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Tue, Mar 16, 2004

Wash. state mulls Pill without doctor's visit

SEATTLE, Washington -- Step right up to the pharmacy counter, answer 23 questions and walk out with birth control pills.


That's all it takes for women enrolled in a study that is believed to be the first effort in the nation to offer hormonal contraceptives at drugstores without a doctor's prescription.

The University of Washington project aims to find out if women and pharmacists are comfortable with drugstore delivery of birth control pills, patches and vaginal rings.

That doesn't mean women should stop going to the doctor for annual checkups to guard against sexually transmitted diseases and other problems. But most medical organizations agree it is not necessary to have a pelvic exam to get birth control pills and the like.

The best situation is for every woman to have immediate access to medical care, "but there are women who don't have access, and there are some barriers and difficulties," said Dr. Robert Palmer Jr., an obstetrician-gynecologist on the study's advisory board. Palmer is also state chairman for the American College of Obstetricians and Gynecologists.

The study is also embraced by family planning and population control experts.

James Trussell, director of the Office of Population Research at Princeton University, is hoping the idea will spread.

"It's a terrific idea. Seeing a pharmacist is just fine for these methods," he said, noting that half the pregnancies in the United States each year are unintended.

"Anything that is expanding access to people where and when they need it is a positive thing," said Robert Harkins of Planned Parenthood of Western Washington.

A good-health checklist
More than 50 women have enrolled since the study was launched February 23 by the UW School of Pharmacy and Department of Obstetrics and Gynecology with funding from the National Institutes of Health. Researchers hope to enroll 300 women.

Women 18 to 45 years old can visit any of eight Fred Meyer or Bartell pharmacies in Seattle and its suburbs, complete a health questionnaire and have their weight and blood pressure checked.

If they pass a good-health checklist, they can obtain three months of birth-control pills or patches right away, and an additional nine months' worth at a follow-up visit. The price is $25 per visit plus the medicine. Insurance companies generally will not pay.

Washington state has a long history of bold moves regarding women's health. It became the first state to legalize abortion through a vote of the people when an initiative was approved in 1970.

And Washington was also the first to allow the morning-after pill to be given out without a doctor's prescription. A University of Washington study in 1997-99 pioneered the practice -- and it spread. Emergency contraception now is available at pharmacists' counters in California, Hawaii, Alaska and New Mexico.

Trussell predicted this latest idea will be copied elsewhere, too. The pharmacies involved report many callers asking about the project.

Lead researcher Jacqueline Gardner, a pharmacy professor at UW, said the birth-control study was an outgrowth of her team's earlier work on access to the morning-after pill.

"The pharmacists were feeling frustrated when a woman came in for emergency contraception and they gave it to her, they would say, `What do you plan to use?' and lots of times they didn't have a prescriber or a method in mind," Gardner said.

Pharmacists get eight hours of special training and operate under a set of rules approved by a doctor -- an arrangement already permitted by the state for other types of medicines.

They screen out women who are very obese, are heavy smokers or have high blood pressure, a history of breast cancer, blood clots or other risk factors.

Mixed reactions
Most of the 50 women already enrolled have previously seen doctors and used hormonal contraceptives but have not had easy access because of a recent move or some other problem, Gardner said.

Pharmacist Don Downing, another researcher, said he believes women who do not have doctors but need birth control are likely to be interested.

"Pharmacies don't have tables with stirrups on them and I think that's a bonus, and we're available after hours and weekends when most clinics are not open," Downing said.

Two women shopping near Bartell's 24-hour pharmacy in Seattle told The Associated Press they have mixed feelings about the program.

"We don't want women being jeopardized in any way taking medicine that is not monitored in some way," said Kim Daley, 27.

Danielle Levine, 23, said annual checkups are important.

Common side effects of hormonal birth control are irregular bleeding, nausea, vomiting, breast tenderness and swelling.

Dr. Elisabeth Evans, an obstetrician-gynecologist at Overlake Hospital Medical Center in Bellevue, said birth control pills are very safe.

However, she said one advantage of seeing a doctor is that a woman gets checked for sexually transmitted diseases, including human papilloma virus, which is a precursor to cervical cancer.

"I think personally the positives probably outweigh the negatives for women," she said. "I think it's hard for women to always go to the doctor to get a prescription for something that's probably safer than aspirin."



Tue, Mar 9, 2004

Cholesterol: How low should you go?

NEW ORLEANS, Louisiana -- Lowering heart attack victims' cholesterol to levels dramatically below current standards appears to be an important strategy for saving lives and preventing new heart problems, a major new study shows.

Drugs called statins are already standard medicine for people recovering from heart attacks. But the study suggests newer, more potent varieties work best for these high-risk patients.

"The message for these people going home from the hospital is they should be on a high-intensity regimen," said Dr. Christopher Cannon of Boston's Brigham and Women's Hospital. "For everyone else, treating cholesterol and getting it down is very important."

The much-anticipated study helps answer one of the most discussed questions in cardiology: How low should cholesterol go? For those getting over recent heart attacks, at least, the answer appears to be very low indeed.

Those who did best in this study saw their levels of LDL, the bad cholesterol, plunge in half to an average of just 62. The goal in current federal guidelines is to get LDL below 100.

The study was to be presented Monday in New Orleans at the annual scientific meeting of the American College of Cardiology. It also will be published in Thursday's issue of the New England Journal of Medicine.

The latest work reinforces the conclusion of another head-to-head comparison of statin drugs released last November. In that study, doctors found the more intensive treatment resulted in less artery clogging. The new report is considered even more persuasive because it looks for differences in the risk of death and other clearly measurable misfortunes of heart patients.

Both studies compared 40 milligrams daily of Pravachol to 80 milligrams of Lipitor, the highest approved doses of both drugs when the research started. Pravachol is an older statin made by Bristol-Myers Squibb, while the newer and more potent Lipitor is made by Pfizer. Last fall's study was financed by Pfizer, and this one was paid for by Bristol-Myers Squibb. Lipitor came out on top in both comparisons.

Getting aggressive
In Cannon's study, 4,162 patients with new heart attacks or severe chest pain were randomly assigned to the two drugs. After two years of follow up, 26 percent getting the weaker Pravachol had died or experienced a variety of other ill events, including new heart attacks, bypass surgery, rehospitalization for chest pain or strokes. The same happened in 22 percent on Lipitor.

LDL levels of those taking Pravachol fell to 95, which is considered successful treatment under the government guidelines drawn up several years ago.

Dr. Thomas Pearson, head of preventive medicine at of the University of Rochester, helped write those guidelines. "The goal of less than 100 was an approximation using some very early data," he said. "It was the best guess at that moment. It may need some improvement. Now we are getting the science, and that's really exciting."

In a journal editorial, Dr. Eric Topol of the Cleveland Clinic called the latest finding "a major surprise," in part because the superiority of the stronger statin became obvious within a month of the start of treatment.

Topol said 36 million Americans should be on statins, although only a third that many actually are. Nevertheless, statins are the biggest selling category of prescription drugs at $12.5 billion in the United States each year.

Other studies in the works should help settle whether people with less serious heart disease benefit from the more aggressive cholesterol lowering possible with the newer statins. The more powerful drugs carry a slightly higher risk of side effects and are more expensive. Topol noted that the dose of Pravachol used in the study costs about $900 a year, while Lipitor costs $1,400.

Dr. Andrew Bodnar, head of medical affairs at Bristol-Myers Squibb, said until more studies are done, "doctors should reserve judgment about the general coronary disease population." He noted abnormal liver enzymes were more common in patients on Lipitor in the latest study and said Pravachol "has an unsurpassed safety record."



Wed, Mar 3, 2004

Test May Be Safer Way to Detect Fetal Problems

CHICAGO (Reuters) - A new technique could make it possible to detect fetal abnormalities with a sample of the mother's blood, instead of invasive procedures which can put the pregnancy at risk, researchers reported on Tuesday.

The new laboratory test uses formaldehyde to stabilize membranes in the blood cells of samples collected from the mother, thus increasing the amount of fetal DNA that can be examined.

Without such stabilization the DNA samples are often destroyed during collection, handling and processing, a problem that has limited the use of maternal blood samples to identify abnormalities such as Down Syndrome or spina bifida.

The test was developed by Ravgen Inc., a private biotechnology company based in Maryland which reported the results in an article published in this week's Journal of the American Medical Association.

Invasive prenatal tests with such techniques as amniocentesis or umbilical blood sampling are highly reliable, but carry a risk for loss of the pregnancy, the study said. As a result women who would otherwise be candidates for a diagnosis, such as those over age 35, decline them, the authors said.

In one part of its test, free fetal DNA in untreated blood samples averaged 7.7 percent compared to more than 20 percent in the treated samples, the company said.

A high percentage of free fetal DNA makes it easier to diagnose chromosomal abnormalities, the report said, and suggests that the technique could provide "a solid foundation for the development of a noninvasive prenatal diagnostic test."

In an editorial in the same journal commenting on the study researchers at Baylor College of Medicine in Houston said the findings have major clinical implications.

"Developing a reliable, transportable technology for cell-free DNA analysis impacts two crucial areas -- prenatal genetic diagnosis and cancer detection and surveillance," the editorial said.

"With prospective studies focusing on clinical applications of these findings, profound clinical implications could emerge for prenatal diagnosis and cancer surveillance," it added. It could mean that leukemia, for example, could be monitored with a blood test instead of having to take a bone marrow sample, it said.



Fri, Feb 27, 2004

Study: Weight gain tied to breast cancer risk

ATLANTA, Georgia (AP) -- The amount of weight a woman gains after age 18 is a strong signal as to whether she will get breast cancer later in life, according to new research released Wednesday by the American Cancer Society.

In one of the largest studies of weight and breast cancer to date, researchers said older women who gained 20 to 30 pounds after high school graduation were 40 percent more likely to get breast cancer than women who kept the weight off.

The risk doubled if a woman gained more than 70 pounds, said Heather Spencer Feigelson, senior epidemiologist with the American Cancer Society.

"Breast cancer is strongly dependent on body weight," Feigelson said. "Even modest amounts of weight gain lead to a significantly increased risk of breast cancer."

Weight gain and body mass have long been known to be risk factors for breast cancer.

The cancer society estimates weight contributes to between one-third and one-half of all breast cancer deaths among older women.

Fat tissue makes estrogen, and estrogen can help breast cancer grow. Weight gain also is the second leading cause of all cancers, according to research the Atlanta-based society published last year in the New England Journal of Medicine.

But the cancer society researchers wanted to examine more specifically the link between weight gain amounts and breast cancer, and this was the first in such a large group.

"The more fat you have -- fat cells are capable of synthesizing estrogen -- the heavier you are, the higher your estrogen levels," said Dr. Paul Tartter, associate professor of surgery at Columbia University, who was not a researcher in the study. "There's no question that estrogen is the common denominator of most of our risk factors for breast cancer."

The cancer society study included 1,934 breast cancer cases among 62,756 women involved in a separate long-term cancer prevention study.

Post-menopausal women ages 50 to 74 were asked their weight when the study began in 1992 and their weight when they were 18 years old. Surveys were sent to the women in 1997, 1999 and 2001 to inquire about any new cancers.

Women taking estrogen hormones were not included in the study.

Lean post-menopausal women not taking hormone replacement therapy produce very little estrogen and had the lowest cancer risk in the study, Feigelson said.



Wed, Feb 18, 2004

Study links antibiotics, breast cancer

(CNN) -- Increased use of antibiotics may heighten women's risk of breast cancer, a study looking at possible connections between the two suggests.


Researchers found that women who took antibiotics for more than 500 days or who had more than 25 prescriptions in the course of a 17-year period more than doubled their risk of breast cancer compared with women who had not taken any antibiotics.

The fewer the days on antibiotics resulted in a smaller risk, the authors wrote in the study appearing in Wednesday's Journal of the American Medical Association.

"It's as strong as any of the risk factors that we know," said Dr. Roberta Ness of the University of Pittsburgh Graduate School of Public Health, who is author of an editorial accompanying the study.

"To put it into perspective, the risk for developing breast cancer from hormone replacement use is about a 30 [percent] to 40 percent increase in risk. And here we're talking about a doubling in risk of those women who are using chronic antibiotics."

But researchers caution that the findings do not mean antibiotics cause breast cancer.

"These results only show that there is an association between the two," co-author Dr. Stephen Taplin of the National Cancer Institute said in a statement. "More studies must be conducted to determine whether there is indeed a direct cause-and-effect relationship."

Taking computerized pharmacy and breast cancer screening data in Washington state, researchers compared the use of some of the most frequently prescribed antibiotics by 2,266 women with breast cancer and almost 8,000 without the disease.

Why antibiotics may possibly increase breast cancer risk is still a mystery, researchers said. The conditions that necessitated the antibiotics in the first place may have put the women at higher risk. Or, researchers said, the women in the study who had never taken antibiotics might have been generally healthier overall.

Another theory suggested in the study involves the way antibiotics affect bacteria in the intestine, which may disable possible cancer-fighting properties of some foods. Other explanations involve the effect of antibiotics on the body's immune system.

The research is not the first to show an association between antibiotics and a higher risk of breast cancer, the second most deadly cancer in women. In 1999, a Finnish study of almost 10,000 women found similar results.

Authors of the new study included members from the Fred Hutchinson Cancer Research Center, Group Health Cooperative and University of Washington -- all in Seattle -- and the National Cancer Institute, based in Bethesda, Maryland.

According to the Centers for Disease Control and Prevention, the overuse of antibiotics has exploded in the past 10 years, with the public mistakenly taking the medicine for colds, flu and coughs. These types of illnesses are caused by viruses and cannot be helped with antibiotics, which fight bacterial infections.

Lead study author Dr. Christine Velicer of the Group Health Cooperative said that more research needs to be done to understand any link between breast cancer and antibiotics and that the drugs remain an important health tool.

"At this point, continued, prudent use of antibiotics and recognizing the substantial benefits that antibiotics have is an important way to go," Velicer said.



Mon, Feb 9, 2004

The leader in homeland security education

PHILADELPHIA, Pennsylvania (AP) -- With classes like "Terrorism Risk Assessment" and "Radioactive Materials" already in course catalogs, community colleges are trying to cement their position as the country's leader in homeland security education.


About 20 community college presidents from around the nation will gather in Washington, D.C., this weekend to develop a long-term strategy and national standards.

"Five years ago if you wanted to take a course on terrorism you basically had to go to the military," said Dan Snyder, president of Lehigh Carbon Community College in Schnecksville, 60 miles north of Philadelphia. "Today I think you're seeing a lot more training, and the facilities that are necessary to provide that high-level training."

Homeland security classes are now offered nationwide. Surging interest after September 11, 2001, has fueled new degree programs and the building of homeland security training centers.

Monroe Community College in Rochester, New York, last month opened the Homeland Security Management Institute, run by a retired Army colonel who was a commander at Guantanamo Bay in Cuba. Owens Community College in Toledo, Ohio, will break ground in April on a $10 million homeland security center featuring an anti-terrorism simulation center.

Community colleges, which educate more than 80 percent of the country's fire, police and emergency medical personnel, teach port security in Miami and border security in south Texas. New courses focus on agriculture, bank and computer security.

And many subject matters -- a course on structural collapse, for example -- now focus on terrorism-related causes instead of natural ones.

Outside experts see community colleges playing an increasing role in national security. Ellen Gordon, Iowa's Homeland Security Adviser and a member of the Senior Advisory Council for the Department of Homeland Security, said Iowa has embraced the security education offered by community colleges.

"I see within the next 20 to 25 years that the community colleges are going to be the base for training and education for all the different areas within our homeland security," she said.

Thomas Flynn, president of Monroe Community College and a member of the American Association of Community Colleges security task force meeting this weekend, said the federal government needs to embrace community colleges even more for security training.

"No one can do it better," Flynn said. "We've proven that."

While the American Association of Community Colleges says attendance is up overall since September 11, numbers were not available.

But a snapshot from Bucks County Community College, north of Philadelphia, shows an increasing interest. Attendance at hazardous materials classes rose 50 percent after the September 11 attacks, from 1,000 to 1,500 students, and new terrorism courses brought in another 250 students, school records show.

College leaders say first responders still aren't uniformly prepared to deal with another large terrorist attack, but that in several years community schools will have them ready. And while school officials say the colleges can educate the nation in the most cost-effective manner, they said that's not the only reason for the terrorism classes.

"We're not looking at this as a business decisions," said Dr. Paul Unger, provost of Owens Community College. "We're looking at this as a duty."



Wed, Jan 28, 2004

Another inflammation marker linked to heart risks

CHICAGO, Illinois (AP) -- Doctors might be able to gauge heart patients' risk of death or heart attack by measuring levels of a growth factor protein in their blood, a German study suggests.


The report adds the protein to a growing list of biomarkers for inflammation that could help predict a person's risk of heart disease and can be detected through a simple blood test.

The newly recognized marker, called placental growth factor protein, or PlGF, has been shown to contribute to inflammation in the arteries. Animal research has shown that blocking its effects suppresses growth of fatty plaques in the arteries.

The latest findings, which appear in Wednesday's Journal of the American Medical Association, suggest that testing for PlGF might be more effective at predicting patients' risks than measuring some other inflammation markers, including C-reactive protein, or CRP.

That is because PlGF appears to be released primarily from cells inside blood vessel walls, whereas CRP levels might rise in response to inflammation or infection elsewhere in the body.

Still, the lead researcher, Dr. Christopher Heeschen of Johann Wolfgang Goethe University in Frankfurt, said more studies confirming the results are needed before doctors can rely on P1GF as an early warning sign.

The discovery of the protein's link to heart disease could also lead to new treatments that would protect against heart damage by blocking the protein's effects, Heeschen said.

The study involved 1,173 patients, mostly men, with either severe chest pain or mild heart attacks.
Blood tests showed high PlGF levels in more than 300 patients. Those patients were about three times more likely than those with low levels to die or have heart attacks within 30 days of their first symptoms.

The study "is an important step forward" but also raises questions, including whether the protein would be useful in assessing risk in the general population, said Dr. Robert Bonow, a Northwestern University cardiologist and former president of the American Heart Association.

The German research will probably help lead to a whole new minimally invasive way of testing patients with chest pain, said Dr. Eric Topol, the Cleveland Clinic's cardiology chief.

"No one would ever have thought that through a few proteins you could know what's going on in the artery walls," Topol said.

He predicted that in the next few years chest-pain patients will routinely be given blood tests for an array of inflammatory proteins.

"This is where we're headed," Topol said.