Sheng Cycle

There is a new controversy on whether or not to vaccinate young girls for cervical cancer — Is the drug effective and is it actually safe?

“Harper: Controversial Drug Will Do Little To Reduce Cervical Cancer Rates”

Dr. Diane Harper, lead researcher in the development of two human papilloma virus vaccines, Gardasil and Cervarix, said the controversial drugs will do little to reduce cervical cancer rates and, even though they’re being recommended for girls as young as nine, there have been no efficacy trials in children under the age of 15. Dr. Harper, director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, made these remarks during an address at the 4th International Public Conference on Vaccination which took place in Reston, Virginia on Oct. 2-4.

Dr. Harper gave these interesting statistics on HPV.

Dr. Harper began her remarks by explaining that 70 percent of all HPV infections resolve themselves without treatment within a year. Within two years, the number climbs to 90 percent. Of the remaining 10 percent of HPV infections, only half will develop into cervical cancer, which leaves little need for the vaccine.

She told the meeting, “even if we get the vaccine and continue PAP screening, we will not lower the rate of cervical cancer in the US.”

Dr. Harper, who also serves as a consultant to the World Health Organization, further undercut the case for mass vaccination by saying that “four out of five women with cervical cancer are in developing countries.”

Merck, the manufacturer of Gardasil, studied only a small group of girls under 16 who had been vaccinated, but did not follow them long enough to conclude sufficient presence of effective HPV antibodies.

In the reported absence of hard science about vaccinating girls as young as 11 in mandated drives, there appears to be reported side effects.

Since the drug’s introduction in 2006, the public has been learning many of these facts the hard way. To date, 15,037 girls have officially reported adverse side effects from Gardasil to the Vaccine Adverse Event Reporting System (VAERS). These adverse reactions include Guilliane Barre, lupus, seizures, paralysis, blood clots, brain inflammation and many others. The CDC acknowledges that there have been 44 reported deaths.

To put that into perspective:

The outspoken researcher also weighed in last month on a report published in the Journal of the American Medical Association that raised questions about the safety of the vaccine, saying bluntly: “The rate of serious adverse events is greater than the incidence rate of cervical cancer.”

Source: http://thebulletin.us/articles/2009/10/25/top_stories/doc4ae4b76d07e16766677720.txt

Authorities in the German states of Hesse and North-Rhine Westphalia have ordered retailers to stop selling Red Bull Cola after they found traces of cocaine in the fizzy drink. The consumer ministries in the two states confirmed on Friday they had ordered retailers to pull the drink off their shelves after a food safety institute in North-Rhine Westphalia found cocaine in samples of the beverage.

“The institute examined Red Bull Cola in an elaborate chemical process and found traces of cocaine,” Bernhard Kühnle, head of the food safety department at the federal ministry for consumer protection said.

Authorities said the cocaine levels do not pose a health threat but are not permitted in foodstuffs.

The Frankfurter Neuen Presse reported that the investigation was prompted by the use of a de-cocainized extract of coca leaf in the drink. That means the drink cannot be classified as a foodstuff but as a narcotic and needs a special license, authorities said.

The newspaper reported that German retail group Rewe had already issued orders to remove the fizzy drink from its shops. Wilhelm Deitermann, spokesman for the North-Rhine Westphalia consumer ministry said he expected other German states to follow suit and ban the drink.

But Red Bull Cola has protested the action. “De-cocainized extract of coca leaf is used worldwide in foods as a natural flavouring,” the paper quoted the company saying. The company added that Red Bull Cola as well as other food that contains coca leaf extract is considered safe in the EU as well as in the US.

The more popular Red Bull, dubbed the “clubbers’ drink,” is often mixed with vodka. It contains caffeine, vitamins, and sugar which, the company claims, kick-starts the body’s metabolism and keeps people alert.

A new study reveals that as many as 1/2 of all medical doctors give their patients a placebo without the knowledge or consent.

About half of American doctors in a new survey say they regularly give patients placebo treatments — usually drugs or vitamins that won’t really help their condition. And many of these doctors are not honest with their patients about what they are doing, the survey found.

That contradicts advice from the American Medical Association, which recommends doctors use treatments with the full knowledge of their patients.

“It’s a disturbing finding,” said Franklin G. Miller, director of the research ethics program at the U.S. National Institutes Health and one of the study authors. “There is an element of deception here which is contrary to the principle of informed consent.”

The study was being published online in Friday’s issue of BMJ, formerly the British Medical Journal.

Insurance companies are unwittingly paying for treatment which is a sham.

Half the doctors reported using placebos several times a month, nearly 70 percent of those described the treatment to their patients as “a potentially beneficial medicine not typically used for your condition.” Only 5 percent of doctors explicitly called it a placebo treatment.

Most doctors used actual medicines as a placebo treatment: 41 percent used painkillers, 38 percent used vitamins, 13 percent used antibiotics, 13 percent used sedatives, 3 percent used saline injections, and 2 percent used sugar pills.

Results from three studies of the cholesterol-lowering drug Vytorin are not enough to prove or rule out a possible link to a higher risk of cancer, so the drug should be used with great caution until more is known, editors of a leading medical journal urged Tuesday.

Vytorin - for the reduction of elevated total-C and LDL-C in patients with high cholesterol.

The New England Journal of Medicine published results of the studies, which also were presented at a cardiology conference in Munich.

Vytorin is a combination of Merck’s Zocor, a long-sold statin drug, and Schering-Plough’s Zetia, a newer type of medicine that lowers cholesterol in a different way.

The possible cancer risk unexpectedly arose in July, when Dr. Terje Pedersen of Oslo, Norway, announced preliminary results from a study testing whether Vytorin could prevent damage to the heart’s aortic valve from worsening.

In the trial, called SEAS, 4.1% of patients taking Vytorin died of some form of cancer — more than the 2.5% of patients who received an inactive placebo.

“While other clinical trial data do not indicate an increase in cancer risk, the FDA is alerting doctors and patients now while it awaits further data from the manufacturers, which they should receive in about three months. After that point, the FDA says it’ll take an additional six months for a complete evaluation of the data.”

It was reported earlier in 2008 a Vytorin clinical trial showed that Vytorin did not reduce artery-clogging plaque better than Zocor alone.

The U.S. Agency for Healthcare Research and Quality reported this week that cholesterol lowering drugs called statins rose by 156 percent between 2000 and 2005. Spending on these stating drugs by US patients jumped from $7.7 billion to $19.7 billion.

However, there is no proof or research to prove that these drugs actually reduce the likelihood of heart attack or stroke. They simply lower a patient’s high cholesterol causing a large number of side effects on skeletal muscle and the liver.

So, what is the point of taking Statins?

The 2006 mumps outbreak in the US has affected also those who got the second booster shot, introduced in 1990. This came as a surprise for many experts, as it was widely believed that the second shot would boost immunity to a high level and for a longer period of time.

The virus is spread by coughing and sneezing and it was nearly eradicated in the U.S. after Merck & Co. released its MumpsVax vaccine in 1967. The current infection rate is about 2.2 people of every 100,000.

MUMPS: The virus, which causes fever and inflamed salivary glands under the jaw and in the cheeks, primarily infected college students in the Midwest who had received the vaccine as children. It was the first time the virus spread among people who followed the recommended two-shot vaccination regimen, showing protection may decline with time, the CDC said.

In the 2006 outbreak, nearly 7,000 got the mumps, most of them in the Midwest and mostly college students ages 18 to 24. Of the people in that group who knew whether they had been vaccinated or not, 84 percent had had two mumps shots, according to the study by the Centers for Disease Control and Prevention and state health departments.

“If there’s another outbreak, we would evaluate the potential benefit of a third dose to control the outbreak,” said researcher Dr. Jane Seward, deputy director of the CDC’s viral diseases division.

It appears that after two doses the vaccine is 80 percent to 90 percent effective, which means that the rest of 10 to 20 percent will get infected but their disease will most likely be less severe. Mumps or epidemic parotitis is usually detected by a painful swelling of the salivary glands. In males, painful testicular swelling may be also present.

“Despite a high coverage rate with two doses of mumps-containing vaccine, a large mumps outbreak occurred, characterized by two-dose vaccine failure, particularly among midwestern college-age adults who probably received the second dose as schoolchildren.”

Source: N Engl J Med Volume 358: pp 1580-1589, April 10, 2008, Number 15.

Surprisingly, the risk of developing metabolic syndrome was 34 percent higher among those who drank one can of diet soda a day compared with those who drank none.

Dietary Intake and the Development of the Metabolic Syndrome. The Atherosclerosis Risk in Communities Study

Pamela L. Lutsey MPH, Lyn M. Steffen PhD, MPH, RD*, and June Stevens PhD, MS, RD

From the Division of Epidemiology and Community Health, University of Minnesota, School of Public Health, Minneapolis (P.L.L., L.M.S.), and Department of Nutrition, University of North Carolina, Chapel Hill (J.S.).

Background—The role of diet in the origin of metabolic syndrome (MetSyn) is not well understood; thus, we sought to evaluate the relationship between incident MetSyn and dietary intake using prospective data from 9514 participants (age, 45 to 64 years) enrolled in the Atherosclerosis Risk in Communities (ARIC) study.

Methods and Results—Dietary intake was assessed at baseline via a 66-item food frequency questionnaire. We used principal-components analysis to derive “Western” and “prudent” dietary patterns from 32 food groups and evaluated 10 food groups used in previous studies of the ARIC cohort. MetSyn was defined by American Heart Association guidelines. Proportional-hazards regression was used. Over 9 years of follow-up, 3782 incident cases of MetSyn were identified. After adjustment for demographic factors, smoking, physical activity, and energy intake, consumption of a Western dietary pattern (Ptrend=0.03) was adversely associated with incident MetSyn. After further adjustment for intake of meat, dairy, fruits and vegetables, refined grains, and whole grains, analysis of individual food groups revealed that meat (Ptrend<0.001), fried foods (Ptrend=0.02), and diet soda (Ptrend=< 0.001) also were adversely associated with incident MetSyn, whereas dairy consumption (Ptrend=0.006) was beneficial. No associations were observed between incident MetSyn and a prudent dietary pattern or intakes of whole grains, refined grains, fruits and vegetables, nuts, coffee, or sweetened beverages.

Conclusions—These prospective findings suggest that consumption of a Western dietary pattern, meat, and fried foods promotes the incidence of MetSyn, whereas dairy consumption provides some protection. The diet soda association was not hypothesized and deserves further study.

Key words: dairy products • diet • food habits • meat • metabolic syndrome X

Source: AHA

FDA Alerts Health Care Providers to Risk of Suicidal Thoughts and Behavior with Antiepileptic Medications

The U.S. Food and Drug Administration today issued new information to health care professionals to alert them about an increased risk of suicidal thoughts and behaviors (suicidality) in patients who take drugs called antiepileptics to treat epilepsy, bipolar disorder, migraine headaches, and other conditions.

An FDA analysis of suicidality reports from placebo-controlled studies of 11 antiepileptic drugs shows that patients taking these drugs have about twice the risk of suicidal thoughts and behaviors (0.43 percent), compared with patients receiving placebo (0.22 percent). This risk corresponds to an estimated 2.1 per 1,000 more patients in the drug treatment groups who experienced suicidality than in the placebo groups.

“We want health care professionals to have the most up to date drug safety information,” said Russell Katz, M.D., director of the Division of Neurology Products in FDA’s Center for Drug Evaluation and Research. “This is an example of FDA working with drug manufacturers throughout products’ lifecycles to keep health care professionals informed of new safety data.”

Patients who are currently taking antiepileptic medicines should not make any changes without first talking to their health care provider. Health care providers should notify patients, their families, and caregivers of the potential for an increase in the risk of suicidal thoughts or behaviors so that patients may be closely observed for notable changes in behavior.

Following a preliminary analysis of data from several antiepileptic drugs that suggested an increased risk of suicidality, in March 2005 FDA requested this type of data from manufacturers of marketed antiepileptic drugs for which there were adequately designed controlled clinical trials. FDA received and reviewed data from 199 placebo-controlled studies of 11 drugs.

The analysis included 27,863 patients in drug treatment groups and 16,029 patients in placebo groups. There were four suicides among patients in the drug treatment groups and none among patients in placebo groups. There were 105 reports of suicidal thoughts or behaviors in the drug-treated patients and 35 reports in placebo-treated patients.

The higher risk of suicidal thoughts and behaviors was observed at one week after starting a drug and continued to at least 24 weeks. The results were generally consistent among all the different drug products studied and were seen in all demographic subgroups. There was no clear pattern of risk across age groups.

Antiepileptic drugs in the analyses included the following:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)

Felbamate (marketed as Felbatol)

Gabapentin (marketed as Neurontin)

Lamotrigine (marketed as Lamictal)

Levetiracetam (marketed as Keppra)

Oxcarbazepine (marketed as Trileptal)

Pregabalin (marketed as Lyrica)

Tiagabine (marketed as Gabitril)

Topiramate (marketed as Topamax)

Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)

Zonisamide (marketed as Zonegran)

Some of these drugs are also available in generic form.

Although only the drugs listed above were part of the analysis, the FDA expects that all medications in the antiepileptic class share the increased risk of suicidality.

FDA will be working with manufacturers of marketed antiepileptic drugs to include this new information in the labeling for these products. The agency anticipates that labeling changes will be applied broadly to the entire class of drugs. FDA is also planning to discuss these data at an upcoming advisory committee meeting.

For more information FDA Information for Healthcare Professionals: Suicidality and Antiepileptic Drugs www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm.

The FDA is being criticized today for approving for sale prescription drugs that eventually led to a doubling of patient injuries from 1998 to 2005. Thomas Moore and colleagues at the Institute for Safe Medication Practices in Huntingdon Valley, Pennsylvania released a study in Archives of Internal Medicine involving patient deaths and injuries from taking prescription drugs.

The number of serious injuries and deaths from drugs reported to the U.S. Food and Drug Administration more than doubled between 1998 and 2005, according to a report in Monday’s Archives of Internal Medicine published by the American Medical Association.

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New Warning About Hospitals and Preventable Blood Clots

One out of three U.S. hospital patients is at risk for dangerous blood clots, but far fewer actually receive treatments to prevent the potentially life-threatening condition, according to a study released this week.

“Blood clots are the most common preventable cause of death in hospital patients. It is profound and puzzling: Why is there a preventable issue that people are dying from?” Frederick Anderson, a research professor in the Department of Surgery at the University of Massachusetts Medical School and director of the Center for Outcomes Research, told United Press International.

Deep venous thromboembolism, a blood clot in the deep vein of a leg or arm, can occur when people are immobilized for two or three days, such as after surgery. The condition is treatable but if ignored, may become deadly if the blood clot travels to the lung.

It is estimated that 5 percent to 10 percent of hospital deaths are due to blood clots that travel to the lungs, also called a pulmonary embolism.

Some people have a genetic predisposition toward blood clots, experts say.

“About 100,000 die of pulmonary embolism. About half of them are in late-stage illness. But 50,000 have a good prognosis and this is a tragedy and preventable,” Anderson said. His research appears in the July American Journal of Hematology and was funded by Sanofi-aventis, which manufactures an anti-coagulant.

Clots can be prevented if patients at risk are given blood thinning drugs, and encouraged to move around if possible. Once a clot forms, blood thinning drugs must be taken for three to six months, Anderson said.

The anticoagulant is given as an injection once a day. It reduces by two-thirds the risk of a pulmonary embolism forming, Anderson said.

The problem of blood clots in hospital patients is not fully recognized by many hospitals and results in needless illness and death, Anderson said.

“There is a big gap in knowledge of this disease. No one knew just how many patients might be at risk,” Anderson said.

An overall estimate of vulnerable patients can bolster a broad, national effort to encourage physicians to recognize their at-risk patients and administer blood thinning drugs and other treatments as a preventive, Anderson said.

To get at the number, he and colleagues reviewed a national database of adult hospitalizations in 2003, a typical year, and divided the patients into categories according to their risk of a blood clot.

Anderson used accepted medical guidelines from the American College of Chest Physicians to determine who was at risk.

More than 38 million adults were hospitalized in 2003, at one or more 6,000 U.S. hospitals, according to the database.

Any person 18 or over who is hospitalized for major surgery, especially hip or knee surgery, and recovers in the hospital for two or more days is at higher risk, Anderson said. About 20 percent of patients were entered into this category.

People undergoing in-hospital hip or knee surgery have a 50-percent chance of developing a blood clot, the researchers concluded.

“Fortunately, it is unlikely you’ll die. But it is worrisome to have it there,” Anderson said of a blood clot.

Moreover, any person age 40 or over who is hospitalized for more than two days for any serious medical illness, such as heart or lung disease, cancer or infection, is also at risk. About 40 percent of people met these criteria, Anderson found.

Further criteria narrowed down those who would be most vulnerable. The result: about 12 million patients at risk of dangerous blood clots.

“Previous studies focused on single hospitals or groups but no one had every looked before at the entire population of acute-care hospitalizations,” Anderson said.

The exact reason for in-hospital blood clots is unclear but it appears that when the body is cut anywhere, such as in surgery, the entire blood system reacts. And when people are immobilized for two or three days the blood stagnates, Anderson said.

In a separate study of 10,000 U.S. patients, Anderson found that about half of those at risk of blood clots actually receive preventive treatment, but a larger study is needed, Anderson said. According to Nigel Key, professor of medicine at the University of North Carolina, the problem of dangerous blood clots is about to gain a higher profile.

“There is a plan to have the U.S. surgeon general conduct a general ‘call to action’ about thrombosis, a big public awareness campaign,” Key told UPI.

“The problem is, when the experts come up with recommendations, it can take a while for that to get translated into clinical practice,” Key said.

“It is a major killer but it hasn’t attracted the medical glamour that many other disorders have. It kills more than breast cancer and AIDS combined, but public awareness is very low,” Key said.

Valentin Fuster, past president of the American Heart Association and director of the Mt. Sinai Cardiovascular Institute, said patients and doctors can be on the lookout for situations that predispose patients to blood clots.

“If you are in bed, mobilize yourself. If it can’t be done, the doctor should give you blood thinners. On a plane, move every two or three hours. If you are undergoing an operation, the doctor should give you blood thinners. If you have varicose veins or venous diseases, you have to be very careful,” Fuster told UPI. “We should not allow this to happen,” he said.

GlaxoSmithKline makes $3 billion annually from the sales of rosiglitazone or Avandia. However, a new study suggests that this drug increased the risk of heart death by 64 percent and the risk of heart attack by 43 percent, U.S. researchers said

Doctors at the Cleveland Clinic analyzed 42 clinical trials and said more than 65 percent of the deaths among diabetic patients in the trials of the drug could be attributed to heart disease.

The study of Avandia, also known as rosiglitazone, will be published this week in the New England Journal of Medicine.

“Unfortunately, rosiglitazone appears to increase, rather than decrease, the most serious complication of diabetes, heart disease,” Dr. Steven Nissen, chairman of cardiovascular Medicine at the Cleveland Clinic, said in a statement.

The ironic part of this story is that the FDA approved Avandia for public release to replace the Pfizer drug Rezulin which was linked to causing liver damage in patients.