Medical advances made in 2004

Our Health

By Kristen Gerencher

CBS MarketWatch

December 29, 2004

SAN FRANCISCO -- It was a mixed year for health care as the United States questioned its system of assuring drug safety, while accumulating a number of pharmaceutical success stories at the same time.

To be sure, this year saw its share of medical embarrassments, from the Vioxx recall debacle to the U.S. flu shot shortage.

But 2004 also brought some notable advances, such as a promising new drug to treat multiple sclerosis, stem cell procedures with the potential to repair damaged hearts and a novel way to restore women's fertility.

Some of this year's breakthroughs are in the burgeoning area of regenerative medicine, which aims to repair damaged tissue or organs, said Dr. Joshua Hare, professor of medicine and director of the cardiology section of the Institute for Cell Engineering at Johns Hopkins University School of Medicine in Baltimore.

"It's a brand-new concept that will revolutionize medicine," Hare said.

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Stem cells derived from human embryos generated both hope and controversy this year as California voters approved a measure to fund stem cell research in the state, despite the refusal by President Bush's administration to fund research beyond existing cell lines.

But adult stem cells also are giving scientists new treatment possibilities. One niche is the use of mesenchymal stem cells, which are drawn from bone marrow. Studies on pigs induced with a heart attack show that mesenchymal stem cells help repair the dead and dying heart tissue without the need to operate, Hare said.

The cells are easy to obtain and purify in large quantities, and can be given from donor to recipient without having to suppress the immune system to avoid rejection, he said. They're delivered by catheter or infusion and travel to the damaged area by responding to an "injury signal," he said.

Today, current therapy for heart attacks involves opening as soon as possible the vessels that have been blocked, but whatever damage has been done prior to that is permanent, he said.

"We have medications to treat the symptoms but nothing that replaces destroyed tissue until now," Hare said. "It's very exciting. It's going to affect many, many millions of people."

Safety trials are set to begin in 2005, and the procedure likely won't be approved for clinical use for several years, he said. Still, mesenchymal stem cell therapy has the potential to broaden treatment options for many heart attack patients and may even replace heart transplantation, Hare said.

"We don't have to remove the damaged area," he said. "That's the beauty and elegance of cell transplantation as opposed to whole organ transplantation."

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Multiple sclerosis is an autoimmune disease that typically hits people around age 30, setting them up for periodic symptoms resulting from brain and spinal inflammation, said Dr. Richard Rudick, director of the Cleveland Clinic's Mellen Center for Multiple Sclerosis Treatment and Research.

MS eventually disables people, robbing them of their vision and the ability to walk and function, he said.

"The key to treating MS is to have an effective mechanism to block brain inflammation and using that in the early stage of the disease before developing brain injury and neurological disability," Rudick said.

For the past 10 years, patients typically have been treated with copaxone or interferon, which can cause flulike symptoms as a side effect. But last month, the FDA approved Tysabri, a biological product known as a monoclonal antibody made by Biogen Idec (BIIB) and Elan (ELN), and that seems to offer patients more benefits, Rudick said.

"This drug appears to turn brain inflammation off," he said. "It seems to block the blood cells that are necessary for inflammation from getting into the brain tissue. It's like there's a brick wall now and they can't get in there.

"I think proper use of this drug for many patients is going to lead to a much more normal life." Rudick said.

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Women suffering from infertility who need surgery to correct the major causes such as fibroids, endometriosis and congenital abnormalities are beginning to see the benefits of the next step in minimally invasive surgery -- robotics, said Dr. Camran Nezhat, president of the Society of Laparoendoscopic Surgeons and a clinical professor at Stanford University.

Stanford is one of a few medical centers in the United States using robots from companies such as Intuitive Surgical (ISRG) of Menlo Park, Calif., to improve patients' chances of getting and staying pregnant.

The robots "have specific characteristics that empower the surgeon to do a better job," Nezhat said. "Robots give you an excellent three-dimensional view."

They also help in suturing and controlling tremor, he said. "No matter how steady you are, you have a certain degree of tremor. Robots eliminate all the tremor from your hands."

Robotics also has the potential to enable remote surgery so patients in rural regions could benefit from medical expertise concentrated in urban areas, he said. A patient in a small town in Alaska, for example, could have an assistant put instruments in his abdomen while a trained doctor like Nezhat performed the procedure from afar. "I would look at the images and do the surgery."

Insurance companies cover the procedures, but hospitals are hard-pressed to afford too big a leap toward robotics since a machine can cost as much as $1.4 million, he said. "The cost is almost prohibitive."

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When it comes to oncology, 2004 may have marked a turning point. For about five years, Novartis' (NVS) Gleevec has stood alone as the targeted cancer therapy that delivered results, said Dr. Herman Kattlove, medical editor for the American Cancer Society in Los Angeles.

This year was the first that others made substantial progress, he said. "Now we're seeing other drugs working that also target some molecules in the cancer cells responsible for the cancer cell's growth."

In treating breast cancer, for instance, a new class of drugs called aromastase inhibitors, such as Novartis' Femara, Pfizer's (PFE) Aromasin and AstraZeneca's (AZN) Arimidex, block the body's ability to produce estrogens and may be easier to tolerate than tamoxifen, he said.

"It works as well, if not better, in preventing breast cancer from coming back," Kattlove said.

In fact, an article in the Dec. 8 edition of The Lancet suggested doctors choose an aromatase inhibitor over tamoxifen as the first-line drug therapy approach for most postmenopausal breast cancer patients to prevent recurrences.

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It's not only new medical devices and drugs that shook up health care this year. A major development also occurred on the delivery side of the equation in the form of new legislation.

The addition of a prescription drug benefit to Medicare in 2006, with a transitional drug discount card program that began this year, is changing the way the federal health insurance program for elderly and disabled Americans operates, said Stephen Schondelmeyer, a professor of pharmaceutical economics at the University of Minnesota in Minneapolis.

"The passage of the Medicare prescription drug benefit, whether you think it's well designed or not, is a major ... sea change event for the distribution of prescription drugs," he said.

Drug manufacturers, wholesalers, retailers, insurers and government agencies are scrambling to re-evaluate how they do business, knowing that older Americans account for 40 percent of prescriptions, Schondelmeyer said. "It changes the whole structure of how dollars and drugs will flow out to patients. It's not a fee-for-service business-as-usual plan."

The new provision that lets about 7 million low-income people get a $600 credit toward their discount drug cards is a positive step, said Karen Davis, president of the Commonwealth Fund, a private foundation.

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This article posted January 20, 2005.