KARAWANG GIRANG, Indonesia (Reuters) – Anti-tobacco advocates in Indonesia plan to file a class action lawsuit this month using cases of child addicts in the hope of forcing tougher regulations on a society where one in three people smokes.

It is a rare attempt of its kind to constrain a tobacco industry which looks to the world’s fourth most populous country and its growing appetite for cigarettes to replace dwindling sales elsewhere.

The suit against tobacco companies and the Indonesian government argues that feeble regulation has left children dangerously exposed to the risks of smoking.

“There are … kids who have fallen victim to the impact of cigarette companies and smoking. They are addicted. In the context of people’s rights, the society has been disadvantaged by the tobacco industry,” head of the National Commission for Child Protection, Arist Merdeka Sirait, said.

Indonesia is something of a paradise for both smokers and tobacco companies, with the world’s fifth largest population of smokers. It is a widely tolerated habit and one which even in this relatively poor archipelago most can afford to feed.

And it is getting more popular as the economy grows. In 1995, one in four Indonesians smoked. Fifteen years later it had risen to one in three.

That in turn has tempted international tobacco firms to join the hugely profitable home-grown ones such as Gudang Garam, P T Djarum and Hanjaya Mandala Sampoerna, which is now part of Philip Morris International.

The government even gives tax incentives for the manufacture of hand-rolled cigarettes because it provides such a major source of employment in east Java where the local firms congregate.

Sampoerna said it had only seen reports of the planned lawsuit and could not comment. Other producers also had no immediate comment.

A spokesman for the Federation of Indonesian Cigarette Manufacturers said he had heard of the suit but declined comment because it was not aimed at the federation.

“If a child is smoking is that the problem of the advertisement or the parents?” spokesman Hasan Aoni said.

ADDICTION TRANCE

Ilham Hadi has become something of a poster child for the anti-smoking campaign.

He began smoking aged four when his mother Nenah said she gave him 3,000 rupiah ($0.32) to buy snacks at school. He bought a cigarette instead.

The addiction has since blackened his teeth, damaged his skin and, his friends say, made the now nine-year old a useless soccer player and slow, wheezy runner.

“He sometimes bangs on the window at 4 a.m. in the morning to buy a cigarette,” said Iin Indriyani, who runs a tiny store from the front room of her home around 100 yards (meters) up a winding path from the two-room house where Hadi’s family lives.

“Whenever he wants a cigarette he looks like he is in a trance,” she told Reuters, saying that he sometimes hit her and her daughters to demand cigarettes.

Hadi smokes two packs a day, adding to the financial stress on his parents given that his father earns only $5-6 per day as a laborer and part-time motor bike taxi driver.

“If there is no money left at home, nothing to sell anymore, he would go to the grocery shop, get money by helping park cars and come back home with cigarettes, sometimes a pack, sometimes two and expensive brands too,” said his father Umar.

His habit has also brought the family unwanted celebrity as media crews troop to their house on a hillside beside a rice paddy in the village of Karawang Girang around 40 miles south of the capital.

The child protection commission paid for Hadi to be treated in March and he quit, but last week he ran away from home – not for the first time – in search of cigarettes and has not been seen since.

His case has triggered a debate among the village’s 344 residents about smoking and an attempt by the head of the village to make Karawang Girang a smoke-free zone, said Husein, a local government health worker.

But the chances of it leading to a broad national conversation about the dangers of cigarettes, seen by many as a sign of sophistication, seem slim.

The vast majority of Indonesian smokers puff cigarettes laced with cloves, called kretek, a word based on the crackling sound made by the burning, heavily scented spice.

So pervasive is the habit that tobacco products are the number two item in household expenditure after rice, according to the statistics bureau.

Health worker Husein blames advertising. Billboards in the main street near the village feature cigarette advertisements and local entertainment events are often sponsored by tobacco firms.

It is a scene replicated across Indonesia’s vast network of islands.

The annual cost of smoking-related diseases is estimated as high as 11 trillion rupiah, said analyst Abdillah Ahsan of the University of Indonesia’s Demography Institute.

By contrast, cigarette firms are expected to produce 268.4 billion cigarettes in 2012 and contribute $8.45 billion in tax r e venue, according to the finance ministry.

It is enough to make national and regional authorities reluctant to tighten regulations and risk losing funds.

“Every time you want to make a regulation, it is very difficult because on every level of the bureaucracy they have been bought by the cigarette industry,” said Tutus Abaci, a member of Indonesia’s National Commission on Tobacco Control.

($1 = 9242.0000 Indonesian rupiah)

(Editing by Jonathan Thatcher)

NEW YORK (Reuters Health) – One out of every seven patients having a non-emergency angioplasty to clear a clogged artery in the heart didn’t meet criteria for needing the procedure, in a new study from New York.

And based on guidelines, it was uncertain whether the stent-inserting surgery was appropriate in another one-half of patients.

“Patients need to be aware that they are sometimes being referred for something that they don’t need, and they can get by with a less invasive option, which is taking medicines,” said Edward Hannan, the lead author of the study from the University at Albany.

During an angioplasty, doctors use a balloon to open up a narrowed artery and insert a wire scaffold called a stent to keep the artery propped open.

Stent procedures have exploded in popularity in recent years — and several studies have raised concerns about overuse (see Reuters Health reports of July 5, 2011 and July 7, 2011).

The American Heart Association, the American College of Cardiology and other professional organizations have published guidelines to help doctors determine whether patients are good candidates for the procedure — based on their symptoms and heart test results, for example.

For patients with severe chest pain or who have recently had a heart attack, the procedure is nearly always recommended.

But for people without such an urgent need, medications such as blood thinners and statins can sometimes be a better approach.

Hannan said angioplasty procedures cost around $12,000 to $15,000, compared to medications, which can be several hundred dollars per year. Many patients who have a heart procedure also take medications.

To see how well doctors are sticking to the AHA and ACC guidelines, Hannan and his colleagues gathered data from 58 hospitals in New York State.

Among more than 24,000 patients who had an angioplasty in late 2009 and 2010, 36 percent met the criteria for being appropriate candidates.

Nearly half of the patients fell into the uncertain category — in which there isn’t good evidence to say whether medications or a stent would be the better option.

And the researchers deemed 14 percent of patients inappropriate for the procedure, they reported in the Journal of the American College of Cardiology.

In other words, based on these patients’ symptoms and heart test results, it didn’t appear that inserting a stent would improve their quality of life or help them live longer, said Dr. John Spertus, a professor at the University of Missouri in Kansas City, who helped write the appropriateness criteria.

The new study didn’t determine why patients sometimes had the procedure when they didn’t need it. Spertus said it’s possible some are asking to get a stent.

“We use an analogy of a clogged pipe. One would feel that if you opened up the clog, the flow would be better. But studies show it doesn’t make (patients) live longer, and without symptoms, it won’t make them feel better,” said Spertus, who was not involved in the study.

Hannan said cardiologists likely play a role in overuse.

The same physician who is doing a probe to determine the extent of heart disease is also the one who would clear the artery, so “that person is referring (the patient) to himself,” he said.

Angioplasty is also a relatively easy procedure to complete once patients have had those heart exams.

“In an ideal world, you might argue that those patients should get the diagnostic procedure, then come off the table, and be given a trial of medications. If the medications fail to alleviate symptoms, then come back and get the procedure,” Spertus told Reuters Health. “But that just isn’t done.”

Hannan said there is a need for more research on the situations in which patients benefit from angioplasty versus medications, given how many patients were on the fence in terms of whether they would gain from the procedure.

The professional societies “are very careful to say you shouldn’t deny (angioplasty) when the patient is uncertain. On the other hand, from the standpoint of cost consciousness, these patients have not been proven to do better with (angioplasty) than with medical therapy.”

He said the New York Department of Health is contacting hospitals and doctors who appear to be overusing angioplasty “so they can be wary of not doing this in the future.”

SOURCE: bit.ly/Kyz8vD Journal of the American College of Cardiology, online May 14, 2012.

SILVER SPRING, Maryland (Reuters) – U.S. advisers recommended against expanding the use of Johnson & Johnson’s blood thinner Xarelto as a way to reduce the risk of new heart attacks and strokes in people with heart problems.

A panel of outside experts to the Food and Drug Administration voted on Wednesday that the pill should not be approved for people with acute coronary syndrome.

J&J developed the drug in partnership with German drugmaker Bayer AG.

Xarelto is already approved for use to reduce the risk of blood clots in the legs and lungs of people who have had knee or hip replacement surgery. It is also approved to prevent strokes among people with a type of irregular heartbeat called atrial fibrillation.

But the companies wanted to expand its use to treat acute coronary syndrome, which refers to people who have heart attacks or chest pain, usually because of a blocked coronary artery.

About 1 million people in the United States are hospitalized each year after having an ACS episode, often a heart attack, according to researchers.

The trial tested Xarelto as an addition to aspirin, and other clot preventers like Bristol-Myers Squibb and Sanofi’s Plavix, which are typically used to treat the condition.

By a vote of 6 to 4, with one abstention, the panel said Xarelto looked promising but missing data could skew results. They were also concerned about bleeding risks.

“I want to see better evidence that this strategy of adding (Xarelto) …is robustly better for the patient,” said Dr. Steven Nissen, panel member and chairman of cardiovascular medicine at the Cleveland Clinic. “And I just wasn’t convinced.”

The FDA usually follows panel recommendations, although it is not required to, and a final decision is expected by the end of June.

“We appreciate the thoroughness of the committee’s review, and will ensure the questions raised today are addressed with the FDA,” said Paul Burton, a vice president with Janssen Research & Development, the J&J unit that markets Xarelto.

THREE-WAY RACE

Xarelto is one of three new medicines that offer potential advantages over older drugs to prevent strokes and other dangerous conditions caused by blood clots, in a market worth up to $10 billion in annual sales, according to Wall Street forecasts.

Investors have tried to bet on which of the three will become the dominant player in a race between Xarelto, Eliquis from Pfizer Inc and Bristol-Myers Squibb Co and Boehringer Ingelheim’s Pradaxa.

Pradaxa gained U.S. approval in 2010, while Eliquis is still under FDA review, with a decision expected by the end of June.

Xarelto’s rivals failed in treating patients with ACS, giving Bayer and J&J a potentially distinct market — although stroke prevention in atrial fibrillation is seen as the most lucrative use for the new drugs.

In a clinical trial of ACS, people who took a 2.5 milligram dose of Xarelto in addition to an aspirin and another anti-platelet medication had a 15 percent lower risk of having a stroke or dying from a heart attack than people just taking the other medicines, FDA reviewers said.

On the other hand, patients taking Xarelto had twice as much risk for a major fatal bleeding compared to the older drugs, while other kinds of bleeding were three times higher with Xarelto. But the overall rates were still low: only 0.1 percent of patients had fatal bleeding while taking the drug and 2 percent had some kind of bleeding.

The FDA advisers decided the balance between the heart benefits of Xarelto and its bleeding risks tilted against the drug because the company lost track of an average of 12 percent of patients during clinical trial. It was unclear how those patients fared while taking the medicine.

“Were there not questions about loss to follow-up and missing data, it would have been a yes,” said Allan Coukell, a pharmacist and the panel’s consumer representative, when explaining his ‘no’ vote on Xarelto.

J&J has said it expected some people to drop out of the final clinical trial since it enrolled about 15,500 patients and studied them for about 2 1/2 years, and the dropout rates were similar between people taking Xarelto and those on the older drugs, meaning the missing data should not impact the results.

(Reporting by Anna Yukhananov; Editing by Gary Hill, Tim Dobbyn, Leslie Gevirtz and Michael Perry)

(Reuters) – Interim results from a mid-stage trial of Celldex Therapeutics Inc’s experimental drug showed trends toward reducing tumors in patients with advanced breast cancer, with rates improving for those patients with high levels of a key protein.

Celldex shares dropped 8 percent in after-hours trading.

The drug, CDX-011, which links a tumor-targeting antibody to a cell-killing chemotherapy drug, was tested in 122 patients whose breast cancer had progressed despite several previous rounds of standard therapy.

In the study, released by the company on Wednesday, 19 percent of patients taking CDX-011 saw their tumors shrink, compared with 14 percent of those treated with standard chemotherapy.

CDX-011 is designed to target GPNMB, a protein produced on the surface of several types of malignant tumors. In trial patients with GPNMB in at least 25 percent of tumor cells, 32 percent responded to the drug, compared with 13 percent of chemotherapy patients.

“GPNMB helps the tumor cell to move around,” said Dr. Linda Vahdat, director of the breast cancer research program at Weill Cornell Medical College and the study’s lead investigator. “It almost seems like this drug puts the brakes on that process by taking away its legs.”

For patients with high levels of GPNMB as well as “triple negative” breast cancer – meaning cancer that it’s not sensitive to estrogen, progesterone or a protein known as HER2 – the response rate was 36 percent compared with no responses in the control group.

“I think that there is a lot of data and that the company has done a great study,” said Wedbush Securities analyst Gregory Wade. “The results are very promising considering how heavily pre treated the patients are … I think that if anything the reason the stock has moved around a little bit is there is a lot to interpret.”

Celldex shares, which closed at $4.26, initially rose after the study results were announced before falling back to $3.90 in after hours trading

Side affects associated with CDX-011, also known as glembatumumab vedotin, included rash and peripheral neuropathy.

The company said it expects to announce updated results from the Phase II trial in the fourth quarter of this year.

“This patient population has a very real need,” said Tom Davis, chief medical officer at Celldex. “It is reasonable to consider a single-arm study … a randomized study is also a possibility.”

In a randomized trial patients are allocated at random to receive one of several clinical interventions. In a single arm trial there is no comparison group.

About 15 percent of breast cancer patients are triple negative, while high expression of GPNMB occurs in about 27 percent, according to Celldex. Because there is some overlap, both groups account for an estimated 35 percent of the total breast cancer population.

About 227,000 U.S. women are diagnosed with invasive breast cancer each year, according to the American Cancer Society.

Chief Executive Officer Anthony Marucci said Celldex will consider partnerships to develop CDX-011, but plans to move forward with the drug regardless of any such deals.

(Reporting By Deena Beasley; Editing by Tim Dobbyn and Carol Bishopric)

(Reuters) – A large real-life test of birth control methods found more U.S. women got pregnant while using short-acting methods such as pills, patches and vaginal rings — and the failure rate was highest when they were used by women under 21.

In a new study published on Wednesday in the New England Journal of Medicine, about 7,500 women and teens in the St. Louis area were allowed to pick from a variety of contraception methods at no cost.

Over the course of the study — more than three years for women who completed all follow-up interviews — participants had a total of 334 unintended pregnancies. For the full study, see: bit.ly/KdMCQp

“We found that participants using oral contraceptive pills, a transdermal patch or a vaginal ring had a risk of contraceptive failure that was 20 times as high as the risk among those using long-acting reversible contraception,” said the research team, led by Dr. Brooke Winner of Washington University School of Medicine in St. Louis.

Long-term contraception methods include intrauterine devices (IUDs), hormone shots and skin implants.

Previous research had suggested that more women have unintended pregnancies when they use contraception that requires daily or weekly use.

But those findings came from national surveys where women tried to remember when they became pregnant and which contraceptive method they were using three or four years earlier.

“If I try to remember what I had for dinner two days ago, I can’t,” Winner told Reuters Health. “So you can imagine that those retrospective studies are not very reliable.”

In the study led by Winner, some of the unplanned pregnancies occurred when women weren’t using their chosen contraception and instead relied on a condom or the pull-out method, in which the male withdraws before ejaculation.

Still, among about 1,500 women who chose to use a contraceptive pill, patch or ring, between 4 and 5 percent became pregnant while using those methods each year.

In comparison, 0.3 percent — about one in 330 — of the 5,800 women who opted for an IUD or skin implant had an unplanned pregnancy each year because of contraceptive failure.

Just 176 women chose to get Depo-Provera hormone shots every three months, and two of them became pregnant during the study.

Depending on the brand, IUDs can prevent pregnancy for five to 10 years. Skin implants last for three years.

AGE IMPACTS RATE OF UNPLANNED PREGNANCIES

The effectiveness of the methods varied with age: women under the age of 21 who used pills, the patch or a vaginal ring had almost twice as many unintended pregnancies as older women who used those methods, the researchers reported.

Half of all pregnancies in the United States are now unintended — about 3 million annually, according to statistics from the Centers for Disease Control and Prevention.

About half of those, in turn, are in women who have been using contraception and either do not use it properly, or the method fails. Of those unintended pregnancies, 1.2 million or so lead to abortions.

The rate of unintended pregnancies in the United States tends to be higher than in other developed nations, the researchers said.

They found that women who asked for pills, a patch or a ring were less likely to have given birth before or have had an unintended pregnancy, abortion or sexually transmitted disease compared with participants who selected other methods.

IUDs and implants usually cost more than $500 and typically aren’t covered by insurance, she said.

“Nationally, only about 5 percent are using long-lasting methods like IUDs and implants. We know one of the barriers to why they’re not using them more frequently is up-front costs,” Winner added.

“One of the beauties of this study is that it shows that when you take cost out of the equation and you educate women objectively and effectively, about 75 percent of them chose a long-acting method,” she said.

“If that many women were using these products nationally, there would be a very significant drop in unintended pregnancies, which would have far-reaching effects.”

(Editing by Michele Gershberg and Cynthia Osterman)