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Review by FDA Committee of Potential Treatment for Lupus - Monday, January 28, 2002 by newsmanager

On April 19, 2001, the FDA's Arthritis Advisory Committee considered data for a synthetic DHEA (dehydroepiandrosterone) product submitted by Genelabs Technologies' (Redwood City, CA) as a treatment of systemic lupus erythematosus, a serious autoimmune condition for which there are few and limited treatments. The meeting largely pitted clinicians against an FDA statistical review that repeatedly characterized Genelabs' data as "not statistically significant," especially for adverse events when compared with placebo. The really odd (and fishy) thing about this meeting was that the FDA did not ask the Arthritis Advisory Committee to vote, thus avoiding a formal recommendation. This is considered highly unusual. We fear that this indicates the FDA will use any ploy to avoid approving DHEA for the treatment of any disease. The FDA well knows that DHEA is available as a dietary supplement and that the courts support First Amendment protection of the communication of truthful information about the effects of dietary supplements. Lost in the FDA's calculations is the suffering of lupus victims. -- Nature Biotechnology 19:500 (2001)

FDA Says No to Drug Imports - Monday, January 28, 2002 by garyfarr

The FDA recommends that U.S. Customs Service agents at mail inspection sites be required to send back all small foreign drug shipments they find, said William Hubbard, senior associate commissioner at the FDA in a House commerce oversight subcommittee meeting. The only exemption would be for "compassionate use," where seriously ill patients order drugs from overseas that are not available in the U.S. Although Congress authorized a rule allowing reimportation of prescription drugs by individuals in last year's final budget reconciliation package (as a way to help individuals buy drugs at the reduced prices often available in other, poorer countries), it is "looking doubtful" that such a regulation will be issued, according to Department of Health and Human Services Secretary Tommy G. Thompson. The FDA claims that such freedom cannot be allowed while the agency is unable to certify that the drugs coming back into the country are safe and are the same drugs that were exported. This is a fine excuse to protect their pharmaceutical company clients from price competition and to ensure the continued availability of six figure salary jobs at pharmaceutical companies for former FDA officials. The Wall Street Journal, June 8, 2001, pg. B2; Pharmaceutical & Medical Device Law Bulletin, April 2001, pg. 9

Long-Term Aspirin Use Lined to Cataracts - Monday, January 28, 2002 by garyfarr

Prolonged aspirin use may raise risks for cataract. Scientists have known that the long-term use of certain drugs, such as corticosteroids, can contribute to cataract development. The investigators found that long-term (more than 10 years) use of aspirin was associated with a 44% higher increase of posterior subcapsular cataracts, compared with nonusers or short-term users of the drug. Posterior subcapsular cataracts are the most common and most disabling form of cataract. This aspirin-related risk was larger among younger (under 65 years of age) individuals compared with older subjects.

Study Warns Against Antibiotic Treatment For E. Coli - Monday, January 28, 2002 by garyfarr

May 25, 2000 BOSTON (AP) - Children suspected of being infected with a particularly nasty form of the E. coli food poisoning bug should not be treated with antibiotics because they may trigger dangerous complications, a study warns. A rare complication in children, usually under age 5, is hemolytic uremic syndrome, which results in destruction of red blood cells and kidney failure. The Centers for Disease Control and Prevention estimates that 2 percent to 7 percent of E. coli infections lead to the complication, and between 3 percent and 5 percent of those victims die. A study by doctors from Children's Hospital and Regional Medical Center in Seattle found the link with antibiotic use, which had already been suspected. Their study is scheduled to be published June 29 in the New England Journal of Medicine, which released it Wednesday. The Seattle doctors reviewed the cases of 71 children under age 10 who had diarrhea caused by the bacterial infection between 1997 and 1999. They found that hemolytic uremic syndrome developed in five of the nine children given antibiotics, compared with five of the 62 who did not receive the medicines. E. coli infections usually clear up without treatment, and use of antibiotics is not recommended for any patients. While the latest study does not prove that antibiotics are to blame for the syndrome, the team led by Dr. Craig S. Wong wrote that the evidence of an association "is strong and plausible." They theorized that antibiotics cause the release of toxins from injured bacteria into the intestine. A variety of the usually harmless E. coli bacteria called causes an estimated 73,000 cases of food poisoning in the United States annually. The infection often spreads through eating undercooked contaminated meat and typically causes bloody diarrhea.

Vaccines May Be Linked to Gulf War Syndrome - Monday, January 28, 2002 by garyfarr

DOD to Review Possible Use of Illegal Additive by Michael Devitt, Associate Editor Less than four months after its publication, the Department of Defense (DOD) has agreed to review a controversial study that appears to link Gulf War syndrome (GWS) with a banned substance used in experimental vaccines. The study, conducted by scientists at Tulane University Medical School, found that an overwhelming majority of sick veterans who had served in the Gulf War, and had received at least one vaccination, tested positive for antibodies to a naturally occurring substance called squalene. None of the healthy veterans in the study tested positive for squalene antibodies. DOD officials originally dismissed the study as flawed and asserted that none of the vaccines administered during the Gulf War contained squalene. In response to pressure from Congress, however, the department has asked the Armed Forces Epidemiological Board (AFEB) to re-examine the study. The Institute of Medicine is also reviewing the research to see what role squalene may play in Gulf-related illnesses.1 Squalene Adjuvant: Friend or Foe? A naturally occurring molecule, squalene is produced by the human liver and plays a role in the metabolism of cholesterol. It is most commonly found in vegetable oils, shark liver oil, cosmetics and various health supplements. Under normal circumstances, squalene is released into the blood to help combat physical injuries. However, people don't usually have enough squalene in their blood to prompt the production of detectable levels of antibodies. Since the late 1980s, squalene has been studied by the DOD and the National Institutes of Health as a possible adjuvant in vaccines. Because adjuvants boost the immune system's response to foreign antibodies, the subtance has sparked the interest of researchers. Drug manufacturers, for their part, have incorporated adjuvants into vaccines in the belief that the substance will render the vaccine more effective. Adjuvants, however, can sometimes trigger unwanted immune responses. While large-scale studies have yet to be conducted in humans, animal studies have shown that squalene adjuvants may generate autoimmune versions of arthritis and multiple sclerosis type-conditions that attack the body from within.2 Although they have been used in a number of vaccines worldwide, only one adjuvant - aluminum hydroxide - has been approved by the Food and Drug Administration for use in vaccines in the United States. And although squalene-adjuvant vaccines have been used on laboratory animals and in experimental human tests, the FDA has not approved the general use of any vaccine containing squalene in the U.S. "We Never Used Squalene in Vaccines" Military officials have said all along that no Gulf War vaccines contained squalene. In August 1997, spokespersons for the DOD claimed that squalene "was not an adjuvant that was in any of the vaccines that were used by the Department of Defense,"3 and that "we never used squalene in vaccines" during the Gulf War. However, in a report4issued in March 1999, the General Accounting Office (GAD) - the investigative arm of Congress - stated: We cannot say definitively whether or not Gulf War-era veterans were given vaccines with adjuvant formulations containing squalene for a number of reasons. Although DoD officials told us they did not administer such vaccines, they stated they did not have documentation on the process and results of decision-making related to the administration of vaccines at the time of the Gulf War. Also, some officials involved in the decisions were no longer employed with DOD at the time of our review, and we were either unable to locate them, or they declined to be interviewed. A month after the GAO issued its 1999 report, the first hint that squalene might be linked to Gulf War syndrome appeared in an article in New Scientist magazine.5 Robert Garry, a virologist at Tulane University, tested more than 400 Gulf War veterans for antibodies to squalene and found that 95 percent of those with GWS had high levels of squalene antibodies. Garry also tested a pair of volunteers who had received experimental herpes vaccines containing squalene in trials conducted by the National Institutes of Health. Both had high levels of squalene antibodies and also suffered from GWS-type symptoms. In February, the peer-reviewed journal Experimental and Molecular Pathology6 published a study written by Garry's team at Tulane University and Dr. Pamela Asa, an immunologist from Tennessee. Dr. Asa was one of the first health professionals to advance the theory that Gulf War syndrome might be an autoimmune disorder caused by experimental vaccinations. The research included blinded and unblinded studies. In the blinded study, 56 Gulf War-era veterans and military personnel who were on active service in 1990-91 were tested for squalene. Of those 56, 38 had been deployed to the Persian Gulf and had GWS-type symptoms; 12 had been deployed but were healthy; and six had not been deployed but were nevertheless ill. The researchers found that among the 38 ill veterans who had been deployed, 36 (94.7 percent) tested positive for squalene antibodies. None of the deployed healthy individuals, however, tested positive. Furthermore, all six subjects who were ill, but had not been sent to the Gulf, also had squalene antibodies. While they did not serve in the war, they had received the same type and number of vaccinations given to Gulf War troops. To see whether squalene antibodies might be a marker for other types of autoimmune diseases, the researchers also tested groups of patients with lupus and chronic fatigue syndrome, as well as a small sample from the general population. Only 15 percent of those with chronic fatigue tested positive for squalene; only 10 percent of those with lupus tested positive; and only five percent of the general population had squalene antibodies. The Tulane study made no conclusion about whether Gulf War vaccines contained squalene, what may have produced the antibodies, or what role they play in Gulf War syndrome. Still, it is hoped that the research conducted by Garry and Asa will prompt others to investigate the role of vaccinations in Gulf War syndrome and the safety of vaccines that contain squalene. "We don't know what caused the immune system to produce anti-squalene antibodies in the Gulf War veterans, but this study shows that the antibodies are indeed there," observed Dr. Russell Wilson, president of Autoimmune Technologies, which helped market the study. Dr. Wilson does not believe that the antibodies were the result of a reaction to squalene added to vaccines. "That possibility must still be formally ruled out,"7 he concluded. Approximately 700,000 Americans served in the Gulf War between 1990-91. One hundred and forty-eight Americans were killed in action; 467 were wounded. The Department of Veterans Affairs estimates that as many as 100,000 veterans may be suffering from Gulf War syndrome or related symptoms, and that approximately 6,500 soldiers have died since the war's conclusion, including more than 1,300 soldiers between the ages of 18-24.8 1. Hughes J. Scrutinizing squalene: government to review study linking gulf illness, antibodies. Associated Press, April 14, 2000. 2. What is squalene? Associated Press, April 14, 2000. 3. Rodriguez PM. The Gulf War mystery. Insight Magazine, September 8, 1997. 4. Gulf War Illnesses. Questions about the Presence of Squalene Antibodies in Veterans Can Be Resolved. United States General Accounting Office, March 1999. 5. Mackenzie D. Victims of vaccines. New Scientist April 10, 1999. 6. Asa PB, Cao Y, Garry R. Antibodies to squalene in Gulf War syndrome. Experimental and Molecular Pathology February 2000;68(1):55-64. 7. New antibodies discovered in Gulf War syndrome patients. AutoImmune Technologies (www.autoimmune.com ), January 31, 2000. 8. Turner A. Death ruling raises issue of Gulf War ills. Houston Chronicle April 15, 2000.

Pfizer Sued Over Nigerian Antibiotic Test - Monday, January 28, 2002 by newsmanager

Pfizer Inc. is under fire for allegedly experimenting on Nigerian children without their guardians' consent. The suit says the U.S. drugmaker tried out an untested antibiotic on children there during a 1996 meningitis epidemic. The lawsuit, notes an article by Tamar Lewin in the New York Times, is the first against a U.S. drug company in a U.S. court over alleged misconduct against people in another country. A Pfizer spokesperson is quoted in the article as saying the company hadn't seen the suit and couldn't comment on its allegations. In the past, the article adds, the drugmaker has called the effort philanthropic and has pointed out that the death rate in its effort was lower than the rate overall for children exposed to the epidemic. Thirty families in the African nation have sued in federal court in New York over the pharmaceutical giant's treatment of 100 children with Trovan, the article says. The suit, it adds, claims that was part of a test to see if the drug, which hadn't been tested on children before, would work on those patients. Pfizer also alleged treated another 100 children with intentionally low doses of ceftriaxone, a well-known meningitis treatment, the article continues. As a result, it says, the suit claims that 11 children died and others suffered brain damage, were partly paralyzed or became deaf. The suit was brought under the Alien Tort Claims Act, the article goes on, and seeks damages and continuing medical care for children involved in the "study." It also seeks, the article adds, an order keeping Pfizer from conducting illegal human experimentation. Pfizer learned about the Nigerian epidemic from a Web site, the article explains, and immediately sent a six-member team to the Infectious Disease Hospital in Kano. The company, the article quotes the lawsuit as alleging, "took the opportunity to accomplish what [it] could not do elsewhere -conduct on young children a test of the potentially dangerous antibiotic Trovan." The suit, the article adds, was filed by the New York firm Milberg Weiss Bershad Hynes & Lerach. The Nuremberg Code of 1947 and the World Medical Associations Declaration of Helsinki require companies that want to conduct medical tests on human subjects to explain the purpose, risks and methods of the study and obtain each subject's voluntary consent, the article continues. Pfizer never did so, the article quotes the lawsuit as alleging, but said it did when asked about it by the FDA. Pfizer, the article adds, also faces two class-action lawsuits and a government investigation in Nigeria. Trovafloxacin mesylate was developed in the mid-1990s, the article notes.

Merck-Medco's Under Fire for Drug Switching - Monday, January 28, 2002 by newsmanager

Pharmacy benefits manager Merck-Medco is under fire for allegedly encouraging doctors to switch patients to more expensive drugs made by its parent company and for securing discounts from drugmakers that it doesn't pass on to customers. The PBM firm says it guarantees overall savings and treats its parent's products just like anyone else's. A groups of lawsuits, says an article by Barbara Martinez in the Wall Street Journal, is being heard in U.S. District Court for the Southern District in New York against Merck-Medco, Franklin Lakes, N.J. The suits, the article notes, have been filed by individuals and employers. They allege, the article continues, that the PBM, which is a subsidiary of Merck & Company, Whitehouse Station, N.J., breached its fiduciary duty to customers by failing to disclose payments it receives from drug manufacturers for promoting certain drugs over competitors in the same therapeutic class. The suits also claim that the PBM sometimes persuades doctors to switch patients to higher-priced Merck drugs, the article reports. PBMs, it notes, are a key element of the Bush administration's plan to add a drug benefit to the Medicare program. The four biggest PBMs, the article points out, cover about 200 million people. Merck-Medco, the Journal article goes on, responds that the lawsuits are simply wrong. The company, the article says, negotiates with manufacturers for packages of drugs whose prices vary. Overall, the article says, those packages are discounted for customers, even if individual drugs are higher than their alternatives.

Antibiotics Don't Speed Sinusitis Recovery - Monday, January 28, 2002 by garyfarr

Most children with cough, runny nose and other symptoms of sinus trouble are unlikely to benefit from antibiotics. In a study of children diagnosed with acute sinusitis lasting at least 10 days, those given an inactive placebo pill were just as likely to get better as children prescribed antibiotics. Symptoms improved within 7 days in 81% of children in each group and within 10 days in 87% of all children. There was no benefit of antibiotics versus placebo for getting rid of symptoms. Children were treated with a placebo or one of two types of antibiotics, amoxicillin or Augmentin. The study also found that antibiotic therapy was no better than placebo for preventing the relapse or recurrence of symptoms, or reducing absences from school or day care. Side effects were similar in all three treatment groups, although children taking amoxicillin were more likely to experience abdominal pain. The researchers concluded that if parents just hang in there, the children will get better on their own. Most cases of sinusitis appear to be caused by viruses, against which antibiotics are powerless. The study does not mean that antibiotics should never be used to treat sinusitis or other acute respiratory illnesses, only that they should be used "judiciously." Some children may have bacterial infections that will respond to antibiotics, so a doctor may prescribe antibiotics for some children with symptoms that will not go away on their own, researchers said. Pediatrics April 2001;107:619-625 Dr. Farr's Comment: When ever infections are present, you should eliminate your intake of mucus forming foods and liquids. This includes all foods and liquids containing sugar and milk and milk products. Since sinus problems can also result from allergies, there can other organs and systems affected as well. This includes the digestive and immune systems. Even though x-rays are sometimes used to confirm a diagnosis of sinusitis, they are unreliable and should not routinely be used, as we know they will increase a child's risk for developing future cancers. For detailed information regarding sinusitis go here.

Cholesterol Drug Taken Off Market - Numerous Deaths Linked to Baycol - Monday, January 28, 2002 by newsmanager

The maker of cerivastatin, a popular cholesterol-lowering drug used by about 700,000 Americans, voluntarily pulled the medicine off the market yesterday because of numerous deaths associated with its use. Officials at the Food and Drug Administration said 31 people have died of complications of severe muscle breakdown, a rare but well-recognized side effect of many cholesterol-lowering drugs. In about one-third of the cases, the person was on a second cholesterol drug, gemfibrozil, known to especially increase the risk of problems. Cerivastatin is one of six "statins," a popular family of drugs prescribed to about 12 million Americans to treat, and possibly prevent, coronary heart disease. Reports of severe side effects, including death, are at least 10 times more common for cerivastatin than for other drugs in the class. "We are not considering any regulatory action with regard to the other approved statins," said John Jenkins, director of the FDA's office of drug evaluation. The other statins are lovastatin (Mevacor), pravastatin (Pravachol), simvastatin (Zocor), fluvastatin (Lescol) and atorvastatin (Lipitor). Bayer AG, the German company that makes cerivastatin, introduced the drug under the trade name Baycol in January 1998. The first death was reported in January 2000, with the number of complications rising markedly when a high-dose pill was introduced last August. Before and after the first death, Bayer officials warned doctors against prescribing cerivastatin with gemfibrozil and strongly advised that patients be started on a low dose. That advice, and changes in cerivastatin's official labeling, appeared to change prescribing behavior to some extent, but not enough to eliminate the problem. "We had options of keeping the lower doses on the market, but we took this decision in the interest of patient safety," said Paul MacCarthy, vice president of medical science for Bayer's U.S. operations. Drug recalls are rare. From 1981 to 2000, the FDA approved 543 new drugs for use. Fourteen, or 2.6 percent, were subsequently recalled -- either voluntarily, or by FDA action -- for safety reasons. Cerivastatin is fifth out of the six statins in number of prescriptions written, according to data provided by IMS Health, a pharmaceutical monitoring company in Pennsylvania. But the drug's market share was growing. It was 6.7 percent at the end of June, up from 2.5 percent at the end of 2000. The drug is the third biggest selling prescription drug in Bayer's portfolio. Worldwide, it accounted for $560 million in sales last year, and was expected to grow to about $880 million this year, said Gunter Forneck, spokesman at the company's German headquarters. Cerivastatin, which is used worldwide by about 6 million people, is also being taken off the market in Europe. It will remain available only in Japan, where gemfibrozil is unavailable. Physicians have known since the first statin was introduced in 1987 that a few patients develop muscle inflammation, experienced as soreness or tenderness, while taking the drug. Occasionally, that progresses to whole-scale muscle breakdown, a condition called rhabdomyolysis. That, in turn, can lead to kidney failure, as the bloodstream is flooded with relatively toxic proteins released by the dissolving tissue. Jenkins said 29 of the 31 people who died had kidney failure. People at increased risk for the complication are those taking both cerivastatin and gemfibrozil (sold under the trade name Lopid), and those taking the 0.8 milligram cerivastatin dose. The FDA advised people in those groups to stop taking cerivastatin and consult their doctors about alternative medicines. Some deaths have also occurred with use of the 0.4 milligram pill, and when the drug is taken alone. The elderly, and possibly women, also appear to be at higher than usual risk for the complication. Combination use of statins and fibrates -- the family to which gemfibrozil belongs -- isn't necessarily a mistake. The two types of drugs alter blood fats in different ways, and are sometimes intentionally prescribed to patients with severe cholesterol problems despite the rare risk of rhabdomyolysis, which generally reverses itself if the drugs are stopped immediately. Because of the signs that the cerivastatin-gemfibrozil interaction was more common, Bayer put in the drug's labeling a specific prohibition against using them together. When the deaths began appearing, the company sent a letter to all doctors and prohibited its salesmen from giving away samples of the 0.8 milligram dose, said Tig Conger, Bayer's vice president for cardiovascular marketing. The company recently presented the FDA data from a managed-care plan showing the education campaign had reduced "concomitant dispensing" of the drugs a little. Eliminating it altogether is nearly impossible, Jenkins said. "There are just too many factors -- patients seeing multiple physicians or going to multiple pharmacies; patients forgetting to tell their doctors what medicines they're on or using leftover medication," he said. The difficulty is clear from a case seen last year by Roberto Lufschanowski, a cardiologist at the Texas Heart Institute in Houston. A man in his seventies appeared with rhabdomyolysis so severe he was too weak to lift his head off the bed. He had been prescribed gemfibrozil and another statin but had recently switched to cerivastatin when a non-physician friend gave him some samples. He survived. Lufschanowski, who reported the case in a medical journal, said he expects cerivastatin's withdrawal will have no effect on statin use overall. "The beneficial effects of statins are so overwhelming. They are a part of our routine care of patients with coronary artery disease," he said

Women's Health Issues Not Disorders, Chiropractor Says - Monday, January 28, 2002 by newsmanager

A new drug marketed to women for so-called "premenstrual dysphoric disorder" (PMDD) is simply repackaged Prozac. But the introduction of the remedy, and its focus on a premenstrual "disorder" has some doctors charging that women are still getting the message that their normal bodily functions – because they aren't the same as men's – are wrong and need to be treated. The PMDD drug, Serafem, is the new name for the antidepressant fluoxetine hydrochloride, an Eli Lilly & Company product, notes an article written by Neil Osterweil and medically reviewed by Dominique Walton, MD, MBA, for WebMD. PMDD, the article points out, is a newly proposed mental disorder that hasn't been officially accepted by the American Psychiatric Association. It is, however, listed in the appendix of the group's diagnostic manual, the article says. Lilly lost the patent for Prozac just this month. The problem with the relaunch, the article points out, is it reinforces messages women get from the time they're pre-teens: that their bodies aren't working right. One source quoted in the article notes that girls are given hormonal drugs if they start menstruating "too early," but if they start "too late," they're said to have "amenorrhea." The package insert for Sarafem cites symptoms of PMDD from the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), that include "markedly depressed mood, marked anxiety, marked affective lability and decreased interest in activities." But,t he article points out, that information leaves out the fact that while PMDD is called a "depressive disorder" in the main body of that manual, its full entry is in a section reserved for conditions for which "there was insufficient information to warrant inclusion of these proposals as official categories." Critics also raise another concern common to research on products for women: that it wasn't sufficiently tested under circumstances that real women face, the article continues. The compound, it notes, was not tested for long-term use prior to FDA approval. Those tests were for six- to eight-week periods, it says. Lilly responds in the article that the Food and Drug Administration said in 2000 in approving Serafem for PMDD that its OK was unanimous, saying PMDD has "well-defined, accepted diagnostic criteria." But, the article says, the document Lilly refers to goes on to say that "the [FDA] committee advised that the drug should be used only to treat women whose symptoms are severe enough to interfere with functioning at work or school, or with social activities and relationships." Source - WebMD Our Comment: Drug companies and psychiatry are two of the worst influences on society. Their "products" are manufactured for the sole purpose to make money. See the article "Inventing Psychiatric "Diseases" For Over 40 Years" and you'll see what I mean.

Deaths Raise Concern About Natural Stimulants - Monday, January 28, 2002 by newsmanager

The recent deaths of three student athletes have raised questions about compounds that contain ephedra, a natural stimulant that jocks say improves their performance. The compound – which goes by several names -- is also used by dieters and gym rats, but scientists differ on whether it's safe, or even effective. A Los Angeles Times article by Benedict Carey emphasizes that doctors aren't certain that ephedra supplements contributed to the deaths of Rashidi Wheeler, Devaughn Darling or Curtis Jones. Ephedra products include Metabolift, Stacker 3, Hydroxycut, Metabolife, Ripped Fuel, Diet Fuel, NaturalTRIM, Xenadrine RFA-1, Metab-O-Lite, Up Your Gas, Truckers Luv It and Yellow Jackets, the article notes. They typically contain caffeine, aspirin and one or more ephedra compounds, it says. Ephedrine, the article adds, is derived from the reedy ma huang shrub native to China. It also is known as ma huang, sida cordifolia, ephedra sinica, epitonin, pseudoephedrine or methyl ephedrine, it notes. The compound activates the "fight or flight" nervous system, it notes, which includes opening bronchial airways, increasing blood pressure and heart rate and releasing adrenaline. In studies, the article continues, researchers mix about 25 milligrams of ephedra stimulants and 200 or so milligrams of caffeine. That dosage, it says, produces heightened awareness and a slight increase in heart rate and blood pressure. But those doses, it adds, are not regulated by the Food and Drug Administration (FDA) – nor is the content of ephedra supplements. In the wrong doses, the article adds, ephedra compounds can cause increased risk of heart palpitations, stroke and cardiac arrest. People who suffer those effects, the article points out, may have a weak blood vessel in the brain or a weak heart valve or may be susceptible to arrhythmia. There is not, it adds, a simple test for those things. Between June 1, 1997, and March 31, 1999, the article continues, the FDA got close to 150 complaints about ephedra compounds. Just over 40 of the incidents reported, it adds, could be linked directly to the supplement. Elevated blood pressure, heart palpitations and rapid heartbeat affected 18 people, it says, while strokes hit four, heart attacks struck two, seizure affected one -- and three people died. Industry executives note, the article says, that millions of people used to supplement during the FDA study period – and just 140 complained about it. But, the article notes, critics counter that studies show that people taking supplements are less likely to attribute unpleasant side effects to them than they are to prescription drugs. Source - Los Angeles Times

Legal Counsel for Vaccine Damaged Children - Monday, January 28, 2002 by newsmanager

The USA Today on October 12, 2001 brought us the latest on Afghanistan and a primer of bacillus anthracis along with a 27 column inch advertisement making the services of the law firm of Williams Bailey of Houston, Texas, known to anyone who needs help with legal action involving adverse vaccine incidents. The ad itself and its subject matter were quite stunning--not from a graphics sense, but from a content and a what-does-this-mean sense. For a firm to place ads with costs in the category of the USA Today’s means there is a significant pool of exposed and affected persons who desire to have their problems addressed. This was way more than an ad; it was a sign of a new era for vaccine-related legal actions in the United States. You can learn more about the Williams Bailey Law Firm, LLP at www.vaccineinjury.org or by calling 888.709.6674

Public-Interest Groups Call on Bayer to Support FDA Ban on Antibiotic Used in Poultry Production - Monday, January 28, 2002 by garyfarr

Measure Will Protect Human Health by Slowing Development of Diseases That Resist Treatment With Antibiotics WASHINGTON - Health, consumer, and other public-interest groups joined together today in applauding the Food and Drug Administration’s (FDA) proposed ban on the use of a valuable antibiotic to treat poultry, in light of recent sharp increases in resistance to that antibiotic in humans. The groups also sent a letter to the sole remaining manufacturer, Bayer, asking the company to consent to FDA’s ban on enrofloxacin (Baytril). FDA’s proposal is based on new evidence that this product increases the danger that humans will become infected with germs that are resistant to treatment. Bayer has 30 days to decide whether to consent to FDA’s proposed ban or to request a formal hearing on the proposed ban — a process that could take many months or even years. Enrofloxacin is in a class of antibiotics called fluoroquinolones, which is one of the last new “miracle drugs,” and is the treatment of choice for some human intestinal illnesses, most particularly food poisoning caused by Campylobacter bacteria. Campylobacter is the most common cause of foodborne illness in the U.S. Fluoroquinolones are also used to treat other illnesses, including urinary tract infections, bone and joint infections, and some types of pneumonia. Physicians have used fluoroquinolones as an essential treatment for foodborne disease since 1986. Very little resistance occurred until its use in poultry began in 1995. By 1998, the Centers for Disease Control found that over 13% of foodborne Campylobacter were resistant to fluoroquinolones. Last year resistance rose to nearly 18%. Abbott Laboratories had also marketed a fluoroquinolone for use in poultry, but following a recent request from the FDA, the drug company agreed to comply with the ban voluntarily. The public-interest groups applauded Abbott for voluntarily consenting to the ban, and called on Bayer to follow Abbott’s leadership in protecting the public health. “Bayer should show it truly cares more about the public’s health than profits by agreeing to the FDA’s proposed ban,” said Richard Wood, Executive Director of Food Animals Concerns Trust, an organization which has long addressed problems related to fluoroquinolone use in poultry. “The problem of inappropriate use of antibiotics in agriculture extends beyond the use of fluoroquinolones to prevent illness in poultry,” said Dr. Rebecca Goldburg, Senior Scientist with Environmental Defense. “FDA also needs to prohibit the feeding of antibiotics to healthy animals to make them grow slightly faster and to compensate for unsanitary growing conditions. That practice accounts for an estimated one-third of all antibiotics now used in the United States,” she stated. Groups supporting FDA’s action and calling for the Bayer withdrawal include: American Public Health Association, Sarah Lister, (202) 777-2513 Center for Science in the Public Interest, Michael Jacobson, (202) 332-9110 Delmarva Poultry Justice Alliance, The Rev. Jim Lewis, (302) 537-5318 Environmental Defense, Karen Florini, (202) 387-3500 Food Animal Concerns Trust, Richard Wood, (312) 860-3930 Global Resources Action Center for the Environment, Alice Slater, (212) 726-9161 Institute for Agriculture and Trade Policy, David Wallinga, (612) 870-3418 National Catholic Rural Life Conference, Brother David Andrews, (515) 270-2634 Physicians for Social Responsibility, Sharon Newsome, (202) 898-0150, ext. 230 Union of Concerned Scientists, Margaret Mellon, (202) 223-6133

EPA bans pesticide Dursban - Monday, January 28, 2002 by garyfarr

The popular pesticide Dursban and hundreds of other products containing the insect-killer chlorpyrifos will be phased out for home and garden use under an agreement between manufacturers and the Environmental Protection Agency announced. Citing possible health risks to children for the decision, EPA Administrator Carol Browner said safer insect-killing alternatives are available. Chlorpyrifos is found in everything from pet flea collars to garden and lawn chemicals and indoor bug sprays. It also is used widely in agriculture to protect fruits, vegetables and grains from insects. CNN, June 8, 2000

Stigmatizing “ADHD” And Stimulant Drugs Ousts Recruits From Armed Services - Monday, January 28, 2002 by newsmanager

Few parents are warned that children labeled with Attention Deficit Hyperactivity Disorder (ADHD) for which they are customarily prescribed dangerous, potentially addictive drugs, can later be disqualified from joining the armed forces to protect their country. The problem could worsen because of recently released guidelines from the American Academy of Pediatrics (AAP) that endorse the psychiatric-invented condition and the cocaine-like drugs prescribed for it. In the light of the recent terrorist attacks on America, consider that in 1998, the U.S. military discharged more than 3,100 recruits with psychiatric histories. Discharges ranged from recruits with lengthy psychiatric treatment to those who had been diagnosed with ADHD. The drugs prescribed for ADHD are amphetamine-like stimulants. Other psychiatric drugs prescribed children include tranquilizers, antidepressants and, less frequently, amphetamines and barbiturates. The most serious problem is the potentially volatile mix of people labeled and drugged with deadly weapons. While on a comparatively minor scale to the terrorist attacks on New York and Washington, in recent years, six teenage shooting sprees linked to psychiatric drugs have led to 19 deaths and 51 wounded. This included 14-year-old Kip Kinkel who killed two and wounded 22 others at his Springfield, Oregon high school, and Eric Harris’s killing rampage at Columbine High School, leaving 13 dead and 23 injured. Both boys were taking prescribed stimulants or antidepressants. Ms. Jan Eastgate, International President of the psychiatric watchdog group, The Citizens Commission on Human Rights®, (CCHR®) said, “The country’s future security is potentially being minimized because of a diagnosis that has absolutely no scientific proof to substantiate it and because of drugs that are known to induce violent rages, suicidal behavior and have even been implicated in terrorist training.” At least 250,000 children worldwide, some as young as seven, have been used by revolutionaries and terrorists for armed combat and in some cases have been trained to kill using psychiatric drugs and cocaine. According to a UNICEF report, many children have been given amphetamines and tranquilizers to enable them to “go on murderous binges for days.” In 1999, Human Rights Watch reported that under the influence of drugs, “child combatants armed with pistols, rifles and machetes actively participated in killings and massacres, [and] severed the arms of other children….” Group spokesperson, Corinne Dufka, said, “It seemed to be a very organized strategy of getting the kids, drugging them up, breaking down their defense and memory, and turning them into fighting machines that didn’t have a sense of empathy and feeling for the civilian population.” Locally, stimulants prescribed for ADHD are like amphetamines and, according to a recent study published in the Journal of the American Medical Association, are more potent than cocaine. The AAP guidelines, influenced by psychiatric, psychological and pharmacological interests, say that stimulants reduce the “core symptoms of ADHD.” Eastgate says, “Hitting a child over the head with a two by four would also reduce his fidgeting, squirming, talking excessively or losing his pencils—all symptoms of ‘ADHD.’ Just because a drug alters behavior doesn’t prove the existence of a disease or that the drug ‘works.’” Beverly Eakman, author of Cloning of the American Mind, says, “These drugs make children more manageable, not necessarily better. ADHD is a phenomenon, not a ‘brain disease.’ Because the diagnosis of ADHD is fraudulent, it doesn’t matter whether a drug ‘works.’ Children are being forced to take a drug that is stronger than cocaine for a disease that is yet to be proven.” Pediatric neurologist Fred Baughman, says, “Virtually all professionals of the extended ADHD 'industry' convey to parents and to the public that ADHD is a 'disease' and that, as such, children are 'abnormal.' This is a perversion of the scientific record and a violation of the informed consent rights of all patients, especially parents.” Critics say that the AAP guidelines give credence to a list of behaviors that in 1987 were literally voted into existence as a “mental disorder” by a show of hands at an American Psychiatric Association Committee. Within a year, 500,000 American children were suddenly stricken with this newly invented “disease.” Today, that figure has reached 6 million, with more than $15 billion spent annually on the diagnosis, treatment and study of childhood psychiatric "disorders." “ADHD is a for-profit disorder at the expense of children’s lives and, it now seems, the expense of our armed services,” Eastgate said. CCHR was established by the Church of Scientology in 1969 to investigate and expose psychiatric human rights violations and to restore rights to the field of mental health. For more information contact CCHR FL @ 800-782-2878 or visit CCHR’s websites www.psychassault.org or www.cchr.org.

Arthritis Drug Recalled - Monday, January 28, 2002 by garyfarr

Oct. 9, 2000 (Ivanhoe Newswire) -- A voluntary recall of a drug called etodolac (lodine) is underway. Etolodac is a generic drug used for arthritis and pain management. Officials from the drug manufacturer ESI Lederle say 4.2 million capsules of etodolac may be contaminated with acebutolol hydrochloride, a drug used for high blood pressure and certain heart problems. In rare cases, this may cause serious or life-threatening side effects in patients with heart conditions. The product was first distributed in October 1999. Consumers can identify this product as a white capsule marked in red with "300" on one end and "59911" over "3607" on the other end. Patients should stop taking these capsules and contact their pharmacist or health care provider. Patients who previously stopped taking etodolac and have not experienced any side effects should not be concerned. Health care providers who need additional information about this recall should contact (800) 747-7016. Patients should contact their own physician and call ESI Lederle to return the 300mg capsules at the same number as above. ESI Lederle says all health care providers and pharmacists are being informed of this recall.

FDA WARNING: Phenylpropanolamine (PPA) Can Cause Stroke - Monday, January 28, 2002 by garyfarr

An FDA requested study has reported an unusually high incidence of stroke (bleeding into the brain or into tissue surrounding the brain) among young women taking phenylpropanolamine (PPA), a drug used in a number of applications including diet pills and decongestants. Men may also be at risk. "Although the risk of hemorrhagic stroke is very low, FDA recommends that consumers not use any products that contain phenylpropanolamine. Strokes usually occur in the first few weeks of taking the drug. There is probably a greater risk associated with phenylpropanolamine in a diet pill than in a nasal decongestant, but this is not clearly established at this time. What is established is that you can reduce stroke in young women by avoiding this medication. Phenylpropanolamine is used to relieve nasal congestion due to colds, hay fever, upper respiratory allergies, and sinusitis. It is available in nonprescription products alone (Propagest™, Rhindecon™, and others) and in combination with other nonprescription drugs, to treat symptoms of allergy, colds, and upper respiratory infections. PPA is also used as a diet pill alone (Acutrim™, Dexatrim™, Dexa-Diet™, Unitrol™ , and others) and in combination with other ingredients for weight loss. Other over-the-counter preparations include Dimetapp™, DayQuil™ Allergy Relief™, and others) Phenylpropanolamine/chlorpheniramine (Contac™ 12 Hour, Triaminic™-12, and others), Phenylpropanolamine/clemastine (Tavist™ D) Phenylpropanolamine/guaifenesin (Entex™ LA and others.) Phenylpropanolamine /guaifenesin/dextromethorphan (Robitussin™ CF and others). So what's the alternative? Well Standard Process has a variety of supplements for handling the sniffles, sinus problems, sinusitis and upper respiratory infections. These include: Allerplex™, Antronex, Catalyn (Cyroplex)®, Cataplex® C, Chlorophyll Complex, Echinacea-C, Emphaplex ®, Immuplex ®, Iplex ®, Lact-Enz ®, Spanish Black Radish, Spleen, Desiccated, and Thymex.

Alcohol and Tylenol - DON'T MIX! - Monday, January 28, 2002 by garyfarr

"A former White House aide who claims that ordinary doses of Tylenol destroyed his liver has been awarded more than $8.8 million in a federal court suit against the manufacturer of the popular pain-reliever. "I had the flu and then I wake up with my liver gone," Antonio Benedi said. "They ruined my life." The drug's manufacturer, McNeil Consumers Products Co., denied that Tylenol had any thing to do with Benedi's liver disorder and said it would appeal Thursday's decision by a federal court jury in suburban Alexandria, Va. Benedi, 39, a former special assistant to President Bush claimed in the suit that his liver had been "sensitized" to react to Tylenol by his habit of drinking wine with dinner every day. When he took the drug for several days to combat the flu, he lapsed into a coma and was hospitalized. Patrick A. Malone, Benedi's attorney, said McNeil Consumer Products knew of the danger of mixing the habitual use of alcohol with the pain reliever but has taken no action to warn the public. Bob Kniffin, a spokesman for Johnson & Johnson, the parent company of McNeil, said the verdict would be appealed. He said the company believed a virus destroyed Benedi's liver and that Tylenol played no role. After hearing four days of testimony in U.S. District Court, a six- member jury awarded Benedi $7.8 million in compensatory damages and $1 million in punitive damages. When Bush left the White House in January 1993 Benedi was offered an executive position with a private firm. "The week before I got sick, I was preparing to join a company as vice president," he said. "After I got out of the hospital, they wouldn't even talk to me." Benedi said his medical bills have topped $325,000 and that for the rest of his life he will take anti-rejection drugs and other medications that cost about $2,000 monthly. Malone, Benedi's lawyer, said his client, who had a liver transplant, is losing his kidneys due to the anti-rejection drugs and that he eventually will have to start kidney dialysis. During the trial, Malone presented testimony from experts who claimed that ordinary doses of Tylenol can cause a toxic reaction in the liver of someone who regularly drinks alcohol. Malone said data from McNeil's own files indicates that the company was aware of the danger but continued to adver tise heavily that "doctor recommended" Tylenol was completely safe. Kniffin said Tylenol has a 30 year record of safety. He said the company has no record of any person ever experiencing liver damage from the combination of moderate drinking and the recommended doses of Tylenol. All cases connecting alcohol and Tylenol with liver damage have involved patients who were alcoholics or who took an over dose of Tylenol, or a combination of both, Kniffin said. The spokesman said the company does not believe Benedi abused either alcohol or Tylenol but that his liver was destroyed by a form of the herpes virus. Malone, however, said laboratory tests show no evidence of virus in Benedi's failed liver. There were signs, he said, of poisoning by acetaminophen, the primary ingredient in Tylenol. A Food and Drug Administration advisory panel recommended last year that Tylenol and several other types of over the-counter pain relievers carry alcohol warning labels. Some Tylenol products do carry the warning label now, but not the Extra Strength Tylenol that Benedi used."

Aplastic Anemia Linked To Prozac - Monday, January 28, 2002 by garyfarr

A 28-year-old Spanish man who had been taking fluoxetine (Prozac) for obsessive-compulsive disorder developed aplastic anemia -- a disease that impairs the ability of bone marrow to generate blood cells . Aplastic anemia is known to be caused by radiation, some chemicals and some drugs, but the man's physicians believe this is the first case related to the use of Prozac. The symptoms of aplastic anemia stem from low levels of blood cells. The disorder leads to decreased amounts of red blood cells, resulting in anemia, decreased amounts of white blood cells, leading to an increased risk of infection, and falling platelet counts, which lead to impaired clotting. About 10% to 25% of patients taking Prozac experience "nausea, nervousness, insomnia, headache, tremor, dry mouth, sweating, and diarrhea. The Lancet April 4, 1998;351:1031

Lollipop Wrappers May Be Tainted With Lead - Monday, January 28, 2002 by garyfarr

NEW YORK (Reuters Health) - 04/27/01 - Fears of potential lead contamination of 'Bolirindo' brand tamarind candy lollipops have prompted the Food and Drug Administration (FDA) to advise consumers against purchasing or eating the candies. "Anyone who suspects they or their child may have consumed these lollipops may want to consult their doctor about having their lead level checked," the FDA warned in a statement. The soft dark-brown tamarind fruit candy lollipops were analyzed by the California Department of Health Services and the FDA after they were linked to three cases of elevated levels of lead in 2-year-old children. The analysis is ongoing, but preliminary results suggest that the outside of the wrapper may have "extremely high concentrations of lead," according to the food safety experts. High levels of lead in the body can cause damage to the brain and central nervous system, reduced growth, hyperactivity and learning problems in children. Consumers should not eat the lollipops, the food safety experts urge. They should also keep the candy out of the hands of children, to avoid dangers arising from the children eating or chewing on the wrappers. The Dulmex brand candies are labeled "BOLIRINDO" and are wrapped in orange-red wrappers with white or orange lollipop sticks.

FDA Says Clinical Trials Skip Race, Age And Gender - Monday, January 28, 2002 by garyfarr

Friday February 16 5:33 PM ET WASHINGTON (Reuters Health) - Despite a law requiring them to do so, drug and biotechnology companies either do not know, or are not fully reporting the gender, racial and age make-up of subjects in their clinical trials to the Food and Drug Administration (news - web sites) (FDA), researchers at the federal agency said Friday. In 1998, the FDA issued a rule requiring companies to tabulate age, race and gender of subjects enrolled in trials and to submit the tally to the FDA in annual investigational new drug (IND) reports. The goal was to gauge participation of minorities and women in clinical trials. The IND reports are a first look at the early phases of a company's trial, and may be the best place to intervene to ensure gender, age and racial balance, said Brenda Evelyn, lead author of the FDA study and a public health specialist in the Office of Special Health Issues at the FDA. In the study, the FDA researchers looked at IND reports submitted to the agency five months after the rule went into effect--from January 1999 to March 1999. In a sampling of 485 reports representing 1,601 trials, only 15% of the studies had all three elements--race, gender, and age--tabulated, said Evelyn. Race could only be determined for 35% of the total 189,453 trial participants, and gender for only 44% of the enrollees. In many cases, the companies just indicated the percentage of whites participating, and did not mention any other race. Despite what seemed to be huge reporting gaps, Evelyn said the study had many limitations. For instance, she said, in these IND reports, submitted just five months after the final rule, companies may not have had time to adjust to the requirements. Seventeen percent of the companies that submitted IND reports had not begun enrolling patients yet, so would not have data on age, sex or race. She also said that the companies probably did have the information available, but might have been lazy about reporting it at such an early stage. Even if the data is eventually tabulated, the agency is hoping to ensure it gets done earlier. ``We do know we need to monitor it more,'' said Evelyn, noting that her office will encourage FDA's drug and biotechnology review divisions to take a closer look at age, race and gender tabulation in IND reports. The agency can take action to enforce the 1998 rule, but with so many competing priorities and limited resources, it's not clear the FDA will go after companies, she said.

Antibiotic Resistance - Monday, January 28, 2002 by garyfarr

The development of antibiotics in the 20th century revolutionized medical treatment of deadly infections. But the widespread use of antibiotics has now allowed certain common types of disease-causing bacteria to develop resistance to the medications that once controlled them. In the United States and other parts of the world, the problem of antibiotic-resistant bacteria has become quite serious and affects nearly every community. For a full-featured article regarding antibiotics go here. The Uncommon Cold As the accompanying article explains, it's counterproductive to take antibiotics for simple upper respiratory illnesses, which are generally caused by viruses, not bacteria. Sometimes, however, a common cold can turn bad and lead to a bacterial infection that does require antibiotic treatment. The most common problem in children is otitis media — infection of the middle ear. In adults, the main complication is sinusitis; pneumonia is less common but even more important. The most serious problem concerns the bacteria Streptococcus pneumoniae, or pneumococcus, which causes many common diseases, including middle-ear infections in children (otitis media), sinusitis, pneumonia, and meningitis. Penicillin and its relatives, such as amoxicillin, are still considered the best weapons against pneumococcal infection, but that may not last if current trends continue. In some communities, fully 25 percent of pneumococcus strains are penicillin-resistant. When other antibiotics are used, pneumococcus sometimes becomes resistant to them, too. In one recent study, Canadian scientists reported that pneumococcus was showing signs of resistance to a relatively new class of antibiotics called fluoroquinolones. "Although new antibiotics are in development, it's a race to keep ahead of the bacteria," concedes John G. Bartlett, M.D., chief of the Division of Infectious Diseases in The Johns Hopkins University School of Medicine. "And some bacteria appear to be gaining on us, or even overtaking us." Right now, hospitals are trying to control vancomycin-resistant enterococcus, a strain of bacteria that's become resistant to all available antibiotics. But even with pharmaceutical companies working overtime, infectious-disease specialists believe that only a finite number of possible antibiotics can be developed. When those have all been exhausted, the bacteria will have won, and common diseases will be untreatable. Contrary to popular belief, Dr. Bartlett points out, antibiotic resistance is not something that occurs only in developing nations or other remote places. In fact, some of the worst resistance problems are seen in the best neighborhoods. More-affluent communities, where there's often better access to health care, may have higher levels of resistance than poorer neighborhoods, where minor illnesses are more likely to be left to run their course without antibiotic treatment. Once bacteria become resistant, that resistance can gain momentum through direct contact with infected people. For that reason, antibiotic resistance is a particular problem in daycare centers, hospitals, and chronic care facilities, where people with high rates of antibiotic use are clustered together. The drugs apply pressure that promotes survival of only the resistant strains of bacteria, which then get passed on to other people. Studies have shown that if one member of a family takes antibiotics for a chronic problem, such as acne, resistant forms of bacteria will appear on the skin of other family members. Reversing Resistance How Bugs Turn Bad From the bacteria's perspective, developing resistance in response to a threat is a matter of life or death. And bacteria have become very efficient in the way they deal with the threat posed by antibiotics. In order to function, antibiotics must first pass through the bacterium's cell wall. Some bacteria have developed a way to pump the antibiotics back out before they can have any effect. Other bacteria make enzymes that either inactivate or degrade antibiotics, which renders them useless. There are three main ways bacteria can become resistant to antibiotics: Random mutation. Every once in a while, a bacterium is "born" with natural resistance genetically coded purely by accident. Inheritance. Resistant bacteria will multiply, and the new bacteria will carry that genetic code, as well. Sharing between bugs. Bacteria freely share genetic information, usually by transferring small rings of DNA called plasmids from one bacterium to another. Bacteria that had previously been nonresistant can then incorporate the code from other bugs and become resistant themselves. "Many people have come to think of antibiotics as a magical cure for nearly any infection," says Dr. Bartlett, "and they feel deprived if the medications aren't prescribed. Physicians have sometimes perpetuated that notion by writing prescriptions when it wasn't clear that antibiotics were needed, or even prophylactically as protection against possible infection." According to the Centers for Disease Control and Prevention, approximately 50 million unnecessary antibiotic prescriptions are written each year. This type of overuse and abuse of antibiotics contributed to the current medical crisis. Continued misuse will create a continuing and escalating problem. A possible solution is to use antibiotics appropriately and judiciously. This will help put the brakes on the resistance and allow some of the resistant organisms to regain their lost sensitivity. Such resensitization was demonstrated recently in Finland, where a national campaign to quit using erythromycin for five years has allowed the bacterium that causes strep throat to become completely sensitive to that antibiotic again. Everyone needs to cooperate and follow the same set of rules if we are to eliminate antibiotic resistance. Here's what you can do: Use natural remedies in place of drugs. If your immune system is weak, taking antibiotics further weakens the immune system. Products such as Immuplex, Congaplex, and Antronex, work very well in controlling the majority of viral and infectious bugs. Avoid using antibiotics for common respiratory tract infections. Antibiotics are useless against the common cold, which is a viral infection, and are not needed for many cases of sinusitis or almost all cases of acute bronchitis. Those illnesses will resolve on their own with time. Bacterial pneumonia, however, requires antibiotics. Make sure it's strep. The main kind of sore throat that's helped by antibiotics is strep throat. Doctors should test for strep bacteria before prescribing a course of antibiotics. Don't pressure your doctor for a prescription. Many patients are used to asking for and receiving antibiotics, especially if they believe the medications cured them of a similar illness in the past. Doctors should prescribe antibiotics only for conditions known to benefit from the drugs. Keep sick children out of daycare. Any child receiving antibiotic treatment for an infection, including otitis media, should stay home. Bringing the child to daycare will perpetuate the infection and resistance as well. If you must take antibiotics, follow directions exactly. That means taking all the medication, even if you start to feel better. And don't skip doses. Avoid antibacterial soaps and cleaners. For surfaces, use bleach, alcohol, ammonia, or hydrogen peroxide, which kill bacteria without promoting resistance.

Planned Latin American drug study called unethical - Monday, January 28, 2002 by garyfarr

WASHINGTON (AP) — A consumer group urged the Bush administration Thursday to stop a U.S. company from giving premature babies in Latin America a placebo instead of proven lung therapy in its quest to test an experimental drug. The planned study is "unethical and exploitive," and will result in the preventable deaths of at least a dozen infants suffering respiratory distress syndrome, said Dr. Peter Lurie of the consumer advocacy group Public Citizen. The complaint comes as scientists worldwide debate if it's ever ethical to compare experimental drugs to placebos, or dummy therapy, when a proven but competing treatment exists. It's a particularly tough issue when U.S. scientists experiment in poor countries that can't afford existing therapy, prompting questions of why a placebo there would be a problem — or if rich countries are obligated to provide expensive treatments in return for doing research. Respiratory distress syndrome, or RDS, often strikes premature infants' underdeveloped lungs. Several competing drugs called surfactants today are sprayed into those babies' lungs, reducing RDS deaths by 34%. Pennsylvania-based Discovery Laboratories has created a new synthetic version called Surfaxin that it contends may be a better alternative to top-selling surfactants made from cow or pig cells. Internal Food and Drug Administration documents say comparing Surfaxin to a placebo in U.S. babies with RDS would be unethical, but that the agency is considering whether to approve a placebo-controlled study in parts of Mexico, Bolivia, Peru and Ecuador. "The researchers have hit upon the idea of experimenting on the poorest of the poor," Lurie wrote Health and Human Services Secretary Tommy Thompson Thursday, urging him to stop the plans. But Discovery Labs chief executive Robert Capetola vigorously defended the planned study: "It's unethical not to do it." The participating Latin American hospitals cannot afford today's $2,200 surfactant treatment, so their preemies get nothing but ventilator care. The proposed study would give hundreds of infants either Surfaxin, the proven competitor Survanta or the "placebo" of standard supportive care. Capetola said cutting out that third comparison would cost an extra year in telling whether Surfaxin works and then selling it for needy babies — and he pledged to sell Surfaxin at a reduced cost in Latin America. He added that speed also is important because other cow-derived surfactants raise fear of mad cow disease, something the FDA strongly disputes. In Europe, Surfaxin already is being studied in comparison to a proven competitor, and there shouldn't be lower standards for the Latin American study, Public Citizen said. FDA drug chief Dr. Janet Woodcock said the agency hasn't decided if the proposed study is ethical, but is carefully debating the question. Thompson spokesman Bill Hall said the HHS secretary won't interfere in the agency's decision.

Do Vaccines Cause Autism? IOM to Investigate - Monday, January 28, 2002 by garyfarr

Experts Warn Public Pressure May Pose Stumbling Block By Ori Twersky WebMD Washington Correspondent Reviewed by Jacqueline Brooks, MBBCh, MRCPsych Jan. 10, 2001 (Washington) -- The controversies surrounding vaccines and their possible side effects continue to rage, but none as heatedly as the MMR-autism debate, one in which parents of autistic children have a huge stake. Though no evidence has established a clear link between autism and vaccinations, the notion has gained broad support in the past 3 years, thanks in large part to a handful of researchers. These researchers allegedly have documented a time-based association between the onset of autism and the administration of the MMR vaccine. For that reason, Congress has ordered the Institute of Medicine to investigate the alleged link. Meeting this Thursday, the IOM is charged with the task of looking for a causal link between childhood vaccinations and autism, as well as the likelihood of an alternative hypothesis. The IOM then will advise U.S. health authorities on what course of action they should take in terms of recommending childhood vaccinations. The current U.S. policy is to encourage timely immunizations. As a result, state authorities generally ban children from attending public schools unless they have been immunized, further adding fuel to the fire. Some states also charge parents with child neglect, even abuse, if they fail to have their children immunized. The diagnosis of autism often occurs around age 2, when the MMR vaccine is administered. And supporters of the alleged link point to an apparent increase in the incidence of autism since the introduction of the MMR vaccine. These time-based associations have spurred some researchers to look for a possible link. Chief among those is British researcher Andrew Wakefield, MD, an expert in bowel diseases at the Royal Free Hospital School of Medicine in London. In 1998, Wakefield sparked the debate by publishing a paper outlining the association and postulating that the MMR vaccine may trigger autism by causing bowel damage. A damaged bowel would fail to properly filter dietary products in the gut and, in effect, allow toxic materials to be distributed in the brain, Wakefield explained. Since then, Wakefield's theory has inspired other researchers to pursue research investigating the link between MMR and autism. Among those researchers is Vijendra Singh, PhD, a research professor at Utah State University, in Logan. "Based upon my research, there is a good possibility that the MMR vaccine might be the culprit," Singh tells WebMD. His research shows that up to 80% of autistic children have antibodies triggered by the measles virus that also appear to attack a particular protein in the brain, Singh explains. Therefore, it is conceivable that the MMR vaccine may be responsible because it exposes the child to the virus, Singh says. It is also conceivable that those children with bowel damage would be more susceptible because their brains would be exposed to a higher level of that virus, he adds. "I cannot conclusively say that I have found a fundamental cause," Singh tells WebMD. "But this is good science. It should not be ignored." Still, the majority of experts disagree. They say the time-based association is coincidental and that autism is a genetic disease triggered by some other environmental factor during the first trimester of pregnancy. In fact, there is absolute proof that the MMR vaccine is not a cause of autism, says Paul Offit, MD, a pediatrician and chief of infectious disease at the University of Pennsylvania School of Medicine. The incidence of autism is really no greater whether or not children receive the vaccine, he explains. And although the diagnosis is often made around age 2, trained experts frequently can identify autistic children at a much earlier age, he adds. As for the increase in the number of reported cases, Offit points out that the U.S. and the United Kingdom recently adopted a broader definition of autism that seems to be capturing a larger number of cases. And as for Wakefield's bowel theory, Offit points out that Wakefield failed to look at children who were vaccinated without developing autism -- although those children often exhibit the same bowel symptoms. Despite being confident that the MMR vaccine does not trigger autism, Offit and his peers are concerned about the scheduled IOM review. "This is not a sound scientific process," Offit tells WebMD. "What bothers me is that this process tends to be political." The possible connection between the MMR vaccine and autism has generated a lot of political attention. It also has managed to capture the attention of at least one powerful Republican in Congress, Rep. Dan Burton of Indiana, whose grandson is autistic. Burton, who chairs the powerful House Government Reform Committee, is believed to be the root-cause of this IOM review. In April, Burton hosted an emotionally charged Congressional hearing, during which he stated his belief that there is a link between the MMR vaccine and autism. Offit now fears that Burton and his supporters will use the IOM review to discourage parents from having their children immunized. "It's sad to see so much time being spent on offering parents an explanation that is so clearly wrong," Offit says. The impact of an autism-vaccine scare could be tragic, according to experts at the CDC. Thanks in large part to the measles vaccine, the number of reported cases of measles has now dropped from more than 27,000 a year to about 100 in just one decade, according to the agency. In 1999, the agency adds, there were no reported measles-related deaths compared to about 64 deaths in 1990. The IOM committee charged with looking into the alleged connection will meet three times this year, and over the course of the next 3 years, the group will attempt to address eight other vaccine-related safety concerns. The CDC and NIH will jointly fund the entire project. "The intent is to have a mechanism by which we can get a fast read by a panel of credible and nongovernment people to look at the issues," Martin Myers, MD, a director