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Will bloodmobiles soon be a thing of the past, like vacuum-tube televisions and glass milk bottles delivered daily?

More important: Will the use of embryonic stem cells, which became a heated issue during the 2004 presidential election, finally produce a breakout product? One that will squelch the controversy for all but a few die-hards who still prefer their milk in glass bottles?

Researchers at Advanced Cell Technology in Worcester, Massachusetts, announced the breakthrough a few days ago. Working with scientists from the Mayo Clinic in Rochester, Minnesota, and the University of Chicago, A.C.T.'s team says it has developed a method for making potentially unlimited and scalable supplies of synthetic blood from embryonic stem cells.

The findings are published in Blood, a scientific journal. A.C.T.'s chief scientific officer Robert Lanza led the team.

If the claim holds up to scrutiny, it would be a huge boon for humankind, which until now has had to collectively open its veins to provide tons of this basic stuff of life for people who need extra blood because of injuries, surgeries or disease.

The discovery also would remove the danger of blood being tainted by pathogens that cause hepatitis, H.I.V. and Creutzfeldt-Jakob disease, among other viruses and bacteria.

But will this promise become reality?

Advanced Cell Technology has made incredible claims before. Under recently departed C.E.O. Michael West—whom some critics compared with the circus promoter P.T. Barnum—the company routinely asserted that stem-cell therapies were likely to reverse the aging process and grow replacement body parts, while most scientists were talking a more cautious line.

The company was the first to clone an endangered species, an Asian bovine called a gaur, which died soon after—possibly from causes unrelated to the cloning. A.C.T. also claimed it had cloned the first human embryo, attracting worldwide attention, though the embryos grew to only a few cells in size.

Some blame the company's over-enthusiasm for playing into the hands of stem-cell opponents in the Bush administration and elsewhere who were bent on squelching this new therapy. President Bush severely restricted federal funding for stem-cell research in 2001—restrictions that remain today, and are likely to until the next administration takes office.

Under Lanza, the company may not have fulfilled all of the promises made by West, but it has produced a string of solid discoveries and observations—though none have proved to be commercially viable. Most recently, Lanza's team has also induced stem cells to grow into retinal cells in eyes.

Creating synthetic blood has proved difficult; decades of efforts have so far been in vain. Several potential products are being tested in human clinical trials, most of them focusing on the critical function that blood plays in transporting oxygen. Other products, however, have been abandoned when they either didn't work, or proved to have dangerous or deadly side effects.

Blood created by stem cells is very similar to the real thing, and may avoid the pitfalls with other, more artificial techniques. If further tests confirm A.C.T.'s discovery—and, critically, show that the process is scalable and affordable—stem-cell blood may make the company more attractive to investors as it desperately seeks cash to carry on.

In July, a filing with the Securities and Exchange Commission revealed that A.C.T. had $17 million in current liabilities, but only $1 million in cash and other current assets, the Boston Globe reported. A.C.T.'s stock has been trading at 6 cents per share, down from $8 per share three years ago.

It's hard to know what the new techniques will cost once scaled up, or what revenues the discovery will bring in; Lanza says that he expects the company to know within two years if the processes will work.

Independent scientists are hopeful that the discovery will pan out. "The problem with relying on donated blood is that there are always shortages," Professor Alex Medvinsky, a blood stem-cell expert at the University of Edinburgh, told the Times of London. "The ability to generate red blood cells in very large numbers would be a very big thing."

The worst time to find out you're highly allergic to something is when your throat suddenly starts to swell shut. Slow the onset of anaphylactic shock by delivering a quick injection of epinephrine as a first aid measure. Modern devices make it easy, but it's best to be prepared, so learn the basics now by following our guide.

For the first time, scientists have made blood from embryonic stem cells, potentially providing a limitless and safe source of transfusions.

Scientists say pinning down chronological age isn't possible, though some countries are trying to find biomarkers to aid in their juvenile justice systems.

Doctors might soon be able to regrow injured muscles, tendons and bones without invasive surgery, simply by injecting a person's own stem cells into the site of an injury. Veterinarians are already doing it with injured horses, and research into human applications is well under way.

The National Institutes for Health seem to think regenerating human muscle and bone using a person's own adult stem cells is nearly ready for prime time. Last week, the NIH announced to its staff that it's creating a bone marrow-stem cell transplant center within the NIH Clinical Research Center.

Researchers at the NIH labs in Bethesda, Maryland, are already growing human muscle, cartilage and spinal disks in vitro. The tissue isn't mechanically sound yet, says lead researcher Rocky Tuan, but that will come with further work.

"I have a piece of tissue that looks like a spinal disc, a sand bag, tough as nails on the outside and like sand on the inside," says Tuan, a Ph.D. and the senior investigator in the Cartilage and Orthopedics branch of the NIAMS. "The mechanical properties are lousy, but it's a beginning."

While the use of stem cells harvested from human embryos has been getting the most media attention, scientists and doctors have also been working with adult stem cells that also have the ability to become one with their environment and to replicate as cells of their adopted tissue. Using adult stem cells -- grown inside the body or in the lab -- has become accepted in the veterinary community, and horses have benefited greatly. Researchers are working to bring those same benefits to humans, but there are still hurdles left to clear.

The NIH project comes in part from what veterinarians have learned from injecting adult stem cells into valuable horses who've suffered injuries. In many cases, those horses' careers were saved when the stem cells regrew damaged tendons and ligaments.

Rodrigo Vazquez, a Southern California veterinarian, has been using adult stem cells to regrow damaged muscles in horses for several years. It's a fairly common procedure in the veterinary arena, and the results are impressive: One of Vazquez's patients is participating in this year's Olympics Dressage events; another is a prize-winning jumper.

The procedure is simple and straightforward. Inside a surgical suite at his equine hospital, Vazquez removes blood full of adult stem cells from the sternum of the anesthetized horse.

Then he rolls his stool to the other end of the horse, where ultrasound data has helped guide needles into the exact areas on the rear leg where the beautiful horse's ligaments are torn. He injects the stem cells into those spots.

"A few years ago, these injuries were career-ending," Vazquez says. Not any more. "In a month, the torn tissue will be completely regrown and healed."

Vazquez would like to put himself in his patients' place. He has had surgery several times for spinal injuries he incurred while lifting horses. Human medicine, unable to regrow or heal the injured spine, simply fuses the bone and tissue through a surgical procedure. At best, the surgery relieves some of the pain and restores some mobility. But it's not a true repair.

"I wish I could have had a procedure like this," Vazquez says of the treatment he gives horses. "This will lead to human treatments, but they can't move as fast as we can."

Tuan, who is using stem cells to cultivate experimental tendons and disks in his lab, thinks it's about time to look to treating humans.

An emerging body of scientific studies from all over the world -- including a cardiac study under way in Miami and a pediatric ACL (anterior cruciate ligament) study at the Harvard-affiliated Children's Hospital of Boston -- is showing that using a patient's own stem cells can prompt the growth of new muscle, from the knee to the heart. And the precursor step, using platelet-rich plasma for injuries, is on the verge of becoming mainstream.

Adult stem cells, particularly mesenchymal cells that come from muscle, bone and fat, are cells with a powerful ability to replicate and not a lot of personal identity. They easily take on the characteristics of surrounding cells and they tend to grow quickly once they get there. Ultrasounds of Vazquez's horses, for example, show regeneration of muscle in four to six weeks.

The final product is this cartilage-like tissue grown around the scaffolding by NIH scientists. Tuan says the tissue resembles the human version, but may not be mechanically sound -- yet.
Courtesy NIAMS

Adult stem cells can be found all over the body, in bone and marrow. Tuan says they're also found in tonsils and in the placenta and umbilical cord, which suggest that the discarded body parts can be stored for later use.

Because researchers are using autologous cells -- from the patient's own body -- the research is not controversial. No one has challenged the ethics or funding of adult stem cell research the way embryonic stem cell studies have been challenged. And because adult stem cells are native to the patient's own body, the chances of a patient rejecting them are slim to none.

Tuan and his team have been able to coach adult stem cells to form muscle and disks using goo from the small intestine and a polymer scaffold to tell cells how to grow. But, he cautions, the primitive structures aren't ready to go into humans.

"After a few weeks (of lab growth), it will turn into something that resembles a tendon, but it has to be the mechanical equivalent and we don't know that we're there," Tuan says. "Stem cells are very promising, but what they do for horses may not work so well for humans because humans are the hardest animal to rebuild."

Once they're perfected, Tuan sees a day when the tendons will change the dreaded surgery for torn anterior cruciate ligaments that sideline up to a quarter-million people in the United States and Canada every year.

"Often, that injury is a complete tear -- the ligament is snapped in two and the ends ball up and even if you untangle them and pull them together, they won't heal," he says. "So they take part of the patella tendon, which is short and tough, and stretch it and staple it to the bones. So not only is your ACL not working too well and you have to stretch it out, but your knee hurts like crazy."

"If we can learn to grow a tendon that works right, or figure out how to make the ACL heal back together, we can save a lot of people a lot of pain," he says.

In fact, doctors are already treating people with adult stem cells. Bone marrow transplants for cancer patients are basically stem cell therapy. But the marrow often comes from other people, and its primary purpose is to boost a weakened immune system, not to generate tissue.

And treating with platelet-rich plasma -- a blood product made by spinning a patient's blood in a centrifuge to concentrate the platelets -- is already in limited use and is becoming more widely accepted as a safe therapy. PRP is routinely used in cardiac surgery, where applying it to a cut sternum before closing has been shown to cut the infection rate in half. The plasma has growth factors that also promote healing.

"PRP helps recruit stem cells to the injury," says Dr. Allan Mishra, who has used PRP on its own and as part of surgery in sports injuries -- including treating tennis elbow and getting Stanford football player James McGillicuddy's patellar tendon to heal after his second surgery. "The body knows how to heal itself -- we're speeding up and concentrating the process."

Last year, Mishra wrapped up a study where he used platelet-rich plasma to treat the 20 worst tennis-elbow injuries he'd culled from more than 100 volunteers. "Ninety-three percent got better with a single injection and stayed better for two years," Mishra says.

The treatments are about one-tenth of the cost of surgery, or about $2,000 to $2,500, he says. The patient's blood is drawn, centrifuged by a specialist called a perfusionist, and injected, all in one visit. "I will guess that five years from now, insurance companies won't authorize surgery until the patient has tried and failed at PRP."

The obvious next step is to isolate the stem cells and send them to work, both inside and outside the body, researchers say. "PRP is reparative. Stem cells are regenerative," says Angela Nava, a perfusionist who processes both animal and human blood for PRP, stem cell and other procedures.

But getting from animals to humans is going to take a lot more research, according to Dr. Thomas Rando, an associate professor of neurology at Stanford University School of Medicine. Rando studies the body's signaling systems that tell stem cells what to do.

"We don't always know how stem cells, when injected into some tissues, work their magic," Rando said. "Veterinarians don't go back and study the horse's tendons to figure out what the stem cells did to promote healing."

"There are all kinds of ways stem cells could work. If we could understand how they are actually promoting better function of the tissue, we might be able to further improve their therapeutic effects," he adds.

Stem cell treatment is not without risks, researchers say. The worst-case scenario is that the stem cells could cause cancer -- or become cancerous themselves.

"You're putting in cells that want to grow. That has to be under control," Rando says. "Or we can end up with cancer."

Tuan also says that researchers don't entirely trust stem cells and their ability to adapt and grow.

"There's a nagging feeling that there's a cancer stem cell, that when it's agitated by exposure to carcinogens or radiation or something, it goes nuts, and that we can't identify it from the other stem cells," he says. "How do you find this bad boy and pull him out?

"And there's a nagging worry it's the same cell. We only know these cells by what they've done, and by the time they've become cancer, it's too late."

While the International Olympic Committee is busy trying to catch today's performance enhancers, athletes are already looking for the next big boost that will give them the edge in 2012.

Most of the positive doping tests in Beijing -- and the IOC president estimates there will be as many as 40 -- will likely be for steroids and the blood-boosting hormone erythropoietin, known as EPO.

But the future of doping could get a lot more complicated. Here are some of the most promising -- or threatening, if you're the World Anti-Doping Agency -- candidates for the next Olympics.

Use your genes to grow more muscle

Manipulating genes to block naturally occurring muscle-growth inhibitors could allow athletes to boost their muscle mass. A lot.

In tests on mice, blocking the protein myostatin gave the mice up to 60 percent more lean muscle mass. Even more promising, Johns Hopkins' Se-Jin Lee recently found that overproduction of one myostatin inhibitor pumps the mice up even more: up to 81 percent in females and a whopping 116 percent in males. Results of human clinical trials are pending.

Complicating the picture, particularly for WADA, is a small number of people with naturally inhibited myostatin who will have to be distinguished from the dopers somehow.

Pop a blood-boosting pill

Who wouldn't love a pill that delivers the same record-breaking benefits of synthetic EPO without the hassle of injections or getting caught?

Clinical trials are under way for a pill that tricks the body into thinking blood-oxygen levels have dropped, causing it to produce more red blood cells, thus improving muscle endurance.

When blood-oxygen levels drop, hypoxia-inducible factor, or HIF, kicks in to stimulate red blood cell production. Once oxygen is back to normal, the HIF breaks down and cell formation stops. The drugs, known as HIF stabilizers, stop the breakdown and keep blood production up.

Some suspect athletes may already be using HIF stabilizers, but the health risks are unknown.

Grow more blood vessels

If you don't mind injections directly into your heart and limbs, vascular endothelial growth factor may be for you. VEGF causes new blood vessels to grow, which in theory could move more oxygen and nutrients between muscles, lungs and the heart with less effort. So more effort could be expended on athletic performance. VEGF gene therapy could potentially help patients with heart and arterial diseases form new blood vessels, keeping them alive and avoiding amputation. But it's not a simple hack, and a failed gene-doping test isn't the only risk. Unregulated VEGF-induced vessel growth appears to also promote tumor growth and metastasis.

Feel less pain, get more gain

Athletes know how to suffer. Raise an athlete's pain threshold, and suffering will occur at a higher level of exertion.

Tests on rats suggest that injecting the beta-endorphin gene into spinal fluid through a spinal tap causes the body to release its own painkilling endorphins. Pain signals get blocked before they reach the brain, without the sleepiness and cloudiness associated with morphine and other painkilling opioids.

Raising an athlete's pain threshold may improve performance, but it may also cause them to ignore warnings of overexertion and injury.

Beef up specific muscles

Say you're a cyclist who wants powerful legs but a light upper body so you don't have to haul the extra weight when riding uphill. Or a tennis player who needs a bit more shoulder muscle. Injecting insulin-like growth factor, or IGF-1, into specific muscles sparks those muscles to grow while avoiding the full-body muscle growth usually associated with IGF-1. Physiologist H. Lee Sweeney at the University of Pennsylvania discovered this while looking for a treatment for muscle-wasting that avoids side effects from unwanted growth, such as cancer and heart enlargement. The targeted therapy may also make IGF-1 harder to detect in a doping test. Sweeney estimates that since his research was published, half of his e-mails are from athletes. He has worked with WADA, but others developing similar techniques may not.

Get more muscles, fewer zits

Want the muscle-building benefits of steroids without the testicle-shrinking, moob-growing, acne-popping side effects? That's the promise of selective androgen receptor modulators.

SARMs bind to specific tissues, such as muscle and bone. Unlike some steroids, they don't indiscriminately also bind to prostate, liver and other tissues. And SARMs come in a pill. No needles or skin patches.

These pills could be a boon to people suffering from muscle-wasting diseases and for athletes concerned about health risks associated with steroids. Sound too good to be true? Perhaps: A test to detect SARMs may be ready before the drugs are widely available. WADA won't tell until they catch an athlete.

Fill up with new blood substitutes

With EPO and blood transfusions increasingly detectable, athletes could return to blood substitutes for an extra hit of oxygen. Several athletes reportedly used substitutes in the past, and one cyclist may have almost died as a result.

Some new substitutes could have similar problems. A report in the Journal of the American Medical Association in April criticized blood substitutes such as PolyHeme and Hemopure for causing heart attacks and deaths in test subjects. But there are alternatives. Oxygen Biotherapeutics claims their experimental substitute, Oxycyte, carries oxygen 50 times more efficiently than natural blood without the risks of older substitutes. And Dendritech patented a blood substitute built from 3-D nanoparticles that the company builds in precise oxygen-carrying shapes. At least some blood substitutes may be easy to detect, but there are rumors the test isn't regularly used.

Take a next-gen EPO

At the Tour de France in July, Ricardo Ricco got caught using a new EPO-like blood booster, CERA, recently released by Roche.

Before CERA was on the market, the pharmaceutical giant cooperated with WADA to have a test ready to trap cutting-edge dopers like Ricco, a sign that WADA is catching up to, and perhaps even staying ahead of, dopers.

Or it's a sign that WADA needs help developing tests to detect each EPO variant, a tall order considering EPO and related drugs make up a $12 billion market. There are also dozens of EPO-stimulating agents available or in the works around the world.

Pump up your muscle fiber

Athletes already have more fatigue-resistant muscle fibers than couch potatoes. But new research shows they may be able widen that gap further by boosting levels of the gene responsible for adding new fibers.

Recently, researchers at the Salk Institute in San Diego found that an existing medication, called GW1516, raises the levels of this gene, resulting in a 68 percent endurance improvement in fit mice.

The Salk researchers are working with WADA on a test to detect use of GW1516. But several other drugs are known to manipulate the muscle-fiber genes, and others are believed to do the same. A test to detect this type of gene doping would need to cover a lot of uncharted territory.

Lastly, use mustard?

Athletes turned off by the latest biotech breakthroughs can try this recipe: Strip down and rub mustard oil all over your body.

While exploring the role skin plays in the production of red blood cells, Randy Johnson's team of researchers at UC San Diego found that rubbing mustard oil on mice caused spikes in natural EPO production, and that led to increased red blood cell levels.

It's unclear how much mustard oil a human athlete would need to enhance performance, or how much mustard oil could lead to strokes and heart attacks.

With all the crazy, complicated doping schemes out there could the journey to the top of the podium simply require a trip to the grocery store?

Scientists have reduced the drug-seeking behaviors of cocaine-addicted rats by disrupting the memories they associate with getting high.

1 Early hominids may have developed a sensitivity to UV rays for the good of the species. Based on a study using blood plasma, just an hour in direct sunlight could cause a 30 to 50 percent drop in folate levels — and low folate is linked to both abnormal sperm and birth defects. Good news for nerds: It's survival of the palest!

2 World War II sailors were early adopters of sunscreen. The zinc oxide they smeared on their noses served to reflect and scatter UV light. Today's lotions have added organic compounds that absorb UV energy and dissipate it as heat.

3 The sun isn't all evil. It stimulates your skin to produce vitamin D, and one study suggests that 1,000 IUs of D per day reduces your risk of certain cancers by up to 50 percent. But that's not a free pass to bake: More than 15 minutes of exposure daily over 40 percent of your body might just be an invitation to skin cancer.

Doctors in rural ERs use webcams to get expert opinions on stroke patients. A study says that this technology helps them make the right decision.

It "doesn't look like something you'd want dripping into your veins," wrote Wil McCarthy in the August 2002 issue of Wired. At the time, he had no way of knowing just how right he was about Hemopure, the artificial blood that seemed so promising. It was universally compatible and had a three-year shelf life (unrefrigerated). But a recent meta-analysis of trials on several substitutes — including Hemopure — contains some gory results. Turns out, the fake bloods scavenge nitric oxide, causing vasoconstriction; patients who get them are 2.7 times more likely to have a heart attack and 30 percent more likely to die. A Journal of the American Medical Association editorial has called for a halt to trials.

A government scientist reports that DNA taken from the bodies of people killed in the 2001 anthrax attacks helped lead investigators to Bruce Ivins, who oversaw the highly specific type of toxin in an Army lab.

Scientists say that a pill designed to mimic exercise's intracellular impacts increased the endurance of out-of-shape mice by 44 percent.

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Secretive and publicity shy, David E. Shaw made billions of dollars using fantastically complex computer algorithms to trade on Wall Street.

Now this former computer scientist at Columbia University-turned-tycoon is about to finish the most powerful supercomputer in history. Not to make a killing on the stock market, but to solve some of the trickiest problems in biology: How the molecules that comprise "life" function and interact at the most basic level.

It may seem like a James Bond movie: mysterious billionaire-genius designs megacomputer to probe life's secrets. Will he perhaps tinker with them, too, in a nefarious scheme to dominate the world by creating enhanced life forms or bio-silicon superbeings?

There's no sign that Shaw is going super-villain. Nor does he need to, considering the practical and potentially profitable uses for his megacomputer.

Knowing more about the complex interactions inside us could lead to better and more efficacious drugs, and to develop computer models that can simulate what happens even at the atomic level of life. It could lead to new ideas for developing computers and other machines based on cells and molecules.

Shaw's device, which he's named "Anton" in homage to pioneering microbiologist Anton van Leeuwenhoek, might also take humans several steps closer to having a schematic of how life works at its most elemental levels.

Several years ago, Shaw stepped down from the day-to-day management of his derivatives firm, D.E. Shaw and Company—which in June 2008 was managing upwards of $39 billion in investments.

He became chief scientist of his own computer laboratory, D.E. Shaw Research, home of the team making Anton.

Characteristically, Shaw has been mostly mum about Anton, referring the inquisitive to a technical paper on the project in the journal Communications of the Association for Computing Machinery.

His computer uses the massively parallel computing technology that Shaw helped develop at Columbia in the 1980s. Anton simultaneously runs 512 specialized processors called application-specific integrated circuits.

Unlike other supercomputers that have more general-use applications, including weather forecasting, these processors are specifically designed to calculate the three-dimensional characteristics of molecules.

Shaw's team could use Anton to solve one of the most perplexing mysteries of molecular life: how proteins, the building blocks of life, each acquire a distinctive three-dimensional shape that allows them to perform millions of functions in a living organism.

Proteins, which include enzymes, hormones, and the collagen in bones and skin, are made in cells according to instructions from DNA. They're strands of amino acids bunched up like wads of string into distinctive shapes and held together by subtle physical forces that are still poorly understood.

Current supercomputers, including IBM's BlueGene/L and Stanford University's Folding@home (which uses legions of idle laptops to increase computing power), can take thousands of hours to simulate the folding of a single protein. Even then, these computers can create simulations of functions in molecules that last only a billionth or a millionth of a second. Scientists must then validate the findings.

Anton could run simulations going up to 1,000 times longer, allowing scientists to get much closer to what really happens when, say, a protein folds. "If you can do a thousand times longer, real proteins come into play," Shaw reportedly said in a lecture at Stanford in 2006.

The more that scientists know about proteins and other critical molecules in the human body, the more precise they can be when developing drugs.

"He's making a big step forward with this," Benoit Roux, a biophysicist at the University of Chicago, told the New York Times.

Roger Brent, director of the Molecular Sciences Institute in Berkeley, California, suggested in the Times article that scientists may not know what such a powerful computer is capable of until they use it.

He pointed out that the original Anton—Van Leeuwenhoek, who perfected the microscope in Holland in the 17th century—didn't know that protozoa and other single-cell organisms existed in pond water until he trained his newfangled lenses on a sample.

Shaw also is a major investor in Schrödinger, a chemical and bio-physical simulation software business that could benefit from Anton's new technology.

Patients with early Alzheimer's disease who exercised regularly saw less deterioration in the areas of the brain which control memory, according to a study released Sunday at the 2008 International Conference on Alzheimer's Disease in Chicago.

George Church is dyslexic, narcoleptic, and a vegan. He is married with one daughter, weighs about 210 pounds, and has worn a pioneer-style bushy beard for decades. He has elevated levels of creatine kinase in his blood, the consequence of a heart attack. He enjoys waterskiing, photography, rock climbing, and singing in his church choir. His mother's maiden name is Strong. He was born on August 28, 1954.

If this all seems like too much information, well, blame Church himself. As the director of the Lipper Center for Computational Genetics at Harvard Medical School, he has a thing about openness, and this information (and plenty more, down to his signature) is posted online at arep.med.harvard.edu/gmc/pers.html. By putting it out there for everyone to see, Church isn't just baiting identity thieves. He's hoping to demonstrate that all this personal information — even though we consider it private and somehow sacred — is actually fairly meaningless, little more than trivia. "The average person shouldn't be interested in this stuff," he says. "It's a philosophical exercise in what identity is and why we should care about that."

As Church sees it, the only real utility to his personal information is as data that reflects his phenotype — his physical traits and characteristics. If your genome is the blueprint of your genetic potential written across 6 billion base pairs of DNA, your phenome is the resulting edifice, how you actually turn out after the environment has had its say, influencing which genes get expressed and which traits repressed. Imagine that we could collect complete sets of data — genotype and phenotype — for a whole population. You would very quickly begin to see meaningful and powerful correlations between particular genetic sequences and particular physical characteristics, from height and hair color to disease risk and personality.

Church has done more than imagine such an undertaking; he has launched it: The Personal Genome Project, an effort to make those correlations on an unprecedented scale, began last year with 10 volunteers and will soon expand to 100,000 participants. It will generate a massive database of genomes, phenomes, and even some omes in between. The first step is to sequence 1 percent of each volunteer's genome, focusing on the so-called exome — the protein-coding regions that, Church suspects, do 90 percent of the work in our DNA. It's a long way from sequencing all 6 billion nucleotides — the As, Ts, Gs, and Cs — of the human genome, but even so, cataloging 60 million bits multiplied by 100,000 individuals is an audacious goal.

The PGP stands as the tent pole of what Church calls his "year of convergence," the moment when his 30 years as a geneticist, a technologist, and a synthetic biologist all come together. The project is a proof of concept for the Polonator G.007, the genetic-sequencing instrument developed in Church's lab that hit the market this spring. And the PGP will also put Church's expertise in synthetic biology to use, reverse engineering volunteers' skin cells into stem cells that could help diagnose and treat disease. If the convergence comes off as planned, the PGP will bring personal genomics to fruition and our genomes will unfold before us like road maps: We will peruse our DNA like we plan a trip, scanning it for possible detours (a predisposition for disease) or historical markers (a compelling ancestry).

Bringing the genome into the light, Church says, is the great project of our day. "We need to inspire our current youth in a way that outer space exploration inspired us in 1960," he says. "We're seeing signs that knowing about our inner space is very compelling."

To Church, who built his first computer at age 9 and taught himself three programming languages by 15, all of this is unfolding according to the same laws of exponential progress that have propelled digital technologies, from computer memory to the Internet itself, over the past 40 years: Moore's law for circuits and Metcalfe's law for networks. These principles are now at play in genetics, he argues, particularly in DNA sequencing and DNA synthesis.

Exponentials don't just happen. In Church's work, they proceed from two axioms. The first is automation, the idea that by automating human tasks, letting a computer or a machine replicate a manual process, technology becomes faster, easier to use, and more popular. The second is openness, the notion that sharing technologies by distributing them as widely as possible with minimal restrictions on use encourages both the adoption and the impact of a technology.

#genome_table {font-size:95%;} #genome_table img {width:100px;height:100px;margin:9px 0px;} #genome_table .img_cell {text-align:center;} #genome_table .txt_cell {padding:12px 25px;} Inside the Personal Genome Project The project will turn information from 100,000 subjects into a huge database thath can reveal the connections between our genes and our physical selves. Here's how. — Thomas Goetz 1. Entrance Exam
Volunteers take a quiz to show genetic literacy. One question: How many chromosomes do unfertilized human egg cells contain? a) 11, b) 22, c) 23, d) 46, or e) 92? (Answer: c.) Only those with a perfect score proceed, but retests are allowed. 2. Data Collection
Volunteers sign an "open consent" form acknowledging that their information, though anonymized, will be accessible by others. They fill out their phenotype traits, listing everything from waist size to diet habits. Suitable respondents go on to the next step. 3. Sample Collection
Volunteers hit the medical center, where they are interviewed by an MD. Then a technician draws some blood, gathers a saliva sample, and takes a punch of skin. Don't worry: It hurts about as much as a bee sting. 4. Lab Work
The tissues are sent to a biobank, where DNA is extracted from the blood. One percent of it — the exome — is sequenced. Meanwhile, bacteria DNA is extracted from the saliva and sequenced to reveal the volunteer's microbiome. 5. Research
Now the fun part: Crunching the numbers. PGP scientists and other researchers start working with the data assembled from 100,000 individuals to investigate potential links between phenotypes and genotypes. The team will look for patterns and statistically significant anomalies. 6. Sharing
The volunteers get access to not only the raw data from their genome, but anything the research team gleans from their information. Insights — a newly discovered cancer risk, for example — are posted in a volunteer's file, which they'll be free to share with other PGP participants.

"I always tell people, your biggest problem in life is not going to be hiding your stuff so nobody steals it," Church says. "It's going to be getting anybody to ever use it. Start hiding it and that decreases the probability to almost zero."

For most of his career, Church has been known as a brilliant technologist, more behind-the-scenes tinkerer than scientific visionary. Though he was part of the group that kicked off the Human Genome Project, he's far less known than scientists like Francis Collins or J. Craig Venter, who took the stage at the end. His obscurity is due partly to his style. He talks about his accomplishments with a certain detachment that one might mistake for ambivalence. "He's not without ego; it's just a different sort of ego," says entrepreneur Esther Dyson, a friend and one of the first 10 PGP volunteers. "Everything is a subject of his intellectual curiosity, including himself."

His low profile may be the result of his tendency to get too far ahead of the curve, working a decade or two ahead of his field — so far that even the experts don't always get what he's talking about. "Lots of George's work is so advanced it's not ready to become standard," says Drew Endy, a professor of bioengineering at Stanford and cofounder with Church of Codon Devices, a synthetic-biology startup. "He's perfectly happy to spin out tons of ideas and see what might stick. It's high-throughput screening for technology and science. That's not the way most people work."

But thanks to the PGP, the Polonator, and the fact that the rest of the world is finally starting to understand what he's been talking about, Church's obscurity is coming to an end. He sits on the advisory board of more than 14 biotech companies, including personal genomics startup 23andMe and genetic testing pioneer DNA Direct. He has also cofounded four companies in the past four years: Codon Devices, Knome, LS9, and Joule Biosciences, which makes biofuels from engineered algae. Newsweek recently tagged him as one of the 10 Hottest Nerds ("whatever that means," Church laughs).

For someone who has spent his whole career ahead of his time, he is suddenly very much a man of the moment.

Most historians would cite Prague or Paris or Berkeley as the intellectual hub of the 1960s, but for people interested in computers, there was no place so significant as Hanover, New Hampshire. There, at Dartmouth College, an experiment in time-share computing was flourishing. Developed by professors John Kemeny and Thomas Kurtz, the Dartmouth Time-Sharing System let students remotely access the power of a mainframe computer to do calculations for mathematics or science assignments or to play a simulated game of college football. It ran on an easy-to-learn, intuitive program that Kemeny and Kurtz called Basic.

In 1967, the DTSS transitioned to a more-powerful GE-635 machine and offered remote terminals to 33 secondary schools and colleges, including Phillips Academy, a prep school in nearby Andover, Massachusetts. The terminal — not much more than a teletype machine, really — sat in the basement of the school's math building, forgotten until the next fall, when a young George Church showed up for his freshman year and began asking whether there was a computer on campus. Someone pointed Church to the basement. "There wasn't even a chair in the room. I had used a typewriter before, but never a teletype. And so I just started pressing keys," Church recalls. "Eventually I hit Return, and it came back with 'What?' And so I started typing in stuff like crazy and hitting Return. And it kept coming back with 'What?' At that point, I was pretty convinced it wasn't a human, but it was actually talking in words. So I just hadn't asked the right question or given the right answer."

Soon, Church found a book on Basic. "I was just sailing," he says. He spent endless hours in that basement — he eventually borrowed a chair — and taught himself the intricacies of coding, learning to program in Basic, Lisp, and Fortran. Indeed, thinking in code came so naturally to Church that he stopped going to his classes (a habit that would later get him kicked out of graduate school at Duke) and taught the computer linear algebra instead.

It turns out that learning how to write code — change it, hit Return, see what it will do — was ideal training for Church's eventual career in computational biology. "That's how we reverse engineer things like E. coli — you change something, and you see how it behaves," he says. "Little did I know that 30 years later, we would use almost exactly the same operations to optimize metabolic networks."

Church first hit on the power of computation to automate biology in the mid-'70s when he was in graduate school at Harvard. At the time, he was working on recombinant DNA, a then-new technique to splice a gene from one organism into another. Identifying a sequence of 80 or so base pairs of genetic code was a slow, tedious process. "You had to literally read off the bases and write them on a piece of paper, one by one," Church says. "So I wrote a sequence-reading program that would crunch it out. When the senior graduate student heard I had automated that, he said, 'What do you want to do that for? That's the only fun part.'"

By 1980, when Church's adviser, Wally Gilbert, won the Nobel Prize for DNA sequencing techniques, the process was still slow and expensive, executing one DNA strand at a time. So Church began working on one of his earlier targets for automation. His idea was to sequence several strands together by combining them into a single sample mixture. He called it multiplexing, drawing an analogy to signal multiplexing in electronics, in which more than one signal flows through a current at the same time. Church thought most of the work could even be integrated into one device rather than numerous machines.

It was a provocative idea, not just because he was substituting several human tasks for machine-driven ones, but also because he didn't make the usual false promise that technology would simplify the process. On the contrary, multiplexing would be complicated, Church maintained. But technology was up to the task.

Four years later, Church was invited to present his work on multiplexing at a small meeting in Alta, Utah. The Department of Energy had gathered about 20 scientists to mull over one question for five days: How might recent advances in genetics be used to measure an increase in genetic mutations arising from radiation exposure, as in Hiroshima? The group quickly reached the conclusion that technology circa 1984 couldn't answer that question. Meanwhile, they still had several more days in the mountains. "There were a bunch of us there who could talk about genomics as if it were an engineering exercise. And then we said, well, as a kind of booby prize, we could think of other things you could do," Church recalls, "like, say, sequencing the human genome."

Though Church was almost entirely unknown before the meeting, his presentation on multiplex sequencing methods stole the show. When he fell into a huge snow drift during a break one afternoon, one participant worried that the future of sequencing had disappeared with him.

That Alta brainstorm would become the Human Genome Project — the effort, adopted by the National Institutes of Health, to sequence one human genome for $3 billion within 15 years. However audacious the HGP seemed, Church was disappointed by it almost from the start. "We could have said our goal was to get everybody's genome for some affordable price," he says, "and one genome would be a milestone" on the way toward that goal.

The HGP also played it safe with its choice of technology. Despite the promise of Church's multiplexing system, the HGP instead used a more established instrument manufactured by Applied Biosystems, based on a technique developed by biochemist Frederick Sanger. As Church saw it, this meant that the project had failed to put its $3 billion toward improving the state of the art. Even worse, the HGP consumed so many of the resources available to the field of genetics that it effectively locked that state of the art into 1980s technology.

The result was nearly two decades of inertia. It wasn't until 2005, when the Human Genome Project was complete and new goals were put forth, that Church finally perfected the multiplexing approach he had presented 20 years earlier at Alta. In a paper published in Science, Church demonstrated a technique that could analyze millions of sequences in one run (Sanger's method could handle just 96 strands of DNA at a time). And Church's method not only accelerated the process, it made it far cheaper, too, elegantly demonstrating the power of automation to drive exponential advances and bring down costs. Church's approach, and a competing innovation developed by 454 Life Sciences that same year, inaugurated the second generation of sequencing, now in full swing.

In the past three years, more companies have joined the marketplace with their own instruments, all of them driving toward the same goal: speeding up the process of sequencing DNA and cutting the cost. Most of the second-generation machines are priced at around $500,000. This spring, Church's lab undercut them all with the Polonator G.007 — offered at the low, low price of $150,000. The instrument, designed and fine-tuned by Church and his team, is manufactured and sold by Danaher, an $11 billion scientific-equipment company. The Polonator is already sequencing DNA from the first 10 PGP volunteers. What's more, both the software and hardware in the Polonator are open source. In other words, any competitor is free to buy a Polonator for $150,000 and copy it. The result, Church hopes, will be akin to how IBM's open-architecture approach in the early '80s fueled the PC revolution.

In the sequencing game, though, the cost of the machine is only half the equation. The more telling expense is the operating cost, particularly the cost of sequencing entire human genomes. Executives at 454 estimate that their latest machine can pull off a whole genome sequence for $200,000. Applied Biosystems claims its instrument has completed a genome for just $60,000. Church maintains that, while the Polonator isn't up to whole-genome reads, it is clocking in at about one-third the cost of Applied Biosystems' estimate. A whole sequence from Knome, the retail genomics firm cofounded by Church, goes for $350,000. (It's worth noting that these figures are only roughly comparable, since each company uses slightly different quality measures and specifications.)

As these numbers continue to drop, the mythical $1,000 genome comes ever closer. Sequencing a human genome for $1,000 is the somewhat arbitrary benchmark for true personalized genomics — when the science could become a component of standard medical care. An important catalyst in achieving that point is the Archon X Prize for Genomics, which is offering $10 million to the team that can sequence 100 complete genomes in 10 days for less than $10,000 each. As of June, seven teams, including Church's lab, had entered the competition. Church, who served for a time on the advisory board of the contest, says that the prize will drive costs down further and help publicize the potential of personalized whole-genome sequencing.

That's important because Church hopes the Polonator and other next-generation instruments will inspire a new generation of smaller labs to begin work in personal genomics, as well as other genetic sciences. Already, the onslaught of technology has jump-started new projects, like sequencing part of the Neanderthal genome, examining extremophile microbes in old California iron mines, and studying the regenerative properties of the salamander. In medicine, cheaper sequencing has enabled research into drug-resistant tuberculosis; the genetics of breast, lung, and other cancers; and the DNA architecture of schizophrenics.

But if the Polonator is going to lead that charge, it has to work — and work on a massive scale. And that means passing a major test: successfully sequencing the 100,000 exomes in the PGP.

Photo: Lloyd Ziff

All of us know our height, weight, and eye color. Fewer of us know our arm span or resting blood pressure. But who among us knows the direction of our hair whorls or the Gell-Coombs type of our allergies? This is the level of detail that the PGP requires the 100,000 volunteers to reveal about themselves, a list staggering in its exhaustiveness. The PGP will tally head circumferences, injuries, chin clefts and cheek dimples, whether volunteers can roll their tongues or hyperflex their joints, whether they dislike hot climates or are hot tempered, if they've often been exposed to power lines or wood dust or diesel exhaust or textile fibers. The project questionnaire asks how many meals they eat a day and whether they prefer their food fried, broiled, or barbecued. It even demands to know how much television they watch. And, of course, PGP volunteers will hand over most aspects of their medical history, from vaccines to prescriptions.

This phenotype data will be integrated with a volunteer's genomic information, then combined with statistics from all the other subjects to create a potent database ripe for interrogation. In contrast to the heavy lifting that genetic research requires now — each study starts from scratch with a new hypothesis and a fresh crop of subjects, consent forms, and tissue samples — the PGP will automate the research process. Scientists will simply choose a category of phenotype and a possible genetic correlation, and statistically significant associations should flow out of the data like honey from a hive. A genetic predisposition for colon cancer, for instance, might be found to lead to disease only in connection with a diet high in barbecued foods, or a certain form of heart disease might be associated with a particular gene and exposure to a particular virus. Genomic discovery won't be a research problem anymore. It'll be a search function. (This helps explain why Google, among others, has donated to the project).

The process began last year, and each of the first 10 volunteers has a background in medicine or genetics. They include John Halamka, CIO of Harvard Medical School and a physician; Rosalynn Gill, chief science officer at Sciona (a personalized genetics nutrition company); and Steven Pinker, the noted psychologist and author. The other 99,990 participants won't be expected to be so elite, though they will have to pass a genetics-literacy quiz to demonstrate informed consent. The general selection process, which starts with registration at personalgenomes.org, is scheduled to begin later this year.

Besides offering up their genomes, subjects will have to part with some spit and a bit of skin. The saliva contains their microbiome — the trillions of microbes that exist, mostly symbiotically, on and in our bodies. If phenotype is a combination of genotype plus environment, the microbiome is the first wash of that environment over our bodies. By measuring some fraction of it, the PGP should offer a first look at how the genome-to-microbiome-to-phenome chain plays out.

The skin sample goes into storage, creating what would be one of the world's largest biobanks. Members of Church's lab have devised a way to automate turning the skin cells into stem cells, and they hope to publish the technique later this year. (Similar work has been done at the University of Wisconsin and Kyoto University.) By reprogramming the skin cells using synthetically engineered adenoviruses, Church's team can transform the skin cells into many sorts of tissue — lungs, liver, heart. These tissues could be used as a diagnostic baseline to detect predisposition for various diseases. What's more, the reprogrammed cells could be used to treat disease, replacing damaged or failing tissue. It's an intriguing hint of how Church's work with synthetic biology complements genomic sequencing.

If the PGP were simply an exercise in breaking down 100,000 individuals into data streams, it would be ambitious enough. But the project takes one further, truly radical step: In accordance with Church's principle of openness, all the material will be accessible to any researcher (or lurker) who wants to plunder thousands of details from people's lives. Even the tissue banks will be largely accessible. After Church's lab transforms the skin into stem cells, those new cell lines — which have been in notoriously short supply despite their scientific promise — will be open to outside researchers. This is a significant divergence from most biobanks, which typically guard their materials like holy relics and severely restrict access.

For the PGP volunteers, this means they will have to sign on to a principle Church calls open consent, which acknowledges that, even though subjects' names will be removed to make the data anonymous, there's no promise of absolute confidentiality. As Church sees it, any guarantee of privacy is false; there is no way to ensure that a bad actor won't tap into a system and, once there, manage to extract bits of personal information. After all, even de-identified data is subject to misuse: Latanya Sweeney, a computer scientist at Carnegie Mellon University, demonstrated the ease of "re-identification" by cross-referencing anonymized health-insurance records with voter registration rolls. (She found former Massachusetts governor William Weld's medical files by cross-referencing his birth date, zip code, and sex.)

To Church, open consent isn't just a philosophical consideration; it's also a practical one. If the PGP were locked down, it would be far less valuable as a data source for research — and the pace of research would accordingly be much slower. By making the information open and available, Church hopes to draw curious scientists to the data to pursue their own questions and reach their own insights. The potential fields of inquiry range from medicine to genealogy, forensics, and general biology.

And the openness doesn't serve just researchers alone. PGP members will be seen as not only subjects, but as participants. So, for instance, if a researcher uses a volunteer's information to establish a link between some genetic sequence and a risk of disease, the volunteer would have that information communicated to them.

This is precisely what makes the PGP controversial in genetics circles. Though Church talks about it as the logical successor to the Human Genome Project, other geneticists see it as a risky proposition, not for its privacy policy but for its presumption that the emerging science of genomics already has implications for individual cases. The National Human Genome Research Institute, for example, has cautioned that the burgeoning personal-genomics industry, which includes research-oriented projects like the PGP as well as straight-to-consumer companies like Navigenics and 23andMe and whole-genome-sequencing shops like Knome, puts the sales pitch ahead of the science. "A lot of people would like to rapidly capitalize on this science," says Gregory Feero, a senior adviser at the NHGRI. "But for an individual venturing into this now, it's a risk to start making any judgments or decisions based on current knowledge. At some point, we'll cross over into a time when that's more sensible."

Church cautions, however, that keeping clinicians and patients in the dark about specific genetic information — essentially pretending the data or the technology behind it don't exist — is a farce. Even worse, it violates the principle of openness that leads to the fastest progress. "The ground is changing right underneath them," he says of the medical establishment. "Right now, there's a wall between clinical research and clinical practice. The science isn't jumping over. The PGP is what clinical practice would be like if the research actually made it to the patient."

In the not-too-distant future, Church says, hospitals and clinics could be outfitted with a genome sequencer much the way they now have x-ray machines or microscopes. "In the old books," Church says, "almost every scientist was sitting there with a microscope on their table. Whether they're a physical scientist or a biological scientist, they've got that microscope there. And that inspires me."

Wired deputy editor Thomas Goetz (thomas@wired.com) wrote about personal genomics in issue 15.12.

The director of the University of Pittsburgh Cancer Institute issues an unprecedented warning to faculty and staff Wednesday: Limit cell phone use because of the possible risk of cancer, especially for children. The advice is contrary to many studies, but Dr. Ronald B. Herberman says he's basing his alarm on early, unpublished data.

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Trevor Foltz was six months old last fall, fresh off a visit to Disney World in Orlando, when the spasms first began.

Healthy until that point in his life, he began thrusting backward in his car seat, repeatedly and forcefully, as he rode with his parents north toward home in Rhode Island. "I thought it was temper tantrums," says his mother, Danielle. The next day, at home, Trevor was hit with a series of 40 convulsions and rushed to the hospital, where he was diagnosed with infantile spasms, a rare form of epilepsy. Treatment would cost $1,600 per vial of steroid drug H.P. Acthar Gel, and Trevor would need three of them.

As if the idea of a $4,800 tab wasn't bad enough, when the Foltzes submitted their claim, they found out the company that made the drug, Questcor Pharmaceuticals, had just recently jacked up the price—to $23,000 per vial, or $69,000 for a three-vial treatment—and the insurance company wasn't going to pay. And all the while, unbeknownst to anyone at that time, an alternative, for $15, existed.

On Thursday, the Joint Economic Committee will open hearings in Congress on dramatic price hikes for drugs used to treat children, with a focus on companies such as Questcor and Ovation Pharmaceuticals, which in 2006 bought rights to a drug that treats heart problems in premature infants, and increased the price 1,800 percent to $1,875 per three-vial treatment.

"We need answers to why a company would increase the price of a drug 18-fold when costs related to marketing, physician education, and research appear stable," says hearing chair Amy Klobuchar, a Democratic senator from Minnesota.

Politicians say they are not opposed to drug companies earning strong returns on the costs of researching innovative drugs, and understand the high prices of many medications. But they are investigating whether some companies are price-gouging, concerned more about executive stock options than about running innovative companies.

Some of those drugs, like Questcor's, are decades-old drugs that were bought on the cheap and redesignated under the federal government's Orphan Drug Act, which marks its 25th anniversary this year. Not infrequently, the drugs' new owners pass on big price hikes to consumers.

At Questcor, the increase is explained as the cost of doing business with an orphan drug.

"The company was heading toward bankruptcy," says Steve Cartt, executive vice president for business development at Questcor, which is based in Union City, California, an industrial enclave on San Francisco Bay.

"The whole rationale for the price increase was to ensure availability of the product," says Cartt. "We talked to physicians. They wanted the drug to be available. The choice was risk of availability or a price increase."

Originally approved for multiple sclerosis in 1952, Acthar Gel had been owned by pharma giant Aventis, which was losing money on it, when the 11-year-old Questcor acquired it in 2001. Questcor, too, failed to gain traction with M.S. patients, so it sought a new track.

Now the gears at Questcor began to turn more quickly. It won orphan designation for Acthar Gel in 2003, and proceeded to the next step: getting F.D.A. approval to market the drug explicitly for infantile spasms, which under the orphan act would also include a seven-year monopoly for Questcor. The company prepared for a marketing blitz and doubled its sales force early last year. But when the F.D.A. rejected Questcor's application in May 2007, the company quickly slashed its staff and jacked up the price.

Cartt says the price was set "within the range of other orphan drugs," noting that many others go from $50,000 to $500,000 a year or higher. For instance, BioMarin, an orphan-drug specialty company, charges $70,000 a year for Kuvan, a drug to treat phenylketonuria, a genetic enzyme disorder that can cause mental retardation and brain seizures. But unlike BioMarin, which spends 64 percent of sales on research and development, Questcor spends very little; in 2007, Questcor's research and development accounted for 9.5 percent of sales revenue.

What other considerations played into the price Cartt would not say. Sales for 2007, when the price hike took effect, were $49.7 million, and net income was $37.5 million—a net profit margin of 75 percent. It was significant not only for its size, but also because it was the first profit since the company was formed, as Cypros Pharmaceuticals, in 1990.

Investors were pleased, driving up Questcor's share price from 40 cents to over $6 after the August 2007 price hike. But executives at the company started selling their shares in December, seven months after the former C.E.O., James Fares, stepped down and around the time Questcor executive Don Bailey took his place. Since December, Cartt himself has sold shares based on grants and options totaling $1.68 million; many of those options were granted at 46 cents a share. He holds nearly a million more options on Questcor stock.

Doctors were unhappy with the price hikes.

"Most of us in the child-neurology community were outraged at the extent of the price hike, unusual even for orphan drugs," says Eric Kossoff, a pediatric neurologist and infantile spasms expert at Johns Hopkins Children's Center. "Most of us had no choice, unfortunately. At the time it was felt to be the best drug out there, and they're the only company that makes it. This is an incredibly serious form of epilepsy with devastating implications if not treated."

Curiously, though, he found that the price hike "was one of the best things that could have happened." Why? "Because we found something better and cheaper." Far cheaper, it turns out. "We spent a few days going through all the medical literature, looking for what works, what doesn't."

The team turned up a study from the United Kingdom that gave infants high doses of prednisolone, a well-known, generic steroid. Prednisolone had been dismissed as relatively ineffective for infantile spasms-based research that used low doses. The high doses made all the difference: The British study found efficacy rates reached 70 percent and more. Johns Hopkins began using high-dose prednisolone and found it worked in about 70 percent of cases, on par with the hospital's experience with Acthar Gel. And the price was $15 per injection—essentially free—compared with the three-injection $69,000 treatment from Questcor. "It was like in times of war. You get focused, and amazing things come out," Kossoff says. "We don't use [Acthar Gel] at Hopkins anymore for infantile spasms because the oral steroids [high-dose prednisolone] work just as well."

It's unclear, though, how many other doctors and hospitals in the U.S. will switch from the $69,000 drug to the $15 drug.

"I don't understand what's behind the price increase," says Finbar O'Callaghan, a pediatric neurologist at the Bristol Royal Hospital for Children and coauthor of the United Kingdom Infantile Spasms Study, or UKISS. The study showed that high-dose prednisolone and a synthetic form of ACTH, the active hormone in Acthar Gel, were equally effective. He cautioned that the purpose of the study was not to compare the two, but to compare steroid treatment with another drug called vigabatrin. "Having said that, you couldn't get a piece of paper between the results of the prednisolone and the results of the ACTH."

Costs aside, Hopkins is achieving the same results against Acthar Gel. "There is no reason to favor one over the other, unless there is a financial reason for doing so. That's been a big issue in the U.S.," says O'Callaghan. Comparing $15 against $69,000 "puts a different perspective on it," he says.

"Historically, and unfortunately," he adds, "doctors in general are very traditional and tend to use what's worked before."

Asked about the $15 price on prednisolone, Cartt said studies from the 1990s show low efficacy rates for the drug. When informed that those studies looked at low doses, not high doses, Cartt said no one knows the long-term implications of high-dose prednisolone, and said the company's higher profits will help it find out. "We can afford to study the long-term effects" of Acthar Gel and the alternatives, he said.

What the congressional hearing may find is that Questcor had a business problem: While its drug had a potential market of 300,000 multiple sclerosis patients, not enough of them were buying. But among a smaller market, just 2,000 babies per year, Acthar Gel was extremely effective in fighting infantile spasms. Questcor's astronomical rates may simply be a matter of hard business realities in a small potential market.

For the Foltzes, Questcor's high prices proved irrelevant, after much struggle. When at first his insurance company, WorldWide Insurance, rejected the claim, Trevor's doctor faxed in a letter stating that there was a good chance Trevor would end up mentally retarded for life without treatment; the insurer relented. But on Thursday, his mother, Danielle, will join those who testify against companies like Questcor. She says, "I feel they're going to soak every penny if they can get it."

A once-ubiquitous symbiotic intestinal microbe, H. pylori, is now found in just one-fifth of young Americans, thanks to antibiotics. Its disappearance may be linked to a rise in asthma rates, researchers suggest.

Climate change won't just spread contagious disease: It'll cause more kidney stones.

What's more refreshing than a waterfall on a hot Brooklyn day? How about four? In one of the most expansive public art projects in New York City's history, artist Olafur Eliasson has constructed four giant waterfalls around the East River made out of scaffolding and water pumps. The installation will be up through the end of the summer, and we want to see photos from our readers who pay the sites a visit.

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