Articles filed under 'SENIORS HEALTH'
Whenever a new drug or medical device comes on the market, the process leading up to FDA approval has been costly and time-consuming. Biotech companies spend many years working in their laboratories to develop new drugs to ready them for testing. Companies that can’t afford their own study staffs are increasingly turning to contract research organizations (CROs) to do the testing. Launched by entrepreneurs, an army of CROs is taking on the daunting task of testing for pharmaceutical companies without the time and resources to perform their own.
 In a few cases, these contract firms which have emerged over the past twenty years have not been up to the rigorous task of controlled clinical trials. Mistakes can lead to a product’s delay in being approved, or test subjects may develop unanticipated side effects. Some bioethicists are urging more regulatory attention for CROs. The FDA is looking at more stringent regulations of firms conducting clinical trials with human subjects, to hold them fully accountable.
Stages in the Drug Approval Process:
Preclinical trials Testing of a new drug is usually tried first on animals.
Phase I studies If laboratory testing of animals shows no harm to them, federal regulators often allow tests on 20 to 80 people, primarily checking for any ill effects.
Phase II studies These studies usually involve groups of up to 300 people in order to provide an initial assessment of the drug’s effectiveness.
Phase III studies Hundreds to several thousand people are involved in an attempt to determine whether a drug is safe and effective. If it holds up well and shows no unacceptable side effects, the medication has a good chance of approval and subsequent sale.
Source: Oakland Tribune; April 25, 2008; business section
May 1st, 2008
For those who have experienced chemotherapy, or watched their loved ones go through it, the idea of an effective cancer treatment with NO side effects seems like a dream come true. Dreams can be a long time in coming, however. The brain child of American inventor John Kanzius may one day be the answer to the prayers of cancer patients. First, his Kanzius Machine must be rigorously tested in laboratory animals before clinical trials are approved for cancer patients. Preliminary lab testing has shown great promise.
The potential new treatment that Kanzius envisioned was featured on CBS’ “Sixty Minutes†(April 13, 2008). In theory, it involves gold or carbon nanoparticles injected into the bloodstream or into a cancerous tumor. These metallic-laced nanoparticles, already FDA-approved, attract radio waves. Once the diseased cells are properly targeted, radio waves would heat them to an optimal temperature to eradicate them. The idea is to destroy cancer cells, leaving healthy cells undamaged. Nanoparticles are so tiny that trillions of them can be contained in a test tube. The chief problem is finding a delivery system in which the nanoparticles would bind only to cancer cells.
How did a man without a medical degree or credentials as a lab scientist come up with a revolutionary idea to treat cancer? Diagnosed with liver cancer six years ago, John Kanzius had endured thirty-six rounds of chemotherapy. During his treatments at a renowned cancer center, he was touched by the faces of young cancer patients, children with teddy bears, fighting for their lives. It was then that he vowed to try to find a better way to fight cancer.
One sleepless night, the retired radio and TV executive envisioned using radio waves to treat cancer. In his childhood, he had built radio sets. He understood that radio waves could harmlessly pass through a living organism but were attracted by metal. Once his primitive tests showed promise, the senior citizen built radio-wave equipment and conducted experiments in his garage. He invested $200,000 of his own money to build prototypes of his radio frequency (RF) equipment. Support and funding for his efforts have since materialized from many sources. His Kanzius RF Machines are now selectively placed in laboratories at the University of Pittsburgh and at MD Anderson Cancer Center in Houston, Texas.
At MD Anderson, Dr. Steven Curley, a surgical oncologist, began to work closely with Kanzius on his invention. Dr. Curley believes the potential treatment to be the most exciting new development he has seen in twenty years of working in oncology. Like an “ultimate weed killer†able to kill weeds without harming grass, the treatment is designed to destroy only the cancer cells. The ability to eliminate solid tumors injected with gold nanoparticles has already been demonstrated in rats and rabbits. The ultimate goal is to be able to target microscopic cancer cells that have circulated throughout the body. Curing metastatic cancers would not be possible without such a selective delivery system. If a way is found to precisely target and destroy only cancer cells, then the potential to cure many types of cancers is tremendous – and with no pain and distress.
John Kanzius is working with the Lee Memorial Health System in southwest Florida to coordinate tentative clinical trials after approval is granted. He hopes to live to see his dream realized some three or four years down the road.
Sources:Â Â
http://en.wikipedia.org/wiki/Kanzius machine; http://60minutes.yahoo.com/segment/159/the_kanzius_machine Â
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April 17th, 2008
In recent years, several large studies have shown that quicker and cheaper “virtual colonoscopy†is a viable alternative to traditional colonoscopy. Although still considered “experimental†and not covered by most insurance for routine screening, the noninvasive X-ray procedure is available for those willing and able to pay the $1,100 cost. Traditional colonoscopy, the “gold standard†for many years, costs roughly $3,000.
Colonoscopy is recommended for persons 50 and over, but most don’t get them unless they are symptomatic. Instead, a sigmoidoscopy may be offered which checks only the lower bowel or intestine by inserting a flexible tube. Perhaps the most unpleasant part of any technique to explore the colon for polyps is drinking laxatives or using enemas to purge the bowel before the procedure.
Colon cancer is the second leading cause of cancer death in the U.S. and is largely avoidable by detecting and removing small polyps before they grow and become cancerous. Each year about 52,000 Americans die of the disease.
The latest study compared two groups of approximately 3,000 persons in each group. One group received traditional colonoscopy and the second one the virtual procedure. Approximately the same number of advanced polyps were found in each group (123 compared to 121).
With virtual colonography, a CT scanner takes a series of X-rays of the colon and creates a computerized 3-D image. A small tube is inserted in the rectum to inflate the colon for better viewing. There is no sedation or recovery time. If polyps are seen, they cannot be removed using this technique. Any significant polyps are then removed the same day using a traditional colonoscopy.
In traditional colonoscopy, a gastroenterologist uses a flexible, thin tube and snakes it through the large intestines. Any polyps spotted are removed in the process. There is a tiny risk of a perforated colon using the traditional procedure, and prompt surgical repair is needed.
The virtual colonoscopy avoids sedation and the risk of colon perforation, but the patient is exposed to radiation. In addition, small, benign polyps cannot be removed. They must be watched and will need to be removed if they grow significantly or become malignant.
If colon cancer screening guidelines are changed as is expected, virtual colonoscopy may be covered by insurance companies in the future. The less invasive procedure may encourage more patients to get checked when they should. Usually, intervals of ten years between examinations are recommended if no polyps are found.
Source:Â MSNBC
October 8th, 2007
The artificial hip is indeed a medical miracle, but the joint replacement surgery usually lasts only 20 years or so. Each year about 300,000 Americans undergo hip joint replacement surgery. As younger patients avail themselves of this type of hip surgery, the problem of “outliving†the joint replacement must be faced.
Middle-aged or younger people with hips damaged by disease or injury are often cautioned to put the surgery off as long as possible. In the meantime, many are plagued with pain and disability.
Now, an alternative surgical procedure may make the waiting game a thing of the past. Because extracting and replacing a worn-out or defective artificial hip is difficult, more surgeons are turning to hip resurfacing. Surgeons using this procedure preserve enough of the healthy bone to allow for a future total hip implant when benefits of hip resurfacing wear out.
In the past decade, tens of thousand of patients worldwide have undergone hip resurfacing. Many U.S. “medical tourists†had the procedure done overseas, where doctors are experienced in the technique and costs are lower. Popular destinations are Britain, Belgium or India, where costs may be half what they are in the U.S.
Hip resurfacing surgery is no easier for the patient or physician than hip replacement, and the incision is usually larger than with a total joint replacement. Complete healing can take six months or longer. The advantage is that the patient will still be eligible for a total hip replacement using an entirely new artificial joint rather than having a revision of the old one.
Hip resurfacing and total hip replacements both involve implanting a metal cup in the pelvic socket. The difference is mainly the way each procedure treats the top of the femur, the long thigh bone that fits into the socket. In resurfacing, the femur is shaved to a rounded shape and covered with a metal cap, with a spike that is cemented into a small hole drilled into the center of the femur.
With total hip replacement, surgeons saw off the entire head of the femur and replace it with a larger, hemispherical device that is anchored with a much longer spike and driven deeper into the femur. This procedure leaves too little strong bone to allow for follow-up with an entirely new total hip replacement if this joint wears out.
Hip resurfacing is not minor surgery. It requires a highly skilled surgeon, and the operation usually takes a bit longer than the three or four hours of total hip replacement. In addition, patients lose more blood, although transfusions are rarely needed.
With either procedure, problems can occur, but they are unlikely. Complications that are possible with either surgery include infections or fractures. Since hip resurfacing is so new, we are unlikely to know how durable the resurfaced hips are until the 20-year mark is reached in the earliest patients.
Doctors advise patients, especially younger ones, not to even think about either procedure unless they are in pain every day. Most people won’t want to take on the risks of either type of surgery, and the complications that could arise, just to improve their golf game or to be able to resume jogging.
Source:Â New York Times
April 16th, 2007
Since the last estimate five years ago from the Alzheimer’s Association, another 10% increase in the disease has occurred in this country. More than 5 million Americans are now living with Alzheimer’s. By the year 2030, some 7.7 million may be affected.
This alarming trend is expected to accelerate, as baby boomers begin turning 65 in 2011. The largest risk factor is age. Currently, 1 in 8 persons over age 65 has the mind-destroying disease. Over age 85, almost half have Alzheimer’s or another type of dementia.
While small drops in the death rates from heart disease and cancer make headlines, Alzheimer’s-related deaths have increased by 33%. Even more disturbing is the trend toward early-onset Alzheimer’s. The disease in those under age 65 is vastly underreported and is often difficult to recognize in its early stages, before full-scale memory problems are involved.
Despite years of research, the causes of Alzheimer’s progressive brain deterioration are still largely unknown, and there is no cure. Medications on the market only temporarily alleviate symptoms. The disease that gradually robs memories and the ability to provide self-care eventually kills Alzheimer’s sufferers.
Medicare spends nearly three times as much for dementia patients’ care as is does on the average beneficiary — $13,207 a year for Alzheimer’s patients compared to $4,454 annually for others. Medicare expenditures do not add in the expense of families and friends proving round-the-clock care, as most Alzheimer’s patients live at home. However, a new report indicates that close to $83 billion is spent annually on nursing home costs for patients in advanced stages of the disease.
Nine drugs for Alzheimer’s are in the final stages of clinical trials. If some of these drugs are successful in slowing or delaying the onset of Alzheimer’s symptoms by even a few years, millions of dollars could be saved in health care costs in future decades. The toll in human suffering could also be greatly alleviated. Experiencing “the long good-bye†in those you love can be excruciating.
Source:Â Yahoo News
March 22nd, 2007
The FDA warned in mid-March that all prescription sleeping pills have the potential to cause bizarre behaviors, such as “sleep-driving.†In extremely rare instances, patients have been known to get up in the night and drive, with no later memory of the event.
About one out of 1,000 persons on these medications has experienced unusual behaviors such as sleep driving, preparing and eating food, making phone calls, or even having sex while asleep. More common than middle-of-the-night excursions is driving while still feeling dangerously drowsy, for example, during an early morning commute.
Although extremely rare, another reported risk is a life-threatening allergic reaction and severe facial swelling. This side effect can occur with first use or anytime thereafter when the pills are taken. Seek immediate emergency treatment for such an occurrence.
Later this year, pharmaceutical companies that manufacture 13 prescription sleep medications will include new, extensive warnings in a special “medication guide†brochure. Some insomnia drugs may be riskier than others. The FDA has recommended clinical trials to compare their complications and frequencies with which they occur.
Ambien and a second drug Phenergan were implicated in sleep-driving headlines last year when Rep. Patrick Kennedy crashed into a barrier outside the U.S. Capitol building. Kennedy stated that he did not recall being behind the wheel.
To lower the risk of sleep-driving and other risky behaviors, patients are advised never to take any prescription insomnia drug with alcohol or another sedating drug. Also, never exceed the recommended dosage.
The thirteen drugs for insomnia, so-called “sedative-hypnotics,†which will carry the new warnings are: Ambien, Butisol sodium; Carbrital; Dalmane; Doral; Halcion; Lunesta; Placidyl; Prosom; Restoril; Rozerem; Seconal; and Sonata.
Source:Â CNN.comÂ
March 17th, 2007
Last fall, the media inundated us with fears of bird flu virus mutating to a form easily transmissible from person to person. To date, this has not occurred. Recent testing of 75,000 wild birds in the U.S. and Canada showed no signs of the highly lethal H5N1 avian or bird flu. Less than 200 persons worldwide have died from avian flu since 2003, and no reported cases have been confirmed in the U.S.
In contrast, the usual viral strains of flu that we can expect to occur each season will in a typical year kill about 36,000 in the U.S. (mostly elderly) and over 500,000 worldwide. You can do much to protect yourself and family members from this actual threat by getting flu shots before the flu season hits hard in the winter months.
Another protection available to families is to have on hand a prescription of Tamiflu (oseltamivir). This drug in tablet or liquid suspension form has proven effective in lessening the symptoms of flu and speeding recovery, and even preventing the disease after exposure to influenza. Tamiflu can improve or decrease the ailments that occur with flu – weakness, headache, cough, fever and sore throat – in just the first day of use.
Tamiflu is generally taken for 5 days to treat flu or half the dosage for 7 days to prevent the virus after having been exposed. Children may take a smaller dose, based on their weight and medical conditions as approved by the physician consulted. You should not stop taking the medication suddenly because you begin to feel better. If serious or very distressing side effects are noted, discontinue the medication and check with your doctor about what to do next.
If you are pregnant or trying to get pregnant, you should not take Tamiflu. Discuss with your doctor whether it would be safe for your baby if you take Tamiflu while breastfeeding. If you have serious medical conditions such as heart, kidney, or lung problems, liver disease or other viral infections aside from Influenza A or Influenza B, your doctor can tell you whether Tamiflu is appropriate for you.
Sources:Â MSNBC.com;
February 17th, 2007
Xenical is a prescription weight loss drug primarily intended for adults who are obese, with a body mass index of 30 or higher. It can also be used effectively in those who are considered overweight (BMI of 27-29). Persons with other risk factors such as high blood pressure, high cholesterol, heart disease or diabetes can also benefit from taking Xenical (orlistat) for weight loss.
Xenical must be taken in conjunction with a regular exercise program and a nutritionally balanced diet containing no more than 30% calories from fat. Taking a daily multivitamin supplement is also important, as Xenical reduces the absorption of vitamins from food.
This weight-loss drug works differently from other diet drugs, as it does not suppress your appetite. Instead, Xenical blocks the absorption of a portion of your dietary fat intake to produce weight loss. As a result, Xenical produces gastrointestinal side effects that usually occur in the first weeks of treatment. Side effects usually taper off after the first few months. You may experience side effects such as gas with oily discharge, underwear stains, and an increased number of bowel movements. These side effects can be minimized by staying within the 30% dietary fat guidelines.Â
If side effects become distressing, discuss the symptoms with your prescribing doctor or pharmacist. You should not take Xenical if you are pregnant, nursing, have food absorption problems or reduced bile flow. Children should not be given Xenical for weight loss.
Several clinical studies have shown that after 52 weeks, persons on a reduced fat diet who took Xenical as prescribed lost an average of twice as much weight as those (in the control group) on the diet alone. That is, 13 pounds, compared to about 6 pounds. Within the first three months, those on Xenical had lost 3% of their body weight. There is clear scientific evidence to demonstrate that obese or significantly overweight persons who lose as little as 5% to 10% of their body weight can improve their health.
The clear health benefits of the effects of weight loss with Xenical on other weight-related health problems such as high cholesterol, type 2 diabetes and high blood pressure have been assessed in seven studies of 1 to 2 years. These studies involved multicenters, double-blind, and placebo-controlled clinical trials. More than 4,100 patients took part.
Clearly, there is now a weight loss drug that effectively takes weight off and helps improve general health if your excessive pounds put you at risk. The question is, will the side effects be tolerable to you? Will you be motivated to do the following:
- Set realistic, achievable weight-loss goals with your doctor?
- Take Xenical three times daily with meals?
- Record your food intake each day, and eat a reduced-calorie diet with 30% or less calories from fat?
- Take one multi-vitamin daily — 2 hours before or after taking Xenical or at bedtime?
- Maintain a realistic exercise program?
An over-the-counter version of Xenical, a reduced-strength version, is now being sold under the name “alli.†This drug is approximately half-strength of the prescription version. Alli is also intended for use along with diet and exercise programs. Taking the drug without the other components is unlikely to produce the desired results.
The FDA recently approved the sale of alli without prescription. The agency cautioned that people who had organ transplants should not take orlistat (Xenical) or alli because of possible drug interaction side effects. Those taking blood-thinning medications or being treated for diabetes or thyroid disease should also consult a doctor before using alli, according to the agency.
Sources:Â xenical.com; cnn.com
 More Information
February 12th, 2007
Researchers are trying to determine whether the virus that causes cold sores can somehow play a role in bringing on Alzheimer’s disease in later years. A study published recently in the journal Neurobiology of Aging is looking at interaction between the ApoE-4 gene and herpes as a risk factor for the brain-robbing disease.
According to one researcher at the University of Manchester, Alzheimer’s patients who have the ApoE-4 form of the gene contain more herpes DNA in brain regions than others without that version of the gene. The team found that the herpes virus infiltrates brain cells and is associated with cellular tangles and amyloid plaques in Alzheimer’s patients.
The oral herpes virus (herpes simplex 1), known to infect 80% of Americans, hides in the body’s nerves in its predominately latent phase. An outbreak is rarely triggered by factors such as stress, fatigue, or sunlight. HPV1 then becomes active, damaging cells and causing cold sores.
Scientists have long known that the ApoE-4 gene is a player in Alzheimer’s, but the idea that it can work in concert with the herpes virus is new. A group at the University of Rochester Medical Center recently found that this particular gene causes a fertile environment for herpes in the brain.
One theory is that the body’s immune response against herpes somehow damages the brain. The damage can be worse in those with the ApoE-4 copy of the gene than in those with another form of the gene, such as ApoE-2 or ApoE-3. No research is conclusive at this point.
In 2006, the Manchester research team published a study that showed inflammation to be the earliest change detected in a brain affected by Alzheimer’s disease, before the hallmark plaques or tangles appear and long before any behavioral changes are seen. Such inflammation can be a byproduct of the body’s immune system fighting an infection.
Much research is being conducted in the field of Alzheimer’s Disease. It is hoped that one day it may be prevented, especially if treatment begins in the early stages before symptoms become obvious.
Source:Â Medical News TODAYÂ
January 27th, 2007
A simple blood test measuring the amount of a protein called NT-proBNP was recently shown to be highly predictive of cardiovascular events in patients with established coronary heart disease.
In a study of almost 1,000 heart patients believed to have stable heart disease, those with the highest blood levels of the protein were eight times more likely to have a heart attack, stroke or heart failure during the 3.7-year study than those with the lowest levels of NT-proBNP.
Among the study participants, patients with highest NT-proBNP level had the strongest association with heart failure. Eighty cases of heart failure were reported during the study, compared with only three cases among patients with the lowest protein levels. There were four times as many heart attacks and four times as many strokes in study patients with the highest NT-proBNP levels, compared to those with lower protein measurements.
The test is already in use in hospital emergency departments to assist ER doctors in identifying heart failure in patients presenting with shortness of breath and other established symptoms. In addition to echocardiograms, stress tests, and other protein biomarkers, the new blood test may be able help physicians to pinpoint heart patients with the highest risks.
Looking at other risk factors such as sex, age, smoking, and elevated cholesterol levels, this new maker provides additional information that other tests don’t reveal. It is still unclear, however, whether the test is valuable for predicting risk in asymptomatic heart patients thought to have stabilized their heart disease.
Also unknown is whether the test could prove useful for identifying heart disease risk in the general public. At this point, it is best utilized with patients with established heart disease. Its role in disease management is still not clear. Those with elevated NT-proBNP can be treated very aggressively, but most patients with serious heart conditions are already being treated in that manner.
More study is needed to determine the value of the NT-proBNP test, the subject of the study at the University of California, San Francisco and the San Francisco VA Medical Center.
Source:Â WebMD
January 11th, 2007
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