Controversial STD drug tied to 16 more deaths

19-year-old reported chest pain, nausea; died of 'cardiac arrhythmia'

Posted: September 28, 2010
8:50 pm Eastern

By Bob Unruh
© 2010 WorldNetDaily

KENILWORTH, NJ - MARCH 09: A car enters the employee entrace at the headquarters for drug maker Merck on March 9, 2009 in Kenilworth, New Jersey. Drug maker Merck will buy rival Schering-Plough in a $41.1 billion deal, with the merged company keeping the Merck name. (Photo by Chris Hondros/Getty Images)

The case report is terse about the 19-year-old woman who was given Gardasil, a vaccine intended to guard against a sexually transmitted disease, and reported, "Headache, nausea, dizziness, chilling, tiredness, shortness of breath, complained of chest pain, severe cramps."

She died of "acute cardiac arrhythmia." Said the report, "Attempts to resuscitate her resulted in a sternal fracture, but were unsuccessful and the patient died."

'SCARY MEDICINE: Exposing the dark side of vaccines'

That's just one of the 16 new reports that have arrived since the middle of last year that document deaths linked to Gardasil.

"To say Gardasil has a suspect safety record is a big understatement. These reports are troubling and show that the FDA and other public-health authorities may be asleep at the switch," said Tom Fitton, president of Judicial Watch, the government watchdog organization that investigates and reports on government corruption.

"In the meantime, the public-relations push for Gardasil by Merck and politicians on Capitol Hill continues. No one should require this vaccine for young children," Fitton said.

Judicial Watch launched a comprehensive investigation of Gardasil's safety record in 2008 after the drug's manufacturer, Merck & Co., began a major effort to lobby in state legislatures to impose requirements that girls be given their product. Eventually the Centers for Disease Control suggested the maker back off its campaign.

It was in 2008 when Judicial Watch obtained documents from the U.S. Food and Drug Administration documenting "anaphylactic shock," "foaming at mouth," "grand mal convulsion," "coma" and "now paralyzed" descriptions of the complications from Gardasil. The drug is intended to address the sexually transmitted human papillomavirus, believed by researchers to be an indicator for future cases of cervical cancer. The company wanted it to be mandatory for all schoolgirls.

At that time, the organization's work uncovered reports of about one death a month, bringing the total death toll from the drug to at least 18 and as many as 20 at that time. The new report documents that there have been at least another 16 fatalities in the months since, along with 789 "serious" reports of reactions submitted to the FDA. Two hundred thirteen of the cases in the most recent reporting period resulted in a permanent disability and 25 resulted in Guillian Barre Syndrome.

According to Judicial Watch, the 19-year-old had "no medical history except occasionally cases [of] bronchitis."

She was given Gardasil and died within 53 days, following health problems that included the long list documented in the federal report.

In another case documented for the current time period from May 2009 to this month, a 13-year-old girl was vaccinated and 10 days later, developed fever.

According to federal reports she "did not recover and was admitted to the hospital. … She developed dyspnoea and went into a coma .. she expired [that day]."

Yet another documented case revealed a 10-year-old developed "progressive loss of strength in lower and upper extremities almost totally ... nerve conduction studies [showed Guillain Barre Syndrome]." The case was considered "immediately life-threatening," Judicial Watch said.

Merck officials did not respond to a WND request for comment.

Judicial Watch said federal documents reveal the mother of a 13-year-old who died 37 days after getting vaccinated reported, "I first declined getting her the vaccination but her doctor [assured] me that it was safe."

Her daughter soon reported no feeling in her foot and a tingling in her leg. A doctor's appointment was scheduled for Oct. 23, 2009.

"My daughter never made it to Oct. 23, which is also her birthday," the mother wrote. "She passed on Oct. 17. I found her cold unresponsive in her room at 7 a.m."

WND has reported on the aggressive push by Merck to lobby state legislatures to make the vaccination mandatory for schoolgirls across the nation.

In 2007 alone, Merck's lobbying campaign and contributions to the Women in Government organization for women state legislators resulted in proposals in at least 39 states to institutionalize such vaccinations. Most of the campaigns failed.

Officials with the Abstinence Clearinghouse had noted at the time in a position paper that groups including the Texas Medical Association, the American Academy of Pediatrics, the Association of American Physicians and Surgeons, and the American Academy of Environmental Medicine have come out publicly against mandatory vaccination.

"The reasoning of these medical associations is clear. They are not opposed to medical progress, and certainly support all efforts to combat life-threatening diseases. The problem, as these organizations see it, lies in the fact that the drug only went through three and a half years of testing, leaving the medical community somewhat in the dark as to what serious adverse effects might result in the long term," the group said at the time.

"Along with the potential of serious adverse effects is the question of efficacy. There is evidence that after approximately four years, the vaccine's potency significantly declines. The long-term value of the vaccine has yet to be determined; if it wears off within six years, will girls and women need to repeat the battery of injections they originally received?" the organization wondered.

Eat Nuts to Fight 8 Ailments

Looking for a nutty way to improve your health? Nuts offer a wealth of vitamins, minerals, and other nutrients in a compact, portable, and tasty package. Scientific research indicates that nuts can help prevent or fight a number of diseases, including heart disease, diabetes, and macular degeneration. Moderation seems to be the key, and a handful every day provides health benefits. So enjoy them daily just don't go nuts and help protect yourself against the following eight ailments.

heart, disease, nuts, harvard

1. Heart disease

A study of 31,000 Seventh-day Adventists at Loma Linda University in California found that eating a serving of nuts daily (about a quarter of a cup or one handful) lowered the risk of heart attack by up to 60 percent when compared with those who ate nuts less than once a month. The Iowa Women's Healthy Study found that women who ate a serving of nuts more than four times a week lowered their risk of dying of heart disease by 430 percent. Another study conducted by the Harvard School of Public Health found similar results, and the Physician's Health Study found that men who ate nuts at least twice a week reduced their risk of sudden cardiac death.

Next: High Cholesterol

Magnesium May Help Prevent Diabetes

Getting enough magnesium in your diet could help prevent diabetes, a new study suggests.

People who consumed the most magnesium in foods and from vitamin supplements were about half as likely to develop diabetes over the next 20 years as people who took in the least magnesium, Dr. Ka He of the University of North Carolina at Chapel Hill and colleagues found.

US restricts, EU bans controversial diabetes pill

European regulators ordered the diabetes drug Avandia off the market and the Food and Drug Administration placed stringent restrictions on its use in the United States, saying heart attack risks associated with the former blockbuster are too great a safety concern to continue its use for most people.

In simultaneous news briefings Thursday, the European Medicines Agency and the U.S. Food and Drug Administration announced their long-awaited decisions on the fate of GlaxoSmithKline's controversial drug. The European regulator said it would stop authorizing marketing of Avandia, which will be banned from sales within the next few months.

$93,000 cancer drug: How much is a life worth?

BOSTON – Cancer patients, brace yourselves. Many new drug treatments cost nearly $100,000 a year, sparking fresh debate about how much a few months more of life is worth.

The latest is Provenge, a first-of-a-kind therapy approved in April. It costs $93,000 and adds four months' survival, on average, for men with incurable prostate tumors. Bob Svensson is honest about why he got it: insurance paid.

"I would not spend that money," because the benefit doesn't seem worth it, says Svensson, 80, a former corporate finance officer from Bedford, Mass.

His supplemental Medicare plan is paying while the government decides whether basic Medicare will cover Provenge and for whom. The tab for taxpayers could be huge — prostate is the most common cancer in American men. Most of those who have it will be eligible for Medicare, and Provenge will be an option for many late-stage cases. A meeting to consider Medicare coverage is set for Nov. 17.

"I don't know how they're going to deal with that kind of issue," said Svensson, who was treated at the Lahey Clinic Medical Center in suburban Boston. "I feel very lucky."

For the last decade, new cancer-fighting drugs have been topping $5,000 a month. Only a few of these keep cancer in remission so long that they are, in effect, cures. For most people, the drugs may buy a few months or years. Insurers usually pay if Medicare pays. But some people have lifetime caps and more people are uninsured because of job layoffs in the recession. The nation's new health care law eliminates these lifetime limits for plans that were issued or renewed on Sept. 23 or later.

Celgene Corp.'s Revlimid pill for multiple myeloma, a type of blood cancer, can run as much as $10,000 a month; so can Genentech's Avastin for certain cancers. Now Dendreon Corp.'s Provenge rockets price into a new orbit.

Unlike drugs that people can try for a month or two and keep using only if they keep responding, Provenge is an all-or-nothing $93,000 gamble. It's a one-time treatment to train the immune system to fight prostate tumors, the first so-called "cancer vaccine." Part of why it costs so much is that it's not a pill cranked out in a lab, but a treatment that is individually prepared, using each patient's cells and a protein found on most prostate cancer cells. It is expensive and time-consuming to make.

It's also in short supply, forcing the first rationing of a cancer drug since Taxol and Taxotere were approved 15 years ago. At the University of Texas M.D. Anderson Cancer Center, doctors plan a modified lottery to decide which of its 150 or so eligible patients will be among the two a month it can treat with Provenge. An insurance pre-check is part of the process to ensure they financially qualify for treatment.

"I'm fearful that this will become a drug for people with more resources and less available for people with less resources," said M.D. Anderson's prostate cancer research chief, Dr. Christopher Logothetis.

For other patients on other drugs, money already is affecting care:

_Job losses have led some people to stop taking Gleevec, a $4,500-a-month drug by Novartis AG that keeps certain leukemias and stomach cancers in remission. Three such cases were recently described in the New England Journal of Medicine, and all those patients suffered relapses.

_Retirements are being delayed to preserve insurance coverage of cancer drugs. Holly Reid, 58, an accountant in Novato, Calif., hoped to retire early until she tried cutting back on Gleevec and her cancer recurred. "I'm convinced now I have to take this drug for the rest of my life" and will have to work until eligible for Medicare, she said.

_Lifetime caps on insurance benefits are hitting many patients, and laws are being pushed in dozens of states to get wider coverage of cancer drugs. In Quincy, Mass., 30-year-old grad student Thea Showstack testified for one such law after pharmacists said her first cancer prescription exceeded her student insurance limit. "They said 'OK, that will be $1,900,'" she said. "I was absolutely panicked." The federal health care law forbids such caps on plans issued or renewed Sept. 23 or later.

_Tens of thousands of people are seeking help from drug companies and charities that provide free medicines or cover copays for low-income patients. Genentech's aid to patients has risen in each of the last three years and the company says nearly 85 percent of Americans earn less than $100,000, making them potentially eligible for help if no other programs like Medicaid will pay.

_Doctors and insurers increasingly are doing the cruel math that many cancer patients want to avoid, and questioning how much small improvements in survival are worth. A recent editorial in a medical journal asked whether the extra 11 weeks that Genentech's Herceptin buys for stomach cancer patients justified the $21,500 cost.

Doctors also have questioned the value of Genentech's Tarceva for pancreatic cancer. The $4,000-a-month drug won approval by boosting median survival by a mere 12 days. Here's how to think about this cost: People who added Tarceva to standard chemotherapy lived nearly 6 1/2 months, versus 6 months for those on chemo alone. So the Tarceva folks spent more than $24,000 to get those extra 12 days.

When is a drug considered cost-effective?

The most widely quoted figure is $50,000 for a year of life, "though it has been that for decades — never really adjusted — and not written in stone," said Dr. Harlan Krumholz, a Yale University expert on health care costs.

Many cancer drugs are way over that mark. Estimates of the cost of a year of life gained for lung cancer patients on Erbitux range from $300,000 to as much as $800,000, said Dr. Len Lichtenfeld, the American Cancer Society's deputy chief medical officer.

Higher costs seem to be more accepted for cancer treatment than for other illnesses, but there's no rule on how much is too much, he said.

Insurers usually are the ones to decide, and they typically pay if Medicare pays. Medicare usually pays if the federal Food and Drug Administration has approved the use.

"Insurance sort of isolates you from the cost of health care," and if people lose coverage, they often discover they can't afford their medicines, said Dr. Alan Venook, a cancer specialist at the University of California, San Francisco. He wrote in the New England Journal in August about three of his patients who stopped taking or cut back on Gleevec because of economic hardship.

Two of the three now are getting the drug from its maker, Novartis AG, which like most pharmaceutical companies has a program for low-income patients. About 5,000 patients got help for Gleevec last year, said Novartis spokesman Geoffrey Cook.

"We have seen a steady increase in requests over the past few years" as the economy worsened, he said.

Showstack, whose leukemia was diagnosed last year, gets Gleevec from Novartis. The dose she's on now would cost $50,000 a year.

"I'm not actually sure that I know anyone who could afford it," she said.

Gleevec's cost is easier to justify, many say, because it keeps people alive indefinitely — a virtual cure. About 2,300 Americans died each year of Showstack's form of leukemia before Gleevec came on the market; only 470 did last year.

"I don't think we quibble with a drug that buys people magical quality of life for years," Venook said.

It's unclear whether Provenge will ever do that — it needs to be tested in men with earlier stages of prostate cancer, doctors say. So far, it has only been tried and approved for men with incurable disease who have stopped responding to hormone therapy. On average, it gave them four months more, though for some it extended survival by a year or more.

Until it shows wider promise, enthusiasm will be tepid, said Dr. Elizabeth Plimack a prostate specialist at the Fox Chase Cancer Center in Philadelphia.

"I've not had any patient ask for it," she said. "They ask about it. Based on the information, they think the cost is tremendous, and they think the benefit is very small."

Logothetis, at M.D. Anderson, said Provenge and other experimental cancer vaccines in development need "a national investment" to sort out their potential, starting with Medicare coverage.

"It's no longer a fringe science. This is working," he said. "We need to get it in the door so we can evolve it."

FDA refuses to require labeling of genetically modified salmon

Mike Adams
Natural News

As the FDA stands poised to approve genetically modified (GM) salmon safe for public consumption, the next logical question concerns how GM salmon would be labeled. Would the fish come with a large red warning that says, "Genetically modified salmon"?

As it turns out, no. In fact, the FDA has already gone on the record stating it will not require any special labeling of genetically modified salmon. You, the consumer, just have to take a wild guess because you're not allowed to know what you're really eating.

CNN

"Snort! Snort!" The plump, pink beast comes rumbling towards me as I approach, then attaches its snout to my leg, sniffing intensely, apparently trying to determine if I bring food.

It looks like a Yorkshire pig, behaves, sounds and smells like one. But genetically the pigs at Canada's University of Guelph swine research laboratory are different. They are "greener", emitting a smaller quantity of pollutants in their manure. Thus, their creators named the species, “Enviropig.” And they hope one day the Enviropig’s descendents may be on your dinner plate.

Associated Press

NEW YORK — Federal regulators have filed complaints against the makers of POM Wonderful Pomegranate Juice, alleging they have made false or unsubstantiated claims about the drink's ability to treat or prevent certain diseases.

The Federal Trade Commission said Monday that POM Wonderful LLC, its parent company Roll International Corp., its creators and an executive have violated federal laws about truth in advertising.

Regulators pointed to ads claiming scientific research shows the juice or related pomegranate supplements prevent or treat heart disease, prostate cancer and erectile dysfunction.

The individuals the complaint names are POM creators Stewart and Lynda Resnick and company President Matthew Tupper.

Body & Mind Woman’s Body Cut in Half to Treat Aggressive Cancer

A Canadian woman is the first patient to undergo an operation in which doctors cut her body in half to remove a tumor—and survive.

Janis Ollson, 31, was pregnant with her second child and doctors assumed her intense back pain was just a typical symptom of pregnancy. But it wasn’t long until she was diagnosed with bone cancer that was untreatable by chemotherapy or radiation, The Winnipeg Free Press reported.

The Manitoba mother was told by experts in Toronto they would have to cut her body in half by removing her leg, lower spine and half of her pelvis—a surgery that had only been performed on cadavers, which meant successfully putting her back together again was a huge risk.

Doctors compared the tumor to the size of a calzone, and said it was the biggest they had ever seen.

"The plan was to remove the tumor, splitting my pelvis in half and removing the left half and left leg and lower spine," Ollson told the newspaper.

With help from the Mayo Clinic, Ollson became the first person to ever receive a “pogo stick” rebuild. She has one leg fused to her body and one prosthetic leg, along with a prosthetic pelvis.
Ollson is determined to live a normal life after her groundbreaking operation, and is now cancer-free. She uses a wheelchair, a walker or crutches, but is not afraid to move around, however she can.

"I have no problem getting around. If I need to, I'll crawl (up stairs) or scooch like a kid," she said. "I don't want people to think 'we can't invite the Ollsons because they can't get in here with a wheelchair.' I want to live life to its fullest," she said.

Click here to read more from The Winnipeg Free Press.

The electric potato: How zapping a spud 'could make it a healthy food'

Scientists have found a way of making potatoes healthier - zapping them with electricity.

Giving the vegetable an electric shock makes it more nutritious, they found.

The electricity tricked potatoes into producing a rush of antioxidants credited with keeping the body and brain healthy, a conference heard last night.

Scaled up to an industrial level, the apparently inexpensive process could give potatoes a whole new image. Other tests in the same study found that using ultrasound on potatoes had a similarly beneficial effect.

Spud shock: Scientists zap a potato with ultrasound

Researcher Kazunori Hironaka said: 'Antioxidants found in fruits and vegetables are considered to be of nutritional importance in the prevention of chronic diseases, such as cardiovascular disease-various cancers, diabetes and neurological diseases.'

Inspired by the observation that drought, bruising and other natural challenges, or stresses, led to vegetables making more ant ioxidants, Dr Hi ronaka decided to investigate man-made means.

Grapefruit’s sour taste holds a sweet promise for diabetics

New joint research by scientists at the Hebrew University of Jerusalem and Harvard University’s Massachusetts General Hospital (MGH) has demonstrated the mechanism by which a single compound in grapefruit controls fat and glucose metabolism, replacing multiple drugs. Naringenin, an antioxidant derived from the sour flavor of grapefruits and other citrus fruits, may cause the liver to break down fat while increasing sensitivity to insulin – a process that naturally occurs during long periods of fasting.

The US-Israeli team reports that naringenin activates a family of small proteins called nuclear receptors, causing the liver to break down fatty acids. In fact, the compound seems to mimic the actions of other drugs, such as the lipid-lowering fenofibrate and the anti-diabetic rosiglitazone, offering the advantages of both. If the results of this study extend to human patients, this dietary supplement could become a staple in the treatment of hyperlipidemia, type-2 diabetes and perhaps metabolic syndrome, the precursor of diabetes. The report appeared two weeks ago in the online journal PLoS (Public Library of Science) One.

“It’s a fascinating find,” says senior author Dr. Yaakov Nahmias of HU. “We show the mechanism by which naringenin increases two important pharmaceutical targets, PPAR alpha and PPAy, while blocking a third, LXR alpha. The results are similar to those induced by long periods of fasting.” The liver is the main organ responsible for the regulation of carbohydrate and lipid levels. Following a meal, the blood is flushed with sugars, which activate LXR alpha, causing the liver to create fatty acids for long-term storage. During fasting, the process is reversed; fatty acids are released by fat cells, activate PPAR alpha in the liver, and are broken down to ketones. A similar process, involving PPARy, increases sensitivity to insulin.

“It is a process which is similar to the Atkins diet, without many of the side effects,” says Dr. Martin Yarmush, director of the MGH Center for Engineering in Medicine and one of the paper’s authors.
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Daily vitamin pill could reduce dementia's effects by up to 50 per cent

Scientists unveiled the latest weapon in the battle against Alzheimer's disease yesterday – a humble vitamin.

Researchers from the University of Oxford have found that taking tablets of three B vitamins every day slows the brain shrinkage that happens with age, causing early signs of dementia such as memory loss.

In a two-year trial, the vitamin supplement delayed the rate of brain atrophy by up to half in a group of elderly people, with a more than 30 per cent reduction overall. Cognitive tests show those with the least shrinkage perform best.

A vitamin pill that curbed the mental decline associated with ageing would have colossal implications. About 1.5 million people in the UK, 14 million in Europe and five million in the US have problems with memory, language or other mental functions known as Mild Cognitive Impairment (MCI), half of whom go on to develop Alzheimer's or another form of dementia within five years. Even a slight slowing of this process would have immense human and economic benefits. However, the researchers said it was too soon to recommend elderly people suffering memory lapses should take B vitamin supplements, until further studies had confirmed the benefits and risks. MORE

Ancient DNA reveals ingredients of Roman medicine

Ancient Roman pharmacies must have looked a lot like vegetable gardens. DNA analysis of 2000-year-old medicinal tablets suggests the pills included onions, carrots and other garden vegetables.

Medical texts written by Pliny the elder and others detail herbal remedies the Romans and Greeks used, but not a lot is known about the contents of individual tablets, says Robert Fleischer, a geneticist at the Smithsonian Conservation Biology Institute in Washington, D.C. He presented early results from the analysis at the International Symposium of Biomolecular Archaeology in Copenhagen, Denmark yesterday.

51 Fantastic Uses for Baking Soda

Baking soda, aka sodium bicarbonate, helps regulate pH—keeping a substance neither too acidic nor too alkaline. When baking soda comes in contact with either an acidic or an alkaline substance, it’s natural effect is to neutralize that pH. Beyond that, baking soda has the ability to retard further changes in the pH balance, known as buffering. This dual capability of neutralizing and buffering allows baking soda to do things such as neutralize acidic odors (like in the refrigerator) as well as maintain neutral pH (like in your laundry water, which helps boost your detergent’s power). It’s a simple reaction, but one that has far-reaching effects for a number of cleaning and deodorizing tasks.

Personal Care

1. Make Toothpaste
A paste made from baking soda and a 3 percent hydrogen peroxide solution can be used as an alternative to commercial non-fluoride toothpastes

You can also just dip your toothbrush with toothpaste into baking soda for an extra boost.

2. Freshen Your Mouth
Put one teaspoon in half a glass of water, swish, spit and rinse. Odors are neutralized, not just covered up.

READ THE REST

9 Easy Ways to Save Your Heart

Wednesday, September 8, 2010 8:08 AM

By Sylvia Booth Hubbard

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Cardiovascular disease has been the No. 1 killer of Americans for more than a century, but you don't have to become the latest statistic. Simple strategies that take little time or effort can lower your risk of heart disease. Follow these easy tips and tricks all backed by research to keep your ticker ticking for many years to come.

1. Drink pomegranate juice

Learn to love pomegranate juice. According to the National Academy of Sciences, heart cells treated with it produced 50 percent more nitric oxide, a substance that fights plaque and staves off hardening of the arteries, and may even reverse it.

Next: Get Enough Dairy

Cockroaches: The Antibiotics of the Future?

Cockroaches, the creepy critters reviled for invading kitchens the country over, might be modern medicine's best option for fending off dangerous, drug-resistant bacterial infections.

British researchers at the University of Nottingham's School of Veterinary Medicine and Science are behind the discovery, which entails harnessing molecules from the tissues of cockroaches and locusts to combat bacteria like E. coli and MRSA (drug-resistant staph infections).

A Thai official displays Madagascar hissing cockroaches.

Sakchai Lalit, AP

Chemicals found in the brain and central nervous tissues of cockroaches are able to kill 90 percent of dangerous bacteria in lab-based tests.

The potent chemicals, found in the brain and central nervous tissues of the critters, are able to kill 90 percent of E. coli and MRSA in lab-based tests.

"Superbugs ... have shown the ability to cause untreatable infections and have become a major threat in our fight against bacterial diseases," Dr. Naveed Khan, who supervised the work of lead researcher Simon Lee, said in a press release. "Thus, there is a continuous need to find additional sources of novel anti-microbials to confront this menace."

In a twist that's an ironic upside to our own revulsion for roaches, it's their "unsanitary and unhygienic environments," Lee speculated, that spurred the critters to develop toxins against the bacteria.
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