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Friday, June 3, 2011

Jack Kevorkian Dead: Assisted Suicide Advocate Dies At Age 83

Jack Kevorkian Dead: Assisted Suicide Advocate Dies At Age 83

Jack Kevorkian Dead
COREY WILLIAMS   06/ 3/11 10:08 AM ET   AP


**Editors notes:  No matter your opinion on Assisted Suicide, humans were never designed to LIVE FOREVER, despite what some patients and their family want or desire.  Too many times physicians are faced with expectations that are not rational or logical and the terminally sick and dying patient has to endure much suffering to extend "life" beyond what biologically and ethically should be allowed.  While I don't believe in the proactive approach of assisting one end their life, as it does violate the Hippocratic Oath in principle, I do advocate the halting of any medical intervention that prolongs the inevitable, painful, unnecessary extension of a terminally ill patient's life.  With rising health care costs, it is in our future to ration care by following a more pragmatic and pedantic protocol with those that are near end of life or who cannot contribute to society in any meaningful way.  -RedBanyan





       DETROIT — Jack Kevorkian, the retired pathologist who captured the world's attention as he helped dozens of ailing people commit suicide, igniting intense debate and ending up in prison for murder, has died in a Detroit area hospital after a short illness. He was 83.
Kevorkian, who said he helped some 130 people end their lives from 1990 to 1999, died about 2:30 a.m. at William Beaumont Hospital in Royal Oak, close friend and prominent attorney Mayer Morganroth said. He had been hospitalized since last month with pneumonia and kidney problems.
An official cause of death had not been determined, but Morganroth said it likely will be pulmonary thrombosis.
"I had seen him earlier and he was conscious," said Morganroth, who added that the two spoke about Kevorkian's pending release from the hospital and planned start of rehabilitation. "Then I left and he took a turn for the worst and I went back."
Nurses at the hospital played recordings of classical music by composer Johann Sebastian Bach for Kevorkian before he died, Morganroth said.
Kevorkian was freed in June 2007 after serving eight years of a 10- to 25-year sentence for second-degree murder. His lawyers had said he suffered from hepatitis C, diabetes and other problems, and he had promised in affidavits that he would not assist in a suicide if he was released.
In 2008, he ran for Congress as an independent, receiving just 2.7 percent of the vote in the suburban Detroit district. He said his experience showed the party system was "corrupt" and "has to be completely overhauled from the bottom up."
His life story became the subject of the 2010 HBO movie, "You Don't Know Jack," which earned actor Al Pacino Emmy and Golden Globe Awards for his portrayal of Kevorkian. Pacino paid tribute to Kevorkian during his Emmy acceptance speech and recognized the world-famous former doctor, who sat smiling in the audience.
Pacino said during the speech that it was a pleasure to "try to portray someone as brilliant and interesting and unique" as Kevorkian and a "pleasure to know him."
Kevorkian himself said he liked the movie and enjoyed the attention it generated, but told The Associated Press that he doubted it would inspire much action by a new generation of assisted-suicide advocates.
"You'll hear people say, `Well, it's in the news again, it's time for discussing this further.' No it isn't. It's been discussed to death," he said. "There's nothing new to say about it. It's a legitimate ethical medical practice as it was in ancient Rome and Greece."
Eleven years earlier, he was sentenced in the 1998 death of a Lou Gehrig's disease patient – a videotaped death shown to a national television audience as Kevorkian challenged prosecutors to charge him.
"The issue's got to be raised to the level where it is finally decided," he said on the broadcast by CBS' "60 Minutes."
Nicknamed "Dr. Death" because of his fascination with death, Kevorkian catapulted into public consciousness in 1990 when he used his homemade "suicide machine" in his rusted Volkswagen van to inject lethal drugs into an Alzheimer's patient who sought his help in dying.
For nearly a decade, he escaped authorities' efforts to stop him. His first four trials, all on assisted suicide charges, resulted in three acquittals and one mistrial.
Murder charges in earlier cases were thrown out because Michigan at the time had no law against assisted suicide; the Legislature wrote one in response to Kevorkian. He also was stripped of his medical license.
People who died with his help suffered from cancer, Lou Gehrig's disease, multiple sclerosis, paralysis. They died in their homes, an office, a Detroit island park, a remote cabin, the back of Kevorkian's van.
Kevorkian likened himself to Martin Luther King and Gandhi and called prosecutors Nazis, his critics religious fanatics. He burned state orders against him, showed up at court in costume, called doctors who didn't support him "hypocritic oafs" and challenged authorities to stop him or make his actions legal.
"Somebody has to do something for suffering humanity," Kevorkian once said. "I put myself in my patients' place. This is something I would want."
Devotees filled courtrooms wearing "I Back Jack" buttons. But critics questioned his publicity-grabbing methods, aided by his flamboyant attorney Geoffrey Fieger until the two parted ways before his 1999 trial.
"I think Kevorkian played an enormous role in bringing the physician-assisted suicide debate to the forefront," Susan Wolf, a professor of law and medicine at University of Minnesota Law School, said in 2000.
"It sometimes takes a very outrageous individual to put an issue on the public agenda," she said, and the debate he engendered "in a way cleared public space for more reasonable voices to come in."
Even so, few states have approved physician-assisted suicide. Laws went into effect in Oregon in 1997 and Washington state in 2009, and a 2009 Montana Supreme Court ruling effectively legalized the practice in that state.
In a rare televised interview from prison in 2005, Kevorkian told MSNBC he regretted "a little" the actions that put him there.
"It was disappointing because what I did turned out to be in vain. ... And my only regret was not having done it through the legal system, through legislation, possibly," he said
Kevorkian's ultimate goal was to establish "obitoriums" where people would go to die. Doctors there could harvest organs and perform medical experiments during the suicide process. Such experiments would be "entirely ethical spinoffs" of suicide, he wrote in his 1991 book "Prescription: Medicide – The Goodness of Planned Death."
His road to prison began in September 1998, when he videotaped himself injecting Thomas Youk, a 52-year-old Lou Gehrig's disease patient, with lethal drugs. He gave the tape to "60 Minutes."
Two months later, a national television audience watched Youk die and heard Kevorkian say of authorities: "I've got to force them to act." Prosecutors quickly responded with a first-degree murder charge.
Kevorkian acted as his own attorney for most of the trial. He told the court his actions were "a medical service for an agonized human being."
In his closing argument, Kevorkian told jurors that some acts "by sheer common sense are not crimes."
"Just look at me," he said. "Honestly now, do you see a criminal? Do you see a murderer?"
The U.S. Supreme Court twice turned back appeals from Kevorkian, in 2002, when he argued that his prosecution was unconstitutional, and in 2004, when he claimed he had ineffective representation.
In an interview at the time Kevorkian was released from prison, Youk's brother Terrence said his brother received "a medical service that was requested and, from my point of view, compassionately provided by Jack. It should not be a crime."
But Tina Allerellie became a fierce critic after her 34-year-old sister, Karen Shoffstall, turned to Kevorkian in 1997. She said in 2007 that Shoffstall, who suffered from multiple sclerosis, was struggling with depression and fear but could have lived for years longer.
"(Kevorkian's) intent, I believe, has always been to gain notoriety," Allerellie said.
Born in 1928, in the Detroit suburb of Pontiac, Kevorkian graduated from the University of Michigan's medical school in 1952 and became a pathologist.
Kevorkian said he first became interested in euthanasia during his internship year when he watched a middle-aged woman die of cancer. She was so emaciated, her sagging, discolored skin "covered her bones like a cheap, wrinkled frock," Kevorkian wrote.
After building a suicide device in 1989 from parts he found in flea markets, he sought his first assisted-suicide candidate by placing advertisements in local newspapers. Newspaper and TV interviews brought more attention.
On June 4, 1990, he drove his van to a secluded park north of Detroit. After Janet Adkins, 54, of Portland, Ore., met him there, he inserted a needle into her arm and, when she was ready, she flipped the switch that released a lethal flow of drugs.
He later switched from his device to canisters of carbon monoxide, again insisting patients took the final step by removing a clamp that released the flow of deadly gas to the face mask.
Kevorkian's fame – or notoriety – made him fodder for late-night comedians' monologues and sitcoms. His name became cultural shorthand for jokes about hastening the end of life.
Even admirers couldn't resist. Adam Mazer, the Emmy-winning writer for "You Don't Know Jack," got off one of the best lines of the 2010 Emmy telecast.
"I'm grateful you're my friend," Mazer said, looking out at Kevorkian. "I'm even more grateful you're not my physician."
When asked in 2010 how his own epitaph should read, Kevorkian said it should reflect what he believes to be his "real virtue.
"I am quite honest. I have trouble lying. I don't like people who lie."
[ he was blessed with a quick death, something I am sure he would have wanted ]

Thursday, June 2, 2011

Colchicine: An Example of Big Pharma Exploitation

Colchicine: An Example of Big Pharma Exploitation

Yusuf M. Saleeby, MD
RedBanyan.org (President, Patient Advocacy Group)

After attending a “medication update” CME course in Charleston, SC in May, it was brought to my attention that a drug that has been around and used to treat gout before I was even born, dispensed as a generic for decades was somehow off the generic list.  Formally “FDA approved” for the treatment of gout recently, the pharmaceutical company that pushed this process through the FDA with two small (and short lived studies) was granted seven years of patent protection.  This drove the cost of a single dose of Colchicine from $0.09 to over $4.85 per pill.  I was outraged to say the least.

Colchicine is an anti-gout drug, derived from the seeds from the Colchicum autumnale plant, also known as "meadow saffron.”  Traditionally, it has been used in a number of ways for over 200 years to treat gouty arthritis flare ups, as an acute agent dosed in rapid succession to reduce the gouty arthritis attacks or as a twice a day drug to prevent gouty attacks. Currently it has FDA approval for the treatment of gout and a very rare genetic inborn condition called familial Mediterranean fever (FMF).  Both these indications and approvals are only a couple of years old, granted by the FDA and as a consequence the drug company was bestowed patent protection.  Colchicine also sees use as an anti-inflammatory agent for long-term treatment of Behçet's disease, another rather rare disorder.  Coincidentally, the combination of Colchicine and probenicid to treat gout as a combination medication was FDA approved decades ago and is still approved.  Colchicines as a standalone drug was never FDA approved until recently despite it pervasive use to treat gout worldwide. 

Colcrys®  is now the new brand name and patent protected form of colchicine, it is the only legal form able to be purchased in America.  The drug company has effectively sued all other manufacturers to halt production and dispensing of generic colchicines.  Since 1810 doctors have prescribed colchicines for gout as an effective treatment, dosing it hourly until effective, but this caused severe gastrointestinal upset and toxicity.  The recent pharmaceutical industry supported studies showed effectiveness in a two dose regiment that was easier on the GI tract.  Additionally, the studies helped warn about potential severe drug reactions.  Certain common inhibitors (drugs) of CYP3A4 and/or P-gp, including grapefruit juice, may increase the risk of colchicine toxicity, namely two calcium channel blocker drugs used in the treatment of hypertension.  The new dosing regimen is one 0.6 mg dose twice daily.  Worth mentioning, colchicines will be the first FDA-approved drug for the treatment of a rare condition called familial Mediterranean fever (FMF), which is an inherited inflammatory disorder.   Because this disorder is so rare, drug companies are given protection with extended patent rights for devoting resources to developing a rather non-profitable drug.  These types of drugs are called “orphan drugs”.  The studies (AGREE trial was one) that were done were not extensive, utilized a small number of subject (184 patients), could not have cost the supporting drug company much money to fund, and was halted early due to data showing effectiveness of treatment.  The data of the AGREE trial was reported in the Journal of Arthritis & Rheumatism in April 2010.

The FDA has been pushing for approval of unapproved drugs on the market.  Incentives have been offered to drug companies who produce evidence based studies to lend credence for their use in the American market.  The FDA wants all medications to be scientifically tested for adherence to modern standards of safety, efficacy, quality and labeling.  While the program is noble in theory, the burden of this particular outcome is upon the end user, the patient who now has to pay 40 times the original cost of the medication. 

Let’s look for a moment at the company that took on the low risk gamble of funding a study to appease the FDA and obtain “FDA approval” for the treatment of gout officially and in so doing obtain patent protection for not just three, but 7 years (as this patent extension covers its use as an orphan drug for FMF).  United Research Laboratories (URL) was established by Albert Roberts a chemist educated at the University of Pittsburgh.  In the early days the company manufactured ACTH to treat arthritis and sold this directly to physicians.  The company built a successful distribution business after these humble beginnings.  Once manufacturers started bypassing distributors, Mr. Roberts established the Mutual Pharmaceutical Company, in 1984, to develop and manufacture generic products.  In 1988 Mr. Robert’s son, Richard Roberts, then a MD, PhD from Harvard joined the company as COO.  The younger Roberts lead the company to great profits.  In 1997 after venture capital groups Elliott Associates and Momar Corporation purchase majority shares of the company, Dr. Roberts was retained with minor shares as the company’s President, CEO and Chairman of the Board.  This heralded a change from manufacturing generic drugs with limited profitability to pursuing development of brand-name medications, launching the company into exponential profit making.  By the year 2001, URL Pharma (formerly known as Pharmaceutical Holdings Corp and spawned from URL) had net sales exceeding $100 Million.  They manufactured 35 products and had 14 abbreviated New Drug Applications (ANDAs) with FDA approval pending.  The company leadership realized by 2004 that the profitability of generic pharmaceuticals would deteriorate as other markets such as Asia gained greater market share with FDA approved drugs, so they took an ambitious path to transform the company away from generics into the realm of branded drugs.  The graph below depicts the transition from generic to brand-name manufacturing and distributing.  URL Pharma also established AR Scientific, Inc., a company that markets four branded drugs, Fibricor®, Qualaquin®, BactrimTM and of course Colcrys®.

Another example of a “generic drug” turned “branded” is Quinine Sulfate.  This drug dates back to the time of the American Civil War.  Generic for almost 200 years, the company in 2006 was able to brand this product gaining FDA-approval (the only company to do so) thus getting brand name protection and orphan drug exclusivity for the treatment of malaria.  The patent runs out in 2012.  According to the company web site, they foresee continued protection and exclusivity past the expiration date.

In 2007, URL Pharma had recorded annual sales of $483 Million, with more than 250 ANDAs approved and more proprietary products underway.  With recent developments in drug delivery systems with NanoBurst, MultiBurst and Z-Burst technologies, the company is expected to earn even greater profits in the near future. 

With the 2009 approval of Fibricor® (fenofibric acid) a cholesterol lowering drug similar to Tricor® or Trilipix®, their web site boasts great savings when compared with these other two drugs (http://www.fibricor.com/patient-landing.htm).  In actuality, the Fibricor® price is around $6/pill versus the now generic Fenofibrate drugs costing only less than a dollar through some outlets.  The Internet site www.pharmacychecker.com is a place that compares drug prices and details this drug price disparity.

I am all for profitability and positive growth in industry, as an unabashed supporter of the free-market economy system, however, I am not a big fan of what may certainly be construed as unbridled greed to the point of causing untoward effects on the end user/ consumer.  Just recently a woman I treated in the Emergency Room with a history of gout, suffering an acute flare up of her arthritic condition, was one of many who are faced with no choices when it comes to suffering this painful malady.  Her drug cost for her colchicines (generic) which she had been on for decades skyrocketed from 20 cents per day (approximately $6 per month) to roughly $10 per day ($300 per month), which she could not afford.  The folks paying the price?  Well this lady suffers with physical pain in her joints.  The tax payer suffer the burden of rising public health costs with the rise of prescriptive drug costs, covering the uninsured or under-insured patient visiting the emergency departments or primary care practices seeking relief.  And of course the small rural hospitals slammed with a rising tide of non-emergent visits choking their emergency rooms and hindering their ability to stay afloat financially.  Those are the victims of this FDA approved branding protection.

I am sure Dr. Roberts and the URL Pharma leadership have been heralded by the company and share holders as “heroes” and are more than likely iconic figures within the corporation, I am sure they are languishing in the profits and productivity of their company and basking in the glory of discovering and taking advantage of that governmental loophole that brought them such profits.  The question remains; is what this company has done with Colcrys®, Fibricor® and Qualaquin® ethical?  Should such great profits be made on the backs of the unfortunate?  The company would argue that nothing illegal was done.  And they are probably right, but ethically, that is another story.  Should human suffering come under the guise and protection of the federal government by some unintended legal loophole?  It must be determined by the general public and their perception and suffering at the hands of Big Pharma, the FDA and the Federal government, to speak out and ask for justice.



Source:  URL Pharma web site.

An announcement in Feb. 2011 on the URL Pharma web site announces a co-pay assistance program for Colcrys users who have health insurance.  Obvious bad public opinion and advocacy groups may have impacted the company’s reputation and they went on “damage control mode” to come up with this program.  Nonetheless, their profits despite these assistance initiative programs will not suffer negatively. 

From URL Pharma web site:

2/9/2011
URL PHARMA ENHANCES CO-PAY ASSISTANCE PROGRAM FOR COLCRYS®
Monthly Co-Pay Reduced to $15 for Most Patients with Health Insurance 

PHILADELPHIA, PA, February 11, 2011 – URL Pharma today announced that it has enhanced the Colcrys® (colchicine, USP) Co-Pay Assistance Program, an initiative designed to help patients save money on their health insurance co-payment for Colcrys. The enhanced program is available to patients immediately. 

Colcrys is the only single-ingredient colchicine product approved by the FDA, and is indicated for the prevention and treatment of gout flares and for the treatment of Familial Mediterranean Fever (FMF). 

The enhanced Co-Pay Assistance Program now enables most patients with health insurance to obtain Colcrys for $15 per month with a reusable coupon. Previously, the co-pay limit was $25 per month. Although the launch of the enhanced program is scheduled for March, patients do not have to wait until then to realize the new benefits. Effective immediately, URL Pharma will honor the currently-available $25 coupons at the new $15 co-pay amount. 

The enhanced program has several other newly-added features: 
·         Patients will now be able to save a maximum of $75 on their Colcrys prescriptions, up from $65 under the previous program
·         Patients may use co-pay coupons 12 times per calendar year
·         The program runs through January 31, 2012

“We are committed to making Colcrys accessible to everyone who can benefit from it,” said Richard H. Roberts, M.D., Ph.D., President and CEO, URL Pharma. “In response to feedback from patients and healthcare providers, we enhanced our Co-Pay Program to facilitate access to Colcrys.” 

The Colcrys Co-Pay Assistance Program works as follows: 
·         Patients may obtain a co-pay coupon directly from their doctor’s office or by downloading it atwww.colcrys.com and present it to their pharmacist when filling a Colcrys prescription
·         Alternatively, patients may have their COLCRYS prescriptions filled at any of more than 32,000 pharmacies nationwide that participate in the evoucherRx™ program from Relay Health. Patients may visithttp://evoucherrx.relayhealth.com/storelookup for a listing of pharmacies participating in the evoucherRx program.


Patients can learn more about the Colcrys Co-Pay Assistance Program by calling 1-800-657-7613 from 8:00 am to 8:00 pm Eastern Time, Monday through Friday. 

The Colcrys Co-Pay Assistance Program is valid only for patients with primary health plan coverage. Patients are not eligible if prescriptions are paid for in part or in full by any state or federally funded program including, but not limited to, Medicare, Medicaid, Medigap, VA, DOD, or TriCare, or where prohibited by law. The coupon is also not valid for cash-paying patients or rejected claims, and is void in the state of Massachusetts and where prohibited by law. 

For patients who are uninsured or have Medicare Part D, URL Pharma offers Colcrys free of charge or at reduced cost to those who qualify through the company’s Patient Assistance Program. Patients may visit
www.needymeds.org or call 1-888-811-8423 from 8:00 am to 6:00 pm Eastern Time, Monday through Friday for more information about the Patient Assistance Program.



Yusuf Saleeby, MD is an emergency room physician and founder and president of the patient advocacy groupRedBanyan.org.  He also heads a team of physicians and staff with a mission statement of bringing affordable and cost-contained health care delivery to the general public.  Online telehealth services such as AtroGene.com and a DAT serviceeStatLabs.com are means by which RedBanyan offers affordability and exemplary care to those uninsured or under-insured in America.

References:

http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000756/

http://www.medpagetoday.com/ProductAlert/Prescriptions/15358

http://www.medpagetoday.com/Rheumatology/GeneralRheumatology/22600

"Colchicine for acute gout: updated information about dosing and drug interactions". National Prescribing Service. 14 May 2010.

Cocco, Giuseppe; Chu, David C.C.; Pandolfi, Stefano (2010). "Colchicine in clinical medicine. A guide for internists". European Journal of Internal Medicine 21 (6): 503.

http://www.nps.org.au/health_professionals/publications/nps_radar/2010/may_2010/brief_item_colchicine.  Retrieved  5/15/11

http://www.urlpharma.com.  Retrieved 6/1/11

http://www.fibricor.com.   Retrieved 6/1/11

http://www.pharmacychecker.com.    Retrieved 6/1/11

Terkeltaub, et. al., High versus low dosing of oral colchicine for early acute gout flare: Twenty-four-hour outcome of the first multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-comparison colchicine study.  Arthritis Rheum. 2010 Apr;62(4):1060-8


MUSC Update on Prescription Drugs Conference, May 12-14th, 2011, Charleston, SC

© 2011