Month: June 2008

By Ron Paul

Oil prices are on the minds of many Americans as gas hits $4 a gallon, and continues to surge.  How high can prices go?  How can we solve these problems?  What, or who, is to blame?

But it's not a war of attrition, it's a war of nutrition, and the flashpoint is Bill C-51. This is the legislation intended to amend the Natural Health Act, which covers natural health products.

"Natural health product" (NHP) is the blanket term for organic supplements said to have medicinal benefits. This includes herbs, vitamins, minerals, amino acids, extracts, fungus, algae, essential fatty acids, and animal materials. It's a huge industry, and a big deal in places like health-conscious Vancouver.

It's not just the NHP manufacturers and retailers who have a stake in this, but the millions of Canadian consumers who swear by the products' health benefits.

Bill C-51 will purportedly protect Canadians from untested NHPs. But with no recorded deaths in Canada from NHPs, the question many Canadians are asking is, why the great urgency to fix something that isn't broken?

One of these critics is lawyer Shawn Buckley, president of the Kamloops-based Natural Health Products Protection Association, who spoke this week at St. Andrew's-Wesley United Church in Vancouver. He says he started "on the other side," representing the Canadian government against a natural health product supplier, but had a "road to Damascus" conversion after the same client asked Buckley to represent him in court.

After years of legislative muscle-flexing against NHPs under both Liberal and Conservative governments, Buckley believes the NHP industry now faces a complete "takedown" from Health Canada.

The Canadian government assumes every natural health product in Canada is dangerous, until it completes the licensing process. Almost all the products you see on health food store shelves are without licences. But Health Canada has allowed them to remain on the shelves for now, because their manufacturers have applications pending. The odds are not favourable. According to the Natural Health Products Protection Association, an estimated 60 per cent of licence applications fail.

Small players in the NHP industry don't have the finances to conduct double blind scientific studies of their own. If Health Canada says they have to remove their products from the shelves, they have to comply, and the government is under no obligation to show them documentation why. Under Bill C-51, NHP manufacturers face up to $5 million for an indictable offence and two years in prison.

The bill has other amendments that would make Joe Stalin nod in approval, Buckley insists. It eliminates the law of trespass, one of the foundations of civil law. Through its enforcement, police are allowed to venture onto property–and seize property–without a warrant.

"I was taught to hate the Communist state because where they were on property rights," says the lawyer of his Cold War youth. Now he believes Canada is picking up some nasty totalitarian habits, under the pretext of protecting Grandma from a bottle of rogue ginseng.

Health Canada critics say that the real purpose of Bill C-51 is to bring Canada into compliance with Codex Alimentarius, a United Nations initiative to globally "harmonize" food and supplement standards.

There's little doubt that there are some NHPs out there with exaggerated health claims. But you could say the same about many pharmaceutical drugs. The major difference is that legal drugs are far more likely to kill you than NHPs. According to New Zealand risk analysis researcher Ron Law, "of the more than two million visits to U.S.A. emergency departments due to poisoning, less than 10 (.000005) were related to fatalities associated with natural health products, whilst 78 per cent of the fatal poisoning cases were associated with pharmaceutical products."

NHPs aren't just safer than physician-prescribed pharmaceutical drugs, they're safer than ordinary store-bought food, says Law. Let that thought roll around in your head for a bit. You are at a greater risk of dying from a ham sandwich on a hot summer afternoon than a natural health product.

As Buckley pointed out in his talk, peanut butter is riskier than any NHP, yet the Canadian government has no "Peanut Butter Directorate" investigating candy bar makers. In terms of tilting at windmills, Tony Clement and his foot soldiers couldn't have mounted a more Quixotic campaign.

Friday, June 06, 2008

FLOYD, Va. —  Starchild Abraham Cherrix has plenty of reason to celebrate his 18th birthday Friday.

June 6, 2008 — Diabetes patients who use Regranex gel to treat dangerous foot and leg ulcers may have a fivefold higher risk of dying from cancer, the FDA today warned.

The FDA will ask Regranex maker Ethicon (a division of Johnson & Johnson) to put a "black box" warning label on the drug. The black-box warning is FDA's highest warning level.

"In announcing this label change, FDA still cautions health care professionals to carefully weigh the risks and benefits of treating patients with Regranex," Susan Walker, MD, director of the FDA's Division of Dermatological and Dental Products, says in a news release. "Regranex is not recommended for patients with known malignancies."

The cancer finding comes from an  FDA review of a postmarketing survey that suggested there might be a link between Regranex and cancer.

"FDA has now completed its review of the study and has concluded that the increase in the risk of death from cancer in patients who used three or more tubes of Regranex was five times higher than in those patients who did not use Regranex," the FDA reports.

Despite this fivefold increase in risk, the finding is based on only four excess cases of cancer, according to an Ethicon news release.

"We remain committed to the safety and efficacy of this product when used according to its label," Ethicon spokeswoman Jackie Jankewicz tells WebMD.

Regranex is a medicine that is a genetically engineered form of a human growth factor that helps wounds heal faster. It is a huge benefit to diabetic patients with slow-healing wounds on their legs or feet that often result in amputation of the affected limb.

Because Regranex makes cells grow faster, there has been concern that it will also make cancer cells grow more quickly. That's why Ethicon has monitored patients since the drug was approved in December 1997.

There's no evidence that Regranex causes new cancers, although the follow-up study has not gone on long enough to rule out this possibility.

By EMILY FRIEDMAN

As Cassandra Jackson watched her 10-year-old son Johnny splash around in their neighborhood pool last week, she had no reason to believe anything was wrong — let alone that her son was slowly drowning.

"He seemed to be fine," Jackson, 41, told ABCNEWS.com from her home in Goose Creek, S.C. "I noticed nothing out of the ordinary, other than him taking a little bit of water in and coughing and then calming down."

Jackson estimated that Johnny had been in the pool for 45 minutes and had been wearing floatation devices on each arm, in addition to being monitored by an adult in the pool, as well as herself and a friend watching from pool chairs nearby.

But less than two hours after getting out of the pool, Johnny had defecated in his pants twice and was complaining of being tired.

After being bathed and dressing himself, Johnny walked to his bed unaided, leading his mother to believe that he was simply tired from playing in the water.

But shortly after leaving him to nap, Jackson discovered her son unconscious and his face covered in a foam-like substance.

"My friend went back into the room where Johnny was sleeping and noticed what appeared to be cotton balls stuffed in his nose," Jackson said of what turned out to be the foam from his nose and mouth. "She asked if I put them there and I said no — I went in and saw him and screamed for help.

"I rolled him over and his body was very limp and I realized he'd soiled himself again and was very purplish-blue looking," said Jackson, who then called 9-1-1. "His tongue was really swollen, too."

Johnny suffered from cardiac arrest on the way to the hospital, his mother said, and was pronounced dead upon arrival.

Berkeley County Coroner Glenn Rhoad examined Johnny's body after the incident and told ABCNEWS.com that the preliminary autopsy showed the cause of death was asphyxiation due to drowning. Rhoad added that the boy had a lot of water in his lungs.

While Johnny had been diagnosed with Attention Deficit Disorder and autism, there is no reason to believe that either condition had anything to do with his death, the coroner said.

How Johnny managed to walk out of the pool and into his bed, communicating with his mother along the way, seems mysterious — but doctors said Johnny may have suffered from a sort of secondary drowning or near drowning, as some refer to it. 

What Happened to Johnny?

"With primary drowning, you inhale water and you can't breathe and you die right away," said Stephen Epstein, a spokesman for the American College of Emergency Physicians. "But with secondary drowning, you die because of a secondary injury to the lung caused by a small amount of the water getting into the lung."

Johnny would have only had to inhale four ounces of water to drown, and even less to injure his lung enough to become a victim of secondary drowning, Epstein said.

"Depending on what's in the fluid, it can have numerous effects on the lung," said Epstein, who practices at Boston's Beth Israel Deaconess Medical Center. "One of the things that keeps the breathing bubbles in your lungs — alveoli — open is a chemical called surfactant, which can get diluted [when fluid enters the lungs]."

What results when the surfactant is diluted and the lung is not working properly, said Epstein, is that the body's natural reactor kicks in and sends other fluids from your body to help — flooding your lungs with fluids.

"Sometimes the body has a natural reaction that is not helpful," Epstein said of this phenomenon. "The fluid comes out of your blood stream and invades the lung, and then we have a lot of fluid inside the lung, leaving no room for the air.

"Then you have pulmonary edema," said Epstein.

Pulmonary edema, or the accumulation of fluid in the lungs, Epstein explained, can later result in cardiac arrest, as oxygen is prevented from getting into the blood stream and eventually stops the heart from beating.

Johnny's death may have also been a result of the chlorine in the pool water, Epstein said.

"The concentration of the water [Johnny swallowed] could have caused a lot of inflammation in the lung," Epstein said. "And then, the body's reaction to inflammation is to send in all sorts of fluids to fight it — and with that, your lungs are filled with fluid."

Parents Must Monitor Swimming Children Closely

Water safety experts advise parents to keep a constant eye on their playing children, and be aware of complaints of difficulty breathing.

"People — especially children — need to be supervised around the water with vigilance, even if there are lifeguards present," said Gerald Dworkin, a water safety expert, who has developed safety training programs since 1984 for Life Saving Resources. "Anyone who has been submerged and has aspirated should seek medical attention."

The Centers for Disease Control estimates there were 3,582 fatal unintentional drownings in the United States in 2005, the most recent year for which data is available, and more than one in four drownings are children, 14 and younger. The CDC does not keep statistics on the number of secondary drownings.

Jackson says she is certain there is nothing she could have done to prevent her son's death, but hopes that, by sharing her story, other parents looking ahead to a summer filled with swimming, will be more cautious.

"If your child comes out of the pool and seems sleepy or lethargic, watch them very, very closely," Jackson said. "Rush them to the hospital or call 9-1-1 immediately."

"It's better to be safe than sorry."

By Roger Harrabin