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Seniors Newsletter
October 1, 2007


In This Issue
• Cataract Surgery: A Bargain, Despite the Price
• Genome Area Linked to Rheumatoid Arthritis
• Once-a-Year Bone Drug Lowers Fracture Risk
• Injuries, Deaths Tied to Consumer Drugs Rise Sharply
 

Cataract Surgery: A Bargain, Despite the Price


SUNDAY, Sept. 23 (HealthDay News) -- Everyone, if they live long enough, will suffer from a cataract that clouds the vision in one or both eyes.

Because of that, doctors expect spending on cataract surgery to surge in the coming decades as the population ages, part of an overall increase in vision costs among older Americans.

However, it's money well spent, experts say.

Cataract surgery is one of the most cost-effective surgical procedures to address vision problems in seniors, said David B. Rein, a researcher with RTI International in Research Triangle Park, N.C., who authored a recent study of the economic costs of vision disorders.

"It gives a great amount of benefit in terms of years of unimpaired vision, compared with dollars spent," Rein said.

In fact, it's one of the only therapies that actually cures the condition, rather than simply holding the line against future deterioration.

"You're removing a lens that is clouded, a dirty lens, and you're replacing it with a lens that's clear," Rein said.

A cataract is a clouding of the lens in the eye, which affects a person's ability to see clearly. Most cataracts are related to aging. By age 80, more than half of all Americans either have a cataract or have had cataract surgery, according to the U.S. National Eye Institute.

Major vision problems cost the U.S. economy about $35.4 billion a year, including $16.2 billion in direct medical costs. And because cataracts are frequent and inevitable, they make up the biggest chunk of those direct costs -- about $6.8 billion, according to Rein's research.

The primary way to treat cataracts is to remove the eye's lens and replace it with an artificial one.

These surgeries have been around for decades, and doctors have become remarkably adept at performing them, said Dr. Marco Zarbin, professor and chairman of the Institute of Ophthalmology and Visual Science in New Jersey.

"During the past quarter century, there have been remarkable advances," Zarbin said. "Ninety-five percent of patients report impressive improvement in their vision."

Most cataract surgery removes the lens through phacoemulsification, in which a probe inserted through a small incision in the side of the cornea breaks the lens into tiny pieces using ultrasonic waves. The surgeon then removes the pieces using suction.

This technique has gone through countless refinements, Zarbin said, and is far evolved from traditional cataract surgery. In that procedure, the lens was simply cut away.

"Back in the 1960s, people were kept in the hospital for two weeks following cataract surgery," he said. "Their heads were held in place with sandbags. Now, people have the surgery with topical anesthesia and go home the same day. It's just what you'd hope for in medicine. It's really true progress."

The replacement lenses are also improving.

In early days, patients were fitted with a lens that only provided one range of focus. Near could be in focus, or far, but not both.

But improvements in intraocular lenses are producing results that are coming closer and closer to mimicking the human eye, allowing people to change their focus from near to far.

"There's a real push to develop intraocular lenses that give people focus at distance and near," Zarbin said. "There's a real interest in improving those capabilities. I'm very sure that one day that's the lens that everyone will get, an accommodative lens."

These improvements mean that, even though more money is being spent on cataract surgery, the American people are getting a bigger bang for their buck, Rein said.

"Compare the cost for cataract extraction surgery to the treatments that address age-related macular degeneration or diabetic retinopathy," he said. "The costs are much lower, and the results are much better."

Patients can actually expect improved vision, rather than vision that simply won't get worse.

"When you're treating glaucoma or diabetic retinopathy, you're trying to prevent further visual impairment from occurring," Rein said. "With cataracts, you can restore their vision to what it was before."

Cataract surgery also helps keep older people entertained and more engaged, Zarbin said. "I think when you're older and have a less active lifestyle, things like reading and watching television gain a greater importance," he said.

"You also have to consider the cost of taking care of those patients if you didn't have the therapy to treat them. We are way ahead as a society by paying for those treatments, because they cost less than caring for all these debilitated and blind people," he added.

More information

To learn more about cataracts, visit the U.S. National Eye Institute.


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Genome Area Linked to Rheumatoid Arthritis


TUESDAY, Sept. 18 (HealthDay News) -- A specific region of the human genome appears to be associated with rheumatoid arthritis, European researchers say.

A team from the Karolinska Institute, Stockholm, and elsewhere, conducted genetic analyses of hundreds of rheumatoid arthritis patients.

They found a consistent association between the disease and one region of the genome. This region, on chromosome 9, includes two genes called complement component 5 (C5) and TNF receptor-associated factor 1 (TRAF1).

TRAF1 is involved in inflammatory response, and C5 plays a role in the complement system, involved in defending the body against foreign molecules, the researchers said.

The chromosome region in which these genes are located may be involved in the binding of a protein that modifies the transcription of genes. The researchers also found that one of the alternative markers in this region is associated with more aggressive rheumatoid arthritis.

The findings add to a growing body of evidence that this region is associated with rheumatoid arthritis, which is caused by an abnormal immune response to various tissues within the body. The condition affects about one percent of people in developed countries.

The findings are published this week in the journal PLoS Medicine.

More information

The American Academy of Family Physicians has more about rheumatoid arthritis  External Links Disclaimer Logo.


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Once-a-Year Bone Drug Lowers Fracture Risk


TUESDAY, Sept. 18 (HealthDay News) -- One annual injection of the drug zoledronic acid (Reclast) not only reduces the number of new hip fractures for older users, it can also save their lives.

So finds the first trial to show an improvement in mortality for the drug. Previous studies had shown a reduced risk of fracture and improved bone density in patients with osteoporosis but not such a boost in outcomes.

"We changed the fracture rate and, when we analyzed the data, we had a significant mortality reduction. We never dreamed we'd have that," said study author Dr. Kenneth W. Lyles. He spoke from Honolulu, where he is presenting the data at the American Society of Bone and Mineral Research annual meeting.

The study was released early by the New England Journal of Medicine to coincide with the presentation.

Lyles is professor of medicine and vice chairman for clinical research in the department of medicine at Duke University Medical Center in Durham, N.C.

Novartis Pharma, which manufactures Reclast, funded the study. Lyles also has ties with the company.

"This is the first test of using this to prevent further fractures in elderly patients, and the reason that is a big deal is people weren't sure if zoledronic acid inhibited osteoclasts [cells] which are needed for repair" of the initial fracture, explained Paul Brandt, an associate professor of neuroscience and experimental therapeutics with the Texas A&M Health Science Center College of Medicine.

"This study shows that it doesn't interfere with that process and does give the beneficial effect of reducing further fracture rates," said Brandt, who was not involved in the trial.

An estimated 345,000 Americans are hospitalized each year with a hip fracture, and as the Baby Boomers age, that number is certain to grow.

According to an accompanying editorial, 36 percent of patients who have sustained a hip fracture will die within two years of the incident. These individuals are also five to 10 times more likely to suffer another hip fracture.

Many such fractures are the result of osteoporosis, a disease which primarily affects women in their postmenopausal years. With this disease, bones thin out and become more fragile, causing them to break more easily. Fracture can often result in severe disability, even death.

Reclast was approved in August by the U.S. Food and Drug Administration to treat osteoporosis in postmenopausal women.

The drug is a bisphosphonate, a class of drugs which also includes Fosamax, Actonel and Boniva. These medications -- the most commonly used treatments for osteoporosis -- work by slowing the body's natural reabsorption of bone.

While the drugs are effective, there has been a problem with getting patients to take them as they should.

For this study, more than 2,100 men and women were randomized to receive Reclast or a placebo within 90 days after surgery for a hip fracture. Participants were followed for an average of almost two years.

Almost 14 percent of those not taking Reclast suffered a new fracture, the researchers found, compared with only 8.6 percent of those taking the drug. Also, 13.3 percent of patients not taking Reclast died, versus 9.6 percent of those taking the drug.

In the end, patients taking Reclast were 28 percent less likely to die and 35 percent less likely to have another fracture than those on placebo.

Bone mineral density also increased in the Reclast group, the team reported.

It seems likely that the decline in mortality was due at least in part to the decline in fractures, the authors stated.

Only 43 percent of participants were classified as having osteoporosis but most likely had some weakening of the bone. "What's happening here is that you have a thinning of the bone that isn't being detected by a scan," Brandt said.

There were some concerns about the design of the trial. For example, patients in the placebo arm did not receive another medication, although many did receive bone-boosting vitamin D. However, the authors noted that the patients enrolled in this trial could not or would not take an oral bisphosphonate.

Patients taking Reclast will also need to take vitamin D and calcium, they added, and some will experience flu-like symptoms which can be alleviated with a nonsteroidal anti-inflammatory drug.

"This appears to be the most potent of the bisphosphonates. It reduced bone turnover more and had a significant effect on fracture rate. The once-a-year dose obviously is attractive," said Dr. Stephen Honig, director of the Osteoporosis Center at the New York University Hospital for Joint Diseases. "This combination makes it potentially a very important drug. The caveat is the potential side effects. Other studies have found atrial fibrillation."

However, unlike one previous trial, the researchers on this study found no differences in reports of the irregular heartbeat known as atrial fibrillation between the two groups. They also found no reports of osteonecrosis of the jaw, a painful jaw condition, which had previously been associated with this class of drugs.

More information

There's more on osteoporosis at the National Osteoporosis Foundation  External Links Disclaimer Logo.


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Injuries, Deaths Tied to Consumer Drugs Rise Sharply


MONDAY, Sept. 10 (HealthDay News) -- The number of serious adverse drug events more than double between 1998 and 2005 in the United States, as did the number of related deaths, a new study found.

"This is the first study to ask the question, 'Are we gaining ground or losing ground in drug safety and improving patient safety in prescription drugs?' And I think, inescapably, the conclusion is that we're losing ground," said study lead author Thomas Moore, of the Institute for Safe Medication Practices, in Huntingdon Valley, Pa.

"This is a subject the public or health professionals just don't like to think about," Moore added. "Doctors don't like to think that what they're doing could be hurting patients. The pharmaceutical industry wants the public focused on benefits, and many people just want to believe this drug is going to help them. We need to focus on this problem. We can manage the risks of prescription drugs if we start to pay attention."

The study results are published in the Sept. 10 issue of the Archives of Internal Medicine.

This is not the first peek into drug-safety issues in the United States. The U.S. Food and Drug Administration recently unveiled a set of initiatives intended to counter growing criticism of its operations and to bolster the country's health safety net. The recommendations include a pilot project to assess the safety of drugs after they're on the market, as well as initiatives to improve communication both within and without the agency.

Many of the initiatives are in response to recommendations in an Institute of Medicine report issued in 2006 and prepared at the request of the FDA. Those recommendations included a push for stronger post-marketing surveillance of approved drugs.

For the new study, Moore and his colleagues analyzed all serious adverse drug events and medication errors reported to the FDA from 1998 to 2005.

A serious adverse drug event, as defined by the FDA, means an adverse event that results in death, a birth defect, disability, hospitalization or is life-threatening or requires intervention to prevent harm. The events are reported voluntarily to the FDA either directly by or through drug manufacturers, who are required to forward any reports.

From 1998 to 2005, the number of reported serious adverse drug events increased 2.6-fold from 34,966 in 1998 to 89,842 in 2005. The number of fatal adverse drug events increased 2.7-fold during the same time period, from 5,519 in 1998 to 15,107 in 2005.

The number of adverse events increased four times faster than the total number of outpatient prescriptions, which rose from 2.7 billion to 3.8 billion during that time frame.

Although a total of 1,489 drugs were associated with adverse events, a subset of 51 drugs accounted for a large proportion of the problem: Each had 500 or more reports in any given year. This group of drugs accounted for 43.6 percent of the total adverse event reports.

Drugs related to safety withdrawals were a small part of the picture and, within the subset of 500 drugs, declined from 26 percent of all reported events in 1999 to less than 1 percent in 2005.

Pain medications and drugs that affect the immune system were disproportionately represented among those that caused death.

Moore and his colleagues pointed to three main reasons for the increase.

"First, we do have a more aggressive use of drugs in a growing and older population, but that explains only about one-quarter of the problem," Moore explained. "We've also got a whole group of products that have entered the marketplace since 1998 -- biotech problems. They play a significant role in the toll of adverse events. The third thing we saw, and I think it's the discouraging part, is we saw increases in drugs whose risks we've really known about and should be able to manage. We've had insulin for 50 to 60 years, yet adverse events are increasing rapidly, and I think it's partly linked to the more aggressive treatment of type 2 diabetes."

FDA spokeswoman Sandy Walsh said the reasons for the increase weren't all known. However, she pointed to an increase in public attention to drug safety and use of the Internet to make it easier for consumers to submit adverse-event reports.

The FDA also said it has "undertaken a pilot program to review the safety of new molecular entities about 18 months after approval. We will determine if this formal, systematic review adds value to our current processes. If we were to do this on a full scale, we would need more staff resources."

That still begs the question of what to do about a growing and serious safety problem. According to the study authors, regulatory issues may be at the heart of the problem.

"I think it's very clear that we need to spend more money, more people, and we need more authority and more independence for the FDA drug safety program," Moore said.

In a prepared statement, the FDA said the study's findings were in keeping with what the agency had been seeing.

More information

Visit the FDA for more on its drug safety initiative.


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