Novartis fights patent rejection in Indian court (AP)

NEW DELHI � In a case that could affect India's role as drug provider to the developing world, the Supreme Court began hearing arguments Tuesday over whether the government had the right to deny a patent to Swiss drugmaker Novartis AG for its lifesaving cancer treatment Gleevec.

A victory for the company, aid groups warned, could open the door to patenting dozens of other generic medicines made by India's $20 billion drug industry and sold to needy nations at far lower costs than those charged by Western drug manufacturers.

"There will be nothing left to defend if we lose," said Leena Menghaney of Medicins Sans Frontieres, or MSF. "The generic industry is just going to pack up and leave."

The case, launched soon after India passed its Patent Act in 2005, revolves around a legal provision aimed at preventing companies from seeking patents or extensions based on minor changes to existing treatments � a practice known as "evergreening" that is common in Europe and the United States.

The provision has allowed India to reject patents for a range of older drugs for cancer, AIDS, tuberculosis, malaria and other illnesses that are made by India's generics industry.

It also led to the rejection of Novartis' application for Gleevec, in which it argued a newer, more easily absorbed version qualified for a patent because it was demonstrably more effective. The blockbuster drug keeps chronic myeloid leukemia and some other cancers in remission. Its earlier version was ineligible for an Indian patent because the country gives no protection to drugs invented before 1995.

Novartis insisted the revamped Gleevec, marketed outside the United States as Glivec, represents a unique breakthrough rather than just a tweak to the old formula, and that the Indian law "intended as a hurdle for 'evergreening' is not applicable at all," the company said in a statement.

But Indian patent officers and an appellate court said the change only amounted to an obvious development on an existing treatment. It's not known when the Supreme Court might rule.

Novartis now is arguing for a wider understanding of the provision requiring innovation toward improved drug efficacy, hoping to set a legal precedent it says is key to preserving financial incentives for companies to develop new drugs.

"We believe there are important issues to be addressed that are essential to the future of intellectual property law in India and the viability of the innovative pharmaceutical business in this country," the company statement said.

Lawyer Anand Grover for the Cancer Patients Aid Association, which has joined the government to defend the patent rejection, said Novartis' stance represents "a very dangerous argument" to India's effort to prevent patent abuse.

The case is just one of many challenges to India's generics industry, which has frustrated multinational pharmaceuticals since 1972 when India decided not to recognize patents on drug products and began churning out low-cost copies of branded medicines.

Current trade talks with the European Union have snagged on the issue of intellectual property, with EU officials wanting stricter provisions that activists say would also kill the generics industry.

India now makes one-fifth of the world's generics, sending about half abroad.

Given India's own enduring poverty � with more than 800 million people living on less than $2 a day � many argue the limits still make sense domestically, particularly as Indian patients bear at least 80 percent of their own medical costs.

Branded and patented drugs are often 10-40 times pricier than generics, said Dr. Amit Sengupta of the People's Health Movement. In the case of Gleevec's generic equivalent, a monthly treatment in India costs about 8,000 rupees, or $175 � one-fifteenth the $2,600 price charged by Novartis in the country.

"That is really the margin between life and death," Sengupta said, particularly if the verdict leads to more drug patents on older products relied on globally. In treating HIV, for example, the medical charity MSF says it buys 80 percent of its medicines from India.

The pharmaceuticals "don't even care if people live or die so long as they make their money," said AIDS activist Loon Gangte of the Delhi Network of Positive People. "We can't let them win."

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UK officials may take 4 obese kids into custody (AP)

LONDON � Scottish officials say they may take four heavy children away from their parents after warnings to help their kids trim down have apparently failed.

The children are aged one to 11. The parents are obese and have three older children who are also heavy. For the past two years, the family has lived in government housing and had their eating habits scrutinized.

Last week, officials in Dundee told the family their four youngest children could be taken into foster care or adopted. A government spokesman said they would act in the children's best interests.

In the U.S., there have been several cases where obese children have been taken into care after their parents couldn't help them lose weight.

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CDC: 2 children sickened by novel swine flu strain (AP)

Health officials say a novel strain of swine flu has sickened two children in Pennsylvania and Indiana.

One had contact with pigs. The other is believed to have been infected by a caregiver who had contact with pigs, suggesting the virus can spread person-to-person.

The Centers for Disease Control and Prevention says the new virus contains a gene from the H1N1 swine flu that caused a worldwide scare two years ago, plus parts of other viruses that have infected pigs over the last decade.

The children were infected in July and August and have recovered. Both had received flu shots last year.

Officials are investigating other reports of illness in people who attended an agricultural fair in Pennsylvania. No additional cases have been confirmed so far.

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WTC studies find no big jump in cancer, deaths (AP)

NEW YORK � Two major medical studies have failed to find significant increases in deaths or cancer among people exposed to dust from the World Trade Center.

In one, researchers who studied cancer rates among nearly 9,000 firefighters who spent time at ground zero found four more cases of the disease than might normally be expected in a group of American men of the same age and ethnicity, an increase independent experts said was small enough to be caused by chance alone.

Fire Department doctors also compared exposed firefighters to a group of 926 colleagues who were never at the trade center, and had no contact with the dust. There, they found that cancer rates were about 19 percent higher for in the exposed group, but, again, experts uninvolved in the study said the difference was not statistically significant.

Advocates for the firefighters said the trend was still worrisome, however, and doctors said they could not rule out the possibility that more cancer cases will develop among the firefighters as time goes on.

In the other study, researchers with New York City's health department who studied death rates among 42,000 people potentially exposed to trade center dust found no evidence of a spike in fatalities. In fact, they found that the 790 deaths among people in the study group was about 43 percent lower than the mortality rate for New Yorkers in general. They were also less likely to have suffered fatal respiratory ailments.

Those findings, however, was also written off by scientists as too premature to mean much. Because the attacks happened in a business district and presumably involved people who were fit enough to be reporting to work, the study group was probably healthier than the general public to begin with, said New York City's health commissioner, Dr. Thomas Farley.

"I wouldn't interpret it as that the World Trade Center has somehow helped people live longer," he said. Also, the types of toxins released in the trade center disaster usually take decades to result in deaths, not the few years covered in the study, he and other experts said.

Donald Berry, a professor of biostatistics at the University of Texas M.D. Anderson Cancer Center, said the two studies "provide no evidence that living or working in the former shadow of the World Trade Center increases one's risk of anything."

"Occupational hazards are real," he said. "An extreme example is the plight of asbestos workers. But occupational risks accrue over years of exposure. With the exception of a nuclear explosion or meltdown, it's difficult for any single event to cause an increase in cancer or in mortality."

Both studies were being published Friday in The Lancet, a British medical journal.

Also set for publication in The Lancet on Friday is a study of nearly 27,500 people enrolled in a World Trade Center health monitoring program that found that nearly 28 percent had asthma, 42 percent had sinus problems and 39 percent had acid reflux disease, a condition related to heartburn. The study also found large numbers of rescue and recovery workers suffering from depression or panic disorders. Those findings echo the results of several other studies.

Dr. David Prezant, the fire department's chief medical officer, said he believed the firefighters study indicated "a moderately strong correlation" between World Trade Center dust and cancer. He said he did not agree with other experts who said the study failed certain key tests of statistical significance.

The inquiry found that 242 of the nearly 9,000 firefighters exposed to the attacks had developed cancer within the study period, compared to the 238 that researchers would have expected in the general public.

Researchers found less lung cancer than expected � only 9 cases instead of the 21 they expected to see. That's reassuring because people are concerned about inhaled dust particles. All 9 of the cases involved smokers.

Conversely, they found 12 cases of thyroid cancer in the study group, compared to the 6 they might have expected based on rates in the general public.

Dr. James M. Melius, director of the New York State Laborers' Health Fund and one of the leading advocates for ground zero workers suffering health problems, said that even though the cancer research on firefighters was inconclusive, it showed enough possibility of a risk that U.S. officials should consider adding cancers to a list of conditions covered by a multi-billion dollar health aid bill passed by Congress last year.

Doing so would qualify exposed people for sizeable compensation payments.

"Are we going to wait until we have definitive evidence, which could be 20 or 30 years? Are we going to say, decades from now, `Yeah, you did get cancer because of the World Trade Center, and we should have helped you out back then?'" he said. "It's limited information. It isn't a perfect study ... It still provides compelling evidence that we should be providing at least health care for these people."

Experts said both the mortality study and the cancer study are limited, in part because of the difficulty of finding a proper comparison group. Drawing conclusions can also be difficult because researchers don't know the full medical history of the subjects.

Dr. Michael Thun, vice president emeritus of epidemiological research for the American Cancer Society, said it isn't surprising that the study would fail to detect any major trends so soon after attacks.

Typically, the types of cell mutations caused by toxic and carcinogenic exposures take decades to develop into a diagnosable cancer, he said.

Outside of cancers in children, he said, "You can't really go from the earliest stage to lethal in just a few years."

But it is possible that a cancer that already existed might have been accelerated by something in the dust, and on that point, "the results are neither conclusively negative, or conclusively positive," Thun said.

He called the Fire Department research "a solid first study on the issue," but said it will likely be another decade before scientists can really see whether people exposed to trade center toxins have an increased risk of getting cancer.

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CDC: Doctors prescribing fewer antibiotics to kids (AP)

ATLANTA � The push to get pediatricians to stop prescribing antibiotics for the wrong illnesses is paying off a bit, a new government report found.

Since the early 1990s, there's been a 10 percent drop in prescription rates for antibiotics for kids 14 and younger, the Centers for Disease Control and Prevention reported Thursday.

Antibiotics are often used � but don't work � against viral illnesses like colds and flu. Antibiotics fight infections caused by bacteria. Misuse can lead to antibiotic resistance.

Experts say doctors inappropriately prescribe antibiotics more than 50 percent of the time, and more often with respiratory infections.

The CDC found larger declines � about 25 percent � in how often doctors used antibiotics against sore throats, colds and some other upper respiratory infections. But there was no significant change in how often they prescribed the drugs for ear infection, bronchitis and sinusitis.

The new findings represent progress, but also suggest that doctors are still prescribing antibiotics too often, said Dr. Lauri Hicks, a CDC epidemiologist who worked on the study.

"The bad news is we still have a long way to go," she said.

The CDC study was the government's first look at the issue in about a decade. It was based on an annual survey of doctors' offices, and compared rates from 1993-1994 to 2007-2008.

The improvement could be partly driven by rapid diagnostic tests that help doctors pinpoint whether a sore throat is caused by a virus or strep bacteria, CDC researchers said. The study also found fewer parents took their kids to doctors for upper respiratory infections, which could be thanks to a vaccine against pneumococcal bacteria that became available in 2000.

A public health campaign about antibiotics may have also had some impact, CDC officials said.

Doctors have not always followed recommendations to cut back on antibiotics, partly because of pressure from parents, said Dr. Kenneth Bromberg, chairman of pediatrics at the Brooklyn Hospital Center in New York.

Moms and dads who have been up with sick, screaming infants in the middle of the night tend to expect more from a doctor than advice to keep an eye on the problem. Often, they want antibiotics, and may not stop at one doctor to get them, he said.

"In this new age of consumerism, they will go somewhere else and get what they want," Bromberg said.

The taxing nature of ear infections may be why the CDC didn't find a decrease in the antibiotic prescribing rate for that problem, he added.

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Online:

CDC report: http://www.cdc.gov/mmwr

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CDC: Half of Americans have a sugary drink daily (AP)

ATLANTA � Health officials say half of Americans drink a soda or sugary beverage each day � and some are downing an awful lot.

A new study found that one in 20 drinks the equivalent of more than four cans of soda each day. The Centers for Disease Control and Prevention research also showed teenage boys drink the most soda, sports drinks and other sugary liquids.

Sweetened drinks have been linked to the U.S. explosion in obesity, and health officials have been urging people to cut back. Many schools have stopped selling soda or artificial juices.

The CDC report released Wednesday is said to be the first to offer national statistics for adults and kids. Past studies have focused on certain groups, particularly school kids.

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