Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Tuesday, July 08, 2008

Did you hear, there's a RABIES VACCINE SHORTAGE?!

Oh you didn't know? Well neither did I, until early today when I took my sons to our local travel clinic.

I thought my lack of knowledge may have been due to being on vacation visiting my parents in Denver at the end of June. When does one really stay as attuned to all the news that affects them when they are visitng family?

So I came home from the tavel clinic today and checked on Dailykos. The result, searching with the keyword either "rabies" or "Rabies" was zero. Nothing, nada, goose egg.

So I went to google news and searched using the words "Rabies Vaccine Shortage." There are, as of this writing, 38 stories written on this subect for the past month.

Newspapers like the Sioux Falls Argus Leader (Sioux Fall, SD), the Daily Camera (Boulder, CO), the Bloomington Pantagraph (Bloomington, IL), and the Dallas Morning News.

According to the google news search, one or two local tv stations have added the story to their web sites and but for a few specialized news sources like American Academy of Pediatrics (subscription required) and Small Animals Channel the only national coverage has been a 5 paragraph article from United Press International (UPI)

For most of us in the USA our "contact" with rabies has been through the movies like "Old Yeller" and Cujo or have pets who need to be vaccinated, and it actual effects, are relatively small.

from Wikipedia

Rabies (Latin: rabies, "madness, rage, fury" also "hydrophobia") is a viral zoonotic neuroinvasive disease that causes acute encephalitis (inflammation of the brain) in mammals. In non-vaccinated humans, rabies is almost invariably fatal after neurological symptoms have developed, but prompt post-exposure vaccination may prevent the virus from progressing. There are only six known cases of a person surviving symptomatic rabies, and only one known case of survival in which the patient received no rabies-specific treatment either before or after illness onset


snip

Any mammal may become infected with the rabies virus and develop symptoms, including humans. Most animals can be infected by the virus and can transmit the disease to humans. Infected bats, monkeys, raccoons, foxes, skunks, cattle, wolves, dogs or cats provide the greatest risk to humans. Rabies may also spread through exposure to infected domestic farm animals, groundhogs, weasels and other wild carnivores. Rodents (mice, squirrels etc) are seldom infected.

The virus is usually present in the nerves and saliva of a symptomatic rabid animal.[4][5] The route of infection is usually, but not necessarily, by a bite. In many cases the infected animal is exceptionally aggressive, may attack without provocation, and exhibits otherwise uncharacteristic behaviour[5]. Transmission may also occur via an aerosol through mucous membranes; transmission in this form may have happened in people exploring caves populated by rabid bats.

Transmission between humans is extremely rare, although it can happen through transplant surgery (see below for recent cases), or, even more rarely, through bites, kisses or sexual relations.

After a typical human infection by bite, the virus enters the peripheral nervous system. It then travels along the nerves towards the central nervous system. During this phase, the virus cannot be easily detected within the host, and vaccination may still confer cell-mediated immunity to prevent symptomatic rabies. Once the virus reaches the brain, it rapidly causes encephalitis. This is called the "prodromal" phase. At this time, treatment is useless. Then symptoms appear. Rabies may also inflame the spinal cord producing myelitis.

The period between infection and the first flu-like symptoms is normally two to twelve weeks, but can be as long as two years. Soon after, the symptoms expand to slight or partial paralysis, cerebral dysfunction, anxiety, insomnia, confusion, agitation, abnormal behavior, paranoia, terror, hallucinations, progressing to delirium.[citation needed] The production of large quantities of saliva and tears coupled with an inability to speak or swallow are typical during the later stages of the disease; this can result in "hydrophobia", where the victim has difficulty swallowing because the throat and jaw become slowly paralyzed, shows panic when presented with liquids to drink, and cannot quench his or her thirst. The disease itself was also once commonly known as hydrophobia, from this characteristic symptom. The patient "foams at the mouth" because they cannot swallow their own saliva for days and it gathers in the mouth until it overflows.

Death almost invariably results two to ten days after the first symptoms; the few humans who are known to have survived the disease were all left with severe brain damage, with the recent exception of Jeanna Giese


(embolden mine)

The whole article on wikipedia is an interesting read. It covers transmission of rabies through the typical animal bite to 3 organ recipients in the US in 2004, transmission through various corneal transplants all over the world and 3 cases of transmission in Germany in 2005, due to transplants.

You say tahmahtoe and I say tomato

We do not have a rabies vaccine shortage. But we are in a supply limitation situation where rabies vaccine supplies are less than ideal." - CDC rabies chief Charles E. Rupprecht, VMD, PhD (June 26, 2008, WebMD)


The shortfall or "supply limitation situation" happened when two events and maybe even four events coalesced.

The first was when French vaccine maker Sanofi Pasteur (IMOVAX) decided to renovate it’s rabies vaccine plant in 2007. Prior to taking the plant off-line Sanofi Pasteur stockpiled enough vaccine to meet the expected demand to the year 2009.

Sanofi Pasteur produces 50% of the USA’s rabies vaccine. The other 50% comes from Novartis who makes RabAvert(pdf) vaccine.

Everything was thought to be fine and everyone thought the world was set until the FDA discovered “manufactoring problems” with RabAvert. This sent the US market to depend on it's full 100% of it’s rabies vaccine need from Sanofi Pasteur.

Then the straw fell on the camels back.

There has been a steady and drastic increase in rabies exposure among humans world wide. Interestingly enough that increase could be one consequence of global warming. Rabies exposures typically increase in animals as well as humans during warm or "summer" months.

The good news is that the rabbies vaccine short fall/supply limitation situation/shortage does not effect animals. You can still get your animals vaccinated - and you should. Vaccinated animals is one of the ways the CDC is hoping the blunt the shortage.

The bad news is for cave explorers, veterinarians, vet staff, animal control workers, and world travelers, as they are being denied preventative Rabies vaccine. This is so that there is enough vaccine for those who have been exposed or possibily exposed to Rabies (as in cases where there has been a bite but the animal cannot be found).

It is also bad news for countries who vaccinate humans for rabies (because their uncontrolled animal population is too large). These are typically developing nations and they are holding the vaccine to post exposure cases only.

A stitch in time, saves nine.

For those countries, like India, this could prove devastating in the long run. India is one of the countries with an extremely high proportion of rabies in animals. With a human rabies vaccine shortage they may well have an increase in incidences of rabies infection in humans.

World wide 50,000 people die from rabies each year.*


For me, as a mother, who depended on at least my yongest son being vaccinated for rabies before we left on our trip to the developing world, I now have another worry.

This child is my "animal whisperer." He has always had an affinity with animals (he wants to be a vet). When a chick who may have fallen out of it's nest, and some how appeared in our garage, the baby bird would only let my son pick it up and then care for it. I fear that his need to be around animals and his desire to help those he sees as suffering will override all common sense. Getting this vaccination was to add to my piece of mind.

The CDC says the shortage will ease just a little as the FDA releases some of Novartis' vaccine in the coming days. More will be available at the end of July and August. But until supplies are back to normal (which hopefully means in ever increasing amounts to deal with the ever increasing exposures) everyone is encouraged to take the following steps


*Vaccinate all pet dogs, cats, ferrets, and other animals that have frequent contact with humans. Consider vaccinating horses and other livestock.

*Do not let pets roam free.

*Spay or neuter pets to reduce dog and cat overpopulation.

*Don't feed or water pets outside -- even empty bowls attract wild animals.

*Keep garbage securely covered.

*Do not keep wild animals as pets.

*Never handle unfamiliar or wild animals, even if they appear friendly.

*If you see a wild animal acting strangely, report it to animal control officials.

*Bat proof your home in the fall and winter.


(But remember bats are also a line of defense against another consequense of global warming; an increasing mosquito population due to the smaller and less severe killing cold snaps of winter)

I have struggled to decide whether to embed a video I found on the internet while reserching rabies, in this diary. It is of a 2 year old boy who has untreated rabies, his family in the Philippines could not afford the vaccination/cure. It is disturbing, so I will not embed it but I will link to it on both Metacafe and youtube

For more information:
CDC - Rabies
CDC Rabies Just 4 Kids
Rabies.com (sanofi pasteur)
WHO

*****

cross posted at DailyKos

Wednesday, May 30, 2007

I coulda had a V-8, except now it's an FDA regulated drug.

"At the end and beginning of a war, that we have to watch out for ourselves. In between, it's like a country club. But you got to know how to keep your balance. Keep the balance and make the right friends because this war is defiantly winding down."
- John Malkovich, Empire of the Sun
Does it seem to you that the Bush administration, and corporate America are ramping up their attack on middle and poor America? It's been bad but now it seems that they are trying to inflict as much damage as they can in the 1 1/2 years left of this administration.

It's so bad that this administration with it's corporate friendly policies, and acting as their personal police force, is trying to reclassify vitamins, herbs, supplements, vegetable juices, even massage oils and rocks.

This move will be a end the 1994 DSHEA law that made supplements legal and OTC. Have you noticed that you now find things like vitamin E, St. John's Wort, even Cranberry capsules, on the super market shelf. This will end and it will be a big victory for Big Pharma.

It is true that the bill does not directly state that it intends to regulate or restrict access to dietary supplements. However, language within the section establishing the Regan-Udall Foundation grants the FDA new regulatory power to brand food ingredients (and thus dietary supplements) as unsafe utilizing the Critical Path Initiative drug-related risk assessment technology.
- Byron Richards

And we all know the devil is in the details.

What will be affected by this act:

  • All vitamins, nutritional supplements and functional foods will be stripped of their structure & function claims, reducing them to empty labels where virtually nothing at all is allowed to be stated.
  • Vegetable juice will be regulated as a drug. Raw juice retreats will be raided or shut down.
  • Growing and selling common garden herbs will get you arrested as a drug dealer.
  • Massage oils and handheld massagers will be regulated as "medical devices."
  • Yoga props, pilates machines and weight machines will be regulated as "medical devices" and require FDA approval before being sold or used.
  • Raw sprouts and other anti-cancer foods will be regulated as drugs.
  • Bottled water that "treats" dehydration will be regulated as a drug.
  • Massage therapists who use hot rocks as part of their therapy will have the ROCKS regulated as medical devices! (It's true. The FDA will actually look at a pile of rocks and declare, "Those are medical devices!")
  • Functional foods, supplements, vitamins and homeopathic remedies will disappear from store shelves, pending FDA "review." (The only things remaining will be processed junk foods and pharmaceuticals, which is exactly what Big Business wants.)
  • Therapeutic tea products, such as green tea, will be outlawed and confiscated.
  • Vitamin store owners will be arrested and prosecuted for "practicing medicine without a license."
  • Citizens owning personal inventories of "unapproved drugs" (vitamins and herbs) may have their homes raided at gunpoint and their inventories confiscated by armed law enforcement agents.
  • The importation of herbs and functional foods from all countries may be banned.

While drug safety is important, and the governement needs to protect the citizenry from the harmful effects of pharmaceutical companies out of control; herbs, vitamins, vegetable juice, etc. should be left alone. These are time honored remedies and a personal health choice. I mean if you are going to really regulate something, shouldn't you do more to make cigarettes a behind the pharmacy counter, controlled substance?

People like Leslee Unruh can scream all they wants about "Big Pharma," but she and all her Republican friends who support this administration and who have voted to keep them in office and every Republican senator and congressman in Washington are their enablers.

The board of directors is composed of the Commissioner of the FDA, the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, the Director of the Agency for Healthcare Research and Quality, 4 representatives from Big Pharma and Big Biotech, 3 representatives from academia (which is funded by Big Pharma), 2 more from the FDA and NIH, 2 from consumers groups, and 1 from health care providers. This means that the FDA/Big Pharma/Big Biotech voting block always has 13 votes -- to at the most 3. Who are you kidding? This front group foundation is run by the FDA in combination with the industry it is supposed to be regulating. This makes the FDA part of the drug business as a drug company
- Byron Richards

As this corporate/big business friendly, average American hostile, administration winds down expect more and more of this. Keep watch or the social and economic buggering we've been getting from this administration will only get worse.

Send a letter to your senator and congressperson (scroll down to "Health Freedom is on the Line").

More Information:
Understanding the Threat to Dietary Supplements
FDA acquiring new powers to suppress alternative health
U.S. Senate attempts damage control as House braces for onslaught
More Byron Richard's articles