FDA Approves New Blood Thinner

Late Friday, the FDA announced that they were approving a new drug -- Effient, Eli Lilly's new blood thinner -- even though this drug comes with extremely dangerous and potentially deadly risks.

The drug is so dangerous that the FDA has technically approved it only for specific patients, people getting angioplasty. Here's the catch: In the study the approval was based on, patients taking Effient faced "a greater risk of significant, sometimes fatal bleeding" when compared to Plavix, a top-selling blood thinner. On top of that, patients who'd already had strokes faced a higher risk of suffering another stroke if they took Effient.

Are the risks worth it? Nope. Not at all. Because while Effient slightly reduced the risk of non-fatal heart attacks, the number of deaths was "similar" with both drugs. So Effient doesn't really work better, and it increases your risk of repeat stroke and fatal bleeding.
Bottom line: If you're heading for angioplasty, make sure the doctor doesn't use Effient.

For information regarding the FDA announcement, go to:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm171497.htm

Source: Health Sciences Institute

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LNH Note: It's challenging to keep up with pharmaceutical news when there are so many drugs introduced to the market with such frequency. We're not anti-pharm. Rather we encourage everyone to start a vibrant health plan for themselves and those they care about to aid in the reduction of or eliminate the need for synthetics in the body.  More information regarding vibrant living is archived in this blog.

The care you give yourself today is the health you'll create for your lifetime.

OC

Pharmaceutical Education: Who's Responsible? Who's Accountable?

Drug education is a deep and seemingly unexplored topic. No, we're not talking about Nancy Reagan's "Just Say No" program. We're talking about responsible pharmaceutical education.  We're not here to point a finger or cast blame, but we are realistic in reviewing how our society arrived in a place where we have been faced with many unnecessary and irresponsible pharmaceutical-related tragedies.

Many people know more about their TV's, iPods and computers than their prescriptions.

Let's face it, Americans are largely trusting people. We trust "Consumer Reports". We trust our teachers. We even trust our news sources.  So when it comes to our health, it's no surprise that many believe that if "the doctor prescribed it, it's gotta be safe and OK". But doctors only know what they are told, and are unable to determine the level of safety to maintain a high standard of practice unless full disclosure has been given by the patient. Omission of fact is not always intentional, as some patients forget to mention a new drug that was prescribed by a different doctor. On the other hand, some patients use fictitious names just to get their hands on more drugs. And some doctors are afraid to say "no" to patients, especially those who are high profile, because they will be fired. Sadly, they sometimes cave in rather than stand their ground and walk away.

Many high profile people live in a relatively cloistered world, meaning they rely largely on handlers for treatment and information. But so does everyone else. Think about it. Our contact person is the treating doctor. The information we receive is only as good as was given to the doctor by the pharmaceutical rep. Many times the doctor doesn't fully understand the drug, it's best and most appropriate use and it's side effects, as they only spend 5-15 minutes with their pharmaceutical rep. The rep leaves samples and some literature, pens, pads and refrigerator magnets and they're on their way to the next office. So if the doctor isn't educated properly, how can we expect their patients to be fully knowledgeable?  The PDR (Physicians Desk Reference) is not updated as frequently as drugs are approved, so where will they find the information they need?

Signing off on the clipboard page at the drug store that you've read the information isn't "education". And in many cases, runners are sent to pick the prescriptions up, so the patient never sees the page anyway. You don't have to be 'high profile' to fit this scenario -- this is the world we live in.

In any event, these scenarios just make everyone look bad --- doctors, medical health practitioners, pharmaceutical companies, drug stores and patients --- and sets everyone up for tragic and unnecessary failures.

President Obama claims he is looking for education and health care programs.  Well, HERE'S A GOLDEN OPPORTUNITY!  

The multi-billion dollar pharmaceutical industry certainly has the resources to be held to a high standard of accountability for it's products.  They arrange for slick, catchy multi-million dollar ad campaigns to get us interested, but not educated --- and running an incomplete list of side effects on a sped-up voiceover during a television commercial is not considered "education". 

We'd like to see them put their money to sensible and viable use FOR the safety of our people, and not just hook them in to 'ask the doctor about the flavor-of-the-moment-recently-released pill' that won't cure anything, but WILL produce side effects so that you'll ask for more drugs to ease the new set of side effects. There's your vicious cycle.  

What they don't tell you:  Drugs are designed to treat symptoms, not cure disease.  

People read tabloid stories and wonder how "those people" can take so many drugs and why the toxicology reports are long in high profile cases.  Truth is, "those people" are your relatives and neighbors -- this happens all day long to people who you may know, but the high profile and tragic cases get the big press coverage.  And even then, it's spun to make them all look like "drug addicts" in the most negative and irresponsible sense and no one is held accountable. The press may turn the tragedy into a witch hunt, when we really need to look to the source (pharmaceutical companies) for a viable solution.

The average 40 year old takes 8 different prescription drugs per day.  

This is astonishing! But it's easy to see how that happens -- Maybe you know someone who was injured and was prescribed pain killers. Years after the injury has healed, they still take pain killers. You even may know someone who became ill and was prescribed drugs to treat the symptoms. Years later, those symptoms may have changed and there are 4 or 5 other symptoms added to the mix -- and more prescriptions were filled.  And then the body becomes more toxic and weakened. More drugs are prescribed.  You get the picture. It happens all day long in America.  

There are efficacious drugs that help relieve symptoms so the body is better able to restore itself. That said, we are a country that has become over-prescribed and under-educated.

Bottom line:

Pharmaceutical Education needs to be addressed and implemented. Pharmaceutical companies need to be involved in the process.

What you can do for yourself:

We all have stress in our lives -- be it emotional, physical, mental, a combination -- stress factors are part of our world.  It's up to each of us to develop coping skills rather than running to the doctor for some 'magic bullet' that is designed to treat symptoms, but may add to the stress level and toxic burden on the system and not fix the problem.  Seriously.  Each of us needs to take responsibility for our own well being.  Learning and instilling good basic lifestyle choices is an excellent start.

 

Drugs are here to stay. The way we relate to them needs to change.  Feel free to address Dr Margaret Hamburg, Commissioner, FDA and President Obama to consider Pharmaceutical Education regarding this issue.           

OC

Gardasil: The Facts

HPV is nothing new. Women have been getting PAP smears for years to check for the Human Papillomavirus, transmitted through sexual intercourse, which, if contracted, will usually CLEAR ON IT'S OWN within 2 years.

Here are some facts about Gardasil (HPV4): 

Gardasil, developed by Merck, is an intramuscular vaccination licensed for use in females 9-26 years of age. Of the 100 known strains of HPV worldwide, Gardasil is designed to prevent four of these strains---6, 11, 16 and 18. Of those four strains, only 2 are found in the US, and only 3.4% American women contract HPV.

Use:

Gardasil is administered in 3 intramuscular injections over a 6 month period.

The clinicals:

• Gardasil was tested on just 20,541 women worldwide ages 16-26.

• Less than 1,200 were girls under the age of 16.

The stats:

According to the Vaccine Adverse Event Reporting System (VAERS), an agency managed by the USCDC and the FDA, there have been more than 15 deaths reported following Gardasil injections which are currently under investigation.

Side effects include asthma, fever, headache, pain, dizziness, fainting, collapsing, facial paralysis, seizure, skin problems, depression, neurological symptoms, tingling, numbness and loss of sensation in the fingers and limbs. Google 'VAERS Gardasil reports' for case information.

Concerns:

• Merck has not published any test reports for carcenogenicity (cancer).

• Merck has not published any test reports for reproductive capacity (fertility).

• Merck has not published any safety studies that it shouldn't be administered with other vaccines. The Advisory Committee on Immunization Practices (ACIP) claims Gardasil can be used in conjunction with other vaccines. VAERS has devastating reports which negate this claim.

• Merck has not published any safety studies that it shouldn't be administered with other medications.

And this is just the beginning:

• How long will it last? It was only tested for 4 years. The 9 year olds who are receiving these injections have a long way to go before turning 39, the age when cervical cancer can start to show up.

• A 'booster' vaccination is already in the works.

• A vaccine for boys is in the works.

• Like other vaccines, Gardasil opens up the possibility/probability to create other strains of the virus which are more aggressive. The current vaccine will get rid of the weak, affected cells and the stronger will rise to the top. Have we learned nothing from the Flu shot?

Pharmaceutical Marketing: A History

• Orginally intended to create products to capture the elderly, largely to treat pain.

• Has been targeting the middle age market since mid 1900's to take an average of 7 prescription drugs for life by age 40.

• The next market share of the pharmaceutical industry are TEENS.

The Advisory Committee on Immunization Practices (ACIP) recommendations for HPV4 include:

• routine vaccination for 11-12 year-old girls

• catch-up vaccination for 13-26 year-old females

• girls age 9-10 may receive the vaccine at provider discretion

Editorial note: THIS IS ALARMING!

Product insert information that no one is talking about:

Gardasil contains 675mcg of aluminum, a known Central Nervous System toxin. It also contains Polysorbate 80, which is reported to cause anaphylaxis on repeated doses.

The numbers:

• Gardasil means a $360 reimbursement for your doctor's office.

• Gardasil is currently estimated at a $1.4 Billion addition to Merck, and will add $17 Billion in revenue to Merck by 2017.

Things you should know:

• 1853 - the start of the Anti-Vaccination Movement

• 1907 was the year of the first vaccination exemption

• Exemptions include:

- Medical

- Religious

- Philosophical

These still hold true today.

NO ONE can mandate vaccinations in the United States. It is against the law!

What can you do?

• Do your homework

• Read the package insert

• Know the risks

• Know your state laws

• Ask questions

US Vaccine Mandates: Fact or Myth?

There has been a huge push to mandate vaccines for school age children in the US for many years. Your school district may tell you that they will not allow entrance for your child unless they are vaccinated.

It is against the law to mandate vaccines in the US. Parents can 'opt out' by providing a medical, philosophical or religious exemption. A doctor or clergy member can assist you.

It's important we all become vigilant about proposed changing of laws in each state in order to preserve our health freedoms. Don't expect to hear about the proposed changes regarding health issues, especially the mandating of vaccines. More often than not, you will hear about them AFTER the laws have been passed. For example, we all heard about the Patriot Act bill in the wake of 9/11, which was passed in October 2001. Holy civil liberties, Batman!....did you know that it was revised and another version was passed in 2006? Yup, 'they' quietly slipped that one by us.

Several states have become a hotbed of activity relevant to the mandating of vaccines. If you live in NY or NJ, you know what I'm talking about! If you live in IL, do your due diligence now! Don't be naive. It's more important than ever to know your state laws and keep up with them.

If you don't have children, don't ignore this information. Mandating for one population will lead to mandating for all....even you. I have more information on this I'll share with those of you who are interested.

In any event, it's crucial we MAINTAIN OUR RIGHT TO A CHOICE REGARDING OUR HEALTH FREEDOMS.

We live in the United States, meaning that each state mandates their own laws, but when a law gets passed that can be of particular benefit to a special interest group, it will be 'worked' to pass nationally. Think cell phones...ever wonder why the law passed for hands-free cell phones? First NYC, then CA, then NJ and the spread continues. Is it really about accident statistics? or is it about this:

http://en.wikipedia.org/wiki/Bluetooth_Special_Interest_Group

And that's only ONE example. There are more:

http://en.wikipedia.org/wiki/Special_Interest_Group

You see where we're going....and going and going...because one thing always leads to another.

Let US decide where the road leads.