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From this month's Endocrine Society News - Cushing's as Cover Story! Double click on any image to view full size.

Jayne presented a table full of Cushing's info at her local Health Fair. She plans to set up something similar at the NIH Health and Wellness Fair May 15th. Double click on any photo to view fullsized.

http://www.nashuatelegraph.com/apps/pbcs.d...EALTH/103200057 Medical detectives put Lenin under the microscope Michael Woods, Medical Journal Published: Sunday, Mar. 20, 2005 Workers such as airline pilots, bus drivers and surgeons - who hold the lives of other people in their hands - are expected to take a break from work when they develop physical or mental illness that could affect their performance. Heads of state who develop incapacitating illness sometimes ignore that basic rule of occupational medicine, even though their decisions can affect millions of people. A long list of political leaders has stayed in power despite serious illnesses that may have lessened their ability to lead. King George III of England, for instance, sometimes had to be put in a strait jacket and chained to a chair to control his insane outbursts. Former United States presidents Woodrow Wilson and Franklin D. Roosevelt had strokes that seemingly affected their judgment. Former President John F. Kennedy looked tan and fit, but actually was taking a dozen medications a day for severe back pain, intestinal problems, Addison’s disease (a disorder of the adrenal glands) and other problems. The newest addition to the list - Vladimir Illyich Lenin - may top them all in terms of the eventual toll in human life. Lenin founded the Bolshevik Party, which ushered the Soviet Union into existence. This year is the 81st anniversary of his death. Lenin died at 53 on Jan. 21, 1924, after a long illness. In those final years, a political enemy named Joseph Stalin positioned himself to seize power after Lenin’s death. Stalin changed the country’s direction. Historians rank Stalin among history’s greatest mass murderers. Through political purges, a contrived famine in the Ukraine and other acts, Stalin may have caused more than 12 million deaths. A new study suggests that syphilis may have let power slip into Stalin’s grasp. Rumors have circulated for decades that Lenin had syphilis, a sexually transmitted disease that can be fatal if not treated. The disease gradually spreads throughout the body and there was no effective treatment in Lenin’s day. In the final stages, it damages the brain and blood vessels in ways that can lead to depression, lethargy, memory loss and strokes. Until the Soviet Union’s collapse in 1991, however, medical records of Lenin’s illness and autopsy were secret. Since then, however, more and more information has leaked out, including recollections of doctors who treated Lenin and those present at the autopsy. That information strongly supports the idea that Lenin died from syphilis that he caught decades earlier - and not from hardening of the arteries as the official Soviet accounts contended. Researchers from the Be’er Sheva Mental Health Center in Israel now have analyzed the full body of information on Lenin’s illness. It included records of Lenin’s treatment by famous psychiatrists who treated only one disease - syphilis. The researchers concluded that syphilis is the only explanation Lenin’s symptoms and the autopsy findings. Lenin must have known his fate. What if he had stepped aside in favor of a trusted associate capable of dealing with Stalin? Michael Woods is a medical writer for The Toledo Blade. Contact him at mwoods@nationalpress.com.

As a result of a message I posted a couple weeks ago, several people have asked me what they can do to help out with the running of the message boards and the websites in general. Several people suggested that I put a link on every page to the area where money could be donated to help defray the growing costs of these sites. I'm hesitant to do that, because I don't want anyone to feel pressured into feeling like they have to pay anything to be a member here, or use any of the features. I've given this a lot of thought over the last week or so and have come up with several other ways to help out. That's what is listed at the top of every page here now: Give Back The first, tentative, list is included below. If you have other suggestions, please post them here and I'll add them to the list. Ways to Give Back... in no particular order: Participate on the message boards and help support others, especially newcomers. If you see a post with no, or few responses, say something so that the person doesn't feel like they're being ignored. I've noticed that many people here are very good at this If you've had successful surgery, stick around to offer hope to those who come after. Far too many cured Cushies leave, and present an unbalanced look of life after Cushing's. Add (or update) your bio. Attend the chats. Offer to talk to others offline. Send cards or little notes to others who are hurting - either online, or through snailmail. There are some free eCards available through this site, through Hallmark, Bluemountain, many places. If you don't know someone's email address for an eCard, you can send it to yourself, get the link (URL) when it comes to you and paste that into a PM for the person. Add a review of this website. Use the "Tell a Friend" links on any page to share it with someone who would be interested. Be a board moderator. Visit other Cushies in the hospital, or go with them to doctor appointments. Call them when you know that they're "down" - or happy! Get some CUSH brochures and pass them out to doctors, Weight Watchers and other similar meetings, people who look Cushie. There are also Cushings-Help business cards available. Wear your Cushing's Awareness pin often and tell everyone what it means. Participate in the CUSH Register. If someone asks how you're doing, explain Cushing's to them, at least a simple version! I've been doing this with my piano students and parents - they're finally getting it! Submit your Helpful Doctor info - we need all the good doctors we can get. Join CUSH, attend meetings, be involved Help Jayne get Cushing's Awareness Day enacted. Participate in the Clothes Closet, the book project, the Cookbook project. Someday, maybe you'll meet a Cushie without a computer. Offer to print out helpful pages for him/her, or invite her over to check out your computer. Invite him to a local meeting, or give her the toll-free number (877-825-0128} to call for more info. Help someone fill out insurance or disability forms. Ask someone how you could help them. Share your good news - it spreads like wildfire! Pray, or send healing thoughts, to those who need them Post relevant News Items that may help someone else. Help people who ask questions in the InstaChat. Refer them to the boards or other places on the site. Use iGive.com when you buy things online; buy books using the links on the book pages; tshirts and such from the giftstore. Then WEAR those tshirts! If you see on the Calendar that today is someone's birthday, or surgery anniversary or other special event, please acknowledge that on the boards. Thank you for your contribution to the Cushing's Help and Support Community! Many thanks to those of you who have sent in donations. They're greatly appreciated!

See What Jayne has Done! She wrote to her representative and she's now in the Congressional Record. She has her first response and it's a fantastic one!

Print out a sample letter to send to your congress person or senator or download it in Word format. More information here

Source: http://www.chicagotribune.com/technology/c...ack=1&cset=true QUALITIES OF LIFE HEALTH Beaming in on the brain New radiation system tackles tumors while bypassing nearby tissue By Marc Davis Special to the Tribune Published February 13, 2005 If it weren't for a unique method of removing residual brain tumor tissue, a treatment offered by Loyola University Health System, Craig Fedder might be blind. Fedder, who lives in Aurora, knew he had a serious problem when, driving home one evening after work in January 2003, he was suddenly stricken with double vision. "I was on the road, speeding along in the middle of traffic, when it happened," said the 60-year-old Fedder, training-development manager for the International Truck and Engine Co. in Warrenville. "I was really scared. I tried to drive with my hand over one eye. That didn't help. I thought I'd have an accident. I was lucky to make it home." Fedder sought medical attention, and eventually an MRI and CT scan revealed a 2.8-centimeter benign tumor on Fedder's pituitary gland. The tumor created pressure against nerves that control eye movement and caused his double vision. His tumor was removed in a traditional surgical procedure in March 2003 by Dr. Thomas Origitano, a neurosurgeon at Loyola University Chicago Stritch School of Medicine. But Fedder still had a problem. Microscopic residual tumor tissue remained in Fedder's brain and had to be removed or the tumor could grow back, causing a recurrence of his vision problems, Origitano explained. The usual method of tumor tissue removal is a monthlong course of external beam radiation. Although the treatment can be effective, the side effects can be rough: fatigue, nausea, time lost from work. Most dangerous, however, is the potential damage to brain tissue. "The danger of injury to adjacent [brain] tissue includes possible hearing loss, blindness, difficulty swallowing, even paralysis," said Dr. Bahman Emami, chairman of the department of radiation oncology at Loyola University Health System. In Fedder's case, the potential injury to his optic nerve, which was being pressured by the tumor, could cause permanent blindness. If his brain tumor tissue were removed in the traditional way, there was a chance of damaging the optic nerve. With Loyola's new Novalis system of radiation, however, the risk was substantially reduced, Emami said. "What's unique about this [Novalis] method is its ability to shape the radio beam to the contours of the tumor," Origitano explained. "This leaves as much healthy tissue as possible untouched. The patient's exposure to radiation is reduced, and side effects are not as severe. It's also now used as a surgical method which can treat smaller tumors, reduces treatment time and causes minimal bleeding. Patients recover more quickly and with fewer or less-troublesome aftereffects." Fedder was scheduled for a course of treatment using the Novalis system in early 2004 at the Loyola University Health System, Maywood. Loyola is the only Chicago-area medical facility using the system, Emami said. Before Fedder's treatment, a plastic mask was made of his face for use as a precision guide for aiming the beam. "They put a roll of plastic mesh over my face," Fedder said, describing the mask-making process. "It was warm and pliable and took an impression. It was not uncomfortable." The finished mask was attached with bolts to fixtures on both sides of Fedder's head that held it steady so that the radiation would target the same place every time. The computer recognized the face and made appropriate targeting adjustments after two X-ray images verified the exact position of the patient's head. The radiation machine then rotated around Fedder's head, dispensing a precise dose of radiation to a pinpoint target. The radiation is a stream of fast-moving subatomic particles generated by a linear accelerator, a machine that uses electricity to generate the high-energy radiation beam. Emami supervised the treatment. After the radiation, about a five-minute exposure, Fedder returned to work the same day. The whole thing took about 30 minutes, Fedder said. "That includes the time it took for me to get ready. After it, I didn't feel woozy, sick or tired." Only near the end of his 25 days of radiation--five days a week, with Saturday and Sunday off--did Fedder start to feel some fatigue. He also lost hair on his head in two small patches. "But I started to feel normal again pretty soon, and my hair grew back quickly," he said. The Novalis system is now being used for both initial brain tumor surgery and the radiation follow-up. The system may also soon be used to treat other types of tumors, including those of the breast and prostate, Origitano said. As for Fedder, "I feel great now," he said. "I have no eyesight problems, I see Dr. Origitano once a year and everything was covered by insurance. I feel pretty lucky." Copyright © 2005, Chicago Tribune

Source: http://news.xinhuanet.com/english/2005-02/...ent_2538750.htm Dental surgery might become easier with new growth hormone injection technique Today, when dentists replace a tooth, they also have the complicated task (painful for the patient) of building a bone structure around the new tooth. They typically transfer excess bone material to the tooth from other areas of the patient's face. But some University of Michigan researchers may have found a better way. The scientist used gene therapy to inject a growth hormone into the mouths of lab mice, and the hormone coaxed bones into growing by themselves. LOS ANGELES, Feb. 2 (Xinhuanet) -- US Researchers have found that introducing a growth factor protein into a mouth wound, using gene therapy, helps generate bone around dental implants, according to a paper in the Molecular Therapy journal published on Tuesday. US Researchers have found that introducing a growth factor protein into a mouth wound, using gene therapy, helps generate bone around dental implants. (yahoo.com) For a patient with a sizable mouth wound, replacing a tooth means more than simply implanting a new one. The patient also needs the bone structure to anchor the new tooth in place. Such reconstructive surgery today involves either taking a bone graft from the patient's chin or jaw, which leaves a second wound needing to heal, or using donated bone from a tissue bank, which yields unpredictable results. A team of researchers at the University of Michigan led by Professor William Giannobile delivered the gene encoding for bone morphogenetic protein-7 (BMP-7) to large bone defects in rats, in an attempt to turn on the body's own bone growth mechanisms. The study showed that the animals produced nearly 50 percent more supporting bone around dental implants after getting BMP-7 treatment. BMP-7 is part of a family of proteins that regulates cartilage and bone formation. Recent studies have shown that BMPs are present in tooth development and periodontal repair. The Michigan study mixed BMP-7 genes with an inactivated virus in a gel-like carrier and injected it into wounds. Researchers said using a virus, with the harmful effects turned off, harnesses the virus' ability to enter into cells and use their genetic machinery. Once inside the cell, the viruses help BMP-7 genes get where they need to be in the host's cells to boost bone production. Gene expression producing BMP-7 proteins peaks after a week. The gene acts quickly to get bone growth started, then disappears within about 28 days. Scientists said a next step in this process could include looking for non-viral approaches to delivering gene therapy to the defect site. Alternatively, they could conduct the gene therapy outside the body using a tissue biopsy and then transplant the genetically modified cells back into the patient. But this would require two surgical procedures instead of one. "This study represents a proof-of-concept investigation. We are encouraged about the promise of this treatment," Giannobile said, adding that more work is necessary before the approach can be tested in humans.

From Yuma Sun - Yuma, AZ, USA http://sun.yumasun.com/artman/publish/arti...story_14728.php Tracking down the cause of women's facial hair BY PAUL G. DONOHUE, M.D. Feb 9, 2005 DEAR DR. DONOHUE: You recently wrote about a woman concerned with losing her hair. I have the opposite problem. I am 43 and have a mustache and goatee, and I must shave daily. The hair on my legs also grows rapidly. What are the treatments for this condition? -- D.S. ANSWER: Some of what I say applies only to premenstrual women, but most can be applied to women of all ages. Many women experience hair growth in places where it is a male feature -- the face, chin, neck or chest. Hair growth in those areas (and often robust leg-hair growth) depends on the influence of male hormones or on hair follicles that are extremely sensitive to low levels of male hormones. Tracking down the cause of the overly abundant supply of the hormone determines the proper treatment. One common condition is polycystic ovary syndrome, which, in its full expression, features large, cystic ovaries, menstrual irregularities, acne, infertility and the failure to ovulate. Male-pattern hair growth is another feature. Tumors of the ovary or adrenal gland that produce male hormones are a rare but other possible cause. So are thyroid gland disorders and a condition called the metabolic syndrome, in which blood pressure is elevated and blood sugar is high, as are blood triglycerides. However, the greatest number of women with the problem fall into the "idiopathic" category, meaning no cause can be found. Shaving is one solution. It doesn't make hair grow faster or thicker. Creme bleaches, chemical hair removers, electrolysis and laser treatments are other answers. Weight loss, when applicable, can lower male-hormone levels. Birth control pills are another way to blunt male-hormone action. So is the blood pressure medicine spironolactone. Vaniqa cream doesn't get rid of existing hair, but it prevents new hair growth.

Sue and Cathy (ChatiCat) have these pins. You could send a PM to Sue to get her current address - she's moved out of Jackson for sure.

Report: School Steroid Use Silent, Rampant .c The Associated Press DALLAS (AP) - Texas high school students yearning for athletic fame or a chiseled physique are easily obtaining and using steroids as many coaches look the other way and parents seem unaware, a Dallas Morning News investigation has found. The same students popping pills and sticking themselves with needles of muscle-building drugs were also found to be abusing other drugs - such as Viagra, the fertility drug Clomid and sedatives - to compensate for steroid side effects. Those side effects include liver damage, tumors, sexual impotency, erratic mood swings and potentially suicidal depression. ``Steroids have made a massive comeback'' in high schools over the past decade, Mike Long, a veteran Texas high school football coach, said in Sunday's editions of The News. Long abused steroids as a young athlete and now counsels teenagers about their dangers. Grapevine-Colleyville officials made headlines last week with a rare admission that nine athletes had confessed to using steroids last spring. Despite more than a decade of research on high school steroid use, coaches and school administrators have largely ignored the issue. Most area coaches interviewed by the newspaper said they don't believe steroid use is a problem. ``I'm telling you, I've never seen steroid use and I've never suspected it,'' said Mike Hughes, head football coach at Plano West Senior High School, where five former students interviewed by The News described widespread use. ``I'm more concerned about other things - alcohol, marijuana and those things.'' Coaches rarely confront players or alert their parents, even when they suspect steroid use. Some cite a lack of screening programs and fear of a lawsuit from angry parents. They also think twice about accusing a key player because of the extraordinary pressure to win. The News interviewed more than 100 current and former high school students, coaches and parents in North Texas high schools. More than 25 of them described their personal encounters with illegal steroid use. Among other findings from the four-month investigation: Teens often obtain steroids from dealers who are friends, classmates and sometimes varsity athletes. Federal and local law enforcement agencies devote little time to curbing steroid use because of tight resources and what they deem more urgent priorities, such as illicit drugs and alcohol. Teens and adults use the Internet to exchange information about buying and using steroids and tips on managing side effects. Many teenage steroid users are non-athletes. So-called ``vanity'' users take steroids to impress classmates and potential girlfriends. A Texas A&M University survey on substance abuse two years ago found that nearly 42,000 Texas students in grades seven through 12 - about 2.3 percent - had taken steroids. Researchers say the number is almost certainly too low. Steroid use, though common, is still shrouded in secrecy. Coaches seldom out students. Few students get caught. And few high schools fund steroid screening, which is expensive at $100-$175 per test. ``In my 58 years, other than pedophilia, I've never witnessed a behavior as secretive as this,'' said Charles Yesalis of Penn State University, a pioneering researcher and writer on youth steroid use. ``People will tell you they smoked pot, they did coke, they did speed, they did crank, they smacked their wife, they smacked their girlfriend long before they tell you they used anabolic steroids. The higher you go up the athletic food chain, the more pronounced this becomes.'' Despite their dangerous health effects, school and law enforcement officials say steroids are a much less serious problem than illicit drugs and alcohol. ``Cocaine, heroin and methamphetamines are what we see a lot of,'' said Plano Police Chief Gregory Rushin. ``That's what's killing our kids. We just don't see that many steroids cases.'' High school steroid users make similar distinctions. In Colleyville, a high school user told The News that steroids shouldn't be viewed ``as a bad-kid drug.'' ``Remember, kids are not breaking into people's houses to get their steroids,'' Yesalis said. ``They're not walking around with dilated pupils looking like a parent's worst nightmare. A lot of kids doing this are captain of the high school football team.'' 02/06/05 15:27 EST

Cops Accused of Using Steroids to Bulk Up By SEAN MURPHY .c The Associated Press OKLAHOMA CITY (AP) - As a brand-new police officer, Chris Holden wanted to do everything he could to protect himself, especially after he heard about a highway patrolman who was shot to death in a struggle over his gun. So he began bulking up with steroids. Now Holden, 31, is out of work, one of four members of the Norman Police Department who were fired last fall after being accused of using or selling bodybuilding steroids. Police officers in Mississippi, Ohio, Connecticut, Hawaii, Colorado, Alabama, Florida, Arkansas and New York have also been accused of steroid-related offenses in recent years. In many cases, they were charged with using, possessing or dealing steroids. Steroids are attractive to some officers who know that an intimidating physique can ward off conflict or give them the upper hand in a life-or-death struggle. ``The thinking is that big is better than small, tough is better than weak,'' said Gene Sanders, a former police officer who has worked for nearly 15 years as a police psychologist for several agencies in California. ``There is sort of an underground, unspoken tradition among several departments that I've worked with that if you really want to bulk up, this is the best way to do it.'' But steroids can also lead to heart disease, liver damage and shrunken testicles, as well as uncontrolled aggression, or ``roid rage,'' which can be especially dangerous in a law officer. ``These substances can cause depression and despondency, and here is a person who has a weapon,'' said Dr. Linn Goldberg, head of Oregon Health & Science University's Division of Health Promotion and Sports Medicine. A former Riverdale, Ga., police officer who received a life sentence in 1995 for the slaying of a bar owner, and an Oregon jail guard who received a 20-year sentence in 1986 for kidnapping, shooting and paralyzing a woman both claimed steroid use contributed to their behavior. Holden was an officer on the streets of Norman for barely two weeks when Oklahoma Highway Patrolman Nikky Green was shot to death on a rural road in 2003. Investigators say the killer wrestled Green's gun away from him and shot him with it. ``If I was making a traffic stop, on a disturbance call or a motorist assist, no matter what call I was going to, I thought about the trooper that was killed,'' Holden wrote in a letter published in The Norman Transcript in November. ``I wanted to physically prepare myself as much as I could and have the confidence to do my job,'' he said. ``I took anabolic steroids so that I would be stronger. If I got into a fight, I felt I stood a better chance of surviving. I wanted to go home when my shift was over.'' Holden, three fellow members of the Norman police force and an Oklahoma highway patrolman got in trouble last fall after a Drug Enforcement Administration investigation found that a Norman bodybuilder was allegedly supplying steroids to cops. One of the Norman officers and the patrolman were arrested; the patrolman is on leave, awaiting disciplinary action. Holden was never charged with a crime. On the Net: Oregon Health & Science University's Athletes Training & Learning to Avoid Steroids: http://www.ohsu.edu/hpsm/steroids.html

From http://www.thirdage.com/news/articles/ALT0...2050117-01.html Your Cholesterol: What Do the Numbers Mean? By Judy Foreman QUESTION: If your cholesterol and HDL are really good, do you need to worry about LDL? ANSWER: Probably not, but it depends. When doctors do a cholesterol blood test, they're looking for your low-density lipoprotein, or LDL cholesterol; your high-density lipoprotein, or HDL; and your triglycerides, or fatty acids in the blood. LDL is considered the "bad" cholesterol because it gets deposited in blood vessel walls as plaque; HDL is "good" because it take cholesterol out of the blood. Your total cholesterol score is the sum of LDL, HDL and very low-density lipoprotein, or VLDL, which is computed by taking your triglycerides and dividing by 5. In people without heart disease and at low or ordinary risk for it, total cholesterol should be 200 milligrams per deciliter or less, according to guidelines issued by cholesterol experts several years ago. LDL should be 130 or less. In those with heart disease or at very high risk, LDL should be less than 100 and, "better still, under 70,'' said Dr. Daniel Levy, director of the National Heart Lung and Blood Institute Framingham Heart Study. HDL should be above 40. Triglycerides should be 150 or lower. So, if your total cholesterol were, say, 208 and your HDL were 100, by mathematics alone, that suggests your LDL is admirably low, said Dr. Zoran Nedeljkovic, an interventional cardiologist at Boston Medical Center. Still, to assess your overall risk of heart disease, doctors also need to know your age, sex, smoking history, blood pressure, family history of heart disease, whether you have diabetes, and how much you exercise. In general, if either your total cholesterol or your LDL is higher than desirable, you can try losing weight and controlling fat intake. If that doesn't work well enough, doctors often prescribe statin drugs. Judy Foreman is an affiliated scholar at the Women's Studies Research Center at Brandeis University. © 2004, Judy Foreman. Distributed by Tribune Media Services

http://www.bend.com/news/ar_view^3Far_id^3D20501.htm OHSU studies 'expectancy effect,' brain disorders From Bend.com news sources Posted: Wednesday, January 12, 2005 2:08 PM Reference Code: PR-20501 January 12 - PORTLAND - It's a question scientists have debated for more than 50 years: Can a person's belief or expectation of overcoming an illness improve that person's overall health? While this so-called "expectancy effect" may not necessarily influence the underlying cause of a disease, evidence suggests it can have an impact on a patient's health outcomes. A new, National Institutes of Health-funded research program at Oregon Health & Science University aims to find out why. The Oregon Center for Complementary and Alternative Medicine in Neurological Disorders (ORCCAMIND) in the OHSU School of Medicine has received a three-year, $2.4 million grant from the NIH's National Center for Complementary and Alternative Medicine to develop "Complementary and Alternative Medicine: Expectancy and Outcomes," or CAMEO. CAMEO's goal is to develop expectancy effect models that can be used to study cognitive and physiological changes contributing to the phenomenon, ranging from perceived self-efficacy - the belief that a person can influence his or her own health outcome - to hormonal activity and genetic changes that affect the brain's neurotransmitter systems, such as dopamine, serotonin and opioid, said Barry Oken, M.D., professor of neurology and behavioral neuroscience in the OHSU School of Medicine, and director of ORCCAMIND and CAMEO. Researchers also hope to improve the design of clinical trials by heightening understanding of how individual differences contribute to the variability in responses to medical interventions. Expectancy effect is considered a component of placebo effect, a long-studied medical outcome stemming from any clinically prescribed, biologically inert substance or inactive procedure for which there is no direct biological effect, including words, pills, gestures, devices and surgery. Expectancy effect is considered more broad and includes all processes and influences that may affect the brain's anticipation of a response. "We're not talking about the patient-physician interaction, which, to some people, is considered part of placebo effect - the contact, the handholding, the bedside manners," said Oken, who wrote a chapter about placebo effect in his 2004 book, Complementary Therapies in Neurology: An Evidence-Based Approach. "We're really thinking about people's hope or expectation that they're going to get better." One recent study, for example, showed Parkinson's disease patients who were administered a placebo experienced changes in brain chemistry similar to that caused by symptom-treating drugs levodopa annd apomorphine. "It's really pretty remarkable," Oken said. "In Parkinson's patients, you can show dopamine release in the basal ganglia with administration" of the placebo. CAMEO will focus on four areas: Parkinson's disease, metabolic syndromes, Alzheimer's disease and a mouse model for multiple sclerosis, Oken said. Each area is led by a two-person team that includes a conventional medicine physician and a complementary medicine practitioner. The grant allows ORCCAMIND to build on relationships it established with the National College of Naturopathic Medicine, the Oregon College of Oriental Medicine and Western States Chiropractic College in Portland. NCCAM developmental centers, such as CAMEO, "clearly require close affiliation with CAM centers because part of the goal was to facilitate development of research infrastructure at the CAM institutions," Oken said. "So each of the four projects is linked." Working with complementary practitioners is important because many of them have "succeeded in harnessing this effect," Oken said. "From my point of view, they have a much better handle on how to maximize this effect than conventional practitioners." The research teams also will study factors that may contribute to clinical benefit from expectancy effect, including stress and personality traits. One area of the brain that CAMEO will examine closely is the hypothalamic-pituitary-adrenal axis, a cluster of neuroendocrine components that includes parts of the hypothalamus, the anterior lobe of the pituitary gland, adrenal glands and hormone-transporting systems. The axis controls reactions to stress and is believed to be linked with mood disorders. "The HPA acts as sort of a stress mediator," Oken said. "Those kinds of things might predispose a person to have a better, bigger response (to placebo) than others." Carlo Calabrese, N.D., M.P.H., a research professor at the National College of Naturopathic Medicine and a clinical assistant professor of neurology in the OHSU School of Medicine, will serve as CAMEO's associate director.

http://www.prnewswire.com/cgi-bin/stories....02812461&EDATE= Needle-Free Delivery Option Exclusive to Saizen® Available for Patients GENEVA, Switzerland and ROCKLAND, Massachusetts, January 10 /PRNewswire-FirstCall/ -- Serono Inc., the US affiliate of Serono (virt-x: SEO and NYSE: SRA), announced today the availability of Saizen® [somatropin (rDNA origin) for injection] for use in the treatment of patients with adult growth hormone deficiency (AGHD), following its FDA approval. "This new indication for Saizen® represents the evolution of our growth hormone portfolio and further demonstrates our commitment to the metabolic franchise," said James Sapirstein, executive vice president of Metabolic Endocrinology at Serono, Inc. "Patients with AGHD who are treated with Saizen® therapy can use our easy-to-use drug delivery devices such as cool.click®, a needle-free device that is preferred by pediatric patients and is now available for use by adults taking Saizen®." Adult Growth Hormone Deficiency (AGHD) can be effectively treated with Saizen®. With the U.S. approval, patients who were growth hormone deficient during childhood and have growth hormone deficiency as an adult, may continue to use Saizen®. In addition, adult patients who have adult onset growth hormone deficiency either alone, or associated with multiple hormone deficiencies, now have access to Saizen® and its line of devices. Saizen® can be administered using a needle-free device, cool.click®, the only FDA approved needle-free device for the administration of growth hormone. It can also be administered with a recently launched autoinjector pen device, one.click®, or by traditional needle and syringe. Serono's portfolio of innovative devices gives patients the choice they want in growth hormone delivery. Patients can learn more about Saizen® and Serono's growth hormone delivery devices by talking with their physician, or by calling Serono Connections for Growth® toll-free at 1-800-582-7989. The full prescribing information for Saizen® can be found online at http://www.seronousa.com. About Adult Growth Hormone Deficiency (AGHD) Growth hormone deficiency can be a significant problem for adults even though they no longer get taller. AGHD is recognized as a specific clinical syndrome with numerous physiological consequences, with effects on: - Changes in body composition, including central obesity; - Lipids in the blood; - Muscle strength; - Bone composition; - Exercise capacity and energy; - Cardiovascular risk; and - Psychological well-being (social isolation and depression). There are also studies indicating that patients with AGHD have an increased risk of mortality from cardiovascular disease, possibly attributable to their growth hormone (GH) deficiency. GH deficiency in adults can result from a pituitary or peri-pituitary tumor or as a direct result of the surgery/radiation used to manage these conditions. Less commonly, GH deficiency in adults arises from a deficiency acquired in childhood. About Saizen® Saizen® [somatropin (rDNA origin) for injection] is a human growth hormone produced by recombinant DNA technology. The recommended dose for adults at the start of therapy is .005 mg/kg daily. The dosage may be increased to not more than .01 mg/kg daily after four weeks depending upon the patient's tolerance of treatment. Saizen® is indicated for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone. It is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency that meets the criteria of adult onset or childhood onset. In patients with AGHD, the most common adverse events with associated growth hormone therapy are joint and muscle pain, edema, carpal tunnel syndrome, and tingling. Growth hormone should be used with caution in patients with insulin resistance, glucose intolerance, diabetes, hypothyroidism, intracranial hypertension, and in women who are pregnant or nursing. GH should not be used in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment; in the presence of active neoplasia; and in patients with proliferative or preproliferative diabetic retinopathy; or in patients hospitalized with acute critical illnesses. Full prescribing information for Saizen®, including important safety information, is available at http://www.seronousa.com.

1) Osteoporosis Research Study. This study is being conducted in: - Tacoma, WA ( http://www.centerwatch.com/patient/studies/stu67678.html ) 2) What's your New Year's resolution? If your goal is to shed those extra pounds, Research Testing Labs can help.. This study is being conducted in: - Great Neck, NY ( http://www.centerwatch.com/patient/studies/stu67718.html ) - Huntington, NY ( http://www.centerwatch.com/patient/studies/stu67717.html ) 3) A Research Study for High Cholesterol. This study is being conducted in: - Renton, WA ( http://www.centerwatch.com/patient/studies/stu67656.html ) 4) Cholesterol Research Study. This study is being conducted in: - Santa Rosa, CA ( http://www.centerwatch.com/patient/studies/stu67676.html ) Additional educational resources that may be of interest to you: Informed Consent: A Guide to the Risks and Benefits of Volunteering for Clinical Trials. http://www.centerwatch.com/bookstore/pubs_...infconsent.html Volunteering for a Clinical Trial, a brief educational pamphlet. If you would like to order this pamphlet click here: http://www.centerwatch.com/bookstore/pubs_...ochureform.html

http://www.kentucky.com/mld/kentucky/sports/10568171.htm Thomas rebounds from tumor scare UK FORWARD CLOSE TO FULL STRENGTH AFTER OCTOBER SURGERY By Jerry Tipton HERALD-LEADER STAFF WRITER "Tumor." That diagnosis sent shockwaves through the Kentucky basketball program last fall. Sophomore forward Sheray Thomas had been sluggish and easily fatigued. Relying on their athletic backgrounds, the coaches urged him to play harder. That didn't help. Then a medical examination revealed the reason why Thomas got tired so quickly: A tumor was growing on his adrenal gland. "It kind of scared me," Thomas said yesterday when asked about his initial reaction to the diagnosis. It scared his coaches and teammates, too. "I got scared," Chuck Hayes said. "That's very scary. Life and death, really." Doctors removed the benign tumor -- which was tennis-ball sized, Thomas said -- in a six-hour surgery in early October. Thomas lost about 40 pounds. UK coaches considered sitting out Thomas this season. But once his daily post-op nausea ended after about two weeks, he began the process of getting back in good enough shape to play. "I pushed myself as hard as I could," he said. "You never realize what you have until it's gone. You want to do anything to go back out and play." Thomas, whose rebounding and physical play off the bench fit an acute UK need, returned for a cameo role against Louisville on Dec. 18. His stints increased to six and 10 minutes against William & Mary and Campbell. He's now well enough to not be satisfied with anything but the maximum playing time possible. In other words, he's like most other college players. When a reporter asked if he'd expect to log eight to 10 minutes against South Carolina tonight, Thomas said his expectation was "more than that." "I'll always say that," he added with a smile. "But that's pretty much up to the coach." UK Coach Tubby Smith, who earlier marveled at how quickly Thomas got back into practice routines, said the player was now "full tilt." Well, not quite full tilt, Smith added. With the physical demands of practice and games, the coach expressed doubt that Thomas will return to his playing weight of 230 pounds. "He probably won't put that weight on until after the season," Smith said. "But he knows how to adapt and adjust to what he has to work with." Thomas tried to adapt long before doctors discovered the tumor. He recalled feeling so weak after his senior year of high school in Upper Marlboro, Md., that he had to stay in bed for long stretches. Thomas did not feel pain, but he noticed how quickly he got tired. "Just from shooting before practice, before stretching," he said. "I didn't feel ready to go. Something was taking away my energy, making me sweat more. "The coaches said I wasn't going as hard as I could. Being lazy, pretty much." Then Thomas learned of the tumor at the end of September. Yes, he said, he wondered if he'd play basketball again. "That was the thought in my head," Thomas said. "People were saying that. I always thought I'd come back. I was scared, but I stayed positive." Doctors needed six hours to remove the tumor, in part, because the adrenal gland is in the back of the abdomen and requires a methodical surgical touch to reach, and because the tumor was large. As difficult as the surgery was, the recovery period was "way worse," Thomas said. "Horrible." Thomas grew nauseous. "Every day I was sick," he said. "It was a rough couple weeks." The surprise of his post-op difficulties, which can be a normal effect of major surgery, probably slowed his recovery. "A big shock," he said. "I guess I didn't ask as many questions (before surgery) as I needed to." Now, Thomas said he feels good. He brushed off a bruised knuckle on his right ring finger. "No injury is fun," he said, rubbing the knuckle, "but this is better than the injury I had before." His return caused a hooray-for-Sheray reaction from teammates and coaches. "It's unbelievable," Patrick Sparks said. "He's made big strides. People were talking of redshirting. It's given us an inspirational lift."

Insmed Completes New Drug Application -NDA- for SomatoKine for the Treatment of Growth Hormone Insensitivity Syndrome; Conference Call Scheduled for 11:00 am January 5, 2005 RICHMOND, Va.--(BUSINESS WIRE)----Insmed Incorporated (Nasdaq:INSM) announced that it has completed the New Drug Application (NDA) to seek regulatory approval of SomatoKine® (Mecasermin rinfabate) for the treatment of growth hormone insensitivity syndrome. The Company will submit the NDA before market open on Monday, January 3, 2005. "The completion of the NDA for SomatoKine represents a great achievement for the Company. An NDA is a huge undertaking for a small company like Insmed and we have made every effort to ensure we have a submission of the highest quality. This important milestone is evidence of our continuing commitment to develop medicines for patients with unmet medical needs," said Geoffrey Allan, Ph.D., President and CEO of Insmed Incorporated. Conference Call Insmed will host a conference call on Wednesday, January 5, at 11:00 a.m. Eastern Time (10:00 a.m. Central Time) to provide an update on recent corporate events and planned activities for 2005. To participate in the conference call dial 800-479-9001(domestic) or 719-457-2618 (international). The call will be webcast live through Insmed's corporate website: www.insmed.com. A telephonic replay of the call will be available for one week at 888-203-1112 (domestic) or 719-457-0820 (international), passcode: 238426. A web replay of the call will be available through the corporate website beginning at 1:00 p.m. More on SomatoKine® Insmed's SomatoKine® is a proprietary delivery composition of insulin- like growth factor-I (IGF-I). The novel compound is administered as a subcutaneous injection, which can restore IGF levels to physiological relevant levels. On July 20, Insmed provided the results from a six-month data analysis of the pivotal Phase III GHIS clinical trial showing a statistically significant increase (p About Insmed Insmed is a biopharmaceutical company focused on the discovery and development of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs. For more information, please visit www.insmed.com. Statements included within this press release, which are not historical in nature, may constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding clinical trials and goals, our regulatory and business strategies and growth opportunities for existing or proposed products. Such forward-looking statements are subject to numerous risks and uncertainties, including risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, the company may lack financial resources to complete development of product candidates, the FDA may interpret the results of our studies differently than we have, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. As a result of these and other risks and uncertainties, actual results may differ materially from those described in this press release. For further information with respect to factors that could cause actual results to differ from expectations, reference is made to reports filed by the Company with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward-looking statements made in this release are made only as of the date hereof and Insmed disclaims any intention or responsibility for updating predictions or financial guidance contained in this release. Insmed Incorporated Investor Relations: Baxter Phillips, III, 804-565-3041 Fax: 804-565-3510 bphillips@insmed.com 12/31/2004 09:22 ET

Trial Using Pain Relieve Aleve Suspended By PAUL RECER .c The Associated Press WASHINGTON (AP) - An Alzheimer's disease prevention trial was suspended after researchers said there were more heart attacks and strokes among patients taking naproxen, an over-the-counter pain reliever in use for 28 years and commonly known under the brand name Aleve. The study, involving some 2,500 patients, was to test whether naproxen or Celebrex, both pain relievers, could reduce the risk of Alzheimer's disease among healthy elderly patients who were at an increased risk of the disease. Officials at the National Institutes of Health said the study was suspended after three years when it was found that patients taking naproxen had a 50 percent greater incidence of cardiovascular events - heart attack or stroke - than patients taking placebo. Another factor, officials said, was the announcement last week that advertising for Celebrex was being halted after a study found that high doses of the drug were associated with an increase in heart attack risk. Preliminary data from the Alzheimer's study, however, did not indicate an increased risk for heart attack or stroke for Celebrex, officials said. Lester Crawford, acting commissioner of the Food and Drug Administration, acknowledged Tuesday that the conflicting studies are confusing and call for continued evaluation. For now, he recommended following the dosage recommendations for the drugs. "Any drug taken long enough and at high enough dosage can cause some difficulty," Crawford said on NBC's "Today." "It would be premature to say what we we're going to do with either one of these drugs, Celebrex or Aleve," he said. "However, we will keep all regulator options open and make some determinations as quickly as possible based on the data." Celebrex, a prescription drug, and naproxen are both commonly used to treat the joint pain of arthritis. Naproxen has been approved for sale, first as a prescription and then as an over-the-counter drug, since 1976. Celebrex is in the same class - COX2 enzyme inhibitors - as Vioxx, an arthritis drug recently taken off the market by its manufacturer after it was linked to an increase in heart attack and stroke. Officials acknowledged that the implications for the continued use of naproxen are not clear and will require further study. Dr. Sandra Kweder of the FDA said the NIH study is the first to show that naproxen might increase the risk of heart attack or stroke and that the findings are "confusing." No immediate action, however, is expected toward naproxen, she said. "We are not contemplating any specific regulatory action over the next few days," Kweder said. "We will be working with the NIH to try to understand the data better and determine what will be appropriate from there." Patients who routinely take naproxen should follow the drug package instructions carefully, Kweder said, including the directions to not take it for more than 10 days, and to consult a doctor if pain persists. Efforts to obtain reaction Monday night produced no answers at phone numbers for Bayer Healthcare, the maker of Aleve. In the earlier studies of the COX2 drugs, an increase in cardiovascular events was noted only after a long-term use of the medications. The Alzheimer's disease study was being conducted by the National Institute on Aging, an arm of the NIH. It called for 2,500 patients aged 70 or older and who had a family history of Alzheimer's, to take either Celebrex, naproxen or a placebo. The group was divided and each division, or arm, was assigned to receive one of the drugs or placebo. The drugs were blinded, which means the patients did not know which medication they were taking, or if they were taking a placebo. The goal was to determine if the pain-relieving drugs lowered the risk of developing Alzheimer's disease. The study started three years ago and was to continue for a few more years. Officials said the patients in the study will be monitored for developing Alzheimer's or cognitive decline, but will not be given the test drugs. Dr. Elias A. Zerhouni, the director of the National Institutes of Health, said the study linking heart attack to Celebrex last week was a major factor in deciding to suspend the Alzheimer's study. He said there was a question whether patients in the study would continue to take their medicine since they knew they might be taking Celebrex. Suspending the study, Zerhouni said, "is the prudent thing to do." John Breitner of the Veterans Affairs medical facility in Seattle and the University of Washington, an investigator in the trial, said only preliminary data is available. But he said it suggests that among the 2,500 patients in the study, about 70 suffered stroke or heart attack. There were 23 deaths. There were 50 percent more of the cardiovascular events among patients taking naproxen than among those taking placebo, he said. On the Net: National Institutes of Health: http://www.nih.gov

U.S. Department of Health and Human Services NATIONAL INSTITUTES OF HEALTH NIH News National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) http://www.niddk.nih.gov/ FOR IMMEDIATE RELEASE Friday, December 17, 2004 CONTACTS: Mary Harris, NIH 301-435-8114 Tim Parsons, JHSPH 410-955-6878 FEW AMERICANS ARE AWARE THEY HAVE CHRONIC KIDNEY DISEASE Ten to 20 million people in the United States have kidney disease but most don't know it, according to researchers at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health, the Johns Hopkins Bloomberg School of Public Health, and the National Center for Health Statistics (NCHS) at the Centers for Disease Control and Prevention. The findings are in the "Journal of the American Society of Nephrology." Over the past decade the number of people with kidney failure doubled and the number starting dialysis or having a first kidney transplant increased by 50 percent, so that more than 400,000 Americans are now being treated for kidney failure at a cost of $25 billion annually. In contrast to these dramatic increases, the study also found that the number of people with earlier stages of kidney disease remained stable. About 7.4 million people have less than half the kidney function of a healthy young adult. Another 11.3 million have at least half of what's considered normal function, but they also have persistent protein in their urine, a sign of kidney disease. The researchers can't explain the paradox between stable prevalence of kidney disease and rising incidence of kidney failure, but they suggest that fewer patients may be dying and more may be progressing faster to dialysis. "Given the high prevalence of chronic kidney disease, we need to increase awareness, diagnosis and treatment if we are going to reduce the rate of progression and complications. Most critical are control of diabetes and hypertension," said Josef Coresh, M.D., Ph.D., lead author of the study and professor of epidemiology, medicine and biostatistics at the Bloomberg School of Public Health in Baltimore. Coresh and his colleagues estimated awareness of chronic kidney disease among 4,101 people in the United States from 1999 to 2000 and compared disease prevalence in those years with that from 1988 to 1994, when 15,488 people were surveyed. Data were from two National Health and Nutrition Examination Surveys by NCHS of nationally representative, non-institutionalized adults. In the most recent survey, participants were asked: "Have you ever been told by a doctor or other health professional that you had weak or failing kidneys (excluding kidney stones, bladder infections, or incontinence)?" Less than 10 percent of adults with moderately decreased kidney function (one half to one quarter the filtering capacity of a young healthy adult) reported being told they had weakened or failing kidneys. Awareness was low in all but the most severe stages of kidney disease. Women with moderately decreased kidney function were significantly less aware of their illness compared to similarly affected men. The researchers determined actual kidney function from blood and urine tests and estimated glomerular filtration rate (GFR), a measure of how well the kidneys are filtering waste from the blood. Lack of awareness may be due in part to doctors' sole reliance on the blood level of a substance known as creatinine. Because muscle mass and other person- to-person variables can alter creatinine levels, a "normal" reading can provide a false sense of security. Instead, creatinine should be considered along with a patient's age, gender, and race to estimate GFR. "Kidney disease can be well advanced before it's found with creatinine alone. GFR is a more accurate gauge of how well the kidneys work, and our free calculator makes finding the rate a snap," said Thomas H. Hostetter, M.D., senior author of the study and director of NIDDK's National Kidney Disease Education Program (NKDEP). "The earlier we identify kidney disease the sooner we can treat it," said Hostetter. NKDEP is asking labs to streamline the process for identifying kidney disease. "The GFR calculator is a great tool, but it's still one more step for busy doctors' offices. We are really pleased that several major labs have agreed to automatically report estimated GFR whenever creatinine is measured, removing a potential barrier to finding kidney disease early," said Hostetter. "We are still working quite hard to standardize tests for kidney disease by all labs." People with chronic kidney disease are at high risk for premature death, heart attacks and strokes as well as hypertension, anemia, bone disease and malnutrition. NKDEP strives to increase awareness about kidney disease and offers the GFR calculator and other free tools at http://www.nkdep.nih.gov . "Chronic Kidney Disease Awareness, Prevalence and Trends among U.S. Adults, 1999 to 2000" was written by Josef Coresh, Danita Byrd-Holt, Brad C. Astor, Josephine P. Briggs, Paul W. Eggers, David A. Lacher and Thomas H. Hostetter. The paper was published online on November 24, 2004, and will appear in print January 2004 in the "Journal of the American Society of Nephrology." Funding for the study was provided by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Center for Research Resources at the National Institutes of Health and by the American Heart Association Established Investigators Award. This NIH News Release is available online at: http://www.nih.gov/news/pr/dec2004/niddk-17.htm

Centerwatch Trial Notification Service 1 ) Do you suffer from Fibromyalgia?. This study is being conducted in: - Rochester, NY ( http://www.centerwatch.com/patient/studies/stu66243.html ) 2 ) Cholesterol Research Study. This study is being conducted in: - Mogadore, OH ( http://www.centerwatch.com/patient/studies/stu66570.html ) 3 ) Fibromyalgia Research Study. This study is being conducted in: - Mogadore, OH ( http://www.centerwatch.com/patient/studies/stu66569.html ) 4 ) Clinical Research Opportunities for Cholesterol. This study is being conducted in: - Tacoma, WA ( http://www.centerwatch.com/patient/studies/stu66580.html ) 5 ) Double-Blind treatment of outpatients with Dysthymic Disorder with Wellbutrin XL.. This study is being conducted in: - New York, NY ( http://www.centerwatch.com/patient/studies/stu66216.html ) 6 ) Hot Flashes Research Study. This study is being conducted in: - Tacoma, WA ( http://www.centerwatch.com/patient/studies/stu66581.html ) 7 ) Struggling With Your Weight? Want to do Something About It?. This study is being conducted in: - Boston, MA ( http://www.centerwatch.com/patient/studies/stu66338.html ) 8 ) Cerebral Metabolic Correlates of Treatment Response in Social Anxiety Disorder. This study is being conducted in: - Boston, MA ( http://www.centerwatch.com/patient/studies/stu66368.html ) 9 ) Obesity, Nutrition and Prevention of Diabetes and Heart Disease. This study is being conducted in: - Boston, MA ( http://www.centerwatch.com/patient/studies/stu66067.html ) 10 ) Are you struggling with your weight?. This study is being conducted in: - Boston, MA ( http://www.centerwatch.com/patient/studies/stu66828.html ) 11 ) Have you been feeling down, had loss of energy, and/or changes in your sleep or appetite?. This study is being conducted in: - Belmont, MA ( http://www.centerwatch.com/patient/studies/stu66256.html ) 12 ) Planning to stop use of your antidepressant?. This study is being conducted in: - Belmont, MA ( http://www.centerwatch.com/patient/studies/stu66257.html ) 13 ) We are looking for subjects to participate in a research study for Knee Pain Due To Arthritis.. This study is being conducted in: - Ann Arbor, MI ( http://www.centerwatch.com/patient/studies/stu66060.html ) 14 ) Menopause: Are your symptoms out of control?. This study is being conducted in: - Philadelphia, PA ( http://www.centerwatch.com/patient/studies/stu66149.html ) 15 ) Depressed and Sexually Active?. This study is being conducted in: - Charlottesville, VA ( http://www.centerwatch.com/patient/studies/stu65862.html ) 16 ) Cholesterol Research Study. This study is being conducted in: - Santa Rosa, CA ( http://www.centerwatch.com/patient/studies/stu66577.html ) 17 ) Are you concerned about Osteoporosis?. This study is being conducted in: - Anaheim, CA ( http://www.centerwatch.com/patient/studies/stu66058.html ) 18 ) Are you suffering from Osteoporosis?. This study is being conducted in: - Charlottesville, VA ( http://www.centerwatch.com/patient/studies/stu66565.html ) 19 ) Are your waistline and blood pressure on the rise?. This study is being conducted in: - Eugene, OR ( http://www.centerwatch.com/patient/studies/stu66922.html ) 20 ) We are looking for women to participate in a research study for the treatment of hot flashes due to menopause. The investigational medication is a hormone gel applied to the arm once daily.. This study is being conducted in: - Ann Arbor, MI ( http://www.centerwatch.com/patient/studies/stu66848.html ) 21 ) Omega 3 Fatty-Acid/ Depression Study. This study is being conducted in: - Boston, MA ( http://www.centerwatch.com/patient/studies/stu66846.html ) 22 ) Do your hot flashes cause you to sweat?. This study is being conducted in: - Philadelphia, PA ( http://www.centerwatch.com/patient/studies/stu66990.html ) 23 ) Cholesterol Research Study. This study is being conducted in: - Cincinnati, OH ( http://www.centerwatch.com/patient/studies/stu66863.html ) Additional educational resources that may be of interest to you: Informed Consent: A Guide to the Risks and Benefits of Volunteering for Clinical Trials. http://www.centerwatch.com/bookstore/pubs_...infconsent.html Volunteering for a Clinical Trial, a brief educational pamphlet. If you would like to order this pamphlet click here: http://www.centerwatch.com/bookstore/pubs_...ochureform.html

Gee, and I was allergic to the Celebrex! Mever tried the Vioxx, thank goodness. I just went back to my tried-and-true trusty Tomectin. Good luck Monday.

U.S. Department of Health and Human Services NATIONAL INSTITUTES OF HEALTH NIH News NIH Office of the Director (OD) http://www.nih.gov/icd/od/ FOR IMMEDIATE RELEASE Friday, December 17, 2004 CONTACT: John Burklow, Don Ralbovsky, Office of Communications and Public Liaison 301-496-5787 NIH HALTS USE OF COX-2 INHIBITOR IN LARGE CANCER PREVENTION TRIAL The National Institutes of Health (NIH) announced today that it has suspended the use of COX-2 inhibitor celecoxib (Celebrex TM Pfizer, Inc.) for all participants in a large colorectal cancer prevention clinical trial conducted by the National Cancer Institute (NCI). The study, called the Adenoma Prevention with Celecoxib (APC) trial, was stopped because analysis by an independent Data Safety and Monitoring Board (DSMB) showed a 2.5-fold increased risk of major fatal and non-fatal cardiovascular events for participants taking the drug compared to those on a placebo. Additional cardiovascular expertise was added to the safety monitoring committees at the request of the Steering Committees for this trial after a September 2004 report that the COX-2 inhibitor rofecoxib (Vioxx TM) caused a two-fold increased risk of cardiovascular toxicities in a trial to prevent adenomas. The APC is a study of more than 2,000 people who have had a precancerous growth (adenomatous polyp) removed. They were randomized to take either 200 mg of celecoxib twice a day, 400 mg of celecoxib twice a day, or a placebo for three years. The trial began in early 2000 and is scheduled to have been completed by Spring 2005. Investigators at the 100 sites in the APC trial located primarily in the United States, with a few additional sites in the United Kingdom, Australia, and Canada, have been instructed to immediately suspend study drug use for all participants on the trial, although the participants will remain under observation for the planned remainder of the study. "Data from the report on rofecoxib (Vioxx TM) informed us of the need to focus on specific cardiovascular issues, and our Institutes brought in the experts to do so," said Elias A. Zerhouni, M.D., NIH Director. "Our overwhelming commitment is to advance the health and to protect the safety of participants in clinical trials. We are examining the use of these agents in all NIH-sponsored clinical studies. In addition, we are working closely with our colleagues at FDA to ensure that the public has the information they need to make informed decisions about the use of this class of drug." "The rigor of our clinical trials system has allowed us to find this problem," said NCI Director Andrew C. von Eschenbach, M.D. "We have a strong system that provides us with the opportunity to both find ways to effectively treat and prevent disease and to do so in a way that protects the lives and safety of the participants." NIH sponsors over 40 studies using celecoxib for the prevention and treatment of cancer, dementia and other diseases. In light of these new findings, NIH Director Zerhouni requested: --a full review of all NIH-supported studies involving this class of drug. -- NIH Institutes to inform the principal investigators for all of these studies and will ask them to communicate directly with their study participants and explain the risks and benefits -- NIH to ask each investigator to inform us of their plan to analyze their data in light of the information -- the Institutional Review Boards (IRBs) for all related trials to assess the new information and to conduct a safety review as well The NIH comprises the Office of the Director and 27 Institutes and Centers. The Office of the Director is the central office at NIH, and is responsible for setting policy for NIH and for planning, managing, and coordinating the programs and activities of all the NIH components. The NIH, the Nation's medical research agency, is a component of the U.S. Department of Health and Human Services. ## ------------------------------------ U.S. Department of Health and Human Services NATIONAL INSTITUTES OF HEALTH NIH News NIH Office of the Director (OD) http://www.nih.gov/icd/od/ National Cancer Institute (NCI) http://www.nci.nih.gov/ FOR IMMEDIATE RELEASE Friday, December 17, 2004 CONTACTS: NIH Press Office (301) 496-5787 NCI Press Office (301) 496-6641 QUESTIONS AND ANSWERS NIH HALTS USE OF COX-2 INHIBITOR IN LARGE CANCER PREVENTION TRIAL The National Institutes of Health (NIH) announced today that it has suspended the use of COX-2 inhibitor celecoxib (Celebrex TM Pfizer, Inc.) for all participants in a large colorectal cancer prevention clinical trial conducted by the National Cancer Institute (NCI). The study, called the Adenoma Prevention with Celecoxib (APC) trial, was stopped because analysis by an independent Data Safety and Monitoring Board (DSMB) showed a 2.5-fold increased risk of major fatal and non-fatal cardiovascular events for participants taking the drug compared to those on a placebo. (Press release: http://www.nih.gov/news/pr/dec2004/od-17.htm ) Q: WHAT IS NIH DOING IN RESPONSE TO THESE FINDINGS? NIH has halted the use of COX-2 inhibitor celecoxib (Celebrex TM Pfizer, Inc.) for all participants in a large colorectal cancer prevention clinical trial. Additionally, Elias A. Zerhouni, M.D., Director, NIH, has called for an immediate review of the entire grant portfolio for studies using COX-2 inhibitor drugs. NIH is also notifying all principal investigators of the NCI study findings and will ask investigators to inform the agency of their plan to analyze their data in light of this information. In addition, NIH is asking the Institutional Review Boards (IRBs) for all related trials to assess the new information and to conduct a safety review. Q: ARE OTHER NIH STUDIES USING COX-2 INHIBITORS? NIH sponsors more than 40 studies using celecoxib for the prevention and treatment of cancer, rheumatoid and osteoarthritis, dementia and other diseases. NIH's commitment is to advance the health and to protect the safety of participants in clinical trials. The agency is examining the use of these agents in all NIH-sponsored clinical studies. In addition, NIH is working closely with colleagues at FDA to ensure that the public has the information they need to make informed decisions about the use of this class of drug. Q: WHY HAS NCI BEEN USING COX-2 INHIBITORS IN CLINICAL TRIALS? Numerous compounds are examined by the National Cancer Institute (NCI) for their potential to prevent or treat cancer. One class of compounds, cyclooxygenase (COX) inhibitors, is currently being tested in both prevention and treatment clinical trials. Epidemiologic studies have shown that people who regularly take non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin and ibuprofen to treat conditions like arthritis, have lower rates of colorectal polyps, colorectal cancer, and death due to colorectal cancer. NSAIDs block cyclooxygenase enzymes, which are produced by the body when there is inflammation and are also produced by precancerous tissues. Inhibition of COX-2 may help treat and prevent cancer, while inhibition of COX-1 may induce certain medical problems, like stomach bleeding, that occur when NSAIDS are taken regularly for long periods of time. Q: WHAT IS CELEBREX AND WHY HAS NCI USED THIS DRUG IN THEIR TRIALS? Pharmaceutical companies have created NSAIDs that block only COX-2; one of them, celecoxib (Celebrex™), manufactured by Pfizer, Inc., New York, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of both osteoarthritis and adult rheumatoid arthritis (diseases in which the joints are inflamed) in December 1998. Because over a decade of scientific work has suggested the potential of COX-2 inhibitors to prevent and treat cancer, the National Cancer Institute (NCI) has clinical trials under way to look at the efficacy and safety of these drugs. Q: WHAT SPECIFIC TRIALS HAS NCI BEEN CONDUCTING WITH CELEBREX? NCI's Division of Cancer Prevention (DCP) began its studies with celecoxib with a trial in people with Familial Adenomatous Polyposis (FAP). Patients with FAP develop hundreds to thousands of precancerous polyps (adenomas) throughout the colon and rectum. Left untreated, nearly all FAP patients develop colorectal cancer by their 40s and 50s. The primary treatment for FAP is surgical removal of most or all of the colon and rectum with subsequent surveillance of any remaining colorectal segment. In an NCI-sponsored trial, celecoxib helped reduce the number of colon polyps in patients with FAP. The results of this study were published in the New England Journal of Medicine on June 29, 2000, and led to FDA-approval of celecoxib as an adjunctive drug (an accessory or auxiliary agent) that could be added to the standard of care in people with FAP. As of October 2004, DCP sponsored 23 trials of varying sizes to test the potential of celecoxib to prevent cancer in a number of organ sites. These trials range in size from under 10 participants to more than 2,000 and aim to prevent bladder, breast, cervical, colorectal, esophageal, head and neck, skin, lung, oral, and prostate cancers, as well as multiple myeloma. The majority of these trials are in collaboration with Pfizer, Inc. Additionally, to examine potential benefits of COX-2 inhibitors for the treatment of patients with cancer, NCI's Division of Cancer Treatment and Diagnosis (DCTD) is sponsoring approximately 20 trials of varying sizes with celecoxib. The majority of these studies are small phase I or II clinical trials in cancers such as pancreatic, breast, ovarian, non-small cell lung, and solid tumors. DCTD also is sponsoring two ongoing randomized phase III clinical trials: the first trial compares two chemotherapy agents, exemestane vs anastrozole, in postmenopausal women with estrogen receptor-positive primary breast cancer; the second trial compares several chemotherapy agents in node-negative breast cancer patients. Both phase III trials randomized women to either those taking celecoxib or not taking celecoxib, in addition to the agents mentioned above. Q: WHAT IS THE STATUS OF THE APC (ADENOMA PREVENTION WITH CELECOXIB) TRIAL? The National Cancer Institute suspended the use of COX-2 inhibitor celecoxib (Celebrex™; Pfizer) on December 17, 2004, for all participants in a large colorectal cancer prevention clinical trial, the Adenoma Prevention with Celecoxib (APC) trial, because analysis by an independent Data Safety Monitoring Board (DSMB) showed a 2.5-fold increased risk of major fatal and non-fatal cardiovascular events for participants taking the drug compared to those on a placebo. Safety monitoring of a similar study that was sponsored by Pfizer, called the PreSAP cancer trial, did not find an increased risk of cardiovascular events. Additional cardiovascular expertise was added to the safety monitoring committees at the request of the steering committees for these trials after a September 2004 report that the COX-2 inhibitor rofecoxib (Vioxx™) caused a two-fold increased risk of cardiovascular toxicities in a trial to prevent adenomas. The APC trial is a study of more than 2,000 people who have had a precancerous growth (adenomatous polyp) removed. They were randomized to take either 200 mg of celecoxib twice a day, 400 mg of celecoxib twice a day, or a placebo for three years. The trial began in early 2000 and is scheduled to be completed by spring 2005. Investigators at the 100 sites in the APC trial, located primarily in the United States, with a few additional sites in the United Kingdom, Australia, and Canada, have been instructed to immediately suspend study drug use for all participants on the trial, although the participants will remain under observation for the planned remainder of the study. Q: WHAT ACTIONS IS NCI PLANNING TO TAKE TO NOTIFY PATIENTS ON OTHER COX-2 INHIBITOR CLINICAL TRIALS? NCI will notify all of the principal investigators of its sponsored trials involving COX-2 inhibitors. They will be instructed to notify their institutional review boards, data safety monitoring boards, and participants about this new information. NCI will also require that the informed consent for these trials be revised to reflect this new information and that individuals in the trials be re-consented (asked to sign new consent forms with updated information about risks and benefits of the trials). -------------------------- For more information about cancer, please visit the NCI Web site at http://www.cancer.gov or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). For more information about regulation of COX-2 inhibitors by the FDA, please visit the FDA Web site at http://www.fda.gov/cder/drug/default.htm . This NIH News Release is available online at: http://www.nih.gov/news/pr/dec2004/od-17.htm The Questions and Answers regarding this release are available online at: http://www.nih.gov/news/pr/dec2004/od-17Q&A.htm To subscribe (or unsubscribe) from this list, go to http://list.nih.gov/cgi-bin/wa?SUBED1=nihpress&A=1.