September 2nd, 2011
By: Alice Park
The government’s recent Dietary Guidelines for Americans had some familiar recommendations for health: eat more fruits and vegetables, exercise more and lower the amount of salt you eat.
Now a new study from Europe challenges that last piece of advice by suggesting that reducing dietary salt may not benefit your heart health after all. Previous studies have shown that people with high blood pressure can lower their risk of developing hypertension and heart disease by eating less salt. But in the new study, people who had the most salt in their diets actually had the lowest risk of dying from heart disease.
Yes, that’s right. The study involved 3,681 people without heart problems, most of whom also had normal blood pressure. Reporting in the Journal of the American Medical Association (JAMA), the researchers found that those with the highest levels of sodium in their urine (the most accurate way to measure how much salt a person consumes) were more than four times less likely to die from heart disease than those with the lowest intake of sodium. During the nearly eight years of follow up, the heart-related death rate was 0.8% among those with the highest sodium levels and 4% among those with the lowest levels.
“Yes, the findings surprised me and those of us at the American Heart Association (AHA),” says Dr. Ralph Sacco, president of the AHA and chairman of neurology at University of Miami. The AHA is hoping to get Americans to lower their sodium intake to 1,500 mg per day by 2020, far below the 2,300 mg daily maximum that the U.S. Department of Agriculture now advises.
“We have to remember that many people are at high risk for high blood pressure,” says Sacco. “And when we start going up in age, the proportion of people with high blood pressure approaches 70% to 80% or more, so your lifetime risk of high blood pressure is exceedingly high.”
Salt can play a role in blood pressure, and the current study confirmed this, finding that the systolic pressure (the upper number in the blood pressure reading) was slightly higher among those consuming the most salt, compared with those consuming the least. Even so, those people were at no higher risk of developing hypertension.
The current study fuels the brewing debate over whether low-salt standards should apply equally to everyone. Some experts suggest that certain people may be more sensitive to salt than others, or that people with normal blood pressure may not benefit from lowering their sodium intake. Most of the gold-standard studies on salt — in which people are randomly assigned to consume diets high or low in sodium — have involved people who either have hypertension or are at high risk of developing it. Based on that data, scientists just assumed that the same low-salt principle would benefit people at lower risk as well.
But as one of the study authors, Dr. Jan Staessen, professor of medicine at University of Leuven in Belgium, told JAMA in a Q&A, “If you decrease sodium intake a lot, you activate some of the systems that conserve sodium and they are known to have a negative influence on cardiovascular outcomes.” While it’s not know if this is indeed the reason for the contrary findings, it could explain why lower sodium levels were linked to greater heart problems in the trial.
Still, Sacco, as well as the authors, acknowledge that there might be other reasons for the surprising results. First, the study population was relatively young on the whole (participants’ ages ranged from 20 to over 60), and therefore at lower risk of hypertension than an older population. The impact that sodium can have on the heart may differ depending on age.
Second, the scientists took only one urinary sodium reading over a 24-hour period from each participant, and such readings can vary; an average of several measurements might have more accurately captured the participants’ true sodium intake.
And, finally, given the young age of the volunteers, an eight-year follow up may not have been long enough to capture the full risk of heart events or death from heart attacks, which tend to occur in advanced middle age and later.
It appears that the question about how salt affects heart risk is a complicated one. There is certainly strong and undisputed evidence that people with high blood pressure can lower their readings by reducing their salt intake. So it would stand to reason that the same applies to healthy people with normal blood pressure — even if there isn’t the gold-standard scientific evidence to support that.
Of course, dropping blood pressure too low comes with its own health risks — dizziness, fainting and even shock — but most U.S. adults aren’t at risk of hypotension. Sacco points out also that because high blood pressure is associated with both age and obesity, there’s good reason for large swaths of the American public to hold off on the sodium.
“Our population is aging, and more and more people are obese, and less physically active, so we felt that [the AHA's] recommendation for all Americans to lower their salt intake is important because a large proportion of Americans are intermediate to high risk for developing high blood pressure,” he says. “One study should not change all the other great evidence out there that says we should be lowering sodium. Lowering blood pressure even by a few millimeters can have an impact over a lifetime. So don’t reach for that salt shaker.”
October 21st, 2010
U.S. health officials are cautioning patients and doctors about possible deadly side effects when using two HIV drugs together: Roche Holding’s Invirase and Abbott Laboratories’ Norvir.
The U.S. Food and Drug Administration, which first warned about the potential heart problems in February, said the caution is now being added to the product labels, saying they could cause an abnormal heart rhythm if used together.
In some cases, the condition, known as torsades de pointes, can lead to a life-threatening irregular heart beat called ventricular fibrillation, the FDA said.
Mixing the drugs can also cause another type of abnormal heart rhythm called “heart block” that can trigger lightheadedness or fainting, it added.
The agency urged HIV patients to talk to their doctors and to make sure they disclose any other medications, vitamins or supplements they are taking in addition to their HIV drugs.
Separately, the European Medicines Agency said it reviewed all the available data on potential heart risk and recommended that patients start off treatment with a lower dose of Invirase for a week as a precaution.
It added that the benefits of the drugs outweighed the potential heart risks.
Invirase is made by Roche’s Genentech subsidiary.
September 12, 2009
By S.L. Baker
At first glance, a study just published in the August 19th edition of the Journal of the American Medical Association (JAMA) is yet another whitewash job about the safety of the quadrivalent human papillomavirus recombinant vaccine –better known as Gardasil, the genital human papillomavirus (HPV) vaccine. Licensed in June of 2006 by the Food and Drug Administration (FDA) for girls and young women between the ages of nine and 26, the enormously hyped and advertised vaccine is designed to prevent infection with four types of HPV: types 16 and 18 can cause cervical cancer and types 6 and 11 are the most common types of genital warts.
The JAMA report says that the Gardasil adverse events reported have been mostly consistent with data gathered before the vaccine was considered safe enough to be widely administered to young girls. But a close reading shows some disturbing additional facts.
Just as NaturalNews has consistently reported, the vaccine has caused an extraordinary number of adverse side effects. And now comes word from the JAMA report that the HPV vaccine has unexpectedly caused episodes of fainting and life-threatening blood clots. In fact, in a statement to the media, these events were called “disproportional” — meaning these side effects are anything but rare. What’s more, among the 12,424 adverse reaction reports about the HPV vaccine, 772 (6.2 percent) were serious and included 32 reports of death.
Other problems caused by the vaccine include local site reactions, skin rashes, nausea, dizziness, headaches and even Guillain-Barre syndrome (a disorder in which the body’s immune system attacks part of the peripheral nervous system sometimes causing paralysis) and anaphylaxis (hypersensitivity reaction that can cause sudden death). As just reported by CBS news, the teenage daughter of physician Scott Ratner and his wife was one of the unfortunate girls who became severely ill with a chronic autoimmune disease, myofasciitis, after her first dose of Gardasil. Dr. Ratner told CBS his daughter was so ill with the neurological problem “..she’d have been better off getting cervical cancer than the vaccination.”
One the lead researchers for Gardasil has also gone public this week, telling CBS news there is no data showing that the vaccine even remains effective beyond five years. That means that if a ten year old girl is given the vaccine and subjected to possibly serious and even life-threatening side effects, the vaccine may offer her no protection at all when she hits her teens or young adulthood.
What makes the debate about Gardasil crazy to begin with is that studies have shown 70 to 90 percent of people with HPV naturally clear the virus from the body within two years of infection — with no help from drugs or vaccines. So the most effective protection from problems caused by HPV is to avoid being infected by the multiple strains of HPV by not engaging in promiscuous, unprotected-by-condoms sex (the virus is transmitted sexually and condoms do not offer 100 percent protection) and by keeping your body’s immune system strong and healthy through good nutrition, exercise and exposure to sunlight.
In an editorial accompanying the JAMA study, Charlotte Haug, M.D., Ph.D., M.Sc., of The Journal of the Norwegian Medical Association in Oslo expressed her concerns about the aggressively promoted Gardasil vaccine: “Whether a risk is worth taking depends not only on the absolute risk, but on the relationship between the potential risk and the potential benefit. If the potential benefits are substantial, most individuals would be willing to accept the risks. But the net benefit of the HPV vaccine to a woman is uncertain. Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened…”
August 19, 2009
By Radha Chitale
A government report released Tuesday raises new questions about the safety of the cervical cancer vaccine Gardasil. The vaccine has been linked to 32 unconfirmed deaths and shows higher incidences of fainting and blood clots than other vaccines.
But while some physicians expressed concern over the findings, other doctors viewed the report as reassuring, showing that the vaccine was not associated with any more unusual and serious side effects as other vaccines.
The results of the report appeared along with an accompanying editorial discussing whether the potential benefit of the HPV vaccine is worth its potential risks in the Journal of the American Medical Association. The editorial, in particular, could give pause to many parents faced with the decision of whether or not to have their 11- and 12-year-old daughters vaccinated against the certain strains of the human papillomavirus, or HPV.
On Wednesday morning, ABC News Chief Medical Editor Dr. Timothy Johnson said that he, too, would encourage parents to learn more about the shot before getting their daughters vaccinated.
“I am very much in favor of childhood vaccines,” Johnson told Chris Cuomo on Wednesday’s “Good Morning America,” adding that there is little doubt that the vaccine does have its benefits.
“We know it does what it says it prevents HPV infections,” he said.
But he added that when it comes to comparing the benefits of the HPV vaccine against its potential risks, he believes there simply is not enough evidence to recommend to all parents that they have their daughters vaccinated.
“I don’t think we yet know the long term benefits or risks,” Johnson said. “I’m taking a pass on this one and saying to parents, ‘Study the issue, read the editorial… talk to your doctor.’”
Those who search for more information on the vaccine may also find stories from other parents who say the vaccine had ill effects on their daughters. One of these parents, Emily Tarsell, started her daughter Christina on Gardasil — a vaccine that protects against four of the most common cancer-causing strains of the human papilloma virus (HPV) — after her first visit to a gynecologist and at the doctor’s recommendation.
Eighteen days after Christina received her final vaccine shot, she died.
“I know it was the Gardasil,” Tarsell said, although the official cause of death was undetermined. “They were really recommending it, saying that there weren’t any side effects, that it was safe. So I kind of went against my better instinct [and let her] get the shot.”
Deaths like Christina’s are one of several types of complications reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) following Gardasil distribution in 2006. Some of these adverse events were serious, including blood clots and neurological disorders, and some were non-life threatening side effects from the vaccine, including fainting, nausea and fever.
Although experts agree that the accuracy of data from VAERS reports — which can be made by anyone and are not verified or controlled for quality — is questionable, they remain divided as to whether extreme adverse events, which are serious but rare, are cause enough to stop recommending and administering the Gardasil vaccine without further investigation.
Report Shows Rare But Serious Side Effects May Result From Gardasil Vaccine
“Although the number of serious adverse events is small and rare, they are real and cannot be overlooked or dismissed without disclosing the possibility to all other possible vaccine recipients,” said Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at University of Missouri. “The rate of serious adverse events is greater than the incidence rate of cervical cancer.”
As of June 1, 2009, the CDC reported that over 25 million doses of Gardasil, which is recommended for women between ages 9-26, have been distributed in the U.S. and there was an average of 53.9 VAERS reports per 100,000 vaccine doses. Of these, 40 percent occurred on the day of vaccination, and 6.2 percent were serious, including 32 reports of death.
In a statement yesterday from Merck, the pharmaceutical company that manufactures Gardasil, the company backed the vaccine’s efficacy and said they encourage further research on its safety.
“We are pleased that the study published by JAMA [yesterday] further reinforces the safety profile of Gardasil,” said Dr. Richard M. Haupt, head of the clinical program for Gardasil at Merck. “We welcome continued study and discussion about the safety of this important vaccine.”
But some clinicians are not ready to accept wide use of the drug based on the available safety data.
Dr. Jaques Moritz, director of gynecology at St. Luke’s-Roosevelt Hospital, said he would not offer the Gardasil vaccine to patients when good cervical cancer screening techniques and treatments exist. He has also chosen not to have his 11-year-old daughter get the HPV shot because of his concerns.
“I’m pro preventing cervical cancer and HPV,” Moritz said. “I’m not pro that the physicians don’t know the risks and side effects.”