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For an online map of fairly current pollen counts throughout the United States, visit the American Academy of Allergy, Asthma & Immunology or Accuweather. Once you get to your destination, click on the Weather Channel, if it's available, or listen to local weather reports to get an accurate pollen count.

Allergy Medication

January 8, 2008

If a child has cold symptoms that go on and on, is it really allergies? Or is it just one long cold? Or several colds, back-to-back? This is especially difficult in the spring when all the flowers and trees are in bloom. Are the treatments the same? Either way the symptoms are miserable!!!

Walking into a drugstore, you are confronted with an overwhelming display of brightly packaged products, each promising greater allergy relief than its neighbors. Many of these products can actually harm your child and make the effects of allergies even worse. The right choices, however, used in the right ways, can dramatically improve your child's springtime.

For years, the centerpieces of over-the-counter allergy therapy have been decongestants and antihistamines. Decongestants are caffeine-like compounds that work by constricting blood vessels throughout the body, including in the nose. By limiting blood flow to the nose, nasal congestion and swelling are somewhat decreased, providing a measure of relief.

Decongestants temporarily raise the blood pressure and make extra work for the heart. Since most kids have strong, healthy hearts this is usually not a problem. Rather, the tendency for kids on decongestants to experience irritability or sleeplessness is a more practical concern. Allergy preparations advertised as "non-drowsy" are typically decongestant preparations. Multi-symptom allergy or cold medicines usually contain a decongestant called pseudoephedrine. Topical decongestants (nose drops or nasal sprays) provide far greater relief with fewer side effects, but these powerful medicines should not be used for more than three days at a time (or they begin to work backwards and can also be habit-forming). These may be a great option for a night or two while another strategy is beginning to work, but are a poor choice for beating the effects of the allergy season.

Antihistamines reduce allergy symptoms by blocking the action of the histamine released by mast cells in response to allergic triggers such as pollen. These can be very effective, but all of the over-the-counter antihistamines cause some change in kids' levels of alertness. Most of the time, they produce drowsiness in children (which can be quite welcome -- especially at night), but around 5% of kids act hyper instead.

Of far greater concern is the effect of antihistamines on thinking and learning. We know that kids who are experiencing allergy symptoms don't think or learn or remember as well as kids who are feeling well (Annals of Allergy, Aug 1993). Careful studies have now been performed to determine whether this reduction in learning ability could be reversed by using over-the-counter antihistamines to relieve the allergy symptoms. The surprising results were that even though kids felt better on the antihistamines, their learning abilities were even worse than with no treatment (Annals of Allergy, Asthma, and Immunology, Mar 1996). Children are better off congested than drugged. (Better yet is having the symptoms relieved in less problematic ways!)

Over-the-counter antihistamines are a reasonable choice for nighttime use, or for an occasional day or two when a child is home from school. I do not recommend them, however, as a long-term solution. Learning --even during play-- is too important a part of childhood to blunt with drugs.

Antihistamines are found in almost all allergy preparations that are not specifically advertised as non-drowsy. Diphenhydramine is the most powerful, but it also makes kids the sleepiest (or most wired). Chlorpheniramine and brompheniramine both are a little less potent but have fewer side effects.

Nasalcrom is an exciting, over-the-counter allergy medicine that is more effective and far safer than either decongestants or antihistamines. Nasalcrom is a nasal spray that creates a protective barrier around the allergy cells in the nose so that pollen, mold,dust, and animal dander can't stick to them. It stops the allergic response before it starts--without causing any drowsiness, irritability, or decreased learning. It doesn't reverse allergy symptoms that are already present, but prevents new allergen exposures from causing symptoms. Unlike decongestant nasal sprays, this gentle medicine can be used for weeks or months at a time with no fear of rebound effects or addiction.

Many people think that Nasalcrom doesn't work well, since when they give Nasalcrom a try, they experience no improvement in their allergy symptoms. Since Nasalcrom is a preventive medicine, though, it is only after using it 3 to 4 times a day for a week or so that the full benefits begin to appear. Nasalcrom is safer than decongestants and antihistamines and was a prescription medication for 14 years before it became over-the-counter.

Preventing exposure to airborne allergies is another powerful way to treat allergies at home. To this end, a HEPA filter can be an excellent investment. These High Efficiency Particulate Arresting filters, available at discount drug stores for about $60 - $100, can remove 99.97+% of the pollen, dust, and animal dander from the air. I highly recommend placing one in the room where a child with hayfever sleeps.

When kids are playing outside during hayfever season, pollen from grasses, weeds, and trees clings to their clothes and hair. Taking off the outside clothes as they enter the house, and perhaps rinsing the hair, can greatly reduce the pollen they are exposed to that night as they sleep. Every little bit of exposure reduction helps. If a child is allergic to pollen, dust, and cats, minimizing exposure to pollen and dust will make the cat allergies less severe by cooling down the allergic response.

The Old Farmer's Almanac advises tying a bag of onions around the neck or around the bedpost as a good home remedy for allergies. My guess is that this works by stimulating tear production, which naturally washes pollen particles out of the eyes and nose. A less smelly way to accomplish the same thing is the liberal use of saline nose drops or saline eye drops (artificial tears). Saline drops are not the same as the eye drops that are advertised to "get the red out." While "get the red out" drops do help to reduce the red appearance of irritated eyes, they are not a good choice for preventing or treating allergies.

The Almanac also suggests turning a piece of orange rind inside out and inserting it in the nose. We now know that some of the ingredients in citrus fruits (including vitamin C) block the histamine response in a safe and natural way. The most potent of these appears to be a vitamin-like compound called quercitin that is found in citrus fruits and buckwheat. Increasing these foods in the diet makes sense. Quercitin/vitamin C supplements are available in health food stores. We know that these reduce hayfever symptoms in rats, but their effect in human children have not been established. They do appear to be safe and gentle, however, and many people report success with them.

Stinging nettle is the other natural remedy that shows a lot of promise. Also available in health food stores, this herbal supplement is now known to reduce the histamine response in test tube experiments. But again, although I have heard many testimonials, the scientific evidence in support of its effectiveness in humans is sparse.

The last remedy suggested by the Old Farmer's Almanac is swallowing a spider. Yuck--the cure is worse than the disease! This can also be the case with oral decongestants, topical decongestants, and over-the-counter antihistamines -- unless used carefully and with the right timing.

Even severe allergy symptoms, however, can often be kept at bay by the proper use of Nasalcrom, HEPA filters and the other remedies we have discussed. Expect an allergy-free springtime. If you are still having problems, make sure to check with your doctor about allergy testing or prescription medicines.

In addition to avoiding the offending allergen, people may use several medications to prevent and treat the symptoms of allergic rhinitis. The mainstay of treatment is a group of medications known as the antihistamines. Antihistamines work against the histamine chemicals that are released during an allergic reaction. Other groups of medications used to prevent or treat allergy symptoms include mast cell stabilizers, decongestants, and anticholinergics. Corticosteroids may be another option. There may be several forms of each medication in the different groups (e.g., pills, nasal sprays, eye drops). Your pharmacist or doctor may recommend other specific medications based on your individual symptoms and medical conditions.

The table below shows the effectiveness of different types of allergy medication.

The more + signs there are, the more effective it is; "0" means not effective.

Table 2. Effectiveness of different types of allergy medications

	Allergy symptom relieved
	Sneezing	Runny nose	Itchy nose	Itchy, watery, or red eyes	Congestion
	Antihistamines
Taken by mouth	++	++	+++	++	+
Nasal spray	++	++	++	0	+
Eye drops	0	0	0	+++	0
Mast cell stabilizers
Nasal spray	+	+	+	0	+
Eye drops	0	0	0	++	0
Decongestants
Taken by mouth	0	0	0	0	+
Nasal spray	0	0	0	0	++++
Anticholinergics
All forms	0	++	0	0	0
Corticosteroids
Nasal spray	+++	+++	++	++	+++

When choosing an allergy medication, people tend to go with what has worked for them in the past. There may be a certain brand that you trust will do the trick for your allergy symptoms. However, if you haven't found an allergy medication that works for your symptoms, ask your pharmacist or doctor. They may be able to help you find the best allergy medication for you. Remember that allergy medications should be taken early to prevent symptoms from getting out of control, and that they can be taken regularly to keep symptoms in check.

It is important to read labels carefully and talk to your health professionals, as some brands of allergy medication have a variety of different products. For example, some medications of the Claritin® brand contain an antihistamine called loratadine, which is taken orally in several tablet and liquid forms, while some other Claritin® products do not contain loratadine (e.g., eye drops, nasal spray, and skin itch cream), and some contain a combination of loratadine and a decongestant. Similarly, there are also combination products in the Allegra® and Reactine® brands.

Side effects are another important consideration when choosing an allergy medication. Different side effects are associated with different allergy medications. Many people are concerned about the drowsiness potential of the antihistamine group of medications. Older antihistamines are often associated with drowsiness, while newer "non-sedating" antihistamines usually do not affect the level of mental alertness, though there are differences in drowsiness potential even among the newer antihistamines. While research studies have not directly compared all of the newer antihistamines to each other, there are more reports of drowsiness and warnings about potential occupational hazards with cetirizine (Reactine®) than with loratadine (Claritin®), desloratadine (Aerius®), or fexofenadine (Allegra®).

Allergy medications are safe for the majority of people. If you have heart disease, high blood pressure, diabetes, eye problems, prostate problems, kidney or liver dysfunction, or a seizure disorder, ask your doctor or pharmacist to recommend the safest allergy medication for you. Women who are pregnant and/or lactating should also consult their health professional.

FDA Doesn't Regulate Supplements, Leaving Consumers on Their Own

September 26, 2007

Many of you recently asked about possible problems with the supplement Red Yeast Rice used for cholesterol-lowering. Doesn't the Food and Drug Administration regulate these things?

The FDA does not regulate any of the myriad vitamins, minerals, herbs, amino acids, and other supplements that line the shelves of pharmacies and health food stores these days.

"Why is this?" In the early 1990s, the FDA considered tightening the regulation of all dietary supplements in order to combat health fraud. Alarmed by this, the health food industry warned consumers that this would lead to restriction in the availability of vitamins and other supplements (though this was not the FDA's intent).

A howl of protest went up in the public; celebrities made television commercials declaring that no one was going to take away their right to buy vitamin C, ginkgo, and the like. Congress reportedly received more mail around this issue than it did for the entire Vietnam War.

Faced with this public outcry, the government backed down, and the Dietary Supplement Health and Education Act was passed in 1994. DSHEA, as it's called, protected the right of consumers to purchase supplements without any interference from the government. In addition, unlike pharmaceutical drugs that must be proven safe and effective by their makers before they are FDA approved, DSHEA established that the supplement industry was not required to prove that its products were safe or useful. Instead, the FDA was given the job of proving harm before it can remove any of these from the market.

As a result, when you purchase a supplement now, you are not guaranteed that the bottle contains a product that is pure, effective or safe. Although these products cannot claim to treat or cure medical conditions, advertisements abound about what various supplements do to reduce or eliminate symptoms.

It's no surprise that sales of supplements have skyrocketed; in 1994 when DSHEA was passed, Americans were spending about $4 billion per year on supplements; in 1996, that number hit $12.2 billion, and last year it was more than $22 billion.

Many of us assume that if it's natural, it's gotta be good, and if a little is good, then lots is probably better. The problem is, a lot of these supplements can be toxic if taken in overdose, and if they happen to be contaminated in any way, your risk of toxicity goes up further.

As an example, products imported from Asia and India have been found to be contaminated with lead, arsenic and even Valium. In 2002, the FDA issued a consumer advisory about the anxiety-reducing herb kava kava because of reports of liver injury, including several cases of liver failure; in 2004, the FDA banned the sale of ephedra after it was linked to more than 100 deaths. In addition, many herbs can interact with prescription drugs.

What about the use of supplements to treat specific medical conditions? A recent study at the University of Iowa showed that many people took herbs and other supplements for which there was no good evidence of efficacy (this unfortunately applies to many of the supplements on the market).

In fact, other studies have shown that some consumers will continue to take a product even when presented with clinical evidence that it doesn't work. And that also points to the power of our minds in all of this _ if we believe something will work, it may indeed have an impact on us physiologically. (Hmmm. What if we just believed in our own potential to heal and dumped most of this extraneous stuff?)

In our opinion, it's no better taking an herb or supplement to treat a medical condition than it is taking a drug made in a lab _ in the end, you're still taking a chemical, and you're also relying on something external to help you heal. And if you really need something, you may be better off taking the pharmaceutical product rather than an herb _ that way, you're more likely to get what the bottle actually says (and no, we are not getting paid off by the drug industry to say this; we just want our patients to be safe and remember, both the drug and the supplement industries are big business).

What can you do to educate yourself about this? Look for reliable information on medical Web sites; WebMD is a good one, as are most of the Web sites at academic universities. Also, the Office of Dietary Supplements at the NIH is excellent; its Web site is http://dietary-supplements.info.nih.gov

Look for products that have the designation "USP" or "NSF/GMP"; this suggests that they have undergone some evaluation of their purity (manufacturers submit to this on a voluntary basis).

If you use a lot of supplements, you may want to consider subscribing to Consumer Lab ($29.95 per year); this is an independent testing lab that provides information about the purity and quality of a number of brand name products on the market.

AstraZeneca Announces More Layoffs

July 26, 2007

PHILADELPHIA _ AstraZeneca P.L.C. said Thursday it will lay off an additional 4,600 employees, trimming its payroll by 7,600, or 11 percent of its work force, within three years.

The London-based drug maker in February announced it would dismiss about 3,000 employees in operations and manufacturing. The company said it decided additional cuts are needed in European sales and marketing, information services and business support, and drug research and development.

"We still haven't finished exploring further opportunities to reduce our cost base and improve future profitability," chief financial officer Jon Symonds told investors and analysts. "Although just to be clear, future projects are unlikely to be near the scale that we have been talking about here."

AstraZeneca said it would shed 1,800 jobs in European sales and marketing, 1,800 in information services, 700 in research and development, and 3,300 in operations and manufacturing.

The company said it could not specify the number of layoffs in the Wilmington, Del., area, where AstraZeneca's U.S. headquarters employs about 5,000 people.

The cuts will cost about $1.6 billion, but the restructuring effort is expected to save the company $900 million a year by 2010.

AstraZeneca also announced that second-quarter profit declined 10 percent. Net income fell to $1.4 billion, or 95 cents a share, from $1.6 billion, or $1.01 a share, a year earlier.

Chief executive officer David Brennan said on a conference call that the "solid underlying financial performance" will enable AstraZeneca to meet full-year earnings and sales goals. He revised the earnings per share range to $3.90 to $4.05, from $3.80 to $4.05 previously.

The latest quarter was negatively affected by 6 cents a share related to the acquisition of MedImmune Inc. in June. MedImmune reported a $103 million operating loss in the quarter. AstraZeneca said it incurred $376 million in restructuring charges for the three months ended June 30.

Revenue rose to $7.3 billion from $6.6 billion, after sales of five key products, including cholesterol treatment Crestor and asthma drug Symbicort, increased 12 percent. U.S. sales of the company's best-selling product, heartburn drug Nexium, fell 1 percent, affected by competition from generic omeprazole heartburn treatment.

U.S. sales of Crestor were $353 million, up 30 percent, but Crestor's U.S. market share was 8.6 percent in June, the same as in December 2006. "Although somewhat disappointing," AstraZeneca said, given an increase in share by generic Zocor, Crestor's market position is "resilient."

Shares closed down $2.70, or 4.9 percent, to $52.30 on the New York Stock Exchange.

Bayer's Nexavar Looks Promising for Liver Cancer

Bayer's Nexavar improved survival of liver cancer patients in a phase 3 trial presented at the American Society of Clinical Oncology meeting recently in Chicago.

Nexavar, which Bayer is developing with Onyx, extended survival of primary liver cancer patients by 44 percent compared to those taking a placebo.

The companies said they are now preparing applications to the Food and Drug Administration and European regulators for a supplement indication for Nexavar, which is currently approved for treating advanced kidney cancer.

"These results represent an unprecedented achievement and Nexavar could become the first widely approved new therapy for this difficult to treat deadly cancer", Jordi Bruix, co-principal investigator of the phase 3 trial and director of the Barcelona Clinic Liver Cancer Group at the hospital clinic of Barcelona, said in a statement issued by Bayer.

In the study, which is known as the SHARP trial, 602 liver cancer patients received Nexavar or placebo. Median overall survival in the Nexavar group was 10.7 months compared to 7.9 months in the placebo arm. No significant differences in serious adverse event rates were detected between the two groups.

*** This article is dedicated to the families of Larry Robert Ross & Fred W. Spencer ***

*** I love you all ***

Generic Form of Ambien Sleep Medication Now Available

A generic version is now available for Ambien(R) (zolpidem), a widely prescribed sleep aid. Since Ambien lost patent protection on April 21, the price for zolpidem has dropped from more than $4 to less than 25 cents per tablet, or $100 per month to less than $10. The price of Ambien(R) increased by over 30 percent in the last year.

"This represents a significant savings for health plans and consumers because prescription sleep aids are one of the most widely used and fastest growing drug classes," said Richard Bruzek, HealthPartners vice president of pharmacy services. "This doesn't however, change our main concern which is the appropriate use of drugs by patients, whether brand or generic."

HealthPartners costs for sleep aids increased 60 percent from 2005 to 2006. About 7,000 HealthPartners members have prescriptions for Ambien(R).

"The introduction of this generic will significantly decrease patient and plan expenses for this category of drugs," Bruzek said. Sixty-seven percent of HealthPartners prescriptions are for generic drugs, an increase of over 15 percent in just three years. Every one percent increase in the use of generic drugs reduces HealthPartners plans and member costs by $7 million annually.

This year, the patent expired on Norvasc(R), prescribed for hypertension. In the upcoming year, patents are also set to expire on other widely used brand name drugs including Coreg(R), prescribed for heart failure, and Zyrtec(R), prescribed for allergies.

Guard Against Prescription Drug Error

Each year more than 3 billion prescriptions are written by doctors in the United States. Trusting patients take prescribed medications with the faith that their health is safely in the hands of medical professionals who ensure that they receive the appropriate prescription drugs and know how to take them correctly. According to the National Academy of Medicine, approximately 1.5 million Americans annually fall victim to prescription drug error. Patients should take precautions to reduce their chances of falling victim to this growing epidemic.

In 2003, Cesar Espinoza, a 46 year-old Bellsouth computer professional died as a result of prescription drug error. After being diagnosed with a brain tumor, he underwent surgery and received an optimistic prognosis that with chemotherapy he likely had a number of years of life yet to enjoy.

Instead of enjoying his life, Espinoza received an incorrect chemotherapy dosage and directions at the hands of the doctor and pharmacist he entrusted with his life. After suffering for 42 days with complications from an overdose, he died as a result of the errors.

Espinoza's family, like others, have sought to bring the negligent medical professionals to justice. An Atlanta jury recently found the doctor in the Espinoza case liable for malpractice for the prescription error that was directly responsible for ending his life. Although the $500,000 verdict against the doctor, and a confidential settlement by the pharmacy before trial was minor compared to Espinoza's contributions, the jury sent a clear message to the medical community that such errors must cease.

"Until the medical community decides to self regulate to avoid these easily preventable prescription errors that they have long been aware of, patients must take precautions in order to not fall prey to sloppy prescription writing and filling practices that may cause serious injury or prove fatal," says Trent Speckhals, the lead attorney at Speckhals & Cora who tried the case in Atlanta. "Unfortunately, some doctors and pharmacies do not do all that they should to ensure that prescriptions are accurate. We all must therefore take action to protect ourselves and our families from dangerous drug errors."

According to James O'Donnell, PharmD FCP, Associate Professor of Pharmacology at Rush University Medical Center and Founding Editor-Journal of Pharmacy Practice in Chicago; patients should follow some basic steps before their next visit to the doctor or pharmacist.

-- Read the prescription back to the doctor before leaving the examination room. Make note of the drug name and dosage instructions.

-- Ask for prescription drug counseling from the pharmacy. Don't sign the pharmacy log for the prescription until the pharmacist has given counseling and clear directions.

-- Read the label on the prescription bottle while at the pharmacy. Make sure that it is what the doctor prescribed.

-- Inform the pharmacist of all the medications being taken and any chronic health conditions

-- Allow time for the pharmacist to fill the prescription. Don't expect the pharmacist to rush. Rushing = Mistakes

-- Research the drug on the internet before taking any new medication. Pictures of the pills on the web will help verify that the correct medication has been filled. Directions and precautions are also on many pharmaceutical websites.

-- Talk with your doctor or pharmacist if you have any questions.

"Juries are sending a strong message to medical professionals and companies by consistently finding on behalf of the victims of prescription error. No amount of money will bring to justice and replace the suffering and agony experienced because of negligence," says Speckhals. "However, pharmacists and doctors who refuse to take steps to prevent these easily preventable errors should be held accountable. Hopefully, this will then cause them to change their ways."

As always, patients should report any adverse effects observed immediately to their doctor and strictly follow guidelines of the doctor and pharmacist.

Study: Doctors Lack Information On Kids' Medications

Critical information about the safety and effectiveness of giving certain drugs to children may not be reaching American doctors, a new study says.

Critical information about the safety and effectiveness of giving certain drugs to children may not be reaching American doctors, a new study says. Fewer than half of studies done by manufacturers under the Food and Drug Administration pediatric exclusivity program to test if hundreds of drugs like anti-depressants, anti-seizure medications and sedatives are appropriate for pediatric use or require a different dose are published in scientific journals, which are the best way to get the news to the medical community, researchers at Duke University Medical Center found in a study published Wednesday in the Journal of the American Medical Association.

Furthermore, the results were less likely to be published if the drug was deemed unsafe or ineffective in children, the study found.

The FDA designed the pediatric exclusivity program to increase knowledge about how children may react differently to commonly used drugs that have not been previously studied in the pediatric population. Based on their study the Duke researchers suggest that the results of these pediatric exclusivity studies are not being widely disseminated outside mandated changes to label information.

The FDA publishes label change information on its Web site, but users must know what they are looking for and where to look in order to find it, the authors write.

Because children have different physiologies than adults, they often absorb drugs differently or experience different side effects, said the study's lead investigator, Daniel K. Benjamin, a pediatrician at the Duke Clinical Research Institute who also holds an appointment at the FDA's Office of Pediatric Therapeutics. Much of pediatric drug use is done 'off label,' meaning that children are often treated based on what has been shown to be effective in older patients, and the results can be beneficial, harmful or not effective, depending on how much information about use of the drug in the pediatric population is known.

Lilly, Alcon to Promote Diabetic Eye Drug

Lilly and Alcon said Friday they have signed a deal to co-promote what could be the first oral drug for diabetic retinopathy.

The drug is ruboxistaurin mesylate and would be sold under the trade name Arxxant. The co-promotional deal covers the United States and Puerto Rico. The treatment is currently being reviewed by the U.S. Food and Drug Administration as a treatment for moderate-to-severe non-proliferative diabetic retinopathy, which is a diabetic eye disease.

"We believe combining the respective expertise of Lilly and Alcon will allow us to maximize the value of this potential new therapy for patients, physicians and our shareholders", said Khoso Baluch, vice president of Lilly's U.S. diabetes business unit. "With this collaboration, we gain a highly reputable and experienced partner in the eye care market."

The deal calls for Alcon to primarily market Arxxant to eye specialists, including retinal specialists and ophthalmologists, with Lilly mainly promoting the therapy to endocrinologists and primary-care physicians. Alcon will make milestone and marketing payments to Lilly, and Alcon will be compensated based on product sales.

To learn more about diabetes, visit the American Diabetes Association.

New Drug Points Up Problems in Developing Cancer Cures

Dec. 22, 2005 - Despite promising discoveries and multibillion-dollar investments, cancer research is quietly undergoing a crisis. Federal drug regulators will soon announce several initiatives that they hope will help salvage the field.

Few drugs are being marketed, and most of those that have been introduced are enormously expensive and provide few of the benefits that patients expect. Officials of the Food and Drug Administration suggest that the failures may result from an obsolete testing system.

There is growing evidence that X-rays, long the standard, may not accurately assess a patient's disease. The drug agency is creating collaborations to develop imaging, blood and other tests that better signal the progression of cancer.

"We need to develop cancer drugs differently," the chief operating officer of the agency, Dr. Janet Woodcock, said in an interview. "The tools we have to develop these treatments are not what we need in cancer."

On Tuesday, the agency approved Nexavar, a drug that officials described as "a major advance" in treating kidney cancer.

That action demonstrates the global confusion surrounding cancer. The manufacturer of Nexavar, Bayer, used X-rays to determine that the drug doubled the time, to 167 days from 84, before tumors grew substantially in number or size, a finding called "progression-free survival."

Officials of the drug agency found the findings so compelling that they urged Bayer to stop the trial early and give Nexavar to subjects who had been taking placebos.

European regulators, on the other hand, wanted the trial to continue because they wanted Bayer to prove that Nexavar actually extended lives, a finding that would have taken many more months to establish, a deputy commissioner of the drug agency, Dr. Scott Gottlieb, said Tuesday in an interview.

"Nexavar is a good example of how we have developed better science around the development process itself that not only enables these drugs to come to market but to come to market more quickly," Dr. Gottlieb said.

Much work remains to be done, he said, adding: "The crux of the crisis in oncology is that for years we have developed tremendous scientific advances in looking at how cancer develops, and that's not being translated into practical solutions that are benefiting patients at the pace you would expect. Look at what the government and all the drug companies are spending, and yet drugs are not reaching the market."

Groups of cancer patients say they, too, want better ways to measure success against cancer.

"That doesn't mean we want drugs pushed through faster," the president of the National Breast Cancer Coalition, Frances M. Visco, said. "It means we want better science, meaningful endpoints and drugs that have less toxicity and actually prolong survival."

There have been successes in oncology besides Nexavar, of course. Platinum-based drugs have mostly ended deaths from testicular cancer. Tamoxifen and Herceptin have saved thousands of women from breast cancer. And early screening has helped push down death rates.

Researchers are not alone in their failures. Drug makers are in the midst of a dry spell that threatens the foundations of the industry. After peaking in 1996 at 53, the number of new drug approvals has steadily declined. This year, it is unlikely to exceed 17.

Although every field has suffered, cancer has had the greatest chasm between hope and reality. One in 20 prospective cancer cures used in human tests reaches the market, the worst record of any medical category. Among those that gained approval in the last 20 years, fewer than one in five have been shown to extend lives, life extensions usually measured in weeks or months, not years.

True cancer cures are still exceptionally rare. Medicines have been approved for colorectal cancer. Patients who take every one of the high-tech drugs has to spend, on average, $250,000, suffer serious side effects and gain, on average, months of life, according to studies.

Drug companies have been promising for years that gene-hunting techniques would yield targeted nontoxic therapies that melt cancer, but few cancer medicines fit that profile.

"There are all these myths having to do with cancer drugs," Dr. Steven Hirschfeld, an F.D.A. medical officer with expertise in cancer, said. "That they're very targeted, when in fact all these drugs have multiple targets. That they're nontoxic, when in fact the latest ones have their own set of side effects. And that they're cures, when they are not."

Nexavar, for instance, seems to affect a variety of crucial molecules involved in powering cancer cells, but its real effects are uncertain. It can cause rashes, diarrhea and increases in blood pressure, although drug agency officials said it was far less toxic than previous therapies.

The disappointing track record in cancer has mostly resulted, of course, because it is not one disease, but hundreds, whose progression is governed by a dizzying array of genetic and environmental factors that are just beginning to be understood.

Drug agency officials are increasingly concerned that failures with cancer may result because the science of human testing, called drug development, has not advanced as rapidly as the understanding of the biology of cancer. "My concern is that these novel drugs being discovered will bump up against an aging development process that can't adapt as quickly," Dr. Gottlieb said.

The agency will soon release a report that lists more than 12 research areas that it will address to try to improve clinical trials. Among the efforts is a search for new ways to measure cancer progression.

For decades, X-rays have been the principal means for researchers to judge whether a cancer drug works. If tumors appear to shrink or stop growing after therapy, the drug is thought to be working.

There is growing evidence that tumor size may not matter much. Small tumors can sometimes be as deadly as large tumors. That discovery has unmoored drug development. Researchers could track which patients live or die. But trials that measure life expectancy often take years and tens of millions of dollars to complete. Researchers and companies would dearly love an interim measure akin to cholesterol or blood pressure readings.

The anxiety over measuring success in trials has led drug regulators around the world to try to provide guidance to companies. By coincidence, the Food and Drug Administration and drug regulators in Europe and Japan all released papers over the summer on cancer drug measurements.

"But I think it's more instructive what these documents didn't say," Dr. Hirschfeld said.

None endorsed any one measurement, he noted.

For Nexavar, the drug agency accepted X-ray measures because the changes were so dramatic, said Dr. Richard Pazdur, director of the oncology office.

The agency also encourages tests of new imaging equipment. Officials are hopeful about research into positron emission tomography, or PET scans. The scans show not only a tumor's size, but also its vigor.

The drug agency is also setting up collaborations with the National Cancer Institute, the Centers for Medicaid and Medicare Services, and other groups to pursue other technologies, blood tests and genetic screens.

In the end, though, the search for new ways to measure cancer may not be successful, said Dr. Susan S. Ellenberg, the associate dean for clinical research at the University of Pennsylvania School of Medicine, who spent much of her career at the drug agency and the cancer institute.

Dr. Woodcock said success was vital.

"The science is at a point where we shouldn't let this opportunity escape us," she said. "There are ways to figure this out, and it's not like I'm some wild-eyed idealist. I'm the F.D.A., for heaven's sake. This is going to happen."

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This page last updated 02-12-2008 - Bryant L. Smith

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