F.D.A. Approves a Stem Cell Trial - And It Is Probably Not A Good Thing

Moral of the story: Playing with fire. This is not the trial that should be done first for embryonic stem cells. The backlash to poor results, which are likely given the data thus far, could be absolutely tremendous. This is yet another example of the FDA doing a shitty job at regulating pharma. Shame on Gera and shame on the FDA and shame on former President Bush.

F.D.A. Approves a Stem Cell Trial
http://www.nytimes.com/2009/01/23/business/23stem.html?ref=health

By ANDREW POLLACK
Published: January 23, 2009
In a research milestone, the federal government will allow the world’s first test in people of a therapy derived from human embryonic stem cells.

Federal drug regulators said that political considerations had no role in the decision. Nevertheless, the move coincided with the inauguration of President Obama, who has pledged to remove some of the financing restrictions placed on the field by President George W. Bush.
The clearance of the clinical trial — of a treatment for spinal cord injury — is to be announced Friday by Geron, the biotechnology company that first applied to the Food and Drug Administration to conduct the trial last March. The F.D.A. had first said no, asking for more data.
Thomas B. Okarma, Geron’s chief executive, said Thursday that he did not think that the Bush administration’s objections to embryonic stem cell research played a role in the F.D.A.’s delaying approval.
“We really have no evidence,” Dr. Okarma said, “that there was any political overhang.”
But others said they suspected it was more than a coincidence that approval was granted right after the new administration took office.
“I think this approval is directly tied to the change in administration,” said Robert N. Klein, the chairman of California’s $3 billion stem cell research program. He said he thought the Bush administration had pressured the F.D.A. to delay the trial.
Mr. Klein called the approval of the first human trial of this sort “an extraordinary benchmark.”
Stem cells derived from adults and fetuses are already being used in some clinical trials, but they generally have less versatility than embryonic stem cells in terms of what tissue types they can form.
The F.D.A. approval comes a little more than 10 years after the first human embryonic stem cells were isolated at the University of Wisconsin, in work financed by Geron.
Because the cells can turn into any type of cell in the body, the theory is they may one day be able to provide tissues to replace worn-out organs or nonfunctioning cells to treat diabetes, heart attacks and other diseases. The field is known as regenerative medicine.
The Bush administration restricted federal financing for research on embryonic stem cells because creation of the cells entails the destruction of human embryos.
Geron’s trial will involve 8 to 10 people with severe spinal cord injuries. The cells will be injected into the spinal cord at the injury site 7 to 14 days after the injury occurs, because there is evidence the therapy will not work for much older injuries.
The study is a so-called Phase I trial, aimed mainly at testing the safety of the therapy. There would still be years of testing and many hurdles to overcome before the treatment would become routinely available to patients.
Geron, which is based in Menlo Park, Calif., said that it had identified up to seven medical centers for the trial but that those sites must first get permission from their own internal review boards to participate.
Even as some researchers hailed the onset of clinical trials, others expressed trepidation that if the therapy proves unsafe — or even if it is safe but does not work — it could cause a backlash that would set the field back for years.
“It would be a disaster, a nightmare, if we ran into these kinds of problems in this very first trial,” said Dr. John A. Kessler, the chairman of neurology and director of the stem cell institute at Northwestern University.
Dr. Kessler, whose own daughter was paralyzed from the waist down in a skiing accident, said he thought Geron’s therapy was not the ideal candidate for the first trial. He said results showing the therapy worked in moderately injured animals might not apply to more seriously injured people.
“We really want the best trial to be done for this first trial, and this might not be it,” he said.
Dr. Okarma of Geron emphasized that the purpose of the first trial was safety, so that lack of efficacy should not be a problem. While researchers will also look for signs the treatment works, he said, the best that could be hoped for would be some slight restoration of function that could then be enhanced through physical therapy.
“We don’t expect to take someone who is completely paralyzed from the waist down and have them dance six months later,” he said. If the first trial shows safety, the company would then hope to test higher doses of cells and treat patients with less severe injuries, he said.
Geron’s therapy involves using various growth factors to turn embryonic stem cells into precursors of neural support cells called oligodendrocytes, which are then injected into the spinal cord at the site of the injury.
The hope is that the injected cells will help repair the insulation, known as myelin, around nerve cells, restoring the ability of some nerve cells to carry signals. There is also some hope that growth factors produced by the injected cells will spur damaged nerve cells to regenerate.
The therapy was developed in collaboration with Hans Keirstead of the University of California, Irvine. He has shown videos of paralyzed rats that were able to walk again, albeit imperfectly, after receiving the therapy. Those videos helped persuade California voters to approve the $3 billion stem cell research program in 2004.
The main safety concern is that if raw embryonic cells are put into the body, they can form tumors. Even though most such tumors do not spread like other cancers, any unwanted growth in the spinal cord can further damage nerves.
“It’s not ready for prime time, at least not in my mind, until we can be assured that the transplanted stem cells have completely lost the capacity for tumorogenicity,” said Dr. Steven Goldman, chairman of neurology at the University of Rochester. He was a member a committee convened by the F.D.A. last April to examine the safety aspects of trials using therapies from embryonic stem cells.
Dr. Okarma said Geron had done numerous studies showing that its cells did not contain residual embryonic cells and did not form tumors in animals even after a year. It submitted 22,000 pages of data to the F.D.A., perhaps the largest application ever for permission to begin a clinical trial.
The embryonic stem cell line used by Geron is one of the oldest ones and was therefore eligible for federal financing under the Bush administration’s policy, Dr. Okarma said.
Nevertheless, Geron paid for its own work, spending $45 million to prepare its F.D.A. application.
Geron, which was formed in 1990 as an antiaging company, is still in the development stage and is not yet profitable, having lost about $500 million since its inception. Besides working on stem cells, it is testing drugs for cancer that influence telomeres, the caps on the ends of chromosomes that help control the aging of cells. Geron’s market value is about $400 million.
While the Bush administration’s policy did not impede the company’s application at the F.D.A., Dr. Okarma said, it did slow progress for the field in general by making it hard for academics to do research.
“It is the private sector that has kept the technology alive so that it can see the light of day in a clinical trial,” he said.
Mr. Klein of the California stem cell program said he thought the next trial might be of a treatment for macular degeneration, an eye disease, that is being developed in Britain.
In the last couple of years, some attention has turned away from embryonic stem cells to a newer technique that allows a patient’s own skin cells to be turned into a cell resembling such embryonic cells.
That might do away with the need for embryos. And the resulting tissue made from those cells would match the patient, doing away with the need for immune suppression to prevent rejection of the transplant. Geron said its trial would require only temporary use of low doses of immune-suppressing drugs.
But the newer technique involves putting genes into the skin cells using viruses, which also raises a risk of cancer.

Philippines pig farm worker infected with Ebola-Reston

Moral of the story: This is some nasty stuff, good thing it never spread out of Reston, VA when it was in the states. The return of this thing is scary, it can travel extremely quickly across the entire globe. I wouldn't be surprised if this pops up again fairly soon somewhere else.

Philippines pig farm worker infected with Ebola strain: WHO

By AFP - Fri Jan 23, 1:00 AM PST
MANILA (AFP) - A Philippine pig farm worker has tested positive for the Ebola-Reston virus, according to Health Secretary Francisco Duque and the World Health Organisation (WHO).


Piglets are seen at a small family farm outside the quarantined commercial pig farm infected with Ebola-Reston virus in Pandi town north of Manila on January 8. Philippine pig farm worker has tested positive for the Ebola-Reston virus, Health Secretary Francisco Duque and the WHO said Friday.(AFP/File/Romeo Gacad)
The strain is different from the Ebola sub-types found in Africa that cause deadly haemorrhagic fever in humans.
Duque told a news conference that the farm worker's blood carried the virus's anti-bodies.
"Otherwise, he is healthy and has no sign of any sickness," he said.
The identity and age of the infected worker and the location of the farm was not disclosed.
Duque said health authorities were still trying to find out how the farmer got the virus.
He said they were not prepared to say if the farm worker was infected by pigs.
The announcement came at the end of a WHO-led mission to the Philippines that investigated the viral outbreak on pig farms last year.
The government earlier quarantined several farms in the northern Philippine towns of Pandi and Talavera after the Ebola-Reston virus was discovered there.
This Ebola strain, which is found only in the Philippines, had been confined to monkeys. But the latest outbreak among pigs was the first time it has jumped species, and later infected humans.
Duque also clarified that only four pigs had tested positive for the virus among about 6,000 tested by authorities between July and September 2008.
Ebola-Reston was first detected in 1989 in laboratory monkeys sent from the Philippines to Reston, Virginia, in the United States.

WomenHeart Series: Depression and the Heart

Moral of the Story: One area of heart health that has been garnering a lot of attention recently in physician circles is the link between depression and cardiovascular disease. This is an in depth discussion about the clinical relationship, which is still unclear, between the two and what screening and preventive actions should be taken. This is specifically about women, however the relationship holds true for men as well.

http://www.theheart.org/article/921585.do

WomenHeart Series: Depression and the Heart
Depression is common among patients with cardiovascular disease (CVD), particularly women. Clinical depression and heightened depressive symptoms have been associated with adverse outcomes in both male and female cardiac patients. The exact mechanisms by which depression affects outcome remain to be elucidated and there is some debate over whether depression precedes or follows cardiac events. Even so, a 2008 AHA Science Advisory supports the need for screening and treating depression in patients with coronary heart disease. Our expert panel discusses the links between depression and CVD and how screening and treatment for depression can be integrated into clinical practice.
To participate in this internet activity: (1) review the target audience, learning objectives, and author disclosures; (2) study the education content; (3) take the post-test and/or complete the evaluation; (4) view/print certificate.
SPONSORSHIP STATEMENT
This program is developed in conjunction with WomenHeart: The National Coalition for Women with Heart Disease.
Purpose / goal
The purpose of this activity is to educate clinicians to recognize and treat depression in patients with cardiovascular disease.
Target audience
This program is intended for cardiologists, primary care physicians and other healthcare providers involved in the management of patients with cardiovascular disease.
Educational objectives
At the conclusion of this program, participants will be able to:
Outline the clinical significance of depression in patients with CVD
Review data on the treatment of depression and CV risk
Summarize guidelines for the screening and treatment of depression in patients with CVD
Accreditation statement
Medscape is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.Medscape designates this educational activity for a maximum of 0.5 AMA PRA Category 1 Credit™. Each participant should only claim credit commensurate with the extent of his/her participation in the activity. For questions or assistance, please contact CME@medscape.net

The Joint Commission to Include Patient Satisfaction Data on Quality Check™

Moral of the story: Health care is becoming more transparent, even if slowly. Check out the link below to check out the survey results for your area.


January 20, 2009
The Joint Commission to Include Patient Satisfaction Data on Quality Check™
Web site provides new information to help patients make decisions
Media Contact: Ken PowersMedia Relations Manager630-792-5175kpowers@jointcommission.org
(OAKBROOK TERRACE, Ill. – January 20, 2009) People seeking information about how patients perceive the care they received at a particular hospital can now find this information on The Joint Commission’s Quality Check™ Web site, http://www.qualitycheck.org/.
The Hospital Consumer Assessment of Health Providers and Systems (HCAHPS) data from the Centers for Medicare & Medicaid Services’ (CMS) Hospital Compare Web site is posted on Quality Check™ beginning this month. This information will be updated quarterly.
HCAHPS information comes from patient ratings of communication with doctors, communication with nurses, responsiveness of hospital staff, cleanliness and quietness of the hospital, pain management, communication about medications, and discharge information. In addition to information about patient satisfaction, Quality Check™ also includes data from CMS on 30-day mortality rates for heart attack, heart failure and pneumonia.
Thousands of people use Quality Check™ each month to find information about the more than 15,000 accredited health care organizations that have earned The Joint Commission “Gold Seal of Approval.” Quality Check™ provides details about an organization’s accreditation status, efforts to prevent medical mistakes by complying with National Patient Safety Goals, and comparison information about how hospitals comply with National Quality Improvement Goals such as giving heart attack patients aspirin within a specified timeframe.

Salmonella Typhimurium Outbreak in Peanut Butter

Moral of the Story: Don't eat peanut butter!

Salmonella Typhimurium Outbreak
Update on FDA's Investigation
January 19, 2009: The Food and Drug Administration (FDA) is conducting a very active and dynamic investigation into the source of the Salmonella Typhimurium outbreak. At this time, the FDA, the Centers for Disease Control and Prevention (CDC), and state partners have traced sources of Salmonella Typhimurium contamination to a plant owned by Peanut Corporation of America (PCA), which manufactures peanut butter and peanut paste—a concentrated product consisting of ground, roasted peanuts—that are both distributed to food manufacturers to be used as an ingredient in many commercially produced products including cakes, cookies, crackers, candies, cereal and ice cream. In addition, PCA peanut butter is distributed to and institutionally served in such settings as long-term care facilities and cafeterias.
The FDA has notified PCA that product samples originating from its Blakely, Georgia (Ga.), processing plant have been tested and found positive for Salmonella by laboratories in the states of Minnesota and Connecticut. Connecticut and Minnesota have reported to FDA that samples of King Nut peanut butter tested in those states are a genetic match to the strain of Salmonella associated with the nationwide outbreak of Salmonella Typhimurium. The results from the Connecticut Department of Health Laboratory are from an unopened container of King Nut peanut butter. FDA wishes to acknowledge the Connecticut laboratory, Infectious Disease Section and Department of Consumer Protection as well as health officials in Minnesota for their efforts. King Nut is a distributor of PCA product. This information, along with the results available from laboratory testing and the CDC epidemiological analysis, have now led FDA to confirm that the source of this outbreak is peanut butter and peanut paste produced by PCA at its Blakely, Ga. processing plant.
On January 18, PCA expanded its previous voluntary recall to include more products and lot numbers relating to peanut butter and peanut paste products manufactured on or after July 1, 2008, at its Blakely, Ga., plant because of potential Salmonella contamination. The peanut butter products being recalled are sold by PCA in bulk containers ranging in size from five (5) to 1700 pounds. The peanut paste is sold in sizes ranging from 35-pound containers to product sold by the tanker container. These products are not sold directly to consumers. PCA has stopped all production at its Blakely, Ga. plant as the FDA continues its investigation. Based on this information, and on the current state of the investigation, the FDA recommends that consumers avoid eating products that have been recalled and discard them.
Major national brands of jarred peanut butter are not affected by the PCA recall. PCA does not sell peanut butter directly to consumers. PCA only sells peanut butter to institutions and food manufacturers (some of which use it as an ingredient in other processed/packaged foods). Some food manufacturers use PCA peanut butter or peanut paste in baked or processed foods, such as crackers, cookies, cakes or ice cream to name a few. The FDA and food manufacturers are working to identify products that may be affected, and to track the ingredient supply chain of those products to facilitate their removal from the marketplace.
Based on available information, FDA and CDC recommendations include:
For Consumers
FDA has created a searchable list of products and brands associated with the expanded PCA recall. This list is available on the FDA website at:http://www.accessdata.fda.gov/scripts/peanutbutterrecall/index.cfm and will be updated on a regular basis as additional sub recalls occur and information is received by FDA from the industry.
Because identification of products subject to recall is continuing, the FDA urges consumers to first visit FDA’s website to determine if commercially-prepared or manufactured peanut butter/peanut paste-containing products (such as cookies, crackers, cereal, candy and ice cream) are subject to recall. If consumers do not find the product of interest on FDA’s website they may wish to call the toll-free number listed on most food packaging or visit the company’s website.
If consumers cannot determine if their peanut butter, peanut butter/peanut paste-containing products or institutionally-served peanut butter may contain PCA peanut butter/peanut paste, we recommend that they do not consume those products. Efforts to specifically identify products subject to the PCA recall and to continuously update consumers are ongoing.
Do not eat products that have been recalled and throw them away in a manner that prevents others from eating them.
Persons who think they may have become ill from eating peanut butter are advised to consult their health care providers.

How should Obama reform health care?

Moral of the Story: Many options to choose from. The unique complexity of America offers many options, some better than others. You should really read the article to fully understand the implications of our situation.


http://www.newyorker.com/reporting/2009/01/26/090126fa_fact_gawande?printable=true

Annals of Public Policy
Getting There from Here: How should Obama reform health care?
by Atul Gawande


Our jerry-rigged health-care system contains many models that reformers can build on.

(exerpt)
In every industrialized nation, the movement to reform health care has begun with stories about cruelty. The Canadians had stories like the 1946 Toronto Globe and Mail report of a woman in labor who was refused help by three successive physicians, apparently because of her inability to pay. In Australia, a 1954 letter published in the Sydney Morning Herald sought help for a young woman who had lung disease. She couldn’t afford to refill her oxygen tank, and had been forced to ration her intake “to a point where she is on the borderline of death.” In Britain, George Bernard Shaw was at a London hospital visiting an eminent physician when an assistant came in to report that a sick man had arrived requesting treatment. “Is he worth it?” the physician asked. It was the normality of the question that shocked Shaw and prompted his scathing and influential 1906 play, “The Doctor’s Dilemma.” The British health system, he charged, was “a conspiracy to exploit popular credulity and human suffering.”

Trials for Parents Who Chose Faith Over Medicine

Moral of the story: Religion and science clash again, with predictably disasterous results.


Trials for Parents Who Chose Faith Over Medicine
By DIRK JOHNSON
Published: January 20, 2009
WESTON, Wis. — Kara Neumann, 11, had grown so weak that she could not walk or speak. Her parents, who believe that God alone has the ability to heal the sick, prayed for her recovery but did not take her to a doctor.
After an aunt from California called the sheriff’s department here, frantically pleading that the sick child be rescued, an ambulance arrived at the Neumann’s rural home on the outskirts of Wausau and rushed Kara to the hospital. She was pronounced dead on arrival.
The county coroner ruled that she had died from diabetic ketoacidosis resulting from undiagnosed and untreated juvenile diabetes. The condition occurs when the body fails to produce insulin, which leads to severe dehydration and impairment of muscle, lung and heart function.
“Basically everything stops,” said Dr. Louis Philipson, who directs the diabetes center at the University of Chicago Medical Center, explaining what occurs in patients who do not know or “are in denial that they have diabetes.”
About a month after Kara’s death last March, the Marathon County state attorney, Jill Falstad, brought charges of reckless endangerment against her parents, Dale and Leilani Neumann. Despite the Neumanns’ claim that the charges violated their constitutional right to religious freedom, Judge Vincent Howard of Marathon County Circuit Court ordered Ms. Neumann to stand trial on May 14, and Mr. Neumann on June 23. If convicted, each faces up to 25 years in prison.
“The free exercise clause of the First Amendment protects religious belief,” the judge wrote in his ruling, “but not necessarily conduct.”
Wisconsin law, he noted, exempts a parent or guardian who treats a child with only prayer from being criminally charged with neglecting child welfare laws, but only “as long as a condition is not life threatening.” Kara’s parents, Judge Howard wrote, “were very well aware of her deteriorating medical condition.”
About 300 children have died in the United States in the last 25 years after medical care was withheld on religious grounds, said Rita Swan, executive director of Children’s Health Care Is a Legal Duty, a group based in Iowa that advocates punishment for parents who do not seek medical help when their children need it. Criminal codes in 30 states, including Wisconsin, provide some form of protection for practitioners of faith healing in cases of child neglect and other matters, protection that Ms. Swan’s group opposes.
Shawn Peters, the author of three books on religion and the law, including “When Prayer Fails: Faith Healing, Children and the Law” (Oxford, 2007), said the outcome of the Neumann case was likely to set an important precedent.
“The laws around the country are pretty unsettled,” said Mr. Peters, who teaches religion at the University of Wisconsin Oshkosh and has been consulted by prosecutors and defense lawyers in the case.
In the last year, two other sets of parents, both in Oregon, were criminally charged because they had not sought medical care for their children on the ground that to do so would have violated their belief in faith healing. One couple were charged with manslaughter in the death of their 15-month-old daughter, who died of pneumonia last March. The other couple were charged with criminally negligent homicide in the death of their 16-year-old son, who died from complications of a urinary tract infection that was severely painful and easily treatable.
“Many types of abuses of children are motivated by rigid belief systems,” including severe corporal punishment, said Ms. Swan, a former Christian Scientist whose 16-month-old son, Matthew, died after she postponed taking him to a hospital for treatment of what proved to be meningitis. “We learned the hard way.”
All states give social service authorities the right to go into homes and petition for the removal of children, Ms. Swan said, but cases involving medical care often go unnoticed until too late. Parents who believe in faith healing, she said, may feel threatened by religious authorities who oppose medical treatment. Recalling her own experience, she said, “we knew that once we went to the doctor, we’d be cut off from God.”
The crux of the Neumanns’ case, Mr. Peters said, will be whether the parents could have known the seriousness of their daughter’s condition.
Investigators said the Neumanns last took Kara to a doctor when she was 3. According to a police report, the girl had lost the strength to speak the day before she died. “Kara laid down and was unable to move her mouth,” the report said, “and merely made moaning noises and moved her eyes back and forth.”
The courts have ordered regular medical checks for the couple’s other three children, ages 13 to 16, and Judge Howard ordered all the parties in the case not to speak to members of the news media. Neither Ms. Falstad nor the defense lawyers, Gene Linehan and Jay Kronenwetter, would agree to be interviewed.
The Neumanns, who had operated a coffee shop, Monkey Mo’s, in this middle-class suburb in the North Woods, are known locally as followers of an online faith outreach group called Unleavened Bread Ministries, run by a preacher, David Eells. The site shares stories of faith healing and talks about the end of the world.
An essay on the site signed Pastor Bob states that the Bible calls for healing by faith alone. “Jesus never sent anyone to a doctor or a hospital,” the essay says. “Jesus offered healing by one means only! Healing was by faith.”
A link from the site, helptheneumanns.com, asserts that the couple is being persecuted and “charged with the crime of praying.” The site also allows people to contribute to a legal fund for the Neumanns.
In the small town of Weston, many people shake their heads with dismay when Kara Neumann is mentioned. Tammy Klemp, 41, who works behind the counter at a convenience store here, said she disagreed with the Neumanns’ passive response to their daughter’s illness but said she was not sure they should go to prison.
“I’ve got mixed feelings,” Ms. Klemp said. “It’s just such a terribly sad case.”
Chris Goebel, 30, a shipping department worker for a window maker, said many people in the area felt strongly that the parents should be punished.
“That little girl wasn’t old enough to make the decision about going to a doctor,” Mr. Goebel said. “And now, because some religious extremists went too far, she’s gone.”

New Thinking on How to Protect the Heart

Moral of the Story: The Mediterranean diet really does work, as proven by a randomized clinical trial (the gold stardard of investigative medicine). The part about C-reactive protein is a bit misleading and I would disagree with Dr. Ozner about getting tested for it. CRP is an indicator but by itself has no effect on heart health. Since you should be following these guidelines anyway there would be no benefit to getting your CRP tested. However, if you are not following the guidelines and you need motivation, get it tested. Otherwise, enjoy some nice fish with veggies cooked in olive oil and you should be good to go.

NY TIMES ARTICLE: http://www.nytimes.com/2009/01/13/health/13brod.html?em

By JANE E. BRODY
Published: January 12, 2009
If last week’s column convinced you that surgery may not be the best way to avoid a heart attack or sudden cardiac death, the next step is finding out what can work as well or better to protect your heart.
Many measures are probably familiar: not smoking, controlling cholesterol and blood pressure, exercising regularly and staying at a healthy weight. But some newer suggestions may surprise you.
It is not that the old advice, like eating a low-fat diet or exercising vigorously, was bad advice; it was based on the best available evidence of the time and can still be very helpful. But as researchers unravel the biochemical reasons for most heart attacks, the advice for avoiding them is changing.
And, you’ll be happy to know, the new suggestions for both diet and exercise are less rigid. The food is tasty, easy to prepare and relatively inexpensive, and you don’t have to sweat for an hour a day to reap the benefits of exercise.
The well-established risk factors for heart disease remain intact: high cholesterol, high blood pressure, smoking, diabetes, abdominal obesity and sedentary living. But behind them a relatively new factor has emerged that may be even more important as a cause of heart attacks than, say, high blood levels of artery-damaging cholesterol.
That factor is C-reactive protein, or CRP, a blood-borne marker of inflammation that, along with coagulation factors, is now increasingly recognized as the driving force behind clots that block blood flow to the heart. Yet patients are rarely tested for CRP, even if they already have heart problems.
Even in people with normal cholesterol, if CRP is elevated, the risk of heart attack is too, said Dr. Michael Ozner, medical director of the Cardiovascular Prevention Institute of South Florida. He thinks that when people have their cholesterol checked, they should also be tested for high-sensitivity CRP.
Diet Revisited
The new dietary advice is actually based on a rather old finding that predates the mantra to eat a low-fat diet. In the Seven Countries Study started in 1958 and first published in 1970, Dr. Ancel Keys of the University of Minnesota and co-authors found that heart disease was rare in the Mediterranean and Asian regions where vegetables, grains, fruits, beans and fish were the dietary mainstays. But in countries like Finland and the United States where plates were typically filled with red meat, cheese and other foods rich in saturated fats, heart disease and cardiac deaths were epidemic.
The finding resulted in the well-known advice to reduce dietary fat and especially saturated fats (those that are firm at room temperature), and to replace these harmful fats with unsaturated ones like vegetable oils. What was missed at the time and has now become increasingly apparent is that the heart-healthy Mediterranean diet is not really low in fat, but its main sources of fat — olive oil and oily fish as well as nuts, seeds and certain vegetables — help to prevent heart disease by improving cholesterol ratios and reducing inflammation.
Virtues Confirmed
It was not until 1999 that the value of a traditional Mediterranean diet was confirmed, when the Lyon Diet Heart Study compared the effects of a Mediterranean-style diet with one that the American Heart Association recommended for patients who had survived a first heart attack.
The study found that within four years, the Mediterranean approach reduced the rates of heart disease recurrence and cardiac death by 50 to 70 percent when compared with the heart association diet.
Several subsequent studies have confirmed the virtues of the Mediterranean approach. For example, a study among more than 3,000 men and women in Greece, published in 2004 by Dr. Christina Chrysohoou of the University of Athens, found that adhering to a Mediterranean diet improved six markers of inflammation and coagulation, including CRP, white blood cell count and fibrinogen.
The same year Kim T. B. Knoops, a nutritionist at Wageningen University in the Netherlands, and co-authors published a study showing that among men and women ages 70 to 90, those who followed a Mediterranean diet and other healthful practices, like not smoking, had a 50 percent lower rate of deaths from heart disease and all causes.
“The Mediterranean diet is one people can stick to,” said Dr. Ozner, author of “The Miami Mediterranean Diet” and “The Great American Heart Hoax” (BenBella, 2008). “The food is delicious, and the ingredients can be found in any grocery store.
“You should make most of the food yourself,” Dr. Ozner added. “When the diet is stripped of lots of processed foods, you ratchet down inflammation. Among my patients, the compliance rate — those who adopt the diet and stick with it — is greater than 90 percent.”
Among foods that help to reduce the inflammatory marker CRP are cold-water fish like salmon, tuna and mackerel; flax seed; walnuts; and canola oil and margarine based on canola oil. Fish oil capsules are also effective. Dr. Ozner recommends cooking with canola oil and using more expensive and aromatic olive oil for salads.
Other aspects of the Mediterranean diet — vegetables, fruits and red wine (or purple grape juice) — are helpful as well. Their antioxidant properties help prevent the formation of artery-damaging LDL cholesterol.
Other Steps
Several recent studies have linked periodontal disease to an increased risk of heart disease, most likely because gum disease causes low-grade chronic inflammation. So good dental hygiene, with regular periodontal cleanings, can help protect your heart as well as your teeth.
Reducing chronic stress is another important factor. The Interheart study, which examined the effects of stress in more than 27,000 people, found that stress more than doubled the risk of heart attacks.
Dr. Joel Okner, a cardiologist in Chicago, and Jeremy Clorfene, a cardiac psychologist, the authors of “The No Bull Book on Heart Disease” (Sterling, 2009), note that getting enough sleep improves the ability to manage stress.
Practicing the relaxation response once or twice a day by breathing deeply and rhythmically in a quiet place with eyes closed and muscles relaxed can help cool the hottest blood. Other techniques Dr. Ozner recommends include meditation, prayer, yoga, self-hypnosis, laughter, taking a midday nap, getting a dog or cat, taking up a hobby and exercising regularly.
He noted that in a 1996 study, just 15 minutes of exercise five days a week decreased the risk of cardiac death by 46 percent.
Even very brief bouts of exercise can be helpful. A British study published in the current American Journal of Clinical Nutrition found that accumulating short bouts — just three minutes each — of brisk walking for a total of 30 minutes a day improved several measures of cardiac risk as effectively as one continuous 30-minute session.
This is the second of two columns on cardiac care. Last week: The drawbacks to interventional cardiology.

Vitamin C Intake

Moral of the Story: Vitamin C intake is critical and must be a part of your diet, but too much is also bad. You should be receiving plenty of vitamin C in your diet, and if you add a glass of orange juice in the morning there is definitely no need for supplements.

Criteria and Recommendations for Vitamin C Intake

Mark Levine, MD; Steven C. Rumsey, PhD; Rushad Daruwala, PhD; Jae B. Park, PhD; Yaohui Wang, MD

JAMA. 1999;281:1415-1423.

Recommendations for vitamin C intake are under revision by the Food and Nutrition Board of the National Academy of Sciences. Since 1989 when the last recommended dietary allowance (RDA) of 60 mg was published, extensive biochemical, molecular, epidemiologic, and clinical data have become available. New recommendations can be based on the following 9 criteria: dietary availability, steady-state concentrations in plasma in relationship to dose, steady-state concentrations in tissues in relationship to dose, bioavailability, urine excretion, adverse effects, biochemical and molecular function in relationship to vitamin concentration, direct beneficial effects and epidemiologic observations in relationship to dose, and prevention of deficiency. We applied these criteria to the Food and Nutrition Board's new guidelines, the Dietary Reference Intakes, which include 4 reference values. The estimated average requirement (EAR) is the amount of nutrient estimated to meet the requirement of half the healthy individuals in a life-stage and gender group. Based on an EAR of 100 mg/d of vitamin C, the RDA is proposed to be 120 mg/d. If the EAR cannot be determined, an adequate intake (AI) amount is recommended instead of an RDA. The AI was estimated to be either 200 mg/d from 5 servings of fruits and vegetables or 100 mg/d of vitamin C to prevent deficiency with a margin of safety. The final classification, the tolerable upper intake level, is the highest daily level of nutrient intake that does not pose risk or adverse health effects to almost all individuals in the population. This amount is proposed to be less than 1 g of vitamin C daily. Physicians can tell patients that 5 servings of fruits and vegetables per day may be beneficial in preventing cancer and providing sufficient vitamin C intake for healthy people, and that 1 g or more of vitamin C may have adverse consequences in some people.

Author Affiliations: Molecular and Clinical Nutrition Section, Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Md (Drs Levine, Rumsey, Daruwala, and Wang); Phytonutrients Laboratory, Beltsville Human Nutrition Research Center, US Department of Agriculture, Beltsville, Md (Dr Park).

Vitamins E and C in the Prevention of Prostate and Total Cancer in Men

Moral of the story: More results from the Physicians' Health Study: Vitamins E and C do not reduce the risk for developing prostate cancer or any other cancer (or cardiovascular disease, as you may remember from the last post).

Vitamins E and C in the Prevention of Prostate and Total Cancer in Men

The Physicians' Health Study II Randomized Controlled Trial

J. Michael Gaziano, MD, MPH; Robert J. Glynn, ScD; William G. Christen, ScD; Tobias Kurth, MD, ScD; Charlene Belanger, MA; Jean MacFadyen, BA; Vadim Bubes, PhD; JoAnn E. Manson, MD, DrPH; Howard D. Sesso, ScD, MPH; Julie E. Buring, ScD

JAMA. 2009;301(1):52-62. Published online December 9, 2008 (doi:10.1001/jama.2008.862).

ABSTRACT

Context Many individuals take vitamins in the hopes of preventing chronic diseases such as cancer, and vitamins E and C are among the most common individual supplements. A large-scale randomized trial suggested that vitamin E may reduce risk of prostate cancer; however, few trials have been powered to address this relationship. No previous trial in men at usual risk has examined vitamin C alone in the prevention of cancer.

Objective To evaluate whether long-term vitamin E or C supplementation decreases risk of prostate and total cancer events among men.

Design, Setting, and Participants The Physicians' Health Study II is a randomized, double-blind, placebo-controlled factorial trial of vitamins E and C that began in 1997 and continued until its scheduled completion on August 31, 2007. A total of 14 641 male physicians in the United States initially aged 50 years or older, including 1307 men with a history of prior cancer at randomization, were enrolled.

Intervention Individual supplements of 400 IU of vitamin E every other day and 500 mg of vitamin C daily.

Main Outcome Measures Prostate and total cancer.

Results During a mean follow-up of 8.0 years, there were 1008 confirmed incident cases of prostate cancer and 1943 total cancers. Compared with placebo, vitamin E had no effect on the incidence of prostate cancer (active and placebo vitamin E groups, 9.1 and 9.5 events per 1000 person-years; hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.85-1.09; P = .58) or total cancer (active and placebo vitamin E groups, 17.8 and 17.3 cases per 1000 person-years; HR, 1.04; 95% CI, 0.95-1.13; P = .41). There was also no significant effect of vitamin C on total cancer (active and placebo vitamin C groups, 17.6 and 17.5 events per 1000 person-years; HR, 1.01; 95% CI, 0.92-1.10; P = .86) or prostate cancer (active and placebo vitamin C groups, 9.4 and 9.2 cases per 1000 person-years; HR, 1.02; 95% CI, 0.90-1.15; P = .80). Neither vitamin E nor vitamin C had a significant effect on colorectal, lung, or other site-specific cancers. Adjustment for adherence and exclusion of the first 4 or 6 years of follow-up did not alter the results. Stratification by various cancer risk factors demonstrated no significant modification of the effect of vitamin E on prostate cancer risk or either agent on total cancer risk.

Conclusions In this large, long-term trial of male physicians, neither vitamin E nor C supplementation reduced the risk of prostate or total cancer. These data provide no support for the use of these supplements for the prevention of cancer in middle-aged and older men.

Trial Registration clinicaltrials.gov Identifier: NCT00270647

Vitamins E and C in the Prevention of Cardiovascular Disease in Men

Moral of the story: Vitamins are finally coming under scrutiny, and the results are not positive. The Physicians' Health Study is the only randomized trial (consisting of physicians) to look at vitamin use and is thus the only reliable source of information on the effects of vitamins. This study shows that vitamins E and C had no protective benefit in the prevention of cardiovascular disease in men.

Vitamins E and C in the Prevention of Cardiovascular Disease in Men

The Physicians' Health Study II Randomized Controlled Trial

Howard D. Sesso, ScD, MPH; Julie E. Buring, ScD; William G. Christen, ScD; Tobias Kurth, MD, ScD; Charlene Belanger, MA; Jean MacFadyen, BA; Vadim Bubes, PhD; JoAnn E. Manson, MD, DrPH; Robert J. Glynn, ScD; J. Michael Gaziano, MD, MPH

JAMA. 2008;300(18):2123-2133. Published online November 9, 2008 (doi: 10.1001/jama.2008.600).

ABSTRACT

Context Basic research and observational studies suggest vitamin E or vitamin C may reduce the risk of cardiovascular disease. However, few long-term trials have evaluated men at initially low risk of cardiovascular disease, and no previous trial in men has examined vitamin C alone in the prevention of cardiovascular disease.

Objective To evaluate whether long-term vitamin E or vitamin C supplementation decreases the risk of major cardiovascular events among men.

Design, Setting, and Participants The Physicians' Health Study II was a randomized, double-blind, placebo-controlled factorial trial of vitamin E and vitamin C that began in 1997 and continued until its scheduled completion on August 31, 2007. There were 14 641 US male physicians enrolled, who were initially aged 50 years or older, including 754 men (5.1%) with prevalent cardiovascular disease at randomization.

Intervention Individual supplements of 400 IU of vitamin E every other day and 500 mg of vitamin C daily.

Main Outcome Measures A composite end point of major cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, and cardiovascular disease death).

Results During a mean follow-up of 8 years, there were 1245 confirmed major cardiovascular events. Compared with placebo, vitamin E had no effect on the incidence of major cardiovascular events (both active and placebo vitamin E groups, 10.9 events per 1000 person-years; hazard ratio [HR], 1.01 [95% confidence interval {CI}, 0.90-1.13]; P = .86), as well as total myocardial infarction (HR, 0.90 [95% CI, 0.75-1.07]; P = .22), total stroke (HR, 1.07 [95% CI, 0.89-1.29]; P = .45), and cardiovascular mortality (HR, 1.07 [95% CI, 0.90-1.28]; P = .43). There also was no significant effect of vitamin C on major cardiovascular events (active and placebo vitamin E groups, 10.8 and 10.9 events per 1000 person-years, respectively; HR, 0.99 [95% CI, 0.89-1.11]; P = .91), as well as total myocardial infarction (HR, 1.04 [95% CI, 0.87-1.24]; P = .65), total stroke (HR, 0.89 [95% CI, 0.74-1.07]; P = .21), and cardiovascular mortality (HR, 1.02 [95% CI, 0.85-1.21]; P = .86). Neither vitamin E (HR, 1.07 [95% CI, 0.97-1.18]; P = .15) nor vitamin C (HR, 1.07 [95% CI, 0.97-1.18]; P = .16) had a significant effect on total mortality but vitamin E was associated with an increased risk of hemorrhagic stroke (HR, 1.74 [95% CI, 1.04-2.91]; P = .04).

Conclusions In this large, long-term trial of male physicians, neither vitamin E nor vitamin C supplementation reduced the risk of major cardiovascular events. These data provide no support for the use of these supplements for the prevention of cardiovascular disease in middle-aged and older men.

Trial Registration clinicaltrials.gov Identifier: NCT00270647

Broccoli May Lower Lung Cancer Risk in Smokers

Moral of the story: Broccoli (and other cruciferous veggies) also helps with lung cancer. Depends on type of cancer how much these veggies help, and raw is better, but yet another example of broccoli fighting cancer. Importantly, this one does not depend on your genetic composition.

Broccoli May Lower Lung Cancer Risk in Smokers
November 18, 2008
WASHINGTON, D.C. - The cancer preventive properties of broccoli and other cruciferous vegetables appear to work specifically in smokers, according to data presented at the American Association for Cancer Research's Seventh Annual International Conference on Frontiers in Cancer Prevention Research.
Cruciferous vegetables have been shown to be protective in numerous studies, but this is the first comprehensive study that showed a protective benefit in smokers, specifically in former smokers, according to lead author Li Tang, Ph.D., a post-doctoral fellow at Roswell Park Cancer Institute.
"Broccoli is not a therapeutic drug, but for smokers who believe they cannot quit nor do anything about their risk, this is something positive," Tang said. "People who quit smoking will definitely benefit more from intake of cruciferous vegetables."
Li and colleagues conducted a hospital-based, case-controlled study with lung cancer cases and controls matched on smoking status. The study included all commonly consumed cruciferous vegetables, and also considered raw versus cooked form. Researchers performed statistical calculations to take into account smoking status, duration and intensity.
Among smokers, the protective effect of cruciferous vegetable intake ranged from a 20 percent reduction in risk to a 55 percent reduction in risk depending on the type of vegetable consumed and the duration and intensity of smoking.
For example, among current smokers, only the consumption of raw cruciferous vegetables was associated with risk reduction of lung cancer. No significant results were found for consumption of vegetables in general and fruits.
Researchers further divided their findings by four subtypes of lung cancer and found the strongest risk reduction among patients with squamous or small-cell carcinoma. These two subtypes are more strongly associated with heavy smoking.
"These findings are not strong enough to make a public health recommendation yet," said Li. "However, strong biological evidence supports this observation. These findings, along with others, indicate cruciferous vegetables may play a more important role in cancer prevention among people exposed to cigarette-smoking. "
# # #
The mission of the American Association for Cancer Research is to prevent and cure cancer. Founded in 1907, AACR is the world's oldest and largest professional organization dedicated to advancing cancer research. The membership includes more than 28,000 basic, translational and clinical researchers; health care professionals; and cancer survivors and advocates in the United States and 80 other countries. The AACR marshals the full spectrum of expertise from the cancer community to accelerate progress in the prevention, diagnosis and treatment of cancer through high-quality scientific and educational programs. It funds innovative, meritorious research grants. The AACR Annual Meeting attracts more than 17,000 participants who share the latest discoveries and developments in the field. Special conferences throughout the year present novel data across a wide variety of topics in cancer research, treatment and patient care. The AACR publishes five major peer-reviewed journals: Cancer Research; Clinical Cancer Research; Molecular Cancer Therapeutics; Molecular Cancer Research; and Cancer Epidemiology, Biomarkers & Prevention. The AACR's most recent publication and its sixth major journal, Cancer Prevention Research, is dedicated exclusively to cancer prevention, from preclinical research to clinical trials. The AACR also publishes CR, a magazine for cancer survivors and their families, patient advocates, physicians and scientists. CR provides a forum for sharing essential, evidence-based information and perspectives on progress in cancer research, survivorship and advocacy.
Media Contact:Jeremy Moore267-646-0557Jeremy.moore@aacr.org In Washington, D.C., Nov. 16-18: 301-965-5422

Broccoli consumption interacts with GSTM1 to perturb oncogenic signalling pathways in the prostate.

Moral of the Story: Broccoli is just plain good for you. The first in the broccoli series, this article explains how broccoli consumption can distrupt oncogenic pathways in your prostate via genetic mechanisms. Basically, you eat broccoli, you have a certain gene, you dont get prostate cancer


Broccoli consumption interacts with GSTM1 to perturb oncogenic signalling pathways in the prostate.

Traka M, Gasper AV, Melchini A, Bacon JR, Needs PW, Frost V, Chantry A, Jones AM, Ortori CA, Barrett DA, Ball RY, Mills RD, Mithen RF.
Phytochemicals and Health Programme, Institute of Food Research, Norwich Research Park, Norwich, United Kingdom.

BACKGROUND: Epidemiological studies suggest that people who consume more than one portion of cruciferous vegetables per week are at lower risk of both the incidence of prostate cancer and of developing aggressive prostate cancer but there is little understanding of the underlying mechanisms. In this study, we quantify and interpret changes in global gene expression patterns in the human prostate gland before, during and after a 12 month broccoli-rich diet.
METHODS AND FINDINGS: Volunteers were randomly assigned to either a broccoli-rich or a pea-rich diet. After six months there were no differences in gene expression between glutathione S-transferase mu 1 (GSTM1) positive and null individuals on the pea-rich diet but significant differences between GSTM1 genotypes on the broccoli-rich diet, associated with transforming growth factor beta 1 (TGFbeta1) and epidermal growth factor (EGF) signalling pathways. Comparison of biopsies obtained pre and post intervention revealed more changes in gene expression occurred in individuals on a broccoli-rich diet than in those on a pea-rich diet. While there were changes in androgen signalling, regardless of diet, men on the broccoli diet had additional changes to mRNA processing, and TGFbeta1, EGF and insulin signalling. We also provide evidence that sulforaphane (the isothiocyanate derived from 4-methylsuphinylbutyl glucosinolate that accumulates in broccoli) chemically interacts with TGFbeta1, EGF and insulin peptides to form thioureas, and enhances TGFbeta1/Smad-mediated transcription.
CONCLUSIONS: These findings suggest that consuming broccoli interacts with GSTM1 genotype to result in complex changes to signalling pathways associated with inflammation and carcinogenesis in the prostate. We propose that these changes may be mediated through the chemical interaction of isothiocyanates with signalling peptides in the plasma. This study provides, for the first time, experimental evidence obtained in humans to support observational studies that diets rich in cruciferous vegetables may reduce the risk of prostate cancer and other chronic disease.
TRIAL REGISTRATION: ClinicalTrials.gov NCT00535977.