Drugs and obesity drive trends in 2004

If next year’s health trends were a book, its fattest chapter might be titled: “Prescription Drugs: A Pill to Cure Your Ills.” Some of the biggest stories of 2004 will involve new drugs to treat an assortment of ills, new uses for existing medications and the possible move of some drugs now sold only by prescription to over-the-counter status.

For many Americans, the more immediate problem will be how to afford the drugs they need. Changes in the Medicare program will make drugs more affordable for many older Americans, but debate will likely continue over the federal program’s changes and such issues as whether consumers should be able to buy cheaper medications in Canada and over the Internet.

Concern over Americans’ obesity epidemic is driving a national effort for new public policies, programs and products to help us trim the fat. Computerized cardio equipment, immune-boosting and disease-fighting foods, and low-carbohydrate diets will increasingly serve as important counterweights to the problem.

And of course, we’re always worried about how we look. Wrinkles and age lines may be smoothed for longer periods of time thanks to a new “face filler” being considered, and the much-maligned silicone breast implant may be poised for a comeback.

Whether any of these trends fully take off or simply fizzle out remains to be seen. But there’s little doubt as the issues play out that millions of Americans striving for better health will be affected.

Over-the-counter drugs

Americans may soon gain convenient access to two classes of drugs traditionally available only via prescription: cholesterol-lowering statins and emergency contraceptive pills.

Merck & Co., in a joint effort with Johnson & Johnson, says it will seek Food and Drug Administration approval to sell Merck’s cholesterol drug, Mevacor, over the counter, some time next year. Three years ago, two companies, including Merck, sought approval to make their cholesterol drugs available without a prescription but were turned down. Statins are medications that lower cholesterol. In use for about 15 years, the drugs -- there are many brands on the market -- are considered safe and effective for most people. The time may be ripe for a change because doctors believe many more people could benefit from taking statins. (They already are one of the most frequently prescribed drugs). Also, federal regulators are interested in converting more drugs to over-the-counter status as a way to help reduce overall health-care spending.

When the FDA turned down the companies’ requests in 2000, regulators said one reason for the denial was that the dosage being sought for the over-the-counter statins -- 10 milligrams -- would be too low. It is likely that the companies will request a dosage of 20 milligrams if they reapply, said Merck spokesman Tony Plohoros.

Bristol-Myers Squibb Co. is also considering asking the federal government to approve Pravachol, another statin, for over-the-counter use, a company spokesman said.

After making national headlines last week, the so-called “morning after” pill may garner more attention next year when the FDA decides whether to allow the prescription-only product be sold over the counter. Last week, a federal advisory panel urged approval for OTC sales. Such a move, the panel said, would reduced unwanted pregnancies and the demand for abortion.

The product, called Plan B, consists of birth control pills that can prevent pregnancy if taken within 72 hours of unprotected intercourse. Officials at Women’s Capital Corp., the company seeking FDA approval, say the pills are safe, and that making them available without a prescription would be more convenient and economical for women. The proposal is backed by the American Medical Assn. and the American College of Obstetricians and Gynecologists but is opposed by some antiabortion groups that say the pill would encourage promiscuity and lead to higher rates of sexually transmitted diseases.

Five states already allow women to obtain emergency contraceptives directly from pharmacists, and many others are considering similar legislation. In California, a law signed by former Gov. Gray Davis shortly before he left office in November will allow women to start buying the pills directly from pharmacists after Jan. 1. Previously, the prescription was available only from doctors or specially trained pharmacists working with a doctor. Emergency contraceptives are different from the so-called abortion pill, mifepristone, because emergency contraceptive pills do not interrupt an established pregnancy.

Prescription drugs

* Mental illness: Popular drugs that changed the way people thought about and treated mood problems became a cultural phenomenon during the 1990s. Yet the increasing use of Prozac, Paxil and other so-called SSRIs (selective serotonin reuptake inhibitors) in children and adolescents recently has caught the attention of regulators. Last month, health officials in England banned the use of all SSRIs except Prozac in the treatment of children younger than 18, after concluding that there was no good evidence that the drugs’ benefits outweighed their risks (in studies, Prozac has shown more benefit, the officials said). Some of the SSRIs have been linked to suicidal thoughts and hostility in children.

The debate is expected to gather steam in February when the FDA convenes a panel of experts to review the evidence on suicide and SSRIs. Already, many child psychiatrists say the issue is getting overblown, and that a ban would deny needed treatments to many children who are severely depressed.

The panel’s findings could also stir up a broader debate in 2004 about the use of psychoactive drugs in children. The number of young children and adolescents on medication for mental problems has more than doubled in the last 15 years. The drugs include antipsychotics, mood stabilizers, antiepileptics -- powerful agents, most of which have not undergone rigorous testing for safety and effectiveness in children. In December, President Bush signed the Pediatric Research Equity Act, giving the FDA authority to require testing of drugs in children before approving them for use in young patients. By the end of 2004, psychiatrists might have a better sense of which psychoactive drugs are most promising for their youngest patients -- and which are most controversial.

* Cancer: A highly anticipated class of cancer drugs called anti-angiogenesis agents may finally become available. Anti-angiogenesis agents act by blocking the formation and growth of new blood vessels that feed tumors.

The drug, Avastin, is for the treatment of advanced colorectal cancer. Studies show that patients who received Avastin along with a particular chemotherapy regimen experienced a substantially longer survival time than patients who received chemotherapy only. The manufacturer of Avastin, Genentech, applied for approval of the drug in September.

* Sleep: The nation’s sleep experts tell us that tens of millions of Americans, from parents of newborns to college students and many older Americans, don’t get enough sleep to maintain optimal health. For those who suffer seriously from loss of sleep, three new sleep drugs are nearing federal approval.

The maker of the drug Provigil, already prescribed for narcolepsy, is seeking FDA approval to expand marketing of the drug to people with excessive sleepiness caused by either shift work or obstructive sleep apnea. Manufacturer Cephalon received an “approvable letter” from the FDA in October and is expected to work out precise labeling language for the new uses by early next year.

Provigil, which is also known by its generic name, modafinil, was first approved in 1999. The two new uses for the drug have been supported by sleep experts, but some doctors have warned that Provigil could be misused as a “lifestyle” drug that would allow people to substitute it for sleep.

Consumers may also have new options to treat insomnia. One drug before the FDA, Estorra, is like other newer insomnia medications in that it is nonaddictive and does not produce next-day side effects. Its manufacturer, Sepracor, has requested FDA approval of the drug for both chronic and transitory insomnia and is expecting a decision in February. In a large study, published recently in the journal Sleep, Estorra produced five to seven hours of uninterrupted sleep, a better result than similar drugs already on the market.

Finally, an insomnia medication called indiplon is in its final stages of clinical research. The drug is being studied for several types of insomnia. Its manufacturer, Neurocrine Biosciences, says it expects to submit an application for approval next year.

* Incontinence: The first medication for the treatment of stress urinary incontinence, the most common type, is expected to win FDA approval early next year. Studies showed that duloxetine significantly reduces the number of incidences of incontinence.

Stress urinary incontinence, which affects an estimated 30 million American women older than 18, is caused by decreased muscle function at the bladder outlet. Urine can leak from an increase in abdominal pressure, such as that caused by sneezing or exercising.

* Health policy

Seniors and other Medicare beneficiaries will see some of the earliest stages of reform next year, following a sweeping rewrite of Medicare adopted by Congress and signed by Bush in December. But even as implementation of the new Medicare law begins, Americans will hear continued debate among lawmakers and on the presidential trail about some of the law’s most controversial provisions, including drug re-importation and the private insurance sector’s leading role in drug benefits.

The bulk of Medicare reform is another year or two away. But this year, Medicare beneficiaries will get their first official notice of changes to come. And by spring, they will begin receiving solicitations to enroll in a Medicare-endorsed drug discount plan. The discounts cards, which will likely cost about $30, should cover somewhere between 10% and 25% of enrollees’ drug costs, according to administration estimates. But it’s a just temporary program until more sweeping changes in drug coverage are put in place.

Meanwhile, presidential candidates, such as Sens. John F. Kerry (D-Mass.), Joseph Lieberman (D-Conn.) and former Vermont Gov. Howard Dean, will continue to assail the Medicare law as a bad deal for seniors, while Bush touts the measure. Among the issues that could be revisited on Capitol Hill in the coming year is the provision that left the importation of drugs from countries like Canada -- a key cost-saving practice used by many seniors -- illegal.

Cosmetic products

Men and women seeking to eliminate facial lines and wrinkles, or to plump up their lips, will have new, longer-lasting alternatives to collagen and Botox next year. Two of them are made from hyaluronic acid gel, which is a natural component of the skin.

Earlier this month, the FDA approved the facial filler Restylane, made from hyaluronic acid found in roosters’ combs. An advisory panel in late November recommended approval of a synthetic form of hyaluronic acid called Hylaform, which is likely to get the agency’s go-ahead as well.

The long-standing controversy over silicone gel breast implants may reach a milestone in 2004 if the FDA decides to allow the devices to be sold again. They’ve been banned since 1992, although breast cancer survivors and some healthy women have been able to get them through research studies. In mid-October, an FDA advisory panel voted nine to six to approve the devices made by Santa Barbara-based Inamed.

Although the FDA typically goes along with its advisory panel’s recommendations, little is certain when it comes to silicone implants.

‘Functional foods’

The FDA announced in July that it would begin allowing food manufacturers to submit petitions to make health claims based on a wide range of scientific evidence. That step should be a boon for the introduction of more “functional foods” promoted for their ability to improve health or lower disease risk. Back in 1999, Benecol became the first margarine you could put on your bread specifically to reduce bad cholesterol. It contains plant sterols, which keep the body from absorbing the cholesterol in foods.

With the FDA opening the door to more food claims, several companies late in 2003 announced that they were introducing other products fortified with these plant sterols. Lifeline Food Co. launched its Lifetime Low Fat Cheese in cheddar, mozzarella and jalapeno Jack. Minute Maid made it possible to drink sterols in your morning juice with its Premium Heart Wise orange juice, and Rice Dream added Heartwise dairy-free rice drink to its product line. All three labels inform consumers that plant sterols “when part of a diet low in saturated fat and cholesterol, may help reduce the risk of heart disease by lowering cholesterol levels.”

Other food companies continue to fortify more products with other beneficial kinds of fats. Smart Balance added to its heart-healthy line a new margarine, Smart Balance Omega Plus, containing both plant sterols and Omega-3 fatty acids from menhaden, a plentiful fish that has long provided oil for European margarines.

Diets

With Americans heaping ever-larger portions on their plates and suffering from ever-increasing rates of obesity, along with Type 2 diabetes and heart disease, everyone wants to know what the ideal diet might be. Nutritionists agree that there is no one-size-fits-all diet plan for everyone.

But evidence has been mounting that limiting carbohydrates (especially the low-fiber, starchy varieties your body turns into sugar) can be beneficial for many people and may even improve levels of some of the most dangerous cholesterol in the blood. Two popular plans, the Atkins and South Beach diets, rely on increased protein and fat for the bulk of daily nutrition. As a result, food producers can be expected in 2004 to continue adding low-carbohydrate products to grocery shelves.

Fitness

Fitness equipment is getting smarter, thanks to sophisticated computer technology that gives users more information about their workouts. That, in turn, will lead to shorter, more efficient routines. Some cardio machines already come equipped with portals to plug in PDAs to track fitness progress, and others have built-in wireless heart rate monitors. In 2004, EVO Fitness will introduce a treadmill with a computerized system that senses if users are pronating (rolling the foot inward) or supinating (rolling the foot outward). The deck of the treadmill then stabilizes to balance the runner’s gait. Also look for small, portable machines that can be taken on vacation. No excuses now for not staying in shape.