What's coming up in the world of new therapies

Times Staff Writers

Even the most astute prognosticator probably would not have predicted that 2002 would bring a cruise-ship crisis spawned by a virus called Norwalk, a smallpox vaccination for the president and controversy over a religious sect's claim to have produced the first human clone. Perhaps 2003 will bring even bigger surprises.

There are, however, a few sure bets for the year ahead: the biggest crop of new drugs in years, a revolutionary new treatment for coronary artery disease and spiraling medical costs that will pinch consumers' pocketbooks. Plus there's the prospect -- many say, a very good likelihood -- that Congress may finally do something about expanding prescription drug benefits for U.S. seniors.

"There will continue to be a strong and ongoing concern about health-care costs everywhere and by everybody," said Drew Altman, president of the Henry J. Kaiser Family Foundation, a Menlo Park, Calif.-based philanthropic and health policy organization. "Every employer and every state and county government will do something to address rising heath-care costs."

Rising costs will probably bring about a number of changes. Double-digit medical inflation will mean higher insurance premiums and out-of-pocket expenses for consumers, whether they get health coverage through their employers or purchase it themselves. There will be increased pressure on doctors, hospitals and other medical organizations to justify their fees, experts said, and perhaps a legislative push to regulate fees charged by private health plans. And the combination of higher medical costs and a still-struggling economy is likely to swell the ranks of the state's uninsured, as smaller businesses drop coverage for their workers and government health programs, such as Medi-Cal, face budget cutbacks.

In 2003, other key developments will involve new technologies and medications for illnesses such as heart disease, depression, impotence and influenza. Here are a few of them:

Heart disease

A new medical device -- a tiny drug-coated stent about the size of the spring in a ballpoint pen -- is about to revolutionize the treatment of coronary artery disease.

By delivering medication directly into the arteries, this new stent promises to make angioplasty a more effective and longer-lasting treatment for people with severe chest pain or heart attacks.

Although angioplasties have spared millions of patients the risks and pain of open-heart surgery, the procedures often fail. Up to 40% of the arteries cleared by angioplasty and propped open with standard metal mesh stents became re-clogged with scar tissue, forcing patients to undergo repeat angioplasties -- or, in some cases, the bypass surgery they hoped to avoid.

Hoping to overcome this problem, researchers developed a coated stent that drastically reduces the rate of re-clogging, called restenosis, after angioplasty. These stents are coated with medications that help to prevent the buildup of scar tissue that may eventually impede blood flow.

The Food and Drug Administration is expected to approve Johnson & Johnson's Cypher stent before April. The Cypher is coated with the antibiotic rapamycin (Sirolimus), which has been used previously to prevent rejection in kidney transplants. In a couple of European studies, none of the cardiac patients given Sirolimus-coated stents developed restenosis. In a U.S. study of more than 1,100 patients, the coated stents reduced re-clogging inside the stent by 91%. The researchers also reported a 67% reduction in cardiac-related deaths, heart attacks or subsequent artery- clearing procedures nine months after the stents were put in place. The numbers were so good that federal health officials agreed Medicare will pay for the coated stents.

However, with Johnson & Johnson expected to charge about $3,200 for the Cypher, at least $2,000 more than traditional stents, there are growing concerns that the coated device could drive up health-care costs, even while saving money in the long run.

Patient safety

As many as 20% of Americans have experienced some kind of medical error, according to a 2002 report from the Commonwealth Fund, a nonprofit health-care philanthropy. Several other reports have shed light on the thousands of preventable errors in medicine and surgery that occur every year, such as doctors amputating the wrong foot or patients dying after being given the wrong medication.

As of Wednesday, an influential hospital accrediting group required health-care facilities to take steps to reduce such mistakes. The Joint Commission on Accreditation of Healthcare Organizations is requiring the nation's more than 17,000 hospitals and health-care clinics to improve in six major areas: identifying patients, communication among caregivers, wrong-site surgery, medication mix-ups, problems with equipment alarms and the unsafe use of pumps that deliver medications into the bloodstream.

The new rules require that health-care providers double-check patient identification to make sure they have the right person before performing blood tests or giving medications. Those might include checking the patient's name, home telephone number or ID number on a hospital wristband. They're supposed to reduce the chance of surgical mix-ups by creating a verification process, such as a checklist, before any surgery or medical procedure; by marking surgical sites and by making sure the patient is alert and involved in the marking before surgery proceeds.

Drugs

As in the past, some of the most important medical news will involve prescription drugs -- and this is especially true this year. The Food and Drug Administration is expected to approve 40% more new drugs in 2003 compared with last year, said C. Anthony Butler, a drug industry analyst for Lehman Bros. in New York.

These drugs hold promise for millions of Americans who suffer from depression, cancer, impotence, psoriasis and other afflictions. While it can be tricky predicting which drugs are likely to receive FDA approval, several breakthrough medicines have completed pre-market testing and are awaiting final clearance.

Two of the first drugs expected to make their debut are FluMist, the first inhaled influenza vaccine, and Amevive, a psoriasis medication that relieves symptoms in an entirely new way. Amevive works by halting the underlying immune system reaction that triggers the itching, scaling and redness that typifies this condition. Later in the year, Raptiva, a similarly acting psoriasis drug, will probably be approved as well.

In addition, bestselling prescription remedies, including the antibiotic Cipro, the sleep aid Sonata, and the wrinkle cream Renova, will lose their patent protection, which means that cheaper generic versions should be available. And Prilosec, the popular ulcer medication that recently went off patent, is expected to be available in an over-the-counter version.

Here's a look at some other promising medications that, at this time, look like good bets for approval in 2003.

Impotence: Two new drugs, Cialis and Levitra, may finally make their debut this year, challenging Viagra in the impotence treatment category. Cialis, which is already approved in Europe, has been shown to last up to three times longer than Viagra, up to 36 hours. And Levitra is said to work about twice as fast as Viagra, in 20 minutes compared with about 40 minutes for the rival drug. Also, both new drugs have been found to have fewer side effects than Viagra.

Depression: For many of the 18 million Americans who suffer from depression, drugs such as Prozac have been lifesavers. But these medications typically take two to four weeks to become effective, and some patients get frustrated and quit before that. Also, up to two-thirds of depression sufferers derive little or no benefit from these treatments.

But a new antidepressant, Cymbalta, which is expected to be available in the first half of 2003, may help these patients. This novel antidepressant enhances levels of two brain chemicals that regulate mood, norepinephrine and serotonin. In contrast, popular antidepressants, like Prozac and Paxil, only boost levels of serotonin. Cymbalta also works faster. Tests show depressed patients experience a significant improvement in their mood within a week.

ADHD: Medication can help children with attention deficit hyperactivity disorder, which by some estimates may affect up to 5% of school-age kids. But parents often have a tough time getting their child to take pills twice a day, especially given the stigma attached to the drugs normally used to treat this disorder.

The MethyPatch, a daily skin patch that dispenses methylphenidate (the active ingredient in established ADHD treatments such as Ritalin), may give parents another option. The discreet patch can be worn on the hip for 12 hours. The patch also will enable children to control their dosages: The patch can be removed earlier in the day if they get too edgy, or in the evening if they have trouble sleeping.

Cancer: Lung cancer is one of the toughest cancers to treat because it's normally not diagnosed until the cancer is advanced. But for the 169,500 Americans expected to be diagnosed with lung cancer this year, a new drug, Iressa, may offer some hope.

This novel cancer drug interferes with the molecular switches responsible for tumor growth. In studies of patients with metastatic lung cancer, whose tumors had spread to the other lung or another organ, the medication shrank tumors by at least half in about 10% of test subjects.

While the results seem modest, Iressa is considered a significant advance since few patients with metastatic disease respond to treatment. The drug is also the first in an anticipated wave of similarly acting drugs, like ImClone's Erbitux, that precisely target cancer cells at the molecular level, rather than killing healthy tissues, too, like today's toxic chemotherapies.

Contraception: A new drug called Seasonale will make birth-control pills more convenient for many women. Seasonale is taken for 84 consecutive days, then stopped, which induces a menstrual period. Under the regimen, women have four periods a year instead of 13. The drug, made by Barr Laboratories, is under review by the Food and Drug Administration. Besides the convenience of reduced menstrual cycles, Seasonale may be helpful to women who experience disorders related to menstruation, such as anemia, premenstrual tension and pain.

Prescriptions: Getting prescriptions properly filled may also be easier, as more health-care providers adopt electronic prescription systems, in which prescriptions are sent instantly to pharmacies. This will make dispensing drugs more efficient and eliminate medication errors caused by doctors' illegible handwriting or confusion about similarly named drugs.

"Technology will continue to play a more and more important role," says Viren Mehta of Meh- ta Partners, an independent health-care advisory firm in New York. "In the future, doctors may even have prescriptions filled in Mexico or Canada, and then couriered over to patients, maximizing the saving opportunities."

In other developments, gene therapy and cloning will continue to make headlines with their promise of dramatic advances in the treatment of disease and reproductive technology. And innovations that may find their ways into homes and doctors' offices this year will range from the first wheelchair that can climb stairs to a vitamin-size pill that doubles as a tiny camera to take pictures of the small intestine. The wheelchair, called STEPS, carries an estimated price tag of $52,000. The pill-camera, dubbed the M2A, reportedly costs $450, plus about $1,000 for the exam.

"Increasingly, people are going to be asked to pay for these things out of their own pocket and that will lead to a reality check," said Dr. Mark D. Smith, president of the California Healthcare Foundation, an Oakland-based health philanthropy. "These shiny toys and zippy new drugs that may be 5% better than the old ones but cost five times as much will require someone to make decisions about whether these are new things worth paying for. And no matter what the decisions, someone won't like it."

Times staff writer David Olmos contributed to this article.

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