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Allergic Responses to Drugs Can be Serious

Jul 02, 2007

(HealthNewsDigest.com) - MILWAUKEE—Although medications are given to help people, nearly all can have side effects. According to the American Academy of Allergy, Asthma & Immunology (AAAAI), about 5% to 10% of adverse reactions to commonly used medications are allergic, which means that a person's immune system overreacts to the drug and causes an allergic response.

"Adverse reactions to medications are experienced by most individuals at some point in their life, and consequences can sometimes be severe," said Roland Solensky, MD, FAAAAI. "It is important to recognize allergic reactions because at times, they can progress and be life-threatening, such as in the case of anaphylaxis. In fact, there are an estimated 106,000 deaths each year related to serious drug reactions."

Most drugs can occasionally trigger an allergic response. However, there are certain medications that are more likely to produce allergic reactions than others, due to their chemical structure. These medications include:

Antibiotics, such as penicillin Anticonvulsants and hormones, such as insulin Certain medicines used in anesthesia, such as neuromuscular blockers Vaccines and biotechnology-produced proteins, such as Herceptin

Severe consequences can occur when an allergic person's immune system produces the allergic antibody called IgE (immunoglobulin E) in response to a drug. When the person's body encounters the drug again, IgE antibodies bound to certain cells, called mast cells, can result in an explosive release of histamine and other chemicals. This triggers symptoms of an allergic reaction. The most frequent types of allergic symptoms to medications include:

Skin rashes, particularly hives Itching Respiratory problems, such as wheezing Swelling of areas of the body that have fat tissue, such as the face

Treatment for drug allergies When an adverse reaction to a medication is minimal, treatment is limited to discontinuation of that drug. However, if there is a more severe reaction that is ongoing, an allergist/immunologist may provide antihistamines, corticosteroids and other medications, including an EpiPen (epinephrine) for emergency situations. Antihistamines block the effects of histamine, which usually initiate an allergic response, and corticosteroids reduce swelling and inflammation.

In most cases, patients with drug allergies can be safely given an alternative medication. However, when there is no alternative available and the medication is essential, an allergist/immunologist will recommend desensitization to the medication. This involves gradually introducing the medication in small doses until the therapeutic dose is achieved.

When to see an allergy/asthma specialist According to the AAAAI's referral guidelines, patients should see an allergist/immunologist if they:

Have had a severe allergic reaction that could have been due to a medication (anaphylaxis without an obvious or previously defined trigger). Have a history of penicillin allergy and likely will need antibiotics in the future. Have a history of penicillin allergy and have an infection with no effective alternative therapeutic options, except for a penicillin class antibiotic. Have a history of multiple drug allergies or intolerance. May be allergic to protein based bio-therapeutics and require uses of these materials. Have a history of an adverse reaction to a non-steroidal anti-inflammatory drug (NSAID) and require aspirin or other NSAID. Require chemotherapy medication for cancer or other severe conditions and have experienced a prior hypersensitivity reaction to those medications. Have a history of possible allergic reactions to local anesthetics. Are HIV-infected patients with a history of adverse reactions to trimethoprim-sulfamethoxazole (TM-S) and need this therapy.

To find an allergist/immunologist in your area or to learn more about allergies and asthma, visit the AAAAI Web site at www.aaaai.orgwww.aaaai.org.

The AAAAI represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic disease. Allergy/immunology specialists are pediatric or internal medicine physicians who have elected an additional two years of training to become specialized in the treatment of asthma, allergy and immunologic disease. Established in 1943, the AAAAI has more than 6,500 members in the United States, Canada and 60 other countries. The AAAAI serves as an advocate to the public by providing educational information through its Web site at www.aaaai.org.

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The HIV Test: What You Know Can Help You

Jun 27, 2007

(HealthNewsDigest.com) - Washington, D.C., June 27, 2007 (PAHO) – Countries throughout the Americas are launching public outreach efforts today urging their citizens to get tested for the human immunodeficiency virus (HIV) as the first step in prevention, treatment, and care for HIV/AIDS.

The campaigns—part of ongoing efforts to promote HIV testing and counseling among the public—are being launched today in observance of HIV Test Awareness Day, June 27. Started in the United States in 1994 by the National Association of People with AIDS (NAPWA), HIV Test Awareness Day is now observed by countries around the world.

Not knowing one’s HIV status is among the main factors in the spread of the AIDS epidemic. In Latin America, an estimated 1.7 million people carry the virus, but more than two-thirds are unaware of it. Those who don’t know they carry the virus do not know that they may need life-saving drugs. Worse, they may inadvertently transmit the virus to others.

In contrast, people who get tested and learn they are HIV-positive can seek treatment to control the virus’s progression. Those who learn they are HIV-negative have extra motivation to protect their HIV-free status.

Testing for HIV has become more widely available and less costly in Latin America and the Caribbean in recent years, and growing numbers of people are taking advantage of the test. The Pan American Health Organization (PAHO) estimates that more than 700,000 people in the region were tested in 2005 and more than 1 million in 2006. The numbers are expected to be even higher this year.

Among the reasons behind the growing numbers is the increasing availability of antiretroviral treatment, which allows people with HIV to lead long and healthy lives, as well as the diminished stigma against people living with the virus. Public health officials are also trying to spread the message that more people need to get tested in order to control and eventually halt the epidemic.

Until recently, many countries struggled just to make HIV testing widely available in their health centers. Countries that have achieved that goal—including Brazil, El Salvador, Mexico, and others—are now trying to boost demand for the tests.

To do so, they are mounting “Know Your Status” campaigns, which try to motivate men and women, especially the young, to get tested for HIV. The campaigns also tackle such obstacles as difficult access to health services, lack of confidence in the health care system, and fear of discrimination in the workplace or among family and friends.

The Pan American Health Organization, founded in 1902, works with all the countries of the Americas to improve the health and quality of life of their peoples. It serves as the

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Patient Dumping: Another Dark Side of Healthcare

Jun 25, 2007

(HealthNewsDigest.com) - Politicians of all stripes love to talk about the crisis in health care, but all you hear about is access and financing. No one ever seems to be concerned with quality and outcomes. But, here is a story where access and financing—of an indigent patient—were no problem, until she had to be discharged. (Michael D. Shaw, Contributing Columnist - HealthNewsDigest.com)

Rumors had been circulating for years about a practice called "patient dumping," whereby hapless patients—largely homeless individuals—are dropped off in Skid Row, upon discharge. The theory is that this part of town would have an abundance of services for these unfortunates, and the hot potato could simply be passed along.

The health care industry tried to relegate these rumors to the status of alien abduction tales, until one of these incidents was caught on tape in March, 2006.

Carol Ann Reyes, a 63-year-old homeless woman, was found wandering in the street near Los Angeles' Skid Row. Reyes had just been discharged from Kaiser Permanente Bellflower hospital where, after taking a fall, she had been treated for three days. Wearing little more than a hospital gown and a diaper—the hospital lost her clothes and even left her without pants or shoes—Reyes was put in a taxi and dumped on Skid Row, a 50 square-block area that is the last stop for approximately 11,000 people.

According to Rev. Andy Bales, who runs Union Rescue Mission, the biggest shelter in Skid Row:

"The cab came this way. He did a u-turn, pulled around, and stopped. The driver didn't even get out of the car. The back door opened and this little lady got out in her hospital gown."

LA City Attorney Rocky Delgadillo chimed in:

"They're dumping a 62-year-old woman with dementia in the heart of Skid Row? That's what's going on. And it's shocking and it's criminal."

For its part, Kaiser admitted the wrongdoing, but stressed that it was certainly not its policy to do such things, and emphasized its many good works benefiting the homeless, pointing to an investment of more than $1.5 million over the past three years in programs to strengthen the homeless health care system in Los Angeles County alone. Kaiser reached a settlement with the city that involves fines, establishment of new programs, and court oversight of its homeless policies.

Back in 1986, as part of COBRA, the Consolidated Omnibus Budget Reconciliation Act, a provision called EMTALA (Emergency Medical Treatment and Active Labor Act) was introduced, which governs when and how a patient may be (1) refused treatment or (2) transferred from one hospital to another when he is in an unstable medical condition.

A person found to be in an "emergency medical condition" or "active labor" must either be provided with medical treatment or transferred. However, if such a person has not been "stabilized," or is in "active labor," the hospital is not permitted to transfer the patient except in certain limited circumstances. Once "stabilized," a person with an "emergency medical condition," but not a person in "active labor," may be transferred without restriction. Both hospitals and physicians may be held liable for EMTALA violations. A hospital's or physician's violation of the Act can result in civil monetary penalties of up to $50,000.00 for each incident.

The above terms are placed in quotation marks since they are quite specifically defined in the statute. More information is available at [http://www.emtala.com]. Upon visiting that site, you will see that the legal/enforcement situation is far from clear-cut.

Many hold that the only answer to such abuses is some sort of Federal single-payer system, akin to the programs in Canada and Europe. However, no matter who pays, the simple fact is that rationing still goes on. In Europe, for example, the elderly, smokers, and overweight individuals are routinely denied certain care. In Canada, rationing takes place by extending the wait for various procedures to a point that has caused death in more than a few instances.

Michael Moore publicizes American fatalities based on denial of treatment in his latest film, but the situation is hardly limited to our shores. Patient dumping is just one more method of health care rationing, and even with draconian laws in place, I doubt that it can be completely curtailed.

Michael D. Shaw Exec VP Interscan Corporation

mds1@gasdetection.com http://www.gasdetection.com

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Shire Receives Approvable Letter from FDA for INTUNIV(TM) (guanfacine) Extended Release, a Nonstimulant for the Treatment of ADHD

Jun 21, 2007

(HealthNewsDigest.com) - 21 Jun 2007 - Basingstoke, U.K., and Philadelphia, U.S. – June 21, 2007 – Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for INTUNIV (guanfacine) extended release tablets (previously referred to as SPD503), a nonstimulant selective alpha-2A-receptor agonist, which has been studied in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Unlike some other ADHD treatments, INTUNIV, a nonstimulant, is not a controlled substance and does not have a known mechanism for potential abuse or dependence. The information requested by the FDA was not unexpected, and Shire is working with the FDA to provide a full and timely response to the agency’s request.

“The FDA’s approvable letter for INTUNIV is positive news, and Shire will be working closely with the agency to address its questions,” said Matthew Emmens, CEO of Shire. “When approved, INTUNIV will be the first medication indicated to treat ADHD symptoms by selectively targeting alpha-2A-receptors in the prefrontal cortex, an area of the brain that is thought to manage executive functioning tasks. Shire is looking forward to further strengthening our broad portfolio of ADHD medications by adding a nonstimulant treatment option with a novel mechanism of action and demonstrated clinical efficacy, which may be ideal for those patients who have not benefited from currently available ADHD medications.”

About INTUNIV (guanfacine) Extended Release Tablets Shire is seeking approval of INTUNIV as monotherapy for the treatment of ADHD symptoms throughout the day in children aged 6 to 17 years, with dosage strengths of 1 mg to 4 mg daily. The INTUNIV New Drug Application (NDA) includes data from two placebo-controlled trials in children and adolescents ages 6 to 17 evaluating the compound’s safety and efficacy in controlling ADHD symptoms evaluated on a once-weekly basis using the ADHD Rating Scale (ADHD-RS-IV), which included both hyperactive/impulsive and inattentive subscales. ADHD-RS-IV is a standardized, validated test for assessing symptoms of ADHD in children and for assessing their response to treatment. This scale, which contains 18 items, is based on the ADHD diagnostic criteria as defined in the APA’s Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision®. In these two clinical trials, treatment related adverse events greater than 10 percent included somnolence, fatigue, upper abdominal pain, sedation and headache.

INTUNIV, a once-daily formulation of guanfacine, provides a controlled, steady delivery of drug throughout the day and evening with a delivery system that minimizes the fluctuations between peak and trough concentrations as seen with immediate-release guanfacine. It has been shown that guanfacine, the active ingredient in INTUNIV, binds selectively to alpha 2A adrenergic cell receptors located in the part of the brain called the prefrontal cortex. The prefrontal cortex is an area of the brain associated with executive functioning, i.e., working memory, behavioral inhibition, regulation of attention, distractibility, impulsivity, and frustration tolerance. The selective alpha-2A agonist strengthens working memory and prefrontal cortex neuronal firing. This research supports the use of guanfacine for the treatment of ADHD.

About ADHD Approximately 7.8 percent of all school-age children, or about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the CDC. ADHD is one of the most common psychiatric disorders in children and adolescents. The disorder is also estimated to affect approximately 9.8 million adults across the U.S. based on a retrospective survey of adults aged 18 to 44, projected to the full U.S. adult population. ADHD is a neurological brain disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. To be properly diagnosed with ADHD, a child needs to demonstrate at least six of nine symptoms of inattention; and/or at least six of nine symptoms of hyperactivity/impulsivity; the onset of which appears before age 7 years; that some impairment from the symptoms is present in two or more settings (e.g., at school and home); that the symptoms continue for at least six months; and that there is clinically significant impairment in social, academic or occupational functioning and the symptoms cannot be better explained by another psychiatric disorder.

Although there is no “cure” for ADHD, there are accepted treatments that specifically target its symptoms. The most common standard treatments include educational approaches, psychological or behavioral modification, and medication.

For further information on Shire, please visit the Company’s website: www.shire.com.

AMA Supports Tobacco Tax Increase to Fund Kids Health Care

Jun 20, 2007

(HealthNewsDigest.com) - In the coming months, Congress faces one of the most important tasks of 2007 -- the reauthorization of the State Children’s Health Insurance Program (SCHIP). Doctors see the benefits of this successful program to cover kids firsthand: parents who work hard, but aren’t able to afford health insurance, are able to get their children the care they need to stay healthy and strong.

For SCHIP to continue to provide substantial benefits to our nation’s children, Congress must find a way to pay for the millions of kids the program will protect – including the many who are currently eligible for SCHIP, but not enrolled. This spending on children’s health is a sound investment in our nation’s future.

Diverse stakeholders in health care join together today to urge Congress to help pay for children’s health care by increasing the federal tobacco tax. The AMA, and more than sixty other voices in health care, recently sent a letter to members of Congress asking them to do the same. This is a win-win proposal: an increase in the federal tobacco tax would serve as a key funding source for SCHIP, and it can help deter current and future Americans from using tobacco.

The American public agrees. According to the recent poll discussed today, two-thirds of Americans support a tobacco tax increase to fund children’s health care and most want to vote for a candidate who does as well.

A tobacco tax increase will act as a deterrent to young smokers and potential smokers. Studies show that for every 10 percent increase in the price of cigarettes, youth smoking is reduced by seven percent, and overall consumption by four percent. The facts are clear – higher tobacco taxes equal lower smoking rates in the long run. The effect is greater among America’s kids. The higher the tax, the more substantial the future public health benefit. A higher tobacco tax will result in long-term health care savings, as fewer smokers means fewer people with strokes, heart attacks, cancer, and other smoking-related health conditions.

It’s been 10 years since Congress last voted to raise the federal cigarette tax. With what we know now about the effects of smoking, and the benefits of raising the price of cigarettes, it is unconscionable that action has not been taken to raise the tobacco tax and protect the health of Americans.

The federal government is falling behind when it comes to taxing tobacco. Today, the tobacco tax is far below historical levels. It has failed to keep up with inflation; manufacturer and retailer price increases; state cigarette taxes; and cigarette taxes in other countries.

Had the tobacco tax kept pace with these standards, tobacco use in the U.S. would have decreased even more substantially over the past ten years. However, smoking remains the number one preventable cause of death in the U.S., and every day four thousand children start smoking and fifteen hundred become daily smokers.

It’s time for Congress to take action to better protect Americans, particularly kids. Increasing the tobacco tax to put the money directly into health care for our nation’s children is a win-win proposal we join together today to support.

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