Issue Date: November 6, 2005
Five new drugs
Be the first to know about these latest medical advances that doctors across America eagerly anticipate.
By Dennis McCafferty and Dan Ferber
New pharmaceutical drugs crop up all the time. For 2005, Food and Drug Administration has OK'd more than 459. Which of these many innovations could be a blessing for you and your loved ones?
To find out, we turned to GfK Market Measures, a top health care market research company. GfK surveys physicians to gauge their awareness of hundreds of new drugs. We learned that a few drugs not only are on the radar of doctors across America, but they are whipping up a storm of interest.
Here are five you need to know more about, along with independent opinion or patient experience.
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1. New for ADHD: A single dose for adults
The drug: Focalin XR
The need: Attention deficit hyperactivity disorder (ADHD) affects up to 7% of school-aged children and 2% to 4% of adults.
The promise: It helps children, too, but Focalin XR -- now out from Novartis -- is the first methylphenidate approved for adult ADHD patients. Methylphenidate is a stimulant that helps the brain's nerve cells communicate more effectively, improving attention span and impulse control problems. The drug, taken as a single morning dose, generally is well tolerated.
One patient's verdict: Erin Hunter, 18, a freshman at Missouri Southern State University in Joplin, Mo., says the drug has helped. "I would have a difficult time studying if there was background noise," Hunter says. "I'm no longer distracted by that. And if I'm taking a test, I'm focusing on what's in front of me, instead of looking to see what the student next to me is doing." Also, Hunter can take a lower dosage compared with other drugs on the market, which helps her avoid side effects like nausea, dizziness and reduced appetite.
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2. New for lung and breast cancers: Tumors stop growing
The drug: Avastin
The need: 211,000 new cases of invasive breast cancer and 172,500 new cases of lung cancer will emerge this year, says the American Cancer Society.
The promise: Since 2004, Avastin has increased the survival rate of colon cancer patients. Members of the medical community are optimistic that within the year, the drug will be approved to treat lung and breast cancers. The drug is taken every two weeks in a doctor's office via an IV. It is an angiogenesis inhibitor, taking a "guided missile" approach to block the growth of blood vessels that feed tumors.
One Loved one's verdict: Shannon Broome's mother-in-law, Heraleen, 68, thought she beat breast cancer in 2001, but she was diagnosed again in 2003. Doctors suggested she try Avastin in clinical trials along with another Genentech drug, Tarceva. Now, her cancer has stabilized. "The doctors were doing cartwheels" when they realized how well she was doing, says Shannon Broome, 42, of Oakland, Calif. "It's a relief. She lives with us. She drives our kids to school. She's the ultimate grandmom. To not have her around isn't an idea we can accept, and now we don't have to."
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3. New for asthma: Potential double-duty to prevent and maintain
The drug: Symbicort
The need: Asthma threatens more than 20 million Americans. To prevent attacks, patients typically need two kinds of medications: a long-acting anti-inflammatory drug that makes airways less likely to constrict, and a quick-acting drug called a bronchodilator that opens airways in an emergency.
The promise: AstraZeneca's Symbicort -- possibly due in 2006 -- combines the anti-inflammatory drug Pulmicort (budesonide) with a quick-acting, long-lasting bronchodilator called Foradil (formoterol), taken daily as an aerosol. AstraZeneca now is applying for U.S. approval of Symbicort as a maintenance drug only. In the near future it intends to apply in Europe to use the drug for maintenance and prevention, leaving open the possibility of a broader application in the United States at a later date.
Independent verdict: Giving patients preventive treatment is key, says Jay Portnoy, M.D., chief of allergy medicine at Children's Mercy Hospital in Kansas City, Mo. "Relief may be important for the many patients who dose themselves only when they feel sick," he says. "But it gives only partial protection from future asthma attacks." With Symbicort, that may no longer be the case.
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4. New for depression: Two drugs in one for treatment-resistant cases
The drug: Symbyax
The need: At least 9.9 million Americans suffer from a major depressive disorder. Prozac and its cousins allow many to function without prolonged sadness, but the drugs, called selective serotonin reuptake inhibitors (SSRIs), are no panacea. One in five depressed people remains depressed even after two or more courses of treatment with SSRIs and other antidepressants. Outpatient treatment for this type of patient is at least $6,850 a year -- with no clear way out of the darkness.
The promise: Symbyax could change that. Produced by Eli Lilly and Company, Symbyax combines two of Lilly's most successful psychotropic medicines -- Prozac and Zyprexa, an anti-psychotic drug. Prozac alone raises the level of serotonin, an essential chemical that helps the brain successfully regulate mood and emotion. The two-drug combination also raises concentrations of two other brain chemicals -- norepinephrine and dopamine -- which the brain uses to achieve a healthy emotional balance. A single pill instead of two may lead patients to take their medications more regularly and save patients money with one co-pay rather than two. This drug is now available.
Independent verdict: "The combination of Zyprexa and Prozac would be very good for treatment-resistant depression," says Jacob Katzow, a prominent psychopharmacologist and clinical professor of psychiatry at George Washington University School of Medicine and Health Sciences in Washington, D.C. "Both are excellent drugs, and psychiatrists already mix them to treat difficult cases of depression."
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5. New for diabetes 1 and 2: insulin to inhale, not inject
The drug: Exubera
The need: Many of the more than 18 million diabetes patients in the United States are reluctant to inject themselves with insulin, even though it may help some of them to manage blood glucose levels.
The promise: Exubera requires inhaling, not injecting. More than 3,500 patients in clinical trials worldwide have taken it, some for as long as seven years. Sanofi-aventis, Nektar and Pfizer, the three companies behind the drug, claim clinical trials show that it's aseffective as injected insulin treatment. It could be approved before 2007.
One patient's verdict: Kim Bayon, 35, a special education teacher from Hollywood, Fla., has lived with type 1 diabetes for more than two decades and has taken part in trials for Exubera at the University of Miami. She couldn't be happier. "Before, I had to take an injection every time I ate," Bayon says. "I'm so relieved. I used to get bruising. Even after you've gotten used to it, you'd occasionally inject into a part of you that hurts."
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How a drug is approved
The Food and Drug Administration is expected to approve the drugs highlighted in this article, but no one knows exactly when. Generally, this is how a new drug gets to your pharmacist's shelf:
Creation. A drug company creates a product in its laboratory and conducts in-house tests with lab animals.
Application. The company files an investigational new drug application with the FDA, asking permission to test the new drug on humans.
Phase 1 trials. Healthy human testers receive the drug in small doses, then larger doses. Researchers look for side effects.
Phase 2 trials. A small number of patients with the ailment inquestion tries various doses. Goal: finding a recommended dose that balances effectiveness and side effects.
Phase 3 trials. A large number of patients with the ailment takes various doses. Researchers hone their data and capture side effects.
Review. FDA scientists review all data -- often enough to fill at least one 18-wheeler's load. This process can take six months or longer.
Decision. If the FDA gives its approval, the drug receives clearance to go on the market for general sales and prescriptions.
After approval. Any drug can be pulled off the market for various reasons -- including side effects that come to light only after the drug was put on the shelves and came into wide use.
Cover illustration by Leon Lawrence III and Saundra Giering for USA WEEKEND
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