FDA warns against the use of homeopathic teething tablets and gels

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm523468

The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA recommends that consumers stop using these products and dispose of any in their possession.

Homeopathic teething tablets and gels are distributed by CVS, Hyland’s, and possibly others, and are sold in retail stores and online.

Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels.

“Teething can be managed without prescription or over-the-counter remedies,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We recommend parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their health care professional for safe alternatives.”

The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. The FDA is currently investigating this issue, including testing product samples. The agency will continue to communicate with the public as more information is available.

Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy. The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.

The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of homeopathic teething tablets or gels to the FDA’s MedWatch Adverse Event Reporting program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm; or 
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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While this might seem like a very good idea.. but it ignores the law of supply and demand…  It is estimated that this “free college for all” will have a price tag of 1.25 TRILLION/yr…  and that is going to add to the national annual deficient and national debt.. since we are taking in 3.2 trillion in taxes and Congress spends 500 billion more than we take in.

I believe that we are at a point in our society and with employers that a person applying for a job with a high school education only is mostly viewed with a YAWN …  National high school graduation rate is around 75%.

About 70% of high school graduates go on to enter a college… Currently just 40% of high school graduates that enter college graduate in FOUR YEARS with a degree  https://www.satprepct.com/sixty-percent-of-all-college-freshmen-do-not-graduate-in-four-years/

So for every 100 high school graduates … four years later there will be abt 25%-30% new college graduates.

Another 20% will graduate at a total of SIX YEARS in college…  which strongly suggests that college is NOT FOR EVERYONE.

What is going to be the cost for our public colleges to expand facilities/student capacity and how long is it going to take for a equilibrium to be reached… what is going to be the drop out rate after the first 1-2 semesters…  How many billions are going to be expended for students that “go no where” ?

Let’s presume that we have 10%-20% increase in the number of high school graduates getting a college diploma in four years… Many people will BS college degrees are working as a waitress , barista or some other job that really doesn’t require a college degree.
Our daughter is the perfect example of a college degree with no where to go… After getting her BS Psychology degree.. the degree provided no real career path.. it wasn’t until a few years later she obtained her Master in Psychology and became a Family Therapist … opened her private practice and now able to charge clients $120/hr for consulting with her.

There are many vocational jobs that go wanting for people to fulfill them… that may take months or 1-2 yr of training.

Could we be setting up the position that employers will not seriously look at a applicant because they don’t have a college degree in some major… just like today they look at those who don’t have a high school diploma ?

As we all know… when there are many more applicants than available jobs.. salaries/hourly rate tends to fall or remain static for years.

Another “good idea” without full considerations if it will produce good or bad outcomes ?

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‘New low’: Dead vets left to ‘decompose’ in VA morgue for weeks without burial

http://www.foxnews.com/politics/2016/09/29/new-low-dead-veterans-left-in-va-hospital-morgue-for-weeks-without-burial.html

An Illinois Veterans Affairs hospital already under fire for excessive wait times, festering black mold and kitchen cockroaches faces a new shame – the bodies of dead patients left unclaimed in the morgue for up to two months without proper burial, whistleblower documents allege.

The whistleblower, whose identity is not being revealed for fear of retaliation, complained last month to the VA’s inspector general about the Edward Hines Jr. VA Hospital’s handling of veterans’ remains in cases where families have not come forward to claim the body. The complaint singled out Christopher Wirtjes, chief of Patient Administrative Services, saying “The Chief of PAS has the funds available, yet has no sense of urgency to lay the veteran to rest.”

Sen. Mark Kirk, R-Ill., whose office also received the complaint along with emails, is now calling for Wirtjes’ firing and in a statement, slammed the hospital – located in the Western suburbs of Chicago — over its recent history of controversies.

“Hines VA — the hospital that has been overrun with cockroaches and mold and left vets waiting for care for months on secret wait lists, has reached a new low in the treatment of our veterans,” Kirk told FoxNews.com. “We now have reports of bodies being left to decompose in the morgue for months on end.”

The whistleblower, who has spoken with Kirk’s office, described a “horrible issue” at the hospital in the letter to the IG: “Some veteran’s remains have been left in our hospital morgue for 45 days or more until they are stacked to capacity at times.”

On at least one occasion, a body had liquefied and the bag burst when staff had attempted to move it, said Alissa McCurley, Kirk’s deputy chief of staff.

Kirk talked to VA Secretary Bob McDonald last week in Washington and demanded the firing of Wirtjes, whom the Office of Special Counsel determined had orchestrated a secret wait list that was exposed by another whistleblower in 2014. McDonald was noncommittal, Kirk said.

Internal VA emails chronicle how a frustrated Hines clerk attempted to obtain permission from Wirtjes for burial of unclaimed veterans on three occasions.

The first email chain began on Dec. 7, 2015.

“[There is] an invoice for an unclaimed veteran that has been here for over 30 days. Please approve for burial at Abraham Lincoln,” the clerk wrote to Wirtjes and several others.

Three days later, the clerk wrote again: “Approval of unclaimed Vet D?? Status?”

On Dec. 23, the clerk wrote to human resources: “Any further on my poor unclaimed? I WILL file a police report, but I hate doing that…”

Emails from  June 14, 2016 and Aug. 29, 2016 state that two different veterans languished in the morgue for a month or more. 

A manager, who is the chief of inpatient and processing, discussed the dilemma of how a local mortuary would be paid for accepting a veteran’s body because the family did not have the money for a burial. He said he would “try to figure it out with the funeral home. … At least he would be laid to rest.”

“I have not heard anything as to the approval for funeral home pick up. It will be a month tomorrow,” the clerk responded.

Cook County policy suggests embalming three days after death “at the discretion of the medical examiner.” Often, the body will be embalmed and returned to a freezer for up to a month while the Coroner’s Office attempts to locate family members. Unclaimed bodies are then buried in a county cemetery. Veterans are interred in a national military cemetery within 60 days.

However, Hines does not employ medical examiners or embalmers to properly care for decedents locked in their freezer for 30 days or more, McCurley said.

Wirtjes could not be reached for comment despite inquiries to him, his office and a VA center spokesman. But the spokesman for the hospital, Rick Fox, disputed the allegations and said Hines was following all laws:

“We take whistleblower allegations very seriously and absolutely agree that all of our veterans deserve dignity and respect, in life and in death. While our investigation into this matter is still ongoing, we have found allegations related to consistent problems with dignified and timely burials to be unsubstantiated. However, we have taken this opportunity to review our policies and procedures and are currently working to improve them.”

Staff from the VA’s Office of Medical Inspector were at the hospital conducting an investigation Monday afternoon, but it’s unclear what they found, McCurley said. 

Asked about the allegations, the IG office said: “The OIG doesn’t confirm or deny the existence of any ongoing investigations.”

Kirk, chairman of the Appropriations Committee on Military Construction and Veterans Affairs, last week introduced a bill titled Respectful Interment for Passing Veterans Act which requires “expeditious and respectful provision of burial and funeral services for indigent, deceased veterans and remains of deceased veterans that are unclaimed.”

Earlier this year, Kirk authored a bill requiring VA kitchens to undergo regular health inspections after Hines whistleblowers repeatedly documented cockroaches served in food. The VA system currently has no required kitchen health inspections from an outside entity.

In September 2015, veterans from Hines’ long-term care facility complained of a black mold infestation that had gone unchecked.

Hines is planning on demolishing the kitchen in an effort to destroy the roaches and will renovate the long-term care facility within 45 days, the spokesperson said.

Kirk sent a two-page letter to the secretary Wednesday to press for Wirtjes’ firing. A 2014 law created after the VA wait list scandal gave McDonald the power to fire civil service employees engaged in misconduct.

“If manipulating scheduling wait times putting veterans’ health at risk and failing to allow the burial of unclaimed veterans’ remains is not misconduct, then I ask you what is,” Kirk wrote. 

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DEA BAN ON KRATOM  DELAYED

http://www.inquisitr.com/3552500/dea-kratom-ban-delayed-herbal-supplement-will-still-be-legal-on-september-30/

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FDA Delays Approval of Possible Antidote As Xarelto Lawsuit Numbers Climb

http://newyorkcity.legalexaminer.com/fda-prescription-drugs/fda-delays-approval-of-possible-antidote-as-xarelto-lawsuit-numbers-climb/

This is a similar issue from the FDA over the dragging their feet on the approval of numerous generic “Epi-pen” that are available in Europe and other countries.  Allowing the $600 brand Epi-pen being the only one available in the USA market.  We don’t hear about our “European cousins” dying in mass from using the generic Epi-pen that is available to them.  Who at the FDA is PROFITING from the delaying at least the approval of the generic Epi-pen ?

TheProductLawyers.com reports on a recent delay issued by the FDA for a possible antidote to Xarelto, a blood-thinning drug that has allegedly caused a number of adverse side effects for patients. According to reports, Portola Pharmaceuticals has been working on a potential antidote for Xarelto known as AndexXa. The FDA recently requested that the company provide additional information related to the manufacturing of the drug when it was submitted for approval.

About Xarelto

Xarelto was approved by the FDA in 2011 to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem. It is also used to treat deep vein thrombosis and pulmonary embolism, and to help reduce the risk of the conditions occurring again. Additionally, it can be used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery, according to the Xarelto website.

The drug has been associated with a variety of adverse events including hemorrhagic pericardial effusion, epidural hematoma, stroke, heart attack, rectal bleeding, pulmonary embolism, brain hemorrhages, and internal bleeding.

Pharmaceutical companies are currently working on developing an antidote for the drug but one has not yet been approved.

The Current Litigation

Thousands of plaintiffs have filed lawsuits against the manufacturers of Xarelto claiming that the drug caused an uncontrollable internal bleeding event, leading to serious injury and / or death. Other allegations include failure by the manufacturer to warn patients of risks, a lack of antidote, negligence for allowing the drug to go to market without an antidote and several others. Since lawsuit numbers continue to increase naming the same defendants with similar allegations, all federally-filed lawsuits were consolidated into a multidistrict litigation in the Eastern District of Louisiana. MDL 2592 will be overseen by Judge Eldon Fallon and encompasses over 3, 400 lawsuits.

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This week a posted the following and it received a comment and I think that my response is important to understand my thoughts on this and what is really going on.

FDA looking for app like YELP/Urban Spoon to find nearby person with Naloxone

I think it should be available to anyone that needs it. Every business should carry it for emergency problems. Why would you not want to save a life. If you don’t want to help someone save a life it would be interesting to hear why you don’t . Please give us your thoughts on this matter. Oh please you say it may involve more risk taking ???????Dear I have a brain freeze . You have to give me a moment.

I have no problem with trying to save a life… but.. how many times should we “save a life” that really doesn’t want to be saved ?  Giving a person who has OD’ed Naloxone is not really saving a life… because without some sort of follow up therapy and just putting them back in the position/environment that they came from.. where they learned to abuse some substance or supported their abusing some substance.. is really not saving a life.. it is – in reality – just postponing what is probably the inevitable end… sooner or later..

I have seen statements from bureaucrats basically “high-fiving” the fact that they have “saved” a single person TEN TIMES in a 24 hr period.  It is not unusual for individuals to be “saved” multiple times.. I have not seen stats published on those issues. Those people who are in the death spiral of substance abuse… maybe even be suicidal … and there is a high probability that they will eventually succeed. We can only save those who wish to be saved.

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DEA: No Timetable for Kratom Ban

http://www.painnewsnetwork.org/stories/2016/9/29/dea-no-timetable-for-kratom-ban

Just think about it… the DEA .. has taken issue with what is a supplement.. used world wide.. that is part of the COFFEE FAMILY… they claim that some 30 people have died from it WORLD WIDE – not per day, per week, per year.. but IN TOTAL…  it claims that the poison control centers received some 500-600 phone calls about use/abuse of this substance over 5-6 YEARS… but … the poison control center receives  abt SEVEN PHONE CALLS EVERY SECOND 24/7. 50+ members of the House has sent the DEA a letter to back off rescheduling Kratom… and reportedly some Senators are doing the same.

Maybe all of the discussion around this rescheduling is going to really put the actions of the DEA into the spotlight that is long past needed to be done and will clearly demonstrate that the DEA has moved far away from the original intend of The Control Substance Act 1970.  There is more and more evidence that legal prescribing of opiates has little to do with the so called opiate epidemic… and that the drugs that are being abused and are killing people are coming from south of our border and China..  It will interesting to see if all this interest by the members of Congress is just a “smoke screen” to get past the Nov election.. if not.. it may be a signal to the chronic pain community to start a call/email/fax campaign to member of Congress about the misdirected actions of the DEA.

An unprecedented grassroots lobbying campaign was also launched to get the DEA to reverse or postpone its decision. Over 135,000 people signed a petition asking the Obama administration to stop the DEA, and hundreds of kratom supporters rallied in front of the White House.  

A bipartisan group of congressmen in the House also signed a joint letter asking the agency to delay the scheduling of kratom to allow for public comment.

Now a second letter to the DEA is circulating in the U.S. Senate that calls the scheduling of kratom “unprecedented for a natural substance” and urges a delay.

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Lie in court, and the DEA still might pay you, audit finds

http://www.mcclatchydc.com/news/crime/article104911966.html

Congress is raking the CEO of Wells Fargo over the coals  http://abcnews.go.com/Business/round-wells-fargo-ceo-testify-front-congress/story?id=42432315   because the bank defrauded tens of thousands customers involving some 5-10 million dollars… which has been refunded to those customers impacted.    Congress fined the bank 185 million dollars and Congress BULLIED the board of directors of Wells Fargo to CLAW BACK $41 MILLION of compensation already paid to CEO John Stumpf  and appears to not be satisfied until Stumpf is FIRED and sitting on the curb.   But there is proof that the DEA has wasted  TENS OF MILLIONS, defrauded the US TAXPAYERS over a similar FIVE YEAR PERIOD… and where is the Congress and all the House/Senate hearings ?  Does the DEA have “something” on some of the senior members of Congress… to keep Congress “in-line” and turn a blind eye to the DEA’s actions ?  Or is it just that 43% of Congress is attorneys and they just understand how our judicial system works and that law enforcement needs to “break laws” to help them enforce our laws ?

WASHINGTON

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Exposed: FBI Director James Comey’s Clinton Foundation Connection

http://www.breitbart.com/2016-presidential-race/2016/09/10/exposed-fbi-director-james-comeys-clinton-foundation-connection/

WASHINGTON, D.C. — A review of FBI Director James Comey’s professional history and relationships shows that the Obama cabinet leader — now under fire for his handling of the investigation of Hillary Clinton — is deeply entrenched in the big-money cronyism culture of Washington, D.C. His personal and professional relationships — all undisclosed as he announced the Bureau would not prosecute Clinton — reinforce bipartisan concerns that he may have politicized the criminal probe.

These concerns focus on millions of dollars that Comey accepted from a Clinton Foundation defense contractor, Comey’s former membership on a Clinton Foundation corporate partner’s board, and his surprising financial relationship with his brother Peter Comey, who works at the law firm that does the Clinton Foundation’s taxes.

Lockheed Martin

When President Obama nominated Comey to become FBI director in 2013, Comey promised the United States Senate that he would recuse himself on all cases involving former employers.

But Comey earned $6 million in one year alone from Lockheed Martin. Lockheed Martin became a Clinton Foundation donor that very year.

Comey served as deputy attorney general under John Ashcroft for two years of the Bush administration. When he left the Bush administration, he went directly to Lockheed Martin and became vice president, acting as a general counsel.

How much money did James Comey make from Lockheed Martin in his last year with the company, which he left in 2010? More than $6 million in compensation.

Lockheed Martin is a Clinton Foundation donor. The company admitted to becoming a Clinton Global Initiative member in 2010.

According to records, Lockheed Martin is also a member of the American Chamber of Commerce in Egypt, which paid Bill Clinton $250,000 to deliver a speech in 2010.

In 2010, Lockheed Martin won 17 approvals for private contracts from the Hillary Clinton State Department.

HSBC Holdings

In 2013, Comey became a board member, a director, and a Financial System Vulnerabilities Committee member of the London bank HSBC Holdings.

“Mr. Comey’s appointment will be for an initial three-year term which, subject to re-election by shareholders, will expire at the conclusion of the 2016 Annual General Meeting,” according to HSBC company records.

HSBC Holdings and its various philanthropic branches routinely partner with the Clinton Foundation. For instance, HSBC Holdings has partnered with Deutsche Bank through the Clinton Foundation to “retrofit 1,500 to 2,500 housing units, primarily in the low- to moderate-income sector” in “New York City.”

“Retrofitting” refers to a Green initiative to conserve energy in commercial housing units. Clinton Foundation records show that the Foundation projected “$1 billion in financing” for this Green initiative to conserve people’s energy in low-income housing units.

Who Is Peter Comey?

When our source called the Chinatown offices of D.C. law firm DLA Piper and asked for “Peter Comey,” a receptionist immediately put him through to Comey’s direct line. But Peter Comey is not featured on the DLA Piper website.

Peter Comey serves as “Senior Director of Real Estate Operations for the Americas” for DLA Piper. James Comey was not questioned about his relationship with Peter Comey in his confirmation hearing.

DLA Piper is the firm that performed the independent audit of the Clinton Foundation in November during Clinton-World’s first big push to put the email scandal behind them. DLA Piper’s employees taken as a whole represent a major Hillary Clinton 2016 campaign donation bloc and Clinton Foundation donation base.

DLA Piper ranks #5 on Hillary Clinton’s all-time career Top Contributors list, just ahead of Goldman Sachs.

And here is another thing: Peter Comey has a mortgage on his house that is owned by his brother James Comey, the FBI director.

Peter Comey’s financial records, obtained by Breitbart News, show that he bought a $950,000 house in Vienna, Virginia, in June 2008. He needed a $712,500 mortgage from First Savings Mortgage Corporation.

But on January 31, 2011, James Comey and his wife stepped in to become Private Party lenders. They granted a mortgage on the house for $711,000. Financial records suggest that Peter Comey took out two such mortgages from his brother that day.

This financial relationship between the Comey brothers began prior to James Comey’s nomination to become director of the FBI.

DLA Piper did not answer Breitbart News’ question as to whether James Comey and Peter Comey spoke at any point about this mortgage or anything else during the Clinton email investigation.

Peter Comey Re-Designed the FBI Building

FBI Director James Comey grew up in the New Jersey suburbs with his brother Peter. Both Comeys were briefly taken captive in 1977 by the “Ramsey rapist,” but the boys managed to escape through a window in their home, and neither boy was harmed.

James Comey became a prosecutor who worked on the Gambino crime family case. He went on to the Bush administration, a handful of private sector jobs, and then the Obama administration in 2013.

Peter Comey, meanwhile, went into construction.

After getting an MBA in real estate and urban development from George Washington University in 1998, Peter Comey became an executive at a company that re-designed George Washington University between 2004 and 2007 while his brother was in town working for the Bush administration.

In January 2009, at the beginning of the Obama administration, Peter Comey became “a real estate and construction consultant” for Procon Consulting.

Procon Consulting’s client list includes “FBI Headquarters Washington, DC.”

So what did Procon Consulting do for FBI Headquarters? Quite a bit, apparently. According to the firm’s records:

Procon provided strategic project management for the consolidation of over 11,000 FBI personnel into one, high security, facility.

Since 1972 the Federal Bureau of Investigation has had its headquarters in a purpose built 2.1 million square foot building on Pennsylvania Avenue. Having become functionally obsolete and in need of major repairs, GSA and the FBI were considering ways to meet the space needs required to maintain the Bureau’s mission and consolidate over 11,000 personnel.

Procon assisted GSA in assessing the FBI’s space needs and options for fulfilling those needs. Services provided included project management related to site evaluations, budgeting, due diligence, and the development of procurement and funding strategies.

Those “funding strategies” included talking to “stakeholders”: “Worked with stakeholders and key leadership to identify strategic objectives, goals and long range plans for capital and real estate projects.”

Procon Consulting obtained its contract for FBI Headquarters prior to James Comey’s nomination to serve as director of the FBI.

In June 2011, Peter Comey left Procon Consulting to become “Senior Director of Real Estate Operations for the Americas” for DLA Piper.

Peter Comey has generated some controversy in that role. According to Law360 in May 2013 (the same month that James Comey was confirmed as someone being considered by Obama to become FBI director):

Two real estate services businesses filed a $10 million suit against the law firm Monday alleging it stiffed them on as much as $760,000 of work done at DLA Piper’s Chicago office and improperly gave proprietary information to a competitor.

….

The plaintiffs take particular aim at Peter Comey, DLA Piper’s senior director of real estate operations. Leasecorp and SpaceLogik include several emails in the complaint that are purportedly from DLA Piper senior real estate partners Jay Epstein and Rich Klawiter and are sharply critical of Comey’s handling of the matter. In one email, Epstein wrote that “it’s an embarrassment for the firm to be treating someone who we are working with like this.”

In another email allegedly from Klawiter on Feb. 20, the DLA Piper partner informed Leasecorp President Michael Walker, a principal for both plaintiffs, that Comey had sent him and Epstein an email claiming that the real estate services firms were behind on their contractual obligations.

“I just received an email from Peter (Jay was also a recipient) that is so inflammatory I can’t even send it or you’ll hit the roof,” Klawiter said in the email, according to the complaint. “This is not going to end well.”

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Our Healthcare system is causing doctors, nurses,pharmacists and pts to commit suicide while the MBA’s with their spread sheets and the middlemen are busy calculating how to pay those who provide healthcare less for needed services while they continue to reap more and more profits.  It is estimated that for every $ paid in health insurance premiums… some 40%-50%  is consumed to fund the infrastructure and profits of the middlemen… who provide NOTHING towards the direct healthcare of pts. The Federal government alone has THREE DIFFERENT HEALTHCARE PROGRAMS (Medicare/Medicaid/Obamacare).  The question is WHY ??  Those who do not qualify for subsidies under Obamacare… have high premiums and high deductibles…both going up DOUBLE DIGITS in 2017… just as Obama LEAVES OFFICE. It would seem that the BUSINESS OF HEALTHCARE is more focused on profits than the health of pts.

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