says that when he lost his job, his wife, Kathy, told him, “People think that kangaroo thing is pretty neat.”

Today, Mr. Sharkey’s company, Ergo Desktop, employs 16 people at its 8,000-square-foot assembly factory in Celina, Ohio. Sales of its several models, priced from $260 to $600, have quadrupled in the last year, and it now ships tens of thousands of workstations a year.

Steve Bordley of Scottsdale, Ariz., also designed a solution for himself that became a full-time business. After a leg injury left him unable to run, he gained weight. So he fixed up a desktop that could be mounted on a treadmill he already owned. He walked slowly on the treadmill while making phone calls and working on a computer. In six weeks, Mr. Bordley says, he lost 25 pounds and his nagging back pain vanished.

He quit the commercial real estate business and founded TrekDesk in 2007. He began shipping his desk the next year. (The treadmill must be supplied by the user.) Sales have grown tenfold from 2008, with several thousand of the desks, priced at $479, now sold annually.

“It’s gone from being treated as a laughingstock to a product that many people find genuinely interesting,” Mr. Bordley says.

There is also a growing collection of do-it-yourself solutions for stand-up work. Many are posted on Web sites like howtogeek.com, and freely shared like recipes. For example, Colin Nederkoorn, chief executive of an e-mail marketing start-up, Customer.io, has posted one such design on his blog. Such setups can cost as little as $30 or even less, if cobbled together with available materials.

UPRIGHT workstations were hailed recently by no less a trend spotter of modern work habits and gadgetry than Wired magazine. In its October issue, it chose “Get a Standing Desk” as one of its “18 Data-Driven Ways to Be Happier, Healthier and Even a Little Smarter.”

The magazine has kept tabs on the evolving standing-desk research and marketplace, and several staff members have become converts themselves in the last few months.

“And we’re all universally happy about it,” Thomas Goetz, Wired’s executive editor, wrote in an e-mail — sent from his new standing desk.

Article source: http://www.nytimes.com/2012/12/02/business/stand-up-desks-gaining-favor-in-the-workplace.html?partner=rss&emc=rss

Filed Under: Business News Tagged With: , ,

The Health Consumer: Some Heart Disease Screens May Be Unnecessary

June 11, 2011 by Leave a Comment

The number of these tests has increased significantly over the last 20 to 30 years, and these days screening may involve any of a dozen procedures — some as simple as taking a patient’s blood pressure, some as complicated as CT angiography, an expensive, controversial test that may carry health risks.

But as important as screening is, excessive and inappropriate testing can lead to “a cascade of unnecessary, costly and in some cases risky follow-up tests and treatment,” said Dr. John Santa, director of the health ratings center at Consumer Reports Health. “Many people who are screened will show signs of heart disease but will never actually suffer from the disease or a heart attack.”

When do you need to be screened for heart disease? What tests are worth having? Here is some advice from experts.

Step 1: In the absence of risk factors, rely on basic, not high-tech, screening tests.

Cost: Insurance should cover the cost as part of your annual physical. There may be some additional lab fees for blood work.

Patients without obvious symptoms of heart disease routinely receive blood pressure and cholesterol tests. Experts say both are relatively simple, inexpensive and worth your time.

High blood pressure, or hypertension, is commonly associated with heart disease and can cause stroke, heart failure and heart attack. Fortunately, the so-called silent killer is readily detectable. A doctor or nurse puts the cuff around your arm and inflates it until blood flow is cut off. As the cuff deflates, the doctor records the points at which blood can be heard to begin flowing again (the systolic pressure) and as it fully resumes (the diastolic pressure).

A normal reading for a healthy person is below 140/90 millimeters of mercury. Any abnormal reading should be confirmed at least three times, as single readings can be misleading. Some patients experience an increase in pressure simply because they’re in the doctor’s office — “white coat hypertension,” it’s called.

A cholesterol screening, also called a fasting lipoprotein profile, helps doctors find coronary artery disease, the most common type of heart disease, and other artery diseases. C.A.D. occurs when fatty deposits, or plaque, choke off the flow of blood in arteries supplying the heart, weakening the muscle and often causing chest pain.

A simple test tells doctors your blood levels of total cholesterol, LDL (or “bad” cholesterol), HDL (“good” cholesterol) and fats called triglycerides. The test indicates a possible risk for heart disease if:

¶ Total cholesterol is above 200 milligrams per deciliter.

¶ HDL is below 40 milligrams per deciliter in men, or 50 milligrams per deciliter in women.

¶ LDL is above 130 milligrams per deciliter.

¶ Triglycerides are above 150 milligrams per deciliter.

The American Heart Association recommends that adults over age 20 receive a blood pressure screening at every doctor’s visit or at least once every two years. Cholesterol screenings should be given once every five years to men under age 45 and women under age 50 who have no other risks for heart disease.

Avoid: Several studies have suggested that expensive tests for biomarkers that are sometimes indicative of heart disease — such as C-reactive protein, a sign of systemic inflammation — are not cost-effective in generally healthy patients. More sophisticated testing should be done only in patients with known heart risks.

Step 2: If you are overweight or obese, get an annual fasting blood sugar test.

Cost: The test usually is included in an annual physical, although you may pay a small fee for lab work. Free diabetes screening often is available at health fairs and community centers.

People with Type 2 diabetes are far more likely than those without to develop heart disease — indeed, it is what kills most adults with diabetes. Up to a third of heart attack patients have diabetes, and 25 percent of heart attack patients have high blood sugar levels.

The test measures levels of blood sugar, or glucose, which is the body’s fuel. A reading of 126 milligrams per deciliter or higher signals a problem. Again, you should undergo the test more than once to get an accurate reading.

While a blood sugar test may provide helpful information, there is controversy over the effectiveness of intensive measures to control heart risks in diabetic patients. Only statins, a type of prescription drug, have been shown consistently to be effective.

Step 3: If preliminary testing turns up signs of heart disease, or if you are experiencing symptoms or are at risk for other reasons, more sophisticated screening tests may be in order.

Cost: An electrocardiogram costs around $50 and a stress test costs about $200. Insurance often covers at least part of the fee.

If your doctor determines you are at risk of heart disease or you have a family history of heart disease, you may need to consider an electrocardiogram, or E.K.G., or an exercise stress test.

In an E.K.G., electrodes are attached to your chest, limbs and abdomen to ascertain your heart rate and its pattern, as well as the size and thickness of the heart walls. The electrodes can detect electrical signals of the heart through the skin, which are transcribed onto a graph. You can get results immediately.

A stress test measures the heart’s ability to function while exercising, usually while walking on a treadmill. Some signs of heart disease aren’t visible when your heart is at rest. During exercise you need more blood and oxygen; if your arteries are narrowed, it will be evident during the test.

Step 4: If evidence of heart disease is present, consider coronary angiography.

Cost: Just under $5,000, depending on where you live and your health care provider. At least part of the cost should be covered by insurance.

If the results of an E.K.G. or stress test are worrisome, or if you are having symptoms of heart disease, doctors may prescribe coronary angiography. In some cases, it may be warranted without a stress test first if the patient has a condition that could make the stress test too risky.

During the test, a flexible tube is threaded from the groin into the coronary arteries. A dye is also injected into the bloodstream, so that any blockages in the arteries can be detected on an X-ray. Physicians look for blood vessels that are 50 percent or more blocked.

Avoid: Some sophisticated, expensive heart disease screening tests may pose risks to the patient and may not be effective. For example, patients who receive CT angiography — in which multiple CT scans are used to produce a three-dimensional image of the heart — are exposed to amounts of radiation.

According to a study published last month in The Archives of Internal Medicine, patients at low risk of heart disease who got this test were more likely to be treated aggressively with invasive and potentially risky procedures, but in the end were not less likely to have a heart attack or other coronary problem. For more information on screening tools, visit Consumer Reports Health (consumerreportshealth.org) or the American Heart Association (heart.org).

This article has been revised to reflect the following correction:

Correction: June 10, 2011

An earlier version of this article misstated the prices of electrocardiograms and exercise stress tests. They cost about $50 and $200, respectively, for patients with insurance, not $1,400 and $3,000 to $4,000. (Those are prices charged to uninsured patients.) The article also misidentified the journal publishing a study on CT angiography; it is Archives of Internal Medicine, not Annals of Internal Medicine.

Article source: http://feeds.nytimes.com/click.phdo?i=a57b59355cfe6c0c5d835d9eb2efb856

Filed Under: Business News Tagged With: , ,