Ad

Showing posts with label treatment. Show all posts
Showing posts with label treatment. Show all posts

Thursday, May 17, 2012

What Did The FDA Rule On Testing New Drug For Chronic Lyme?


So, if there isn't late-stage or chronic Lyme disease, why would the FDA rule on a new drug to treat chronic Lyme?  I have chronic Lyme or late-stage Lyme and we are literally dying to receive a drug treatment.  I have scoured the Internet and the following is the only information I could find.  I could not find the ruling anywhere.

----------------------------------------------------------


FDA to Rule on Testing New Drug for Chronic Lyme

Published 10:15 a.m., Monday, April 2, 2012


Researchers led by Time for Lyme grantee, M. Karen Newell-Rogers, Ph.D, have submitted a pre-IND briefing document to the US Food and Drug Administration, a preliminary step toward developing proposals for clinical testing of a new drug that could one day end the suffering of those with chronic, or long-term Lyme disease.

Stamford, CT (PRWEB) April 02, 2012

“To our knowledge this is the first novel drug candidate that has been proposed for study in the treatment of chronic Lyme Disease post-infection in some time,” said a representative of Viral Genetics, that submitted the proposal for its drug candidate, VGV-L, to the FDA. A response is expected in April.


Tests led by Dr. Newell-Rogers, a professor at Texas A&M Health Science Center College of Medicine and Scott & White Hospital, and a scientific advisor to Viral Genetics, have been conducted for over two and a half years. The results were submitted this month to the FDA, along with a protocol for a proposed human clinical trial designed under the guidance of a leading Lyme clinician at one of the nation’s top medical centers. Testing to date was conducted by Dr. Newell-Rogers with significant contributions from other clinicians at the University of Colorado, Texas A&M Health Science Center and Scott & White Hospital in Texas.

Prior research had established the insight that certain immune characteristics may contribute to whether a person is susceptible or resistant to the development of chronic inflammation as a result of infection. Dr. Newell-Rogers theory proposes a “targeted” peptide to replace or remove the self-peptides and restore a healthy immune response in patients.

Much of the funding for the pre-clinical studies leading to the FDA filing was provided by Time for Lyme, acting in concert with Richard Gerstner, the ex-IBM Executive VP who saw the potential applicability of Dr. Newell’s work, to Lyme disease.

Time for Lyme has raised over $5 million since its founding in 1998 to fund research on Lyme and other tick-borne diseases at esteemed institutions across the U.S., including the establishment and endowment of Columbia University Medical Center’s Lyme and Tick-borne Disease Research Center.

“Time for Lyme is focused on its clear and single mission of promoting research into Lyme and tick borne diseases,” said Peter Wild, executive director of the organization. “At present there is no recognized treatment for Lyme once it has developed into its chronic, long-term state. We are hopeful that Dr. Newell-Roger’s work will provide the solution that long-term Lyme disease sufferers have been hoping for, for decades.”





Press Release
Source: Viral Genetics, Inc.
Viral Genetics Publishes March 2012 Monthly Letter to Shareholders.
Cites Pre-IND Filing with FDA for Lyme Disease, Other Drugs in Pipeline & Progress in Algal BioFuel Subsidiary, VG Energy
Business WireSan Marino, CA (PRWEB) March 14, 2012
Viral Genetics (Pinksheets: VRAL.PK - News) today published its March 2012 Letter to Shareholders. Providing updates on the company’s progress, the letter discusses the recent Pre-IND filing for its Lyme Disease drug candidate, notes other drugs in the pipeline that have developed out of the company’s Metabolic Disruption Technology Platform, and talks about progress in proving the efficacy of the yield enhancement in the company’s algal biofuels subsidiary, VG Energy.
The letter is available on the company’s website at http://www.viralgenetics.com/shareholder-letters/Letter-to-Shareholders-Mar-12.PDF.
About Viral Genetics, Inc.
San Marino, California-based Viral Genetics discovers drug therapies from two platform technologies based on over 60 patents: Metabolic Disruption (MDT) and Targeted Peptides (TPT). Founded in 1994, the biotech company is researching treatments for HIV/AIDS, Lyme Disease, Strep, Staph and drug resistant cancer. A majority-owned subsidiary, VG Energy (www.vgenergy.net), is dedicated to exploring biofuel and agricultural applications for the MDT platform. For more information, visit www.viralgenetics.com.
About VG Energy
VG Energy Inc. is an alternative energy and agricultural biotech company that is a majority-owned subsidiary of Viral Genetics Inc. Using its Metabolic Disruption Technology (MDT), Viral Genetics' cancer research led to discoveries with major consequences in a wide variety of other industries, including production of biofuel and vegetable oils. VG Energy holds the exclusive worldwide license to the MDT patent rights for use in the increase of production of various plant-derived oils from algae and seeds. Application of MDT technology to the biofuel industry could potentially allow it to overcome its major obstacle in the area of production efficiency: namely, an increase in production yields leading to feasible economic returns on investment, allowing renewable biodiesel to be competitive with fossil fuels. For more information, please visit www.vgenergy.net.
SAFE HARBOR FOR FORWARD-LOOKING STATEMENTS:This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical trials, regulatory approvals, and other risks described by Viral Genetics, Inc. from time to time in its periodic reports, including statements about its VG Energy, Inc. subsidiary. None of Viral Genetics' drug compounds are approved by the US Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world, nor are any non-pharmaceutical products of VG Energy, Inc. commercialized. While Viral Genetics believes that the forward-looking statements and underlying assumptions are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Viral Genetics to establish the efficacy of any of its drug therapies in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of those drug compounds in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests including clinical trials on time or at all, the successful outcome of such studies or tests, or the successful commercialization of VG Energy, Inc.’s non-pharmaceutical products. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the forward-looking statements should not be regarded as a representation by Viral Genetics or any other person that the objectives and plans of Viral Genetics will be achieved. 
Contact:BlueWater Advisory Group, LLCBryan Crane, 805-294-3723
Contact:Viral Genetics, Inc.Haig Keledjian, 626-334-5310 
Click here to return to our Press Release selection page. 

Friday, April 6, 2012

Hyperbaric Chamber Controversy

Here is a PDF regarding the subject of the controversy of hyperbarics... click here


Here is a rather entertaining and informative video regarding the controversy...




Here is an old article regarding the controversy of using hyperbaric chambers in sports...



PROBLEMS ASSOCIATED WITH USE OF
THE HYPERBARIC CHAMBER IN SPORTS:
August 23,1996
Update; Nov. 15,1996The following report was sent to all 26 General Managers in the N.H.L. in January 1995

This past season the Vancouver Canucks were using a hyperbaric (oxygen tank) chamber as part of their training program. At the beginning of the season this chamber was used primarily for speeding up recovery time of injured players. Very soon after this the Canucks began to use it on uninjured players. This is when the problems began.

The Canucks management and training staff had been in touch with myself in mid August of 1993 about trying out our ionization system for a period of two weeks (this try out was canceled two days before we were to start). In our meetings before this, the Canucks management had asked me if our system was similar to their hyperbaric system. I told them it was but I was not about to tell them their system could have major drawbacks. (It would have looked like we were trying to put down their hyperbaric system over ours.) In failing to warn the team at the time I must take partial responsibility over the misuse of the hyperbaric system. Thinking the Canucks had a system similar to the one we were proposing there was no need for them to try our system. They began putting players in the chamber who had no injuries, hopefully to improve endurance, reaction time and balance. Initially this seemed to be the case as the Canucks won 7 of 8 games since the beginning of the season. At this time I could not say anything about the problems until they began to surface.

How does the hyperbaric system work ? The chamber is sealed from the outside atmosphere and pressure is increased on the inside of the chamber. The occupant inside the chamber puts on a breathing device that supplies him with 100% pure oxygen. If the player has an injury, the oxygen together with the increase in pressure pushes the oxygen deeper into the injured area. Recovery time can be cut in half for the injured player. I do not dispute these claims.

Why would there be problems using the hyperbaric system? The system is totally cut off from the outside atmosphere. A natural ion count of 5000 ions per cubic centimeter can be measured in nature. This count can fluctuate but no matter where we go, there are ions. In the hyperbaric tank the ion count would be zero. There is no natural or artificial way to produce ionization in the chamber since the corona discharge from an ionizer would cause the oxygen to ignite. Every human being must have ions to survive. It is this reason why the hyperbaric system is so dangerous.

The Russian ion scientist Tchijewsky tried raising mice, rats, guinea pigs, and rabbits in totally de ionized air. Within two weeks almost all of them had died. Despite the fact the autopsies proved they had died for a variety of reasons - fatty liver, kidney failure, heart degeneration, and , among other ills anemia - Tchijewsky concluded that the real cause of death was the animals' inability to utilize oxygen properly.' An organism receiving the cleanest type of air for breathing is condemned to serious illness if the air does not contain at least a small quantity of air ions."

Tchijewsky's colleague D.A. Lapitsky tried raising small animals in air depleted of oxygen. As they were about to die of suffocation he added neg-ions and found that "animals already near death from asphyxiation began to feel better, sat up sniffed the air, and began to run around the chamber. Their respiration frequency increased. Switching off the ionizer again brought them to the verge of asphyxiation." Lapitsky decided the traditional belief that oxygen alone was the sole prerequisite for the creation and sustenance of life had "demonstrated to be false." Or as Tchijewsky had said, "Death of animals in [de ionized] air must be attributed to the absence of aero ions of oxygen essential to the life activity of an organism." More simply put, without ions we couldn't absorb oxygen in the quantities needed to live. And the fewer ions there are, the lower the efficiency of our minds and bodies.

Tchijewsky also discovered increased performance in athletes using negative ion generators in the late 1940's.

In late November side effects from lack of ionization in the players who were using the hyperbaric chamber for injuries became apparent. Two of these players were Gino Odjick and Pavel Bure. Both had come down with flu symptoms and repiratory problems. The Canucks doctors were unable to find the cause of the respiratory problems. I faxed Pat Quinn on Dec. 16, 1993 with an explanation to these problems and background information on problems with the Hyperbaric chamber. He chose to continue using the chamber. In January I talked with Bruce Newton of the Players Association. I explained the problems with the hyperbaric system but he was unable to help me. "The team and the teams doctors were responsible for any training system and the Players Association had no say over those systems."

The fans of Vancouver began to call the Canucks "TEAM SCHIZOPHRENIC". The Canucks were playing poor at home and great on the road. I contacted Pat Quinn by fax again previous to the playoffs to warn him again. He chose to ignore my advice again. I talked to one of the Canuck players just as the playoffs were starting. He confirmed most of the team was using the hyperbaric tank to increase their play.

Word that this news leaked to me must have gone back to management. At this point management gave the doctors and players permission to speak to the media about how the system worked. (The plan was to bury any controversy before it was started).
Why did the Canucks do so well in the playoffs? First, the playoffs took them away from the hyperbaric chamber for extended periods. Second, the brain under environmental stress from increased positive ions or lack of ions produces hormones and chemicals to deal with this stress. The two main hormones released are melotonin and serotonin. Serotonin is increased and fed into the blood stream. The increased serotonin triggers the release of adrenaline which allows the body to work through the stress. Adrenaline is not quickly renewed as are other chemicals in your body. If a body produces to much serotonin for long duration's, the adrenaline gets used up and the chemical system in the body is unbalanced. This is what was happening with these players. A list of side effects from increasing the serotonin levels in your body for a long period of time are as follows:

Anxiety, nervousness, tremors, sweating, dizziness, lightheadedness, dry mouth, upset or irritated stomach, appetite loss, nausea, vomiting, diarrhea, stomach gas, rash and itching.

Less common side effects include changes in sex drive, impotence, abnormal dreams, difficulty concentrating, acne, hair loss, dry skin, chest pains, allergy, runny nose, bronchitis, abnormal heart rhythms, bleeding, blood pressure changes, headaches, fainting when rising suddenly from a sitting position, bone pain, bursitis, twitching, breast pain, fibrocystic disease of the breast, cystitis, urinary pain, double vision, eye or ear pain, conjunctivitis, anemia, swelling, low blood sugar, and low thyroid activity.
In addition, many other side effects affecting virtually every body system have been reported. They are too numerous to mention.

All side effects mentioned are also experienced from the pill Fluoxetine Hydrochloride (PROZAC). Prozac is an antidepressant drug and works on increasing serotonin levels in the body. It is the natural cortisone levels in the body that are triggered by the serotonin. This added adrenaline gives the personality a boost. Long term studies on Prozac and other antidepressants that work on increasing serotonin are finding most patients on these drugs are worse off after treatment than before treatment. The Food and Drug Administration (F.D.A.) has never in their history had as many problems with a drug as they have had with these forms of antidepressants.

Side effects from positive ions winds (such as the Chinook wind in Calgary and the Santa Ana winds in southern California) compiled by a Swiss meteorological report in 1974 are as follows:

Physical side effects: Body pains, sick headaches, dizziness, twitching of the eyes, nausea, fatigue, faintness, disorders in saline (salt) budget with fluctuations in electrolytical metabolism (calcium and magnesium; critical for alcoholics), water accumulation, respiratory difficulties, allergies, asthma, heart and circulatory disorders (heart attacks approx. 50% higher) low blood pressure, slowing down in reaction time, more sensitivity to pain, inflammations, bleeding embolisms of the lungs, and thrombosis.

Psychological side effects: Emotional unbalance, irritation, vital disinclination, compulsion to meditate, exhaustion, apathy, disinclination or listlessness toward work (poor school achievement), insecurity, anxiety, depression (especially after age forty to fifty); rate of attempted suicide about 20% higher, larger number of admittance's to clinics in drug cases.

In over 90 years since ions were discovered, no side effects have ever been found from negative ions.
SOURCE: 



Here is information (only a piece) from Cancer.org about the use of hyperbaric chambers for therapy.  This is positive information that tells me that they are not dangerous and that more illnesses should be treated through the use of this therapy, and that it should be covered by insurance.

What is the evidence?
There is scientific evidence showing HBOT works to treat a number of conditions. The Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medicine recommends it for treatment of:
  • Decompression sickness
  • Arterial gas embolism (bubbles of air in the blood vessels)
  • Carbon monoxide poisoning (with or without cyanide poisoning)
  • Delayed radiation injury of the soft tissue or bones, including osteoradionecrosis
  • Gas gangrene (a serious infection)
  • Skin grafts and flaps that are not healing well with standard treatment
  • Soft tissue infections in which tissues are dying (necrotic)
  • Anemia due to severe blood loss (when transfusions are not an option)
  • Crushing injuries in which there is not enough oxygen to the tissues
  • Certain wounds that are not healing with standard treatment
  • Thermal (heat) burns
  • Abscess in the brain or head
  • Osteomyelitis (chronic bone inflammation) that does not respond to standard treatment
  • Blockage of the retinal artery (blood vessel in the back of the eyeball)
These are considered to be proven uses of HBOT. For some of these conditions, HBOT is the preferred treatment. For some others, HBOT is one of many treatment options to consider. 
There is conflicting evidence about whether HBOT is helpful in treating fast-spreading infections of the skin and underlying tissues. 
A Swedish study of 94 people with diabetic foot ulcers were divided into 2 groups: one group used HBOT for 85 minutes a day, 5 days a week, for 8 weeks (40 treatment sessions) for treatment, and the other had placebo sessions. Of the group that was supposed to get HBOT, 52% of them had ulcers that were healed at 1 year, while 29% in the placebo group were healed. Of those in the treatment group who actually got more than 35 HBOT sessions, the healing rate was higher, at 61% in the treatment group. This may reduce the risk of foot amputation in some diabetic patients, but more study is needed to be sure that it works. It would also be useful to find out which patients are most likely to be helped by this procedure. 
Early evidence had suggested HBOT might help people with lymphedema (swelling in arms or legs after surgery, which can happen after modified radical mastectomy or other treatments in which lymph nodes are removed or irradiated). A controlled clinical trial published in 2010 looked at 58 women after breast cancer surgery and radiation to the armpit area. There was no difference in arm size between women who had HBOT and those who had standard care, either right away or 12 months after treatment. 
The lack of randomized clinical studies makes it hard to judge the value of HBOT for many of its claims. Available scientific evidence does not support claims that HBOT stops the growth of cancer cells, destroys germs, improves allergy symptoms, or helps patients who have chronic fatigue syndrome, arthritis, multiple sclerosis, autism, stroke, cerebral palsy, senility, cirrhosis, or gastrointestinal ulcers. 
Carefully controlled scientific studies are still going on to find out whether HBOT may be helpful for cluster headaches, migraines, heart attacks, and other conditions. 
Are there any possible problems or complications? 
HBOT is a relatively safe method for selected patients getting approved medical treatments. Complications are lessened if pressures within the hyperbaric chamber stay below three times the normal atmospheric pressure and sessions last no longer than 2 hours. There are some people who should not get HBOT, however. 
Milder problems associated with HBOT include claustrophobia, fatigue, and headache. More serious complications include myopia (short-sightedness) that can last for weeks or months, sinus damage, ruptured middle ear, and lung damage. A complication called oxygen toxicity can result in seizures, fluid in the lungs, and even respiratory (lung) failure. Patients at high risk of oxygen toxicity may be given "air breaks" during which they breathe ordinary air rather than pure oxygen for short periods during treatment. 
People with severe congestive heart failure may have their symptoms worsened by HBOT. Patients with certain types of lung disease may be at higher risk of collapsed lung during HBOT. Pregnant women should be treated with HBOT only in serious situations where there are no other options. People getting certain chemotherapy drugs (such as bleomycin, doxorubicin, or cisplatin) should not get HBOT. Anyone getting disulfiram (Antabuse) or using sulfamylon cream should not get HBOT, nor should anyone with a collapsed lung.
A person with a pacemaker, high fever, or even a cold can be harmed by HBOT. Someone with claustrophobia would likely have trouble being in the HBOT chamber. 
Hyperbaric oxygen chambers can be a fire hazard: fires or explosions in hyperbaric chambers have caused about 80 deaths worldwide. Medical hyperbaric chambers today are generally well-built and have good safety records, but certain cautions must always be observed.
Relying on this treatment alone and delaying or avoiding conventional medical care for cancer may have serious health consequences.
SOURCE: CANCER.ORG

Wednesday, August 17, 2011

What if you lost electricity, water, ability to get to the grocery store, etc? Are you prepared? Do you have a 72 hour kit for each member of your household?

What would you do if there was an outage of electricity, shortage of water, inability to get food from the store, shortage on gas, or other emergency?  You ask "what would cause these issues" and I reply with a list...
Solar Flare
Geomagnetic Storm
Earthquake
Hurricane
Volcanic Eruption
Asteroid Impact
Going through the tail of Comet Elenin
Etc.


In any case, what have you prepared for?  We have discussed water storage in past posts.  Here is what you should be doing for every member of your household in the case of possible evacuation...



Here is another checklist for your 72hour kits...

by Work It, Mom! Team  |  11227 views  |  1 comment  |      Rate this now! 
Working moms are always short on time. Our lists make things a little easier -- just print and you're good to go! According to the Red Cross, the best way to make sure your family and home are safe is to be prepared before an emergency occurs.
Here is a synopsis of what they recommend you have on hand for a three-day emergency situation -- one where you are stranded in your own home with no transportation or utilities. For a more detailed list of what to keep in your kit, or for more information on how to store your kit or what else you can do to be prepared, go to the Red Cross's "Prepare at Home" page; also, be sure to read up on what people who have actually lived through disaster situations (like Hurricane Katrina) do to stay prepared, and take a moment to check out the suggestions at Ready.gov.
Food and Water:
  1. One gallon of water per person
  2. Water purification tablets or plain bleach
  3. Protein bars
  4. Canned meats and fish
  5. Dried fruit
  6. Nuts
  7. Instant Soup packets or boullion cubes
  8. Dry cereal
  9. Crackers
  10. Peanut butter
  11. Canned juice or juice boxes
  12. Baby formula
  13. Bottles and sippy cups
  14. Non-electric can opener
  15. Non-electric bottle opener (for puncturing juice cans)
Bedding and Clothing:
  1. Complete change of seasonally appropriate clothing, including socks, sturdy shoes or work boots, and underwear for each person
  2. Thermal underwear
  3. Sunglasses
  4. Prescription glasses
  5. Waterproof poncho
  6. Waterproof tablecloth (to use as tarp or floor covering)
  7. Light blanket
  8. Sleeping bag or heavy blanket
  9. Inflatable pillow
  10. Towels
  11. Work gloves
Sanitation and Medication
  1. First Aid Kit with gauze, bandages, tweezers, medical tape, and alcohol pads
  2. Anti-bacterial ointment
  3. Saline solution (for washing dust out of eyes)
  4. Toilet Paper
  5. Baby wipes
  6. Diapers
  7. Hand Sanitizer
  8. Dish Soap
  9. Prescription medication (and copies of prescriptions)
  10. Over-the-counter medications
  11. Anti-diarrheal pills
  12. Antacid tablets
  13. Sanitary pads (good for covering wounds as well)
  14. Activated charcoal
Equipment:
  1. Flashlights
  2. Extra batteries
  3. Dehydrated Food
  4. Glow sticks
  5. Long-burning candles
  6. Waterproof matches
  7. Hand/body warmers or "heat patches"
  8. Sterno (fuel for camp stove)
  9. Camp stove
  10. Metal cooking pot
  11. Mess kit (reusable dishes, cups, utensils)
  12. Hand crank radio
  13. Pens
  14. Pencils
  15. Paper
  16. Pocket knife or "Leatherman" multipurpose tool
  17. Pliers
  18. Small fire extinguisher
  19. Rope (50 feet long)
  20. Plastic garbage bags
  21. Duct tape
  22. Aluminum foil
  23. Zip-top storage bags
  24. Compass
  25. Whistle
  26. Deck of cards, small games, books
Documentation and money (place in waterproof container)
  1. Cash
  2. Emergency credit card
  3. Emergency debit card
  4. Local map (to find shelters)
  5. General road map (for possible evacuation)
  6. Copy of Emergency Evacuation plan
  7. Immunication records
  8. Medical and Dental records
  9. Major financial records (deeds, titles)
  10. Notarized copies of birth certificate
  11. Notarized copy of marriage certificate
  12. Photocopy of passport
  13. List of important phone numbers and emergency contacts, both in and out of state
  14. Copy of bank and mortgage account numbers and contact info
  15. Copy of insurance policies (homeowners, auto, life, health) and contact info
  16. Copy of investment account numbers and contact info
  17. Copy of serial numbers for needed medical devices and manufacturer's contact info

Here is another example of a 72 hour kit...

How to Build a 72-hour Kit

Who knew that a garbage can could hold things you might actually want?


Taking a few moments to fill up a clean garbage can with emergency supplies could save the lives of you and your loved ones.


Download this Basic Emergency Checklist [from 3Days3Ways.org]

[This requires a PDF reader. Download one from Adobe]

You can also buy a kit from the Red Cross.


Here is another example of a 72 hour kit.

72 Hour Emergency Kit Checklist
Every family should have an emergency kit prepared in case of natural disaster.  Emergency kits should be practical and be able to accommodate all family members for a minimum of 72 hrs.
Items to include in your emergency kit should include basic items such as food and water, bedding and clothing, fuel and light, equipment, personal supplies and medication, and personal documents and money.    Here is a complete list of items for each category.
Food and Water
Bedding and Clothing
Fuel and Light
MRE
Equipment
  • Basic Toiletries (toilet paper, toothbrush, feminine products)
  • Hand Sanitizer/Antibacterial Soap
  • Shot Records
  • Analgesics (Tylenol)
  • Prescription Medication (minimum 3 day supply/14 day recommended)
Personal Documents and Money
  • Legal Document (home and vehicle titles, marriage and birth certificates, insurance policies)
  • Cash (small bills and coins)
  • Credit Cards
  • Pre-Paid Phone Cards
  • Other Documents (as deemed necessary)
Emergency kits should be kept in waterproof containers, backpacks, bags, etc. and should be easy to carry.  The items should be checked every six months and rotated as necessary.  If you have pets and/or small children then make sure to include additional items such as pet food, diapers, formula, etc. are included in your kit as well

ULTIMATE Zombie Apocalypse Survival Kit