Reality Check: 2002 Promises Substance, Not Just Promise
After a year in which the biggest health stories seemed to come straight out of a sci-fi crime novel--stem cell research, anthrax cases, human embryo cloning--2002 promises a return to meat-and-potatoes plot lines. New drugs awaiting approval. Court decisions expected to have deep and lasting consequences. And legislative measures sure to ignite debate about fundamental reforms in health insurance.
“We’ve got what some people call ‘the perfect storm,’” said Larry Levitt, vice president of the Kaiser Family Foundation, a health policy think tank. “Rising health care costs, during a recession, in an election year. The pressure to do something about health insurance and the uninsured will build and build.”
At the same time, drug companies will not only be exploring new uses for existing medications, doctors say; they’ll introduce smart-bomb agents that attack diseases such as cancer without harming healthy tissue. “Companies are looking at much more precisely targeted therapeutics,” said Kenneth I. Kaitin, director of the Tufts Center for the Study of Drug Development in Boston.
The debates over stem cell research and human cloning will continue, of course. But for now they will be little more than that--debates, over research whose benefits for people with illnesses like Parkinson’s disease and diabetes are still years away, if they materialize at all. In 2002, experts say, new developments in everything from end-of-life care to insurance reform to sexual dysfunction will do more than generate discussion: They will alter the lives of millions of Americans, and quickly.
Drugs
Some of the biggest breakthroughs in health care will likely involve prescription drugs. The coming year should bring fresh methods of treating severe depression, chronic pain and other disorders that affect millions of Americans, doctors say.
Osteoporosis: Leading the pack is Teriparatide (Forteo), which should get clearance by the Food and Drug Administration early next year to combat osteoporosis, the dangerous bone-thinning disease that afflicts more than 10 million Americans and threatens 30 million more. Current drugs slow bone loss, but Forteo actually reverses the process and builds new bone. It’s the first of a novel class of drugs that mimic human parathyroid hormone, which triggers the formation of new bone. In human tests, Forteo boosted bone density of the spine by 27% and slashed overall fracture risk by more than half.
ADHD: Atomoxetine, a nonstimulant alternative to controversial medications like Ritalin, Adderall and Concerta, should be available soon for children with attention deficit hyperactivity disorder (ADHD). Tests show it blocks the release of brain chemicals believed to control attention and impulsivity. The drug appears to be as effective but doesn’t have the side effects, like insomnia and weight loss, of current treatments.
Impotence: Also scheduled to debut next year are two new anti-impotence drugs that could rival Viagra in popularity. Cialis, which should hit the market first, and Vardenafil work in a similar way but appear to be more potent, last longer and have fewer side effects than Viagra, which can cause headaches, nasal congestion, a flushed face and blurry vision.
Sleep: In our 24/7 world, it was probably inevitable: a drug that keeps us alert without the harsh side effects of habit-forming amphetamines. Modafinil (Provigil), which was devised by French drug makers and stimulates the brain circuits that regulate our sleep-wakefulness cycles, was approved by the FDA in 1998 for treating narcolepsy, a condition in which sufferers have trouble staying awake. Psychiatrists also prescribe Modafinil for bipolar disorder.
Studies currently being conducted by the U.S. military and by academic sleep researchers should greatly broaden the applications of this drug, which enables users to stay awake for 20 hours or more without any loss of acuity or alertness. Some scientists even believe it may eventually eliminate the need for regular sleep.
Alzheimer’s: Among the legions of aging Americans and their parents, one drug is expected to stand out: The first medication to help patients with moderate to severe forms of Alzheimer’s disease could reach U.S. patients this coming year. Memantine, which will likely get the FDA go-ahead in 2002, is the first in a new class of drugs used to slow the progression of Alzheimer’s.
Up to now, patients with mild to moderate Alzheimer’s could take one of four drugs--Cognex, Aricept, Exelon or Reminyl--all of which boost the function of brain cells that use a nerve-signaling chemical called acetylcholine. These drugs help Alzheimer’s patients speak, think and function better for longer, although they’re effective for only a limited time.
But memantine, available in Germany for more than a decade, works another way. It interferes with a protein on the surface of cells, preventing a chemical called glutamate from harming brain cells. Excess glutamate has been implicated in many degenerative brain diseases.
Cancer: Doctors are awaiting several novel compounds that block cancer’s uncontrolled cell growth. Gleevec, for example, made its debut in May. A treatment for a rare but deadly form of leukemia, it was the first in an expected wave of new cancer treatments. “This drug is a landmark because the mechanism of action is entirely new, and it’s not toxic like current therapies,” said Kaitin. “Targeted approaches like this open up a tremendous number of doors for future drug development.”
Despite these advances, high drug development costs--which now top $800 million--have prompted a consolidation within the pharmaceutical industry. “Companies are now concentrating on those few areas where they have a reputation, history and expertise,” says Kaitin.
Independent Review
In mid-January the U.S. Supreme Court will consider whether to uphold or overturn state laws allowing patients to seek a second opinion when denied a test or treatment by their HMO.
Most consumers currently have that right, with California one of 41 states that have adopted “independent review” laws. Such laws allow patients to appeal their cases to a panel of medical specialists who can require plans to cover treatment or tests if the care is determined to be necessary. Last year, more than 200 Californians had their cases reviewed by an outside panel of specialists, who sided with HMOs two-thirds of the time.
But health plans are beginning to challenge independent review laws. This month, for instance, Blue Shield of California sued state regulators, arguing that they overstepped their authority in calling for an independent review of a decision to deny a weight-loss drug to an obese patient. Similar objections have spurred lawsuits in other states, and courts have issued contradictory rulings--some side with the states’ review process, others with health plans.
If the U.S. Supreme Court upholds the laws, policy experts say, the review panels would stay in place as needed. If the court overturns them, the action could wipe out independent review altogether. “The only external appeals we’ll have are those put forth voluntarily by the health plans,” said Paul Ginsburg, president of the Center for Studying Health System Change, a health policy research group in Washington, D.C.
Rising Health Care Costs
In the first half of the year, policy researchers anticipate that Congress will weigh some combination of tax breaks, subsidies and expanded government programs to offset rising health care costs and the growing number of uninsured. The Senate is considering a proposal, for example, that would extend federal subsidies for CHIP coverage (Children Health Insurance Program) to include parents as well as children of low-income families.
“We could very well get a bill with a combination of these expanded subsidies and some tax credits for individuals” whose incomes are slightly too high to qualify for CHIP, Ginsburg said.
Experts doubt that Congress will attempt fundamental reform of health care. But health inflation is back in double digits for the first time in a decade; hundreds of thousands of workers are being laid off; and costs are biting, in higher drug prices, co-payments, premiums, and deductibles. The Kaiser Family Foundation estimates that 1.5 million Americans will join the ranks of the uninsured next year.
That’s why any proposal to relieve costs--a prescription drug benefit for Medicare recipients; subsidies to help laid-off workers stay covered--is expected to restart a broader call for health reform, policy researchers say. Already, during debate on the economic stimulus package that died in December, one congressman proposed overhauling America’s health care system by converting the current, employer-based health care system to one that is based on individuals buying their own health coverage.
A coalition nicknamed the “strange bedfellows” group, which includes the American Medical Assn., the AFL-CIO and the Health Insurance Assn. of America, is pushing for reform to reduce costs and cover the uninsured. “These issues should be very prominent in the next year,” said Ron Pollack, executive director of Families USA, a health consumers’ rights group and “bedfellow” in Washington, D.C.
Right to Die
In March, a federal court in Oregon is expected to decide whether a state law allowing physician-assisted suicide violates federal statutes. In November, Atty. Gen. John Ashcroft declared that it is illegal to dispense or use controlled medications to hasten the death of a terminally ill patient.
The Ashcroft decree calls for the revocation of prescription licenses for doctors who use drugs to help a patient die. It is the latest blow to the right-to-die movement, which seemed to be gaining strength through much of the 1990s, and the implications go far beyond Oregon. “This is the most serious challenge we’ve faced in the history of the movement,” said Ryan Ross, a spokesman for the Hemlock Society, which has campaigned for patients’ right to design their own end. “The Ashcroft decree threatens to wipe out what we’ve worked for across the country.”
The court has blocked implementation of the directive until arguments can be heard from the state and the U.S. attorney general’s office.
Smallpox and Anthrax
By the end of the year the federal government should have enough vaccine to inoculate every American against smallpox, even though it has no plan to do so. The year’s events made congressional leaders and federal health officials painfully aware of the risk of biological warfare with rare and deadly germs. The House and Senate passed legislation to accelerate the production and stockpiling of vaccines against smallpox as well as anthrax. And health officials ramped up their prevention efforts accordingly, ordering enough smallpox vaccine to protect every man, woman and child against the deadly bacterium that was declared vanquished in 1980. Such a huge stockpile takes time to manufacture, however, and isn’t expected to be ready until year’s end.
Vaccines against anthrax, formerly available only to the military, began to be made available in late 2001 to postal workers, House and Senate staffers and others potentially exposed to inhalation anthrax through tainted mail from a still unidentified source.
This post-exposure treatment remains experimental, but it has opened the door to greater use of the vaccine as a treatment--should it be necessary next year--rather than as a purely preventive measure.
Lifestyle Changes
Starting Tuesday, the federal Medicare program will provide benefits for medical nutrition therapy--dietary advice, in effect--for people with diabetes, as well as those with kidney disease. The government currently pays for some nutrition services for kidney dialysis patients, among others. But the new program amounts to a significant expansion of nutrition benefits because the counseling will be covered not only to treat an acute problem but to slow the progression of a very common disease, making the benefit available a lot earlier for millions of Medicare recipients.
What nutritionists consider a healthy diet is by now familiar: fruits and vegetables, whole grains, small amounts of fat and sugars. Registered dietitians’ skill is in making the diet varied, palatable and tailored to the person’s symptoms and condition. Combined with other lifestyle changes, namely regular exercise, a good nutrition plan can reduce the frequency of diabetes complications, help obese people lose weight and keep it off, and reduce the risk of heart attack and stroke.
The new Medicare benefit will make good diet advice more available--and more credible--to millions of Americans, public health researchers say. “There’s been a lot of lip service paid to the role of nutrition in health,” said Gail Frank, a professor of nutrition at Cal State Long Beach and spokesperson for the American Dietetic Assn. “Now we’re biting our lips and saying it really works, it really saves people money.” And it’s covered.
None of these developments would make a good subject for the next futuristic thriller about human clones or bioterror. But who needs special effects when you’ve got immediate impact?
*
Times Health writers Linda Marsa and Jane E. Allen contributed to this report.
