Swine-Flu - A Threat for Asthmatics?

EAACI, the largest European organisation in the field of allergy, immunology and asthma, today hosted a specialist forum on “Swine-flu - a threat for asthmatics? What people with asthma should know” at its new premises on Genferstrasse 21 in Zurich. Dr. Thomas Heiniger, Cantonal Councillor and Head of the Department of Health of Zurich, extended a warm welcome to the EAACI’s new Executive Director Silvia Schaller, along with a top-class international delegation from the field of immunology and asthma.

One out of three Europeans suffers from allergies or asthma. For a person with asthma, a virus infection can be life-threatening. The swine-flu presents a similar risk. The potential complications are heavily dependent on the underlying health of the patient. Among those at risk from serious life-threatening symptoms and even death are patients with pre-existing respiratory illnesses and also asthmatics. “One of the differences between the H1N1 swine-flu virus and the seasonal flu is that younger people become more frequently unwell than they do with the seasonal flu. Younger asthma patients should therefore take special care to keep their asthma under control,” states Professor Nikos Papadopoulos from the University of Athens.

What asthmatics should know about swine-flu

People with asthma are advised to take special note of general preventive measures such as hand hygiene or a change in greeting habits, and also to take special care of their health. If flu symptoms are suspected - aching joints, high fever, coughing, and headaches - asthmatics should consult their doctors immediately. “If asthma gets out of control, there is a risk of severe and possibly even life-threatening attacks during a flu epidemic. Influenza is not the most frequent cause of asthma attacks. However it can be an important trigger of such severe symptoms,” says Professor Papadopoulos.

Does a flu vaccination make sense for asthmatics?

Severe asthmatics are a risk group and vaccination against swine-flu is recommended. It can be assumed that the vaccine is very similar to previous flu vaccines, and that vaccination would be the lesser evil for asthmatics. “Is a commonly held misbelief that flu vaccination causes illness in asthmatics”, says Professor Papadopoulos. “This misbelief is due to the fact that vaccinations are normally given at times of year with high rates of flu-like illnesses from other viruses. When the symptoms then occur, they are falsely attributed to the vaccination.”

Zurich - a new centre for allergology and immunology

EAACI, the European Academy of Allergy and Clinical Immunology, which is represented in 107 countries, has recently moved its headquarters to Zurich. From here, effectively at the heart of Europe, the European association wishes to promote scientific and educational projects in the field of allergy, immunology and asthma.

“As the world’s No. 1 location for science and technology, this is a further milestone for the Canton of Zurich,” says Dr. Heiniger with pride. EAACI is making a big investment in the future.

“We aim to provide the most efficient platform for scientific communication and education in the field of allergy and immunology, striving to ultimately ease patients’ lives,” says EAACI President Professor Jan Lötvall. EAACI has already made a name for itself by organising the largest annual European congress for allergologists and immunologists and bringing together a broad range of specialists. The EAACI 2010 Congress will take place from 5th to the 9th June in London. Approximately 8′000 participants from all over Europe are expected.

About EAACI

EAACI - The European Academy of Allergy and Clinical Immunology is a non-profit organisation active in the field of allergic and immunologic diseases such as asthma, rhinitis, eczema, occupational allergy, food and drug allergy and anaphylaxis. EAACI was founded in 1956 in Florence and has become the largest medical association in Europe in the field of allergy and clinical immunology. It includes 5′500 individual members from 107 countries, as well as 40 National Allergy Societies.

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New drug-free treatment helps with asthma

Every day in the United States, 40,000 people miss school or work because of asthma, according to the Asthma and Allergy Foundation of America.

In addition, 5,000 people visit the emergency room and 11 people die every day due to asthma.

Alarmingly, death rates have increased more than 50 percent since 1980 and there is no cure for asthma.

Treatments include avoiding allergy triggers and medications. Inhaled corticosteroids are prescribed to decrease inflammation of air passages, and bronchodilators to open up the windpipes.

Both treatments are inhaled through a device and are intended to be taken on a daily basis.

The American Academy of Allergy Asthma & Immunology said it is important to follow your physician's instruction regardless of whether or not you are experiencing symptoms.

A recent Food and Drug Administration analysis of four drugs used to treat asthma, including Serevent, Advair, Foradil and Symbicort, found the drugs carry an increased risk of asthma-related side effects, especially for children.

All four drugs fall into a class called long-acting beta-antagonists, or LABAs.

Researchers analyzed 110 trials involving the drugs and 60,954 patients. About 43,000 patients were involved in trials for the drug Serevent. There were 20 asthma-related deaths overall, and 16 of those patients were on Serevent.

For some asthma patients, symptoms are uncontrollable even with high doses of medications. Through a new treatment called bronchial thermoplasty, doctors are helping some of these patients by using heat to reduce the amount of muscle tissue in the lung's air passages.

Reducing the amount of tissue helps inhibit narrowing of those passages. During the procedure, patients are sedated.

In a recent study evaluating the treatment, patients underwent the procedure three times, three weeks apart. After treatment, those treated with bronchial thermoplasty experienced 84 percent fewer visits to the emergency room for respiratory symptoms than untreated patients.

"[Bronchodilators] help relax that smooth muscle, but they last for about four to six hours, whereas this is a permanent treatment where we actually alter the smooth muscle," Washington University School of Medicine pulmonologist, Mario Castro, M.D., said.

After each bronchial thermoplasty treatment, patients experienced a temporary, mild asthma attack.

"We clearly want to discuss that with our patients ahead of time so they’re aware of that risk, and then you have to balance that with the benefits from the procedure," Castro said.

After treatment, however, treated patients experienced fewer attacks than other participants. The device used in the procedure called Asthmatx has been submitted to the FDA for review, and experts expect a ruling sometime this fall.

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FDA Flags Psychiatric Risks Of Asthma Drugs

New labels on popular asthma drugs like Merck's Singulair must highlight language about suicidal behavior, depression and anxiety seen in a small number of patients, federal regulators said Friday.

After 15 months of investigation, the Food and Drug Administration said Merck & Co. Inc., AstraZeneca and Cornerstone Therapeutics will have to raise label warnings about psychiatric problems reported by a handful of patients taking their drugs.

"Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications," the FDA said in a posting to its Web site.

A spokeswoman for Merck said the language already appears in Singulair's label, but will be raised to the "precautions" section. It's now listed in a section about various side effects reported by patients.

"We've been working with the FDA since Singulair came to market and every time we update the label it's in cooperation with them," said Merck spokeswoman Pamela Eisele.

Singulair was Whitehouse Station, N.J.-based Merck's best-selling product last year, with U.S. sales of $3.5 billion.

A spokesman for London-based AstraZeneca said new labeling on its drug would only mention two psychiatric problems: depression and insomnia.

A spokesman for Cary, N.C.-based Cornerstone Therapeutics had no immediate comment Friday evening.

FDA regulators last spring began reviewing a handful of reports about mood changes, suicidal behavior and suicide in patients who had taken Singulair. The agency also launched probes into other drugs in the class, including AstraZeneca PLC's Accolate and Cornerstone Therapeutics Inc.'s Zyflo.

Earlier this year, the agency said company studies of the three drugs did not show an increased risk of suicidal behavior, though they were not designed to detect such problems. An FDA spokeswoman said Friday the agency is monitoring ongoing reports of suicide and other psychiatric problems among patients.

"We did move this language to the 'precautions' section to highlight that we're continuing to see these things," said FDA spokeswoman Karen Riley.

The exact language of the labeling updates has not been released, but the FDA said it could mention a slew of psychiatric problems, including: "agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior -- including suicide -- and tremors."

In general, the FDA has started notifying the public earlier about possible safety issues with drugs after the agency came under fire for acting too slowly on drugs like Merck's painkiller Vioxx, which was removed from the market in 2004 because it doubled the risk of heart attack and stroke.

Source : www.wdsu.com

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Fraudulent Trials Behind Asthma Drugs Cited

A Texas physician is charging that a major allergy and respiratory management company knowingly produced flawed clinical trials of FDA-approved drugs currently on the market.

Trials of Singular, Serevent, Foradil, Flovent, Xolair, Accolate, and Xopenex conducted at the Tucson, Ariz., facility of Vivra Asthma & Allergy were corrupted by protocol violations and outright falsifications, says Robert Davidson, M.D., a former clinical research subinvestigator (SI) at the facility.

San Mateo, Calif.-based Vivra Asthma & Allergy was the nation’s largest respiratory disease physician practices until a merger with Lakewood, Colo.-based Gambro in 1997 and with El Segundo, Calif.-based DaVita in 2005.

Davidson charges that during aggressive recruitment schemes in the late 1990s, patients with abnormal EKGs, multiple risk factors for coronary artery disease, arrhythmias, pulmonary embolisms, rheumatic fever histories, acute illnesses, and even pituitary tumors were enrolled with impunity in trials that earned investigators as much as $10,000 per patient.

Patients were “prescreened” for asthma drug trials with medically unnecessary pulmonary function tests (PFTs) without their knowledge or consent and had medication dosages reduced in apparent efforts to qualify them for the lucrative trials.

Staff could be seen entering rooms where placebos and real drugs were mixed and unblended, invalidating entire studies sent to the FDA as data for new drug applications.

The brazen “study buddy” and “crossover” arrangements, as staff referred to them, included churning or serially enrolling patients into clinical trials despite risks to their health and early terminations, coercing unwilling patients to participate, and directly falsifying patient study diaries, say documents filed by Davidson in a federal complaint.

In 2006, the FDA mandated black box warnings on Serevent and Foradil, tested at Vivra and elsewhere, for increasing the risk of asthma-related death after adverse outcomes forced the early termination of a large clinical trial.

Warning labels for Singulair, also tested at Vivra and under FDA investigation for suicidal side effects, were strengthened four times in 2007, and Raxar, an antibiotic tested at Vivra, was withdrawn in 1999 after being linked to 13 deaths.

FDA inspections of the Vivra Tucson facility, where Jay Grossman, M.D., served as principal investigator (PI) from 1993 to 2000, confirm the clinical subterfuge.

“Three study coordinators stated that they saw diary card blank prior to subject entering exam room with PI for visit 2,” reads a report from a May 5 though June 28, 1999, inspection obtained under the Freedom of Information Act. “Five to ten minutes after, the diary had approximately two weeks of diary symptoms and peak flow entered.”

“On multiple occasions, over the last 8 months, the PI strongly counseled the SI to NOT mention potential risks of study participation to potential study subjects, (such as arrhythmia, drug-drug interaction, and so on) so as to not ‘scare them away,’” the report reads elsewhere.

“Coordinator stated that subject called to say she could not participate in a 12-hour-a-day study due to her schedule. PI called the subject’s [sic] estranged husband to say that they had to get the disease under control.”

Nor was patient safety apparently protected.

“PI enrolled subject into study despite subject having a clear study exclusion (maintenance inhaled corticosteroid therapy),” a report states elsewhere. “Subject subsequently experienced a SAE [severe adverse event] (hospitalized) while in the study. Moreover, this subject had recently participated in a prior study [in] which she required multiple prednisone bursts and multiple courses of antibiotic therapy for several bouts of acute sinusitis with asthma exacerbation.”

According to witnesses, FDA reports from a 1999 inspection at the Tucson Vivra facility document missing informed consent forms, clinical records changed to minimize alcohol and cigarette consumption, and records rewritten and ripped up by Dr. Grossman.

Reached by telephone, communications officials at Gambro and DaVita were unable to discuss the trials. Dr. Grossman did not respond to faxed and email messages.

Nor was billing apparently done by the book.

Pulmonary function tests were performed on all patients regardless of medical necessity, states former Vivra Tucson nurse Joanne Wray in court documents—amounting to a gratuity for drug companies, shouldered by insurers, to prevent costly “screening failures” when studies began.

In 2000, Gambro, which acquired Vivra in 1997, agreed to a $40 million settlement for submitting false claims to Medicare, Medicaid, and TRICARE and entered into a Corporate Integrity Agreement with the Department of Health and Human Services only to have to agree to another settlement for $350 million in 2004.

Yet despite red flags, clinical trials at the Vivra Tucson facility, which still appear in the New England Journal of Medicine and the Annals of Internal Medicine, were not stopped by the FDA, institutional review boards, trial sponsors, contract research organizations, or the Justice Department. Nor was the facility's clearance to conduct trials revoked.

In fact, inspections were actually delayed to facilitate the new drug applications the studies were for—a paradoxical but expected outgrowth of the 1992 Prescription Drug User Fee Act (PDUFA), which allows drug companies to pay the FDA to accelerate approvals, says Davidson.

“It takes time to obtain a properly administered, formal informed consent with full disclosure of risks and benefits, and that slows study-subject recruitment and ultimately, delays the time to obtain market approval from [the] FDA,” says Davidson. “It is virtually certain that there have been deaths of U.S. citizens because of the fraudulent or seriously flawed clinical research PDUFA encourages. Nor is FDA likely to revoke expedited market approvals because that would be tantamount to admitting that they ‘goofed.’”

When presented with 51 allegations of Vivra's medical wrongdoing in 2000, the Arizona Board of Medical Examiners also did not act, calling the evidence “insufficient to support a violation” of Arizona Revised Statutes.

Recently, Alabama physician Anne Kirkman Campbell began serving a sentence in a federal prison in Lexington, Ky., for clinical trials she conducted of the controversial antibiotic Ketek, linked to liver failures and deaths.

Campbell “got greedy” and enrolled her own family, staff, and more than 1 percent of the adult population of the town of Gadsden, Ala., in clinical trials, wrote the St. Petersburg Times in 2007.

Despite revelations of Campbell's fraud and problems regulators found at other study sites while the drug was being tested, Ketek sailed through the FDA and was approved on April 1, 2004.

Ketek was also tested at the Vivra facility.

Source : www.theepochtimes.com

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U.S. FDA Accepts Aridol New Drug Application for Review

Pharmaxis today announced it had received notification from the United States Food and Drug Administration (FDA) that the New Drug Application (NDA) for its mannitol bronchial challenge test Aridol(TM) has been accepted for standard review. The FDA will advise the result of the review on 27 December 2009.

Pharmaxis is seeking approval for Aridol for "the assessment of bronchial hyperresponsiveness to aid in the diagnosis of patients with symptoms of or suggestive of asthma." Asthma affects more than 34 million people in the U.S. with an annual economic cost of $19.7 billion. When approved, Aridol will be the first dry powder bronchial challenge test available in the U.S.

Alan Robertson, Pharmaxis Chief Executive Officer said: "We have been greatly encouraged by the interest respiratory physicians have shown in Aridol at recent U.S. scientific conferences. We estimate that 200,000 bronchial hyper-responsiveness tests are performed in the US each year and hope that the introduction of a dry powder test kit will encourage more physicians to utilize this test when diagnosing asthma. We look forward to working with the FDA to complete the review."

Aridol is approved for sale in most major European countries, Australia and Korea. Aridol has been included in the Global Initiative for Asthma guidelines, and in the U.S. Asthma Management Guidelines. It is one of the tests recommended by the World Anti-Doping Agency, and other sports governing bodies to ensure elite athletes who are asthmatic are properly diagnosed and treated.

Source : news.prnewswire.com

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