Jennifer S. Altman for The New York Times

The New York Times, January 24, 2011, By GARDINER HARRIS

The Obama administration has become so concerned about the slowing pace of new drugs coming out of the pharmaceutical industry that officials have decided to start a billion-dollar government drug development center to help create medicines.

The new effort comes as many large drug makers, unable to find enough new drugs, are paring back research. Promising discoveries in illnesses like depression and Parkinson’s that once would have led to clinical trials are instead going unexplored because companies have neither the will nor the resources to undertake the effort.

The initial financing of the government’s new drug center is relatively small compared with the $45.8 billion that the industry estimates it invested in research in 2009. The cost of bringing a single drug to market can exceed $1 billion, according to some estimates, and drug companies have typically spent twice as much on marketing as on research, a business model that is increasingly suspect.

The National Institutes of Health has traditionally focused on basic research, such as describing the structure of proteins, leaving industry to create drugs using those compounds. But the drug industry’s research productivity has been declining for 15 years, “and it certainly doesn’t show any signs of turning upward,” said Dr. Francis S. Collins, director of the institutes.

The job of the new center, to be called the National Center for Advancing Translational Sciences, is akin to that of a home seller who spruces up properties to attract buyers in a down market. In this case the center will do as much research as it needs to do so that it can attract drug company investment.

That means that in some cases, the center will use one of the institutes’ four new robotic screeners to find chemicals that affect enzymes and might lead to the development of a drug or a cure. In other cases, the center may need to not only discover the right chemicals but also perform animal tests to ensure that they are safe and even start human trials to see if they work. All of that has traditionally been done by drug companies, not the government.

“None of this is intended to be competitive with the private sector,” Dr. Collins said. “The hope would be that any project that reaches the point of commercial appeal would be moved out of the academic support line and into the private sector.”

Whether the government can succeed where private industry has failed is uncertain, officials acknowledge, but they say doing nothing is not an option. The health and human services secretary, Kathleen Sebelius, sent a letter to Congress on Jan. 14 outlining the plan to open the new drug center by October — an unusually rapid turnaround for an idea first released with little fanfare in December.

Creating the center is a signature effort of Dr. Collins, who once directed the agency’s Human Genome Project. Dr. Collins has been predicting for years that gene sequencing will lead to a vast array of new treatments, but years of effort and tens of billions of dollars in financing by drug makers in gene-related research has largely been a bust.

As a result, industry has become far less willing to follow the latest genetic advances with expensive clinical trials. Rather than wait longer, Dr. Collins has decided that the government can start the work itself.

“I am a little frustrated to see how many of the discoveries that do look as though they have therapeutic implications are waiting for the pharmaceutical industry to follow through with them,” he said.

Dr. Collins’s ability to conceive and create such a center in a few short months would have been impossible for most of his predecessors, who had nice offices but little power. But Congress in recent years has invested real budgetary and administrative authority in the director’s office, and Dr. Collins is the first to fully use these new powers.

Under the plan, more than $700 million in research projects already under way at various institutes and centers would be brought together at the new center. But officials hope that the prospect of finding new drugs will lure Congress into increasing the center’s financing well beyond $1 billion.

Hopes of new money may be optimistic. Republicans in the House have promised to cut the kind of discretionary domestic spending that supports the health institutes, and officials are already bracing for significant cuts this year. But Dr. Collins has hinted that he is willing to cannibalize other parts of the health institutes to bring more resources to the new center.

“There are some people that would say this is not the time to do something bold and ambitious because the budget is so tight,” he said. “But we would be irresponsible not to take advantage of scientific opportunity, even if it means tightening in other places.”

For the plan to go into effect by October, the administration must by law get rid of one of the 27 centers and institutes already in existence at the N.I.H. — something that has never been done before. So the administration plans to downgrade the National Center for Research Resources, in part by giving some of its functions to the new drug center.

Researchers and staff members connected to the research resources center have inundated a complaint blog about the coming change. Mark O. Lively, a professor of biochemistry at Wake Forest University and a member of an advisory council to the research resources center, said that he could not understand why the administration was moving so quickly with its plans.

“And the N.I.H. is not likely to be very good at drug discovery, so why are they doing this?” Dr. Lively asked.

But Dr. Garret A. FitzGerald, a professor of medicine and pharmacology at the University of Pennsylvania, said the new center could inspire universities to train a new generation of investigators who could straddle the divide between academia and industry.

“It could be a really good idea,” he said.

Both the need for and the risks of this strategy are clear in mental health. There have been only two major drug discoveries in the field in the past century; lithium for the treatment of bipolar disorder in 1949 and Thorazine for the treatment of psychosis in 1950.

Both discoveries were utter strokes of luck, and almost every major psychiatric drug introduced since has resulted from small changes to Thorazine. Scientists still do not know why any of these drugs actually work, and hundreds of genes have been shown to play roles in mental illness — far too many for focused efforts. So many drug makers have dropped out of the field.

For Dr. Thomas R. Insel, director of the National Institute of Mental Health, the drug industry’s departure from this vital research area shows that the government must do something, although he acknowledges the risk.

“Would we be foolish — we being an agency that has never developed drugs and actually doesn’t know how to do therapeutics that well — to get into this space?” Dr. Insel asked.

But Dr. William Potter, who was once a top researcher at the mental health institute and retired last year as the vice president of translational neuroscience at the giant drug maker Merck, said that far more basic research needed to be done on the causes of mental illness before anyone — industry or government — could successfully create breakthrough drugs.

“We still don’t even understand how lithium works,” Dr. Potter said. “So how do people think we can find drugs systematically for mental illness?”   Source:, January 24, 2011

Editor, Nicole Perlroth’s Note: This post was written by Bryan Roberts, a PhD and partner at the venture capital firm Venrock, in response to House Republicans’ efforts to repeal the healthcare reform act, or the Affordable Care Act (ACA). What he has to say is worth your attention.]

Virtually everyone agrees that our healthcare system is unsustainable in its current form. The impact of escalating healthcare costs combined with mediocre value created for each dollar spent has finally entered the national consciousness.  Over the last 30 years, there have been amazing advances in our abilities to combat human disease and equally impressive innovation within information technology that has changed the way we live, yet there has been staggeringly little application of innovation to the efficiency of our healthcare system.

No one should be surprised by this situation.  Healthcare in America is provided, and paid for, by the transaction – per office visit, per surgery, per x-ray – with little visibility into performance, efficiency, quality or cost.  We pay for volume and, as in any industry, people who are paid by the widget will seek to produce more widgets at ever increasing prices. Why has it worked this way?  It is easier to measure transactions than outcomes.  Until recently, the system has lacked both the information technologies and political will to advance a better model.

Our simplistic, static and misaligned incentive system has succeeded at one thing in addition to gobbling up ever increasing amounts of US GDP: stifling creativity.  For years entrepreneurs have turned their attention to other challenges, and not unreasonably.  There has been no incentive for change in the system – patients did not pay; providers were driven by volume; employers were focused on other parts of their businesses.  So who would be compelled to adopt an entrepreneur’s innovation? No one. So they went on to create enormous advances, efficiencies and value in the internet, software and China to name a few.

The stage is now set for this all to change. A confluence of forces is propelling the healthcare information technology and services sector from an uninteresting backwater to a central topic of conversation in start-up and investment circles.  A major catalyst for this dramatic reversal has been the Affordable Care Act (ACA, aka “Healthcare Reform”).  Cutting through the political grandstanding, the ACA will create enormous new opportunities for entrepreneurship and innovation in healthcare.

Perhaps those in Congress who favor repeal of the ACA have not fully digested the law, or perhaps they don’t actually understand the demonstrated economic power of innovative technology start-ups over the last 30 years.  But from Silicon Valley, failure to wholeheartedly endorse, implement and nurture the ACA, and its downstream innovations, would be rescuing defeat from the jaws of victory.  The ACA encompasses multiple provisions designed to enable and nurture approaches that can shift the payment (and therefore incentives) of healthcare providers from “pay for volume” to “pay for value” approaches.  Examples of innovative approaches include:

  • Pay for performance programs: Providers can be financially rewarded for better outcomes in various situations such as reducing hospital errors and minimizing near-term hospital readmissions.
  • Accountable Care Organizations (ACO):  ACOs will launch in January 2012 and allow physician organizations and health systems to earn a significant share of any savings generated by more efficient healthcare delivery.
  • Healthcare market transparency: The ACA supports healthcare market transparency, including affording visibility into healthcare coverage options and healthcare provider quality performance.  As it represents 1/3 of the US insurance market, Medicare has long had a treasure trove of information on cost and quality in healthcare, but it was largely inaccessible until now
  • Center for Medicare and Medicaid innovation (CMMI): Funded with $10 billion to support the identification and testing of new models of payment and care delivery that will improve quality while reducing cost.
  • Streamlined rollout: The ACA gives the Secretary of Health and Human Services the power to adopt any new model validated by CMMI, so long as Medicare’s chief actuary certifies the model as improving quality while lowering costs or holding costs neutral.  Entrepreneurs can thereby foresee broad adoption of successful innovations without the historical roadblocks.

The net result of the ACA is a rising tide of innovation and venture creation that has the opportunity to save lives, save money, help transform our health system for the better and create many jobs. . Healthcare IT/services is gaining dramatic traction in the garages, dorm rooms and tree houses of talented, creative people who are seeking to create businesses to change the world because, at long last, there is a compelling business case to do so.  All of this, at a time when America is seeking every means possible to improve its economy, employment and global competitive advantage.

It would be a shame to repeal, or even diminish support for, the ACA and thereby derail the efforts, and potential success, of the one economic sector of the US that has outshone and outcompeted the rest of the world for 30+ years – our entrepreneurs.,, January 24, 2011, by Marilynn Marchione, HOUSTON —

She inspired the nation with her fairy-tale recovery. Now Rep. Gabrielle Giffords must inspire herself through the ordeal of rehabilitation, and doctors say it’s likely to be the hardest work she’ll ever do.

Just a couple of decades ago, rehab was little more than physical therapy for shuffling stroke victims and wheelchair-bound quadriplegics, a last resort after doctors had done all they could.

Now it’s a sophisticated science at the forefront of treating people like Giffords, who was shot in the forehead two weeks ago while meeting constituents in Tucson. An early start on rehab is key to limiting permanent damage, and the Houston hospital where she will be treated uses high-tech tools to push the brain to rewire itself.

The Arizona congresswoman arrived Friday at the Texas Medical Center, where she is expected to spend a few days in intensive care before moving to TIRR Memorial Hermann rehab hospital.

Instead of doctors making you well, rehab means “teaching you how to help yourself” to get your life back, said Dr. William Donovan, a former medical director of the rehab hospital who still works there part-time.

It’s frustrating when your muscles and mind won’t work the way you want them to. Emotional challenges, post-traumatic stress and physical problems like seizures, headaches and infections loom as risks that could complicate her recovery.

No one can predict how she will do, or what her “new normal” will be, as the hospital’s CEO, Carl Josehart puts it. A CT scan on arrival showed “really minimal” injury for the mortal wound she had, said Dr. Dong Kim, neurosurgery chief for University of Texas Health Science Center.

The type of bullet, its path, good trauma care and her general health before the injury bode well for her, but “a bigger impact on recovery is the amount of family and social support after the injury,” said Mark Sherer, a neuropsychologist at the rehab hospital.

After doing a head-to-toe mapping of her injuries and abilities, “we’ll have to figure out how to meet each and every deficit,” said Dr. Gerard Francisco, the hospital’s chief medical officer.

The first step: setting a goal, such as being able to live independently or to return to work or school.

“We try to tailor that to what’s realistic,” Josehart said.

His hospital is a modern, six-story, red-brick building with hacienda-style arches and signs with the “O” in Memorial Hermann made into a hopeful yellow sunburst. The rooms are standard hospital ones – no VIP suites, the doctors quip.

A large gym can treat 30 to 40 patients at a time with state-of-the-art equipment. There are therapy pools, treadmills with harnesses to help support weight and sophisticated recumbent bikes that send electrical signals to help muscles move.

A day’s stay costs several thousand dollars, and the hospital treats a mix of public insurance, private pay and uninsured patients. About two-thirds have brain injuries – everything from gunshot wounds to strokes – and most of the rest are spinal cord injuries.

“In the early days of rehabilitation – 20, 30 years ago – it was not uncommon for patients to be in a rehab hospital for a year,” Josehart said.

Now, three to six months is a very long stay, partly due to better treatments and new technology that allow more care to be given at home – portable lifts to help people out of wheelchairs, for example.

How does someone get better in rehab?

“Practice, practice, practice, and I’m not being facetious,” said Dr. Paul Schulz, a UTHealth neurologist who works at the hospital.

A patient having trouble speaking – as doctors suspect Giffords might – could be given a Ouija board and asked to form words on it. Or encouraged to sing what they are trying to say to a familiar tune like the ABC’s or Happy Birthday while tapping their fingers, said Dr. David Lacey, medical director of rehab services at Wake Forest University Baptist Medical Center.

That engages more body systems and encourages new connections and nerve growth, he explained.

“Sometimes you can break through the speech deficit by using the auditory pathway. They can get the word out rather than just thinking of the word and saying it,” said Lacey, who is not involved in Giffords’ care.

At the Houston hospital, therapists sometimes test cognitive function by showing patients the word “red” written in blue, and ask them to read the word. Impaired people often say “blue,” distracted by the color, and that can signal the need for training like flash card drills, Schulz said.

“You have to do it with a lot of empathy because you don’t want to frustrate the person,” he said. “A lot of times you say ‘very good’ even if it’s the not the right answer because you want to keep them motivated on the task.”

Computer games like Nintendo’s Wii can be used to enhance coordination, and as rehab progresses, patients can join basketball and hockey teams or do gardening and other hobbies. They go on field trips to the grocery story or the airport to practice going through security screening and boarding a plane.

Doctors hope Giffords will do all these things, but Lacey cautions:

“Very positive early recovery does not guarantee an excellent long-term outcome. It certainly puts her more in that category of people who are likely to do much better, but some patients can plateau and not progress much further.”

Mark Steinhubl wishes he could give Giffords advice. The 20-year-old was shot in the head two years ago in downtown Houston and had rehab at Memorial Hermann. He still can’t see out of one eye or hear out of one ear, but he can walk and talk and is a sophomore majoring in chemical engineering at Texas A&M.

“She needs to realize that it won’t be instantaneous like I thought it would be,” he said. “I felt like I was accomplishing something every day, meeting a benchmark.”

When he came into the rehab hospital on a stretcher, “I couldn’t even sit up,” Steinhubl said. When he left a month later, “I didn’t walk out, I ran out.”

By Kathleen M. Zelman, MPH, RD, LD

Most lists of nutritious super foods don’t include beet juice, but according to recent research it belongs right up there with salmon and blueberries. Beet juice deserves a spot on the list because it may boost stamina to help you exercise longer, improve blood flood, and reduce blood pressure.

Emerging studies suggest that beet juice (also known as beetroot juice) is one of the richest dietary sources of antioxidants and nitrates that may improve blood pressure and blood flow throughout the body, including the brain, heart, muscles, and more.

Role of Dietary Nitrates

Like most fruits and vegetables, beets contain nitrates and antioxidants that can have a beneficial effect on health.

Beet juice research is in its infancy, says Wake Forest researcher Gary Miller, PhD. “We are starting to unravel the intriguing health benefits of beet juice primarily because of dietary nitrates and its impact on blood flow and blood pressure,” Miller says.

Through a chain reaction, the body converts the nitrates in beet juice into nitric oxide, a compound that enhances blood flow throughout the body and helps lower blood pressure.

Beet Juice Promotes Heart Health and Blood Flow

A diet rich in beet juice may be a natural approach to help lower blood pressure and improve heart health. Nutrition experts have long recommended diets rich in fruits and vegetables to promote heart health and help lower blood pressure.

Although there is not a substantial amount of research on beets, a 2001 study showed the antioxidant nutrients may prevent oxidative processes that contribute to the onset of certain degenerative diseases, says John Cuomo, PhD, of Usana Health Sciences, which makes nutritional supplements. The study states that “red beet products used regularly in the diet may provide protection against certain oxidative stress-related disorders in humans.”

In other studies, drinking about two cups of beet juice daily or taking nitrate capsules reduced blood pressure in healthy adults, suggesting that dietary nitrates have a beneficial effect on blood flow and could be a natural approach to reducing the risk of heart disease.

Nitrates Boost Exercise Performance

Beet juice can also have a positive effect on the body during exercise. A recent study showed six days of beet juice enhanced overall physical performance and heart functioning during exercise.

In a 2009 study, researchers found nitrates enabled people to exercise up to 16% longer because of nitrates’ ability to reduce oxygen uptake, making exercise less tiring.

Eating beets won’t give you the same quantity of nitrates as beet juice because the cooking process deteriorates some of the nitrates, but it certainly is good for your health, says American Dietetic Association spokeswoman Marjorie Nolan, MS, RD.

Beets are a great source of nutrition. They’re rich in folate, potassium, vitamin C, fiber, antioxidants, and nitrates. The active ingredient in beet juice is an antioxidant called betanin.

One cup of raw beets has 35 calories and 8 grams of carbohydrates. A cup of beet juice is usually around 100 calories and 25 grams of carbohydrates because of added sugar.

Lots of fruits and vegetables are rich sources of antioxidants but not necessarily good sources of nitrates. In addition to beets, other good sources of dietary nitrates include spinach, radishes, lettuce, celery, and Chinese cabbage.

Nitrates are not routinely evaluated as part of a food’s nutrient composition. Therefore, the nitrate quantity of foods may be difficult to find in most nutrient databases.

Who Should Drink Beetroot Juice?

From athletes to the elderly, the benefits of beet juice could result in improved blood flow and enhanced performance. Part of the ongoing research is designed to determine who would benefit most from more beet juice and nitrates. Miller and colleagues at Wake Forest showed that blood flow to the brain improved in healthy elderly people, as measured by MRI.

“Healthy individuals are not likely to see tremendous benefits if they start adding beet juice to their diets, but foods high in nitrates are healthy foods and it might improve blood pressure and blood flow to key tissues like skeletal muscles, especially as you get older,” Miller says.

Nolan says as little as one cup of beet juice has dramatic effects and may be a natural alternative to blood pressure medication for some people and just 2-3 ounces per day can be a natural approach to preventing constipation.

Increasing blood flow to muscles benefits athletes but could be a huge advantage in the elderly to help improve muscle strength which in turn will reduce falls, fractures, and impairment associated with muscle weakness, Miller says.

Finding Beetroot Juice

Available at specialty stores, a 16-ounce bottle costs about $7. It has a distinctive flavor, much like beets, and tastes a little earthy. Nolan recommends blending the juice to make it more palatable.

If you start adding beet juice to your diet be prepared for the potentially alarming side effects of drinking ruby red beet juice. The powerful red dye is excreted in urine and stools, giving both a reddish appearance.

Further research is needed before experts recommend drinking large quantities of beet juice each day. In the meantime, a diet rich in fruits and vegetables has been shown to be a potent weapon against disease.

Kathleen Zelman, MPH, RD, is director of nutrition for WebMD. Her opinions and conclusions are her own.

Simple Beet Juice Recipe

Equipment – you need a vegetable juicer that you can buy from any health food store.

One small bunch of beets (3)

1 apple

Bunch of carrots (3)

Few stalks of celery (3)

Wash all of the above ingredients, well (use a veggie scrub brush).  Peel the beets, but not the other ingredients. Follow the directions that come with the vegetable juicer, and cut the above Ingredients into several large pieces, and push into the juicer to make the Juice.  Obviously, you can adjust the next juice to your taste.

Did you know……………..?

Reducing the need for diesel generators improves security and decreases the need for supply convoys

Kevin Bullis, 01/17/2011, MIT Technology Review

A U.S. Marine regiment in Afghanistan has used solar panels to reduce the amount of diesel it uses in generators from 20 gallons a day to just 2.5 gallons, according to a news report from the Marines.

“Our generators typically use more than 20 gallons of fuel a day. We are down to 2.5 gallons a day,” said [Staff Sergeant David] Doty, 3rd Squad Leader, with 1st Platoon, ‘I’ Company, and Fulton, Mo., native. “The system works amazing. By saving fuel for generators, it has cut back on the number of convoys, meaning less opportunity for one of our vehicles to hit an IED.”

The panels are used to recharge batteries for laptops, radios, and lighting. They’re part of a program called the Experimental Forward Operating Base (ExFOB).

According to Staff Sgt. Greg Wenzel, 1st Plt., platoon sergeant, this has helped PB Sparks’ security when the sun goes down. “It’s way more tactical not running the generators at night,” said the Altoona, Pa., native. “At night the noise of a generator can carry a long way, become a calling card for insurgents.”

“When we first got the gear, I was a skeptic. As Marines, we do not always like change. I expected ExFOB to be a burden,” added [Gunnery Sergeant Willy] Carrion, a native of Philadelphia. “Now that we are in theater, and we have so many [patrol bases] set up, we all see the how crucial and important renewable energy is. Every infantry battalion should have the ExFOB, it has proven to be an extremely valuable asset!”  Some experts have suggested that the military’s use of alternative energy, including solar panels and biofuels, can help lower costs by increasing the scale of manufacturing, helping these technologies compete with conventional sources of energy.

Some experts have suggested that the military’s use of alternative energy, including solar panels and biofuels, can help lower costs by increasing the scale of manufacturing, helping these technologies compete with conventional sources of energy.