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"We are pleased with the FDA's decision to once again make Natalizumab available to patients and their families suffering from this chronic, debilitating disease, " said Kelly Martin, Chief Executive Officer, Elan. "There continues to be a significant unmet medical need where Natalizumab will be an important treatment option. "
Today's action follows a March 8, 2006 unanimous recommendation by the FDA's Peripheral and Central Nervous System Drugs Advisory Committee to allow the reintroduction of Natalizumab. TOUCH (TYSABRI?[Natalizumab] Outreach: Unified Commitment to Health) Prescribing Program was developed in conjunction with the FDA to facilitate the appropriate use of Natalizumab and to assess, on an ongoing basis, the incidence and risk factors for PML and other serious opportunistic infections associated with Natalizumab treatment. This program represents Biogen Idec and Elan's commitment to making the unique benefits of Natalizumab available in a responsible manner. Elements of the TOUCH Prescribing Program include revised labeling with a prominent boxed warning of the risk of PML; and warnings against concurrent use of Natalizumab with chronic immunosuppressant or immunomodulatory therapies, and patients who are immunocompromised due to HIV, hematological malignancies, organ transplants or immunosuppressive therapies, mandatory enrolment for all prescribers, central pharmacies, infusion centres and patients who wish to prescribe, distribute, infuse, or receive, respectively, Natalizumab; controlled, centralized distribution only to authorized infusion centers, mandatory FDA-reviewed educational tools for patients and physicians, including a patient medication guide, TOUCH enrollment form and a monthly pre-infusion checklist, ongoing assessment of PML risk and overall safety, a 5,000 patient cohort observational study over five years, the Natalizumab Global Observation Program in Safety (TYGRIS)
Natalizumab treatment also resulted in sustained and statistically significant reductions in brain lesion activity as measured by MRI. The two-year data from the SENTINEL add-on trial also demonstrated that treatment with Natalizumab in addition to AVONEX?(Interferon beta-1a) had a significant effect on disability progression, relapse rate and brain MRI disease activity compared to AVONEX alone.
Natalizumab increases the risk of PML, an opportunistic viral infection of the brain that usually leads to death or severe disability. Three cases of PML occurred in clinical trial patients who were concomitantly exposed to immunomodulators (interferon beta in the patients with MS) or were immunocompromised due to recent treatment with immunosuppressants (e.g., azathioprine in the patient with Crohn's disease). A third case of PML occurred among 1,043 patients with Crohn's disease after the patient received eight doses. The number of cases is too few and the number of patients treated too small to reliably conclude that the risk of PML is lower in patients treated with Natalizumab alone than in patients who are receiving other drugs that decrease immune function or who are otherwise immunocompromised. Healthcare professionals should monitor patients on Natalizumab for any new signs or symptoms that may be suggestive of PML. Natalizumab dosing should be withheld immediately at the first sign or symptom suggestive of PML.
Natalizumab is contraindicated in patients who have or have had PML or with known hypersensitivity to Natalizumab or any of its components. In Phase III placebo-controlled trials of Natalizumab in MS, the overall incidence and rate of other infections were balanced between Natalizumab-treated patients and controls. Herpes infections were slightly more common in patients treated with Natalizumab. Commonly reported infections with Natalizumab included urinary tract infections, lower respiratory tract infections, gastroenteritis and vaginitis. Serious opportunistic and other atypical infections have been observed in Natalizumab-treated patients, some of these patients were receiving concurrent immunosuppressants.
Serious events that occurred in Natalizumab-treated patients included hypersensitivity reactions (e.g., anaphylaxis), depression and gallstones. Appendicitis was more common in patients receiving Natalizumab with AVONEX. Common adverse events reported in Natalizumab-treated patients include infusion reactions, headache, fatigue, joint and limb pain, abdominal discomfort, diarrhoea and rash.
- Biogen Idec and Elan Corporation, plc
www.biogenidec.com
For any corrections of factual information, to contact the editors or to send any medical news or health news press releases, use feedback form
Herpes Treatment
Researchers say that a combination of antiviral drug medications will reduce nerve pain following a shingles infection. The study, led by Dianna Quan, MD and her colleagues at the University of Colorado and Health Sciences Center, Denver, administered the antiviral therapy to 15 patients (12 men and three women).
The participants received 10 milligrams of the medication acyclovir intravenously every eight hours for 14 days and then took three 1,000-milligram pills of the medication valacyclovir every day for one month. The patients were asked to rate their pain from a scale of zero to 10, both before and after the treatment, and than again a month after finishing the valacyclovir therapy.
The results were hopeful. One month after the therapy, eight (or 53 percent) patients reported that their pain had reduced significantly (by two or more points). This is about the same as those who reported such an improvement after day 15 (seven) and after day 45 (eight).
Although most patients tolerated the treatment well, there were five who dropped out of the study early. Three of these patients dropped out due to complications related to the therapy.
The research, which will appear in the July 2006 print issue of Archives of Neurology, one of the JAMA/Archives journals, is considered a small study. The researchers said "Although our study was small and without placebo control, the findings suggest a promising effect of antiviral treatment on postherpetic neuralgia. Treatment of postherpetic neuralgia with IV acyclovir will be expensive. However, elimination or reduction of pain coupled with reduced burden of disease and use of health care resources would offset treatment costs."
Shingles (herpes zoster) is caused by the varicella-zoster virus. This is the same virus that causes chickenpox, according to background information in the article. The virus will remain dormant in the nervous system for decades after infection with chickenpox. When the virus becomes reactivated, it causes a rash and nerve pain called postherpetic neuralgia. Postherpetic neuralgia can last for months or years and affects as many as one million people in the United States.
The Food and Drug Administration (FDA) has just approved a drug produced by Merck, Zostavax, for the prevention of shingles in individuals 60 years of age and older. This is the first and only medical option approved for preventing shingles.
About 90 percent of all adults in the US have been infected with chickenpox. The drug could reduce the incidence and severity of shingles infections.
The disease usually starts as an unusual or painful sensation on one side of the body or face, followed by a blistering rash. The problem is that shingles can cause long term never pain. The pain has been described as tender, burning, throbbing, stabbing, shooting and/or sharp pain. Even the touch of soft clothing can cause pain. Other complications include hearing loss, pneumonia, visual impairment, and scaring.
Zostavax is not a treatment for shingles, but only a preventative measure. It is hoped that the dual antiviral treatment can relieve the nerve pain associated with shingles.
Herpes Treatment
A new study suggests that the risk of transmitting the virus that causes most cases of genital herpes could be cut in half by more testing and informing sexual partners of infection. The study is published in the July 1 issue of The Journal of Infectious Diseases, now available online.
Until recently, there was little evidence to show that knowledge of infection would lead to decreased transmission of herpes simplex virus (HSV) to others. But Anna Wald, MD, MPH, and colleagues at the University of Washington and the Fred Hutchison Cancer Research Center in Seattle studied 199 patients with newly acquired genital HSV-2 infection and found that patients were about half as likely to transmit the virus when they knew they had genital herpes and informed their sexual partners.
According to Wald, "these findings suggest that testing persons with HSV type-specific serologic assays and encouraging disclosure may result in decreased risk of HSV-2 transmission to sexual partners."
The importance of this finding is described by editorialists Edward Hook III, MD, of the University of Alabama at Birmingham and Peter Leone, MD, of the University of North Carolina at Chapel Hill as one of three effective tools to prevent the spread of this sexually transmitted disease (STD). "Genital herpes is one of the few common STDs for which, at present, there is little coordinated emphasis on control efforts," say Hook and Leone. The two experts also support suppressive antiviral therapy and condom use as the other necessary elements to control the spread of genital herpes nationwide.
This most recent study also found that most people who transmitted HSV did not know that they had genital herpes. Wald, Hook, and Leone suggest that physicians should not only increase testing for HSV, but should also counsel their patients about transmitting the virus and disclosing their HSV status to sex partners.
Founded in 1904, The Journal of Infectious Diseases is the premier publication in the Western Hemisphere for original research on the pathogenesis, diagnosis, and treatment of infectious diseases; on the microbes that cause them; and on disorders of host immune mechanisms. Articles in JID include research results from microbiology, immunology, epidemiology, and related disciplines. JID is published under the auspices of the Infectious Diseases Society of America (IDSA). Based in Alexandria, Va., IDSA is a professional society representing about 8,000 physicians and scientists who specialize in infectious diseases.
For more information, visit http://www.idsociety.org.
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Doctors could soon have a new weapon for fighting one of the toughest malignancies - ovarian cancer.
Tests conducted in mice show that a virus engineered to target cancer cells and kill them can completely suppress these tumours if it is given quickly enough. The authors hope to begin human clinical trials of the therapy within two years.
Scientists began exploring the idea of using specially modified viruses to fight ovarian cancer in the early 1990s, trying modified adenoviruses and herpes viruses. These were 'safe but not effective' in treating the disease because they were not aggressive enough, explains David Bartlett of the University of Pittsburgh School of Medicine in Pennsylvania, US.
Preferred viruses
His team instead focused its efforts on the vaccinia virus group, which has previously been used to vaccinate people against smallpox and is generally safe to humans. These viruses are more potent than adenoviruses and herpes viruses because they carry an enzyme called DNA polymerase to kick-start viral replication within cells.
Bartlett's team created a modified vaccinia virus that would target and kill cancer cells. They did this by removing genes in the virus that help it to produce a growth protein. This means that the virus survives best in cancer cells that can supply it with large quantities of this growth protein, as opposed to non-cancerous cells that only produce very small amounts.
The vaccinia virus was also engineered to carry a gene for an enzyme called cytosine deaminase that causes cell suicide in the cells it infects.
The researchers injected mice with ovarian cancer cells and then either gave them an immediate injection of the engineered vaccinia virus, or waited 30 or 60 days before infecting them with the virus. A fourth group of mice injected with cancer cells were not given any treatment.
Survival boost
Of the mice given the immediate injection, 90% were still alive 180 days later and showed no signs of tumour growth, says Bartlett. Some 10% of the mice given the virus 30 days after being injected with ovarian cancer cells survived to that point as well.
The mice that received vaccinia virus injections 60 days after exposure to the cells lived on average to 125 days - around 50% longer than their control counterparts - though all mice in these groups were eventually killed by the cancer.
The findings were presented on Saturday at the annual meeting of the American Society of Gene Therapy in Baltimore, Maryland, US.
This year, more than 20,000 US women are expected to be diagnosed with ovarian cancer and 15,000 will die from the illness, according to figures from the American Cancer Society.
Promising treatment
Bartlett hopes that his treatment could one day be adopted to treat women, particularly to obliterate ovarian cancer cells that linger after surgery.
Ovarian cancer is a 'particularly good target' for this kind of therapy, according to David Curiel of the University of Alabama at Birmingham, who plans to start human clinical trials using adenoviruses to treat the illness in the autumn.
He explains that at a certain stage of the disease the tumour cells may spread within the peritoneum, a membrane that forms the lining of the abdominal cavity. Because the peritoneum is a confined space, the therapeutic viruses can be delivered and concentrated within that area.
Curiel says Bartlett's approach is also promising because it involves 'arming' the virus with a gene to kill cancer cells.
However, one potential problem is that the human immune system may be able to detect vaccinia viruses and stamp them out before they can have the desired effect.
This is a particular concern in people who have previously been immunised against smallpox because their immune systems will already be primed to identify and destroy vaccinia virus. Bartlett's group is currently trying to overcome this problem.
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Researchers are working on a new drug that can inhibit the growth of cancer cells 'C through starvation.
By JOSEPH LOH
THERE appears to be a ray of hope that can lift the gloom surrounding cancer. Researchers in Australia have developed a drug that inhibits the growth of cancer cells by starving them.
The drug, called PI-88, works by impeding the creation of new blood vessels to tumour cells, thereby curtailing its blood supply and preventing them from developing any further.
This is in contrast to current methods of cancer treatment that targets the tumours directly by radiotherapy or chemotherapy. Additionally, curtailing the growth of blood vessels effectively cuts off means for cancer cells to spread. Tests done on animal subjects so far have been successful and the drug is at an intermediate stage of clinical development.
The heparanase hurdle
The development of PI-88 has its roots way back in 1985 when Prof Chris Parish of the John Curtin School of Medical Research (JCSMR) at the Australian National University (ANU) in Canberra demonstrated that there were high levels of heparanase activity present in malignant cancer cells.
Heparanase is an enzyme that is normally present in the human body, and works during embryonic development, wound healing and inflammation. The enzyme works by facilitating white blood cell entry into damaged or developing tissue. The white blood cells degrade the walls of the blood vessels, which in turn invoke the body's natural healing process (utilising growth factors) to stimulate cell growth and hence aid tissue regeneration.
The abovementioned discovery found that cancer cells were hijacking the normal function of heparanase, and using it to promote its own growth and spread. One essential factor for the growth of cancer is the development of new blood vessels (known as angiogenesis) to the cancerous tissue. These not only supply blood to the affected tissue but also provide an easy method of transportation for cancer cells to invade the entire body though the bloodstream.
In 1991, Dr Craig Freeman joined the JCSMR, and began to study the heparanase enzyme in detail. There were several conflicting studies on heparanase at that time, according to him. 'We had to start from scratch and develop a new, quick and simple way to detect the presence of the enzyme, and this had been a major impediment to studying heparanase.'
Although heparanase was first described 30 years ago, it was thought that the enzymes found in cancer cells and normal tissue regeneration were different. 'We were one of the first to show that the various heparanase activities in cancer cells, immune system cells and probably in all cell types, were in fact the same. Much of the existing literature characterising heparanase activity was wrong!' explained Dr Freeman.
Cooking up the PI-88
Heparanase is essentially a degradative (or destructive, in not-so-accurate terms) enzyme that cells use to pass through blood vessel walls. Cell walls are supported by a membrane of a complex protein structure, which is bound together by a sulphated carbohydrate called heparan sulphate 'C think of it as bricks in a wall held together by cement.
Heparanase works to digest or break down the heparan sulphate, and with the glue holding the cell walls removed, the structure is destroyed and cells can pass through. Surrounding the blood vessel walls is a similar protein/heparan sulphate complex (the extracellular matrix), which contains growth factors that is released.
Normally, the body's healing process kicks in by stimulating cell growth and repair, but in instances of cancer, blood vessels that feed the tumour are formed.
The goal was therefore to come up with a compound that could mimic the structure of heparan sulfate and bind to the heparanase enzyme, thus stopping its adulterated function.
As Dr Freeman described, the breakthrough came in 1995, when they identified an oligosaccharide (essentially a carbohydrate), which could be easily obtained in large quantities from yeast cell walls, and chemically modified it, adding sulphate groups (a sulphuric chemical compound) to allow it to mimic the structure of heparan sulphate. 'This compound became known as PI-88 and was found to be a potent inhibitor of tumour growth by inhibiting heparanase activity and the action of the growth factors ' said Dr Freeman.
But the key advantage of PI-88 is that it has shown negligible toxicity levels in early human trials except for some small anti-coagulant activity. This is in contrast to side effects observed with other forms of cancer treatment.
Beyond cancer
PI-88 too has more potential than just a cancer drug. Many viruses such as HIV, herpes and dengue bind to cell surface heparan sulphates prior before invading the cells, and PI-88 or similar compounds can prevent this.
Dr Freeman added, 'We are also involved with collaborations on the role of heparanase and heparan sulphate in diabetes, kidney disease, Alzheimer's Disease and blood triglyceride levels.'
PI-88 was also shown to be an inhibitor of restenosis, which is the recurrence of narrowing in a coronary artery following the removal or reduction of a previous narrowing by balloon angioplasty.
A cure for cancer?
To provide funding to develop their initial discovery, ANU Enterprise, the commercial arm of the ANU, negotiated a deal with Progen Industries Ltd, an Australian biotechnology company to fund research which led to the development of PI-88. The company has provided A$4.3mil (RM12.2mil) over five years to JCSMR to support their work, and has guided PI-88 through several Phase I and II clinical trials, and is gearing up for the next stage, which will cost a staggering A$50mil (RM137mil).
More recently on May 16, Progen announced that it had received notification from the US Food and Drug Administration (FDA) guiding the accelerated development of PI-88. This essentially reduces the development timeframe of PI-88 by up to three years, which means that it could be available to the public earlier if the drug proves to be viable. But there's one thing for sure 'C a cure for cancer can never arrive too soon.
Herpes Treatment
Combined Population of Stage IV M1a and M1b Melanoma Patients Who Received at Least 10 Vaccinations Experienced Increased Survival of 143 Percent
Antigenics Inc. (NASDAQ: AGEN) today announced in an oralpresentation at the 42nd annual meeting of the American Society ofClinical Oncology (ASCO) updated findings from a Phase 3 clinicaltrial of the company's investigational cancer vaccine Oncophage(R)(vitespen; formerly HSPPC-96) in metastatic melanoma (abstract #8002).In the study, patients who received at least 10 doses of vaccineexperienced an extension in median survival of 29 percent comparedwith those who received physician's choice (hazard ratio = 0.749;nominal, one-sided P value = 0.130). In a subset analysis, Oncophagewas associated with a potentially clinically relevant benefit (hazardratio = 0.427; nominal, one-sided P value = 0.017) compared withphysician's choice for patients with stages IV M1a and M1b melanoma,if at least 10 doses of vaccine were administered.
"This is the first time a cancer vaccine has shown evidence of apotential survival benefit in this patient population," Jon Richards,MD, PhD, of the Oncology-Hematology department at Lutheran GeneralCancer Care Center, Park Ridge, IL, and lead investigator of thestudy. "These findings are consistent with preclinical and earlyclinical research conducted to date and lay a solid foundation for thecontinued exploration of Oncophage vaccine in better-prognosis stageIV melanoma patients."
Study Findings
The Phase 3, international, multicenter, open-label trial(protocol C-100-21) randomized 322 patients with stage IV melanoma toone of two treatment arms: Oncophage or physician's choice, in a 2:1ratio favoring Oncophage, and prospectively stratified based on AJCCmetastatic stage (M1a, M1b, M1c). Physician's choice includedinterleukin 2 (IL-2) and/or dacarbazine-/temozolomide-based therapyand/or complete tumor resection, and could also include any otherlicensed treatments for cancer. The primary endpoint of the trial wasoverall survival, and comparison of survival data was made using theKaplan-Meier method (an estimate of the cumulative probability ofsurvival for a set of data) and a one-sided log-rank test. Overall, inthe intent-to-treat analysis, patients in the Oncophage arm (M1a, -band -c combined) fared similarly to those in the physician's choicearm in terms of survival (9.4 months vs. 10.7 months, respectively;hazard ratio = 1.157; nominal, one-sided P value = 0.157).
Researchers also found that patients who received at least 10doses of vaccine (44 patients) experienced an extension in mediansurvival of 29 percent compared with those who received physician'schoice (72 patients; 16.5 months vs. 12.8 months, respectively; hazardratio = 0.749; nominal, one-sided P value = 0.130). A more pronouncedeffect was observed in M1a and M1b patients who received at least 10vaccines (25 patients) compared with those who received physician'schoice (33 patients), with an improved survival of 31.2 months vs.12.8 months, respectively (hazard ratio = 0.452; nominal, one-sided Pvalue= 0.017).
Adverse events reported during the trial were generally mild andexpected. The more frequently reported adverse events were mainlyconstitutional in nature and included, but were not limited to nausea,pyrexia (fever), fatigue, constipation, dyspnea (difficultybreathing), arthralgia (pain in the joints), headache, back pain andabdominal pain. Approximately 50 percent of patients receivingOncophage reported a serious adverse event (SAE), but only two SAEswere considered by the investigators to be related and unexpected.These events included one report of a thyroid disorder and anotherreport of cellulitis (inflammation of connective tissue).
Oncophage, Antigenics' lead product in development, is aninvestigational personalized cancer vaccine based on the company'sproprietary heat shock protein technology. Derived from each patient'scancerous tissue or cells, the vaccine is designed to capture the'antigenic fingerprint' of the patient's particular cancer. This isdesigned to reprogram the body's immune system to target and destroyonly cells bearing this fingerprint, leaving healthy tissue unaffectedand minimizing debilitating side effects associated with traditional,broader-acting cancer treatments. Oncophage has been granted fasttrack and orphan drug designations from the US Food and DrugAdministration (FDA) in both metastatic melanoma and renal cellcarcinoma.
"These clinical data add to the growing set of observations inother clinical research with Oncophage that the potential benefit ofour vaccine may be most apparent when more doses are administered tobetter-prognosis patients," said Garo H. Armen, PhD, chairman and CEOof Antigenics Inc. "We will soon have results from the in-depthanalysis of our Phase 3 kidney cancer trial, the largest studyconducted in the adjuvant setting, which we expect to show a similarpattern of effect in a much larger patient population. We are alsoexploring our next steps from a clinical development perspective,including potential combination treatments in melanoma as well asother indications."
About Melanoma
Melanoma is the most serious form of skin cancer. According to theAmerican Cancer Society, melanoma accounts for only about 4 percent ofskin cancer cases, but causes most skin cancer deaths. It is estimatedthat in 2006 there will be 62,190 new cases of melanoma in the UnitedStates and that about 7,910 people will die of the disease.
Oncologists treat advanced or metastatic melanoma, also known asstage III or IV melanoma, with surgery, radiation therapy,immunotherapy or chemotherapy, depending on the case. Approximately 15percent of all melanoma patients at the time of first diagnosis havestage III or stage IV disease. Existing treatments have notsignificantly improved overall survival of patients with melanoma.According to published literature, the median survival of patientswith late-stage III melanoma is about 24 months, and patients withstage IV melanoma have a median survival of about seven months.Although oncologists use various treatments, the only FDA-approvedtherapies for patients with metastatic melanoma are high-doseintravenous interleukin 2 and alpha interferon, another humancytokine.
About Antigenics
Antigenics is working to develop treatments for cancers,infectious diseases and autoimmune disorders. The company'sinvestigational product portfolio includes Oncophage(R) (vitespen;formerly HSPPC-96), a patient-specific therapeutic cancer vaccinebeing evaluated in several indications; Aroplatin(TM), a liposomal,third-generation platinum chemotherapeutic; ATRA-IV, a liposomalretinoic acid; AG-707, a therapeutic vaccine for the treatment ofgenital herpes; AU-801, a preclinical program targeting autoimmunedisorders; and QS-21, an adjuvant being evaluated by Antigenics'corporate partners in several late-stage clinical trials. For moreinformation, please visit www.antigenics.com.
Herpes Treatment
And he's not kidding: present at his recent Clinton Foundation meeting were Warren Buffett, Laura Bush, Bill Gates, Jacques Chirac, Richard Branson, and Rupert Murdoch. What they discussed over lunch were the current objectives of the Foundation: Poverty Alleviation, Religious and Ethnic Conflict Reconciliation, Global Energy Solutions, and Global Public Health. Well, that about covers it: we can relax. The world's poverty, energy, religious discrimination, and health problems are as good as gone.
Of course, it is unnecessary to point out that this group seeks solutions to these problems using other people's money, taken from them by government. Nor shall I point out the utter and absolute illegitimacy of this. As regards the U.S. Constitution, all people fall into one of two groups: the first knowing what the Constitution mandates, and aware that it is a dead letter, not taken seriously; and the second neither knowing what the Constitution says, nor caring.
Into which category does Mr. Clinton fall? Who cares? At a recent press conference he bemoaned "our meager contribution to fighting the global (AIDS) epidemic." That "meager" contribution (although it wasn't so much contributed as exacted) amounts to billions of dollars yearly, with as much as fifteen billion sent to Africa in a single year recently. Obviously, if the Constitution doesn't authorize government involvement with health care in the U.S. 'C and it doesn't 'C it couldn't begin to imagine U.S. government involvement with health care in Africa! (And, of course, "our" contribution means yours and mine, extracted from us by force, or the threat of it.)
Yet Africa plays a major role in the Clinton Foundation's anti-AIDS campaign. Perhaps that's because AIDS in America has proven a disappointment to those with a vested interest in "fighting" the disease. Even prior to protease inhibitor therapy, AIDs cases were dropping: from 60,000 in 1997 to 48,000 in 1998. In the same time period, new cases among women fell from 13,000 to 11,000. The predicted heterosexual explosion of the "epidemic" wasn't materializing, in other words. The anti-AIDS business had to look elsewhere.
Africa beckoned! AIDS is all over the place in Africa, largely because it is diagnosed quite often with the "Bangui Definition." By the Bangui Definition, AIDS is present in anyone with two of these three symptoms: prolonged fever for a month or more, weight loss over 10%, or prolonged diarrhea, in conjunction with any one of these: swollen nodes, persistent cough, herpes, itching skin inflammation, or several others. No blood test required. Indeed, the widespread presence of such diseases as tuberculosis, leprosy, or malaria, result in so many false positives, that, according to the Journal of Infectious Diseases, HIV tests are useless.
In other words, almost anyone chronically ill in Africa is considered to have AIDS. It may not be good medicine, but it's sure good business! Billions of dollars of drugs sold, billions in aid spent and received, corruption more rife than germs, and no end in sight!
This expensive, and therefore profitable, assault upon AIDS is, as indicated, not remotely lawful (i.e. Constitutional), but it doesn't make a whole lot of sense medically, either. While most of the medical profession accepts the HIV-AIDS hypothesis, it is by no means a settled issue. Dissenters, such as Dr. Peter Duesberg, have excellent credentials, and claim that AIDS is not a disease, but merely the name given to a person with a chronic disease, such as TB, who also happens to test HIV positive 'C the HIV infection being incidental and not a cause of serious illness. If Duesberg and his colleagues are correct, then the current medical treatment of AIDS is a preposterous boondoggle, with potent drugs such as AZT killing more people than it saves 'C indeed, it can't "save" anyone, if the HIV virus is an innocuous parasite.
Does the current AIDS lobby, such as Clinton's Global Initiative, give any consideration to the fact that they may be spending billions treating a mythical disease? Apparently not. Indeed, if AIDS were curable with the treatments recommended, the "fight" against AIDS would end, along with the profits attendant thereto. We shouldn't be too surprised: if fighting AIDS is a profitable racket, we'd expect politicians, especially of the stripe of Bill Clinton, to be in the front lines. Perhaps no one has ever been cured of AIDS, but that only indicates the need for more spending, more research, more clinical trials, and, just possibly, more bribery, graft, and corruption. It's a government project, after all.
Herpes Treatment
Pregnant women can get a variety of infections with consequences that range from minor to dire ' for mom, baby or both.
Those charged with providing prenatal care and delivering babies must know when to wait for symptoms, when to screen and what the treatment options are, according to a certified nurse-midwife who spoke to her peers Wednesday at a national conference in Salt Lake City.
Jan M. Kriebs of the University of Maryland provided an update on infections during pregnancy as part of the American College of Nurse-Midwives conference at Grand America Hotel. The five-day education session ends today.
Pregnant women can take steps to avoid some infections, starting with good hygiene. Hand washing prevents transmitting many types of bacteria. For example, staph aureus colonizes on the skin or in the nose of 25 to 30 percent of the population, and 1 percent of the population carries an antibiotic-resistant strain called MRSA. Hand washing is a power tool against spreading it.
Some foods, like unpasteurized milk, raw smoked seafood and soft cheeses can cause a severe food-poisoning called listeriosis. One-third of the cases involve pregnant women, who may have only mild flu-like symptoms, while their babies may be born early, be stillborn or develop severe illness.
Pregnant women shouldn't change kitty litter, because although the risk of infection is very slight ' less than 1 percent ' it can lead to toxoplasmosis, which may also be caused by undercooked meats or contaminated soil. Infants who get the infection from their mothers may appear healthy at birth and develop symptoms later, some of them very severe.
Most pregnancies proceed just fine. But infection is a potential problem that must be considered. And how rare or common a bacterium is has little to do with the damage it can cause or whether screening is needed.
It's believed one in four adult women have Herpes Simplex virus 2 (most often affecting genitals) or 1 (more commonly affecting faces), usually transmitted from someone who has no symptoms. An estimated 45 million Americans have the disease, Kriebs says, and 70 percent don't know they have it. Early in the pregnancy, risk of infecting a baby is small. Infection may not be discovered until seven to 11 days after delivery. Symptoms or complications run the gamut from mild, localized sores to long-term disability or death.
Kriebs predicts the high incidence among women will soon prompt routine screening for the infection as part of prenatal care.
Syphilis cases in women have plummeted in the United States since they peaked in the late '80s and early '90s. Still, if it is untreated in pregnant women, there's a good likelihood it will be passed on to the fetus. Many of those fetuses are stillborn.
A study of 451 babies nationwide who were born in 2002 infected with syphilis found that two-thirds of the mothers received some prenatal care. But three-fourths of the time, treatment was inadequate or missing altogether.
"We ought to be able to do something about this with prenatal care," Kriebs says, "But if two-thirds had care and three-fourths were not adequately treated, where were we?"
Risk and outcomes can be vastly different for mom and baby, depending on the type of infection.
Cytomegalovirus is very common in adults, most with no symptoms. Screening for it, absent symptoms, is not recommended. It is seldom transmitted in pregnancy, and there's no way to prevent infecting a baby. Treatment focuses on symptoms, but unfortunately, many of the babies who develop symptoms die.
While mumps poses little threat to mothers long-term, it may increase the risk of miscarriage. Rubella carries a low rate of complication for mothers, but babies may be miscarried, be born early or develop a syndrome that may include deafness, cataracts, heart problems and other complications such as liver damage or mental retardation.
Chicken pox raises the stakes for mothers. Kriebs says 10 percent of pregnant women who are infected develop severe pneumonia. Babies, depending on when in their development they're exposed, may have limb atrophy, scarring and other problems. Exposure close to time of birth may be fatal to a baby. Influenza danger increases as women get further into their pregnancies. And unlike many of the infections, where a vaccine is not recommended after the woman is pregnant, women who will be in their second or third trimester during flu season are encouraged to get a vaccine.
Herpes Treatment
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