December 13th, 2010
The maker of the painkiller Darvon is pulling the drug off the market under pressure from public health officials who say it causes dangerous heart rhythms.
The Food and Drug Administration says the drugmaker Xanodyne will halt marketing of Darvon and related brand Darvocet. The FDA has also called on generic drugmakers to stop marketing low-cost versions of the drug.
The FDA action puts the U.S. in line with Britain, which banned Darvon several years ago due to suicides and accidental overdoses.
Darvon, first approved in the 1950s, is an opioid used to treat mild to moderate pain.
Dr. Manny Alvarez, senior managing health editor of FoxNews.com, said Darvon is still prescribed for chronic pain, mostly in generic form, although not very often.
“These types of drugs are in a class of their own,” Alvarez said. “They are old and there are certainly newer drugs that are far more sophisticated and even safer.”
The consumer watchdog group Public Citizen had petitioned the FDA to ban the drug, saying its benefits didn’t justify a risk that added up to several hundred deaths a year.
September 28, 2010
The Washington Post
By: Arthur Allen
For most parents with young children today, whooping cough is a disease that exists in vintage movies or the Burl Ives song where it causes a chicken to “sneeze his head and tail right off.”
But whooping cough is far from a whimsical memory. It is staging a comeback in California, in what public health officials worry could be a harbinger of a national trend.
Nine infants have died of the disease in California this year, and more than 600 other babies have become desperately ill. To keep them alive, doctors have sometimes resorted to blood transfusions, hooking the babies up to devices resembling heart bypass machines. More than 4,100 cases have been reported so far, creating what officials call the worst pertussis epidemic in the state since 1955.
The resurgence of the highly contagious disease is particularly alarming because most children in California, as in the rest of the country, have received six doses of vaccine by age 12.
A combination of factors may be to blame.
In California it is legal and quite easy to refuse vaccination, and the discredited theory that vaccines cause autism has created clusters of unvaccinated children. In affluent Marin County north of San Francisco, for example, about 13 percent of parents refused vaccination for their kindergartners in 2009, according to the state’s Department of Public Health. Marin has one of the highest rates of infection this year.
Pertussis is more infectious than smallpox, polio or influenza, and it spreads quickly through the unprotected. It often escalates from what seems to be a regular cold into a severe respiratory infection that causes some patients to gasp for air with a distinctive high-pitched whooping sound.
But while shunning vaccine is probably playing a role in the epidemic, particularly in some areas of the state, it isn’t the only cause, according to Kathleen Harriman, California’s chief epidemiologist for vaccine-preventable diseases. Better detection explains some of the increased reports of pertussis. But Harriman and other experts worry that the epidemic could also point to serious problems with the current vaccines.
In the view of some pertussis experts, the vaccines in use since the mid-1990s aren’t as effective as some of the vaccines they replaced.
“The acellular vaccines simply aren’t as good as the good whole-cell vaccines,” says James Cherry of UCLA, who has studied whooping cough for the past 30 years.
Those whole-cell vaccines, developed in the 1940s, were made by deactivating whole pertussis bacteria. While they were effective against whooping cough, they caused seizures and high fevers in some children and were blamed for rare cases of brain damage. The controversy over the whole-cell vaccines began in the late 1970s and never really ended, but they were replaced in the United States by vaccines that instead contained varying amounts and types of purified pertussis proteins.
These acellular vaccines were safer and are said by the Centers for Disease Control and Prevention to be 80 to 90 percent effective. But Cherry believes that the trials that established this figure – most of those studies were done in Europe – overestimated the degree of protection. Sometimes the vaccines prevented classic whooping cough, but the patients got lighter versions of the disease and were still contagious, said Cherry, who was involved in the trials.
Frits Mooi of the Dutch National Institute of Public Health and the Environment, holds another disturbing view. His research shows that pertussis bacteria have evolved mechanisms to evade vaccine-produced immunity.
While he emphasized, in an e-mail exchange, that increased vaccination is still the best way to lower the pertussis rates at present, in the long run public health officials can’t avoid facing the evidence of bacterial mutation and “should strive for pertussis vaccines that protect longer.”
Although Cherry and other experts are skeptical about whether the pertussis evolution found by Mooi has diminished vaccine effectiveness, they agree with him on one unpleasant fact: Unlike with many other diseases against which we immunize, such as measles, vaccination doesn’t always prevent you from getting whooping cough. Neither, in fact, does natural infection.
“My one-line explanation is, ‘There’s no such thing as being fully vaccinated against pertussis,’ ” said Thomas Clark, a leading pertussis tracker at the Centers for Disease Control and Prevention in Atlanta. “Your immunity is always waning over time.”
Decline, then revival
Despite current concerns, there is no question that vaccines have done a good job at suppressing a disease that used to be a scourge. Before the introduction of whole-cell vaccines, whooping cough was at best an unpleasant passage of childhood, at worst a deadly tragedy. It claimed up to 10,000 lives each year in the United States.
As vaccination became widespread, the number of U.S. cases declined by more than 99 percent. But after bottoming out in 1976, the numbers began to creep up, especially in the past decade. In 2009, according to the CDC, there were nearly 17,000 reported cases, including 14 deaths nationally.
The acellular vaccines prevent disease in many people, and when disease occurs it is less serious in the vaccinated. Of the nine fatalities in California, eight were children too young to be vaccinated. The ninth child was 2 months old, had been born very premature and had received one shot.
Whooping cough is a cyclical disease. The last nationwide peak year was 2005, when more than 25,000 cases were reported and 39 people died.
There’s no sign of a major outbreak this year in this region, with only 89 cases reported so far in Maryland and about 150 in Virginia. In both states and the District, it is much more difficult than it is in California for parents to exempt their children from vaccination.
But CDC officials say the California epidemic could herald a wider spread and are recommending that parents make sure their kids are vaccinated. Last week, officials in Indiana and South Carolina said they were seeing an upsurge of the disease.
Before 2005, there was no persussis-containing vaccine for anyone older than 6. Since then, booster vaccines have been licensed, and most jurisdictions, including Maryland, Virginia and the District, require adolescents to get a booster by age 12.
Public health authorities are urging adults to get boosters, too, especially hospital employees, new mothers and others in contact with vulnerable infants.
November 30, 2009
By Paul Harasim
George Anter knows he has a lot to be thankful for during the holidays.
The heart he received during a transplant procedure 12 years ago, for which he gives thanks every day, continues to do its job.
He has won bouts with prostate and skin cancer, and his non-Hodgkins lymphoma remains under control with chemotherapy.
His four children and four grandchildren are thriving in their careers and in school.
And in December, Anter and his wife, Madeline, will celebrate their 53rd wedding anniversary.
But as grateful as he is, the 74-year-old Anter admits one thing will be bugging him during the holidays.
“The truth is,” the retired paper sales executive said last week, “when I think about not being able to get a swine flu shot, I get real pissed off.”
Two months after H1N1 flu vaccine was first distributed to public health districts around the country, people 65 and older with serious medical conditions still can’t get vaccinated.
Anter’s doctors at Stanford University Hospital, where he received his transplant, tell him he has a compromised immune system and “the H1N1 flu could do me in.”
He takes at least nine prescription medications daily to stay alive.
“But when I try to get a shot, I’m told I’m too old ” he said as he sat in the study of his Peccole Ranch home.
“I feel that they see me and other older people as garbage and are just waiting for the trucks to come pick us up,” Anter said.
“I served my country. I enlisted during the Korean War. You don’t treat people this way just because they’re older.”
The priority groups for the vaccine, which public health officials say is still in short supply, remain pregnant women; people who live with or care for children younger than 6 months; health care and emergency first responders; persons between 6 months and 24 years of age; and adults up to 64 with chronic health conditions.
The evidence has shown that, as a group, seniors need the vaccine less than younger age groups, according to Dr. Anthony Fiore with the federal Centers for Disease Control and Prevention.
And when there is a vaccine shortage, he said, you must prioritize.
Public health authorities admit they have been inundated with calls from the elderly who want to know when they can receive vaccinations.
Many seniors have called the Review-Journal to complain. Some refrain from giving their names because they fear their complaints could cause their Social Security benefits to be cut off.
No one knows when the system will change.
“We are working collaboratively with the Nevada State Health Division and other local health authorities in the state to determine if the state is in the position to expand vaccine availability,” Stephanie Bethel, a health district spokeswoman, said in an e-mail.
Mary Ann Sokol, a 79-year-old cancer and heart attack survivor profiled by the Review-Journal in August after the priority groups were announced, said last week she and her husband no longer go out to dinner for fear her compromised immune system won’t be able to fight off the H1N1 virus.
“I have to admit I’m sometimes really scared,” she said. “When I feel that way, I always wear a mask when I go out.”
When public health officials realized last August that the vaccine would be in short supply this fall, they studied the 44,000 cases of the virus that had been reported to the CDC since the outbreak began in April.
Seniors were affected the least, Fiore said. It appeared that older people have a pre-existing immunity to the H1N1 virus.
CDC researchers suggested that the immunity older adults appear to enjoy was built up either because they were infected with or vaccinated against an older seasonal flu strain that closely resembled H1N1.
Americans up to 24 years of age are about 20 times more likely to contract the virus than people older than 65.
People ranging in age from 25 to 49 are five times more likely to be hit by the virus than seniors.
And men and women in the 50 to 64 age bracket have a three times greater chance of catching the virus than those older than 65.
Anter is familiar with the statistics. But he says many seniors have underlying medical conditions that render their immune systems defenseless.
“You’ve got to make exceptions for people with very serious health conditions,” he said.
Exceptions aren’t favored by public health officials, however, including those with the health district who have repeatedly said that this would slow down the process of trying to contain the outbreak.
And private physicians who have enrolled in the H1N1 vaccine provider program aren’t supposed to bypass public health regulations. They sign documents saying they will abide by the program’s designated priorities if given vaccine to distribute.
The health district had stockpiled thousands of doses of vaccine while claiming there wasn’t enough vaccine to vaccinate those between the ages of 25 and 64 with chronic health conditions.
Then, earlier this month, state health officials forced the health district to start vaccinating that group.
The district still has nearly 50,000 doses of vaccine on hand, as of Wednesday.
“Why not give it to those who need it?” Anter said. “They’ve given clinic after clinic to those they said were in priority groups, and they still have it left over.”
Martha Framsted, a state health division spokeswoman, has said public health officials are continually reviewing the situation to see when vaccinations can be made available to more Nevadans.
“We want to give it to everybody,” she said.
But Anter doesn’t see any sense of urgency.
“When you get as old as I am, they see you as a big zero,” he said. “They don’t really care if we die.”
October 27, 2009
Campaign for Liberty
By Adam Murdock
The H1N1 “swine” flu is an extraordinarily deadly virus.
You need to get the vaccine or you could suffer the consequences.
So-and-so has died in your neighborhood. Do you want to be next?
The above statements are typical of the lines that have been fed to the people of the world from the controlled media. In fact, the drum beat has been so deafening that you would think that people were dropping like flies. Sure there have been some deaths related to the flu but most have affected individuals with risk factors such as pre-existing lung conditions or people who are immunocompromised. Most healthy individuals that I have personally seen and in general have experienced nothing more than run of the mill flu symptoms.
Unfortunately, a lot of the hysteria has arisen out of disinformation or lack of information. I am going to address some of the disinformation by posing a few questions. First, do people die from the virus itself? And, if so, why do some individuals succumb to the virus and not others? The answers to the above questions are not commonly known but are pretty well established in the medical community. The facts are that the flu virus is seldom the sole cause of death, even among compromised individuals. In fact, many of the fatal cases arise from individuals that acquire bacterial superinfections. These bacterial infections arise after the lining of the lung is damaged by the virus which leaves the lung susceptible. The reason for this is that the lining of the lungs are critical for the removal of infectious elements and debris acquired during inhalation or from the upper respiratory tract. When these normal mechanisms breakdown or are already impaired, as is the case in pre-existing lung conditions, fatal bacterial infections can arise. It is these infections that are frequently the culprits in the flu. A result of this knowledge is that, I, as a physician am particularly cognizant of examining patients with presumed flu for signs and symptoms of pneumonia and in particular bacterial pneumonia.
What facts about the 1918 flu made some infectious disease experts worried about the swine flu this time around? The timeline of the 1918 flu was really composed of two flu seasons. The particularly virulent form of the flu was preceded by a mild flu much earlier in the season. It is believed that the milder form of the flu was able to acquire virulence factors by “mutating” into a more virulent form that affected younger, healthier patients. It was the second more virulent form that was the cause of the millions of deaths. Or was it? The media and public health officials like to blame all the deaths on the flu. As usual, there are some “confounding” variables, which in the case of the flu are other variables that may have affected the outcomes of flu victims. The first variable was sanitation. The cities of the early twentieth century were not known for their high sanitation standards. Nor was the importance of methods for preventing transmission of the virus such as hand washing and limited close contact understood. The second variable was an understanding about the virus itself and how it spreads, which as you might expect was rather limited at that time. Finally, treatment for flu patients at the time consisted entirely of supportive care. The advent of antivirals and antibiotics for the treatment of bacterial complications of the flu had yet to be invented. These factors greatly contributed to the mortality of the disease.
What about this year’s swine flu? This year’s flu also started earlier in the year, somewhat like the 1918 virus and has been relatively mild. The fear was that this virus would also acquire the factors that would make it more virulent. It is this question that has generated all the hysteria and government intervention.
This leads me to the next question: Did we really need all the hysteria over a highly speculative event with little probability of happening?
October 21, 2009
By Evelyn Pringle
The pharmaceutical industry, with public health officials and the mainstream media acting as a mass marketing team, is about to pull off the biggest profiteering scheme in the history of the world. The swine flu hoax, perpetrated on a global level, will generate unheard of profits from a non-existent pandemic.
The Obama administration declared the spread of swine flu a public health emergency on April 26, 2009. The Associated Press reported that “Swine flu is now formally a pandemic, a declaration by U.N. health officials that will speed vaccine production and spur government spending to combat the first global flu epidemic in 41 years,” on June 11, 2009.
“WHO chief Dr. Margaret Chan made the long-awaited declaration after the U.N. agency held an emergency meeting with flu experts and said she was moving to phase 6 — the agency’s highest alert level — which means a pandemic is under way,” the AP advised.
Since the “highest alert” warning was issued, the only estimation that has turned out to be true is that the drug companies are experiencing a windfall of tax dollars pouring into their coffers.
The US government “has committed $1.8 billion to companies to make a swine flu vaccine,” Reuters reported on September 30, 2009, in an article with the headline, “Big pharma jumps back into flu business.”
“Three big U.S. pharmaceutical companies announced vaccine deals this week,” Reuters noted, for companies that included Johnson & Johnson, Abbott Laboratories and Merck.
“Abbott Labs bought a Belgian drug business, along with its flu vaccine facilities, for $6.6 billion. Johnson & Johnson invested $444 million in a Dutch biotech firm (Crucell) that makes and develops flu vaccines. Merck which already makes vaccines for shingles and other diseases, struck a deal to distribute flu shots made by Australian CSL,” ABC News reported on October 14, 2009
“Smaller biotechs are also angling for a slice of the action, making vaccines one of the fastest-growing areas of research in the biotech industry,” ABC noted.
Dr Robert Belshe, director of Saint Louis University’s Center for Vaccine Development, told Reuters that the US is on the verge of recommending that all citizens get a flu shot. “We’re at 270 million people who should get vaccinated. It’s a big market. I think manufacturers are just now catching up,” he said.
“The vaccine market is booming. It’s an enormous growth area for pharmaceuticals at a time when other areas are not doing so well,” Bruce Carlson, a spokesperson for the market research firm Kalorama, told ABC News.
On October 1, 2009, under the headline, “Vical shares soar on Navy’s H1N1 contract,” Fierce Vaccines advised that: “Anyone doubting just how hot H1N1 news is right now should check out Vical’s stock price this morning.”
“The developer announced a modest $1.3 million contract with the Navy to fund the manufacturing and testing of its swine flu vaccine and the company’s stock shot up 22 percent,” the report said.
On September 29, 2009, Reuters noted that the H1N1 flu pandemic is not “the first flu outbreak to have lifted the shares of small vaccine makers.”