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.

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.

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.

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.

The decades-long hunt for an obesity pill has been sullied by market withdrawals and clinical failures. The largely fruitless quest was recently dubbed the “$11 billion market that never was” by Datamonitor, a research firm that predicted drug sales in the space would reach just $560 million in 2018.

“Current approaches just aren’t good enough to capitalize on this opportunity,” the firm reported.

Nevertheless, the hunt continues. Last month for example, Arena Pharmaceuticals announced a $1.3 billion marketing and supply agreement which calls for the company to sell its experimental obesity-fighter lorcaserin to Eisai for a purchase price beginning at 31% of Eisai’s annual net sales, with escalator clauses reaching as high as 36.5% if sales exceed $750 million. Arena can also receive up to $1.2 billion in purchase price adjustment payments, according to BurrillReport.

Lorcaserin, the most advanced drug in Arena’s pipeline, is a so-called selective serotonin 2C receptor agonist. The serotonin 2C receptor is located in the hypothalamus, an area of the brain known to help control appetite. According to Arena, stimulation of the serotonin 2C receptor is associated with a sensation of satiety.

Also last month, Orexigen reported that a late-stage trial of its experimental obesity drug Contrave had achieved promising results. Contrave includes the antidepressant Wellbutrin and an opioid blocker that is currently used to treat drug and alcohol addiction.

The Contrave trial involved patients with type 2 diabetes. After 56 weeks of treatment, obese patients with diabetes lost more weight and achieved better glycemic control than those receiving a placebo. In addition, more than twice as many patients taking Contrave lost 5% or more of their body weight.

Arena has a date with the FDA this October. Orexigen’s big day comes next January.

Allopurinol, for 40 years a mainstay in the treatment of gout, has been shown to work for angina too, according to scientists at the University of Dundee.

To reach this surprising conclusion, Awsan Noman and colleagues enrolled 65 patients with chronic stable angina pectoris and angiographically proven coronary artery disease into a randomized, controlled trial of high-dose allpurinol (600 mg per day) vs. placebo.

The scientists found that patients randomized to receive allopurinol increased the median time to ST depression (a sine qua none of coronary ischemia) from 232 seconds to 298 seconds, whereas in placebo-treated subjects that statistic increased from 232 seconds to 249 seconds, a significant difference.

Allopurinol also increased total exercise time and the time before onset of chest pain. There were no adverse treatment effects.
 
Noman’s group suspects the beneficial effects of Allopurinol are caused by its ability to inhibit an enzyme known as xanthine oxidase. This in turn reduces myocardial oxygen (energy) consumption for a particular stroke volume.
 
Next up for the scientists is to determine how best to use allopurinol in the management of chronic stable angina. They were optimistic in this regard, noting that compared with nitrates and beta blockers allopurinol does not reduce blood pressure or heart rate, or trigger headaches and tiredness, which commonly accompany standard drug treatments.

They also noted that allopurinol may be quite useful in developing countries where the incidence of coronary artery disease is exploding and access to more expensive drugs and invasive therapies is limited.

The article appears in Lancet.

The National Institutes of Health has announced it intends to revise its policies governing financial conflicts of interest. The changes will increase disclosure responsibilities on institutions that receive funding from the agency,  increase transparency and accountability, and toughen-up rules it first promulgated in 1995.

“We cannot afford to take chances with the integrity of the research process,” NIH Director Francis Collins remarked at a press conference introducing the proposed changes. “We believe it is essential to tighten up this situation in order to be sure that we are obtaining and maintaining the public trust in the integrity of the scientific enterprise.”

Among the revisions, the NIH proposes to reduce the reporting threshold for conflicts from $10,000 to $5,000. In addition, the NIH wants to shift responsibility for deciding whether a particular relationship is in fact a conflict from the investigator to his or her institution. This would require institutions to establish review processes for potential conflicts and report such matters to the NIH.

The NIH is also proposing that for the first time, Phase 1 Small Business Innovation Research grants and the Small Business Technology Transfer Program would be covered under these policies.

The new rules do exclude income from teaching, lectures, seminars, or service on review or advisory committees review panels for institutions of higher learning or government agencies.

A further change would require grant receiving bodies to disclose on publicly accessible websites any significant financial interests involving their faculty or others related to the entities.

“The public may not always understand the intricacies of rigorous science, but most individuals quickly grasp the concept of bias,” wrote Collins in a commentary in JAMA. “Americans do not want financial conflicts of interest to influence the federally funded research.”

In an innovative effort to find new uses for existing drugs, pharmaceutical giant Pfizer has struck a deal with the Washington University School of Medicine enabling the University’s scientists to access information regarding over 500 pharmaceutical compounds in Pfizer’s archives.

The 5-year agreement also calls for Pfizer to contribute $22.5 million to the University. Proprietary information will be shared for drugs that are currently on the market and those that failed during  testing. The deal is believed to be the first of its kind in the industry.

The parties expect the partnership can reduce the time-to-market for drugs that are found to have new applications, because the time consuming, pre-clinical (safety) studies have already been performed on these compounds.

“There are two realities in drug discovery,” Don Frail told BurrillReport. The chief scientific officer of Pfizer’s Indications Discovery Unit explained that “the majority of candidates tested in development do not give the desired result, yet those drugs that do succeed typically have multiple uses. By harnessing the expertise at this academic medical center, the collaboration seeks to discover new uses for these compounds in areas of patient need that might otherwise be left undiscovered.”

To foster collaboration, Pfizer developed a web portal that permits Washington University scientists to access clinical and preclinical data regarding Pfizer’s proprietary compounds. An oversight committee composed of scientists from both organizations will evaluate research proposals that have been co-authored by researchers from the University and Pfizer.

Pfizer’s Indications Discovery Unit will move its laboratories closer to the Washington University campus to further promote idea exchange.

“This is a tremendous opportunity for both partners,” Jeffrey Gordon, director of the University’s Center for Genome Sciences told Burrill. “It leverages the complementary strengths and interests of both Washington University and Pfizer.”

Simply hearing mom’s voice on the telephone triggers a marked calming effect in girls. The response is triggered by the release of a stress-reducing hormone, say scientists at the University of Wisconsin-Madison. 
 
To reach these conclusions, Leslie Seltzer created a stressful situation by asking a cohort 7- to 12-year-old girls to deliver an extemporaneous speech and solve difficult math problems in front of an audience of strangers.

The stressed-out pre-teens were then randomized into 3 groups. Girls in the first group received hugs and related in-person comforting from their mothers. The second group received phone-based support from their mothers. The third group was hung out to dry watching an emotionally neutral video.
 
Seltzer’s group found that girls in the first two groups experienced a marked rise in oxytocin levels, whether their contact with mom was in person or via the telephone. They also found that the calming effects of the interaction, and the associated bump in oxytocin and reduction in cortisol, lasted for hours after the comfort session with mom.
 
Oxytocin is known to be associated with emotional bonding, but increased levels of the female hormone had previously been thought to require physical contact between mother and daughter.

“It’s clear that a mother’s voice can have the same effect as a hug, even if they’re not standing there,” Seltzer told BurrillReport.
 
“For years I’ve seen students leaving exams and the first thing they do is pull out their cell phone and make a call,” Seth Pollak, a psychology professor at UW-Madison told Burrill. “I used to think, ‘How could those over-attentive, helicopter parents encourage that?’ But now? Maybe it’s a quick and dirty way to feel better. It’s not pop psychology or psychobabble.”
 
The write-up appears in Proceedings of the Royal Society B.

Scientists at the Lawrence Livermore National Laboratory have developed a new tool that could help law enforcement authorities detect bioterrorism attacks, doctors in need of a rapid diagnostic tool for infectious diseases, and regulatory agencies responsible for food safety.

The device, blandly named the Microbial Detection Array, will be able to identify 2,000 viruses and 900 bacteria within 24 hours, according to officials at the lab.
 
“The ability to detect the major bacterial and viral components of any sample can be used in countless ways,” Tom Slezak, an associate program leader for Informatics at Lawrence Livermore National Laboratory told BurrillReport. “This is important because it fills a cost-performance gap that is relevant to many missions: biodefense, public health and product safety.”
 
If the cost of the array can be reduced, it could become a helpful tool for public health diagnostics, Slezak added. The array has the huge advantage of being able to detect a far wider range of viral and bacterial pathogens than the best available technology. That would be multiplex polymerase chain reaction or PCR, which is able to detect 50 organisms at one time.
 
The same benefits would apply to biodefense, where current systems are similarly designed to detect a much smaller set of high-risk pathogens. Not surprisingly, the US Department of Homeland Security is testing the array for its own use.
 
And there’s more: the Livermore group is now testing a new array that has probes covering 5,700 viruses and several thousand bacteria.

Spouses who care for a husband or wife that has dementia are 6 times more likely to develop the condition themselves, according to study by scientists at Utah State, Johns Hopkins and Duke.

To reach this conclusion, the scientists looked at 1,221 married couples who were at least 65 years old. The subjects had been enrolled in the Cache County (Utah) Memory Study, which has followed more than 900 people with dementia since the study began in 1995.

The six-fold increase in dementia rivals that associated with a well-known gene variant, APOE ε4, according to the scientists. The risk was found to be present even after the scientists accounted for socioeconomic status and other factors that are known to increase the risk of dementia. 

Researchers have studied this general topic for years, although most of the earlier studies focused on emotional distress experienced by caretakers rather than any impact on the cognitive abilities of spouses who cared for persons with dementia. 

The scientists suspect that stress associated with caregiving is driving their findings.  

“Caregiving has positive aspects, as well as negative ones,” Peter Rabin, a professor of psychiatry at Johns Hopkins University told BurrillReport. “If we can boost the positive aspects and reduce the negative ones, we may be able to reduce a caregiver’s risk of developing dementia.”

Ongoing production problems at the factories of biotech giant Genzyme have caused massive disruptions in the lives of people with Gaucher disease and Fabry disease, a pair of rare, inherited conditions in which enzyme deficiencies allow fatty substances to build-up in the body and damage internal organs.

The factories produce Cerezyme, the enzyme used as replacement therapy for the 1,500 patients with Gaucher disease, and Fabrazyme, the enzyme used to treat about 1,000 patients with Fabry disease.

Genzyme’s production problems began nearly a year ago, after it discovered its main production facility had been contaminated by a virus.

Genzyme initially predicted the shortages would last 2 months, but subsequent glitches have impeded progress. At one point, some vials of the drugs were found to contain particles of fiber, rubber or steel.

The problems are particularly acute for Fabry patients, who can experience cardiac or kidney failure in the absence of drug replacement therapy. Fabry patients have been receiving about 30% of their normal doses during the crisis.

In Gaucher disease, which can cause anemia, bleeding and enlarged livers and spleens, severely affected patients have been receiving full doses of the drug, while others received nothing for months late last year.

“If most businesses run like this they’d be out of business,” one patient, Mark Malone told the New York Times. “Unfortunately, they have the drug we need.”

Henri Termeer, Genzyme’s CEO, acknowledged his company had let patients down. “We have to re-earn our standing with these patients,” he said.

Genzyme says it should be able to supply Cerezyme to all affected patients by May 1. Fabrazyme patients will have to wait until at least later this summer. Genzyme stock, which traded above $72 last year, now trades in the low 50s.

Genzyme booked a $175 million hit to its first quarter earnings in anticipation of a fine it expects the FDA to levy for the mess-up.

Chocolate is more than an indulgence! It lowers blood pressure and the consequent risk of heart disease–especially dark chocolate–say German scientists who published the heartening news in the European Heart Journal.

The scientists added that just a small square of chocolate per day is enough to reap the cardiovascular benefits…after that, it really is just an indulgence.
 
To reach these conclusions, Brian Buijsse and colleagues followed 19,357 people between the ages of 35 and 65, for at least 10 years. They found that people in the highest quartile for chocolate consumption  (averaging 7.5 grams of chocolate per day), had lower blood pressure, a 27% lower risk of heart attack, and a 48% lower risk of stroke than those in the lowest quartile for chocolate consumption (about 1.7 grams per day).

Buijsse’s team believes it’s the flavanols in cocoa that are responsible for these beneficial effects. There are more flavanols in dark chocolate than milk chocolate.
 
“Flavanols…are responsible for improving the bioavailability of nitric oxide from the cells that line the inner wall of blood vessels–vascular endothelial cells,” explained Buijsse. “Nitric oxide…causes smooth muscle cells of the blood vessels to relax and widen. This may contribute to lower blood pressure. Nitric oxide also improves platelet function and makes vascular endothelium less attractive for white blood cells to attach and stick around.”
 
Buijsse warned that people who chose to increase their chocolate intake should not increase their overall caloric intake or their consumption of healthy foods. “Small amounts of chocolate may help to prevent heart disease, but only if it replaces other energy-dense food, such as snacks, in order to keep body weight stable,” he told BurrillReport.

Clinical trials are often stopped early when they show a convincing, apparent difference between an experimental intervention and either a placebo or an existing standard of care. The rationale for halting such trials is to let participants who were randomized to the placebo switch to the apparently effective intervention, and to help get the presumably improved therapy to market.

However, a recent study by Dirk Bassler and colleagues at McMaster University suggests that halting trials early may lead to misleading overstatements concerning the apparent benefits of the intervention.

To reach this conclusion, Bassler’s team compared treatment effects from truncated randomized clinical trials (RCTs) with those observed in trials that addressed the same question but that were not halted early.

The analysis included 91 truncated RCTs and 424 matched, non-truncated RCTs. The results showed that the halted trials had reached exaggerated or misleading conclusions. Remarkably, 62% of the non-truncated RCTs showed no benefit at all for the intervention. Large differences between truncated and non-truncated trials were common when the truncated RCTs had fewer than 500 outcome events.

“Our research shows that in most cases early stopping of clinical trials resulted in misleading estimates of treatment effects,” Victor Montori, a Mayo Clinic endocrinologist and corresponding author of the study told BurrillReport.
 
The authors recommended that scientists truncate clinical trials only near the very end of a study and then only with “a very good reason.” Otherwise patients and physicians will be making treatment choices based on inaccurate information, or worse, opting for a treatment when another one may be more effective.

The study appears in the Journal of the American Medical Association.

Cancer is always in the news. Yet although nearly half of all US cancer patients die of their disease or related complications, no one seemed to know whether news reports reflected this reality.

Jessica Fishman and colleagues at the University of Pennsylvania decided to look into the matter by reviewing the content of cancer news stories in 8 high-circulation newspapers and 5 popular magazines.

The scientists identified 2,228 cancer-related articles appearing between 2005 and 2007, and focused on a randomly selected sample of 436 of them. They found that in general, the stories were overly optimistic about survival, more likely to focus on aggressive treatments and rarely covered negative things like death, treatment failure and adverse events. Almost none of the stories covered end-of-life issues.
 
In particular, 140 stories focused on people who survived or were cured of the disease, while 33 focused on people who were dying or had died of cancer. Just 57 articles mentioned that aggressive cancer treatments can fail. A majority of articles (249) discussed aggressive treatment exclusively, but only 57 reported that such treatments can fail to extend life or cure the disease, or that some cancers are incurable. Just 131 mentioned adverse events associated with treatment, and a grand total of 2 articles focused on palliative or hospice care exclusively.

“These portrayals of cancer care in the news media may give patients an inappropriately optimistic view of cancer treatment, outcomes, and prognosis,” the authors write in the Archives of Internal Medicine.

“For many patients with cancer, it is important to know about palliative and hospice care because this information can help them make decisions that realistically reflect their prognosis and the risks and potential benefits of treatment.”

Coffee drinkers are less likely to be hospitalized for heart rhythm disturbances, according to scientists who presented at an American Heart Association conference last month.

The findings might seem counterintuitive for people that experience palpitations after drinking coffee, especially if they believe palpitations are associated with heart rhythm disturbances (they are, but the association is weak, especially in young, healthy people).
 
Nevertheless Arthur Klatsky and colleagues from the Kaiser Permanente Division of Research reached this conclusion by following 130,054 people. Those who reported drinking four or more cups of Joe per day had an 18% reduction in the risk of hospitalization for arrhythmias. People who reported consuming one to three cups per day had a 7% lower risk.
 
Previous studies showing the opposite result—that caffeine can produce arrhythmias—were based on much higher levels of caffeine intake, Klatsky said. He also cited the findings of a Danish study showing that heavy and light coffee drinkers experienced the same risk of atrial fibrillation, a common major disturbance of cardiac rhythm.
 
 “Coffee drinking is related to lower risk of hospitalization for rhythm problems, but the association does not prove cause and effect,” Klasky told BurrillReport. It is possible, for example, that other characteristics of coffee drinkers, like their dietary habits or how much they exercise, could be driving the apparent association.

As a result, it’s certainly not possible to advise people to drink coffee in order to prevent heart rhythm disturbances. Still, Klatsky felt his findings might reassure people who drink moderate amounts of coffee: their habit isn’t going to trigger a major rhythm disturbance.