The New York Times, December 8, 2008, by Gardiner Harris — Two federal drug officials have concluded that asthma sufferers risk death if they continue to use four hugely popular asthma drugs — Advair, Symbicort, Serevent and Foradil. But the officials’ views are not universally shared within the government.
The two officials, who work in the safety division of the Food and Drug Administration, wrote in an assessment on the agency’s Web site on Friday that asthma sufferers of all ages should no longer take the medicines. A third drug-safety official concluded that Advair and Symbicort could be used by adults but that all four drugs should no longer be used by people age 17 and under.
Dr. Badrul A. Chowdhury, director of the division of pulmonary and allergy products at the agency, cautioned in his own assessment that the risk of death associated with the drugs was small and that banning their use “would be an extreme approach” that could lead asthmatics to rely on other risky medications.
Once unheard of, public disagreements among agency experts have occurred on occasion in recent years. The agency is convening a committee of experts on Wednesday and Thursday to sort out the disagreement, which has divided not only the F.D.A. but also clinicians and experts for more than a decade.
Sudden deaths among asthmatics still clutching their inhalers have fed the debate. But trying to determine whether the deaths were caused by patients’ breathing problems or the inhalers has proved difficult.
The stakes for drug makers are high. Advair sales last year were $6.9 billion and may approach $8 billion this year, making the medication GlaxoSmithKline’s biggest seller and one of the biggest-selling drugs in the world. Glaxo also sells Serevent, which had $538 million in sales last year. Symbicort is made by AstraZeneca and Foradil by Novartis.
Whatever the committee’s decision, the drugs will almost certainly remain on the market because even the agency’s drug-safety officials concluded that they were useful in patients suffering from chronic obstructive pulmonary disease, nearly all of whom are elderly.
Dr. Katharine Knobil, global clinical vice president for Glaxo, dismissed the conclusions of the agency’s drug-safety division as “not supported by their own data.” Dr. Knobil said that Advair was safe and that Serevent was safe when used with a steroid.
Michele Meeker, a spokeswoman for AstraZeneca, said that the F.D.A.’s safety division improperly excluded most studies of Symbicort in its analysis, and that a review of all of the information shows that the drug does not increase the risks of death or hospitalization.
Dr. Daniel Frattarelli, a Detroit pediatrician and member of the American Academy of Pediatrics’s committee on drugs, said that he was treating children with Advair and that his committee had recently discussed the safety of the medicines.
“Most of us felt these were pretty good drugs,” Dr. Frattarelli said. “I’m really looking forward to hearing what the F.D.A. committee decides.”
About 9 percent of Advair’s prescriptions go to those age 17 and under, according to Glaxo. Ms. Meeker could not provide similar figures for Symbicort.
In 1994, Serevent was approved for sale, and the F.D.A. began receiving reports of deaths. A letter to the New England Journal of Medicine described two elderly patients who died holding Serevent inhalers. Glaxo warned patients that the medicine, unlike albuterol, does not work instantly and should not be used during an attack.
In 1996, Glaxo began a study of Serevent’s safety, but the company refused for years to report the results publicly. In 2001, the company introduced Advair, whose sales quickly cannibalized those of Serevent and then far surpassed them.
Finally in 2003, Glaxo reported the results of its Serevent study, which showed that those given the medicine were more likely to die than those given placebo inhalers. Glaxo said problems with the trial made its results impossible to interpret.
Asthma is caused when airways within the lungs spasm and swell, restricting the supply of oxygen. The two primary treatments are steroids, which reduce swelling, and beta agonists, which treat spasms. Rescue inhalers usually contain albuterol, which is a beta agonist with limited duration. Serevent and Foradil are both beta agonists but have a longer duration than albuterol and were intended to be taken daily to prevent attacks.
Advair contains Serevent and a steroid. Symbicort, introduced last year, contains Foradil and a steroid. In the first nine months of this year, Symbicort had $209 million in sales.
The problem with albuterol is that it seems to make patients’ lungs more vulnerable to severe attacks, which is why asthmatics are advised to use their rescue inhalers only when needed. The long-acting beta agonists may have the same risks.
But drug makers say this risk disappears when long-acting beta agonists are paired with steroids. The labels that accompany Serevent and Foradil instruct doctors to pair the medicines with an inhaled steroid.
REALLY?; Dust mites make allergies worse.
The New York Times, by Anahad O’Connor — Most people with allergies or asthma know well the hazards of dust mites, the microscopic household critters long said to be one of the most common triggers of allergic symptoms.
But that is not what studies show. Scientists have repeatedly found that various physical and chemical methods recommended for controlling dust mites, like sprays and impermeable bed covers, do little by themselves to prevent allergies. If they do work, it is usually as one of several steps taken to reduce household allergens.
A meta-analysis published in 2008, for example, looked at 54 randomized studies that compared various mite-control measures with placebo interventions, or none at all, in people with asthma. It found that the control measures made no significant difference. A 2007 study followed 126 asthma patients, some of whom were trained to use control measures like impermeable bed covers and others who used placebo interventions. After two years, the scientists found that the groups showed no difference in their use of inhalers or reductions in symptoms like wheezing and coughing.
These and other studies suggest that people with allergies and asthma would do well to rely on a broad program of interventions, like frequently washing clothes and blankets, using air conditioning instead of humidifiers, and strictly limiting exposure to allergens like smoke and strong odors.
Research suggests that controlling dust mites alone may not prevent allergies.
The New York Times, December 9, 2008, by Tara Parker-Pope — How, when and where a child is born may all play a role in lifetime asthma risk, new studies suggest.
Asthma occurs when airways in the lungs spasm and swell, restricting the supply of oxygen. The incidence of asthma in the United States has risen steadily for more than two decades, and now affects about 6 percent of children, up from less than 4 percent in 1980, according to the Centers for Disease Control and Prevention.
The reasons for the increase are not entirely clear. Genetics probably plays a role in risk for asthma, but an array of environmental factors — pollen, dust, animal dander, mold, cockroach feces, cigarettes, air pollution, viruses and cold air — have all been implicated in its development.
This month, The American Journal of Respiratory and Critical Care Medicine is reporting that children born in the fall have a 30 percent higher risk for asthma than those born in other seasons. The finding is based on a review of birth and medical records of more than 95,000 children in Tennessee.
A possible explanation is that autumn babies tend to be about 4 months old at the peak of cold and flu season. By that age, many babies are in day care, regularly exposed to the outside world.
And while their lungs are still developing, they have lost immunities conferred in the womb and have yet to develop their own strong immune systems. As a result, fall babies are at particular risk to contract a severe winter virus, which may in turn increase their risk for asthma.
The lead researcher, Dr. Tina V. Hartert, director of the Center for Asthma Research and Environmental Health at Vanderbilt University, says some parents with a high familial risk for asthma may want to consider timing conception to avoid a fall birth.
But since that is impractical for many people, Dr. Hartert says all parents should take precautions to reduce a baby’s risk of a respiratory infection.
“It’s premature to say you should time conception so children aren’t born in the fall,” she said. “But it’s good sense to use typical hygienic measures to try and prevent illness.”
As for how a baby is born, Swiss researchers are reporting in the journal Thorax this month that a Caesarean delivery is linked to a much higher risk for asthma compared with babies born vaginally.
In a study of nearly 3,000 children, the researchers found that 12 percent had been given a diagnosis of asthma by age 8. In that group, those born by C-section were nearly 80 percent more likely than the others to develop asthma. The explanation may be that a vaginal birth “primes” a baby’s immune system by exposing it to various bacteria as it moves through the birth canal.
Finally, researchers at Tufts reported last month in The Journal of Asthma that a baby’s place of birth also influences asthma risk. In a study of black families in Dorchester, Mass., they found that babies born in the United States were more likely to have asthma than black children born outside the country.
The reason for the disparity isn’t clear, but the sterile conditions under which American babies are born may be a factor. Babies in developing countries encounter more infections, so they may be better equipped to withstand less serious assaults associated with asthma,like mold and dust mites.
Many studies suggest that for both men and women, it’s not how much you weigh that matters most, but where you carry those pounds.
Hiroko Masuike for The New York Times
A cooling treatment is credited with helping Dr. Syed Hasan Naqvi recover from cardiac arrest.
The New York Times, December 9, 2008, by Anemona Hartocollis — Starting on Jan. 1, New York City ambulances will take many cardiac arrest patients only to hospitals that use a delicate cooling therapy believed to reduce the chances of brain damage and increase the chances of survival, even if it means bypassing closer emergency rooms.
The move by the city’s Fire Department and Emergency Medical Service, after a year of preparation, indicates a shift away from the prevailing view among emergency workers and the public that how fast critically ill patients reach the hospital is more important than which hospital treats them.
It amounts to an endorsement by the Bloomberg administration of a labor-intensive, often expensive and still-developing therapy that smaller community hospitals say they lack the staffing and financial wherewithal to provide.
Some hospital officials fear that the policy could be unfair to these smaller hospitals, depriving them of income from emergency-room patients and hurting their reputations with the public.
Since the Fire Department sent letters to hospital chief executives this week informing them of the impending change, about 20 of the 59 hospitals with emergency rooms have said they will have cooling operations ready by the Jan. 1 deadline.
Dr. David J. Prezant, chief medical officer of the New York Fire Department, acknowledged the culture change and the possibility that some hospitals would feel slighted. But he argued that scientific data shows the survival rate of cardiac arrest patients treated with therapeutic hypothermia, as the cooling process is called, is so much better than with conventional treatment that it would be irresponsible not to provide it.
“Theoretically every closest 911-receiving hospital will be able to provide this service,” he noted. “Whether that will be a reality or not is not for me to say.”
New York joins a handful of other American cities, including Seattle, Boston and Miami, as well as Vienna and London, in requiring transport to hospitals with cooling systems. But given New York’s large population and concentration of hospitals, the policy may provide the largest test to date of therapeutic hypothermia.
Most patients who suffer total cardiac arrest outside hospitals die because their brains have been starved of oxygen. But studies show that if the pulse of patients can be restarted and the body temperature cooled to about 8 degrees Fahrenheit below normal, brain damage can be reduced or minimized.
Only those cardiac arrest patients revived enough to show a pulse and whose heart problems are not associated with some other trauma are eligible for the cooling treatment, Dr. Prezant said. In New York City, that represents 1,500 to 2,000 of the about 7,500 out-of-hospital cardiac arrest cases reported each year.
Dr. Prezant said that in deference to hospital finances, the city has set no requirements for the kind of cooling techniques hospitals must use — some may start with inexpensive saline solutions and plastic bags filled with ice, while others employ sophisticated equipment manufactured and aggressively promoted by companies like Alsius, Innercool Therapies and Medivance.
The American Heart Association endorsed cooling for some types of cardiac arrest patients after two studies on its effectiveness were published in The New England Journal of Medicine in 2002. One study found that 55 percent of the patients who received the cooling treatment ended up with moderate or no brain damage, compared with 39 percent who received standard treatment. About 41 percent of the cooled patients died within six months, compared with 55 percent of the others.
But hospitals have been slow to adopt the treatment because it requires a precision of temperature regulation that is difficult to achieve, constant vigilance and cooperation among nursing, emergency, cardiac and neurological units.
The research has shown that cooling is effective for cardiac arrest from ventricular fibrillation, in which the heart muscle wriggles ineffectively.
If a pulse can be restarted quickly enough — within a matter of minutes — with a defibrillator, such patients can walk away relatively unscathed. But if not, they become comatose and suffer a cascading series of cellular-level injuries to the brain, which frequently lead to permanent brain damage or death.
Inducing moderate cooling of the body within 6 hours, for 24 hours, followed by gradual warming, slows cerebral metabolism and seems to reduce such injuries, studies have shown. (The technique’s effectiveness on other medical problems, including traumatic brain injury, is more controversial.)
Dr. Stephan Mayer, chief of the neurological intensive care unit at NewYork-Presbyterian/Columbia hospital in Manhattan, spearheaded New York’s effort by bringing the idea to a critical-care committee of the Greater New York Hospital Association and United Hospital Fund a year ago. Soon after, the committee held a symposium on hypothermia, where Dr. Mayer continued to advocate for the therapy, and the ambulance protocol developed from there.
“It was a very slow process in terms of really getting it to take hold,” Dr. Mayer said of the cooling treatment. “One reason is that cardiac arrest patients have just been surrounded by this shroud of therapeutic nihilism. They come in after cardiac arrest, they’re intubated, in a coma, everybody’s reflex thought process in terms of caregivers is ‘Oh God, there’s nothing you can do for these people.’ ”
Dr. Mayer has served as a consultant for Medivance, and holds stock options in the company, which stands to benefit from the shift. He said in an interview that he has “worked directly or indirectly with cooling technology startup companies since 1998” and helped design “the next generation of equipment” for Medivance, earning about $10,000 from the company.
He said that his main motivation was not financial but experiential, and that he had been converted by seeing patients who were comatose and given up for dead recover full or near-full function after hypothermia.
Under the New York protocol, patients would be eligible for cooling if they suffered cardiac arrest and regained a pulse within 30 minutes of the start of resuscitation but remained neurologically compromised. Hospitals without the ability to cool patients would be bypassed if one that did was within a 20-minute drive. Dr. Prezant said his goal is, within six months, to begin the cooling process in the ambulance, accelerating treatment.
NewYork-Presbyterian has been a leader in hypothermia in New York, but a number of other major hospitals in the city — including Mount Sinai, Bellevue Hospital Center and St. Vincent’s Hospital Manhattan, Elmhurst Hospital Center in Queens, Maimonides Medical Center in Brooklyn and Staten Island University Hospital — also practice cooling, and others are developing plans to start. Dr. Prezant said enough hospitals in each borough had indicated interest in cooling to keep transport time to an average of 10 minutes. “If people knew about it, of course they’d want it,” Dr. Mayer said.
One recent success story is Dr. Syed Hasan Naqvi, 56, who had just finished jogging on the treadmill in his Long Island home on Oct. 18 when his daughter heard a thud and found him on the floor in cardiac arrest. An ambulance took him to Nassau University Medical Center, where he was revived, but he remained comatose and breathing on a ventilator.
Unable to accept that there was nothing else to be done, Dr. Naqvi’s wife, Nina, contacted a neurologist at the hospital who knew Dr. Naqvi, a consulting neurologist at North Shore University Hospital. The neurologist at Nassau had recently heard Dr. Mayer describe the cooling treatment, unavailable at Nassau, and so he called him and then urged Mrs. Naqvi to get her husband to NewYork-Presbyterian.
Since more than five hours had elapsed since the cardiac arrest — the optimal time for cooling was running out — Dr. Mayer suggested putting ice packs on Dr. Naqvi during the hourlong trip to Manhattan. When he got there, Dr. Mayer said, Dr. Naqvi’s score on the Glasgow coma scale was a 4, near bottom on a scale of 3 to 15, and he had a high chance of remaining in a vegetative coma permanently.
“The brain waves were very flat,” Dr. Mayer said. “But we decided to give it a try.”
Dr. Naqvi was cooled for 24 hours, and woke up five days later, though he was confused and had memory lapses. Now, six weeks later, he is back to seeing patients two days a week, and said in an interview that he remains physically weak but has regained all of his mental function.
“The hospital does make a difference,” Nina Naqvi said. “The knowledge of the doctors does make a difference.”
The New York Times, by Laurie Tarkan — The average person walks the equivalent of three times around the earth in a lifetime. That is an enormous amount of wear and tear on the 26 bones, 33 joints and more than 100 tendons, ligaments and muscles that make up the foot.
In a recent survey for the American Podiatric Medical Association, 53 percent of respondents reported foot pain so severe that it hampered their daily function. On average, people develop pain in their 60s, but it can start as early as the 20s and 30s. Yet, except for women who get regular pedicures, most people don’t take much care of their feet.
“A lot of people think foot pain is part of the aging process and accept it and function and walk with pain,” said Dr. Andrew Shapiro, a podiatrist in Valley Stream, N.Y. Though some foot problems are inevitable, you can slow the progress of many problems.
The most common foot conditions that occur as you get older are arthritic joints, thinning of fat pads cushioning the soles, plantar fasciitis (inflammation of the fibrous tissue along the sole), bunions (enlargement of the joint at the base of the big toe), poor circulation and fungal nails. If you have the following risk factors, take more preventive steps as you age.
Are you overweight? The force on your feet is about 120 percent of your weight. “Obesity puts a great amount of stress on all the supporting structures of the foot,” said Dr. Bart Gastwirth, a podiatrist at the University of Chicago. It can lead to plantar fasciitis and heel pain and can worsen hammertoes and bunions. It’s also a risk factor for diabetes, leading to the next question.
Are you diabetic? Being farthest from the heart, the feet can be the first part of the body to manifest complications like poor circulation and loss of feeling, both of which can lead to poor wound healing and amputation. Diabetics should have their feet examined annually by a doctor and avoid shoes that cause abrasions and pressure.
Do you have poor circulation? If you’re suffering from peripheral artery disease — a narrowing of arteries in the legs — your feet are more susceptible to problems, said Dr. Ross E. Taubman, president of the American Podiatric Medical Association. Smoking also contributes to poor circulation.
Do your parents complain about their feet? Family history is probably your biggest clue to potential problems.
Do you have flat feet or high arches? Either puts feet at risk. A flat foot is squishy, causing muscles and tendons to stretch and weaken, leading to tendinitis and arthritis. A high arch is rigid and has little shock absorption, putting more pressure on the ball and heel of the foot, as well as on the knees, hips and back. Shoes or orthotics that support the arch and heel can help flat feet. Those with high arches should look for roomy shoes and softer padding to absorb the shock. Isometric exercises also strengthen muscles supporting the foot.
Are you double-jointed? If you can bend back your thumb to touch your lower arm, the ligaments in your feet are probably stretchy, too, Dr. Gastwirth said. That makes the muscles supporting the foot work harder and can lead to injuries. Wear supportive shoes.
Do your shoes fit? In the podiatric association’s survey, more than 34 percent of men said they could not remember the last time their feet were measured, and 20 percent of women said they wore shoes that hurt weekly; 8 percent wore painful shoes daily. Feet flatten and lengthen with age, so if you are clinging to the shoe size you wore at age 21, get your feet measured (especially mothers — pregnancy expands feet).
Do you wear high heels? “The high heel concentrates the force on the heel and the forefoot,” Dr. Gastwirth said. Heels contribute to hammertoes, neuromas (pinched nerves near the ball of the foot), bunions and “pump bump” (a painful bump on the back of the heel), as well as toenail problems. Most of the time, wear heels that are less than two and a half inches high.
Do your feet ever see the light of day? Fungus thrives in a warm, moist environment. Choose moisture-wicking socks (not cotton), use antifungal powders, and air out your toes at home.
Have you seen a podiatrist? Minor adjustments — using drugstore foot pads or prescription orthotics — can relieve the pressure on sensitive areas, rebalance the foot and slow the progress of a condition.
Do you walk? Putting more mileage on your feet is the best way to exercise the muscles and keep them healthy.
The New York Times, December 9, 2008, by Denise Grady — For nearly 15 years, Kim and Walt Best have been paying about $200 a year to keep nine embryos stored in a freezer at a fertility clinic at Duke University — embryos that they no longer need, because they are finished having children but that Ms. Best cannot bear to destroy, donate for research or give away to another couple.
The embryos were created by in vitro fertilization, which gave the Bests a set of twins, now 14 years old.
Although the couple, who live in Brentwood, Tenn., have known for years that they wanted no more children, deciding what to do with the extra embryos has been a dilemma. He would have them discarded; she cannot.
“There is no easy answer,” said Ms. Best, a nurse. “I can’t look at my twins and not wonder sometimes what the other nine would be like. I will keep them frozen for now. I will search in my heart.”
At least 400,000 embryos are frozen at clinics around the country, with more being added every day, and many people who are done having children are finding it harder than they had ever expected to decide the fate of those embryos.
A new survey of 1,020 fertility patients at nine clinics reveals more than a little discontent with the most common options offered by the clinics. The survey, in which Ms. Best took part, is being published on Thursday in the journal Fertility and Sterility.
Among patients who wanted no more children, 53 percent did not want to donate their embryos to other couples, mostly because they did not want someone else bringing up their children, or did not want their own children to worry about encountering an unknown sibling someday.
Forty-three percent did not want the embryos discarded. About 66 percent said they would be likely to donate the embryos for research, but that option was available at only four of the nine clinics in the survey. Twenty percent said they were likely to keep the embryos frozen forever.
Embryos can remain viable for a decade or more if they are frozen properly but not all of them survive when they are thawed.
Smaller numbers of patients wished for solutions that typically are not offered. Among them were holding a small ceremony during the thawing and disposal of the embryos, or having them placed in the woman’s body at a time in her cycle when she would probably not become pregnant, so that they would die naturally.
The message from the survey is that patients need more information, earlier in the in vitro process, to let them know that frozen embryos may result and that deciding what to do with them in the future “may be difficult in ways you don’t anticipate,” said Dr. Anne Drapkin Lyerly, the first author of the study and a bioethicist and associate professor of obstetrics and gynecology at Duke University.
Dr. Lyerly also said discussions about the embryos should be “revisited, and not happen just at the time of embryo freezing, because people’s goals and their way of thinking about embryos change as time passes and they go through infertility treatment.”
Many couples are so desperate to have a child that when eggs are fertilized in the clinic, they want to create as many embryos as possible, to maximize their chances, Dr. Lyerly said. At that time, the notion that there could be too many embryos may seem unimaginable. (In Italy, fertility clinics are not allowed to create more embryos than can be implanted in the uterus at one time, specifically to avoid the ethical quandary posed by frozen embryos.)
In a previous study by Dr. Lyerly, women expressed wide-ranging views about embryos: one called them “just another laboratory specimen,” but another said a freezer full of embryos was “like an orphanage.”
Dr. Mark V. Sauer, the director of the Center for Women’s Reproductive Care at Columbia University Medical Center in Manhattan, said: “It’s a huge issue. And the wife and husband may not be on the same page.”
Some people pay storage fees for years and years, Dr. Sauer said. Others stop paying and disappear, leaving the clinic to decide whether to maintain the embryos free or to get rid of them.
“They would rather have you pull the trigger on the embryos,” Dr. Sauer said. “It’s like, ‘I don’t want another baby, but I don’t have it in me; I have too much guilt to tell you what to do, to have them discarded.’ ”
A few patients have asked that extra embryos be given to them, and he cooperates, Dr. Sauer said, adding, “I don’t know if they take them home and bury them.”
Federal and state regulations have made it increasingly difficult for those who want to donate to other couples, requiring that donors come back to the clinic to be screened for infectious diseases, sometimes at their own expense, Dr. Sauer said.
“It’s partly reflected in the attitude of the clinics,” he said, explaining that he does not even suggest that people give embryos to other couples anymore, whereas 10 years ago many patients did donate.
Ms. Best said her nine embryos “have the potential to become beautiful people.”
The thought of giving them up for research “conjures all sorts of horrors, from Frankenstein to the Holocaust,” she said, adding that destroying them would be preferable.
Her teenage daughter favors letting another couple adopt the embryos, but, Ms. Best said, she would worry too much about “what kind of parents they were with, what kind of life they had.”
Another survey participant, Lynnelle Fowler McDonald, a case manager for a nonprofit social service agency in Durham, N.C., has one embryo frozen at Duke, all that is left of three failed efforts at the fertility clinic.
Given the physical and emotional stress, and the expense of in vitro fertilization, Ms. McDonald said she did not know whether she and her husband could go through it again. But to get rid of that last embryo would be final; it would mean they were giving up.
“There is still, in the back of my mind, this hope,” she said.
At the Genetics and IVF Institute in Fairfax, Va., Andrew Dorfmann, the chief embryologist, said many patients were genuinely torn about what to do with extra embryos, and that a few had asked to be present to say a prayer when their embryos were thawed and destroyed.
Jacqueline Betancourt, a marketing analyst with a software company who took part in the survey, said she and her husband donated their embryos at Duke “to science, whatever that means.” It was important to them that the embryos were not just going to be discarded without any use being made of them.
Ms. Betancourt, who has two sons, said: “We didn’t ask many questions. We were just comfortable with the idea that they weren’t going to be destroyed. We didn’t see the point in destroying something that could be useful to science, to other people, to helping other people.”
Ms. Betancourt said she wished there had been more discussion about the extra embryos early in the process. If she had known more, she said, she might have considered creating fewer embryos in the first place.
This micrograph shows a colony of undifferentiated human embyonic stem cells.
Credit: Argonne National Laboratory
Dubious stem cell therapies are being advertised directly to consumers via the internet.
MIT Technology Review, December 9, 2008, by Emily Singer — Nearly 20 companies across the globe are peddling dubious stem cell therapies directly to consumers, according to a study published today in the journal Cell Stem Cell. These companies, offering treatments for disorders ranging from autism and Parkinson’s disease to spinal cord injury and heart disease, provide little proof that their therapies are truly stem cells, and little experimental evidence exists in the scientific literature to back their claims. The treatments are expensive–Timothy Caulfield of the University of Alberta in Canada and his colleagues found that the average price was about $21,500 among the sites listing price.
In the same journal, the International Society for Stem Cell Research issued a set of guidelines to ensure responsible research. According to a statement from the society, “These guidelines define a roadmap for medical researchers and doctors, outlining what needs to be accomplished to move stem cells from promising research to proven treatments for patients.”
According to an article from HealthDay:
“Stem cell research is progressing so rapidly and has sparked a lot of interest in translational research [including] among patients in hopes for therapies,” said Insoo Hyun, lead author of the paper outlining the guidelines and an associate professor of bioethics at Case Western Reserve University School of Medicine in Cleveland.
“At the same time,” he said, “legitimate science is speeding ahead and getting to the point where there needed to be more of a road map to take the basic knowledge to clinical applications.”
Different clinics in China (Beike Biotech), the Ukraine (ACT) and elsewhere claim to have treated thousands of patients for neurological disorders including multiple sclerosis, Parkinson’s disease, spinal cord injury and Alzheimer’s disease, congenital conditions such as autism and cerebral palsy, as well as allergies, heart conditions and even cosmetic procedures. However, the University of Alberta team was unable to find any studies that had even investigated stem cell therapy for Parkinson’s disease or for Alzheimer’s, for example.
Nowhere, apparently, was there any authentication of whether the stem cells actually were stem cells, or where they had come from.
“Most of the time, stem cell products are presenting entirely novel products that are unpredictable in humans,” Hyun said. “Unlike drugs, you can’t just create a batch and put them on the shelf and expect they will be the same. We need uniform quality control and manufacturing. And if they’re embryonic or pluripotent stem cells, they could form unwanted tissues or tumors. So, we have to be very careful about following up and monitoring patients.”
A 2005 feature in Technology Review, “The Problematical Dr. Huang Hongyun”, examined the practices of a Chinese physician offering cell therapy for spinal cord injury.
It’s not clear what kind of impact the guidelines, which are not binding, will have on companies and clinics offering these dubious treatments.
According to an article on the Nature news site:
Olle Lindvall, a professor of neurology at Lund University in Sweden and one of the two co-chairs of the task force, doubts that the guidelines will cause clinics operating outside the scientific mainstream to reform. “More of the clinics are interested in making money than in helping patients,” he says. But, he adds, “we hope that governments and regulatory bodies will act so that these clinics will have to close.”