On July  23 the FDA held a public meeting concerning the “extended release” (aka – OxyContin) products under the guise of creating new “safety guidelines”.  The guidelines were presented under the auspices of REMS – Risk Evaluation and Mitigation Strategy.  REMS was initiated in 2007 to bring greater information to the public if a “DRUG’S BENEFITS OUTWEIGH ITS RISKS”.

The radio show revealed the hypocrisy and  continuing disingenuous efforts by the FDA.  Thousands dying, tens of thousands addicted and millions dependent and the FDA continues to allow the unencumbered marketing of the long term opioids for “moderate to severe pain”.  The lunacy of the public meeting was missed by all in the media.  The psychological, emotional and brain altering results from the opioids should have been the first order of discussion at the meeting.  The inept and insincere efforts of the “corrupted” FDA officials leading the proposals and meeting should have been revealed.  The quote by John Jenkins, the director of the  FDA’s office of  new drugs, said “the agency’s plan was designed to address legitimate use of the drugs, not deliberate abuse”.   Volumes can be written on Jenkin’s misunderstanding of “legitimate” use, but to publicly state that abuse is not under the auspices of the FDA’s concerns should immediately create the dismissal of Jenkins.

Margaret Hamburg, the Commissioner of the FDA, is allowing the ineptness of Woodcock, Throckmorton, Rappaport, Jenkins and Hirsh to be remembered as  the most ineffective FDA Commissioner in History.  Millions of individuals and families continue to be affected by  the inaction of the FDA and the clock is ticking on revealing Hamburg’s ineffectiveness in representing the safety of the American people.  The fiasco of the July 23^rd meeting was a glaring reminder of Hamburg being out  of touch.  Hamburg should become familiar with Napoleon at Waterloo.

On Sunday, The St. Pete Times ran a story about a man who overdosed.  Aside from quoting a bereaved parent who said "but I think he was weak" in reference to his son, The Times didn't stop there from furthering the agenda of the pain management industry. 

A list of 21 prescriptions was published that the deceased man received from a pharmacist.  The final prescriptions were sold to the man after his father asked the pharmacist to stop dispensing the dangerous narcotics to his son.

Michele Weizer, Chairperson of the Florida Board of Pharmacy was quoted, "We are required to fill the prescription unless there is a really good reason not to fill it".  "This is health care.  It's a patient safety reason more than anything else".

As a pharmacist, I am both outraged and embarrassed by the quotes.  The Florida Pharmacy Statute is clear.  Sec 64B16-27.831- 4.    An order purporting to be a prescription issued not in the usual course of professional treatment nor in legitimate and authorized research is not a prescription and the pharmacist knowingly filling such a purported prescription shall be subject to penalties for violations of the law.  The following criteria should cause a pharmacist to question whether a prescription was issued for legitimate medical purpose".

As of this writing, I am assuming the Chairperson was misquoted.  To insinuate that there was a good reason to fill all 21 prescriptions for the deceased man should call for the immediate removal of Ms. Weizer from her position.  Is it possible that Ms. Weizer was placed in the Chairperson position by affiliates of the pain management organizations?

If Ms. Weizer reaffirms the quotes, then I would encourage her to review the Florida Supreme Court ruling that entrusts pharmacists with the duty to warn.   

NOTE:  Shortly after this posting, Leonora Anton LaPeter, the author of the article responded: 

Why would you take a quote and not give it it's context? This is what she said:

 >>>But they are in a delicate position. Pharmacists have an obligation to help the people who walk in their door.

"We are required to fill the prescription unless there is a really good reason not to fill it," said Michele Weizer, chairperson of the Florida Board of Pharmacy and a pharmacist from Palm Beach County. "This is health care. It's a patient safety reason more than anything else."

Some time ago the Pinellas County Sheriff's department arrested a number of people for "doctor shopping" and passing "fraudulent" prescriptions.  Last night I reported on the recent story from Hernando County on the arrests of 23 people who were part of "an organized prescription drug ring".  It was reported that many fake prescriptions were created to acquire thousands of narcotics. 

Again, many people with the disease of addiction were arrested and not a single pharmacist or drug wholesaler who was complicit in putting thousands of drugs onto our streets shared the same cell.  The phoniness of reporting on phony prescriptions needs to come to an end.  The pharmacists who fill prescriptions for people who are unknown to the pharmacist for hundreds of pills should immediately lose their pharmacy license.  The Florida Pharmacy Board has been negligent and egregiously complicit in allowing the tools for addiction and death to be so readily available via the middle man for the drug deals.  Pharmacists who fill prescriptions for large quantities to people who are young and their physical characteristics are "glassy eyes" should both lose their pharmacy license and be prosecuted for drug dealing.  The privilege for having a pharmacy license should not be allowed to be abused.  

The DEA should be prosecuting the drug wholesalers who ship to the few pharmacies who put the drugs out onto our streets.  We have a system in place that has created "legal" narcotic drug distribution and most of our public officials, police officials, business and media pretend to remain "dumbfounded". 

It is my hope that the police departments around the country stop protecting the legal drug cartels.  The fact is that the "fraudulent prescriptions" are not fooling anyone.  They are a continued excuse to turn a blind eye to the tens of thousands of individuals and families who have suffered from the "less than forthcoming" information from the police reporting.  

The Goat and the Goatherd 

A GOATHERD had sought to bring back a stray goat to his flock.He whistled and sounded his horn in vain; the straggler paid noattention to the summons.  At last the Goatherd threw a stone,and breaking its horn, begged the Goat not to tell his master.The Goat replied, "Why, you silly fellow, the horn will speak though I be silent."

The radio show has been critical of the present state of Florida's  response to the growing drug problem in our state.    The epicenter and glaring distribution point for the drugs entering our streets  are the "Pain Clinics".   With the new drug monitoring bill soon to be implemented, over 900 clinics have mandatorily been registered as legal narcotic distribution points in Florida.   There is plenty of blame to go around for the dismal response Florida officials and law makers have had over past years.  However, it has become time for solutions. 

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/UCM187082.pdf

The comment was in reference to Purdue requesting to bring a new OxyContin product to the American people.  That was a lie.  Purdue never revealed to the FDA that the new product may have been susceptible to separating out the active ingredient from the polyethylene oxide matrix.  As time progresses since the September 24th meeting the radio show grows more confident in saying the FDA has either been incredibly incompetent in dealing with Purdue Pharma or the FDA has some corrupt individuals within its organization.  If the radio show did not reveal the lack of heating studies publicly on September 24th, this country would have had a more dangerous product released to the streets than the existing product. 

The public and media continue to bypass a modern day David and Goliath story.  Five courageous citizens went to Washington to take on the FDA and a giant pharmaceutical company.  The "fix" was in on September 24th and Purdue and the FDA won the first round when the Advisory Committee overwhelmingly voted for the new product.  At the meeting, the five citizens were ignored and outnumbered by the industry representatives  (12 to 5) during the public comment portion of the meeting.

The radio show has always believed the truth will direct us to the final decisions.  Is it possible the truth is starting to come to the surface?  We have Dr. Steve Gelfand,  Steve Hayes, Sandra Kresser, Pete Jackson, Ed Vanicky and a radio show to thank for revealing the truth on Sunday night.

Sunday night's guest was Barbara Allen, Regional Coordinator for The Compassionate Friends in the Delaware/Maryland areas. The Compassionate Friends is an organization that I hope every listener of the radio show will show their support and learn more about http://www.compassionatefriends.org/home.aspx

On this week's show we learned about the Chase Community Giving, a grassroots campaign launched November 16th using Facebook. Facebook's 350 million users chose from more than 500,000 of their favorite small and local charities and voted for them to win their share of $5 million. Chase Community Giving fans nominated tens of thousands of charities from all 50 states and the District of Columbia

In round one voting, The Compassionate Friends, out of 500,000 eligible nonprofits, became one of the 100 finalists awarded $25,000 for receiving the most votes from its members and friends. In the second round, the charity receiving the most votes will receive a $1 million grant and five runners-up will each receive a $100,000 award. The second round of voting ends this Friday, January 22nd.

The radio show hears from family members and friends who have lost a loved one to drugs. The mystery of life screams out loudest when someone special is taken from them. For anyone faced with the horrific loss of a loved one I urge them to visit The Compassionate Friends page. http://www.compassionatefriends.org/about_us.aspx    For whatever reason, I am told that to lose a loved one to drugs is more painful to some because of the silence drug and alcohol use brings to those bereaving.

I urge all to listen to the show from Sunday night. Barbara Allen from The Compassionate Friends explains how the organization may help you, a loved one or a friend. After listening, don't forget to vote in the Chase Community Giving contest. http://www.compassionatefriends.org/home.aspx    

The majority of the media and legislature has been focused on the egregious acts from the proliferation of "pain management clinics".  The radio show made it clear that the marketing for the "legitimate" pain clinics has been ingenious and has created an opening for more drug distribution onto the streets of Florida.  As of last week, over 700 clinics registered as pain clinics in our state.  Few citizens have read the Florida Statute on what constitutes the definition of a pain clinic. 

Florida Statute 459.005 (4) (i) - "A physician is primarily engaged in the treatment of pain by prescribing or dispensing controlled substance medications when the majority of the patients seen are prescribed or dispensed controlled substance medications for the treatment of chronic nonmalignant pain. Chronic nonmalignant pain is pain unrelated to cancer which persists beyond the usual course of the disease or the injury that is the cause of the pain or more than 90 days after surgery."

The radio show promises continued growth of dependence and addiction from the legal distribution of narcotics from the drug mavens in our state.  By sanctioning and registering two bit doctors who admittedly specialize in narcotic distribution has opened up a new chapter for the communities in Florida.  Florida Statute 459.005(4)(i) clearly states the misnomer for the title of pain clinics.  DRUG MANAGEMENT CLINIC is a more appropriate name. 

It appears Purdue Pharma took their lesson from the Bayer company who successfully marketed Heroin beginning in 1898 as a "cough medicine and pain reliever".    Heroin was written about in medical journals and studies endorsed heroin for treating asthma, bronchitis, phthisis and tuberculosis. Free samples were sent out by the thousands to physicians in Europe and the US.  Between 1899 and 1905, at least 180 clinical works on Heroin were published around the world.  In 1906, the American Medical Association approved heroin for medical use. 

The most telling fact about Heroin is how its name was derived.  In the Bayer laboratory, in testing the "workers loved it, some saying it made them feel "heroic" (heroisch)". http://www.opioids.com/heroin/heroinhistory.html     The name "Heroin" was born. 

Moving the clock forward, today we have an active ingredient called oxycodone that is essentially interchangeable with Heroin for both therapeutic and misuse potential.  OxyCodone is the active ingredient of OxyContin. 

From a logical perspective, how did a chemical similar to Heroin in today's knowledgeable and aware society so masterfully get passed off as a product to treat the fabricated notion that pain is being undertreated?   How long are the intellectual elite in this country going to allow a product that makes one feel heroic to freely be distributed on our streets in every community in America?  When is the mainstream going to ask what "undertreated pain" means?   That catch phrase has been used to create the growing opium epidemic in every community in our country.