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Women-in-Towels Evista Ad Critiqued

Posted by medconsumers on July 1, 2008

The women in Eli Lilly’s new ad campaign are attractive, healthy-looking and wearing nothing but towels. “Cut two risks with Evista. The only agent indicated to treat osteoporosis and reduce the risk for invasive breast cancer.”

That two-for-one claim for Evista makes it different from other drugs taken by symptom-free people. Studies showed that the harm related to each disease drops a percentage point or two in those who took Evista, compared to those who did not. The drug is better than a placebo (or it would not get FDA approval), but not much better. This is a recurring theme in Center for Medical Consumers articles because it’s a recurring theme in many drug trials. And often the small risk of a serious adverse reaction to the drug equals that small chance of benefit.

Evista (generic name: raloxifene) has been on the market since 1997 as an osteoporosis drug. It produces a 2%-3% increase in bone density; reduces the rate of vertebral (spinal) fractures; but does not prevent the most serious type of fracture (hip). Vertebral fractures can cause pain and a dowager’s hump in advanced age, but many are symptomless. The studies did not last long enough for Lilly to make claims regarding prevention of a dowager’s hump or loss of height.
Breast Cancer “Risk Reduction”

Last year Lilly received FDA approval to promote Evista as a drug that can “reduce the risk of invasive breast cancer.” This careful wording from the Evista ads is important. Lilly cannot claim its drug prevents breast cancer because the disease can take anywhere from 8 to 17 years to develop. There were, in fact, fewer breast cancers diagnosed in the women taking Evista, compared to those taking placebos. But the trials didn’t last long enough to determine whether the drug prevents breast cancer or simply delays its onset. In Evista trials that lasted up to eight years—breast cancer was diagnosed in 2.5% of the women taking a placebo and 1% of the women taking Evista.

The other claim for Evista is based on the fact that the women in the studies already had osteoporosis (bone loss). One way bone drug companies can inflate the benefit of their product is to count symptomless vertebral fractures that can be detected only on x-ray. (In other words, the women are unaware of them.) At the start of the Evista trial about half the women had painful vertebral fractures and the other half had “fractures diagnosed radiographically.” After four years, things looked better for Lilly when results for all women were combined, but less impressive when women with painful fractures were singled out. In the latter group, only about 1% fewer Evista-treated women had new painful vertebral fractures than the women taking placebos.

Thus far serious adverse reactions to Evista include deep vein thrombosis, pulmonary embolism, retinol vein thrombosis and an increased risk of fatal stroke. (See boxed warning of the FDA-approved label). Separately, each is classified as rare, which, according to FDA standards, describes any drug reaction that occurs in less than 2% of study participants. Collectively, though, these potentially fatal adverse reactions could reach 1-2% which comes close to the percentage of women who benefited from Evista in the FDA-required clinical trials.

And lastly, the visual message conveyed by the women-in-towels ad is misleading. Most of the women look to be in their fifties. At the start of the Evista trials, however, most participants were over age 65 years, a time of life when vertebral fractures are far more likely to occur.

Maryann Napoli, Center for Medical Consumers ©
July 2008

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Chantix: Another FDA Failure?

Posted by medconsumers on June 1, 2008

For an inveterate FDA watcher like me it was an interesting spring. First, the agency’s failure to police the safety of imported medical products became front-page news when it was revealed that batches of the blood-thinner heparin caused fatal allergic reactions because of contaminated ingredients imported from China. Coming on top of the lead-painted children’s toy and poisoned pet food episodes of a year earlier, the incident confirmed that the FDA lacked sufficient resources to carry out the requisite inspections of overseas manufacturers under its jurisdiction.

The predictable result was a firestorm of criticism from Congress and the press. For the first time that anyone could remember an FDA Commissioner violated the Washington protocol that political appointees do not lobby Congress on behalf of their own agency. Andrew von Eschenbach did just that in a letter to a key Senator requesting $275 million as a supplemental appropriation

Predictably, a Bush Administration spokesperson said that the additional funds are not necessary.
Besides introducing legislation to provide additional funding, lawmakers are considering a requirement that imported drugs, medical devices and food products be labeled with the country of origin and a special identification number to help FDA track unsafe products back to their manufacturer. Legislation has also been proposed that would impose fees on manufacturers and importers to fund overseas inspections of their manufacturing facilities. Significantly, some lawmakers want to give the FDA the power to order recalls of unsafe imported food and medical products. At present the FDA can only ask a manufacturer to withdraw its product.

On the domestic front, a report linking the antismoking drug Chantix to a large number of deaths and serious injuries was released recently by the Institute for Safe Medication Practices (ISMP). Earlier, the FDA had issued a Public Health Advisory warning that the drug was associated with serious neuropsychiatric reactions, including suicide.

The ISMP researchers found that Chantix users had an inordinately large number of severe injuries, major seizures, movement disorders and heart rhythm disturbances often leading to loss of consciousness, as well as transient blindness.

Chantix, which is made by Pfizer, has become the most frequently mentioned drug in serious injury reports to FDA after only 18 months of availability. From October to December 2007, almost 1,000 Chantix injury reports were received by the FDA compared to a median of five injury reports for other problem drugs over the same time span, according to the ISMP.

Because the antismoking drug’s side effects could render a user unconscious or temporarily blind, the ISMP findings set off immediate alarms about Chantix’s risks to airline pilots, train, bus, and subway operators, truck drivers and those who operate any other heavy machinery. To avoid the possibility of a catastrophic airline accident, the FAA promptly banned the drug’s use by flight crews. And, the Federal Motor Carrier Safety Administration issued a warning advising medical examiners “to not qualify anyone currently using this medication for commercial motor vehicle licenses.”

Since drivers of motor vehicles include almost the entire U.S. population over age 16, the FDA should be asking Pfizer to immediately withdraw Chantix from the market. Helping people stop smoking may be an important public health goal but not when the trade-off is an even earlier drug-related death.

Arthur A. Levin, MPH, Center for Medical Consumers ©
June 2008

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Drug-Induced Memory Loss

Posted by medconsumers on June 1, 2008

Memory Loss and the Drugs That Can Cause It

Memory loss, cognitive impairment, dementia, Alzheimer’s disease. As the media frequently remind us, all these problems will soon reach epidemic proportions because more and more Americans are living to an advanced age. Virtually no media attention has been given to the research that is slowly building a case against one large category of prescription drugs linked to a more rapid decline in cognitive function in older people. Known as anticholinergics, these drugs include everything from antihistamines and bronchodilators to blood-thinners and anti-nausea medicines.

The latest study to indict anticholinergic drugs was presented recently at the annual meeting of the American Academy of Neurology. As reported on Medscape, the on-line news service, one woman’s experience with Detrol, a drug for overactive-bladder symptoms, provided the impetus for the new study. It was led by Jack Tsao, MD, associate professor of neurology at the Uniformed Services University of the Health Sciences, Bethesda, MD.

The woman went to her doctor with memory difficulty and hallucinations, Dr. Tsao explained, but tests showed that she did not have Alzheimer’s-type dementia. The focus then went to Detrol, which she had just started taking. Fortunately, her doctor recalled the experience of another patient on the same drug with the same symptoms. That patient’s problems had resolved once the drug was stopped.

The experiences of these two patients prompted Dr. Tsao to contact researchers at Rush University in Chicago, who scrutinized data generated by a large study that has been following nearly 900 older Catholic nuns and clergy ever since it began in 1993. The stated aim of the Rush Religious Orders Study is “to discover what changes in the brain are responsible for memory and movement problems” and “to look closely at the transition from normal functioning of the aging brain to the mild cognitive impairment that can be an early sign of Alzheimer’s disease.” At the time of enrollment, all participants were free of dementia.

Tsao and colleagues found that cognitive decline was more rapid after participants began to use anticholinergic drugs compared to those who did not take these drugs. In a telephone interview, Dr. Tsao emphasized a key discovery about those on anticholinergics. “Even though their cognitive performance was worse, we did not find that they were at an increased risk of being diagnosed with Alzheimer’s disease or dementia.”

Although Dr. Tsao’s study is preliminary, its findings are consistent with those of earlier studies. One, for example, was conducted in France and published in 2006 in the British Medical Journal. Unlike the Religious Orders Study, this one recruited people over age 60 specifically to assess the “potential of anticholinergic drugs as a cause of non-degenerative mild cognitive impairment.”

The 372 participants were given annual cognitive performance assessments as well as blood tests. Over 9% had continuously used anticholinergic drugs during the years before their cognitive skills were tested. “Compared with non-users, they had poorer performance on reaction time, attention, delayed non-verbal memory, narrative recall, visuospatial construction, and language tasks but not on tasks of reasoning, immediate and delayed recall of word lists, and implicit memory,” wrote the French researchers led by Dr. Marie I. Ancelin.

Similar to Dr. Tsao’s conclusion, Ancelin and colleagues found that mild cognitive impairment does not put someone on the path to dementia: “Although the consistent users of anticholinergic drugs were significantly more likely to have a diagnosis of mild cognitive impairment at one-year follow-up (80%) than consistent non-users (35%), we found no difference in overall dementia rates at eight-year follow-up between the drug users and non-users.”

Then there’s the problem of drug interactions. The French researchers noted that it would be inappropriate, even counterproductive, for doctors to prescribe acetylcholinesterase inhibitors to people who are already taking an anticholinergic drug. Sold under brand names of Aricept, Exelon and Razadyne, acetylcholinesterase inhibitors are an aggressively promoted, but minimally effective, class of drugs prescribed for Alzheimer’s and dementia.

Dr. Tsao was asked whether doctors know these two classes of drugs should not be prescribed together. “There have been published reports of people who were taking anticholinergics and then being started on Aricept. So you are pushing and pulling on the same system with different antagonistic drugs. One is inhibiting the anticholinergic system, and the other is trying to enhance it. It’s a common concern among nursing home patients with dementia. They’re already on Aricept and then they are given an anticholinergic, which defeats the purpose.”

Ancelin and colleagues had their own warning about prescribing practices. “Not only do doctors commonly fail to associate cognitive dysfunction in elderly people with anticholinergic agents, they also underestimate anticholinergic toxicity, prescribing such drugs at high to excessive doses.”

What you can do:

  • If you must take an anticholinergic drug for a chronic condition, question your doctor about the dose. It may be possible to lower the dose without losing effectiveness.
  • See below for a partial list of anticholinergics.
  • Exercise regularly. In her new book entitled, “Can’t Remember What I Forgot,” (Harmony Books), Sue Halpern found aerobic exercise is the only memory improvement remedy that has good studies to back it up (and she looked at everything from drugs and supplements to fish oil and crossword puzzles). Brisk walking is enough because no additional benefit is shown for extreme or prolonged exercise. Eat lots of blueberries, too.
  • Drink at least three cups of coffee, or six cups of tea, per day. Caffeine protected women over age 65 years from cognitive decline, compared to women who drink one cup or less, according to studies published last year in the journal Neurology.

Maryann Napoli, Center for Medical Consumers ©
June 2008

Is Your Drug an Anticholinergic?

Ask your pharmacist or doctor whether a drug you are taking is an anticholinergic. The usual advice—read the written material that comes with the drug—does not hold in this case. The much-abridged list of anticholinergics below came from a medical journal, but a spot check of the written information that comes with these drugs failed (with one exception) to mention the word anticholinergic.

Lomotil, Lofene, Logen, and many other drugs that contain atropine for diarrhea;

Detrol, Enablex, Trospium, Ditropan for overactive bladder;

Hyosol, Hyospaz for disorders of the gastrointestinal tract;

Prednisone Intensol, Sterapred for certain types of arthritis, severe allergic reactions, etc;

Bronkodyl Elixophyllin, Slo-bid, Theo-24 and other drugs containing theophylline for asthma, chronic bronchitis and other lung diseases;

Codeine for pain and inflammation. Sold under more than two dozen brand names and present in more than 30 combination products;

Xanax, Alprazolam Intensol for anxiety disorders and panic attacks; Valium and Diazepam Intensol for anxiety disorders, muscle spasms, and seizures;

OxyContin, Oxydose, Roxicodone for moderate to severe pain;

Capoten, or captopril, for hypertension and heart failure;

Lasix to reduce the swelling and fluid retention caused by various medical problems, heart or liver disease. It is also used to treat high blood pressure.

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Pharmaceutical Industry to Public: Drop Dead

Posted by medconsumers on May 1, 2008

The Pre-emption Shield Explained

The scenario has become depressingly repetitive: A heavily promoted drug prescribed to millions over the years is found to have potentially fatal adverse reactions; a hundred or so deaths are linked to the drug; the drug maker acts as if it just learned of the harm; a lawsuit precipitates the release of in-house documents showing that company officials knew of the dangers long before its drug went on the market; the injured patients have their day in court.

The last phase of this scenario, the one where people go to court to seek compensation for their injuries, will be eliminated if the pharmaceutical industry gets its way. The industry takes the position that a drug’s safety must be proven to the FDA’s satisfaction before it is allowed on the market; therefore, the drug maker should be held harmless for anything that happens thereafter. “The FDA should not be second guessed by the courts” goes the pharmaceutical industry’s legal argument for what is called pre-emption. Not surprisingly, it has the strong backing of the Bush Administration.

Proof of Safety Inadequate

The presumption that the FDA approval process guarantees safety is absurd. The two clinical trials required by the FDA are usually short-term and always conducted by the drug makers themselves. Rare or uncommon serious adverse reactions to drugs are typically not apparent until hundreds of thousands of people take the drug over the course of many years. Worse of all, drug companies are known to withhold negative trial results from the FDA.

And if that’s not bad enough, a bipartisan Congressional panel recently confirmed what has been known for years: The FDA’s ability to protect the public’s interest is obstructed by the fact that it is seriously underfinanced. This affects everything from the agency’s inability to vet all drug advertising for misleading claims to its drug-safety monitoring system that, according to the nonpartisan Government Accountability Office, captures less then 10% of all serious adverse reactions to drugs after they go on the market.

Most Recent Industry Crimes

Within a recent three-week period alone, the national media spotlighted three cases in which pharmaceutical giants misled the FDA about the safety of their products. Eli Lilly and Alaska agreed to a $15 million settlement on behalf of the state’s Medicaid patients who developed diabetes as a result of Lilly’s antipsychotic drug Zyprexa. The company hid the risks (e.g., deaths, strokes, pancreatitis) and exaggerated the benefits of Zyprexa while encouraging primary care doctors to prescribe it for unapproved uses.

Another case involved the bestselling pain-reliever Vioxx withdrawn in 2004 by its maker Merck because it increased the risk of heart attacks and strokes. And lastly, there’s Johnson & Johnson’s birth control patch, now known to cause blood clots, strokes and deaths. In all three cases, the dangers would have remained unknown—and people would continue to be injured—had it not been for lawsuits.

Among the e-mails, letters and other internal documents released during the Vioxx litigation was damning evidence that Merck knew of the drug’s dangers early-on. The company’s initial research made “the surprising discovery” that “Because selective COX-2 inhibitors [Vioxx, Celebrex, Bextra] do not affect platelet function whereas standard NSAIDs [aspirin, ibuprofen, etc] do, it was hypothesized that selective COX-2 inhibitors might…increase the risk of cardiovascular events.” This warning was repeated twice (at a meeting and in a memo), according to Merck documents—all dated prior to Vioxx’s approval by the FDA in 1999.

Vioxx made news again recently when the most comprehensive study of Merck’s internal documents released during the Vioxx litigation revealed the manipulation of the company’s clinical trial results. One example: Merck conducted several trials trying to prove that Vioxx slows the progression of cognitive impairment in people with dementia. The company’s early analysis of these trials showed “a significantly increased mortality risk” among the participants assigned to take Vioxx (their death rate was more than twice that of the placebo group). This, however, was not the way Merck reported the results to the FDA. Instead, Merck minimized the death risk by using a less-valid type of data analysis of the same trial results and concluded that Vioxx was “well tolerated.”

When the study of the Merck documents was published last month in the Journal of the American Medical Association, the accompanying editorial made it clear that the manipulation of trial results is not the sole purview of one company. The editors also noted that the evidence necessary to demonstrate Merck’s misdeeds became public—and publishable—only because of litigation. Last fall, Merck agreed to a $4.85 billion settlement to resolve tens of thousands of lawsuits filed by former Vioxx patients or their families.

This is not likely to be the way things will turn out for the young women injured by Johnson & Johnson’s popular Ortho Evra birth control patch. The patch delivered far more estrogen into the bloodstream than standard oral contraceptives, increasing the risk of potentially fatal blood clots. More than 3,000 women and their families have sued Johnson & Johnson claiming that the patch caused heart attacks, strokes and at least 40 deaths. Documents made public by this lawsuit showed that Johnson & Johnson’s own trial revealed these risks in 1999. The company, as The New York Times put it, “obscured the finding in a 435-page report to the FDA.”

The Pre-Emption Dodge

The Ortho Evra plaintiffs are now on hold while a similar lawsuit against yet-another drug company (Wyeth) becomes the test case for the pre-emption shield when it goes to the Supreme Court in November. The Court is expected to rule in favor of industry and make pre-emption the legal standard. A precedent was set in February when the Court ruled that the device industry is immune from damage suits filed by people injured by defective pacemakers, stents, etc.

Pre-emption is just the latest in a series of outrages perpetrated by the pharmaceutical industry against the public. At a time when criminal charges should be brought against company officials who withhold evidence of harm, the industry wants a pass. And it’s likely to get just that given the pro-business, anti-consumer Supreme Court decisions over the last few years.

In the meantime, if you are scheduled for a knee replacement or stent or a new heart valve, be aware that medical devices now come with an invisible warning from industry:

In event of a major defect or other serious harm: You’re on your own.

Maryann Napoli, Center for Medical Consumers © May 2008

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Avoid Drug-Related Injury

Posted by medconsumers on May 1, 2008

One Way to Avoid a Drug-Related Injury

It can take years to learn the full range of serious adverse reactions to prescription drugs. That point was driven home last month when, in one issue of the journal Archives of Internal Medicine, several studies revealed new-found harms. The popular diabetes drugs, Actos and Avandia, increase the chance of having a fracture. Fosamax and other drugs in the class known as bisphosphonates, widely prescribed for osteoporosis since 1995 to prevent fractures, can cause an irregular heartbeat called atrial fibrillation. And postmenopausal hormone drugs, once aggressively urged for all women over 50 to prevent heart attacks and strokes actually cause strokes in some women, regardless of the type of hormone regimen or when it was started.

You get the picture: the drugs taken to prevent one major health problem can often cause another. The editorial that accompanied these new studies offered the excellent suggestion that doctors should quantify the benefits and risks so their patients can fully understand what they are getting into once they are told to go on long-term drug therapy. If, say, a bone drug helps only one in 100 women avoid a hip fracture and the same drug causes a potentially fatal atrial fibrillation in one in 100, then it’s a wash.

Jerry Avorn, MD, and William H. Shrank, MD, Harvard Medical School, offered a more immediate suggestion for avoiding drug-related injuries that targets people over the age of 65 years, the group with a high prevalence of adverse drug reactions. In a recent issue of the British Medical Journal, Avorn and Shrank wrote, “When an elderly person experiences an adverse drug reaction, it may be mistakenly attributed by the patient or doctor to a new disease or (even worse) the aging process itself. Examples include the parkinsonian side effects of many antipsychotic drugs and the fatigue, confusion, or depression-like symptoms that can result from excessive use of heavily marketed psychoactive drugs.”

Avorn and Shrank go on to describe what they called an opportunity for “total cure” by stopping the offending drug or lowering its dose. “In our own practices we have often seen patients on a seemingly inexorable trajectory towards institutional care whose functional capacity was restored by thoughtful reassessment of their drug regimens. This has led to the useful if overstated recommendation that any new symptoms in an older patient should be considered a possible drug side effect until proved otherwise.”

Maryann Napoli, Center for Medical Consumers ©
May 2008

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Anemia Drugs For Cancer Patients

Posted by medconsumers on March 13, 2008

Testimony Submitted to FDA Oncologic Drugs Advisory Committee Meeting
March 13, 2008

Maryann Napoli, Associate Director, Center for Medical Consumers

As a consumer advocate who attended the May ODAC meeting, I came away wondering why these drugs remain on the market. They cause some patients to die sooner. They have many other risks that are severe and well documented, and any quality-of-life benefit has yet to be proven. The FDA approved the first ESA because it reduced the percentage of patients transfused. But the agency has since acknowledged that the infectious disease risks of a blood transfusion are far lower now than they were in 1993.

No doubt there are many cancer patients who see these drugs as an instant cure for chemotherapy-induced fatigue or as the means of allowing chemotherapy to continue. The former indication was fostered by Johnson & Johnson’s fraudulent ad campaign for Procrit, which continued for seven years in the mainstream TV and print media. I urge ODAC to discuss the misconceptions imparted by these ads and to consider recommending that the FDA require J&J to run a corrective ad campaign.

The ability of a cancer patient to make a truly informed decision with the help of her oncologist is seriously compromised by J&J’s and Amgen’s reprehensible practice of offering rebates—that is, kickbacks—to oncologists. Patients are always encouraged to discuss their treatment decisions with their doctors. Yet it’s hard for patients to believe oncologists’ recommendations are unbiased when they are “reaping millions” from the prescription of anemia drugs, as The N.Y. Times reported last May. (1) Companies that give kickbacks and other financial incentives intended to manipulate oncologists into using the most expensive drugs are poisoning the doctor/patient relationship.

Where can people turn for unbiased information? It should be the FDA, but it’s not clear to me that black box warnings are the way to go. The changes in the product labeling in 2004 did not change clinical practice. (2) And what do we know about the effects of black box warnings on the ones who need them the most—the cancer patients? The cancer patient should be given scientifically accurate, written information about ESA well before she needs it. The time to weigh the risks and benefits is not when she’s awaiting her next chemo treatment and just learned that her hemoglobin is too low for the next round.

Patients cannot make truly informed decisions unless they are given quantitative information to help them decide whether ESA is appropriate. They need to know, for example, the chances of…1) needing a transfusion; 2) suffering harm by foregoing a transfusion, 3) experiencing a serious adverse effect from the transfusion itself, and 4) having a severe adverse effect from the ESA. Patients need to know the magnitude of each of these four risks. Telling them that ESA will reduce their risk of having a blood transfusion is simply too vague. It gives them no way to compare this purported benefit with the other risks of taking ESA. If the FDA will not remove these drugs from the market, it must find the best ways to get clearly written, accurate quantitative ESA information to cancer patients.

(1) Berenson A, Pollack A. “Doctors Reap Millions for Anemia Drugs.” N.Y. Times, May 9, 2007

(2) Blau AC. “Erythropoietin in Cancer: Presumption of Innocence?” Stem Cells 2007; 25;2094-2097; originally published online Apr 26, 2007.

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Overtreated—Why too much medicine is making us sicker and poorer

Posted by medconsumers on March 1, 2008

New Book:  Overtreated  by Shannon Brownlee (NY: Bloomsbury, 2007)

In a nutshell, overtreatment is unnecessary treatment. It’s treatment that has no positive impact on health or longevity, and in many cases, causes harm. It’s the coronary-artery opening procedures given yearly to more than one million Americans for whom drug therapy has been proven to be the better choice. It’s the long-term drug regimens recommended to people at low-risk for hip fracture, heart attack or stroke. It’s the PSA blood test for finding prostate cancer at its earliest stage, despite the fact that studies have yet to prove immediate treatment is better than no treatment at all. Just to name a few.

About one-third of the medicine we receive is unnecessary, according to “Overtreated” by journalist Shannon Brownlee. “We spend between one fifth and one third of our health care dollars, between $500 and $700 billion, on care that does nothing to improve our health.” Central to this excellent book is the work of John Wennberg, MD, whose pioneering research spans four decades.

Wennberg was the first to detect wide geographic variations in medical care, first within his home state of Vermont and later in the country at large. Wennberg recalls that he embarked on this research project in the late 1960s with a notion shared by many doctors of that era: The most serious problem in American health care was that many citizens were not getting enough of it. Still, it was startling to find, for example, that in Middlebury, VT, 7% of children under the age of 16 had their tonsils removed, and in Stowe, VT, 70% of children had the operation. Similar variations were shown for other procedures like hysterectomy, hernia operations and hospitalizations for heart attacks.

Extensive interviews of 4,000 people living in this most homogeneous of states ruled out the obvious explanations like patient demand and the possibility that people were sicker in some areas of Vermont. The high rates of surgery were, in fact, driven by doctors not patients. Findings like these ultimately led Wennberg to conclude, “Medicine had wrapped itself in the mantle of science, yet much of what doctors were doing was based more on hunches than good research.” Wennberg’s work drew hostile reactions from fellow physicians, and medical journals turned down publication of his findings. When they were finally published in Science magazine in 1973, they drew no attention. More medical care was still considered to be better care.

Cost Becomes an Issue

In time Medicare provided Wennberg, who had moved on to Dartmouth Medical School, with a treasure trove of patient records to learn not only about regional variations in care for everyone over age 65 but also the cost of treatment. Cost had become a major issue for Medicare by 1995 due to the huge 6000% increase in spending over the 30 years following its launch. With Dartmouth colleagues, Wennberg spent the next three years combing through the Medicare data. One example of what they found: Medicare spent an average of $8,414 for an enrollee living in Miami compared with $3,341 for an enrollee in Minneapolis.

The price of major treatments, as it turns out, played an insignificant role in explaining the differences. The cost of a hip replacement, for example, was only slightly more in Miami than in Minneapolis. Another obvious possibility—elderly people are sicker in some areas of the country than in others—also accounted for only a small difference in cost.

Findings like these began to get national media attention, but the Dartmouth researchers still had to determine whether more care means better care. In 2000 Wennberg’s colleague Elliott Fisher, MD, conducted another study that showed Medicare recipients living in high-cost regions were no healthier and no less disabled than those in regions that got less medical care. The big shocker, however, was this: More care sometimes led to more deaths.

Ultimately, Fisher showed that the people in high-spending regions were not getting more major surgery. Rather they were getting more tests, drugs and procedures that were likely to be done even when it didn’t make sense in frail elderly people with a short life expectancy. An excess of specialists was a major part of the problem. “Patients with heart attack, hip fracture or colon cancer got more care—but not better care—in hospitals where there were more specialists,” concluded Fisher.

Eventually Fisher determined that the 2-6% increase in deaths among Medicare recipients living in high-cost regions was due to the fact that they spent more time in the hospital. Patients are exposed to all the risks that include hospital-borne infections, medical errors and the complications and side effects that come with any treatment.

The results of the Wennberg and Fisher studies have been known for years and have long been available to all in the Dartmouth Atlas of Health Care (www.dartmouthatlas.org). The author of the new book “Overtreated,” Shannon Brownlee, a senior fellow at the New America Foundation, provides a public service by calling attention to this important research which is even more relevant today when the newest costliest imaging, cardiac and other high-tech procedures receive almost instant uncritical acceptance.

Brownlee brings us up to speed on the few surgical procedures and drugs that are well studied and proven to be of value…but to a much smaller proportion of current recipients. One outstanding example is the coronary-artery-opening procedure called angioplasty, which, by the way, was shown to have wide regional variations by West coast researchers building on the Dartmouth researchers’ work.

Each year two million Americans receive an angioplasty, but studies show that only 800,000 of them who are in the midst of a heart attack are likely to benefit. The majority have other cardiac-related conditions like stable angina or shortness of breath, which can be more safely and effectively treated with the same drugs that will be given after an angioplasty. In a 2006 federally funded trial, the rate of death and heart attack was lower in those treated with multiple-drug therapy alone than in those given angioplasty plus multiple-drug therapy. Angioplasty with a stent costs insurers $10-15,000.

While angioplasty is an example of doctors ignoring scientific evidence that clearly shows who should get this treatment and who should not, there is no definitive information one way or another about the vast majority of tests and treatments. The Institute of Medicine estimates that only 4% are backed up by strong scientific evidence, more than half have very weak evidence or none.

Malpractice fears cause doctors to order more tests, but to Brownlee the more powerful reason doctors and hospitals overtreat is they are paid more for doing more. She calls for an overhaul of malpractice laws because they fail to punish and weed out incompetent doctors and to compensate patients for injuries that result from medical errors.

Brownlee takes consumers to task for contributing to overtreatment by making irrational demands for drugs advertised on TV or over-the-top diagnostic tests like an MRI for a sprained ankle. She calls for more independent sources of information like the federal Agency for Healthcare Policy and Research so that consumers can be better informed. Studies show that when they are given high-quality decision aids describing the benefits, risks and unknowns about treatment options, many will make an informed decision not to be treated.

The last chapter called “Less is More” presents solutions that will go a long way toward fixing our dysfunctional system. The ideal medical care system Brownlee envisions is one that rewards doctors for using evidence to improve quality; keeps specialist care to a minimum; coordinates care in ways that will reduce errors and overtreatment—among other ideas. Pie in the sky? Brownlee says that several U.S. health care systems have already implemented these ideas—Kaiser Permanente, Veterans Health Administration (VHA), Group Health of Puget Sound and the Mayo Clinic where doctors are on salary.

The VHA is especially interesting because it managed to turn around a failed medical care delivery system in less than a decade. The VHA decentralized its health care; put doctors on salary; makes sure every veteran has a primary care doctor at a local VHA clinic; rewards hospitals that hit performance measures set by Washington; negotiates discounts for drugs; and computerizes patient records to reduce medical errors and repeat testing. In 2003 The New England Journal of Medicine published a study that compared veterans’ health facilities with traditional Medicare. The quality of the care delivered at VHA health facilities proved to be significantly better on nearly all 11 performance measures.

Yet-another kudo for the VHA came from the independent National Committee for Quality Assurance which ranks health-care plans according to 17 performance measures, such as prescribing beta blockers for patients after a heart attack. By every measure, the VHA system outperformed the highest rated non-VHA hospitals, including those widely perceived to be the best in the country.

If the VHA can do it….

Maryann Napoli, Center for Medical Consumers©March 2008

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Failed Vytorin Study Raises Questions About Cholesterol

Posted by medconsumers on February 1, 2008

A firestorm of bad publicity erupted over cholesterol drugs last month when an expensive combination drug proved to be no better than an older drug alone. This finding was suppressed for 20 months by Merck and Schering-Plough, the two companies that make Vytorin, which is a one-pill combination of Zetia and Zocor. Their two-year trial failed to prove that Vytorin is better than Zocor alone for slowing plaque accumulation; instead atherosclerosis worsened in those taking Vytorin.

But the study results were not revealed until the two drug companies were pressured into doing so by an article in The New York Times and a Congressional inquiry. Worldwide, about one million prescriptions for Vytorin and Zetia are written each week, and they generated about $5 billion in sales last year. Zocor can be purchased under its generic name simvastatin for less than $6 for a month’s supply; whereas an equivalent amount of Vytorin costs about $100. It was obviously in the two companies’ interest to withhold the negative results for as long as they could get away with it.

When Vytorin came on the market two years ago, it was impossible not to be cynical about its purpose. Merck’s patent for Zocor was running out, and its blockbuster status would soon be diminished with generic competition. The company joined forces with Schering-Plough, maker of Zetia, and sought FDA approval for Vytorin. Their FDA-required trials showed a 17% greater reduction in LDL, the so-called bad cholesterol, than Zocor alone.

Making this 17% reduction in LDL look like an amazing achievement was not much of a stretch. Merck and the makers of other statin drugs like Lipitor and Pravachol had already paved the way. Their respective marketing machines had long ago misled most of us (doctors included) into thinking that cholesterol reductions equal heart attack reductions. One consistently overlooked fact about statins: They are far better at lowering cholesterol than preventing heart attacks or strokes. And those small reductions in heart attacks and strokes shown in clinical trials are largely confined to high-risk middle-aged men and those with heart disease or diabetes. Vytorin, on the other hand, has not been proven to reduce heart attacks or strokes in anyone.

LDL Reduction Irrelevant

Though doctors tend to focus their statin-taking patients on the size of their LDL reductions, heart disease researchers have long ago noted that this is likely irrelevant. Statin trials often show that the size of the cholesterol reductions are not consistent with reductions in heart attacks. Such observations led researchers to suspect that the ability of statins to reduce heart attacks and strokes has less to do with cholesterol reduction and more to do with other biological effects like plaque stability and anti-inflammatory effects. Another important but overlooked observation: “Elevated LDL identify less than one half of individuals who will die from coronary heart disease” (Rosenson et al. Antithrombotic Properties of Statins, JAMA, May 27, 1998).

The fall-out from the Vytorin debacle continues to reverberate. At this writing, Merck and Schering-Plough are running full-page ads daily in the Times and Wall Street Journal, warning people not to be confused by a single study and to continue taking Vytorin. The advice was backed by the American Heart Association, which appeared to be an independent source until The Times reported that the AHA receives nearly $2 million a year from Merck/Schering-Plough Pharmaceuticals.

One of the unintended consequences of two drug companies withholding their negative trial results is that it led some in the media, notably Alex Berenson, an investigative reporter for the Times, to look back at another important failed cholesterol drug trial and question the very foundation of heart disease prevention. In his heretically titled article “Cholesterol as a Danger Has Skeptics,” Berenson cites Pfizer’s trial of its much-anticipated drug torcetrapib that raised HDL, the good cholesterol, and lowered LDL. The trial had to be stopped in 2006 because the drug caused heart attacks and strokes. (Sound familiar? Postmenopausal hormones were widely prescribed because they were so good at improving cholesterol levels but they also increased the risk of heart attack, stroke and blood clots.) “Torcetrapib’s failure shows that lowering cholesterol does not prove a drug will benefit patients,” said a skeptical Walter Reed cardiologist quoted in Berenson’s article.

Many researchers, physicians and scientists around the world have long questioned the import of high cholesterol for anyone other than middle-aged men. In fact there is an International Network of Cholesterol Skeptics (disclosure: we belong), but the skeptics have been marginalized over the years. Now some mainstream media like Business Week and the cardiology Web site, TheHeart.org are willing to give them voice.

Could the house of cards be falling? Would the house of cards be allowed to fall when a worldwide $40 billion-a-year industry is at stake?

For More Information

The International Network of Cholesterol Skeptics www.thincs.org

Business Week magazine (www.businessweek.com) click into past issues, January 17, 2008 Lipitor cover story: “Do Cholesterol Drugs do any Good?”

TheHeart.org from Web MD www.theheart.org, see video blog of Eric J. Topol, MD, who questions the import of LDL reduction in “Temple of the LDL Cholesterol.”

Maryann Napoli, Center for Medical Consumers ©
February 2008

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Heart News 2007

Posted by medconsumers on December 31, 2007

The heart-related news has lately been a roller coaster of good, bad, and maybe not so bad. One popular prescription cholesterol-lowering statin drug might soon be sold over the counter. Defibrillators of the kind implanted years ago in Vice President Dick Cheney were in the news last month when studies showed they are more likely to be given to white men. But this needn’t be seen as yet-another example of women and minorities deprived of appropriate heart care. A new study showed that men with implanted defibrillators had a higher death rate than women with exactly the same heart condition who were not given implanted defibrillators.

And remember those drug-coated stents that scared heart patients over a year ago when it was announced that they increased the risk of potentially fatal blood clots long after they were inserted to prop open a constricted artery? Well, drug-coated stents made headlines again last month suggesting that they may not be so dangerous after all.

What do we make of all this?

For starters, an over-the-counter cholesterol-lowering drug might be a good idea for certain people. Not simply as a money-saver, but as a means of getting good-quality written drug information to the user. With a few exceptions, prescription drugs do not automatically come with FDA-approved printed information, though it comes tucked into the packaging of virtually all drugs sold over the counter.

We might be grasping at straws here, but mandated consumer drug information produced with FDA oversight is far better than the current situation. Then warnings like this about Lipitor—“tell your doctor if you have more than two drinks a day”—might actually reach the people who take the drug.

The prescription drug under consideration for over-the-counter status is Mevacor. That it is a statin drug and therefore a member of the top-selling drug class worldwide—$35 billion in annual sales—makes the switch all the more interesting. (Other statins are Lipitor, Crestor, Lescol, Pravachol, and Zocor.) Merck, the company that makes Mevacor, has recently applied to the FDA for permission to sell the drug over the counter. And an advisory committee of experts will decide the issue this month. (In 2005, an FDA Advisory Committee rejected a similar application for Mevacor.)

Two statin drugs Pravachol and Zocor are already available generically, which means that their patents have run out and now any company can produce these drugs under their generic names at a far lower cost than any brand-name statin. For example, Zocor, prescribed generically as simvastatin, costs from 75 cents to $1 a day at most retail drug stores and 10 cents a day, if purchased at a discount pharmacy like Costco’s. Lipitor, on the other hand, can cost $2.50 to $4 a day. From the FDA point of view, generic versions are equivalent to branded drugs because they must go through a process of proving that to the agency.

Many drug plans are encouraging members who take an expensive statin to switch to one of the generic versions with financial incentives like lower co-payments. And if Mevacor gets FDA approval for over-the-counter sale, statin users will have yet another low-cost alternative with the added feature of eliminating some doctor visit charges.

All this is cutting into the huge profits long enjoyed by Pfizer, the company that makes Lipitor, which is the most prescribed drug in the world. Naturally, the company wants to make as much money as possible before Lipitor loses its patent in March 2010. Consequently, Pfizer has escalated its long-running ad campaign featuring Dr. Robert Jarvik, inventor of the Jarvik artificial heart, who has been hugely successful in convincing many doctors and consumers that Lipitor is superior to other statins.

Currently, some of the Jarvik/Lipitor ads, say, “There’s a common misconception that all cholesterol-lowering medications are the same.” And more specifically, “In clinical studies LIPITOR lowered bad cholesterol significantly more than generic Zocor and Pravachol.”

Both points refer to a 2004 clinical trial that found people with heart disease showed a reduced degree of atherosclerosis progression if they were on high-dose Lipitor (80 mg) for 18 months, compared with those on a moderate dose of Pravachol (40 mg). There was also a greater reduction in LDL, or “bad” cholesterol, shown in the heart patients who took the high-dose Lipitor.

Three things to keep in mind about this trial, known by its acronym REVERSAL: Its participants all had heart disease (the overwhelming majority of U.S. statin-takers do not); REVERSAL was not designed to see whether Lipitor or Pravachol prevented heart attacks or strokes. And lastly, it compared a high-dose of Lipitor with a moderate-dose of Pravachol, leaving open the possibility that Pravachol at 80 mg might be just as good. Still, REVERSAL provides the basis for the Pfizer claim that Lipitor is not only better than other statins but it should also be prescribed in high doses for people with heart disease.

As for the most crucial goals of statin therapy: all statins, with the exception of Crestor, have been shown in clinical trials that predate REVERSAL to reduce the risk of heart attack and stroke in people who already have heart disease.

Healthy But High Risk

As for people without heart disease, the proven benefit of statins is largely confined to high-risk men between 30 and 69 years. The magnitude of this benefit, however, is not impressive—1.5% fewer of those taking a statin will suffer a non-fatal heart attack. But one analysis of all statin primary prevention trials showed that this 1.5% benefit was canceled out by an equivalent risk of experiencing a serious reaction to the statin.

The promotional activities of statin manufacturers have successfully focused most doctors and the general public on the excellent cholesterol-lowering effects of these drugs. But no head-to-head comparison study of all six statins has answered the most important-to-consumers questions: Which drug is best at preventing a heart attack or stroke? How large is the benefit?

There is a Jarvik/Lipitor print ad that answers the how-large-is-the-benefit question for high-risk people without heart disease. “In patients with multiple risk factors for heart disease, Lipitor reduces risk of heart attack by 36%* if you have risk factors such as family history, high blood pressure, age, low HDL (‘good’ cholesterol) or smoking.” In smaller print, the same ad has this explanation of “reduces risk” under the asterisk: “That means in a large clinical study, 3% of patients taking a sugar pill or placebo had a heart attack compared to 2% of patients taking Lipitor.” This ad is a rarity because it explains the 36% reduced risk. Take Lipitor for years and your risk of having a heart attack drops from 3% to 2%.

Lately, Pfizer has been trying to stem the exodus to generic statins by touting a new study that purportedly shows more heart attacks or strokes in people who switched from Lipitor to simvastatin, compared with those who stayed on Lipitor. There’s little reason to take this study too seriously.

First of all, Pfizer funded the study, and drug company-funded studies are notorious for coming up with conclusions that favor their products. Second, it was presented on a poster at a recent European cardiology conference, and has yet to be published or fully peer reviewed. (The New York Times, however, recently reported that this study has been accepted by the British Journal of Cardiology and will soon be published.) Lastly, the study is based on an analysis of medical records of British heart patients who did or did not switch from Lipitor to the generic version of Zocor (simvastatin). The study’s design is not regarded as high quality; in fact the authors describe its limitations this way: “This is an observational database study, and as such has recognizable limitations; therefore the findings should be regarded as hypothesis-generating.”

NB: There’s a consensus among cardiologists that statins are generally safe and are extensively studied. Perhaps they are, but three of the five major primary prevention randomized trials have not released all of their statistics on serious adverse reactions, according to James Wright, MD, and John Abramson, MD, who co-authored a commentary early this year in The Lancet, entitled “Are Lipid-Lowering Guidelines Evidence-Based?” The full story about the safety of statin drugs is unknown.

NEWS ABOUT DEFIBRILLATORS

An unexpected finding showed up when a team of Duke University researchers tracked elderly people with heart failure who did and did not have defibrillators implanted to prevent sudden death. Those who had a defibrillator implanted lived no longer than those who did not. That was the contrary-to-expectations finding 180 days after implantation.

But when these heart patients were followed longer, the results were worse for the men. Their mortality rate in the year after implantation was higher than that of women without defibrillators, though all had similar heart problems. To take into account the fact that women live longer than men, Leslie H. Curtis, PhD, and colleagues at Duke University School of Medicine, confined their study to men and women under the age of 75 years.

Their new findings come at a time when implantable defibrillators are, once again, in the news for having serious defects that have caused a few deaths. These devices monitor the patient’s heart rhythm and deliver an electric shock once dangerously erratic rhythms are detected.

The Duke researchers analyzed a national 5% sample of the Medicare claims filed for more than 35,000 people from 1991 through 2005. All had been diagnosed with heart attack and either heart failure or cardiomyopathy. Men were three times more likely than women to have the device implanted. Of those with heart disease but no prior cardiac arrest or tachycardia (rapid heartbeat), defibrillators were implanted in 32 per 1,000 men and about 9 per 1,000 women.

The gap between man and women didn’t close for the most seriously ill patients—those with prior cardiac arrest or tachycardia. For this group, the implanted defibrillator rate was 102 per 1,000 men and 38 per 1,000 women.

A related study, published in the same October 3 issue of the Journal of the American Medical Association, found that black men and women were also less likely to have a defibrillator implanted than white men.

“The bad news may not be for women and minorities, but for white men who are undergoing a procedure that for primary prevention does not extend their lives,” wrote Rita F. Redberg, MD, in an editorial that accompanied the two studies.

NEWS ABOUT DRUG-COATED STENTS

The bad news about this topic originally came from the World Congress of Cardiology in September 2006. Presented at this international conference were clinical trials that found a slightly increased risk of death and a higher rate of potentially fatal blood clots in people who had drug-coated stents implanted during a coronary-artery-opening procedure called angioplasty. The trials compared them with other heart patients whose constricted coronary arteries were propped open with stents not coated with a drug.

The higher risks among those given drug-coated stents did not show up until four years of follow-up. These complications were confirmed in two separate analyses of the combined results of company-sponsored trials by Boston Scientific, maker of the Taxus stent, or Johnson & Johnson, maker of the Cypher stent. The medicine coating these stents is intended to keep the constricted arteries from closing up again.

Last month the national media reported good news about drug-coated stents from the annual meeting of the American Heart Association in Orlando, Florida. Two-year follow-up results from a new, yet-to-be-published clinical trial showed that drug-coated stents are no more risky than bare-metal stents. Some media reports left the impression that the issue of stent safety had been resolved with this trial. “Heart Stent Gets a Reprieve From Doctors” was the over-the-top New York Times headline.

Keep in mind that the new trial announced at the heart meeting lasted only two years and the blood clots in the above-mentioned company-sponsored trials did not show up until four years. More details will be available when the new trial is published in Circulation, the journal of the American Heart Association, according to a “Late-Breaking News Release” from the heart meeting.

The meeting organizers managed to focus the media on stents rather than the more critical issue—overuse of artery-opening procedures. Many of the one million or so Americans who undergo angioplasty each year (with or without stents) can be treated just as successfully with drug therapy. It is generally the same multiple drug therapy advised for everyone who undergoes angioplasty. This was proven in a government-sponsored study called the Occluded Artery Trial, or OAT, published last year in The New England Journal of Medicine. A follow-up analysis of the OAT results was presented at the American Heart Association meeting. Yet no mainstream media reported the new OAT analysis, according to Health News Review, a medical media watchdog group led by journalist Gary Schwitzer.

All 2,166 OAT participants had a totally blocked major coronary artery and were 3 to 38 days away from suffering a heart attack. All were randomly assigned to receive an artery-opening procedure plus drug therapy or drug therapy alone. The multiple-drug therapy included daily aspirin, beta-blockers, ACE inhibitors and cholesterol-lowering drugs.

After four years, the OAT participants in the angioplasty/drugs group had the same rate of survival, second heart attack, and heart failure as the group given drug therapy alone. When the 469 American OAT participants were singled out (this was an international trial), the angioplasty-treated heart patients generated costs that were $10,000 higher than the drug-treated people. After three years, the cost difference had dropped to $7,000.

In an editorial that accompanied the OAT findings last year in The New England Journal of Medicine, L. David Hillis, MD, and Richard A. Lange, MD, wrote, “The open-artery hypothesis, although not previously validated in a prospective, randomized study, has nonetheless been embraced by many practicing physicians.” Translation: Heart surgeons have been opening constricted coronary arteries for years on the unproven premise that this will save lives and reduce the risk of a future heart attack. The OAT results failed to validate that hypothesis.

Opening a blocked artery during or right after a heart attack has been proven beneficial, but the OAT results showed no benefit to the common practice of performing angioplasty well after the patient had been stabilized—3 to 38 days after suffering a heart attack.

Maryann Napoli, Center for Medical Consumers ©
2007

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Sinusitis: Saline Irrigation Works

Posted by medconsumers on September 1, 2007

An Old Sinusitis Treatment Makes a Comeback: Nasal Saline Irrigation

Sinusitis sends millions of adults and children to the doctor each year. And many receive inappropriate treatment. Though studies show that viruses are by far the most frequent cause of a sinus infection, U.S. physicians reported that they prescribed antibiotics in 82% of visits nationwide for this condition. Despite contradictory results from studies exploring the efficacy of inhaled nasal corticosteroids, these drugs are also prescribed frequently.

These are some of the alarming findings from a study reported early this year in Archives of Otolaryngology. The authors, Hadley J. Sharpe and colleagues at the University of Nebraska Medical Center in Omaha, based their study on physician-generated information from two national surveys of patient data collected during visits for ambulatory care from 1999 to 2002. The misuse of antibiotics is of particular concern because it contributes to the increase in more virulent and drug-resistant bacteria.

“Watchful waiting, lavage with saline solution, and use of decongestants or proper antimicrobial agents are the treatments of choice,” wrote the University of Nebraska research team, referring to the steps doctors should go through in treating acute sinusitis. Acute rhinosinusitis, as it is also called, usually lasts less than four weeks, and a short-term antibiotic regimen can in fact provide relief to a minority with a bacterial infection. But the effects of antibiotics on chronic sinusitis, defined as symptoms lasting 12 weeks or longer, were described by the University of Nebraska researchers as questionable.

Enter Saline Irrigation

This study exposed the poor quality of sinusitis treatment in the U.S. Does it provide an impetus for increased use of a home treatment called nasal irrigation, which involves sending a buffered salt-water solution up one nostril and out the other? “Absolutely,” agreed Otolaryngologist Donald A. Leopold, MD, a co-author of the University of Nebraska study, in a telephone interview.

“90% of my patients are rinsing their noses. It’s so easy and inexpensive, and in many ways, solves the whole problem,” said Dr. Leopold, who is professor and chair of the department of otolaryngology-head & neck surgery at the University of Nebraska Medical Center, Omaha. “It’s the every day, and sometimes twice a day, use of this stuff that makes the difference. It’s something the patients have to do on an ongoing basis, and if they do, they get better.”

Nasal saline irrigation recently received validation from a Cochrane review of all relevant clinical trials. After noting that this treatment has its foundations in yogic and homeopathic traditions, the Cochrane review concluded, “There is evidence that [saline irrigations] relieve symptoms of chronic rhinosinusitis, help as an adjunct to treatment and are well tolerated by the majority of patients.”

Allergies can also be relieved with daily nasal saline irrigation, according to two studies involving children with seasonal allergic rhinitis. Those who were randomly assigned to nasal irrigation had a decrease in symptoms and a reduced intake of antihistamines.

Range of Products Available

In the practice of yoga, nasal irrigation involves the use of a neti pot, which can be purchased at most health food stores and resembles a teapot with a narrow spout. With the head tilted sideways, the salt-water solution is poured into one nostril and, in turn, goes down the other. Today nasal irrigation can be accomplished more conveniently while leaning over the bathroom sink and using one of the over-the-counter variations on a flexible plastic squeeze bottle.

Available at most pharmacies under such brand names as NeilMed Sinus Rinse™ and SinuCleanse,TM the products are sold with packets that combine sodium chloride (salt) and sodium bicarbonate (baking soda). The latter acts as a buffer against the stinging and burning sensation caused by salt water alone. These products make saline irrigation easy for children as well as adults.

Another product called Rhinotip™ is designed to fit over the jet tip end of most dental irrigators.

No independent head-to-head comparison study of these over-the-counter nasal wash products has been conducted to determine which is best in terms of ease of use and the reduction of symptoms and use of medications.

Whatever Works

“It’s up to the individual,” said Dr. Leopold when asked which product he recommends to his patients. “I will typically introduce all the different ideas [for nasal irrigation] and if a patient says, ‘I thought it was uncomfortable pressure,’ then I will switch them from a squeeze bottle to a neti pot, for instance. And some of my patients prefer a power wash with WaterPikR which is inserted a number of inches into the nose,” Dr. Leopold continued “Whatever product makes them comfortable and lets them do it on a regular basis is the one I would like to push. Most feel better after they’ve done it, especially if you have a cold, it’s the best way to make cold go away. A small minority feel irritated by [saline irrigation], but most want to do it all the time.”

The lead author of the Cochrane review about saline irrigation, otolaryngologist Richard Harvey, MD, Royal National Throat Nose and Ear Hospital in London, U.K., was asked by e-mail whether he advises his patients to do regular nasal saline irrigations and if so, which product is recommended. “While this is an area of ongoing research, my clinical judgement and experience from working with world leaders in nose and sinus care, suggests that squeeze bottles, such as NeilMed Sinus RinseTM, and pressurised sprays which can deliver high volumes, such as Physiomer (Goëmar Laboratories, France), under positive pressure are probably the most effective.”

In a telephone interview, K.C. Mehta, MD, the California-based lung specialist who developed NeilMed Sinus RinseTM, explained the importance of “positive pressure” and “high volume” in clearing out the nasal passages. “The key to symptom relief is to physically displace and wash away excess mucous and along with it allergens, such as grass and tree pollen, dust particles, pollutants and bacteria from the nasal passages. This in turn reduces inflammation of the mucosa membrane allowing you to breathe more normally.”

Dr. Mehta says that he suffered for years with sinus infection; had all types of treatments, including surgery; and finally decided that saline irrigation worked the best in terms of controlling symptoms. He went on to develop his own products that overcome the messiness of using the traditional neti pot and introduce the high-volume, positive pressure needed to wash out the excessive mucous and allergens. A step-by-step illustration of how to use the product can be found at www.neilmed.com. [Disclosure: The writer of this article has a friend who works for the company that makes NeilMed Sinus RinseTM.]

A Trend in the Works

Saline nasal irrigation appears to be catching on, and it is the ear/nose/throat specialists who are leading the way, rather than primary care physicians. The specialists first recommended the practice as aftercare for people who have had sinus surgery. Now, saline irrigation is becoming day-to-day standard care.

And according to Dr. Leopold, word of mouth from satisfied customers is also driving the trend. “People are becoming missionaries giving saline packets to their friends with sinus problems.” Consumer satisfaction is reflected in the sales of these saline irrigation products which have doubled annually for the last few years, according to the independent market data provided by A. C. Nielsen.

Role of Antibiotics

Given the fact that the University of Nebraska study found misuse of antibiotics to be common in the treatment of rhinosinusitis, Dr. Leopold was asked how people would know when antibiotics are appropriate. “If the person has a high fever, that could be an indication for an antibiotic,” he answered. “And if they have chronic respiratory problems like asthma, I typically tell them to take antibiotics early on. I’m aggressive up front with those folks.”

But the symptoms of a cold should be gone in two or three days in people without chronic respiratory problems who rinse their noses regularly, Dr. Leopold explained, and if they are still clogged up, then an antibiotic may be appropriate. He dismissed as “unreliable” the prevailing notion that greenish-yellow mucous always signals the need for an antibiotic.

The treatment of sinus infection seems to have come full circle where it concerns saline irrigation. “Medicine rolls in trends, just like fashion,” said Dr. Leopold. “Rinsing the nose had been a huge deal around the turn of the last century. There were a lot of articles back then about rinsing solutions and rinsing devices,” he explained, but interest died out once antibiotics, “the miracle drugs,” became available.

Now nasal saline irrigation is making a comeback.

Maryann Napoli, Center for Medical Consumers ©
September 2007

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