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.

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.

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 ***

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.

New Drug Points Up Problems in Developing Cancer Cures

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."