Archive for November, 2010

Should Genes Be Eligible for Patents?

November 30th, 2010 | No Comments | Source: Commentary

Last May, US District Court judge Robert Sweet threw out patents on BRCA1 and BRCA2, a pair of human genes in which mutations are linked to breast and ovarian cancer. In his decision, Sweet ruled the patents were “improperly granted” since they involved a “law of nature.” He rejected the notion that isolating a gene made it patentable, calling that “a ‘lawyer’s trick’” which circumvents the “prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.”

The BRCA case had been brought by the American Civil Liberties Union, patients and medical organizations. Among other things, they argued that patents drive up testing costs and stifle biomedical innovation.

Sweet’s ruling caused quite a stir at the time, since nearly 20% of all human genes had already been patented, and entire industries had been created around the intellectual property rights granted by these patents.

Myriad Genetics is the company that holds the BRCA patents. It markets a $3,000 test that detects the  offending mutations in those genes. Not surprisingly, Myriad appealed the ruling.

What’s New
As the appeal moved forward, the US Department of Justice surprised many observers by releasing an amicus brief in which it asserted that human, and indeed all genes should not be eligible for patent protection. This amounted to a complete reversal of its position on the issue.




Near-Death Experiences

November 29th, 2010 | 1 Comment | Source: Wall Street Journal

It’s hard to know whether Clint Eastwood’s new movie, Hereafter, prompted a recent surge in interest concerning near-death experiences, or whether the flick simply tapped into the surge. Regardless, an otherworldly 15 million American adults claim to have had a near-death experience, according to the results of 1997 survey. That number might be a lot higher now that automatic external defibrillators have become commonplace.
It’s also hard to know what to make of these claims from a scientific standpoint, but there’s no denying that near-death experiences are described in stunningly similar ways by people with diverse cultural, ethnic, and religious backgrounds, and across all age groups, right down to toddlers.

People typically describe a near-death experience as a sensation of floating above one’s body, and/or moving through a tunnel towards a light. Often, there are associated feelings profound of joy and peace, and visions of past experiences or deceased acquaintances. The experience usually ends with a realization that it’s not time to die, and a return to one’s injured or failing body.

Some people who’ve experienced the phenomenon and then manage to recover their health undergo personality changes that they attribute to the experience. Others, as is the case with the lovely French reporter played by Cecile de France in Hereafter, become convinced there is an afterlife.

What have scientists learned about the physiologic underpinnings of near-death experiences? The answer, as you might guess, is not much.

The traditional explanation, first promulgated 25 years ago by British neuroscientist Susan Blackmore, was that cerebral oxygen deprivation caused the experience. She noted that astronauts and fighter pilots experience visual disturbances and cognitive abnormalities during high altitude maneuvers in oxygen-poor environments, and their experiences mimic near-death experiences. Alas, a recent study seemed to contradict her theory by showing that people who had near-death experiences actually had higher oxygen levels in their blood than those who did not.

Earlier this year, a study of cardiac-arrest patients in the Journal of Critical Care reported finding high blood levels of carbon dioxide in patients who had near-death experiences. This condition is known to cause hallucinations and out-of-body experiences, even in people who are not on death’s door.

A second study of dying patients in the Journal of Palliative Medicine found that EEG patterns in dying patients revealed a spike in electrical activity just before they passed away. The surge began in one part of the brain and spread in wave-like fashion to other regions. The study authors postulated that such activity could trigger visual and auditory experiences consistent with near-death experiences.

Other scientists have proposed that areas of the brain which control memory could become activated by severe physiologic abnormalities, and that could explain the recollections some people have as a part of their near-death experience. Similar abnormalities could trigger the release of endorphins which could in turn evoke feelings of joy and euphoria.

As for the actual existence of an afterlife, we’ll leave that discussion to others.



The Rise and Fall of The Tone Deaf Entrepreneur

November 28th, 2010 | No Comments | Source: Commentary

40 million people have no health insurance, 20 million kids live in poverty, the obesity epidemic remains unchecked…and The Tone Deaf Entrepreneur releases THIS?

Noted VC firm invests $10m in company led by The Tone Deaf Entrepreneur.

TechCrunch all over incredible story of The Tone Deaf Entrepreneur.

Tone Deaf app fastest-ever to 1 million downloads.

Three months pass.

No one is using the Tone Deaf app. People can’t remember who The Tone Deaf Entrepreneur is. Noted VC firm updates portfolio company list.

40 million people still have no health insurance, 20 million kids still live in poverty and the obesity epidemic remains unchecked, still.



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Gene Therapy for Depression

November 26th, 2010 | 1 Comment | Source: BurrillReport, Science Translational Med.

Gene therapy involves replacing or altering a small part of DNA whose abnormal expression causes a disease. The new therapeutic technique has shown promise for the treatment of cystic fibrosis, hemophilia and muscular dystrophy. Now, according to scientists at Weill Cornell Medical Center, perhaps depression should be added to this list as well.

In mice that is. Perhaps someday gene therapy can be used to treat humans as well.

That’s the suggestion made by Michael Kaplitt and colleagues in their write-up summarizing the results of their recent experiments which appears in Science Translational Medicine.

Kaplitt’s team knew that abnormalities in a particular region of the brain-the nucleus accumbens-were associated with depression in humans and behaviors akin to depression in mice (specifically, murine responses to rewards and pleasurable experiences). They knew that the problem in the nucleus accumbens had to do with abnormalities in the way the neurotransmitter serotonin impacted chemical pathways that mediated mood, appetite and sleep patterns. And they knew that most antidepressant drugs acted to regulate serotonin metabolism in the brain.

Kaplitt’s group went from there to isolate the problem with serotonin metabolism in the nucleus accumbens of “depressed” mice. It turned out to be the lack of a single protein, known as p11, which normally serves to transport serotonin receptors to the surface of nerve cells. When p11 was missing or didn’t work properly, nerve cells could produce adequate amounts of serotonin receptors, but the receptors never made it to the surface of the nerve cell membrane where they could bind serotonin and thus trigger normal behavioral responses.

Kaplitt’s team then used somatic gene transfer (that is, “gene therapy”) to replace the gene responsible for producing the defective p11 protein in the nucleus accumbens of their depressed mice. They subsequently observed that the depressive symptoms disappeared.

“We potentially have a novel therapy to target what we now believe is one root cause of human depression,” Kaplitt told BurrillReport. Kaplitt’s team hopes to launch a clinical trial of gene therapy in humans with depression sometime soon.



Role of Parents in the Treatment of Anorexia Nervosa

November 24th, 2010 | No Comments | Source: Wall Street Journal

Traditional approaches to anorexia nervosa are based on the assumption that parental behaviors—or at least their interactions with afflicted individuals—helped cause or exacerbate the problem. Consistent with this assumption, treatments for the potentially deadly eating disorder typically exclude family members.

But a recent study by scientists at the University of Chicago and Stanford provides strong evidence that parents can play a decisive role in improving outcomes for patients with anorexia.

The study of 121 patients with the condition was published earlier this month in the Archives of General Psychiatry. It focused on the so-called Maudsley model, in which parents are present at each meal until the anorexic child eats.

The Maudsley model was developed in London 2 decades ago. It calls for parents to assume responsibility for mealtimes involving their anorexic child, “making it impossible not to eat,” study author Daniel Le Grange explained to the Wall Street Journal.

The study by Le Grange and his colleagues showed that that anorexia patients who received care according to the Maudsley model were more likely to achieve and maintain a therapeutic weight than those treated using conventional one-on-one interventions with a behavioral therapist.

The relative improvement vs. conventional therapy was present one year after treatment ceased, and increased over time. Thus at the end of the second year post-treatment, almost half the patients receiving family-treatment were in remission, whereas only 23% of the patients in the therapist treatment group were in remission. The difference was statistically significant.

“This is additional evidence that involvement of the family can be a very effective way in helping kids overcome their problems,” said B. Timothy Walsh, a professor of psychiatry at Columbia University Medical Center.



Work-out in a Gym? The French say “Sacre Bleu!”

November 23rd, 2010 | 2 Comments | Source: MSNBC

Like their counterparts in other first-world countries, French people know about the health benefits of exercise. And French culture has emphasized, even worshipped, good looks (which these days translates to “fit and trim”).

So it’s surprising that the French avoid fitness centers as vigorously as factory-produced croissants.
But they do. According to the International Health, Racquet and Sportsclub Association, just 5.4% of French people were members of a fitness club in 2008. That’s substantially less than their counterparts in Italy (9.5%), the UK (11.9%) and Spain (16.6%).

“It appears that more people are sitting in cafes smoking cigarettes and drinking coffee than working out … the French don’t see fitness as a lifestyle,” American-born fitness consultant Fred Hoffman told MSNBC. Hoffman has lived in Paris for 2 decades.
The only part of the fitness market that is growing in France is the one for cut-rate, no-frills facilities. “It’s a lot simpler just to open a shoebox and throw in some machines,” explained Michel Parada, who directs operations for Fitness First in France.

However, Hoffman doubts these facilities will be able to sustain themselves, as the French folks who do join fitness centres aren’t savvy about work-out regimes and typically require a personal trainer to carry out a safe, effective work-out.

The problem, it seems, is that working-out has an image problem in France. Celebrities in particular seem to shun sweaty workouts, at least in public. And it’s unlikely that this will change even if the government began promoting fitness.

That became clear in 2007, when President Nicolas Sarkozy was observed jogging in the streets of Paris after his election. “I would rather see the president in his suit than in his sweat,” philosopher Alain Finkielkraut said at the time.


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Drug Companies May Benefit from GOP Landslide

November 22nd, 2010 | No Comments | Source: Wall Street Journal

People forget the stir Big Pharma created 16 months ago when it gave Big-Ups to the Big O at a time when he desperately needed passengers to ride the Health Reform Express.

The dust-up took place before Massachusetts produced “Guess Who’s Coming to Dinner” starring Scott Brown, and before Congressional parliamentarians reminded us what reconciliation meant. And it happened before Congress managed to vote 100% along party lines on what was inarguably one of the most important pieces of social legislation in our generation.

But it did happen. In June, 2009, Big Pharma’s main lobbying arm offered the Big O a deal he couldn’t  refuse: “We’ll cut prices on drugs purchased by Medicare by $80 billion over the next 10 years if you don’t push Medicare to import cheap drugs from Canada or direct it to negotiate price cuts with us.”

At the time, the Party of No was aghast! How could Big Pharma do such a thing? John Boehner was so moved by the treasonous behavior, he accused the lobbying group of trying to appease a “bully.”

(Oh c’mon John! Obama? A “bully”?)

Of course all of this is old news especially since Republicans cleaned house in the midterms and are now threatening to repeal and replace the Big O’s health reform law altogether.

Will the purge include a bit of pay-back for Big Pharma? Alas, probably not. There have been no calls for retribution by the Republicans. In fact, many industry insiders believe drug companies might make out just fine in view of the antiregulatory, antigovernment sentiments espoused by the Boehners.

These insiders doubt the GOP would seek to reverse the “doughnut hole” savings for Medicare beneficiaries that was part of the original deal, since that would be panned by senior citizens and why give the Pelosis an issue they can leverage?

Beyond this, Big Pharma believes the GOP might just help them out by reauthorizing the Prescription Drug User Fee Act, which permits drug and device companies to funnel cash to the FDA in order to expedite product reviews. The drug industry claims this process assures new drugs get to market more quickly by assuring the FDA has enough resources to move things along (and want you to ignore those silly consumer advocates who argue such fees could bias the FDA process!).

The impetus to repeal the PDUFA in the first place came from Connecticut Rosa DeLauro and other House Democrats, who are now playing second fiddle to the Boehners. “Consumer groups will be neutered in this discussion,” analyst Ira Loss of Washington Analysis LLC told the Wall Street Journal.

And it didn’t hurt matters that Big Pharma donations, which tilted uncharacteristically toward the Big O in 2008, flowed heavily toward GOP candidates this time ‘round…


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Needless Screening Tests for Cancer Patients

November 19th, 2010 | No Comments | Source: JAMA, MedPageToday

The US health care system is generally recognized to be obscenely wasteful and to deliver poor value for the money. But even the most jaded observers are likely to be shocked by the results of a new study which shows that many patients with advanced or metastatic cancer and a correspondingly short life expectancy undergo routine screening tests like cholesterol checks, Pap smears, mammograms and PSA tests.

For example, 14% of male Medicare beneficiaries with advanced pancreatic cancer underwent PSA testing. Similarly, 18% of women with this condition had at least one mammogram and 5.4% had a Pap smear. Nearly 20% of these patients had a cholesterol test.

The appalling findings come from a study by Camelia Sima and colleagues at the Memorial Sloan-Kettering Cancer Center. These scientists looked at Medicare billing data from 88,000 beneficiaries that had been diagnosed with advanced cancer between 1998 and 2005.

The scientists compared utilization rates for screening tests in this group with a control group of Medicare enrollees that did not have cancer, but were matched by gender, age, race and area of residence.

The first group included patients with stage IIIb to IV lung cancer, advanced stage pancreatic cancer and stage IV breast,colorectal, and gastroesophageal cancer. The vast majority of these patients have a life expectancy of less than 2 years.

Screening rates for the cancer patients were about half that of their matched controls. There were no differences in screening rates for patients with each kind of cancer. Married and more affluent cancer patients tended to get more screening tests than their counterparts.

“In an ideal healthcare system, healthcare practitioners would discontinue cancer screening for patients whose prognosis is too limited for the benefits of early detection to be realized,” Sima’s team wrote. “Each medical specialty needs to engage in thoughtful self-scrutiny to identify episodes of unnecessary care,” they added.

The write-up appears in JAMA.



Do the New Republican Governors Threaten Health Reform?

November 18th, 2010 | No Comments | Source: Commentary

The GOP’s landslide victory in this month’s mid-term elections did more than reshape politics inside the beltway. Republicans will now govern 8 more states than they did before, and the party controls both the executive and legislative branches of government in 20 states. That was the case in just 9 states before the bloodbath.

These gains can impact the fate of the Affordable Care Act, since this particular federal statute relies on state governments to implement many of its key provisions.

So, how much of a threat do all those new Republican governors pose to health reform? To be sure, many of them despise the law, and made no secret about it during the campaign. The health reform law is “an intolerable expansion of federal power,” Tennessee governor-elect Bill Haslam told the Washington Post, for example. Matt Mead and Paul LePage, who are Haslam’s counterparts in Wyoming and Maine respectively, expressed similar sentiments. Many others did as well.

The Affordable Care Act’s much heralded health insurance exchanges would seem to be a likely target for these governors. The architects of the Act designed the insurance exchanges to be a place where individuals and small businesses purchase health coverage, often using federal subsidies to do so.

No governor will flat-out ignore the requirement to establish an exchange in his or her state, because the law allows the Feds to offer one of their own if they deem a state’s exchange to be inadequate. But governors can sabotage the exchanges by forcing insurers to adhere to onerous requirements such as establishing outcomes measurement systems, or providing excessively detailed justifications before enacting rate increases, for example. They can also minimize regulatory oversight of the exchanges or underfund them in various ways.

Supporters of health reform are acutely concerned about the latter possibility. “The worst-case scenario is that a state does the bare minimum and sets up an exchange in form only that’s destined to fail,” Ethan Rome, executive director of the advocacy group Health Care for America Now told the Post. (more…)



Biotech Grant Program: Are a Few Crumbs Better Than No Crumbs At All?

November 17th, 2010 | No Comments | Source: Washington Post

After assuming control of the House in the mid-term elections, Republicans vowed to eviscerate the Affordable Care Act, the health reform law signed by the Big O last March. Thank heavens therefore, that the Boehners were too busy congratulating themselves to even notice those federal helicopters dumping $1 billion in cash on some needy biotech companies just as the election results were being tallied.

Yep, it happened. Federal disbursements in the form of grants and tax credits were made last week, as required by a provision in the reform law known as the Qualifying Therapeutic Discovery Project Program. According to the terms of this Program, biotech and life sciences companies with less than 250 employees could apply for federal funds to cover research costs they had incurred in the last 2 years, so long as the research focused on the prevention, diagnosis and treatment of chronic diseases.

The Program amounted to nod by the Feds to biotech and life sciences, 2 industries that had been battered to near oblivion by the Great Recession of 2008-2010. Biotech and life sciences fared worse than most industries because the core of their business, research and development, consumes enormous capital early-on and there are long delays before these projects hit pay-dirt–if they ever do. Early-stage companies in these industries are therefore high risk investments, the sort VCs steer clear from when the going gets tough.

Unfortunately for the targeted industries, the Program turned out to be a small nod, indeed. It attracted 5,600 applications, far more than expected, and by rule all 4,600 that met congressional requirements had to be funded. With the pool capped at a bil, qualifying projects attracted far fewer dollars than requested.

The maximal allowed disbursement was supposed to be $5 million per project. As it turned out, no project received more than $244,000 (some firms received more than this because they submitted proposals for multiple projects). 

The grant requests were reviewed by the National Institutes of Health and Internal Revenue Service. “It was an indication of the great opportunity and interest that there were so many applications received,” NIH Director Francis Collins told the Washington Post.

“Of course, with a $1 billion total amount of money available and with so many of the applicants being judged appropriate for this program, it was not possible to make awards as large as $5 million.”

The Fallout
Biotech CEOs are thankful for the pittance, but they’re back on the street, in search of serious cash. For many of them, it’s already too late.

The Pelosis are kicking themselves for not allocating more than $1 billion to fund the Qualifying Therapeutic Discovery Project Program in the first place. It’s the same mistake they made with the stimulus package–they underfunded that one too, by golly.

The Boehners, are, arms crossed, not permitting any more “government handouts” like this. Not on their watch. It doesn’t matter that biotech and life sciences are among the few industries in which the US maintains a competitive advantage over international economic rivals. It doesn’t matter that firms in these industries can serve as a legitimate source of job creation for decades to come…if only they can survive the Great Recession and that may only happen with, you guessed it, federal support.

A right-minded idea, yet it seems nobody’s happy with the outcome. Back to the drawing board!


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