Test Detects 12 Types of Respiratory Viruses

Talk about a "shotgun workup" -- this is a test which simultaneously looks for presence of 12 viruses that infect the human respiratory tract.

The U.S. Food and Drug Administration has just approved the xTAG Respiratory Viral Panel, which with a single patient sample, can detect 12 separate viruses in a few hours. These tests previously required several days. This test might help identify patient with viral infections earlier. Patients with viral respiratory infections are frequently misdiagnosed as having bacterial pneumonia. Earlier and more accurate diagnosis might prevent the use of ineffective antibotics -- used to treat bacteria -- and allow the earlier use of antiviral agents.

According to the press release, the xTAG Respiratory Viral Panel tests for

-- Influenza A, influenza A-H1, influenza A-H3 and influenza B,
which cause the majority of flu cases in the U.S.;

-- Adenovirus, which is responsible for approximately 10 percent
of respiratory infections and a subtype of which the Centers
for Disease Control (CDC) have recently identified as causing
multiple deaths;

-- Respiratory syncytial virus (RSV) A and B, the most common
cause of bronchiolitis and pneumonia in infants and children;

-- Metapneumovirus, a recently-discovered virus that causes
flu-like symptoms and is thought to be the second leading
cause of respiratory infection in children;

-- Parainfluenza 1, 2, and 3, which can cause upper or lower
respiratory infections in adults and children and, are thought
to be responsible for about half of croup cases and 10-15
percent of bronchiolitis and bronchitis cases; and

-- Rhinovirus, which causes the common cold.

The xTag Respiratory Viral Panel is the first multiplexed nucleic acid test for respiratory viruses approved by the FDA.

Labels: fda, xtagrespiratory viral panel

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iGuard: A New Drug Safety Website

iGuard.org, a new website that recently launched, aims to help patients be better informed about their medications and about new safety alerts.

All medications have potential side effects, and it's sometimes difficult for patients to determine by looking at medication labels whether a given drug is truly "risky." iGuard seeks to simplify concerns about side effects by placing medications in one of five general risk categories: low risk, general risk, guarded, elevated risk, and high risk.

iGuard uses Risk Ratings to convert medical jargon into simple, actionable information. iGuard Risk Ratings form the basis of a new language that helps you understand more about the safety of your drugs - and respond more effectively as new information emerges.

Anyone who has tried reading a drug label or a medical journal knows how difficult they are to understand. iGuard makes it simple for you to be aware of your risk of developing serious side effects, and to respond effectively to future drug safety information through our iGuard Risk Ratings.

In addition to proving risk ratings, which may highlight medications that have a higher potential for side effects, iGuard provides safety alerts. These alerts may come from the FDA, a drug manufacturer, or from new research studies. If patients register on iGuard, they can receive updated risk profiles and new safety alerts for each of their medications. Patients can have optionally also have these alerts sent to their physicians so they can be informed about what information iGuard is sending them.

Has the nightly news become your source for new drug safety information? Wouldn't you prefer your safety information be sent directly to you in a timely and personalized manner? Welcome to iGuard.

An iGuard Safety Alert is a short message sent to you the patient and your physician (subject to your consent). These alerts are sent as soon as something new is learned about a medicine you have reported taking in your iGuard Profile.

iGuard also encourages physicians to report new potential drug side effects through an interface that also reports to the FDA's MedWatch site. iGuard's business model seems to involve using information provided by patients on side effects to provide partners and clients with early, useful information:

To cover the cost of operating our efficiently structured communication network, iGuard will offer customized drug safety studies, risk management programs, and other research opportunities. We are confident that these market opportunities will cover the cost of our communication network and further our knowledge of drug safety.

Labels: drug safety, fda, iguard

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Risks of the Drug Avandia (Rosiglitazone)

Avandia (rosiglitazone) is a commonly used medication to treat type 2 diabetes. In a study published in the New England Journal of Medicine released online yesterday, Dr. Steven E. Nissen and Kathy Wolski from the Cleveland Clinic analyzed 42 previously performed trials of rosiglitazone. They found that the use of this medication was associated with a 42% increase in the risk of myocardial infarction (heart attack) compared with placebo or other medications used to treat diabetes. The authors caution that this data is preliminary and has many limitations, but it does point to the potential for increased cardiovascular risk from rosiglitazone as compared with other medications used to treat diabetes.

Based on this study, the FDA has issued a safety alert for rosiglitazone:

"FDA remains committed to assuring that doctors and patients have the latest information available to make treatment and medication use decisions. In this case, FDA is carefully weighing several complex sources of data, some of which show conflicting results, related to the risk of heart attack and heart-related deaths in patients treated with Avandia," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "We will complete our analyses and make the results available as soon as possible. FDA will take the issue of cardiovascular risk associated with Avandia and other drugs in this class to an Advisory Committee as soon as one can be convened."

Rather than removing Avandia from the market, the FDA has decided to further study the data. They caution that patients shouldn't stop Avandia on their own without first speaking with their doctor. They also say that is an open question whether the other medication in the same class as Avandia, Actos (pioglitazone), has the same cardiac risks.

Interestingly, in his paper Dr. Nissan suggests that he believes that Actos may have fewer cardiac risks than Avandia. He points to the PROACTIVE trial, which actually show lower cardiac risks with Actos:

The question as to whether the observed risks of rosiglitazone represent a "class effect" of thiazolidinediones must also be considered. Pioglitazone is a related agent also widely used to treat type 2 diabetes mellitus. However, unlike rosiglitazone, pioglitazone has been studied in a prospective, randomized trial of cardiovascular outcomes, called Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROACTIVE). The primary end point, a broad composite that included coronary and peripheral vascular events, showed a trend toward benefit from pioglitazone (hazard ratio, 0.90; P=0.095). A secondary end point consisting of myocardial infarction, stroke, and death from any cause showed a significant effect favoring pioglitazone (hazard ratio, 0.84; P=0.027). Notably, pioglitazone appears to have more favorable effects on lipids, particularly triglycerides, than does rosiglitazone.

Patients taking Avandia and the physicians caring for them have three choices.

1. Continue Avandia.
2. Stop Avandia and use a diabetes medication in a different class instead.
3. Stop Avandia and substitute Actos, which is the same class of medication but which may be safer.

I predict that many physicians and patients with choose option 3, as long as no significant cardiac risks from Actos are identified.

An interview with Dr. Steven Nissen from the Wall Street Journal is below.



Related Link: Medications to Treat Diabetes

Labels: actos, avandia, cleveland clinic, diabetes, fda, new england journal of medicine, steven nissen

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This Week's Interesting Links: Creating Medical Blogs, the FDA and Anemia Drugs, Governor Corzine's Doctors, & Angioplasty isn't like Plumbing

Here are some links that caught my eye over the last week:

Clinical Cases and Images, an outstanding medical blog by Dr. Ves Dimov at the Cleveland Clinic, has a post on "How to start a medical blog in 2 minutes." It points to a video on YouTube by Google showing how to create a new blog with Blogger, a free service. Also described are ways of working with medical RSS feeds to create your own webpage of medical journals.

I spoke about the controversies over anemia drugs in a previous post. Over at the Wall Street Journal Health blog -- an interesting source of information about current health and business issues -- they're following the FDA hearings on the use of drugs like Aranesp, Procrit, and Epogen by oncologists. A sample question by an FDA doctor: "What data do you have to assure me that this is not Miracle-Gro for cancer?"

Governor Jon S. Corzine of New Jersey survived a motor vehicle collision at 91 miles an hour without wearing a seatbelt. He spent 11 days in intensive care and required 3 surgeries on his broken femur. The New York Times has an article including interviews with his doctors.

Finally, Slate, a sharp and well-written online magazine, explores the implications of recent medical studies on angioplasties in Plumber's Butt? The Right and Wrong Way to Think about Heart Attacks. The piece argues that the idea that interventional cardiology is like plumbing is wrong; that not every clogged artery needs to be opened; and that opening up narrowed blood vessels does nothing to prevent future heart attacks. It also features an entertaining look at the history of cardiac catheterization:

Before angioplasty became widespread, the only emergency treatment for heart attacks was to infuse clot-busting drugs like streptokinase into a patient's whole body. This was like running concentrated Drano through a city's water supply to fix a stopped-up sink. It wasn't very effective and also caused side effects like bleeding. In 1929, a budding German crackpot named Werner Forssmann took the first tentative steps to directly unclog blocked vessels, by inserting a urinary catheter deep into his own arm. (A nurse tried to stop him, but he tied her to an operating table.) Forssmann walked up a flight of stairs and took an X-ray showing that the catheter had entered his heart—a feat that earned him the Nobel Prize.

Labels: angioplasty, aranesp, cardiology, corzine, epogen, fda, medical blogosphere, medical blogs, procrit

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The Controversy Over Anemia Drugs (ESAs)

The lead story in yesterday's New York Times had this first paragraph:

Two of the world’s largest drug companies are paying hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines, which regulators now say may be unsafe at commonly used doses.

To summarize: the article not only implies that medications like Epogen, Procrit, and Aranesp -- used to increase the blood count to treat anemia -- are given needlessly, but that doctors and others have strong financial incentives to prescribe these medications and have disregarded the safety of patients.

One physician I know, a nephrologist, was furious at this article. Prior to the advent of Epogen (erythropoetin) and other erythropoiesis-stimulating agents (ESAs), he said, patients with kidney disease on dialysis were routinely dependent on blood transfusions. (Anemia is a common side effect of kidney disease.) They routinely felt awful. In fact, it wasn't until the widespread correction of anemia with Epogen that physicians realized that it wasn't the kidney disease itself that was making dialysis patients feel awful -- it was often the accompanying anemia. The article in the New York Times, he complained, failed to stress this important benefit of Epogen and other drugs.

Previous studies looking at qualify of life of kidney disease patients have suggested that the optimal hemoglobin is 11 - 12 g/dL, and for many years, this range has been the target for therapy. Some physicians assumed that higher hemoglobin levels were likely to be better for certain patients. But recently, studies in kidney disease and cancer patients have noted an increase in heart attacks, blood clots, and other complications when ESAs are given to maintain a hemoglobin of above 12 - 13 g/dL.

From the FDA web site:

Patients currently using or considering the use of an ESA should know the following:

• A higher chance of death and an increased rate of tumor growth were reported in patients with advanced head and neck cancer receiving radiation therapy and in patients with metastatic breast cancer receiving chemotherapy, when ESAs were given to maintain hemoglobin levels of more than 12 g/dL.
• A higher chance of death was reported and no fewer blood transfusions were received when ESAs were given to patients with cancer and anemia not receiving chemotherapy.
• A higher chance of death was reported and an increased number of blood clots, strokes, heart failure, and heart attacks was reported in patients with chronic kidney failure when ESAs were given to maintain hemoglobin levels of more than 12 g/dL.
• A higher chance of blood clots was reported in patients who were scheduled for major surgery and given ESAs.
• ESAs are not approved for treatment of the symptoms of anemia, such as fatigue in patients with cancer, surgical patients and patients with HIV.
• If you have any questions you should talk with your health care provider.

Important study results include the following:

• Patients with chronic kidney failure had an increased number of deaths and of non-fatal heart attacks, strokes, heart failure, and blood clots when ESAs were adjusted to maintain higher red blood cell levels (hemoglobin more than 12 g/dL).
• Patients with head and neck cancer receiving radiation therapy had faster tumor growth when ESAs were adjusted to maintain hemoglobin levels higher than 12 g/dL.
• Patients with cancer not receiving chemotherapy died sooner and had no fewer blood transfusions when ESAs were given according to the dosing recommendations for cancer patients receiving chemotherapy.
• Patients scheduled for orthopedic surgery who received ESAs to reduce blood transfusions during and after surgery had more blood clots than those not given an ESA.

Physicians who prescribe ESAs should consider the important study results above and:

• Understand that ESAs are given to decrease the need for red blood cell transfusions;
• Consider both the risks of transfusions and those of ESAs when deciding to prescribe an ESA;
• Adjust the dose of ESA to maintain the lowest hemoglobin level necessary to avoid the need for transfusions.
• Monitor patients’ hemoglobin levels to ensure they do not exceed 12 g/dL;
• Understand that ESAs have not been shown to improve the outcomes of chemotherapy treatment (e.g., better tumor shrinkage, delay in tumor growth or longer time for survival); and
• Understand that in patients with cancer whose anemia is caused by chemotherapy and in patients with HIV whose anemia is caused by AZT (zidovudine), there are no data to support claims of improvement in health-related quality of life, including effects on fatigue, energy or strength.

In light of new information from recent studies, the FDA and major medical societies are reviewing their guidelines and are expected to issue revised guidelines on the use of medications to treat anemia in the next few months.

Labels: anemia, aranesp, epogen, erythropoetin, fda, new york times, procrit

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