How women can empower their retirement

Fidelity Viewpoints — 06/28/11

Why taking an early and active role can be key to financial success.

Saving for retirement can be a daunting task for the average American, but for half the population—women—it can pose even more challenges. Why? Because women tend to live longer, save less, and not be as engaged as men when it comes to retirement and financial planning. But women who take an active role in their finances can overcome the odds and feel potentially more confident about their financial future.

“It’s especially important for women to engage in and prepare for retirement,” says Kathy Murphy, president of Personal Investing at Fidelity Investments. “Women often haven’t saved enough—especially if they have taken time out of the workforce to raise a family or care for an aging parent. Therefore, they need to carefully consider how they will live in and pay for their retirement years. I strongly believe every woman needs to be informed, involved, and prepared for retirement. Women cannot afford to take a backseat when it comes to this important financial issue.”

Getting more involved in financial planning at any age, whether you are working with a spouse, never married, divorced, or widowed, is a positive step toward a rewarding retirement.

Let’s take a closer look at some of the key issues that have been proven to affect women more than men, and some steps you may want to consider taking.

Consider longevity and lifestyle

Women live longer than men — Women generally live longer than men, three years more, in fact. Currently, there are  six million more women than men ages 65 and over in the United States.¹ So planning for a lengthy and financially healthy retirement, one that could last 30 years or more, is crucial.

By taking an active role in your finances now, you can help ensure that you will have a reliable income stream that can help support your anticipated spending habits, housing needs, and leisure activities throughout retirement. Once you have an idea of how and where you want to live in retirement, you’ll want to reexamine your portfolio on a regular basis. Your desired future lifestyle may have a direct effect on the types of investments you consider to help build a reliable income stream. Read: Turning into retirement.

Women often live alone — Because women tend to live longer, they are likely to outlive their spouses and spend considerable time alone in retirement. Today, 57% of American women 65 or older are single, compared with just 26% of elderly men.² There may be additional financial burdens that come with living alone, such as paying all the bills yourself, caring for your home, paying for long-term care, or moving to an assisted living facility.

Take action:

• Having a solid income plan in place may help ensure a steady stream of reliable income. To learn more about how to structure your retirement portfolio, see our online education center
• Speak to your family members and loved ones about how and where you want to live in retirement, and document your desires so your wishes are known should you become incapacitated. You may also want to start or revisit your estate plan.

Factor in saving and investing

Women save less than men — Unfortunately, because of historical work patterns and lower income levels, women are likely to enter retirement with fewer resources than men. Despite some progress in recent years, women still earn significantly less than men in almost every occupational classification. Full-time, working women earn 77 cents for every dollar a man earns, according to the latest Census Bureau statistics.³ However, there is encouraging news here. According to Ecommerce Journal, working women in their 20s have now closed the wage gap and are earning as much as men, and those who remain single earn more throughout their lives than men.

Women do need to have a realistic view of how their retirement savings opportunities can be impacted should they decide to work part-time or leave the workforce for any length of time to care for children or aging family members. First, women who continue to work part-time for an employer that offers a retirement plan are less likely to be vested if they are covered.⁴

Second, of the 62 million wage and salaried women (age 21 to 64) working in the United States, just 45% participate in a retirement plan.⁴  And women's average defined contribution plan balances are only 60% of men's average balances.⁵ All these factors mean many women have not saved enough in their plan and need to consider stepping up their contributions whenever possible.

Women tend to be more conservative investors — Many women tend to gravitate toward conservative or “safer” investments, which is often a knee-jerk reaction to the investing process.⁴ If you haven’t done so already, learning more about the importance of long-term growth for your retirement portfolio, the relationship between risk and reward, the benefits of diversification and ongoing portfolio rebalancing, and the importance of tax-advantaged investing may be a great way to help ensure that your portfolio is balanced appropriately and is geared toward meeting your financial needs.

Be sure to track income sources — How much have you saved in your workplace savings plan? Are you aware of how and when to take Social Security? Do you understand survivor benefits should your spouse pass away? Are you entitled to a pension? Do you know if you are eligible for a portion of your husband’s pension or Social Security benefit if you are divorced or widowed? Being aware of all income that is due to you and how to distribute it in a tax-efficient manner is a key component of retirement success. Read: Social Security tips for couples and Social Security tips for singles.

Consider a retirement income plan — Given women’s longer life spans, it’s important to think about putting your own retirement income plan into place so that you don’t outlive your retirement income sources. Perhaps you never married, or are divorced or widowed. You need to know exactly how much income you can count on each month and where the sources will come from. Be sure to discuss your plan with your investment professional.

Take action:

• Consider maximizing your retirement savings through automatic investing in your workplace savings plan. In addition, consider making catch-up contributions after age 50.
• Confirm that your investment mix is aligned with your short- and long-term financial goals. Your Fidelity investment professional can help you plan appropriately.

Put the power of knowledge to work

Women often lack investing confidence — Many women say they don’t feel fully secure about making financial decisions. According to a recent Fidelity study on couples’ behavior,⁶ wives are much less confident (85%) than husbands (96%) when asked if they could assume full financial responsibility of their retirement finances, if necessary. At the same time, more wives are concerned about being financially prepared if their spouse passes away first (23% vs. 6% of husbands.) Be sure to cover any and all investing questions with your investment professional. Make a list of questions before your visit and ensure they get answered.

Be prepared for the unexpected — Be prepared for potential threats that could jeopardize your financial security. This includes the risk of serious illness or disability, the threat of inflation or increasing tax liabilities, a sudden market downturn, and the risk of poor investment decisions or inappropriate risk management, to name just a few. Having an emergency fund and proper insurance can help. Likewise, proper asset allocation is critical, particularly during times of extreme market expansion and contraction, as asset classes grow at different rates and lose value at varying levels. Being prepared also means knowing where critical documents are kept and what you would need to do if a spouse or loved one were no longer able to assist with financial decision making. Read: Leave more to your loved ones.

Take action:

• Stay on top of changes in the markets by reading the wide variety of Viewpoints market commentary, investing, and personal finance topics.
• Make sure you document all necessary financial paperwork and track all sources of income to which you are entitled, including pensions, Social Security, and bank, brokerage, and retirement accounts.
• Read up on what you can do to be better prepared, and create a retirement income plan. Visit Fidelity's Guide to Retirement Income Investing.

Next steps

Fidelity can help by offering you one-on-one guidance.⁷ Call 1-800-FIDELITY to speak with a Fidelity representative.

1. Women's Institute for a Secure Retirement, June 23, 2011.

2. U.S. Census Bureau, America’s Families and Living Arrangements, “Current Population Survey, 2010 Annual Social and Economic Supplement.”

3. Census Bureau reports and data, Current Population Reports, “Median Earning of Workers 15 Years Old and Over by Work Experience and Sex,” updated September 2010 by the National Committee on Pay Equity.

4. U.S. Department of Labor, “Women and Retirement Savings,” June 23, 2011.

5. LIMRA study, Retirement Savings of Working Man and Women, Februray 3, 2011.

6. 2011 Fidelity Investments Couples Retirement Study. The survey was fielded in May 2011 through Knowledge Networks Inc.’s nationally representative panel and conducted by Richard Day Research.

7. Although consultations are one on one, guidance provided by Fidelity is educational in nature, is not individualized, and is not intended to serve as the primary or sole basis for your investment or tax-planning decisions.

Keep in mind that investing involves risk. The value of your investment will fluctuate over time and you may gain or lose money.

Diversification and Asset Allocation do not ensure a profit or guarantee against loss.

Always consult an attorney or tax professional regarding your specific legal or tax situation.

Fidelity Brokerage Services LLC, Member NYSE, SIPC, 900 Salem Street, Smithfield, RI 02917

586837.2.0

For the first time, scientists have figured out how re-grow big chunks of human skeletal muscle by tricking the human body into accepting a biological matrix of pig proteins. If successful, this cellular regeneration method promises new life for injured war veterans and other trauma victims who are missing more than 25 percent of a limb and/or who face amputation.

The researchers base their optimism on 20 years of clinical research, animal trials and a single “human guinea pig” patient, a U.S. Marine who nearly had his legs blown off in Iraq seven years ago, but who is now playing softball and jogging three years after surgery.

WIDE ANGLE: Tissue Engineering

“This offers the possibility of creating new functional tissue,” said Stephen Badylak, deputy director of the McGowan Center for Regenerative Medicine at the University of Pittsburgh Medical Center. Badylak has been credited with performing this treatment for the first time on a human.

Badylak said the regenerative technique uses proteins taken from pig intestines, which are inserted into the damaged human tissue. The proteins attract human stem cells to migrate to the limb and start creating matching bone and tissue cells.

“We put a homing device inside and it recruits (human) stem cells on its own,” Badylak said. “It’s a shortcut.”

Since the regenerative technique uses “decellularized” material around the cells, Badylak says he’s able to avoid conflicts with the human body’s immune system, which normally would attack cells and other recognizable biological material from another species.

Badylak’s team is now screening patients for a Pentagon-funded clinical trial that will launch at Pittsburgh and four other medical centers across the country later this year with 80 subjects. A separate study that is also being done at the Pitt Medical Center will be trying to re-grow bone material in patients with head injuries, according to a university spokeswoman, using a special "bone cement."

BLOG: Artificial Human Ovaries Aid Infertility Research

What’s new here is the promise of re-growing skeletal muscle and bones, something that hasn’t been done before in human subjects. Badylak and other researchers say they are optimistic at the results of animal studies in which it worked, but they need to test how it works in patients that have lost at least 25 percent of their muscle tissue in an arm or leg. Other experts in this field say that it’s still early days, even though they agree the experiments are promising.

“We know this technique works with soft tissue,” said Anthony Atala, who is director of the Institute for Regenerative Medicine at Wake Forest University and a member of the scientific advisory board of Acell, a Pittsburgh-based company that manufactures the pig protein matrix. “The question is whether it will be able to regenerate bone tissue as well. With all these technologies, we have to look at them long term and assess the functionality of the patients,” said Atala.

One patient who’s already happy with the results is 25-year-old Marine Cpl. Isaias Hernandez of San Antonio. While deployed in Iraq’s dangerous Al-Anbar province back in 2004, Hernandez was carrying a TV set from a base store to his truck when a mortar landed nearby. Shrapnel from the explosion killed a man next to him and sliced through Hernandez’s legs. The 12-inch TV monitor protected his upper body and probably saved his life.

NEWS: Skin Cells Switch to Beating Heart Cells

Hernandez was severely injured and lost more than a quarter of his right thigh. He has undergone more than 50 surgeries since then to repair tissue, remove infections and insert or fix screws holding his damaged leg together. In 2008, Hernandez volunteered to be the first human subject in Badylak’s new experimental tissue regeneration therapy.

“They cut a little slit into my thigh where they were going to put the material,” Hernandez told Discovery News. “It was like blood in an envelope.”

This envelope was a cellular matrix taken from a pigs’ intestine, which then grew and formed human skeletal muscle, according to Badylak. Hernandez has been the only human patient so far.

“It feels pretty good,” Hernandez said. “I’ve been losing weight and playing sports.”

Hernandez has been on medical leave while he awaits a second surgery in Pittsburgh. He says he’s been trying to get fit enough to re-join the Marines.

Washing sheets and pillow cases rids us of bacteria and other buildup we drag into bed with us.

Or so we think.

One report, presented at the Healthcare Associated Infections 2011 meeting in London, found an array of microorganisms and debris inside pillows. In fact, within 2 years of use, one-third of a pillow's weight comprises dead skin cells, bugs, dead dust mites and their droppings, according to the research cited in a Daily Mail article.

BLOG: U.S. Meats Tainted with Bacteria

The data were gathered from Barts and The London NHS Trust hospitals, where pillows are washed regularly.

But the range of waste found in pillows wasn't the only reason for concern. Researchers found a total of 30 microbes responsible for a slew of health issues such as chicken pox, methicillin-resistant staphylococcus aureus (MRSA) infections and leprosy, according to the Daily Mail and one Telegraph article. They also found another bacterium called Clostridium difficile, or C. diff, that poses problems for health care environments.

It's not clear, however, whether the insides of pillows pose a risk of transmission for patients, but tears in materials and openings from stitching may increase the chances of transferring microbes from pillow to patient.

Discovery Fit & Health: Allergy Treatment Options

It should be mentioned that the study was supported by a company called Gabriel Scientific, which has developed airtight SleepAngel medical pillows. To no surprise, these special pillows did not harbor the same microbes and debris collected by normal hospital pillows.

Despite company sponsorship and collecting data from hospitals, the findings likely apply to pillows at home as well. While mites and allergens in pillows increase certain health problems is debated, it can't hurt to be on the clean side just in case.

NEWS: Bacteria-Laden Soap Not So Clean

One New York Times blog post suggests listening to allergy experts and purchasing mite-proof covers to place under sheets and pillow cases if mites are a problem in the area. Knowing where nighttime pests, such as bed bugs, thrive is important, too.

Discovery News contacted Barts and The London NHS Trust to obtain the report and was told the preliminary findings open up new opportunities to help eradicate hospital-acquired infections.

Photo by Kim / Apps via Flickr.com

Full of hope: T.J. ­Atchison was the first patient to be treated with a new approach to mending spinal-­cord injuries. The treatment uses cells grown from embryonic stem cells. Credit: Cary Norton

Audio »

Hans Keirstead wakes up every morning at his home near Los Angeles and checks CNN. He's looking for news about the first-ever human test of embryonic stem cells, launched in October by the biotechnology firm Geron. Mostly, he's looking for bad news. "If someone dies, or is in pain, then it's over," he says, pushing a hand through his tawny hair. Keirstead, dressed in a loose linen shirt and wearing a thumb ring, is a biologist at the University of California, Irvine, who has variously been called the "rock star," "miracle worker," and "Pied Piper" of stem-cell science. Today he has a corner office in a new $67 million research center paid for in part by California voters, whom he helped persuade to vote for a $3 billion stem-cell spending plan in 2004 with a video of partially paralyzed rats walking again after stem-cell transplants performed in his laboratory.

That same treatment is now being tested in human beings. No wonder Keirstead is anxious. Although he is not directly involved in the clinical trial, the discovery he patented, promoted to Californians, and later licensed to Geron has now become the leading test of whether embryonic stem cells will finally live up to their medical potential. "I'm dying to know if it works," he says.

As Technology Review went to press, Geron had so far treated two patients: a 21-year-old nursing-school student named T. J. Atchison, who was paralyzed at the chest in a car crash last September, and a second person who has not been publicly identified. The hope is that cells injected into their spinal cords could help mend damaged nerves and restore at least a degree of mobility and sensation. Even if the treatment fails, many researchers believe the test is a critical step toward a time when bodies are healed and regenerated with living cells, not chemical drugs. "Cell therapy is now here to stay," says Wise Young, a professor at Rutgers University and an expert on spinal-cord injury. "I tell my students that this will be the future—that they will be the first generation of doctors to use cell therapy."

Thirteen years of public debate, scientific surprises, lawsuits, and presidential decrees have gone by since embryonic stem cells were first isolated, in 1998. Stem cells drawn from early-stage human embryos have the potential to develop into any type of cell in the body. In a lab dish, they can give rise to nerves, skin, even pulsating heart cells. And Geron, a 180-person biotech outfit in Palo Alto, has promised for a decade that treatments based on the cells could be just around the corner. The company says it spent $45 million on amassing the evidence needed to persuade the U.S. Food and Drug Administration to allow the first-of-a-kind human trial to proceed—an effort that included animal tests it calls exhaustive. "The agency told us our application was the largest they'd ever received," says Geron's interim CEO, David Greenwood, sweeping his hand over a double-length conference table that once creaked under the weight of all 22,500 pages.

Geron's success in getting the FDA to green-light the trial has already triggered a small explosion of other embryonic-stem-cell studies. Advanced Cell Technology, a smaller competitor in Marlborough, Massachusetts, has been cleared to begin two trials that will involve replacing cells in the eyes of people going blind from macular degeneration: lab workers will use stem cells to manufacture a type of retinal pigment cell that the disease kills off. Next in the pipeline is a startup company's effort to transplant lab-grown replacement nerves into infants with a fatal genetic disease called spinal muscular atrophy. That trial is planned by California Stem Cell, which has raised $10 million from wealthy donors and has signed up Keirstead as its chief scientific advisor. Keirstead, bounding through the still empty offices with a tape measure in hand, says he is considering leaving his lab to join the company full time. He thinks that with the Geron trial now under way, other human studies can advance much more quickly and cheaply.

But that depends on what happens in the Geron trial. And even some of stem cells' most ardent advocates worry that things may be moving too fast. Arthur Caplan, a bioethicist at the University of Pennsylvania and a defender of stem-cell research (see Q&A, September/October 2006), calls the Geron study poorly designed and says it should never have been allowed to proceed. "This is nuts and hugely risky," says Caplan. "The animal studies are not adequate to justify the trial." Those studies provide too little proof of safety, he contends, and Keirstead's original findings in rats offer thin evidence that people will be helped.

Looming large is the history of gene therapy, another advanced biomedical technology, which badly misfired when a young volunteer named Jesse Gelsinger died in a safety study in 1999. Caplan, who was close to those events, sees worrisome similarities (see "The Glimmering Promise of Gene Therapy," November/December 2006). "If they get an adverse event, there will be hell to pay," he says.

No Miracle

Spinal-cord injuries cause paralysis by killing off nerves that transmit sensory impulses and leaving others stripped of their myelin sheath, the layer of fatty insulating material that helps nerve signals travel. Geron manufactures its treatment, known as GRNOPC1, by coaxing embryonic stem cells to form what are known as oligodendrocyte precursor cells. Those cells are bottled and frozen, and Geron scientists believe they may help restore some degree of sensation and limb movement to patients if transplanted soon after a spinal-cord injury. That is because oligodendrocyte cells produce myelin and may serve other purposes as well, such as encouraging new blood vessels to form. In Geron's initial human trial, designed to test the safety of the treatment, doctors plan to inject two million cells each into the spines of 10 people whose legs have been paralyzed in accidents.

Credit: Associated Press (Bush); Frazer Harrison/Getty Images (Prop. 71); Associated Press (Geron); Larry Downing/Reuters (Obama)

Will the treatment be a cure? The odds are against it. In general, most new treatments, never mind highly experimental ones, bomb out early. What's more, GRNOPC1 faces an uphill fight against medical dogma, which says that it's impossible to reverse damage to either the brain or the human spinal cord. That means few experts expect a miracle from GRNOPC1. Richard Fessler, a surgeon at Northwestern Memorial Hospital in Chicago who is leading patient recruitment for the Geron trial at seven U.S. medical centers, calls the study a "rational" attempt to reverse spinal-cord damage. But he cautions against expecting too much. "We wouldn't be doing this if we didn't have hope, but I don't want to instill false hope," Fessler said in a news conference in May, after the second patient received the treatment. "I'm not going to go to one of these patients and say, 'We're going to give you a transplant and you're going to walk.'"

Still, some patients are clamoring to join the Geron study, even though only people with extremely recent injuries—the kind that lab research suggests might be helped—are allowed to participate. A Dutch man offered Geron $1 million to treat his son, and ­Keirstead says he received an even bigger offer from a paralyzed Texas millionaire. "He said he'd pay me whatever millions it takes to set up a clinic in Mexico, and another $2 million for me, just to treat him," he says. "It made me pause, but not for long."

One person who made a public plea to enter the trial is Michael Martinez, a 24-year-old jockey who was paralyzed after falling from a horse at San Francisco's Golden Gate Fields last year. Martinez was refused, in part because his injuries, including three crushed vertebrae, were too extensive. "He is the most challenging candidate for stem cells—if they can have any impact in him, that would be extraordinary," says David Seftel, the doctor who came to ­Martinez's aid at the track and has led a campaign to have him treated with stem cells. Seftel complains that the spinal-cord specialists who treated Martinez view stem-cell research with skepticism and were reluctant to get behind the idea. "We experienced a lot of resistance," he says. "We were told it's an irresponsible option to present to patients at this time. But the science only advances if people take carefully calculated risks."

With Seftel's help, and a letter-writing campaign by other paralyzed people, Martinez is now a candidate (pending Swiss government approval) to join a study in Switzerland sponsored by a California company called StemCells Inc. In that study, doctors are implanting nerve cells obtained from early-stage human fetuses; unlike embryonic stem cells, such fetal cells have already begun to differentiate into other cell types. "We have moved heaven and earth here to make sure he gets in," says Seftel. If he's approved, Martinez will travel to Switzerland for screening and then, if he passes, undergo 30 days of additional tests before being cleared to participate in the trial.

Martinez, a Panamanian who speaks little English, says he believes the operation "could help me regain sensation in my legs, and return to capacities I had before." As with most paraplegics, being unable to walk is the least of his problems. His biggest difficulty is bladder infections, since he must urinate through a catheter. Martinez says he's aware that there are dangers associated with the stem-cell treatment, but as a jockey, he's used to long odds. "I know it has certain risks, but I don't want to think about those," he says. "I want to stay focused on the positive."

Too Powerful

The human embryonic stem cell was isolated in 1998 by James Thomson at the University of Wisconsin (Geron, in a farsighted gamble, funded his work). Thomson made two main scientific claims about his discovery. The first, and better known, involved the cells' capacity to differentiate into any tissue type in the body. Less well understood but equally important was that embryonic stem cells are immortal: they keep dividing, never running down as normal cells do. They are, in short, like no other human cells.

The truth of those claims is evident at Geron's one-story headquarters in Palo Alto. In its labs, the company grows not only nervous-­system cells but also heart muscle, which is being transplants into 100-pound pigs, and cartilage cells that are being tested in the knees of sheep. Amazingly, all the billions of cells that Geron has grown for its spinal-cord program—including those injected into Atchison's spine—are direct descendants of the very first supply of stem cells that Thomson created from an embryo, a cell line known as H1. "There is no further destruction of human embryos required to keep this work going, and there hasn't been since 1998," Ed Wirth, Geron's medical director, told a Phoenix audience last year. "[It's] very, very powerful how you can multiply these cells."

Watching closely: Biologist Hans Keirstead, a self­-proclaimed optimist about stem cells, says he is now anxiously awaiting the results of human tests. Credit: Cary Norton

If anything, embryonic stem cells are too powerful. Early on, scientists hoped they would be magic bullets for a variety of diseases. Just inject them—and watch them race to injury sites and fill in for dying cells. In one early study, embryonic stem cells placed in the brains of rats suffering from symptoms of Parkinson's disease did precisely that. Not only did the cells become new neurons, but they began to squirt out dopamine, the chemical lost in Parkinson's. The problem was that they often ran amok, multiplying into frightening tumors called teratomas—disorganized mixtures of tissues, such as teeth, hair, and jawbone. Rats that developed such tumors died.

The brain tumors were a sign that the stem cells were still attempting to carry out their original mission: to form an entire person. Researchers quickly settled on a new strategy. They would use stem cells, but only to manufacture daughter cells restricted to a particular destiny—cells already committed to becoming liver, say, or new muscle. "No one wants to put embryonic stem cells into humans, only the product," Keirstead explains today. What he worked out at his Irvine laboratory was a recipe for turning embryonic stem cells into relatively pure populations of oligodendrocyte precursors. It's not easy: his recipe requires 42 days of coaxing, coddling, and adding growth factors at just the right moment. Then, in 2005, Keirstead published a report saying that when he injected the oligodendrocyte cells into the spinal cords of crippled rats, they went from dragging their hind paws to walking again in a matter of days. That result was a bombshell, and Geron, which has poured $1.8 million into Keirstead's lab, quickly decided that pursuing a stem-cell treatment for people with spinal injuries would become the company's flagship program.

One of Geron's challenges has been to create an industrial recipe for growing the large numbers of cells needed for treating patients. The company's senior director for manufacturing operations, Sean Cullen, says Geron is now, with its technology, where companies such as Amgen and Genentech were with protein and antibody drugs a decade ago, when they began manufacturing them. But if proteins were harder to make than ordinary chemicals, cell therapy is an order of magnitude more difficult still. "Think about it," Cullen says, pointing through a glass porthole into the clean room, where the cells multiply in jars of pink medium. "The cell is a living thing—you can't define what it is with the same granularity." Indeed, the product that Geron makes can't be characterized like a chemical compound. Rather, it's a mixture of different types of cells, including oligodendrocytes. The manufacturing process is in many ways still undefined, Cullen says—still an art. When he heard that cells he'd cultured had been injected into someone's spine, "that brought it home," he reflects. "Now you know it's life and death."

Risks versus rewards

What worries some scientists is that Keirstead's results in rats have never been independently confirmed and published. That's not unusual in science, but it may be reason for caution in this case, since many discoveries in the stem-cell field have later unraveled. "I do think it matters if it is replicated," says Thomas Lane, a neuro­scientist at the University of California, Irvine, who once collaborated with Keirstead to use the cells in mice with symptoms of multiple sclerosis, only to find that the cells didn't survive and did not appear to produce new myelin. While the two studies can't be compared head to head, says Lane, "at the end of the day [the cells] didn't work for us."

One complication in trying to reproduce the results is that other labs may begin with different populations of embryonic stem cells, and each lab has its own tricks for inducing the cells to differentiate, which makes direct comparisons difficult. Wenbin Deng, a professor at the University of California, Davis, has tried to replicate Keirstead's recipe, and the results leave him cautious about human tests. "I think it's still a little bit premature at this point," Deng says. "Even though this type of cell is ideal for transplant studies, there is still a lot of uncertainty about their safety and efficacy."

Geron scientists say they have replicated and extended ­Keirstead's findings, although the data haven't been published. "We would like to publish, but that is not the focus of the team," says Anna Krassowska, a stem-cell scientist who now works as Geron's director of investor relations. "Sometimes there is the perception that our entire trial is based on the seven rats of Hans Keirstead, and that is not true."

Yet even if the treatment heals rats, it is still unclear exactly what it does. Originally, the theory was that new oligodendrocytes should restore the missing myelin on axons, the projections of nerve cells that transmit electrical signals. But Ann Parr, a spinal surgeon and researcher at the University of Michigan, says the benefits appear so quickly—in a matter of days—that new myelin can't be the whole story. Maybe the cells emit chemicals that help prevent ongoing damage in some other way. "I think there is pretty good evidence that transplanting the cells can have a beneficial effect, but nobody knows how they work," says Parr.

For critics such as Caplan, the caveats add up to serious doubts. He says he doesn't see a reason for human tests given the "unimpressive" results in rodents, whose injuries were not as severe as those of Geron's human subjects. What's more, the patients Geron is treating aren't terminally ill. People who are paralyzed in accidents often adapt after the initial shock and return to relatively normal lives. "At first you think they don't have much to lose," Parr says, "but they actually do. They could die." None of those concerns weighed too heavily on Atchison, Geron's first patient. He signed the forms to join the trial only 30 minutes after reading them. Since the injection, Atchison has worried more about the prospect of developing a tumor, but he has come to terms with the danger. "Even if I became sick," he says, "I would still be contributing to the health of someone else, somewhere down the line" (see "The Right Decision").

Looking ahead: Atchison, shown here at his home in Chatom, Alabama, says he sometimes worries about the dangers of Geron’s new treatment but has faith that his participation in the clinical trial will help others. Credit: Cary Norton

The job of balancing the evidence for and against stem-cell therapy fell to the U.S. Food and Drug Administration in 2008, when Geron first submitted its application to test the treatment in people. For the agency, which is charged with ensuring the safety of all medicines, embryonic stem cells were not only a charged political subject but a huge technical challenge. When the FDA called together its top advisors that year, at the Hilton Hotel in Gaithersburg, Maryland, to discuss whether to approve Geron's treatment, one participant called stem cells "probably the most complex biological therapeutic humanly imaginable."

Everyone was well aware of how some previous attempts to alter the body's cellular and genetic makeup had gone wrong. In addition to the infamous gene-therapy death, there was the case of Parkinson's patients who began to experience uncontrolled movements after receiving transplants of tissue from fetuses. Also worrying was a French study a decade ago in which transplants of genetically altered bone marrow had cured children of severe combined immunodeficiency, or "bubble boy" disease, only to cause leukemia years later. Unlike ordinary drugs, whose action quickly fades, these treatments threatened to get stronger. "For some products," agency officials noted, "unchecked proliferation is a real possibility."

The FDA's overriding worry was that a stray embryonic stem cell could cause a tumor. After the 2008 meeting, the agency told Geron that its trial couldn't proceed. The problem: some of Geron's rats had developed tiny cysts where the treatment had been injected. Jane Lebkowski, Geron's chief scientific officer, says the growths were harmless masses of epithelial cells, like "microscopic water balloons." Harmless, maybe. But they didn't belong in the spinal cord, and who knows how much they might grow during a human lifetime. Lebkowski says Geron adjusted its manufacturing recipe to eliminate the unwanted tissue. But it took the company another two years—and a hundred or so more rats—to persuade the FDA that its product was safe enough to test in people. Even so, the FDA demanded unusual safety precautions—stipulating, for example, that the patients be tracked for years to come.

Such delays add up, and some believe the FDA is creating a roadblock. Several companies have gained the agency's approval to test injections of stem cells taken from immature human fetuses, an older but related technology that has also raised concerns at the FDA. "The problem is that the agency is overworked and understaffed and isn't so familiar with cell therapy," says Richard Garr, CEO of NeuralStem, a company that recently began tests of fetal spinal-cord cells in patients with Lou Gehrig's disease, or ALS. For NeuralStem's study, like Geron's, the agency required that patients be treated at least 30 days apart, to allow time to tell whether problems would arise. It will take the company at least a year and a half to complete the study, given that 18 patients are expected to enroll. "And here is a disease that kills you in three to five years, on average, after diagnosis," says Garr. "So it feels like they are slowing you down. I think the FDA believes the caution is justified. I can tell you that the patient advocacy groups are frustrated."

Indeed, many patients opt not to wait. Unregulated clinics, cranks, con men, and quacks have popped up from Cancún to Beijing, tempting patients to pay as much as $40,000 for the chance of a stem-cell miracle. But medical tourists who dodge U.S. safety regulations for overseas injections run unknown risks. In 2009, Israeli doctors treating a 13-year-old boy reported the first case of a brain tumor caused by a stem-cell therapy. The boy's parents had taken him to a fly-by-night Moscow clinic where cells gathered from human fetuses had been injected into his brain.

Patients who join the Geron study, by contrast, will be subject to a battery of MRIs, blood tests, medical exams, and follow-ups lasting 15 years. Perhaps because of the demands put on candidates, the trial has been moving at a crawl. In April, the company surprised investors when it reported that in six months it had managed to enroll only one patient. The good news was that the patient, Atchison, had suffered no unexpected side effects. The bad news, even after the second patient was enrolled in May, is that at this pace it will take Geron an agonizing three years to finish. CEO David Greenwood says that the company has asked the FDA to loosen the strict criteria for subjects. "Cell therapies are new, and the agency appropriately, I think, takes a very conservative posture," he says. But, he adds, "you can narrow your funnel so much you don't get any patients."

Back at his office at UC Irvine, Keirstead says he has received several phone calls from people who were considering joining the Geron trial: "They were looking for a level of confidence, a feeling from me. Is it really going to work, and is it safe?" The calls have put Keirstead in a difficult spot. "My ridiculous sense of optimism may be clouding my judgment," he says. "But I tell them we've done everything we can possibly do scientifically and in animals. And we still don't know if it works in humans."

Antonio Regalado is the Latin America contributor to Science magazine. He is based in São Paulo, Brazil.

We're all familiar with what you do if life hands you a lemon. You make lemonade, right? But what if life literally hands you a turd? Well, if you're Japanese researcher, Mitsuyuki Ikeda, you do this: create an edible steak made from human feces.

We've previously reported on some colorful bowel movements, but this bowel-to-plate movement is way beyond colorful. In fact, it's almost beyond the pale. However, once your dry-heaves subside, what's even more absurdly stomach-churning is this idea is not only plausible, its already been taste-tested.

When Tokyo Sewage approached Mitsuyuki Ikeda, a researcher from the Okayama Laboratory, and asked him to explore potential uses for an overabundance of sewage mud, Ikeda found that, because of all the bacteria, the mud contained large amounts of proteins.

WIDE ANGLE: Poo Power

Ikeda and his team isolated those proteins, combined them with a reaction enhancer and put it in an exploder, thereby creating le cuisine de merde. The lab-grown steak is made from 63 percent proteins, 25 percent carbohydrates, 3 percent lipids, 9 percent minerals (and 100 percent you've-got-to-be-kidding-me). Researchers enhanced the flavor with soy protein and used red coloring to give the poo-burger that appetizing, meaty charm. According to DigitalTrends, initial taste-tasters have said the butt steaks even tastes like beef.

But is this meat safe?

Experts say, in theory, yes. But to kill any toxic pathogens, the meat must obviously be cooked.

WIDE ANGLE: Tissue Engineering

"In the food safety world we say, 'don't eat poop," Douglas Powell, a professor of food safety at Kansas State University, told MyHealthNewsDaily. "But if you're going to, make sure it's cooked."

Powel did say there was a potential for cross contamination in the lab where the bowel loaf was developed, but said the idea in not that different from eating vegetables that have been fertilized with manure or other excrement.

"Theoretically, there's nothing wrong with this," Powell added."It could be quite safe to eat, but I'm sure there's a yuck factor there."

Bon appétit!

[Via Yahoo News]

Credit: Lew Robertson/Corbis

This is one steak I will be avoiding!