• Eric Topol MD: The Wireless Future of Medicine

Eric Topol is a leading cardiologist who has embraced the study of genomics and the latest advances in technology to treat chronic disease.

Why you should listen to him:

As director of the Scripps Translational Science Institute in La Jolla, California, Eric Topol uses the study of genomics to propel game-changing medical research. The Institute combines clinical investigation with scientific theory, training physicians and scientists for research-based careers. He also serves on the board of the West Wireless Health Institute, discovering how wireless technology can change the future of health care.

In his early career, Topol was credited with leading the cardiovascular program at Cleveland Clinic to the topmost position in the US. Eric Topol, M.D. is a noted American cardiologist, geneticist and administrator. He is the Director of the Scripps Translational Science Institute, in La Jolla, California, which is a National Institutes of Health funded flagship grant, to accelerate research to change medicine. He also serves as the Chief Academic Officer for Scripps Health, a Professor of Translational Genomics at The Scripps Research Institute, and was recently named The Gary and Mary West Chair of Innovative Medicine. In addition, he serves on the Board of the West Wireless Health Institute as Chief Medical Officer.

In 2008, Topol launched an impressive large-scale long-term study of personal genetic testing to assess its impact on people who choose to get tested. Through the Scripps Genomic Health Initiative, his team is following 10,000 people who take a Navigenics genetic test to see if the knowledge they glean from the process encourages them to improve their lifestyle and get regular and recommended health care. Topol’s team is also assessing the psychological impact of genetic testing, and whether participants are able to prevent or delay diseases such as type 2 diabetes, some cancers, Alzheimer’s disease and more by taking action after getting their results. Besides the Scripps Translational Science Institute, study partners include Navigenics, Affymetrix and Microsoft.

Before this, he was Professor of Genetics at Case Western Reserve University School of Medicine. He was the Founder of the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. Prior to moving to Case Western, Topol was Chairman of Cardiovascular Medicine at the Cleveland Clinic where he is widely credited with leading its cardiovascular program to the topmost position in the US. Topol left the Cleveland Clinic in early 2006 after drawing “attention to the mounting tensions between the clinic’s research mission and its deep ties to the businesses that finance that research.

Topol gained prominence as the first physician researcher to raise questions about the safety of Vioxx. He has been elected to the Institute of Medicine of the National Academy of Sciences. He was named Doctor of the Decade by the Institute for Scientific Information for being one of the top 10 most cited medical researchers.

  • Catherine Mohr MD: Surgery’s past, present and robotic future

Surgeon and inventor Catherine Mohr tours the history of surgery (and its pre-painkiller, pre-antiseptic past), then demos some of the newest tools for surgery through tiny incisions, performed using nimble robot hands. Fascinating.

Catherine Mohr works on surgical robots and robotic surgical procedures, using robots to make surgery safer — and to go places where human wrists and eyes simply can’t.

Why you should listen to her:

Catherine Mohr began her career as an engineer, working for many years with Paul MacCready at AeroVironment to develop alternative-energy vehicles and high-altitude aircraft. Her midcareer break: medical school, where she invented a brilliantly simple device, the LapCap, that makes laproscopic surgeries safer.

Mohr now oversees the development of next-generation surgical robots and robotic procedures, as the director of medical research at Intuitive Surgical Inc. She also works at Stanford’s School of Medicine, where she studies simulation-based teaching methods to teach clinical skills to budding doctors. And she’s a senior scientific advisor to the GlobalSolver Foundation, an innovative funding and study group that looks at ways to match up scientists and money to help the world’s oceans.

“They take away some of the impreciseness of the human hand.”

Dr. Nikhil Shaw on CNN.com

  • Dr. Paul Ewald asks, Can we domesticate germs?

Evolutionary biologist Paul Ewald drags us into the sewer to discuss germs. Why are some more harmful than others? How could we make the harmful ones benign? Searching for answers, he examines a fascinating case: diarrhea.

After years of studying illness from the germs’ point of view, microbiologist Paul Ewald believes that Big Pharma is wrong about some very big issues. What’s right? The leader in evolutionary medicine posits radical new approaches.

Why you should listen to him:

Paul Ewald has a problem with modern medicine: It ignores the fact that many diseases of unknown origin can be linked to slow-growing infections caused by viruses, bacteria and other microorganisms.

Ewald — whose theory stems from both a formal education in biological sciences, ecology, and evolution, and a personal bout with diarrhea in the 1970s — aims to change this thinking. To that end, he has written popular news articles, academic papers, and two books (Evolution of Infectious Disease and Plague Time) that explain and expand his idea. Ewald is regarded as the leading expert in the emerging field of evolutionary medicine. He directs the evolutionary medicine program in the Biology department at the University of Louisville, Kentucky, and lectures worldwide.

Among other honors, Ewald was the first recipient of the Smithsonian Institution’s George E. Burch Fellowship in Theoretic Medicine and Affiliated Sciences, which was established to foster pioneering work in health sciences.

“Ewald smashe[s] the old, and unfortunately still widely accepted, notion that parasites and their hosts inevitably evolve toward a benign coexistence.”

Scientific American

Paul W. Ewald specializes in the evolution of infectious disease. He received his B.Sc. in 1975 from the University of California, Irvine, in Biological Sciences and his Ph.D. in 1980 from the University of Washington, in Zoology, with specialization in Ecology and Evolution. He is currently director of the program in Evolutionary Medicine at the Biology Department of the University of Louisville.

Ewald asserts, along with a growing body of peer reviewed studies published in mainstream scientific journals, that many common diseases of unknown origin are in fact the result of the presence of slowly acting infections caused by viruses, bacteria or protozoa. For example, cervical cancer can be caused by the human papilloma virus; some cases of liver cancer are caused by hepatitis C or B; the bacteria Helicobacter pylori has been proven to cause stomach ulcers. His research extends these findings to a wide variety of other ailments.

Ewald disagrees with the popular theory that genes alone dictate certain disease susceptibility. He says “A disease-causing gene that reduces survival and reproduction would normally eliminate itself over a number of generations.” One example of this is schizophrenia; patients with the mental illness rarely reproduce. Schizophrenia may be caused by Borna virus. He argues that this disease would have already been eliminated if it were from a strictly genetic cause. He also points out that in the case of gene sharing identical twins where one develops breast cancer, the other twin has only a 20% chance of developing the disease.

His background in evolutionary biology helped form these theories, not to discredit a fateful case of diarrhea in the late 1970s. His first thought during this bout was that his body was using diarrhea to expel the pathogen and he should avoid anti-diarrheal medication. Looking at the problem from the standpoint of the organism, expulsion was not an evolutionary benefit. The only benefit to the pathogen causing the sickness would be the potential transmission to other hosts; much like the particulate expelled during coughing, diarrhea can be a means of distribution. This thinking sparked his curiosity of the evolutionary process of infections.

Another major influence has been the AIDS virus which is inactive for years (allowing it to spread) before terminal, chronic and deteriorative ailments incapacitate and finally kill the victim.

The apparent evolutionary disadvantage of homosexuality has led Ewald to argue that it might be caused by an as-yet undetected virus working in utero that triggers hormonal responses. (See pathogenic theory of homosexuality).

Quotes

  • “[Ewald’s theory] opens our eyes to many quite weird possibilities about disease that most medical scientists, tending to be unaware of current evolutionary thought, don’t think of.” – William D. Hamilton

BusinessWeek.com, GoogleNews.com, April 1, 2010, by Tim Greene  –  Researchers at the University of Florida have combined RFID, microchips and printed nano-particle antennas to make pills that communicate with cell phones or laptops to tell doctors whether patients are taking their medicine.

Tech Secrets: 21 Things ‘They’ Don’t Want You to Know

Still a prototype, the inventors hope their tattletale technology can be applied commercially to a range of medications in clinical trials and in treatment of patients with chronic diseases in which it is essential that the doses are taken and taken on time.

The pill is a white capsule with a microchip embedded and with an antenna printed on the outside with ink containing silver nanoparticles. A device worn by the patient energizes the microchip via bursts of low-voltage electricity. The chip signal confirms the pill is in the stomach and the device sends a signal that the pill has been swallowed. The messages can go to cell phones or laptops to inform doctors or family members.

The printed antenna dissolves, leaving traces of silver no greater than traces that can be found in tap water. The chip passes through the patient intact and is eliminated through the gastrointestinal tract.

The pill has been tested in models that approximate humans and in cadavers. The researchers used simulated stomach acid to determine that the antennas break down and what residue they leave behind.

Patients frequently forget or refuse to take their medicine, resulting in expensive complications that can endanger health, says Rizwan Bashirullah, an assistant professor of electrical and computer engineering at UF who led the research, which was funded by $700,000 in grants from the National Science Foundation, Convergent Engineering and the Florida High Tech Corridor Council.

A UF spinoff company is seeking to develop the next generation of the pill that will be suitable for FDA testing. The researchers have applied for patents on the pills.

A university release about the project says that failure to take prescriptions on schedule is the number one problem in treating illness, according to the American Heart Association.

Read more about anti-malware in Network World’s Anti-Malware section.

Original story – http://www.networkworld.com/nwlookup.jsp?rid=205251

Is Alzheimer’s disease actually a form of diabetes?

PET scan of a brain with Alzheimer’s disease

The-Scientist.com, by Amanda Schaffe  –  When the brazen James Watson had his genome sequenced, he declined to find out whether he carried a gene variant that would increase his risk for Alzheimer’s disease. Ditto for Steven Pinker. There are virtually no treatment or prevention options for those who have or are at risk for Alzheimer’s. Nor do scientists fully understand what causes it, though for years, opposing camps have duked it out over hypotheses that have focused largely on brain abnormalities called plaques and others called tangles, neither of which has so far proved a good therapeutic target.

Now some experts are proposing an avant-garde way of approaching Alzheimer’s: as a form of diabetes. Some even dub it “type 3 diabetes” or “diabetes of the brain.” The idea is that memory loss and cognitive deterioration in at least some Alzheimer’s patients may be caused by low insulin or insulin resistance in the brain, much as lack of production or poor response to insulin in the body is central to the pathologies of type 1 and type 2 diabetes. Effective Alzheimer’s treatments, then, might aim to boost brain insulin levels or decrease resistance while addressing destructive factors like inflammation and oxidative stress. If the theory holds up, as early research suggests, it could be a boon to a field scarred by disappointments and dead ends.

Alzheimer’s researchers have been bitterly divided over what initially causes the disease and where to look for treatments. For years, the dominant view was that plaques—sticky deposits of a protein called beta-amyloid—were the central culprits, destroying neurons and causing cognitive decline. More recently, some researchers in the amyloid camp have begun to focus on toxic, soluble forms of the protein, rather than the plaques themselves, as the real instigator. At the same time, another faction has emphasized abnormal modifications of a protein called tau that results in so-called tangles, which also turn up in brains ravaged by Alzheimer’s. But neither the plaques nor the tangles seem to account fully for the onset of the disease. Plaques often appear in the brains of elderly people without Alzheimer’s, and some evidence suggests that tangles form later in the disease’s progression, rather than triggering it. Nor has either abnormality yet proven to be a fruitful target for new drugs. Meanwhile, the pitched battles have done damage to the field. It’s been “one army against another,” a prominent researcher told me. “You see them fighting at meetings,” she says.

Which brings us to insulin. Insulin is the hormone that allows cells, including some brain cells, to take up energy in the form of glucose. Proper insulin function in the brain appears necessary to the formation and maintenance of memories. And, crucially, a lack of insulin or insulin resistance is connected both to amyloid protein regulation and to the modification of tau proteins, which can cause tangles. In other words, insulin seems to hold up a conceptual umbrella under which the amyloid and the tangle camps might finally meet. (Type 2 diabetes is also a risk factor for Alzheimer’s and cognitive decline.

 In 2005, researchers at Brown University showed that by knocking out insulin production and causing brain insulin resistance in rats, they could create a model of Alzheimer’s, complete with plaques and abnormal accumulations of tau. (Suzanne de la Monte, who led this group, was the first to dub Alzheimer’s “type 3 diabetes.” She reviews the evidence to date on this theory here.) Scientists have also described links between abnormal insulin and other hallmarks of Alzheimer’s, such as oxidative damage and inflammation. And Bill Klein at Northwestern found that in an in vitro model using rats’ brain cells, insulin could shield the cells from an onslaught of soluble amyloid proteins. That is, he found that when memory-forming cells from the brain’s hippocampus were dosed with insulin, their cell connections were not as badly damaged by the amyloids. This suggests insulin might help to preserve or improve memory circuitry in the face of disease.

Insulin-related therapies look preliminarily good in clinical trials, too. In 2007, researchers in Seattle conducted a small, randomized clinical trial in which patients with early Alzheimer’s disease received daily puffs of insulin in the nose for 21 days. (The team chose this method of administration so that the insulin would move more directly to the brain without circulating throughout the body, where it might cause an unwanted drop in blood glucose.) The group, led by Suzanne Craft of the VA Puget Sound Medical Center, found that patients who received insulin were better able to pay attention to a story that was read to them and recall details 20 minutes later. Their caregivers also rated their mental functioning more highly. The team is now conducting a larger clinical trial.   Craft says she is optimistic that insulin may open new doors for Alzheimer’s patients. However, she shies away from dubbing the disease a “diabetes of the brain,” noting that diabetes is normally diagnosed on the basis of elevated glucose levels, which do not appear to be at play here.

Other promising, early results come from the diabetes drug rosiglitazone, which has a checkered reputation. In patients with type 2 diabetes, rosiglitazone (aka Avandia) acts to increase insulin sensitivity in the body. But it may also raise the risk of heart attacks. The hope is that in some Alzheimer’s patients, at least, the drug will have benefits for the brain—without the cardiovascular downside. In a small trial in 2005, Alzheimer’s patients who received rosiglitazone for six months showed better attention and better recall than those who received a placebo. A more substantial, phase-two trial, published in 2006 and sponsored by GlaxoSmithKline (which makes the drug), found that patients who received rosiglitazone also fared better after 24 weeks of treatment—but only if they did not carry a particular gene variant. (This variant, called APOE-E4, is known to predispose people to the disease.)

GSK has sponsored several multinational phase-three trials, involving roughly 3,000 patients in 22 countries, which are expected to show more definitively whether rosiglitazone helps to improve cognition and functional capacity in patients with mild to moderate disease. GSK researcher Michael Gold says that the Data Safety and Monitoring Board, which oversees these studies and has access to unblinded data, has not signaled a need to change or stop the studies based on safety. Still, researchers like Craft, who has served as a consultant to GSK, suggest that other drugs in the same chemical class as rosiglitazone might ultimately offer benefits to Alzheimer’s patients with less cardiovascular risk.

Of course, taking intranasal insulin or a diabetes drug like rosiglitazone is not the only possible way to boost the brain’s sensitivity to insulin. Another, even better option may be to do aerobic exercise, says Craft. And this seems to hold for older adults in general, including those without Alzheimer’s: Better insulin signaling and glucose uptake in the brain may offer them a cognitive boost as well. One more reason, it seems, to close the medicine cabinet and work up a good sweat.

Times of India, 11 January 2010

                   
A new study by scientists at Temple University in Philadelphia has shown that the DNA of babies conceived through IVF differs from that of other kids, putting them at higher risk of diseases such as diabetes and obesity later in life. 

According to researchers, their study could explain why IVF babies tend to be at higher risk of low birth weight, defects and rare metabolic disorders. 

The changes are not in the genes themselves but in the mechanism that switches them on and off, the study of which is known as epigenetics. 

“These epigenetic differences have the potential to affect embyronic development and foetal growth, as well as influencing long-term patterns of gene expression associated with increased risk of many human diseases,” Times Online quoted Professor Carmen Sapienza, a geneticist at Temple University in Philadelphia, who jointly led the research, as saying. 

There is a possibility that such changes could be transmitted to the children of IVF babies, meaning they could spread through the human gene pool. 

For the study, Sapienza and his colleagues took blood samples from the placenta and umbilical cords of 10 IVF children and 13 children who were naturally conceived. 

They studied the DNA of cells taken from the blood to see if there were differences in the level of methylation. 

This is the process by which molecules known as methyl groups are attached to genes to shut them down when they are not needed. 

The results showed that the level of methylation in the cells taken from IVF babies was significantly lower – implying that some genes were becoming active at the wrong times. 

“We have shown that in vitro conception is associated with differences in gene methylation and that some of these differences may affect gene expression,” said Sapienza. 

According to the researchers, the findings could have serious implications for the booming industry in assisted reproduction. 
http://timesofindia.indiatimes.com/life/health-fitness/health/IVF-babies-at-higher-diabetes-obesity-risk/articleshow/5430340.cms

All Press Releases for April 1, 2010

Leading Orthopaedic Surgeon and acclaimed Regenerative Medical Authority Dr. Thomas A. Einhorn Advances Safe and Successful Adult Stem Cell Therapy To Eliminate Hip Replacement Surgery in Patients 60 and under who have Avascular Necrosis

Boston, MA (PRWEB) April 1, 2010 — Dr. Thomas A. Einhorn, internationally renowned Orthopaedic Surgeon and Chairman of the Department of Orthopaedic Surgery and Professor of Orthopaedic Surgery, Biochemistry and Biomedical Engineering at Boston University, is safely reversing early avascular necrosis (AVN) of the hip in patients aged 20 to 60 with his innovative Bone Marrow Aspirate Concentration (BMAC) treatment utilizing Adult Stem Cells. Harvesting non-embryonic stem cells from one’s own bone marrow, Dr. Einhorn has for the past two years successfully reduced, and in many cases eliminated, AVN using the direct inoculation of autologous bone marrow stem cells, a method that reduces the risk of rejection. This safe alternative to the more invasive hip replacement, practiced safely by only a select few surgeons nationwide, grows new bone for restoration of function and pathology of hip joints. “The idea is that once the stem cells are in the cavity, they will induce the development of new blood vessels and start to grow, differentiating into bone tissue,” says Dr. Einhorn. “This new bone tissue should then use the surrounding necrosed tissue as a scaffold, putting living bone back where it belongs.” After the procedure, patients can bear full weight after a week, and resume exertional physical activity at six months.

Dr. Einhorn believes “A total hip replacement is often a sub-optimal solution for patients under 60 years of age due to possible activity restrictions and the fact that a synthetic hip joint will wear out with time. Stem cell therapy could prevent some patients from requiring this operation.”

Dr. Einhorn’s BMAC procedure, which used my own stem cells injected into a core decompression to generate new bone, changed my life. No longer in a wheelchair, I am able to kick a soccer ball and ride bikes with my son, and to take walks with my husband.

Einhorn’s Groundbreaking Stem Cell Treatment Substantiated by Clinical Protocol and Extensive Research

With numerous unsubstantiated claims pertaining to stem cell cures for conditions that include cardiac failure, multiple sclerosis, osteoarthritis, neurological disorders, tissue regeneration, and muscle damage, Dr. Einhorn advises patients to be cautious when selecting stem cell treatments, as many have not been proven safe or effective. As Einhorn reported at the March 2010 American Academy of Orthopaedic Surgeon’s Annual Meeting, “In the last decade, there has been a lot of excitement with the development of new procedures and technologies. It is critical now to push the envelope on research to determine if these new technologies are effective.”

To support his high success rate with BMAC stem cell treatments, Dr. Einhorn is conducting a four-year prospective case series study, initiated in December, 2009, which has been approved by his Institutional Review Board. Its purpose is to assess the relationship between clinical results in the patient and several indices of stem cell vitality that include the number and distribution of specific types of stem cells, the ability of those cells to grow in cell culture in the laboratory, the ability of stem cells to make tissue that can calcify like bone, and the ability of cells to induce the formation of blood vessels, as blood vessels enhance healing. In addition, Dr. Einhorn will quantitate the patient’s functional and systemic recovery, and release preliminary results at periodicintervals at national and international medical society congresses.

Dr. Einhorn’s research at the Boston University Orthopaedic Research Lab has been funded by the National Institutes of Health since 1990. Working closely with a team of 50 physicians and scientists, including orthopaedic surgeons, Ph.D. scientists, graduate students, orthopaedic doctors in training, nurse practitioners, and post doctorate fellows, Dr. Einhorn continues to research and develop new therapies to enhance the repair of bone, and the blood supply to bone.

Stem Cell Therapy could eventually eliminate the need for joint replacement,” says Dr. Einhorn. Rather than surgically replacing joints, as has been the standard medical approach in the past, therapies of the future will focus on the use of stem cells and gene therapy in the new scientific field of tissue re-engineering. “It’s the future of our specialty,” adds Dr. Einhorn.   

“In July of 2008 I traveled from Texas to Boston for a BMAC procedure with Dr. Einhorn. Over the previous two years I had undergone multiple surgeries for Avascular Necrosis in both hips and the right knee. While the surgeries helped for awhile, they were not a solution, and I had no choice but to use a wheelchair.Through my research, I learned about Dr. Einhorn and the BMAC procedure, which used my own stem cells injected into a core decompression to generate new bone. I emailed Dr. Einhorn and within minutes I had a reply and was speaking to his assistant. I was overjoyed to make contact with a doctor that was so sincerely willing to listen to my case.In It has been a little over a year since my stem cell procedure performed by Dr. Einhorn. I arrived in Boston using a wheelchair and crutches. Today I am able to kick a soccer ball with my 8 year old son. I am able to run around the park with him and ride bikes together. I am able to hold hands with my husband on evening walks. Being in a wheelchair did not stop me from living, but now I live life on my terms- and on my own two feet. Dr. Einhorn and his entire team were tantamount to my recovery.” Cindy Preece, Dallas, Texas

Thomas A. Einhorn, M.D., is Chairman of the Department of Orthopaedic Surgery, and Professor of Orthopaedic Surgery, Biochemistry and Biomedical Engineering at Boston University. Since 1982, Einhorn has been regarded as a leading surgeon specializing in

 

reconstructive surgery of the hip and knee in Boston and New York. Internationally acclaimed as an authority in the field of regenerative medicine, an area heralded as the future of orthopaedics, Dr. Thomas A. Einhorn has been consistently recognized in Castle Connolly’s America’s Top Doctors, Best Doctors, Best Doctors of Boston, and Best Doctors of New York.

WebMD.com (Heartwire), by Michael O’Riordan, March 31, 2010 (New York, New York) — Do statins work equally for men and women? That’s the question put forth by Time magazine last week in an article examining the relative risks and benefits between the sexes. While some question whether the evidence is strong enough to support their use, most experts believe that the lipid-lowering medications have undeniable value in women and worry the Time article may cause undue fear or drug cessations.

“I think a take-home point is that, on average, women have lower risks of coronary heart disease than men, at any age and over a lifetime,” Dr James Stein (University of Wisconsin, Madison) told heartwire . “So it is more difficult for a woman to reach risk thresholds that indicate need for treatment. But heart disease is the leading killer of women. If you are at increased risk, it does not matter if you are male or female–you need intervention, and statins are effective and safe in both men and women.” 

The article, by Catherine Elton, documents the case of one woman, “healthy by nearly every measure–except her cholesterol level,” treated with a statin that led to severe muscle pain. Eventually, the myopathy is so severe, she stops the statin. Another woman, with high cholesterol and diabetes, begins treatment with a statin and soon forgets how to do basic math and gets lost driving to familiar places.

“Researchers also don’t know why women are more likely than men to suffer side effects from statins and many other drugs but posit that lower body weight and hormonal fluctuations play a role,” writes Elton. “Biological explanations aside, the larger point is the same: with any treatment, the benefits should outweigh the risks.”

Dr Richard Karas (Tufts University Medical Center, Boston, MA) told heartwire the article is “having a large impact in the community” and that he disagrees with the fear and uncertainty it may have caused. Patients are upset, he added, and are calling clinicians asking if they should stop their medication.

Lower Absolute Risk in Women

Speaking with heartwire, Dr James de Lemos (University of Texas Southwestern, Dallas) said that he “finds it hard to believe there are any biological differences in the effects of statins between the sexes.” The relevant issue, he said, is that women have a lower absolute risk of ischemic events than men, and this alters the risk/benefit profile, as well as the relative costs. He added that “myopathy is a bit more common in women, but usually in older women, usually treated with higher doses of statins.” He said statin therapy typically doesn’t pose a problem in younger women treated with the drugs.

Regarding the side effects, Karas noted that women are smaller and tend to be older when they are prescribed statins, and this might contribute to the different side-effect profile between the sexes. Still, these differences are not reasons enough to think the drugs would benefit women to a lesser extent than men, especially since LDL cholesterol predicts coronary heart disease risk in women.

Dr Scott Grundy (University of Texas Southwestern, Dallas) told Time that the “underrepresentation of women in drug trials does not discount statins’ benefit; it results only in a failure to show a statistically significant effect,” something most experts polled by heartwire also believe.

Grundy highlighted a recent analysis of Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER), a study he believes provides evidence supporting the use of the cholesterol-lowering medication in women. In that analysis, looking just at women enrolled in JUPITER, led by Dr Samia Mora (Brigham and Women’s Hospital, Boston, MA), rosuvastatin 20 mg significantly reduced the relative risk of the primary end point–a composite of MI, stroke, revascularization, hospitalization for unstable angina, and death from cardiovascular causes–by 46% [2]. The reduction in risk was supported by evidence in a meta-analysis of 13 154 women included in primary-prevention statin trials.

In addition to these findings, Stein pointed to the Cholesterol Treatment Trialists’ collaboration, a prospective meta-analysis of data from 90 056 subjects in 14 randomized statin trials from 1994 to 2000, a study that found no difference in statin effectiveness by sex.

In Time, Elton writes that the women were more likely to develop diabetes than men in JUPITER and that the number needed to treat to prevent one event was also higher. Moreover, the article suggested that the reduction in clinical events was the result of larger reductions in softer end points, such as hospitalization for unstable angina and revascularization.

Dr Rita Redberg (University of California San Francisco), who is quoted in the Time article, told heartwire the key issue is that “millions of healthy American women are taking statins, which have never been shown to reduce MI or lengthen life and have an untold number of side effects, worse in women than men.”

To heartwire , de Lemos said these findings are likely the result of a lack of statistical power. With fewer women and their lower baseline risk, it is harder to demonstrate a benefit, he said. Dr Pamela Douglas (Duke University, Durham, NC) agreed, adding that this “also may mean that the threshold for use should be different in men and women, but it doesn’t mean statins don’t have value in women. de Lemos added that clinicians are now beginning to address the importance of lifetime risk, and from this perspective, even in women with lower baseline risk, statin therapy reduces clinical events.

In response to the Time article, as well as a recent Food and Drug Administration advisory released last week about simvastatin (Zocor, Merck/Schering-Plough), the American Heart Association (AHA) issued a commentary reminding “patients that controlling cholesterol is critical for preventing coronary heart disease and reducing heart attack.” It says that myopathy is uncommon and reversible, but it can be a reason to discontinue or reduce the dose of treatment.

“Because of the well-documented benefit of cholesterol lowering with statins, the association advises that patients respect the benefit of statin therapy and consider discontinuation only after a discussion with the appropriate healthcare provider,” according to the AHA. “For the person who experiences myopathy with a statin, other alternatives should be discussed with their physician. Patients who are taking statins and not experiencing any side effects should continue to take their medication unless advised for other reasons to stop by their healthcare provider.”

Karas reports receiving research grants from AstraZeneca and Kos Pharmaceuticals; serving on the speakers’ bureaus of and/or receiving honoraria from Kos, AstraZeneca, Merck, and Pfizer; and serving as a consultant to Kos Pharmaceuticals. de Lemos reports consulting fees/honoraria from Tethys and Johnson & Johnson; speaker’s bureau fees from the Bristol-Myers Squibb/Sanofi-Aventis partnership; research grants from Roche; serving on the data safety and monitoring board of Bristol-Myers Squibb; and financial benefits from AstraZeneca and Daiichi-Sankyo. Stein reports research grants from Siemens and serving on the data safety and monitoring board of Abbott, Lilly, and Takeda. Grundy reports grant and research support from Bristol-Myers Squibb, Merck, and Pfizer and serving as a consultant or on the advisory board of Merck, Merck/Schering-Plough, AstraZeneca, Pfizer, and GlaxoSmithKline. Redberg reports no conflicts of interest.