Israel's Teva Pharmaceutical Industries has won U.S. approval to market a copy of GlaxoSmithKline's best-selling Advair inhaler, although the real battle is still to come.
Teva's version of GSK's blockbuster medicine, called AirDuo RespiClick, is not directly substitutable for Advair and is only approved for asthma, while Advair is also widely used for chronic obstructive pulmonary disease (COPD).
Teva said on Monday it would launch AirDuo later this year. It has not said how much its product will cost.
AirDuo provides patients with the same two drugs as Advair, fluticasone propionate and salmeterol, but it delivers a lower dose of salmeterol. It also uses Teva's Respiclick inhaler rather than a copy of GSK's device.
Producing cut-price copies of Advair is a major opportunity for generics companies at a time when fewer blockbuster medicines are losing patent protection.
For GSK, it is a challenge since Advair has sold more than $1 billion annually since 2001. Global Advair sales were $5.6 billion in 2015, with half that generated in the United States, although sales are now shrinking.
Teva's product promises to grab some of this business in asthma but the bigger threat will come from fully substitutable generic copies of Advair, which are still pending approval.
The U.S. Food and Drug Administration is due to decide whether to approve the first of these, from Mylan, by March 28. A rival version from Hikma and Vectura is close behind, with an approval date of May 10.
GSK said that as Teva's product was not substitutable for or equivalent to Advair it did not "pose the same competitive dynamics as market entry of generic products in the U.S. would."
Advair is already available generically in Europe, but demand for copies is expected to take off more swiftly in the United States, where managers of prescription plans can quickly drive conversion to such cheaper products.
Investors are watching closely to see how GSK's Advair sales will fare in the face of new competitors. One big unknown is the scale of discounts that will be offered by generic companies.
Reporting by Ben Hirschler
Editing by Susan Fenton
Signage for GlaxoSmithKline is seen on its offices in London, Britain, March 30, 2016. REUTERS/Toby Melville/File PhotoRead more..
Antipsychotics have been tied to acute respiratory failure in patients with chronic obstructive pulmonary disease (COPD), Taiwanese researchers reported.
In a population-based, case-crossover study, more COPD patients had filled a prescription for antipsychotics 2 weeks before having acute respiratory failure compared with a control period several months prior (11.7% versus 8.8%), Meng-Ting Wang, PhD, of National Defense Medical Center in Taipei, and colleagues reported online in JAMA Psychiatry.
That translated to a significantly higher risk of respiratory failure during the first 2 weeks of antipsychotic use, independent of cardiogenic, traumatic, and septic factors (adjusted OR 1.66, 95% CI 1.34 to 2.05, P<0.001).
"The results of this study indicated a life-threatening adverse respiratory effect of antipsychotic treatment, which has been described previously only in case reports," they wrote.
Antipsychotics have been linked to acute respiratory failure in case reports, but population-level data are lacking, the researchers explained. Also, this effect is of particular concern among COPD patients, who are already prone to respiratory failure and are commonly treated with antipsychotics.
For their study, the team looked at data from the Taiwan National Health Insurance Research Database for patients with COPD who were newly diagnosed with acute respiratory failure in the hospital or in emergency care settings from Jan. 1, 2000 to Dec. 31, 2011. The protocol excluded patients with prior acute respiratory failure, lung cancer, and cardiogenic, traumatic, or septic respiratory failure.
For the main outcome, the study compared self-reported use of antipsychotics in the two weeks before their respiratory failure with a control period of 75 to 88 days prior to the event.
Over a mean of 3.5 years, a total of 5,032 of the 61,620 COPD patients were diagnosed with acute respiratory failure.
The team found that more patients filled at least one prescription for an antipsychotic medication during the case period than during the control period (11.7% versus 8.8%), which corresponded to a significantly higher risk of acute respiratory failure (adjusted OR 1.66, 95% CI 1.34 to 2.05, P<0.001).
There was also a dose-dependent risk of acute respiratory failure associated with antipsychotics (aOR 1.35, 95% CI 1.19 to 1.52, P<0.001), which rose from a 1.52-fold risk for a low daily dose (95% CI 1.20 to 1.92, P<0.001) to a 3.74-fold risk for a...Read more..
With New Year’s resolutions kicking into high gear in the month of January, why not help your patients truly stop smoking in this New Year. Especially with your pregnant patients, it is even more important to support a high quality smoking cessation program in our daily practices.
Women who smoke during pregnancy may be more likely to have children with kidney damage than mothers who steer clear of cigarettes, a study suggests.
Smoking during pregnancy has long been linked to preterm and underweight babies and a wide range of birth defects. The current study offers fresh evidence that the kidneys are among the organs at risk for damage, said lead author Dr. Maki Shinzawa, a public health researcher at Kyoto University in Japan.
“Cigarette smoking releases nicotine and other harmful or potentially harmful substances, such as nitrogen oxide, polycarbonate, and carbon monoxide, some of which cross the placenta,” Shinzawa said by email. “Some of these trans-placental substances may affect fetal programming of the kidney during pregnancy.”
Shinzawa and colleagues examined data from urine tests from 44,595 children to look for elevated levels of protein in the urine, which can indicate impaired kidney function.
Data on maternal smoking was collected during women’s prenatal checkups, and researchers also had records from their children’s health checkups at four, nine, 18 and 36 months of age.
Overall, 79 percent of women said they never smoked and another 4 percent said they stopped smoking during pregnancy. About 17 percent of the mothers said they continued to smoke while they were pregnant.
The absolute risk of kidney damage among the children was low. But compared with children born to nonsmoking mothers, kids whose mothers smoked while pregnant were 24 percent more likely to show signs of kidney damage in their urine tests by age three.
Urine tests showed elevated protein levels in 1.7 percent of children born to smokers, 1.6 percent of kids whose mothers were former smokers and 1.3 percent of children born to women who never smoked.
Children exposed to second-hand smoke at home also appeared to have a higher risk of kidney damage than kids who didn’t live with smokers, but the difference wasn’t big enough to rule out the possibility that it was due to chance.
One limitation of the study is its reliance on women to accurately report and recall how much they smoked before or during pregnancy, and a lack of...Read more..
Many people believe electronic cigarettes (also called e-cigarettes or vapes) are a safe alternative to traditional cigarettes. But with a new report from the U.S. surgeon general calling e-cigarette use “a major public health concern,” this may not be the case. The FDA reports an alarming 900% rise in e-cigarette use among high school students from 2011 to 2015. Get the facts on this popular, and potentially dangerous, product.
How do they work?
You don’t actually “light-up an e-cig”. They’re powered by a rechargeable lithium battery. Instead of burning tobacco, the “e-liquid” is vaporized in a heating chamber when the user inhales.
The replaceable liquid cartridge contains nicotine mixed with a base (usually propylene glycol), along with flavorings and chemicals. The tip often contains LED lights that simulate the glow of a burning cigarette.
E-cigarettes are available in flavors like cherry, bubble gum, and cotton candy, and can be advertised on TV, which may increase their appeal for children and teens.
Are they safe?
Proponents of e-cigarettes claim they’re safer than smoking because they don’t contain the more than 60 cancer-causing chemicals in tobacco smoke. But e-cigs still deliver harmful chemicals, including nicotine, the extremely addictive substance in cigarettes. And studies show that brands claiming to be “nicotine-free” may still have trace amounts. Developing teenage brains are especially sensitive to nicotine's addictive properties.
Is your smoking cessation program in place at your practice? See how MD Spiro can help!
See what e-cigs do to your body:
As we have found with the recent deaths in Australia in the news from “thunderstorm asthma” it is important to remember that storms can trigger your patient’s asthma and allergies that could, in severe situations, kill a patient.
Asthma and thunderstorms
Thunderstorm asthma is a potentially dangerous mix of pollens, weather conditions and rain that can trigger severe asthma symptoms. People residing in metropolitan, regional and rural areas can be affected.
How does a thunderstorm cause asthma symptoms?
Thunderstorms cause a rapid increase in the number of triggers in the air such as pollens, mold and dust and changes in humidity and temperature. Breathing this air in can irritate the lining of the airway causing swelling and extra mucus to be produced. This causes the airway to narrow and triggers an asthma flare-up. These flare-ups may become severe very quickly.
Do you have to be allergic to pollens or grasses to experience thunderstorm asthma?
Thunderstorm asthma can affect anyone. In fact, during very severe storms, some people who have never been diagnosed with asthma may experience breathing difficulties.
If you have asthma, be alert to the potential dangers of thunderstorm asthma.
What do you do if a thunderstorm is in the forecast?
Always carry your emergency inhaler
Know the signs of worsening asthma and the asthma first aid steps
Cigarette smokers who are HIV positive appear to have a higher chance of dying from smoking-related complications than from HIV, according to research published in the Journal of Infectious Diseases.
Numerous health problems are associated with smoking. Smokers have a high chance of developing heart disease, cancer, serious lung diseases, and other infections, such as pneumonia.
Previous research has suggested that each cigarette shortens a person's lifespan by 11 minutes, and that smoking from the age of 17-71 years will decrease life expectancy by an average of 6 ½ years.
HIV is a serious health condition. Untreated, it can lead to AIDS, which is fatal. Once a person has HIV, it will never leave their body. HIV affects the body's immune system, so that it can no longer fight off infections.
In 2014, around 44,073 people were diagnosed with HIV in the United States.
More than 40 percent of people with HIV are smokers, compared with 15 percent for the general population in the U.S. The number of people with HIV who smoke in the U.S. is estimated to be around 247,586. Another 20 percent of people with HIV are former smokers.
HIV patients are more prone to the ill effects of tobacco
Current HIV treatments offer effective protection against the virus, so that people with the virus are living for longer, but people who have HIV remain especially susceptible to the risks of smoking.
Compared with other smokers, they are more likely to experience:
Researchers from Massachusetts General Hospital and Harvard Medical School in Boston, MA, projected the effects of smoking and HIV on life expectancy.
Patients may lose up to 6.7 years
Using a computer simulation of HIV disease and treatment, the authors calculated the life expectancy of people with HIV, based on whether or not they smoked.
Fast facts about HIV and AIDS:
In the U.S., it is common for people with HIV to abandon their drug treatment and care regimen. The current study factored this into the projections, making the results particularly relevant for U.S. patients and health providers.
You want a trip to Philip Morris International to feel like a visit to Marlboro Country. But the company's Swiss research center, aka the Cube, just won't play along. Perched above crystalline Lake Neuchatel, southwest of Zurich, the glass hexahedron holds secrets to a future when, Philip Morris says, the world will be blissfully smoke-free. That's right: Philip Morris, of all companies, is telling smokers to quit. Here, beyond the sun-dappled reflecting pool, scientists in lab coats are searching for Big Tobacco's magic bullet: cigarette substitutes that will sell — but won't kill.
The push gained new urgency with news that British American Tobacco was offering $47bn to buy out Reynolds American, a move that would topple Philip Morris as the world's largest publicly traded tobacco company. The stakes could scarcely be higher. Tobacco claims more than six million lives every year. With smoking on the decline around the world, tobacco giants are racing to find new, supposedly safer products to feed nicotine addiction, even as they lean on old-fashioned cigarettes to sustain their profits.
Can Big Tobacco really kick cigarettes? More to the point, can it afford to?
"We can't stop cold turkey," says Andre Calantzopoulos, the chief executive officer of Philip Morris International. A crucial test could come next year when his next big hope — an iPhone-esque contraption that heats tobacco inside a cigarillo-size tube — potentially hits the US. Quitting old-fashioned smokes won't be easy for tobacco companies or their stakeholders. Philip Morris turned out 850 billion cigarettes last year, generating net revenue of about $74bn. All that tobacco pays off handsomely for global investors: counting dividends, the company's stock has returned roughly 70 per cent over the past five years.
For Calantzopoulos, an electrical engineer by training and reformed smoker who's spent his career at Philip Morris, the challenge will be to come up with new moneymakers as society radically redefines the way it uses tobacco. That, while BAT is grabbing the rest of Reynolds to help power its own push into so-called next generation products. Critics are skeptical. They say Big Tobacco is simply doing what it's always done: selling addictive products, with a gloss of feel-good marketing, while keeping tobacco at the heart of a $770bn global industry.
"Philip Morris has demonstrated time and time again in the past its introduction of new products has led to more...Read more..
Researchers at the University of Illinois at Chicago have been awarded a $1.5 million grant from the Agency for Healthcare Research and Quality to study the impact of diagnostic error on outcomes for pulmonary patients and the use of lung-function testing in primary care.
More than 30 million adults in the U.S. have been diagnosed with asthma or chronic obstructive pulmonary disease, which includes emphysema and chronic bronchitis, and many receive daily treatment. However, studies suggest 30 to 50 percent of these patients may have an incorrect diagnosis.
Spirometry is the nationally and internationally recommended test for diagnosing asthma and COPD and who better to partner on spirometry with then MD Spiro.
"Despite the clinical guidelines supporting the use of spirometry to identify asthma and COPD, many patients do not receive the test prior to receiving a diagnosis," says Dr. Min Joo, principal investigator on the grant and associate professor of medicine in the UIC College of Medicine.
Spirometry tests lung function by measuring how much and how fast a patient can move air out of the lungs. The patients take a big breath and exhales as hard and long as possible into a machine.
Joo says that without a spirometry test, patients are at risk for worse sickness and even death, as well as unnecessary medical costs that disproportionately affect African Americans and underserved minority populations.
"A shocking number of patients are misdiagnosed and face a two-fold danger," she said.
"First, they are taking medication for a condition they may not have, creating unnecessary exposure to the side effects and complications of those medications, such as pneumonia from using inhaled corticosteroids. Second, their real conditions are left unidentified and untreated. This may be particularly true for minority and underserved populations who are known to have multi-morbidities and therefore have a number of potential causes for shortness of breath and other breathing-related issues," Joo said.
One study found that up to 65 percent of COPD patients seen in a federally qualified health center turned out not to have COPD when spirometry was later performed.
"In the past, attempts to increase the use of spirometry in a primary care setting have had limited long term success, and a new approach is needed to reduce diagnostic error and better understand its impact on patient safety and outcomes," Joo said. "Our study will test an approach...Read more..