AbledAlert Testosterone Supplements Linked To Surge In Heart Attack Risk

POSTED ON February 1st  - POSTED IN AbledAlert
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AbledAlert Post Banner shows a graphic from CBS News titled Testosterone Treatment 55 thousand 593 Men within 90 Days of treatment Heart Attack Risk Almost Tripled in those younger than 65 with a history of heart disease. The AbledAlert headline reads: Testosterone Supplements: Linked to Double and Almost Triple Risk of Heart Attack.

US Food & Drug Administration Investigating The Safety of Testosterone-Boosting Products

 

It’s an issue where the buzzwords are flying everywhere, from “manopause” to “the He Hormone”, and the ads are everywhere, especially in men’s sports programming, touting the benefits of “Low-T” testosterone therapy to help rev-up men who are feeling tired and “not up to snuff” sexually. But what may send some men to the pharmacy may subsequently send others to the OR after a pair of recent studies show the dangers of taking the hormone may be more serious than previously thought.

 

A new study published in the Public Library of Science journal PLOS ONE confirms and builds upon previous research published in November in the Journal of the American Medical Association. And it’s all in the numbers.

 

In the United States, almost 3% of men aged 40 and older have been prescribed testosterone replacement therapy – a market Bloomberg Businessweek estimates could top $5 billion by 2017. The AMA published study at the University of Texas at Southwestern Medical Center in Dallas checked angiogram records for over 87 hundred men diagnosed with low testosterone levels between 2005 and 2011. They found a 30% increased risk of heart attack, stroke or death in the more than 12 hundred men who got Low-T therapy.

 

The more recent study at UCLA looked at the insurance records of more than 55 thousand men and the numbers were even more ominous:

 

Heart Attack Risk in the 90 Days After Low-T Treatment

 

Men 65 and older:  More than double.

 

Men 75 and older: More than triple.

 

Men under 65 with a history of heart disease:  More than triple.

 

The study also compared men getting Low-T therapy with those getting treatment with erectile dysfunction drugs such as Viagra and Cialis but found only a slightly raised risk of heart attach from the ED drugs.

 

All this has prompted the FDA to say it will reassess the safety issues of Low-T therapy, but also issued the following ‘moderating message: “At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals. 

 

Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy. Other examples include problems with brain structures, called the hypothalamus and pituitary, that control the production of testosterone by the testicles,”

 

We’ll follow the FDA reassessment and report any updates.

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AbledHealth-Meningitis-The-Princeton-Vaccine

POSTED ON November 25th  - POSTED IN AbledHealth
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AbledHealth Special Report post banner has the headline: Meningitis: The Princeton Vaccine - Unapproved by the FDA but deemed necessary. Photos in the background show on the left a 3D rendering of the meningococcal bacteria next to a wide photo of the front of Princeton University's Nassau Hall which features a large bell tower.

8th Meningitis Case Since March Now Reported At Princeton – No Effect On Vaccination Plans

 

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UPDATE: 10/12/13 : Almost 2,000 of the estimated 6,000 students at the Princeton University campus lined-up on Monday to get the first emergency vaccinations of Bexsero, a vaccine approved in Canada, Europe and Australia, but not yet approved in the United States. Administrators at Princeton agreed to provide the vaccinations after officials at the CDC requested special permission from the FDA. The vaccinations will continue through Thursday and booster shots will be given in the new year.

 

Photo provided by Princeton University shows students lined-up in a large hallway with round pillars and between roped-off rows to get the Bexsero vaccination against meningitis B.

 

The vaccinations were given under the shadow of an unrelated outbreak of meningitis B at the University of California, Santa Barbara where at least 4 students have been infected in the past month. One of them, 18 year old freshman lacrosse player Aaron Loy had to have his feet amputated following complications from the infection. He is slowly recovering.

* * * * * * * * * * * * * * * * * *

 

After developing symptoms Wednesday night, November 21st, a female student at Princeton University in Princeton, New Jersey was diagnosed with meningitis and hospitalized the next day. Health officials are awaiting test results to see if her infection is related to the seven meningococcal serotype B cases reported in the University community since March of this year.

 

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UPDATE: 26/11/13 : New Jersey Department of Health officials have confirmed that this 8th case of meningitis at Princeton is a serotype B case. The student involved has been treated at hospital and discharged and is now recovering. Meanwhile, a student at Monmouth University in New Jersey has been hospitalized in stable condition with meningitis serotype C which is the more common strain found in the United States. College students in New Jersey must get the approved U.S. form of the vaccine before attending colleges in the state. 

Princeton University officials have now confirmed that two rounds of vaccinations with Bexsero will be made available, starting for four days as of December 9, with a second follow-up round in February next year.

* * * * * * * * * * * * * * * * * *

 

The Daily Princeton quotes CDC spokesperson Allison Patti as saying this latest case shouldn’t change the current response to the outbreak. The University has issued a health advisory to all students and parents and will sponsor two rounds of free and voluntary vaccinations with the Bexsero vaccine from Norvartis which has won approval in the European Union and Australia, but has yet to receive approval from the U.S. Food and Drug Administration (FDA). The FDA is allowing the Bexsero vaccine to be administered under an Investigational New Drug Application.

 

Photo provided by Novartis Pharmaceutical company shows a lab technician stacking some boxes of the Bexsero meningitis vaccine. The boxes are white with purple printing.

 

All incoming college students are required by state law to receive licensed meningococcal vaccines, but those that have cleared the FDA only cover the A, C, Y and W-135 serogroups.

 

All undergraduates, all graduate students who live in dormitories, and other University community members who have existing medical conditions predisposing them to meningococcal disease can opt to receive the Bexsero vaccination.

 

The CDC says  based on studies of serogroup B meningococcus that cause disease in the United States, this vaccine would cover 91% of circulating strains. Lab testing has been done to confirm that the vaccine would help protect against the exact strain of meningococcal bacteria that is causing the outbreak at the University. The outbreak strain at Princeton University is ST409.

 

The CDC has made the following information available on meningococcal disease and serogroup B meningococcal vaccine:

 

What Is Meningococcal Disease?

 

Meningococcal disease can refer to any illness that is caused by the type of bacteria called Neisseria meningitidis, also known as meningococcus. Fewer than 1,000 cases of meningococcal disease occur each year in the United States.

These bacteria can cause serious infections like meningococcal meningitis (infection of the protective membranes of the brain and spinal cord) and meningococcal septicemia (bloodstream infection causing bleeding into the skin and organs).

There are five main serogroups (“strains”) of meningococcal bacteria: A, B, C, Y, and W. The most common ones that cause disease in the United States are B, C, and Y. In 2012 there were about 500 total cases of meningococcal disease, and 160 of those cases were caused by serogroup B.

View CDC’s guidance for evaluating and managing meningococcal disease outbreaks.

 

Symptoms of Meningococcal Infection

 

Two photos show an infant with meningococcal disease with red rashes on the arms and face and dark purple bruises and spots on its legs and feet. The attached infographic reads: How can you tell if a baby has meningococcal disease? Not all these symptoms may show at once. Fever, refusing feeds or vomiting, fretfulness, child is difficult to wake, high pitched moaning cry, pale or blotchy skin, rash of red - purple spots or bruises.

 

Part 1 of 3 Infographics by Novartis are titled Meningococcal Disease - A Story by numbers. A red circle clock with the hands at 11 o'clock  against a global map with the text: Every 10 minutes 1 person dies from meningococcal disease worldwide. Every minute 1 new person is diagnosed world-wide. It can kill within 24 hours and is easily misdiagnosed. In the next level of the infographic 10 small teddy bears are shown - 9 are brown and one is red. The text reads: 1 out of 10 cases ends in death. Two large teddy bears are shown in the next level with the text 2 out of 10 survivors suffer permanent disability, incuding brain damage, kidney failure, hearing loss or loss of limb.

 

The second panel of the Novartis infographic on Meningococcal disease reads: The most vulnerable population: Infants. A baby bottle half full of milk accompanies the text: 50 percent of meningococcal disease cases in the UK occur in infants.  17 baby carriages accompany the text: Infants are 17 times more likely to contract the disease compared to the general population in europe. The next section is titled: The Unmet Need. The bacteria that causes meningococcal disease includes five main types, classified as serogroups (A, B, C, W and Y). A set of children's alphabet blocks show the first letters of each serogroup: A,B,C, W and Y with the text: These five serogroups cause the majority of all meningococcal disease cases around the world. The next set of blocks are A, C, W and Y with the text: These four sergroups are vaccine-preventable. One block containing the letter B accompanies the text: Serogroup B has no broad effective vaccine - at the time of the infographic's printing.

 

Panel three of the Novartis infographic on meningococcal disease reads: In many countries, the majority of meningococcal disease in infants is caused by meningococcal serogroup B (MenB) disease. Outlines of each country mentioned show the percentage of serogroup B cases: UK 96 percent; France 86 per cent; Australia 86%; Canada 81 per cent; Germany 85 per cent; Italy 56 per cent. The next section reads: Scientific Breakthrough for MenB shows a quote by Rio Rappuoli, Glibal Head of Vaccines Research at Novartis Vaccines and Diagnostics and reads - Most of the time, treatment is given too late, and the best way to win with this disease is to prevent it. This info graphic was prepared by Novartis in presenting its Bexsero vaccine for MenB.

 

 

FAQ’s Related To Princeton Vaccination Program

 

A serogroup B meningococcal vaccine is being considered for use at Princeton University. The FDA is allowing the use of the vaccine at Princeton University under an Investigational New Drug application.

 

Q: Who is investigating the meningococcal disease outbreak at Princeton University and is a vaccine being considered to help protect the University’s population?

A: The Centers for Disease Control and Prevention (CDC), the New Jersey Department of Health (NJDOH), Princeton University officials, and local health authorities have been working closely together since the first case of meningococcal disease was reported in association with Princeton University in March 2013. At the request of the NJDOH, CDC reviewed the seven cases of meningococcal disease that occurred among Princeton University students and visitors since March 2013. All of these cases were caused by meningococcal bacteria known as serogroup B (“strain” B).

The number of cases and lack of direct connection among the cases means this is an outbreak. Given cases have occurred during two school years, it is anticipated that there will be more cases and vaccination may be an option to control the outbreak. A new vaccine that helps protect against meningococcal disease caused by serogroup B is being considered. The vaccine under consideration is licensed for use in Europe and Australia, but not in the United States.

 

Q: Who would the serogroup B meningococcal vaccine be recommended for and why?

A: Pending final approval by CDC, the vaccine would be recommended for all Princeton University undergraduate students (those who live in dormitories or off-campus) as well as graduate students who live in dormitories. Certain other individuals associated with the University may be evaluated for vaccination if they have specific medical conditions, including problems with their spleen (including sickle cell disease) or complement pathway (a specific type of immune deficiency). These groups would be recommended vaccine because young adults and people with certain medical conditions are at increased risk of getting this infection, especially those who live in close quarters, such as dormitories.

Meningococcal disease can be very serious and sometimes life-threatening. The best way to protect students may be vaccination. If vaccination is recommended, it will be important to get as many students vaccinated as possible to help stop the outbreak of serogroup B meningococcal disease at the University.

 

Q: How soon could a vaccine campaign begin at Princeton University?

A: Everyone involved is working hard to organize a potential serogroup B meningococcal disease vaccine campaign as quickly as possible that fits into Princeton University’s academic calendar. Expanding access for use of an investigational vaccine that helps protect against serogroup B meningococcal disease requires careful review of the particular circumstances of the outbreak, including the number of cases, the duration of time between cases, and the characteristics of the bacteria causing the outbreak. This work also involves making sure the vaccine can be safely administered in a timely manner and ensuring the appropriate systems are in place for safety follow up after vaccination. The campaign can begin once all approvals are gained and the vaccine is on hand.

 

Q: What additional approvals are required before the vaccine can be recommended and used at Princeton University?

A: Agreements between all the partners involved need to be finalized. In addition, CDC’s Institutional Review Board will need to approve the vaccine use procedure.

 

Q: Why wasn’t the vaccine considered earlier?

A: In similar college outbreaks, disease prevention recommendations include encouraging behaviors that minimize the likelihood of catching meningococcal disease and recommending vaccination against meningococcal disease. However, the outbreak at Princeton University is caused by a strain of the bacteria that is not covered by any vaccine licensed in the United States. Once the outbreak was recognized at the University, CDC began looking into whether a vaccine licensed in other countries could be made available.

The initial recommendation for University students was to encourage behaviorsExternal Web Site Icon that minimize the likelihood of catching meningococcal disease. Given the pattern of cases since March 2013, with the most recent case reported in November 2013, we believe there is a strong likelihood that even with such measures in place there will be more cases.

 

Q: I thought the school was doing other things, like telling students not to share cups, to help prevent the disease from spreading. Why would a vaccine be needed?

A: The University and NJDOH have taken appropriate public health measures to prevent cases, including offering preventive antibiotics to close contacts of ill students and educating students about meningococcal disease. Students should:

  • Know the symptoms of meningococcal disease;
  • Avoid activities — like smoking or sharing respiratory secretions (such as saliva, by kissing or close coughing) — that can increase their risk of illness; and
  • Seek medical attention immediately if they have any symptoms of meningitis or a bloodstream infection. Symptoms may include sudden onset of a high fever, headache, stiff neck, nausea, vomiting, rapid breathing, or a rash. It is important to remember that someone with meningococcal disease may have a high fever and no other symptoms.

Getting plenty of rest and not sharing saliva are good general hygiene recommendations, but their effectiveness at protecting against meningococcal disease is probably limited. The best protection may come from getting vaccinated.

 

Q: Do students who have already gotten a meningococcal vaccine need this one, too?

A: If recommended, yes. In the United States, the vaccine students can routinely get protects against four serogroups (“strains”), known as serogroups A, C, Y, and W, but not against B. New Jersey regulation requires that all students who enter a four-year university and reside in a campus dormitory get the shot against the four serogroups. There is very high vaccine coverage among students at Princeton University for the vaccine that protects against serogroups A, C, Y, and W. Serogroup B is the cause of the outbreak at Princeton University. The vaccine under consideration helps protect against serogroup B. Students did not have the opportunity to get this vaccine in the past because there wasn’t one available or licensed that would have been effective.

 

Q: Will the vaccine help protect students against the strain of meningococcal disease identified at Princeton University?

A: Yes. Based on studies of serogroup B meningococcus that cause disease in the United States, this vaccine would cover 91% of circulating strains. Lab testing has been done to confirm that the vaccine would help protect against the exact strain of meningococcal bacteria that is causing the outbreak at the University. The outbreak strain at Princeton University is ST409.

 

Q: How safe is the vaccine?

A: More than 8,000 infants, children, adolescents, and adults were safely vaccinated with the vaccine as part of the studies that resulted in its approval in Europe and Australia. The most common side effects take place where the shot was given (in the arm), which can include pain and tenderness, swelling, and hardness of the skin. Other common side effects for adolescents and young adults include nausea, feeling a little run down, and having a headache. These reactions usually last a short amount of time and get better on their own within a few days. Like any vaccine, this one can potentially cause a serious problem such as a severe allergic reaction, though the risk of serious harm from the vaccine is extremely small.

 

Q: Does the Food and Drug Administration (FDA) think it’s safe to get this vaccine?

A: Yes. FDA has allowed the use of the vaccine at Princeton University under an Investigational New Drug application. FDA has stayed informed about development of serogroup B meningococcal vaccines over the years and recently reviewed the latest available data. From this review, FDA has concluded that the benefits of using the vaccine to prevent meningococcal disease outweigh the risks of possible adverse events, supporting its possible use during the serogroup B meningococcal disease outbreak at the University.

FDA and CDC would work with Princeton University to monitor the safety of the serogroup B meningococcal vaccine when the proposed vaccination program begins.

 

Q: Why is the vaccine referred to as an “investigational new drug”?

A: This is a term FDA uses to describe a medication or vaccine that is not licensed (approved) in the United States, but which may be used in certain specific situations.

 

Q: Is this vaccine considered “experimental”?

A: CDC does not consider this vaccine to be experimental. FDA is allowing the use of the vaccine at Princeton University under an Investigational New Drug application, which is a term FDA uses to describe a medication or vaccine that is not licensed (approved) in the United States but which is made available for healthcare providers to use it in certain situations. Clinical trials in other countries have shown the vaccine to meet safety and efficacy standards to allow licensure in the European Union and Australia. Before these countries approved the vaccine’s use, their regulatory agencies — those similar to the FDA in the United States — completed a thorough review of the available data.

 

Q: Would those recommended to get the vaccine be required to get it?

A: No, getting the vaccine would be voluntary.

 

Q: Why is the vaccine not approved for use in the United States?

A: Novartis, the company that makes the serogroup B meningococcal vaccine, has completed phase II clinical studies in the United States. After careful review of requirements for licensure, existing vaccination schedules, and feedback from public health experts, the company has decided to advance a meningococcal vaccine that helps protect against five serogroups (A, B, C, Y, and W) into late stage development. Such a vaccine would cover the most common serogroups that cause meningococcal disease circulating in the United States. The exact timeline for approval in the United States depends on many factors. The serogoup B meningococcal vaccine is approved in Europe and Australia. Approvals in additional countries are expected soon. Questions regarding Novartis’ plans to seek licensure in the United States should be directed to them.

 

Q: Will a serogroup B meningococcal vaccine eventually be licensed for use in the United States?

A: It is possible that manufacturers will get this type of vaccine licensed in the United States in the future. In April, 2011, an FDA advisory committee discussedExternal Web Site Icon the data available at that time about serogroup B meningococcal vaccines and approaches for getting those vaccines licensed in the United States.

 

Q: Where is the vaccine licensed and how new is it?

A: The vaccine is currently licensed for use in Europe and Australia. The European Union approved its use in January 2013, and Australia approved its use in August 2013. These countries have higher rates of meningococcal disease caused by serogroup B compared to countries like the United States. Before these countries approved the vaccine’s use, their regulatory agencies — those similar to the FDA in the United States — completed a thorough review and concluded the vaccine was effective and met safety standards.

 

Q: Have vaccines similar to this one been used before?

A: Yes. The vaccine is similar to, but likely more effective than, a serogroup B vaccine (MeNZB) that was used for several years in New Zealand. The vaccine used in New Zealand protected against one type of serogroup B. More than 1.1 million people were vaccinated with MeNZB in New Zealand from 2004-2011, helping to stop a country-wide outbreak of serogroup B meningococcal disease.

The company (Novartis) who makes the vaccine under consideration for use at the University produces another meningococcal vaccine (Menveo®) that has been licensed and recommended for use in the United States since 2010 to help protect against serogroups A, C, Y, and W. However, Menveo® does not offer protection against serogroup B, the bacteria causing the outbreak at the University. Students would need to get the vaccine in order to be best protected against serogroup B meningococcal disease.

 

Q: Has this vaccine been used at other colleges or universities in the United States?

A: No. This is the first time the vaccine is being considered for use in the United States. However, more than 8,000 infants, children, adolescents, and adults have safely received this vaccine worldwide. More than one million people got a similar vaccine in New Zealand and no unusual pattern or occurrence of serious reactions was seen with that vaccine.

 

Q: How many doses of the vaccine are needed?

A: Two doses are needed for maximum protection. The second dose should be given one to six months after the first dose (but not sooner).

 

Q: How long does it take to get protected after getting the first dose of the vaccine?

A: After getting the first dose of the vaccine, it will take about 2 weeks for the body’s immune system to develop enough protection (antibodies) to help prevent serogroup B meningococcal disease. Since that protection declines over time, a second dose is needed to maintain protection. It is critical that high levels of protection are achieved during an outbreak if the vaccine is recommended.

 

Q: Can the vaccine give someone meningococcal disease?

A: No, since the serogroup B meningococcal vaccine does not include any live bacteria, but is instead made of inactivated parts of the Neisseria meningitidis bacteria, the vaccine cannot give someone meningococcal disease.

 

 

Q: Is it safe to get the vaccine right after getting another meningococcal vaccine, like Menveo® or Menactra®, or after getting a flu vaccine?

A: Yes, it is safe to get the vaccine after receiving another meningococcal vaccine or a flu vaccine.

 

Q: Is there anything someone should tell the doctor or nurse before getting the vaccine?

A: Yes. They should tell the doctor or nurse if they:

  • Are not feeling well. If the person has a severe infection with a high temperature, vaccination should be delayed. But the vaccine should be given on time if there is only a minor infection, such as a cold.
  • Have a chronic medical problem, like hemophilia.
  • Have a severe (life threatening) allergy to any vaccine component.
  • Are pregnant or breastfeeding. There is not enough data to know if the vaccine is safe to use during pregnancy. Pregnant or breastfeeding women should not get the vaccine.

 

Q: Who is paying for this vaccine?

A: Princeton University would cover the cost of the vaccine for all eligible groups who receive it.

 

Q: What kind of consent would be needed to get the vaccine?

A: Those who are 18 years of age and older would give their own informed consent. Those younger than 18 years old of age would need a signed consent form from their parent or guardian before receiving the vaccine. Before the vaccine campaign, the University will provide further information to everyone who would be recommended to get the vaccine and parents of students to assist in the decision-making process.

 

Q: Would the vaccine be offered to other people?

A: No. As of this time, the vaccine is only being considered for specific groups at Princeton University who are at increased risk for getting meningococcal disease. These groups include undergraduate students, regardless of where they live, and graduate students who live in dormitories. Certain other individuals may be evaluated for vaccination if they have specific medical conditions.

 

Q: Why would the residents of the town of Princeton not be eligible to receive the vaccine?

A: Tracking for cases of meningococcal disease is very good and no cases have been seen in the town of Princeton during this outbreak, which indicates that members of the general public are not currently at increased risk. Rates of meningococcal disease have been declining in the United States since the late 1990s. There are now fewer than 1,000 cases reported each year, and 98 out of 100 cases are sporadic (not associated with an outbreak).

Since the serogroup B meningococcal vaccine is not licensed for use in the United States, an Investigational New Drug application is being used to allow the vaccine for everyone associated with Princeton University who is considered at increased risk for meningococcal disease. The vaccine could not be given to anyone who does not fit the eligibility criteria established in the Investigational New Drug application. For that reason, only undergraduate students (regardless of where they live), graduate students who live in dormitories, and certain other individuals associated with the University who have a medical condition that puts them at increased risk for meningococcal disease could receive the vaccine.

While anyone can get meningococcal disease, adolescents and college-aged adults are at increased risk. The bacteria that cause meningococcal disease require prolonged (lengthy), close contact in order to spread. The bacteria are much harder to spread than the virus that causes the flu and cannot live outside of the body for very long. The bacteria are not spread by casual contact like being in the same room as someone who is sick or carrying the bacteria or handling items that they touched. You must be in close contact with the person’s saliva (spit) or other respiratory secretions in order for the bacteria to spread. Close contacts include people in the same household, roommates, or anyone with direct contact with a patient’s saliva (such as a boyfriend or girlfriend through French kissing).

 

Q: Should Princeton University students cancel their holiday plans or be quarantined until the outbreak is over?

A: We recognize that when cases of meningococcal disease occur, there is increased concern about the potential spread of disease and desire to take appropriate steps to prevent additional cases. There is no evidence that family members and the community are at increased risk of getting meningococcal disease from casual contact with Princeton University students. Therefore, CDC does not recommend curtailing social interactions or canceling travel plans during the upcoming holidays as a preventive measure for meningococcal disease. Instead, we continue to recommend that Princeton University students remain vigilant to the symptoms of meningococcal disease and seek treatment immediately if they experience any of those symptoms.

 

Q: Should outside sports teams, clubs, or other people who plan to visit Princeton University, or host Princeton University students, cancel their plans?

A: No, plans should not be cancelled or delayed. Please see more information about this questionhere Adobe PDF file.

 

Q: Why can’t antibiotics be used for everyone instead of the vaccine?

A: Antibiotics are given to close contacts of those who have been diagnosed with meningococcal disease. Anyone who is a close contact of a person with meningococcal disease is at extremely high risk for getting the infection. Close contacts are identified by asking people about the extent of their contact and interactions with the person who got meningococcal disease. For example, living with the person who got sick puts you at high risk, but working together in an office generally does not.

Recommending antibiotics to the entire student body is not an effective strategy. Meningococcal bacteria are spread from person to person and cause “carriage” in the nose and throat. Carriage means that the bacteria live in the nose and throat, but don’t invade your body and make you sick. Most carried strains are unlikely or unable to cause disease. Though certain strains are more likely to cause disease, at any given time only a very small number of people may carry the outbreak strain. If you are exposed to the outbreak strain you either develop disease within a few days or you develop immunity and the carried bacteria disappear from your nose and throat.

If you wanted to try and control an outbreak with antibiotics, you would have to treat every single person at risk in the outbreak at the same time. Otherwise, if one person is still carrying the bacteria in their nose and throat, it can continue to spread since people would not have lasting protection like a vaccine can provide. Even if you can treat everyone at once, antibiotics are about 85% effective at eliminating the carried bacteria in the nose and throat, but not 100%. The strain could still circulate at the University. For the same reason, it is not possible to test everyone and treat the carriers with antibiotics.

On the other hand, the vaccine helps protect people for a much longer period of time. Even if you are exposed, the vaccine helps protect you against the bacteria. It is also possible for the vaccine to decrease or stop spread of the bacteria, which would help protect the community as a whole by stopping carriage in the nose and throat.

In addition, about 1 in every 100 people is allergic to an antibiotic. Some may not even know it. Treating many people unnecessarily with antibiotics also carries risks, possibly causing more harm than good. To help prevent the growing threat of antibiotic resistance, it is critical that antibiotics only be used when necessary and appropriate.

 

If you have further questions about the serogroup B meningococcal vaccine, please emailmeningvaccine@cdc.gov.

 

 

 

AbledFacts infobox reads: Pirnceton Meningitis Outbreak: 8 cases of MenB since March; FDA clears use of Bexsero vaccine unapproved in U.S.; Voluntary vaccination program planned"

 

AbledFacts box is titled Meningococcal Disease Signs and symptoms in white text over a blue background. There are two columns. The left is titled Meningococcal Septicemia and lists the following signs and symptoms: Shivering, chills, cold hands or feet; skin color change; Sudden, severe pain in arms, legs, joints or stomach; Fever, thirst, nausea, vomiting, maybe diarrhea; Drowsiness, loss of consciousness, rapid breathing; Spots or pinprick rash (develops to purple blotches). The second column reads: Meningococcal Meningitis and lists the following signs and symptoms: Severe headache; Stiff or painful neck; Sensitivity to light; Drowsiness, loss of consciousness, fits; A rash may develop in the later stages.

 

Commentary banner

 

Commentary link box to Op-Ed by Benjamin Dinovelli titled: The media who cried meningitis. Click here to read it at The Daily Princetonian.

 

Related Organizations banner

 

Abled Public Service Ad for the Confederation of Meningitis Organizations. Their logo consists of their name circling a round map of the world.  The words join hands against meningitis are shown next to an illustration of a hand. Click here to go to their website.

 

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POSTED ON November 8th  - POSTED IN AbledConditions
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Two Human Clinical Trials Are Underway – Results Go To The FDA

 

Of the nearly 26 million Americans who are living with diabetes, 5% of them have Type 1 or what used to be called Juvenile Diabetes in which the pancreas doesn’t produce enough insulin. That insulin is needed to convert sugar, starches and other food into energy.

 

A screengrab from an animated video by Blausen explaining diabetes. Click on the photo to open the video window.

 

Most Type 1 diabetics regulate their blood sugar levels by using injectable insulin in slow-release and/or fast-release forms. That’s why you may sometimes see someone injecting insulin into their abdomen or arm at a restaurant, because the fast-release insulin is usually taken around meal times.

 

Then there’s the tedious and painful process of having to prick the ends of fingers to check blood sugar levels with a glucose tester that uses disposable strips. There are even talking testers for blind diabetics.

 

A lot of research has been going on to find a better and easier way of providing the insulin and checking resulting glucose levels and it’s divided along two tracks: biological solutions and hardware/software solutions.

 

Some diabetics have been fitted with external insulin pumps that automatically monitor and regulate the blood glucose levels, and scientists are on the verge of a breakthrough in making an artificial pancreas. We’ll cover that in a related story.

 

In this report, we’ll deal with one of the promising advances in biological solutions, and while medical science is not quite at the stage where pancreas transplants are a viable option, the next best thing might be the transplantation of Islets of Langerhans cells, named for the 22 year-old German pathalogical anatomist who discovered them in the late 1800’s.

 

The islets are the parts of the pancreas that contain its hormone-producing endocrine cells, and there’s usually about a million of them in a healthy adult. The islets’ alpha cells produce the hormone glucagon, and their beta cells produce insulin, both instrumental in regulating the blood sugar levels in the body.

 

Graphic diagram by Bruce Blaus  shows the location of the pancreas in the human body just under the bottom central part of the ribcage. It also shows closeups of the pancreas and a further closeup of the islet cells .

Diagram by BruceBlausen

 

As CNN reports: In the 1990s, scientists in Alberta, Canada, figured out how to isolate these islets from a deceased donor’s pancreas and transplant them into the liver of a diabetic patient. The procedure was dubbed the “Edmonton Protocol.”

 

Since then, researchers have been trying to improve the survival rate of the cells during transplantation. Most patients who undergo the procedure now need two infusions of islet cells to maintain normal glucose levels long-term.

 

Dr. Michael Rickels, associate professor of medicine at University of Pennsylvania and his colleagues recently published a study in the journal Diabetes detailing a new protocol, which gives the extracted islets three days to “rest” before they’re transferred to the living recipient. All of the patients in Rickels’ study were able to come off insulin therapy for at least a year after a single transplant.

 

Data from patients in other countries where the procedure has already been approved shows some patients can stop using insulin for anywhere from five to 10 years.

 

Read the complete story at CNN and meet two people whose lives have been changed by a young man’s decision to be an organ donor and how it facilitated an islet transplant operation.

 

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POSTED ON October 15th  - POSTED IN AbledIssues
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[ozy_content_divider caption=”SPECIAL REPORT: THE UNITED STATES GOVERNMENT SHUTDOWN”]
AbledIssues Link Banner shows a photo of the US Capitol building on a sunny day with the headline: US Government Shutdown: Is it impacting Special Needs? Four gradient black to transparent frames flank the Capitol dome as a backdrop to the bullit-point summaries for each category: Food Safety: FDA/CDC Workers furloughed. Update: Some recalled for salmonella outbreak. Routine inspections suspended. Under Health, NIH: No new patients-exception for 12. FDA: Reviews and Approvals halted for Rx and products. CDC: Outbreak monitoring limited. Under the Military summary, Disability: Backlog of claims stalled. Death Benefits: Halted. Update: President signs bill to restore benefits to families of the fallen. And under the final category Social benefits: Social Security/Medicare: Benefits being paid out. Disability: Possible delays in new applications. Unemployment: being paid. A red diagonal transparent banner contains the headline: UPDATE: Congress votes to end shutdown - President Signs Bill. Click to go to the story.

Split-screen photo shows the lawn of the National Mall with the Capitol building in the distance with a sign in the foreground stating, 'Because of the Federal Government SHUTDOWN, All National Parks Are Closed'. The photo on the right shows a similar sign on a portable gate on the driveway at the Lincoln Memorial.

 

Tracking the impact of the shutdown on those who are most in need

UPDATE (Oct.16): IT’S OVER! GOVERNMENT SHUTDOWN ENDS AFTER 16 DAYS

After a little over two weeks of a back-and-firth game of political ‘chicken’, U.S. President Barrack Obama moved quickly to sign an 11th hour deal passed by Congress to end the partial government shutdown and rescue the world’s largest economy from the brink of an unprecedented debt default.

The House of representatives voted 285-144 to end the stalemate after the Senate voted 81-18 to end the political standoff. President Obama signed the bill into law just just a half-hour after midnight eastern time. Federal workers returned to work later that same Thursday.

 

 

On CBS’ ‘Face The Nation‘, host Bob Schieffer says it’s not just federal workers who have been hurt by the political games in Washington:

 

 

Two weeks into the U.S. Federal Government shutdown, the political stalemate continues, and as more time goes by, more services risk being reduced or halted altogether.

It’s been particularly tough on communities and people reliant on tourism because of the closure of national parks, although the federal government is now giving state governments the option of using their own funds to cover park operations.

Let’s take you through the categories that affect our general health and welfare and give you a status report on whether they are being impacted:

 

Food Safety

Both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have furloughed much of their staff, but claim they can handle recalls and food-borne outbreaks that are high risk.

However, the CDC had to re-call many of those employees to deal with the salmonella outbreak in raw chicken that has sickened as many as 317 people in 20 states and Puerto Rico and put 42% of them in the hospital.

Read more in our AbledALERTTM ongoing coverage of the outbreak.

 

In this photo from NPR/AP, Former Agriculture Secretary Ed Schafer dressed in white sanitation overalls, hairnet, glovers and safety glasses with a coral red helmet,  follows the work of USDA inspectors at a Cargill meat packing plant in Schuyler, Nebraska in 2008.

 

The U.S. Department of Agriculture (USDA) is required, by law, to have meat inspectors on the processing lines in meatpacking plants every day in order for the plants to remain open – and, so far, those inspections are proceeding as usual.

 

Health

Medical research at the National Institutes of Health (NIH) has been affected, delaying some studies. Usually, about 200 new patients enroll every week in studies at the NIH research hospital, but because of the government shutdown, that has been halted. They have made an exception to allow 12 patients with immediate life-threatening illnesses into clinical trials.

The CDC’s tracking ability for disease outbreaks, such as the flu or the MERS virus from the Middle East has been severely limited.

 

This 2005 photograph depicts one of the Centers for Disease Control's (CDC) staff microbiologists using an electronic pipetter to extract reconstructed 1918 Pandemic Influenza Virus from a calibrated vial containing a supernatant culture medium. The image was captured in a Biosafety Level 3-enhanced laboratory setting, where this scientist was working beneath a flow hood, whereupon, air outside the hood is pulled into the hood’s confines and is then filtered of any pathogens before being re-circulated inside the self contained laboratory atmosphere.

 

The FDA has halted the evaluation and approval process for pharmaceutical drugs and medical products.

 

Military

If the government shutdown drags-on into November, $6 billion worth of checks won’t go out, and that will be a double-blow to the 33% of Veteran’s Affairs employees who are veterans themselves.

 

A photo shows the Department of Veterans' Affairs Hospital in Palo Alto, California with a curved caramel brick and glass facade set into the middle of diagonal rectangular lighter sandstone colored wings.

 

Inpatient and outpatient care at hospitals and Vet centers is still being provided because the Congressional funding for it is approved a year in advance. But efforts to reduce the backlog in disability claims have stalled because overtime for claims processors has been cut-off, and compensation and pension payments will be halted if the shutdown rolls into late October.

When the government shutdown began, it halted the authority of the Defense Department to pay the typical $100 thousand death gratuities to the survivors of fallen U.S. Armed Forces members killed in action. That cash payment is usually made within three days of the service member’s passing. 

The Defense Department had a Plan B in the form of contracting with the Fisher House Foundation, which supports military families, to provide the $100 thousand payments for the duration of the government shutdown, pending repayment. But a few days later, President  Barack Obama signed legislation that Congress had passed to resume the payments, while the politicians were left fighting among themselves over who to blame for the interruption of the payments.

 

Social Benefits

Medicare and Social Security benefits are being paid out. Unemployment benefits continue to be paid. However, there could be delays in processing new disability applications.

The biggest immediate area of concern is for nine million moms and babies at risk because the $7 billion dollar Special Supplemental Nutrition program for Women, Infants and Children – known simply as ‘WIC’ – was expected to run out of money. Some states have stopped accepting new participants.

 

A screen grab from the USDA's website shows information about the WIC program at a glance. Click on the photo to go to the USDA website.

 

UPDATE:

The the USDA has announced it is reallocating funding to cover WIC costs for the remainder of the month. WIC provides formula and breastfeeding support, as well as nutrition education for mothers and children across the country in co-ordination with state Departments of Health.

 

Graphic design shows the logo of the Supplemental Nutrition Assistance Program (SNAP) which features a green bag full of groceries, such as a milk carton, egg carton, bread,fruit and vegetables in solid colors in stencil form next to the words that make up the acronym SNAP.

On the morning of Saturday, October 12th, recipients of federal food stamps in several states, officially known as the Supplemental Nutrition Assistance Program (SNAP), and some WIC recipients were blocked from being able to use their payment cards and tokens when a computer failure caused a system shutdown in the network provided by subcontractor Xerox.

A Xerox representative said the glitch, which occurred during a test of back-up systems, was fixed by Saturday night.

 

 

 

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Visit Abled.com often as we continue to monitor the impact of the U.S. Government Shutdown on persons with special needs and others dependent on social programs.

 

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