So-called pay-for-delay settlements involving generic and branded drug makers are becoming more common and costing consumers $3.5 billion each year, according to FTC Chairman John Liebowitz, who testified before Congress that he wanted to eliminate such agreements altogether.

These deals allow branded drug makers to sell their expensive products without generic competition for a period longer than the duration of the patents they hold on their drugs.

In the first 9 months of fiscal 2010, drug makers entered into 21 patent litigation settlements.  That’s more than the entire previous year.

“That’s almost an epidemic,” Leibowitz told BurrillReport. “Every single FTC Commissioner, going back through the Bush and Clinton administrations, has supported stopping these unconscionable agreements.”

The FTC supports legislation designed to halt pay-for-delay settlements. At the moment, this legislation is tucked into a Senate spending bill.

Both branded and generic drug companies would prefer to leave things just as they are. “The FTC’s testimony fails to present the whole story regarding patent settlements,” according to a statement released by the Generic Pharmaceutical Association. “Over the past 10 years, patent settlements have enabled dozens of first-time generics to come to market many months before patents on the counterpart brand drugs expired.”

The Pharmaceutical Research and Manufacturers of America, which represents branded drug makers, agreed. “A blanket ban could decrease the value of patents, remove an important option for a patent-holder’s defense of intellectual property, and reduce the incentives for future innovation of new medicines,” it said.

A Senate panel has already recommended banning pay-for-delay deals, but narrowly. Pennsylvania Democrat Arlen Specter introduced an amendment to remove the ban from the spending bill, but that amendment did not pass. The ban must pass the full Senate and House before becoming law.

Recently, 5 scientists clambered into a steel capsule and shut the door behind them, unceremoniously beginning a scientific experiment designed to simulate a 520-day flight to Mars. Their mission is to help space crews of the future understand the stresses of interplanetary travel.

The all-male crew includes 3 Russians, a Chinese man, a Frenchman and an Italian-Colombian. They will execute a rigorous series of experiments and exercises, while being video-monitored the whole time by researchers from the European Space Agency, Russia’s Institute of Medical and Biological Problems and China’s space training center.

Conditions inside the capsule will mimic space travel in every respect, with the important exception of weightlessness.

The participants will communicate with “Earth” using an Internet connection that will be intentionally delayed and disrupted from time-to-time, to simulate likely communication outages during space travel. Their diet will consist of canned food similar to that consumed by astronauts on the International Space Station. They will shower once, and have 2 days off, per week except during simulated emergencies.

Of course, they can’t go far on their days off.

“For me, it will be mainly my family, the sun and fresh air,” French participant Romain Charles answered in response to a reporters question regarding what he will miss most during the project.

“Certainly, the crew is on its own here, with limited communications with the outside world,” the European Space Agency’s Martin Zell told the Washington Post. “They have to cope with a lot of conditions and organize themselves.”

Human beings are decades away from an actual Mars mission because of cost and technological barriers, including the creation of a lightweight shield to protect crews from space radiation.

Paying people to avoid sexually transmitted diseases effectively reduces their spread, according to a proof-of-concept study carried out by scientists at UC Berkeley, the Development Research Group at the World Bank and the Ifakara Health Institute in Tanzania.

The study involved young adults in southwestern Tanzania. Subjects were randomly assigned to a high-payment group, a low-payment group and no-payment control group. Participants in the high payment group received $20 every 4 months–up to $60–if they tested negative for STDs. Those in the low-payment group received half that amount.

Participants in all groups received individual counseling and could attend monthly group counseling sessions as well. Any participant that tested positive for an STD received free care for the condition.

By the end of the year, 9% of participants in the high-payment group had tested positive for an STD. That was significantly better than the 12% rate seen in both the control group and the low-payment group. The cash reward had the same impact in men and women. It had a more pronounced effect in people with lower incomes.

“For many of our study participants, $60 represented about one-fourth of their reported annual income, so it was a significant incentive,” says Will Dow, a study author and a health economist at Berkeley. “The question we tested is whether the cash reward was enough of an incentive to reduce risky behavior. The fact that disease prevalence decreased suggests the incentives worked.”

Participants were tested for chlamydia, gonorrhea and syphilis. HIV/AIDS status was not tested, but the same sexual behaviors that increase the risk of the STDs increase the risk of HIV.

UK-based consumer-products giant Reckitt Benckiser Group has entered the bedroom by acquiring SSL International, the maker of Durex, for $3.9 billion. Durex is the world’s best-selling condom brand.

Before purchasing the condom-maker, Reckitt had accumulated a ménage of decidedly unsexy products including d-Con mousetraps, Clearasil acne cream, Veet hair remover, Mucinex decongestant, Lysol disinfectants and Harpic toilet-bowl cleaner.

In marketing Durex, SSL had recently moved from a “safe sex” message to “better sex.”  It introduced a line of lubricants and began selling vibrators in supermarkets and pharmacies. It also entered emerging markets like India and China. Durex sales rose nearly 5% last year, to $410 million.

In addition to condoms, the SSL deal allows Reckitt to market Scholl bunion pads outside the US (Merck has rights in the US), where they can enhance Reckitt’s already profitable line of OTC health care products including Gaviscon heartburn elixir and Strepsils cough drops. Even before the deal, health and personal care had been Reckitt’s largest market, accounting for about 40% of its $9.3 billion in sales.

In this market, shoppers will pay a premium for trusted brands, according to Julian Hardwick, a Royal Bank of Scotland analyst. “If you’ve got a sore throat, runny nose or splitting headache,” she explained to the Wall Street Journal, “You want something to sort that out for you. You really don’t care how much you pay for it.”

Reckitt’s offer of £11.71 per share was 45% above SSL’s average share price over the last 6 months. SSL shares traded below £5.50 just 9 months ago, suggesting the acquisition might have come a bit late for Reckitt.

The deal was prompted by pressure from consumer-goods colossus Procter & Gamble, which had been gaining market share vs. Reckitt in several categories in Western Europe over the last year.

In Victorian times, dreams were believed to represent repressed sexual desires or random brain activity. Now scientists believe they reflect an attempt by the unconscious mind to process and store emotion-laced events from the day.

“We take our problems to sleep and work through them during the night,” Rosalind Cartwright, a neuroscience professor at Rush University Medical Center told the Wall Street Journal.

According to Cartwright, during dreams the mind juxtaposes unprocessed emotions encountered during waking hours with older, related memories. “That’s why dreams look so peculiar. You have old memories and new memories Scotch-plaided into each other,” she added. “They are emotional connections rather than logical ones.”

If this theory is true, it may be possible for people to direct their own dreams. For example, people who experience recurring nightmares might learn to substitute happier endings or eliminate them altogether.

A small group of people who practice “lucid dreaming” believe this is indeed possible. According to these people, recurring nightmares are caused when people wake up from the frightening experiences, thereby interrupting the normal process of emotional reconciliation that takes place during dreaming. Without the reconciliation, the dream is left to repeat itself.

“Your brain seems to think that it’s helping you to prepare, but you don’t allow yourself to finish it so it becomes a broken record,” Shelby Freedman Harris, a Behavioral Sleep Medicine expert at Montefiore Medical Center explained to the Journal.

Harris runs a program that tries to help folks either rewrite or delete the script of recurring dreams using a technique known as Image Rehearsal Therapy. In implementing the technique, dreamers recreate the nightmare with better endings or more palatable story-lines (substituting dolphins for sharks, for example), and rehearse the new script several times per day. 

While far from 100% effective, many of Harris’ patients are able to dream the revised script, while others stop having the nightmare completely.

Private health insurance companies have long since required patients to pay higher out-of-pocket fees when they see physicians who are not in the insurers’ contracted physicians network. In a more recent development, they have begun to rank physicians according to quality and cost parameters and offer enrollees lower out-of-pocket charges if they see physicians who fare better on these parameters.

In such programs for example, a doctor shown to order fewer imaging tests that are of questionable value would rank in a higher category.

Physicians have always objected to these practices. A March article in the New England Journal of Medicine brought the issue to a boil by showing that these tiered rating systems misclassified 22% of all doctors.

The study prompted provider organizations to release a letter protesting the payer’s practices. “Physicians’ reputations are being unfairly tarnished using unscientific methodologies and calculations,” the letter claimed.

“There are serious flaws in health insurers’ programs to try to rate individual physicians,” AMA President Cecil Wilson added in an interview with the Wall Street Journal.

The provider organizations implored payers to reevaluate their ranking programs.

Payers’ reactions to the letter were lukewarm. For example, Cigna told the Journal that its doctor-rating program already addressed issues raised in the study by focusing on physician groups rather than individuals. Besides that, “Some physicians do provide higher-quality or more-efficient care, and it makes sense to provide modest incentives for choosing that care,” said Dick Salmon, the company’s VP for network quality.

A spokesperson for WellPoint responded it has “taken a thorough, thoughtful approach in introducing measures of physician quality and cost effectiveness” and that the effort is “collaborative with the physician community.”

Last week, 2 Iowa-based egg producers recalled more than half a billion eggs after federal investigators traced a recent salmonella outbreak to their production facilities. The outbreak began in May. So far, it has not been linked to any deaths.

The two companies are Wright County Egg, which recalled 380 million eggs that had been distributed across the nation, and Hillandale Farms, which recalled 170 million eggs that had been distributed to 14 states in the West and Midwest. According to the Washington Post, the companies use some of the same suppliers of feed and young chickens, a fact that may help investigators trace the source of the outbreak.

Hinda Mitchell, a spokesperson for Wright County Egg told the Post that her company “recognizes the significant consumer concern about the potential incidence of Salmonella Enteritidis…we continue to work cooperatively with FDA after our voluntary recall. This is consistent with our commitment to egg safety.”

It turns out that the Iowa-based DeCoster family owns or has close ties with both egg producers.

For what it’s worth, the Post reported yesterday that the family has a long history of run-ins with federal officials. In 1996 for example, another DeCoster-owned egg farm was dunned $3.6 million for health and safety violations after inspectors found employees handling dead chickens and manure with their bare hands.

Then, in 2001, Iowa’s Supreme Court cited the family as a “repeat violator” of its environmental laws, singling-out violations involving DeCoster’s hog-farms. Later that year, the family settled a complaint that company supervisors subjected 11 female workers to a “sexually hostile work environment,” including assault and rape.

What is more, in 2002 and again in 2008, OSHA cited the family for several violations that resulted in the exposure of workers to dangerous conditions.

Of course none of this is directly relevant to the salmonella outbreak…

An FDA advisory panel has voted to allow ongoing sales of the diabetes drug Avandia despite the fact that Glaxo’s former blockbuster poses a “significant safety” concern by increasing the risk of cardiovascular events.

The FDA is not required to follow the recommendations of its panels, although it usually does.

Nearly one-third of the 33-member panel voted to ban Avandia. Most panelists who voted to keep the drug on the market called for increased restrictions on its use, and said it should be used only as a second- or third-line drug for the treatment of diabetes.

For example, David Oakes, a statistics professor at the University of Rochester, told the Wall Street Journal that his vote for continued sales of Avandia should not be construed a “vote of confidence,” but rather that he was concerned about the quality of studies which link Avandia to heart attack risk.

Janet Woodcock, who heads-up the FDA’s drug division, said her agency will decide on the matter within the next few weeks.

Avandia sales have plummeted since a 2007 article in the New England Journal of Medicine reported a 43% bump in heart attack risk with the drug. Q1, 2010 world-wide sales of Avandia were reported to be $245 million, off 10% year-over-year.

The FDA panel also concluded that Avandia posed a greater heart attack risk than Actos, a rival drug made by Takeda. Both drugs were approved in 1999 for blood-glucose control in patients with Type 2 diabetes.

In the wake of the panel’s announcement, Glaxo’s Chief Medical Officer Ellen Strahlman defended the safety record of Avandia. She said the drug would remain on the market pending the FDA’s decision.

The Affordable Care Act has catapulted the US Preventive Services Task Force from an obscure agency which produced unenforceable guidelines about screening and preventive services into one whose recommendations directly impact reimbursement.

The health reform law requires insurers to pay in full for services receiving an A or B recommendation from the Task Force. The flip-side is that insurers may not have to pay at all for services that are not recommended by the Task Force. As a result, the Task Force’ new best friends include lobbyists and disease advocates who want their priorities – things like screening for Alzheimer’s disease, HIV and diabetes or HIV – to get covered.

The American Diabetes Association, for example, is advocating that insurers be required to cover a broader population than current Task Force recommendations suggest. Current recommendations are that only patients with high blood pressure should be screened.

The HIV Medicine Association has made a similar argument to the Task Force. It claims that a key reason why 20% of people infected with HIV are unaware of that fact is because most insurers don’t cover the costs of testing.

“If you want to be evidence-based, lobbying doesn’t fit,” Ned Calonge, the chairman of the Task Force told the Washington Post. “My charge to members would be to stay true to the methods and the evidence.”

The Task Force, by the way, is the same one that caused a stir before the 2008 presidential election when it recommended that women should start receiving screening mammograms at the age of 50, rather than 40. That move was eventually trumped by an amendment to the Affordable Care Act which required insurers to cover mammograms for women in their 40s.

In the 4 months since the Deepwater Horizon blew up and oil began spilling into the Gulf of Mexico, scientists have been trying to understand the magnitude of the gusher’s ecological impact.

The gusher has been plugged thankfully, although there is no consensus on how much damage has been done. Some believe the gulf has largely avoided an ecological disaster. Others say that the spill has pushed already damaged ecosystems to the brink.

Take those ghastly pictures of oiled birds, for example. Officials say they’ve found only 1,200 of them, a fraction of the 35,000 that were discovered after the Exxon Valdez disaster. Of course, officials only count the birds they find. Some scientists believe the number is much higher.

“It’s an instinctive response: They’re hiding from predators while they recover,” Kerry St. Pé, told the Washington Post. St. Pe, who oversees a marsh protection program, added “They plan to recover, and they don’t. They just die.”

What about coastal marshes, whose oil-stained shores made regular appearances on the evening news? “The marsh grasses, the canes, the mangrove are dying,” Robert Barham, secretary of the state’s Department of Wildlife and Fisheries told the Post. “There’s visible evidence that the ecosystem is changed.”

But the National Audubon Society’s Paul Kemp disagreed. According to him, the impact of the spill was small by comparison to the marsh’s existing problems.

“We have a patient that’s dying of cancer, and now they have a sunburn, too,” Kemp said. “What will kill coastal Louisiana is not this oil spill.” (It’s) what was killing it before this oil spill,” he explained, citing erosion and river-control projects.

There is also disagreement about the presence of “plumes” of dissolved or submerged oil offshore. Some scientists claim to have found underwater oil many miles from the gusher.  But an official at the National Oceanic and Atmospheric Administration said his agency found significant submerged oil only within 6 miles of the well.

“Right now,” John Valentine, a gulf researcher told the Post, “we should be more impressed by what we don’t know than what we do know.”

Boston University scientists claim to have identified a small set of genetic variants that predicts extreme longevity.

The scientists, Paola Sebastiani and Thomas Perls, examined the DNA of 1,055 centenarians living in New England. They isolated 150 gene variants that were common in this population. They subsequently examined a separate sample of centenarians and found that 77% of them had many of the same genetic variants.

The centenarians in the original cohort had as many disease-associated gene variants as shorter-lived people, so the scientists reasoned that the genes they identified must protect against disease.

This conclusion is at odds with current thinking about extreme longevity which is predicated on the assumption that long life is caused by the absence of disease-causing gene variants, rather than the presence of protective genes.

To find the protective genes, the scientists implemented a genome-wide association study, a technique that has so far failed to meet expectations that it would unlock genetic secrets behind common conditions like diabetes and Alzheimer’s disease.

Some scientists questioned the findings of the BU group. Kari Stefansson, a geneticist who works for Decode Gentics told the New York Times for example, that he was “amazed at how many loci of genome-wide significance have been found in a modest sample size.”

Stefansson’s company has also studied extreme longevity. Apparently, none of the BU group’s 150 genetic variants showed up in the population studied by Decode Genetics.

There are roughly 80,000 centenarians in the US right now. Roughly 15 % of the general population has some or many of the 150 genetic variants found in the BU study. Most of them fail to reach a ripe old age because of accidents or an unhealthy lifestyle.

Their report appears in Thursday’s issue of Science.

Continuing a trend that began more than 2 decades ago, the death rate from cancer in the US dropped 1.3% year-over-year in 2010. It now stands at about 178 people per 100,000 per year.

The news is contained in a report prepared by epidemiologists at the American Cancer Society and published in CA: A Cancer Journal for Clinicians. The scientists estimate there will be about 1,530,000 new cancer cases in the US in 2010 (790,000 in men and 40,000 in women), and 569,000 deaths due to cancer (299,000 in men and 270,000 in women) in the US in 2010.

According to the report, cancer death rates have dropped 21% in men, and 12% in women since 1991. The report attributes the fall-off to fewer people smoking, improved treatment, and better screening.

In men, cancers of the prostate, lung, and colon will be the cause of 52% of all newly diagnosed cancers this year. Prostate cancer alone will cause 28% of these, and 90% of these cases will be discovered at local or regional stages, for which the five-year survival rate is nearly 100%.

In males who are less than 40 years of age, leukemia is the most common fatal cancer. In older men, lung cancer becomes the leading killer.
 
For women, cancers of the lung, breast and colon account for 52% of newly diagnosed cancer cases. Breast cancer alone will cause of 28% of all new cancers in women this year.

Leukemia is the leading cause of cancer death among women less than 20 years old. Breast cancer ranks first for those between the ages of 20 and 59. After that, lung cancer becomes the leading cause of cancer death.

Lung cancer surpassed breast cancer as the leading cause of cancer death in women in 1987. It will be responsible for 26% of all cancer deaths in women this year.

In years past, environmental catastrophes have helped environmental advocates win some of their biggest victories. In 1969, the Santa Barbara oil spill and images of a river on fire in Cleveland helped drive the passage of several anti-pollution laws. In 1989, the Exxon Valdez disaster helped spark a key clean-air law.

But this year, the oil spill in the Gulf of Mexico, by far the biggest in US history, hasn’t had the same effect.

The Senate remains gridlocked on an energy bill. Public opinion has barely changed, and the demand for gasoline continues to surge.

It’s not that environmentalists aren’t trying. It’s just that they’re facing headwinds from a lousy economy, general mistrust of government and lingering suspicions from “Climategate,” which were sparked by since disproven allegations that environmental scientists were cooking their data to promote their views about global warming.

The dreadful economic tailspin has caused public officials and the public to back-off proposals that would lessen our dependence on fossil fuels, for example. Just 2 summers ago, gasoline cost $4-a-gallon, and millions cannot afford a return to such prices.

A related factor is the site of the oil spill. Louisiana residents, devastated by the calamity, have targeted BP rather than the oil industry itself, in part because the industry powers the state’s economy.

These issues are reflected in recent opinion polls which show that after the spill, only about 53% of people are concerned about climate change. That is unchanged from January, and down from 63% before the economy went south.

“It’s the short-term concerns overriding longer-term benefits” of greenhouse-gas laws, Ralph Izzo told the Washington Post. Izzo is CEO of the Public Service Enterprise Group, a New Jersey-based utility that supports carbon emission price control legislation.

A Presidential commission tasked to explore ethical issues associated with man-made life has held initial meetings to better understand the matter and begin figuring out whether additional regulations are needed for the burgeoning new field.

In May, J. Craig Venter and colleagues reported creating a self-replicating synthetic bacterial cell, a landmark achievement that many believe represents the dawn of an era in which man can create brand-new organisms that produce drugs and fuels, and perhaps gobble up oil spills on the cheap.

The report prompted President Obama to organize the commission. He has asked it to produce recommendations within 6 months.

Venter attended the opening meetings himself. He suggested that researchers in the field could, perhaps, produce seed stock for a flu vaccine in just 12 hours. “With rapid DNA sequencing, we can predict, we think, well in advance what the changes will be for next year’s flu before the WHO even makes the decision as to the vaccine stocks,” he told  BurrillReport.

Venter added that synthetic biologists could also potentially cause harm—as by producing new, highly lethal viruses. Venter insisted however that such behavior could “be readily prevented by some straightforward regulations.”

Kristala Prather, a Chemical Engineering professor at MIT concurred that, that although the potential benefits are large, so too are the risks. “Because there is this information gap between what we understand about biology and what our capabilities are, it is impossible to predict what’s going to happen in every experiment,” she told GenomeWeb News.

The commission will hold more meetings in September and November.

Surgeons at UC San Diego have removed a woman’s gallbladder through her mouth. The procedure, known as natural orifice translumenal endoscopic surgery (NOTES), was performed as part of a prospective multicenter clinical trial designed to compare it with laparoscopy.

Soon after laparoscopy was introduced in the 1980s, it became the technique of choice for gallbladder removal (cholecystectomy), because it was associated with reduced costs and morbidity.

Typically, laparoscopic cholecystectomy requires creating 3-5 incisions in the abdominal wall. In contrast, NOTES involves accessing the gallbladder through the mouth and a subsequent a hole created in the stomach (the so-called transgastric approach). An alternative NOTES procedure accesses the gallbladder through the vagina (the transvaginal approach).

“What is unique about this trial is that we will not only evaluate the safety and efficacy of NOTES compared to laparoscopy but will also assess and compare pain levels, cosmetic outcomes, operative costs and logistical outcomes,” said Santiago Horgan a principal investigator in the study and chief of minimally invasive surgery at UCSD Health System. Horgan has performed more than 70 NOTES surgeries.

Horgan said that traditional laparoscopy is highly effective, but suggested the newer approach might reduce post-operative infection, hernia, scarring and pain.

“We hypothesize that NOTES procedures may reduce pain and infection by eliminating abdominal wall incisions altogether,” Horgan explained. “Post-operatively, many patients experience pain while walking or coughing due to contraction of the abdominal muscles. This discomfort is absent following the natural orifice approach.”

The trial is designed to perform 70 NOTES cases (35 transgastric and 35 transvaginal) and 70 laparoscopic cases. The UCSD site plans to enroll 20 patients.

Cholecystectomy is one of the most common surgeries in the US. Nearly 750,000 patients undergo the procedure each year.

The dream of an effective vaccine against the AIDS virus may have moved one step closer to reality, according to federal scientists.

The scientists identified 2 naturally occurring antibodies that destroy nearly 90% of all strains of HIV, the virus that causes AIDS. They say their finding could hasten development of new HIV treatments as well as a vaccine.

HIV is deviously mutable. Frequent mutations in its DNA change the composition of surface proteins on the virus, allowing it to escape an immune response. This enables the virus to continue infecting cells even after antibodies targeting it have appeared — it has thus been able to avoid vaccines developed against it so far.

There are hundreds of variants of the HIV virus around the world. Finding so-called broadly neutralizing antibodies that can kill the majority of these strains has been the goal of HIV researchers for 2 decades.

To date, the best researchers have been able to do is find antibodies that block about 40% of the known HIV strains. Key to a breakthrough in this regard is to isolate antibodies that attack relatively unchanging parts on the surface of the HIV virus. And that’s what may just have been accomplished.

“I am more optimistic about an AIDS vaccine at this point in time than I have been probably in the last 10 years,” Gary Nabel of the National Institute of Allergy and Infectious Diseases told the LA Times. Nabel headed the project reporting the breakthrough. The write-up appears in Science.

Nabel’s team isolated antibodies from a 60-year-old African American man that had been infected with HIV. Using new imaging and analytical techniques, the team isolated 2 antibodies, known as VRC01 and VRC02, which are directed against a protuberance on the surface of the HIV virus. The spike facilitates binding to something called the CD4 binding site on white blood cells of humans. When an antibody binds to to the spike, it prevents the virus from entering the cell.

The HIV virus relies exclusively on this receptor to enter human white blood cells, so it can’t infect them when antibodies are attached to the spike.

Nabel’s team is currently testing a synthetic version of the spike as a possible vaccine in animals. They hope to begin human testing fairly soon.