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New Study Finds HPV Vaccine Protects Against Genital Warts

Fri, Jul 30, 2010

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A new study finds that the human papillomavirus (HPV) vaccine protects not only against the sexually transmitted virus that causes cervical cancer, but also helps prevent genital warts and low-grade cervical growths.

The findings are published in the July 21 online edition of BMJ. Health officials in the United States have been urging vaccination of young women and girls.

The researchers estimate that the virus causes an estimated 500,000 cases of cervical cancer in women each year around the world. The virus can also cause warts in the genital area and low-grade cervical growths. Those two conditions are thought to strike 30 million people annually.

In the just-released randomized control trial, researchers studied 17,622 women in 24 countries and territories who had been assigned to take the vaccine or a placebo over a six-month period. The women were aged 16 to 26.

Joakim Dillner, of the department of medical microbiology, Lund University, Malmo University in Sweden, and colleagues found that the vaccine provided significant protection against the warts and tumors in susceptible women. For example, 168 of 7,632 women who took the placebo developed cervical growths attributed to HPV strains, while just seven of the 7,629 who took the vaccine did, they noted.

In the big picture, the study authors wrote, the vaccine “provided strong and sustained protection” for four years against various types of warts and low-grade female genital growths.

The study was funded by Merck Research Laboratories, a division of Merck & Company, maker of the HPV vaccine Gardasil.

Dr. Clyde Crumpacker, a professor of medicine at Harvard Medical School in Boston, said in an interview that the study is useful because it shows the vaccine can do more than prevent the virus from spreading.

“The vaccine has not yet been licensed for boys, but this study provides a strong case that boys should be vaccinated to prevent acquisition of HPV and prevent genital warts,” said Crumpacker.

HealthBr.com reminds that top medicine for genital warts cure is Condylox.

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Court ruling could pave way for Gemzar generics

Wed, Jul 28, 2010

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A decision by a U.S. appeals court could pave the way for cheaper generic drugs forms of Eli Lilly and Co’s Gemzar cancer drug to be launched in the United States beginning in mid-November.

Many industry analysts have expected Gemzar to lose U.S. marketing exclusivity in mid-November, when protection on the blockbuster drug’s basic chemical patent lapses. But Lilly has contended that Gemzar — approved to treat ovarian, lung, breast and pancreatic cancer — should not lose exclusivity until mid-2013 because it is protected until then by a separate patent involving the method it is administered.

But a panel of judges from the U.S. Court of Appeals for the Federal Circuit on Wednesday sided with a Michigan federal district court that last August ruled the method-of-use patent was invalid.

“We strongly disagree with the ruling,” Lilly said in a statement, adding it believes the method-of-use patent should remain in effect another three years.

The lawsuit was originally filed by Lilly in Michigan against Sun Pharmaceuticals Industries Ltd of India, which planned to launch a generic form of Gemzar.

Lilly said it will consider “all possible legal options” in fighting the decision, including a request for a further review of the matter by all members of the Washington, D.C.-based appeals court.

In the meantime, Lilly said it expects Gemzar to retain market exclusivity until November 15, and consequently the company will not need to modify its full-year 2010 earnings forecast.

Global sales of Gemzar, which is already facing generic competition in many overseas markets, fell 17 percent to $293 million in the second quarter. It is approved to treat ovarian, lung, breast and pancreatic cancer.

Lilly shares slipped 1.2 percent to close at $35.67 on the New York Stock Exchange. (Reporting by Ransdell Pierson; Editing by Richard Chang)

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U.N. urged to probe U.S. trade stance on generic drugs

Sat, Jul 24, 2010

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AIDS groups on Tuesday accused the United States of violating the health rights of millions of poor people around the world through trade policies that make it harder for them to get life-saving drugs.

A coalition that includes Health Gap, the Foundation for AIDS Rights and the Thai Network of People Living with HIV/AIDS formally asked Anand Grover, the UN Special Rapporteur on the Right to Health, to look into the matter.

The special rapporteur can respond to alleged violations by asking the concerned government to clarify its policies, reminding it of health right obligations and requesting information on any corrective action the government is taking.

The groups were to hold a press conference at the International AIDS Conference in Vienna on Tuesday.

Their ire is directed at an annual report produced by the U.S. Trade Representative’s office that ranks countries with the worst records on protecting U.S. intellectual property rights for goods ranging from CDs to medicines.

They accused the United States of using the “Special 301″ report to pressure countries to give up certain public health rights they have under a World Trade Organization agreement on intellectual property rights known as TRIPS.

“Up to and including the 2009 Special 301 report, Brazil, India, Thailand and other countries were threatened with sanctions under Special 301 for taking advantage of TRIPS flexibilities, including utilizing transition periods and issuing compulsory licenses” to allow domestic firms to produce cheaper versions of drugs patented by U.S. companies, the groups said in their allegation letter to Grover.

This year’s Special 301 report again put Thailand on its “priority watch list,” one step short of its most serious designation. The country has battled with U.S. drug companies over steps it has taken in its aggressive anti-AIDS campaign.

USTR also announced a special “out-of-cycle” review of Thailand’s intellectual property rights regime, a step praised by Pharmaceutical Research and Manufacturers of America, the U.S. drug industry’s powerful lobby group.

But in the same report, USTR reaffirmed its support for countries using their TRIPS flexibilities as embodied in an international pledge known as the Doha Declaration, which says they are not bound by global intellectual property rights from taking steps to deal with public health crises.

Sean Flynn, associate director of the American University’s Program on Information Justice and Intellectual Property, accused President Barack Obama of not following through on a campaign promise to support access to low-cost generic drugs.

Obama’s campaign literature pledged “to break the stranglehold that a few big drug and insurance companies have on these life-saving drugs,” said Flynn, who is the counsel of record on the groups’ letter to the UN special rapporteur.

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Glaxo says settles some Paxil birth-defect cases

Tue, Jul 20, 2010

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GlaxoSmithKline said on Tuesday it had agreed to settle certain U.S. lawsuits alleging its Paxil antidepressant caused birth defects in some patients but declined to put a figure on the settlements.

“GSK has reached agreement to settle certain cases involving the use of Paxil during pregnancy. The details of those settlements are confidential,” spokeswoman Claire Brough said in an e-mailed statement.

“Other cases remain pending. Three cases are scheduled for trial in Philadelphia in September,” she added.

“GSK considers options for every case, including settlement when it makes sense. The company has agreed to these settlements, despite its litigation defenses, in order to avoid the costs, burdens and uncertainties of ongoing litigation.”

Bloomberg News, citing people familiar with the settlements, earlier said the drugmaker had agreed to pay more than $1 billion to resolve more than 800 birth-defect cases related to Paxil.

News of the Paxil settlements comes after British-based Glaxo said last week it was taking a 1.57 billion-pound ($2.4 billion) legal charge to cover litigation related to Paxil, as well as to its diabetes pill Avandia and a former factory in Puerto Rico.

In the case of Paxil, the company said on July 15 that it had settled the “vast majority” of product liability cases.

Glaxo is due to report second-quarter financial results at 1100 GMT on Wednesday,

($1=.6583 pounds)

(Reporting by Ben Hirschler; Editing by Greg Mahlich)

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Mental health a growing concern after Gulf spill

Wed, Jul 14, 2010

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Gulf Coast native Kindra Arnesen is so anxious about the effects of the Gulf of Mexico oil spill she is packing up her family and leaving town.

“Stress? Dude my clothes are falling off me (because of weight loss). The level of stress here is tremendous. My husband has aged 10 years in two months,” Arnesen said on Friday as she loaded possessions into a van outside her trailer home in Venice.

Fears are growing of an increase in stress-related illness and mental health problems from the BP Plc spill. Anecdotal evidence abounds but mental health officials say they lack data about the scale and scope of suffering.

Arnesen recently set up the Wives of Commercial Fishermen network to respond to pressures in the community. Two days ago, a friend told her he was so upset about his failure to get hired by BP’s cleanup program he was considering suicide.

Arnesen has her own worries. Her husband cannot work as a shrimper because authorities have closed swathes of Gulf waters to fishing and her children and other relatives have fallen sick from what she believes are airborne toxins from the leak.

“The mental health impact here … (and) the level of uncertainty is taking a toll on people and that’s a huge, huge concern,” Arnesen said. She declined to say where she and her two children would settle but said her husband would stay behind to work for BP on the cleanup.

Thousands of Gulf Coast fishermen face financial ruin because of the spill. Some say the stress is worse than after Hurricane Katrina hit the Gulf Coast in 2005.

Then it was possible to get back to work despite the destruction. Now it is impossible to say when waters will reopen especially since oil continues to gush into the Gulf.

At the same time, many fishermen now rely on BP’s cleanup program as a financial lifeline and while that has provided a windfall for a few, others have yet to find employment.

FINANCIAL STRAIN

“We hear it over and over again,” said environmental scientist Wilma Subra of the Louisiana Environmental Action Network, a nonprofit group with deep community roots. “It is the stress because of the possibility of not being able to earn a living and pay their bills.”

Some experts caution it is possible to falsely perceive an uptick in a health phenomenon just by looking for it. But crisis counseling teams working with Gulf fishermen say anecdotal reports point to increased anger and anxiety and “a lot of marital discord,” said Acquanetta Knight, director of policy and planning at the Alabama Department of Mental Health.

Data on the problems should be available in the next two weeks, she told reporters on Friday.

Residents suffering mental distress may hesitate to seek help because of a fiercely individualistic culture and strong ethic of self-reliance on the Gulf, where many earn their living working long hours alone on the water.

“This is sometimes a population that’s not so accustomed to utilizing traditional services,” said Pamela Hyde, administrator of the Substance Abuse and Mental Health Services Administration.

Hyde said her agency, part of the Department of Health and Human Services, is looking at national suicide and domestic violence hotlines and state mental health agency reports to find data.

Louisiana, Alabama, and Mississippi state mental health agencies have requested millions of dollars from BP to help pay for expanded mental health monitoring and services.

In a June 28 letter to the energy company, the Louisiana Department of Health and Hospitals asked for $10 million and warned that health effects from the spill will be an “ongoing challenge.”

The department first requested funds for mental health care on May 28. BP has not yet responded to the request.

(Additional reporting by Emma Ashburn in Washington; Editing by Bill Trott)

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