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)

Technorati Tags: cancer drug, Gemzar

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.

Technorati Tags: drug companies, generic drugs, Obama

The researchers’ work, done on rodents, builds on findings that all mammals, including humans, make brain cells throughout their lives. Most of these die, but this drug helps more of the baby cells survive and grow to become functioning brain cells.

“We make new neurons every day in our brain,” Andrew Pieper of the University of Texas Southwestern Medical Center in Dallas who worked on the study, said in a telephone interview. “What our compound does in allow more of them to survive.”

The compound is called P7C3 for now, and the researchers have already started tweaking it to make it more effective. They said it seems safe and appears to work even when taken as a pill.

The compound is similar to Medivation Inc and Pfizer Inc’s experimental Alzheimer’s drug, Dimebon, and may provide ways to improve its effects, Pieper and colleagues reported in the journal Cell.

It is also similar to some compounds owned by Serono, the researchers said.

Dimebon, originally a Russian-made antihistamine also known as latrepirdine, failed in a clinical trial for Alzheimer’s disease in March.

“For the sake of patients suffering from Alzheimer’s disease, it is hoped that the apparently marginal clinical utility of Dimebon might be enhanced by improvements in both its potency and ceiling of proneurogenic, neuroprotective efficacy,” the researchers wrote.

“If so, our work offers concrete assays for the development of improved versions of these neuroprotective drugs.”

Alzheimer’s gradually destroys the brain and affects 26 million people globally. Drugs, such as Pfizer’s Aricept, improve symptoms only minimally.

OLD RATS, NEW TRICKS

The researchers went through 1,000 representative compounds from 300,000 chemicals, pooled them and administered them to mice. They then dissected the brains to see whether any of the mice had made new cells in the hippocampus, a region of the brain associated with learning and memory.

They eventually narrowed the field to P7C3.

When they gave it to old rats for two months, the elderly rodents did far better than other old rats in learning their way around a water maze.

When dissected, the treated rats turned out to have three times the usual number of newborn neurons in a brain region called the dentate gyrus.

They made a derivative of P7C3 called A20 that worked even better.

When the researchers tested Dimebon and the Serono compounds, they found these drugs also stimulated the growth of new brain cells. Being able to target their effects could lead to better drugs to treat Alzheimer’s and perhaps other diseases that destroy brain cells like strokes and amyotrophic lateral sclerosis, also know as ALS or Lou Gehrig’s disease.

“This striking demonstration of a treatment that stems age-related cognitive decline in living animals points the way to potential development of the first cures that will address the core illness process in Alzheimer’s disease,” said Dr. Thomas Insel, director of the National Institute on Mental Health, which helped pay for the study.

Technorati Tags: Alzheimer's disease, Alzheimer's drugs, Aricept, Dimebon, latrepirdine, neuroprotective drugs

But unless they’re spring-cleaning, many people don’t bother throwing away these items. And when they do, people often turn to the toilet and flush the products away.

Both behaviors are big mistakes.

Keeping out-of-date medications in the house poses dangers to everyone in the family. And flushing old medications down the toilet can be harmful to the environment.

Old drugs and remedies kept moldering in the medicine cabinet may not be able to help you when you need them the most.

“The big reason to dispose of these medications would be that they may be ineffective. They lose potency over time,” said Jeffrey C. Delafuente, an associate dean and professor in the School of Pharmacy at Virginia Commonwealth University. “After the expiration date, there’s no guarantee they’ll be of any benefit.”

Someone with severe asthma, for instance, might reach for an inhaler during an asthma attack only to find that it’s full of expired medication, Delafuente said. “That could put them in the emergency department, or they could die from the attack,” he said.

Old medications also pose an overdose hazard. Statistics from the American Association of Poison Control Centers show that most childhood poisonings are due to ingestion of over-the-counter medicines or prescription drugs.

So, if you should get rid of medications after their expiration date, why not flush them?

Because biologists have found that flushed medications are getting into the ecosystem and have the potential to cause environmental damage, said Tiffany Parson, a biologist with the U.S. Fish & Wildlife Service.

“We’re concerned about aquatic habitats, and medications getting into them,” Parson said. “We don’t want medications flushed directly into the sewer system. If they are flushed, there is that potential that they could get more directly into an aquatic ecosystem, compared with putting them in the landfill.”

The chemicals in medications can cause hormonal changes and affect aquatic organisms at the cellular level, Parson said. Drugs intended to lower people’s cholesterol, for instance, can retard metabolism and growth in fish, and antipsychotic and anxiety medications can impact behavior, growth and reproduction.

“Fish may be expressing different hormones that they wouldn’t normally,” Parson said. “We don’t want any kind of impurity in any of our waters. Pharmaceuticals are just one of those potential substances.”

However, people shouldn’t depend on a waste treatment plant to remove pharmaceutical chemicals from wastewater, either. “Most treatment facilities don’t have the technology to filter out these substances from sewage,” Parson said.

That’s led experts to suggest that the best way to get rid of expired medications is to throw them away in the household trash.

Take-back programs do exist — with expired drugs being collected and disposed of by pharmacies, government agencies or community groups — but most aren’t meant for consumers, Delafuente said.

“At the retail or pharmacy level, they can have a pick-up service come, collect the old medications and dispose of them, usually by incineration,” he said.

However, some medications are just too risky to be put in the trash and should, instead, be flushed, according to the U.S. Food and Drug Administration. These include controlled substances such as methadone, OxyContin, Percocet and Dilaudid. Flushing such drugs, the agency says, ensures that they won’t fall into the wrong hands. Some drugs on the list could be fatal if taken by someone who doesn’t need the medication, the FDA warns.

Medications disposed of in the trash, though, can be disguised, Delafuente said. Simply crush the pills or tablets or add kitty litter, coffee grounds or sawdust to the trash bag. “That way it doesn’t look attractive to anyone or any thing,” he said.

The FDA also suggests putting the mixture in a sealed container as an extra measure of protection against animals ingesting the drugs should they scrounge through the trash.

Technorati Tags: anxiety medications, expired medications, medications, Outdated Meds

In 2008, ERS saw an estimated 1 million visits from people abusing prescription or over-the-counter medicines — mostly painkillers and sedatives. That was about the same number of visits from those overdosing on heroin, cocaine and other illegal drugs, according to a government report released Thursday.

Only five years earlier, illegal drug visits outnumbered those from legal medications by a 2-to-1 margin.

In other words, the number of ER visits from medication abuse doubled, said Peter Delany of the Substance Abuse and Mental Health Services Administration.

“It’s a pretty startling jump,” Delany said. He led a team that worked with the Centers for Disease Control and Prevention on the report.

Painkillers and sedatives clearly drove the trend. ER visits for the painkillers oxycodone and hydrocodone more than doubled from 2004 to 2008. And cases from one kind of tranquilizer nearly doubled.

The estimates are based on emergency room data from more than 200 U.S. hospitals. Many of the cases may be overdoses, but some may come from mixing drugs or combining them with alcohol, Delany said.

Health officials are not sure why painkiller abuse rose so dramatically. But the number of prescriptions has been increasing, so some of those who ended up in ERs may have gotten their medicine legally.

The authors did not estimate how many of the ER patients died. A CDC report last year found that the rate of drug-related deaths roughly doubled from the late 1990s to 2006, and most of the increase was attributed to prescription opiates such as the painkillers methadone, Oxycontin and Vicodin.

“The abuse of prescription drugs is our nation’s fastest-growing drug problem,” Gil Kerlikowske, director of the Office of National Drug Control Policy, said in a statement.

The use of painkillers has grown in recent years as doctors tried to correct the traditional undertreatment of pain, and pharmaceutical companies ramped up marketing of new pain medications.

But many doctors and patients don’t fully recognize the medications’ dangers, said Susan Foster, a vice president at Columbia University’s National Center on Addiction and Substance Abuse.

“People believe they’re safer because they’re prescribed by doctors and approved by the FDA,” she said.

The report is being published this week in a CDC publication, Morbidity and Mortality Weekly Report.

Technorati Tags: abuse of painkillers, abuse of prescription drugs, methadone, oxycodone, pain medications, Vicodin

Researchers studied the effects of tranexamic acid, or TXA, in more than 10,000 adult trauma patients in 40 countries who received the drug within 8 hours of being injured. They compared those patients’ outcomes to more than 10,000 accident victims who got a placebo treatment. The study was published online Tuesday in the medical journal Lancet.

Doctors found that patients who got TXA had a 15 percent lower chance of dying from a hemorrhage than those who didn’t get it. They also had a 10 percent lower chance of dying from any other cause, including organ failure and a head injury, versus patients who didn’t receive TXA. The study was paid for by the British government.

The drug is commonly used in wealthy countries during elective surgeries to stop bleeding, but isn’t prescribed for accident victims.

TXA is off-patent and manufactured generically by many companies. It costs about 3 pounds ($4.50) per gram, and a typical dose is two grams. It is usually given via an injection and would be relatively easy to introduce, even in poor countries, experts said.

“This is one of the cheapest ways ever to save a life,” said Ian Roberts, a professor of epidemiology at the London School of Hygiene and Tropical Medicine and one of the study’s main investigators.

Previous tests of the drug regarded its use in elective surgeries, such as heart operations, but this was the first study to test the drug on accident victims.

Doctors were worried it might increase side effects such as blood clots in the heart and lungs, strokes, or heart attacks. There was no evidence of that in the Lancet study, though the authors said it was possible they might have missed some of these incidents.

For people between 5 and 45, accidents are the second leading cause of death worldwide after AIDS, and about 600,000 injured patients bleed to death every year. Nearly 6 million people die of injuries every year, more than AIDS, malaria and tuberculosis combined.

Roberts and colleagues estimated that if TXA were readily available, between 70,000 and 100,000 lives a year could be saved. Though the drug wasn’t tested in children, he said it would almost certainly work in them as well.

Etienne Krug, director of violence and injury prevention and disability at the World Health Organization, said the drug would likely have the biggest impact in developing countries such as China and India, where 90 percent of injury-related deaths occur.

“People often have a fatalistic attitude about accidents and think nothing can be done to save people,” he said. “But this study shows that isn’t true.”

Experts said rolling out TXA could save as many lives as other measures such as making seatbelts compulsory or strengthening drunk-driving laws.

The drug also could save thousands of people in the West.

“This is not just something for developing countries,” said Dr. Karim Brohi, who works at one of London’s busiest emergency rooms at Barts and the London School of Medicine and University of London-Queen Mary. “We could probably use tranexamic acid on a daily basis.”

Last week, Roberts and colleagues submitted an application to WHO to include TXA on its List of Essential Medicines, which is used by many developing countries as a shopping list for drugs. Once drugs are on WHO’s list, other U.N. agencies such as UNICEF often buy the drug for poor countries.

“In many developing countries, emergency departments are like war zones, even when there’s no war,” Roberts said. “If (TXA) is available, a lot of those deaths could be avoided.”

Technorati Tags: accident victim, cheap drug, drug, placebo treatment

Researchers found that non-smokers exposed to a lot of secondhand smoke were 50 percent more likely to suffer from psychological distress than those not exposed to other people’s smoke.

And their risk of being admitted to a psychiatric hospital over the next six years was nearly tripled (it was almost quadrupled for smokers).

So-called “passive smoking” is very common, Dr. Mark Hamer of University College London in the UK and colleagues note in the Archives of General Psychiatry. One US study found evidence of secondhand smoke in 60 percent of non-smokers.

Studies measuring the nicotine byproduct cotinine have made it possible to precisely measure secondhand smoke exposure and its health effects, they add, but there is “very limited information” on how other people’s smoke might affect mental health.

To investigate, Hamer and his colleagues studied 5,560 non-smoking adults and 2,595 smoking adults, none of whom had a history of mental illness. The study subjects answered questions about psychological distress and admissions to psychiatric hospitals were tracked for six years.

Exposure to secondhand smoke among non-smokers was determined using saliva levels of cotinine, which is formed when nicotine is broken down in the body and is an established marker of nicotine exposure.

A total of 14.5 percent of study subjects reported psychological distress. According to the investigators, the higher a person’s secondhand smoke exposure, the greater their risk of psychological distress, while the risk was highest for people who were themselves smokers.

People with high exposure to secondhand smoke (those with the highest cotinine levels) who didn’t actually smoke themselves were 62 percent more likely to report psychological distress than those unexposed to secondhand smoke, while the risk for smokers was 2.45 times greater.

During follow-up, which averaged about six years, 41 people were admitted to psychiatric hospitals. The risk of hospitalization was 2.8 times greater for secondhand smokers compared to people not exposed to secondhand smoke, while it was 3.7 times greater for smokers.

The effects were stronger for never-smokers than for ex-smokers, Hamer noted; the fact that former smokers were able to quit could suggest they were intrinsically less vulnerable to the effects of nicotine.

Studies like the current one can’t prove that something caused something else, Hamer said in an interview. However, he added, the link remained even after he and his colleagues accounted for social status, alcohol intake and other factors that could influence both the risk of mental health problems and the likelihood of being exposed to secondhand smoke. “We did see pretty robust associations that remained after those adjustments,” he said.

Moreover, Hamer and colleagues note that animal studies have hinted that tobacco may depress a person’s mood and some human studies have also suggested a potential link between smoking and depression. “Taken together, therefore, our data are consistent with other emerging evidence to suggest a causal role of nicotine exposure in mental health,” the investigators conclude.

SOURCE: http://archpsyc.ama-assn.org/cgi/content/full/2010.76

Technorati Tags: cotinine, mental health, mental health problems, psychological distress, Secondhand smoke

Researchers at the University of Leeds found that Metformin and AICAR can prevent the hepatitis C virus from replicating in the body.

“We’re very excited about these findings. These drugs are already on the market, and whilst substantial clinical trials still need to take place before they can be used to treat hepatitis C infection, we think it could be an enormous step forward in the battle against the virus,” Mark Harris, a professor in the Faculty of Biological Sciences, said in a news release from the university.

Metformin and AICAR stimulate an enzyme called AMP kinase (AMPK), which regulates energy within cells. The hepatitis C virus needs to suppress AMPK to replicate. By stimulating the enzyme, metformin and AICAR halt hepatitis C replication and enable cells to clear the infection, according to Harris and colleagues.

They’ve applied for a patent on the discovery and will soon begin a small-scale clinical trial with the University of Nottingham.

Hepatitis C virus, which damages the liver, affects about 3 percent of the world’s population. Only about 40 percent of people with hepatitis C fully recover, while many patients develop cirrhosis and liver cancer.

Technorati Tags: diabetes drug, hepatitis C infection, Metformin, treat hepatitis C

The label will advise consumers to use this class of medicines, called proton pump inhibitors (PPIs), carefully, because high doses have been associated with an increased risk of fractures of the hip, wrist and spine, the agency said.

PPIs, which include prescription and over-the-counter drugs, work by blocking stomach acid from being produced. However, as with any drug, this benefit comes with some risk, the FDA said.

“Epidemiology studies suggest a possible increased risk of bone fractures with the use of proton pump inhibitors for one year or longer, or at high doses,” Dr. Joyce Korvick, deputy director for safety in FDA’s Division of Gastroenterology Products, said in an agency statement.

“Because these products are used by a great number of people, it’s important for the public to be aware of this possible increased risk and, when prescribing proton pump inhibitors, health care professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient’s condition,” she said.

Based on a review of the scientific evidence, the agency is instructing the makers of the drugs to change the labels for both the prescription and the over-the-counter versions of the proton pump inhibitors. The FDA based its decision on the results of seven studies, six of which noted a link between PPIs and fracture, primarily among users aged 50 and over.

Proton pump inhibitors include the drugs esomeprazole (Nexium)), dexlansoprazole (Dexilant), omeprazole (Prilosec, Zegerid)), lansoprazole (Prevacid)), pantoprazole (Protonix)), and rabeprazole (Aciphex)). These medicines are used to treat gastroesophageal reflux disease (GERD), stomach and small intestine ulcers and inflammation of the esophagus. Over-the-counter versions of Prevacid, Prilosec and Zegerid also fall into this class of drugs.

The FDA is advising consumers to not stop taking PPIs until they have consulted with their doctor. However, patients should be aware of the increased risk for fractures. The highest risk was seen in people taking higher doses of PPIs, or among those who took them for a year or more, the agency said.

For people taking over-the-counter proton pump inhibitors, the FDA said they should only be taken for 14 days to help ease frequent heartburn. If heartburn continues, people should see their doctor. Under no circumstances should over-the-counter PPIs be taken for more than three 14-day periods in a year, the agency said.

Dr. Amar R. Deshpande, an assistant professor of gastroenterology at the University of Miami Miller School of Medicine, said the data behind the FDA decision “is not new.”

PPIs may disrupt the body’s ability to absorb calcium, which, in turn, can increase the risk for fractures, Deshpande explained. He also believes that this class of drugs is overused and often taken by patients for too long.

There’s a need to “be judicious in general, irrespective of this data,” Deshpande said. “With PPIs we should really have a targeted endpoint to come off these medications. There is more reason to do that now that we are seeing data that they can have potential side effects.”

It is probably also a good idea to shy away from high doses of the heartburn medications, unless absolutely necessary, he said.

“Everything in medicine is a risk/benefit ratio,” Deshpande said. “Patients need to talk to their doctor about what they are on the PPI for and look at the risk/benefit ratio and see if they should be on it indefinitely or should be able to come off the PPI.”

Technorati Tags: heartburn medications, Nexium, over-the-counter drugs, prescription drugs, prevacid, Prilosec, proton pump inhibitors

The drug, called vorinostat and sold in the United States under the name Zolinza, is a new type of therapy called a histone deacetylase (HDAC) inhibitor.

It is thought to work by stopping tumor growth by altering the levels of several genes needed for cancer cells to grow.

In a study published in The Lancet Oncology journal, Norwegian researchers said they found vorinostat could enhance the effect of palliative radiotherapy and may in future become an important part of long-term curative pelvic radiotherapy, including in rectal cancer patients.

Palliative radiotherapy treatment is designed to shrink tumors, reduce pain and possibly prolong the life of patients who are unlikely to have their cancer cured. Curative radiotherapy is aimed at destroying cancer cells and shrinking tumors before or after surgery.

The Phase I trial was designed to examine the safety and effects of four different doses of vorinostat in 16 patients receiving palliative radiotherapy for advanced pelvic cancer.

The researchers said the drug was generally well tolerated and most side effects were not too serious, with symptoms such as nausea and fatigue. Seven out of 16 patients taking the highest doses of 300mg and 400mg of vorinostat had more serious side effects but there was no toxicity, the study found.

Most patients’ tumors had shrunk six weeks after completion of treatment and the researchers concluded that 300mg of vorinostat daily in combination with palliative radiotherapy for two weeks was the maximum tolerated dose.

“This study adds to mounting evidence supporting the use of HDAC inhibition in cancer therapy. These data encourage further examination of this class of molecularly targeted agents in clinical radiotherapy,” Anne Hansen Ree of the Norwegian Radium Hospital in Oslo, wrote in the study.

The once-a-day oral drug Zolinza is licensed in the U.S. for use in treating a rare and slow-growing skin cancer called advanced cutaneous T-cell lymphoma (CTCL).

Merck acquired Zolinza when it bought Aton Pharma in 2004. Analysts see the drug reaching annual sales of $137 million by 2013, according to Thomson Reuters consensus forecasts.

Technorati Tags: advanced pelvic cancer, anti-cancer pill, cancer treatment, Merck, Vorinostat, Zolinza