Novartis are attempting to prevent imitation drugs being sold on at cut prices in India, showing that drug companies are about profit, not cure. 

Nitin Sawhney 

February 16, 2007 11:32 AM | Printable version 

As an asthmatic, I remember watching the BBC’s Panorama programme a few years ago, which featured a comparative investigation into the relative benefits of a breathing technique known as “Buteyko” against conventional drugs. I was shocked to discover that the non-drug related method virtually cured its sample whereas those subjected to conventional medicine showed little or no improvement. These results had already been predicted by previous sensational tests in Australia some time before. My surprise was exacerbated by the fact that there had been little or no further investigation or formal experimentation pursued after encouraging statistics favouring Buteyko. The programme strongly suggested that it simply would not be in the interest of pharmaceutical companies to finance any potential cures for illnesses that were not related to tangible medication. Basically, drug companies are about profit, not cure. 

Following this programme, I have used a combination of breathing techniques, exercise and drugs to help my asthma. Having heard about pharmaceutical companies Novartis and Pfizer taking legal action in India and the Philippines against those wishing to supply cheaper imitation drugs to the masses, I was again reminded that curing sickness is not necessarily their primary concern - at least, not for the poor. 

Currently, in India, the Swiss drugs company Novartis is engaged in a legal battle to patent a drug used to combat stomach tumours and leukaemia known as Glivec. Novartis is attempting to enforce intellectual property rights, thus enabling them to sell Glivec in the Indian market at Rs120,000 ($2,500) per patient per month - pricing this crucial drug way out of reach for poor people. Generic versions of the same drug cost Rs8,000 ($175) per patient per month. Novartis are pursuing this case through the appeal courts despite a ruling last January by an Indian court that Glivec could not be patented on the grounds that it “lacked real innovation”. 

The case has huge ramifications. India is simply trying to interpret global intellectual property rules in a manner that would guarantee affordable medicines for the poor, which it is perfectly entitled to do under global trade rules. 

It is difficult for me to really understand the thinking behind huge corporations putting profit before life, let alone in a country where most of the population is well below the poverty line. This case could create a legal precedent in India. It is, indeed, amazing that such an important case has not been given an international platform for greater scrutiny. Setting a legal precedent in India may be a clever strategic move on the part of Novartis, as India is the producer of approximately 67% of medicines sent to developing countries, including nearly 80% of medicines exported to sub-Saharan Africa; the ability of Indian companies to export cheaper generic drugs will be undermined if Novartis wins this case. 

When I heard that the global pharmaceutical industry achieved 22% sales growth in India, Brazil, China and Russia last year - as opposed to relatively unimpressive single digit growth in US, Europe and Japan - it became obvious to me why India has become such as important battleground. 

I often wonder if the fat cats who run Novartis have ever been to India, let alone any other country affected, and witnessed the pain and suffering of those in need. Surely, their simple humanity would demand a change of perspective. Who knows? All I can say is that their attitude undermines the work of virtually every charitable organisation in India and beyond, one of whom I intend to raise money for by running next year … without my inhaler. 

June 26, 2006, 6:07AM

King Features Syndicate
Breathe deeply. This simple act sustains life, and yet most of the time we don’t even notice it.
Not being able to catch your breath can be terrifying. People with asthma may gasp desperately for air. Sometimes they even die with their inhalers in their hands.
Asthma deaths have been rising for decades, although the drugs to treat it are more powerful than ever before. Researchers now blame some of the most popular asthma drugs for this increased mortality.
A new analysis published in the Annals of Internal Medicine (June 20, 2006) reports that “salmeterol may be responsible for approximately 4,000 of the 5,000 asthma-related deaths that occur in the United States each year.”
Salmeterol is one of the most widely prescribed asthma drugs in the world. It is a long-acting bronchodilator found in inhalers such as Advair and Serevent.
The Food and Drug Administration has strengthened the labeling for salmeterol and another long-acting bronchodilator, formoterol (Foradil). Physicians are warned that such medications should not be used as initial treatment since they may increase the risk of serious asthma attacks and asthma-related deaths.
What’s an asthma patient to do? Experts encourage physicians to consider other kinds of asthma medicines. Inhaled corticosteroids can ease the underlying inflammation that triggers breathing problems. When a bronchodilator is needed, shorter-acting beta-agonist medicines may be somewhat safer than long-acting ones. Whatever bronchodilator is used, however, it must not be overused.
Other asthma medications that ease inflammation include montelukast (Singulair), zafirlukast (Accolate) or zileuton (Zyflo). Cell stabilizers such as cromolyn (Intal) or nedocromil (Tilade) are different prescription options. An anticholinergic asthma medicine called ipratroprium (Atrovent) can be helpful for some asthma victims.
In addition, there is interest in breathing exercises to help asthma patients. A study published in the journal Thorax (online June 5, 2006) showed that people with mild asthma may benefit from practicing breathing techniques.
In the study, asthma patients who were using reliever medication four or more times a week were given a video instructing them in one of two breathing techniques. One focused on shallow breathing through the nose, capturing elements of a complementary therapy called Buteyko. A control program coordinated breaths with gentle upper-body movements.
Practicing either technique reduced the use of reliever drugs by 86 percent. Patients also needed lower doses of their inhaled corticosteroids. These results suggest that breathing lessons may be worthwhile for asthmatics.
We have spoken with experts about how changing breathing patterns can affect health, especially asthma and blood pressure.

Task Force says no to OTC nasal steroids

(PRLEAP.COM) A natural asthma cure could mean the end of a multi-million dollar business. With Ventolin tablets and inhalers selling in such high numbers, a drug-free alternative would definitely prove to alter conditions in the asthma treatment industry.

These methods include a drastic change in one’s diet from what is coined as a Mucus/disease forming diet in the Naturopathy Fraternity to a body healing one. This discipline is also being used in the “Breath Retaining Program For Asthmatics” developed by the Russian, Dr. Buteyko and within a few weeks of adhering to this advice, many a chronic asthmatic have been able to give up the use of synthetic drugs.

When told, the tips on his website might be seen as a milestone in natural treatment modalities, Aje offers a warm, yet modest smile saying: “Several people everyday are becoming more aware that nature has provided us with the means to treating ourselves. If a change in dietetic habits and common-sense factors might be all that’s needed to combat a disorder, then there is no need to waste money on chemicals, which inevitably cause more havoc and side-effects.”

Perhaps more people should be informed of this, Aje says, and it remains one of his many missions to inform patients of asthma treatments with a natural approach via his website for the increased healing of the affected.

So the next time one is told there is no cure for asthma, it may be safe to re-visit that remark with emphasis on the drugless methods which according to Aje do work.

ISLAMABAD: Babies who taken even just one course of antibiotics during the first year of their life may face an elevated risk of developing childhood asthma, according to a new Canadian study published in the April issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians (ACCP).

Asthma is a chronic respiratory disease characterized by episodes or attacks of inflammation and narrowing of small airways in response to asthma “triggers.” Asthma attacks can vary from mild to life-threatening and involve shortness of breath, cough, wheezing, chest pain or tightness, or a combination of these symptoms.

The study found those who were exposed to antibiotics in the first year of life were twice as likely as those who were untreated to develop asthma in childhood. In addition, there was a dose-response relationship between the risk and the number of courses of antibiotics.

“Antibiotic use in children has been found to coincide with an increased incidence of childhood asthma,” said lead author Carlo Marra, Pharm D, PhD, University of British Columbia, Vancouver, BC, Canada. “Although the causal nature between antibiotics and asthma is still unclear, our overall results show that treatment with at least one antibiotic as an infant appears to be associated with the development of childhood asthma.”

To examine the association between antibiotic exposure during infancy and the risk of developing childhood asthma, researchers from the University of British Columbia meta-analyzed results of seven studies involving 12,082 children among whom 1,817 cases of childhood asthma were recorded.

Overall, infants exposed to at least one course of antibiotics in the first year were twice as likely as those who were untreated to develop childhood asthma. The effect of antibiotics was more significant in the retrospective studies than the prospective studies.

Researchers also conducted a dose-response analysis of 27,167 children among whom 3,392 asthma cases were documented in five studies.

They found for each additional course of antibiotics taken during the first year of life, the risk increased by 16 percent compared with those who were not exposed to antibiotics. The effect of antibiotics was more significant in retrospective studies than prospective studies.

The antibiotic-asthma association did not seem significant in infants born with high risk factors such as a family history of the condition or a genetic tendency to develop allergies, the study found.

“Asthma is one of the most common chronic childhood diseases, affecting millions of children in the United States,” said W. Michael Alberts, MD, FCCP, President of the American College of Chest Physicians. Asthma is diagnosed in about 30 million people in the US during their lifetime - 22 million adults and 8 million children age 0 to 17 years. In the US, asthma results in about 4,500 deaths every year - about 200 deaths in children.

“By identifying potential risk factors for asthma and educating patients and families about risk factors, we may begin to see a reduction in the overall incidence of asthma,” said Alberts.

The researchers question the rational behind the current recommendation on use of antibiotics in young children. “In children, antibiotics are commonly used to treat ear infections, upper respiratory tract infections, and bronchitis, but not every childhood infection requires an antibiotic,” said the study’s co-author Fawziah Marra, MD, University of British Columbia.

“Current guidelines recommend that children under age 2 receive an antibiotic for diagnosed ear infection. However, the majority of upper respiratory tract infections and bronchitis is viral for which antibiotics are ineffective.”

The use of antibiotics would kill beneficial bacteria in the body and promote growth of molds and or parasites, which in turn make the immune system hyper sensitive to pollen, dust and other harmless substances.

The studies were carried out based on the survey data, not medical records. Because of this, possible errors and bias make the studies used in the meta-analysis less reliable. Although the association was statistically significant, the results of previous studies and the current meta-analysis did not mean use of antibiotics definitely causes asthma.

Further, some cases of asthma may not be identified before antibiotic exposure, which could make the results less reliable, researchers noted.

One possible explanation for the antibiotic-asthma link is that those infants who received antibiotics may be more susceptible to asthma in the first place.

Does the world’s bestselling asthma drug sometimes kill the patients it is supposed to help?

Frank A. Dittig was recovering from a nasty bout of pneumonia in the spring of 2004 when he developed a wheeze that wouldn’t go away. For this his doctor prescribed Advair, the hot- selling asthma inhaler, though Dittig didn’t have asthma and never had.

 He used it and immediately began to feel worse. “When I sucked it in, it felt like I was collapsing my lungs,” he recalls. He complained but says his doctor told him the drug couldn’t possibly be making him worse. Soon, the wheezing was so bad he couldn’t walk. Against his doctor’s advice, he stopped taking Advair after a week and recovered. Dittig, who runs his father’s office supply business near Pittsburgh, Pa., says his 14-year-old son has asthma and had problems on Advair, too, as did Dittig’s father.

 Marcus Faulk of Louisville, Ala. also had a bad reaction to Advair or to Serevent, one of the two drugs it comprises. He started out on Serevent and “said that every time he took the medicine it made him feel worse,” says his aunt, Annette Glanton. A few weeks after Faulk tried Advair, he collapsed on the floor of a relative’s home, late on the night of Jan. 6, 2003. Just 20 years old, he was dead by the time the ambulance pulled up to the hospital, his Serevent inhaler still clutched in one hand. Three years later his father, Earl Faulk, a truck driver, still can’t talk about it without breaking down and sobbing. He has sued Advair’s maker, GlaxoSmithkline. It says the drugs’ benefits outweigh their risks, and, in court filings, denies the charges.
Advair is the fourth-best-selling drug in the world, with $5.6 billion in sales, up 19% in 2005, and 21.1 million U.S. prescriptions. Many patients swear by it. It also is one of the most heavily advertised drugs: GlaxoSmithkline spent $137 million on Advair ads last year, says TNS Media Intelligence. Thanks to that and Advair’s nifty delivery system–a plastic purple puck that is easy to use–the drug has moved far beyond a narrow audience of severe asthma patients to reach those with mild cases and nonasthmatics who simply have a bad bronchial cough.

 Now growing evidence suggests that a small percentage of patients–perhaps 4,000 people a year, by one doctor’s estimate–may be dying because of Advair or its Serevent component. This highlights a tough dilemma in drug safety: what to do about drugs that help many but harm a few. It could mark the start of the next great drug-liability war, and already the drama seems all too familiar: scared patients, contradictory studies, a company that calls the evidence “inconclusive” and is accused of skewing clinical data–and lawyers looking at whether there’s enough damage here to cash in.

 “If we got these drugs off the market, we could prevent 4,000 deaths a year,” argues Shelley Salpeter, a clinical professor of medicine at Stanford University who says both Advair and Serevent should be recalled. She pored over the results of 19 previous trials of Serevent-style drugs and found that patients have twice the rate of asthma hospitalizations, twice the rate of life-threatening asthma and four times as many deaths as patients who aren’t on those drugs. She believes Advair and Serevent cause four of every five asthma-related deaths each year. “These drugs make asthma worse,” she says. By some estimates, asthma kills roughly 5,000 Americans a year.
“Every death is a potential lawsuit that Glaxo will have to face, and rightly so,” says trial lawyer W. Chad Cook. Adding to the risk, some of these deaths are children and young adults such as Marcus Faulk. Cook’s law firm, Beasley Allen in Montgomery, Ala., filed the Faulk lawsuit and three others and is reviewing hundreds of potential cases. “We have people calling us literally every day who have had adverse reactions on these drugs,” he says.

 Glaxo says its detractors are exaggerating the risks. “The data we have are inconclusive,” says Kathy A. Rickard, a Glaxo vice president, echoing early responses by Wyeth (nyse: WYE - news - people ) about its Redux diet drug and Merck (nyse: MRK - news - people ) & Co. about its Vioxx painkiller. Both drugs were pulled from the market, with Wyeth now paying $22 billion in damages and Merck facing lawsuits that Wall Street expects will cost it billions (its market value is off by $22 billion since Vioxx was recalled).
Advair, approved by federal regulators in 2000, was more a miracle of marketing than of science. The purple puck delivers a blast of two Glaxo medicines that won approval years before: Serevent, a “beta agonist” that was cleared in England in 1990 and in the U.S. in 1994, and Flovent, an inhaled steroid that won U.S. approval in 1996. Advair’s one-two punch seemed ideal: Serevent to expand constricted airways, Flovent to ease inflammation. Glaxo touted it as “the first and only” drug to treat both underlying components of asthma at once and bragged that it yielded “nearly twice as many symptom-free days.”
But Serevent had been under suspicion from the start, and earlier beta agonists had stirred doubts for decades. In 1948 one study of 2,200 asthma patients found a fivefold-higher death rate for patients who inhaled epinephrine, a beta drug, versus those who hadn’t. In the late 1970s asthma deaths in New Zealand soared after a beta agonist called fenoterol hit the market.
In 1993, a year before Serevent made its debut, a Glaxo study found 12 asthma deaths among almost 17,000 patients on Serevent for four months, three times the death rate in an equivalent control group of asthma patients. But this difference was deemed statistically insignificant.
Serevent was introduced in 1994, touted as longer lasting than older beta agonists like albuterol (12 hours versus 4 to 6 hours). Soon after, the Food & Drug Administration received reports of several deaths. A letter to the New England Journal of Medicine described two elderly patients who had died while still clutching their Serevent inhalers. Glaxo added warnings on proper use (it doesn’t work instantly, so don’t take it to quell a new attack) but denied any problem: “No patient is known to have died as a direct result of taking Serevent,” it said at the time.
But in response to the worries, Glaxo set up an even bigger study in 1996, ultimately aiming to track a massive 60,000 patients on Serevent. It wouldn’t report any results for several years, and by that time Advair was on the market and roaring. It debuted in 2001 and soon after had largely replaced Serevent-only prescriptions. Last year Advair’s 21 million prescriptions dwarfed the 1.7 million for Serevent, according to IMS Health.
Glaxo promoted the new brand heavily. It also ran an ad featuring “the Bus,” former Pittsburgh Steelers running back Jerome Bettis, hailing new hope for controlling asthma. It encouraged people to take a five-question “asthma control test.”
“A large number of patients are being treated uselessly,” says Fernando Martinez, professor of pediatrics at the University of Arizona. “We have to target these medicines to those that need them. What’s happening now is many patients get the combination straight away.”
Yet a Glaxo study in 2004 found that 60% of asthma patients could control their disease with just the inhaled steroid Flovent, the other half of Advair. Compared with steroids alone, using Advair helped only an extra 15% of patients.
The rampant prescribing of Advair grew a bit more alarming in 2003 when results were released from Glaxo’s big safety trial of Serevent. Though it had hoped to track 60,000 patients in the effort that began in 1996, Glaxo got up to only 26,000. The six-month study, when extrapolated, suggested one extra death for every 700 patients on Serevent for one year. The company put out a warning to doctors; then it ended the trial because of difficulties in signing up more patients.
In that trial Glaxo found a total of 13 people on Serevent had died of asthma, while only 3 people had died in the placebo inhaler group (everyone was allowed albuterol). But Glaxo’s Kathy Rickard says, “We cannot tell whether it is due to pharmacology or socioeconomic status or patients who don’t take their medicines or whether it is a genetic predisposition.” Why? Because the trial “wasn’t designed to test those issues,” she says.
Nationally, asthma deaths have eased recently, even as use of long-acting beta agonists has risen, Rickard notes, inconsistent with an epidemic of drug-induced deaths. With Advair, “patients get control of their asthma faster,” she maintains. People died clutching their inhalers long before Serevent came along.
It may be that the presence of the second drug in Advair, the steroid Flovent, quells any threat posed by Serevent (the beta agonist) in many patients. Yet GlaxoSmithkline never has expressly studied whether Advair, too, might cause a higher death rate in a giant trial. And it has no plans for such a trial. Instead, it is conducting a 460-patient trial looking at Advair versus Flovent in black patients; a 540-patient study looking at whether genetic variations influence response to Serevent and Advair; and an “observational study” using Medicaid data.
Some doctors defend Glaxo and Advair. George Washington University internist Matthew Mintz says the safety issue “has been blown way out of proportion” and that the bigger threat is underuse, not overprescribing. Doctors who bash the drug are “irresponsible,” because they may scare away patients who would do well on Advair, he adds. (Mintz is a consultant to GlaxoSmithkline; Advair critic Martinez has consulted to Merck, which makes an Advair rival; and Advair foe Salpeter of Stanford has consulted to trial lawyers on the matter.)
The FDA has strengthened label warnings for Serevent and Advair three times amid wrangling with the company over how to interpret trial data. Last July an FDA advisory panel, which included Martinez of Arizona, voted unanimously in favor of keeping both Advair and Serevent on the market, although the FDA now says Serevent should never be used on its own. In November the FDA warned that Advair should be used only after other drugs had failed; Glaxo objected and the final label, released in March, was softened a bit.
A recalcitrant company, a suspect drug, young patients dying–and lawyers smelling blood. This could get very ugly.

NEW YORK (Reuters Health) - It is known that stress exacerbates the symptoms of asthma in children, but the biological reason for this has been unknown. Now, scientists in Canada have discovered that a stressful home life diminishes the expression of certain proteins on the surface of cells that regulate airway responses and inflammation.
“Collectively, these findings suggest that in children and adolescents with asthma, the quality of home life and family relationships are important determinants of health and well-being and appear to have stronger effects than other life domains, such as academics and peer relationships,” conclude Drs. Gregory E. Miller and Edith Chen, from the University of British Columbia in Vancouver.
They interviewed 39 children with asthma and 38 healthy children, ages 9 to 18, regarding acute and chronic stress over the preceding 6 months. Blood specimens were obtained to measure levels of the so-called glucocorticoid receptor and beta-2-adrenergic receptor.
In general, children with asthma expressed higher levels of beta-2-adrenergic receptor and glucocorticoid receptor than did healthy children.
However, the researchers found that asthmatic children exposed to chronic stress, such as abrasive family relationships or an unstable home environment, expressed less beta-2 than those not exposed to chronic stress, whereas healthy children expressed more.
Major life events alone did not affect expression of these proteins in either group of children.
But in children with asthma who experienced a major life event in the previous 3 months along with chronic stress, the expression of beta-2-adrenergic receptor decreased 9.5-fold and expression of glucocorticoid receptor decreased 5.5-fold. In healthy children, this pattern was reversed and was weaker.
In Proceedings of the National Academy of Sciences, Miller and Chen explain that attenuated expression of both receptors would likely lead to airway inflammation and airway constriction after exposure to allergic triggers. It could also diminish patients’ sensitivity to asthma medications, they suggest.
SOURCE: Proceedings of the National Academy of Sciences USA 2006.

Australian researchers have suggested a simple and natural remedy for reducing the intensity of asthma attacks or even putting off an attack, by just eating more fruits and vegetables. They have enough evidence to show that diets deficient in antioxidants, are capable of accelerating and worsening an attack.

A small group of asthma sufferers were subjected to a diet low in antioxidants and their asthma was observed along with levels of antioxidants, like carotene and lycopene in their blood .It was observed that those who had low levels of antioxidants circulating in the blood, especially antioxidant lycopene, showed symptoms of asthma on the rise. Incidentally lycopene is found in abundance in tomatoes.

The study was conducted by Lisa Wood, a research fellow at the Respiratory and Sleep Medicine Unit at the Hunter Medical Research Institute in Newcastle. She said “There has been no evidence that if you take these foods out of the diet it will affect your asthma outcome. The thing that’s most exciting is a proof of concept, that if you take antioxidants out of your diet it will be bad for you, and that hasn’t been scientifically proven before.”

Associate Professor John Wilson, chairman of the National Asthma Council, said “The study was highly significant and very important for our understanding of inflammatory mechanisms. The researchers will no doubt want to go on and explore the relationship in their findings to the usual diet of Australians, and how that might be improved to improve asthma outcomes.”

During a debate in the British House of Commons, Westminster, London, on June 25th, 2000, Mrs. Anne Campbell (Cambridge) commented as follows: