Tuesday, December 28, 2010

Pill Mills are Gearing up for Big Business

Thanks to the ideological rigidity of our legislature and almost monoptic "vision" of our Governor-Elect the Prescription Drug Monitoring Program is almost dead before even going online. The Office of Drug Control is being dissolved and all employees are gone by January 3rd!
In today's Miami Herald editorial the issues at hand are being pointed out as they are.
Dr. Viamonte Ross, one of the few agency heads asked to resign, has the final opportunity to declare a public health emergency thereby forcing the state to approve an existing PDMP vendor contract. Unfortuantely, the Attorney General (and the Board of Medicine) do not believe that the current status quo justifies such an emergency order. The rate of prescription drug overdose death increased to 7 Floridians a day. So whats the "magic" number 10,20, 100...?
I urge all of you to contact your legislator to support an immediate declaration of a public health emergency.
Yours
Bernd


The Miami Herald
Posted on Tue, Dec. 28, 2010
Pill mills still going strong


When it comes to the unsavory and downright illegal, South Florida owns the market in healthcare scams. Miami-Dade County is the nation's epicenter of Medicare fraud. Broward County is the state's biggest black market in prescription pain killers like oxycodone. By now, many of the pill mills should have been shut down. They're not.

Thanks to lax state oversight, walk-in pain clinics have flourished in Florida in the last three years. A 2009 Miami Herald series highlighted the proliferation of these pill mills. Broward clinics alone sell more oxycodone than is sold in several states. Anyone can get hundreds of pain pills from these clinics. The powerful narcotics are then resold on the street.

The growth of pain clinics, often run by discredited doctors, is causing an epidemic of prescription overdose deaths, says Florida drug czar Bruce Grant. The rate of deaths is about seven per day -- a shocking number that's preventable.

By now, these clinics were supposed to be regulated under tough new rules. Instead, most reforms are in limbo thanks to a contract dispute and a blunder by the Legislature during its November special session.

In 2009, the Legislature passed a bill to create a statewide database of all prescription narcotics sold by doctors and pharmacists to prevent patients from ``doctor shopping'' -- going to multiple clinics and doctors for pills to later resell. Tougher rules governing doctors working in pain clinics and who could own them are also in the new law.

The due date for the database was Dec. 1. The deadline came and went, however, because a company bidding on the project has legally challenged the contract award. Mr. Grant has asked Florida's surgeon general, Dr. Ana M. Viamonte Ros, to approve the contract on an emergency basis to protect public health.

Dr. Viamonte Ros is one of the few agency heads told to resign by Gov.-elect Rick Scott. But she is on the job till Jan. 3. Given those seven daily drug overdoses, Dr. Viamonte Ros should set the database in motion.

The other big glitch in moving forward with the regulations happened because of GOP lawmakers' zeal to override outgoing Gov. Charlie Crist's vetoes. They revived an anti-regulation bill requiring any new rules that may cost businesses or the government more than $200,000 a year to be subjected to legislative review before implementation.

This has stalled many pill-mill regulations, which now must await lawmakers' scrutiny in 2011. In vetoing the bill in its first incarnation, Gov. Crist wisely warned that the law would have required almost every new rule -- which can number in the hundreds in one year alone -- to await mandated review before being applied. What a nightmare.

Despite the setbacks, the state health department commendably has enforced a few rules. In November, state officials began inspecting pain clinics for the first time. So far, 17 clinics have been shut down.

That's a start, but as of November, there were 142 registered clinics in Broward and 94 in Miami-Dade. So much more could be happening right now to prevent more unnecessary deaths.


© 2010 Miami Herald Media Company. All Rights Reserved.
http://www.miamiherald.com


Read more: http://www.miamiherald.com/2010/12/28/v-print/1990879/pill-mills-still-going-strong.html#ixzz19SfYkR8i

Wednesday, December 22, 2010

Closing the Office of Drug Control is Bad For Business

Governor-Elect Rick Scott notified all four full-time employees working in the governor's Office of Drug Control that their services will no longer be needed after he takes office next month. The office will be dissolved and all its duties turned over to the departments of Health and Law Enforcement.
Rick Scott has pledged to cut waste in state government and the annual budget of about $551,300 for funding the operations of the Office of Drug Control is considered "waste" that needs to be eliminated too.
But lets analyze and examine the facts:

* The Office of Drug Control was created by then Governor Jeb Bush in 1999 and is authorized by state statutes.
* The Office collaborates with other agencies on the implementation of a three-pronged approach of Prevention, Treatment and Law Enforcement to eliminate the devastation of substance abuse rampant in Florida's diverse communities.
* The Office issued a series of excellent reports http://www.flgov.com/drugcontrol/odc_statsreports.php documenting the increasing problem of drug abuse in Florida.
* The Office was instrumental in getting legislation passed that is intended to help curb prescription drug abuse — one bill targeting pain management clinics, which are often disguises for "pill mills," and another that establishes a prescription drug monitoring program.
* The Office championed the creation of a Prescription Drug Monitoring Program, which almost reached the point of going on-line.
* Prohibited by law to use state funds to pay for the PDMP Director Bruce Grant and his superb staff successfully obtained the necessary funding through federal grants and other sources

The current political leadership in Tallahassee seems to be under the impression that we DO NOT have a significant drug problem in Florida.
Governor Scott's spokesman Brian Burgess was quoted in an article that "I don't think we're going to have cocaine bales stacking up on the docks of Miami if we close this office."
Obviously, he did not bother to check the facts:

· Years of lax state laws and a plethora of pain clinics have made Florida a destination for prescription drug traffickers, drug peddling doctors and abusers.

· The DEA, using its most recent data, says that 49 out of 50 of the top oxycodone prescribers are located in Florida.

· The number of deaths caused by at least one prescription drug increased more than 100 percent from 2003 to 2009.

· Mark Fontaine, executive director of the Florida Alcohol and Drug Abuse Association, said a recent study showed that substance abuse has a $43 billion negative impact on the state economy due to loss of job productivity, and costs associated with hospital and emergency room visits and incarceration. Fontaine said about 65 percent of Florida inmates have substance abuse problems.

· A 2009 Florida Department of Law Enforcement study concluded seven people in Florida die every day- ALMOST 2500 FLORIDIANS A YEAR - due to prescription drug abuse.



YES, WE DO HAVE A DRUG PROBLEM IN FLORIDA AND YES IT HAS REACHED EPIDEMIC PROPORTIONS WITH ADVERSE SOCIAL AND ECONOMIC RAMIFICATIONS.


Is cutting $500,000 of "wasteful" spending is worth more than all of the above listed adverse impacts of substance abuse and diversion?
Isn't it penny wise and pond foolish to close the Office of Drug Control? Shouldn't such decisions be based on recommendation made as the result of a careful review process involving experts?

SAVING $500,000 IS A BAD BUSINESS DECISION!
I am certain that closing the Office of Drug Control will have a significant adverse impact on our efforts to combat and control substance abuse and diversion forcing the allocation of much higher funding of law enforcement to deal with the consequences of a failed policy.


GOVERNOR-ELECT RICK SCOTT PLEASE RECONSIDER THIS DECISION!

THE ELIMINATION OF THE OFFICE OF DRUG CONTROL IS BAD FOR BUSINESS AND BAD FOR OUR GREAT STATE OF FLORIDA.


Bernd Wollschlaeger,MD,FAAFP,FASAM
Family Physician& Addiction Specialist

Saturday, December 18, 2010

Marijuana Debate

Attached an interesting letter to the editor published in the Miami Herald.
As addiction professionals we need to be able to respond to questions posed regarding Marijuana use and abuse.
We should gather the facts and discuss the issue openly and objectively.
Maybe the attached letter can contribute to stimulate the discussion.
Looking forward to your feedback.
Yours
Bernd


The Miami Herald
Posted on Tue, Dec. 14, 2010
Marijuana is not the `safer' drug


Re the Dec. 2 story Presidential hopeful: Legalize marijuana: Former New Mexico governor Gary Johnson's statement, ``Marijuana is a lot safer than alcohol,'' cannot go unchallenged and should be debated in a larger context. One important factor, often left out of the conversation, is that marijuana use (especially in young adults) can lead to or aggravate mental illness.

Studies support findings that risk of schizophrenia doubles in young abusers. Pot is also a gateway drug, leading abusers to graduate to harder drugs such as heroin and methamphetamine.

I am a certified addiction specialist specializing in adolescent substance-abuse, and my message is this: Beware marijuana's potency, no matter the arena of debate. Whether one discusses the medical merits or legal ramifications, one must also consider real-life implications.

• The medical debate: The medical merits of THC, the main ingredient in marijuana, have been identified, and THC is available in pill-form as Marinol and Cesamet. However, according to proponents of legalizing medical marijuana, the medical merits of THC are best experienced by smoking it -- absent FDA approval or review.

• The legal debate: The legal merits of marijuana cannot be supported. One argument is to tax the drug and collect revenue. According to Joseph Califano Jr., CASA founder and chairman of Center on Addiction and Substance Abuse (CASA), for approximately every $1 of tax revenue, there could be as much as $7 incurred in medical costs.

Califano also points out that legalizing marijuana means easier availability to children, and the debate is already contributing to teens' softening attitude about drugs, specifically marijuana. According to CASA findings, ``Despite reported declines in teen marijuana use -- in 2007 almost 11 million teens report using marijuana -- marijuana is a major substance abuse among teens, more than five times the increase in such findings for all other substance abuse.''

Here's the real debate: Today's marijuana is not the pot of the 1970s. Its THC potency, the amount of psychoactive ingredient found in the drug, has more than doubled since 1983. This decade has brought a 175-percent increase in pot potency. According to a 2008 analysis from the University of Mississippi's Potency Monitoring Project, the drug's potent effects have severe consequences. Marijuana's growing potency not only affects the risk of addiction and increased experimentation to harder drugs, but also the ``risk of psychological, cognitive and respiratory problems.'' In addition, the study found that marijuana abuse increases the risk of developing mental disorders by 40 percent -- another serious side effect that's rarely reported.

There are several issues in the marijuana debate. We must consider all of them.

MARINO E. CARBONELL, South Miami

Wednesday, December 8, 2010

Florida Legislators and Pain Clinics

Posted on Wed, Dec. 08, 2010; Miami Herald

State lawmakers must not give `pill mills' a pass

The Dec. 3 editorial, Tallahassee's pill mills, correctly points out how the Republican-dominated state Legislature voted to delay the implementation of tough new pain-clinic regulations.
Consequently, unscrupulous clinic operators and drug dealers in white coats, wrongly called ``doctors,'' can continue to churn out prescriptions for powerful painkillers.
Legislators seem more concerned with ideological correctness and purity than the sobering facts detailed in a report released in June by the Florida Department of Law Enforcement. It indicated that an average of seven Floridians a day die from prescription-drug overdose.

Our lawmakers seem to live in another universe than most of us. In their world, reality has to be adapted to fit political theory. In their world, government regulation can only do harm and never do good. In their world, pain clinics are successful businesses contributing to the overall economy, and more regulations will drive them away from our state.

Legislators forget that the regulations were carefully crafted by Democrats and Republicans to protect Floridians from these unscrupulous businesses.

Now, the proposed rules must be submitted to the Legislature by Feb. 4 to qualify for consideration. Those that don't make it would have to wait until the 2012 legislative session.

I am outraged by this political checkmate and concerned about its adverse impact on public health. This issue is too important to allow politicians to gamble away the lives of Florida residents. We need to return to pragmatism and sound reasoning to address and resolve the problem of prescription-drug abuse in the state. Ideological grandstanding will only worsen the situation. We do not have much time left -- and the clock is ticking.

Bernd Wollschlaeger,MD
North Miami Beach

http://www.miamiherald.com


Read more: http://www.miamiherald.com/2010/12/08/v-print/1963311/state-lawmakers-must-not-give.html#ixzz17a0ATueT

Saturday, December 4, 2010

Pain Clinic Regulations Stalled

Attached some troubling updates regarding the pain clinic regulation issues:

1. A letter to the editor published in the Sun-Sentinel http://articles.sun-sentinel.com/2010-12-03/news/fl-pain-clinics-letter-1203-20101203_1_pain-clinics-prescriptions-for-powerful-painkillers-prescription-drug
2. Article about persistent over dose deaths in Florida http://www.sun-sentinel.com/health/os-deaths-florida-report-20101202,0,1564941.story
3. Medical Board Yanks License of Pediatrician http://www.sun-sentinel.com/health/fl-doctor-discipline-20101203,0,5563711.story
* Several troubling statements taken from the article:
* "On a related matter, a medical board panel decided not to take emergency action to initiate a strict set of pain clinic rules that have been delayed by legislative action. Legislators last month passed a law saying rules with substantial impact on small business cannot take effect until lawmakers give approval. The medical board could have declared the pill mill problem to be an emergency and put the rules into effect, but the panel found no grounds to do so."
* What other grounds do we need to declare an emergency??

Yours
Bernd

Tallahassee's Pill Mills

Attached a stinging editorial published in yesterday's Miami Herald and my response in the form of a letter to the editor.

Yours
Bernd


The Miami Herald
Posted on Fri, Dec. 03, 2010
Tallahassee's pill mills


Lawmakers don't usually side with pill traffickers. But that's what the Florida Legislature unwittingly did during its brief, vengeance-fueled special session last month.

In the lust to override lame-duck Gov. Charlie Crist's vetoes on a handful of bills, the overwhelmingly Republican Legislature passed a law that requires legislative approval for any new government rules that cost more than $1 million over five years.

The law was touted as a measure to help stop the government from imposing excessive restrictions on business. All well and good. But it turns out the measure had a nasty side effect: It also halted the imposition of new regulations on the state's pill mills, which help feed an illegal pill pipeline.

How embarrassing. And predictable.

Lawmakers ignored warnings

Pill mills cause real suffering for addicts and their families, but lawmakers were more interested in the politics of punishing Gov. Crist for leaving the Republican Party than they were on studying what's good for the state and its residents. They ignored warning bells and rushed to pass a new law without understanding its implications.

Two years ago, lawmakers vowed to get serious about regulating pill mills -- after a Miami Herald series of articles spotlighted South Florida as the pill-mill capital of the United States. Doctors at these pain clinics, many in Broward County, served dual roles as pain and addiction specialists. The black market for painkillers in Florida flourished, spawning an epidemic of overdose deaths in Kentucky, Ohio, West Virginia, Tennessee and other states.

The new regulations, which were set to kick in Nov. 28, would have helped to curb some aspects of the abuse, specifying basic standards for pain clinics and surprise inspections each year, among other provisions.

Victims of the pain pill business counted the legislation a victory. And then lawmakers got the bright idea to override Gov. Crist's veto of the rule-making bill.

In his veto, Gov. Crist warned that nearly every rule would have to wait for the Legislature's approval under the new law, a mind-boggling thought given the number of rules that government can propagate. As of right now, there are roughly 600 proposed rules that have yet to take effect. No one knows how many of them now will require final legislative approval.

One, for sure: pill mill regulation.

Little opposition

There were a few voices of dissent amid the cry to override Gov. Crist's veto. Sen. Mike Fasano, R-New Port Richey, voted against the rule-making bill, saying it needed more study. Mr. Fasano was also the sponsor of the pill mill legislation.

Re-imposing the regulations may be delayed until the 2011 legislative session in the spring. The state Board of Medicine will discuss the regulations at its December meeting in Orlando.

For now, until lawmakers fix this unintended consequence of their own haste, the pill pushers win.


© 2010 Miami Herald Media Company. All Rights Reserved.
http://www.miamiherald.com


Read more: http://www.miamiherald.com/2010/12/03/v-print/1954918/tallahassees-pill-mills.html#ixzz176r4uQ3s


An editorial in today's Miami Herald entitled “Tallahassee's pill mills” correctly points out how the Republican dominated legislature voted to delay the implementation of tough new pain clinic regulations. Subsequently, the unscrupulous clinic operators and drug dealers in white coats, wrongly called “doctors,” can continue to churn out prescriptions for powerful painkiller. The legislators seem to be more concerned with ideological correctness and purity than the somber facts detailed in a recent report from the Florida Department of Law Enforcement released June 30th 2010 indicating that an average of seven Floridians per day die from prescription drug overdose! It appears that our legislators seem to live in another universe than most of us have to live in. In their world reality has to be adapted to fit political theory. In their world government regulation can only do harm and never do good. In their world pain clinics are successful businesses contributing to the overall economy and more regulations will drive them away from our state. They seem to forget that the regulations were carefully crafted by Democrats and Republicans to PROTECT our citizens from those unscrupulous businesses, which contribute to the DEATH of seven Floridians a day!! Now, the proposed rules must be submitted to the Legislature by Feb. 4 to qualify for consideration. Those that don't make it would have to wait until the 2012 legislative session. I am not only outraged by this political checkmate but also deeply concerned about its adverse impact on public health. This issue is too important to allow politicians to gamble away the lives of Florida’s citizen. We need to return to pragmatism and sound reasoning to address and resolve the problem of prescription drug abuse in Florida. Ideological grandstanding will only worsen the situation. We do not have much time left and the clock is ticking.



Bernd Wollschlaeger,MD,FAAFP,FASAM

Board certified Family Physicians & Addiction Specialist

16899 NE 15th Avenue, North Miami Beach,FL 33162 Phone: (305) 940-8717

E-mail: info@miamihealth.com

Member of the Prescription Drug Monitoring Implementation and Oversight Task Force

Friday, November 26, 2010

Siberia in Florida: GOP Senator Gets the Cold Shoulder

It used to be you'd have to start every debate thinking: compromise. Now, the only constraint is their good judgment.''

Former Rep. Tom Feeney, R-Orlando, who Speaker of the Florida House from 2000 to 200.


Today’s Miami Herald article “Veteran senator won’t toe the line,” http://www.miamiherald.com/2010/11/25/1943608_p2/veteran-senator-wont-toe-the-line.html clearly points out the power shift in Tallahassee. The new GOP leadership is flexing its ideological muscles. No one will be allowed to think or act independently. Its the party line or political exile. Senator Fasano, a strong supporter of Governor’s Christ Senate campaign, had to endure the punishment straying from the ideological talking points. Fasano took to the Senate floor during last week's half-day special session and railed against a GOP blueprint for fixing Medicaid. The symbolic ``memorial'' resolution informs Congress that Florida plans to steer its Medicaid patients into managed care networks, an idea that has gained popularity in the state House. ``This is more than intent. We are setting policy today by doing this,'' scolded Fasano, a 16-year legislative veteran. ``This should have gone through committees. If you think you got a few phone calls last year, put people in an HMO and the phones will be ringing off the hook.''

But Fasano's protests were quickly drowned out by a GOP stampede in favor of the bill. In the new Senate, where newcomers value business and economic development over Fasano's populist consumerism, he has morphed from conservative stalwart to moderate maverick.

Lets not forget that Senator Fasano was also the sponsor of the pain clinic legislation that cracked down on facilities freely dispensing medications that are being used by drug abusers who were doctor-shopping. Fasano also was critical of the Legislature for passing the new rule-making bill, arguing it needed more study. As a result the state Department of Health now must determine whether the new rules exceed the threshold and require a legislative sign-off -- if they have a $1 million adverse impact over five years on economic growth, competitiveness, employment, investment, job creation or regulatory costs. For now, the upshot is that the rules are stalled. What will happen in the meantime? "What's going to happen is nothing," said Sen. Mike Fasano, R-New Port Richey. "And seven more people will die each and every day until the Legislature ratifies these rules that are being approved by the Board of Medicine and the Department of Health."

I wish we would have more outspoken politicians in Florida like Senator Fasano who think and act according to their conscience and not according to party discipline.

History provides a treasure trove of failed attempts to scuttle dissent and to impose rigorous party discipline. I hope that Floridian’s learn soon to regret their electoral choices. Otherwise we will be in big trouble.



Yours truly,

Bernd

Saturday, November 20, 2010

Florida Legislature Delays Crackdown on Pain Clinics

In today’s Sun Sentinel front page article entitled “Crackdown on pain clinic stalls again” http://articles.sun-sentinel.com/2010-11-19/health/fl-hk-pain-clinic-rules-delayed-20101119_1_millions-of-narcotic-pills-pain-clinic-pills-for-drug-dealers Bob LaMendola reports how the Republican dominated legislature voted to delay the implementation of tough new pain clinic regulations. Subsequently, the unscrupulous clinic operators and drug dealers in white coats, wrongly called “doctors,” can continue to churn out prescriptions for powerful painkiller. As a result an average of seven Floridians per day will die from prescription drug overdose. The legislators seem to be more concerned with ideological correctness and purity than the somber facts detailed in a recent report from the Florida Department of Law Enforcement released June 30th 2010 http://www.fdle.state.fl.us/Content/News/June-2010/2009-Report-by-Florida-Medical-Examiners-Commissio.aspx:

• Prescription drug deaths monitored by the state Medical Examiner's Office continued to climb to 2,488 last year. That's an average of seven deaths per day.
• Oxycodone was the cause of 1,185 state deaths in 2009, a 26 percent increase from the year before and a whopping 249 percent increase from 2005.
• Deaths caused by some illegal drugs declined. Heroin deaths decreased by 20 percent to 111. And cocaine deaths decreased by 18.4 percent to 529.Law enforcement officials have attributed the opposing trends to the fact that prescription drugs are much easier and cheaper to obtain than illegal drugs.
• Prescription drugs account for 79 percent of all drug occurrences in this report when Ethyl Alcohol is excluded. Oxycodone occurrences increased by 23.8 percent in 2009 and deaths caused by Oxycodone also rose by 25.9 percent when compared to the previous year.

So what happened? According to the article the Legislature on Tuesday had taken action to override Gov. Charlie Crist's veto of HB 1565 that was passed during the 2010 legislative session. The bill, which now becomes law, says that proposed rules having significant financial impact – more than $1 million over five years – on small businesses such as pain clinics could not take effect until legislators ratified the rules. Because the pain clinic rules were not in effect on Tuesday, state officials said they cannot be enforced. One of the law's sponsors, Rep.Matt Gaetz, R-Fort Walton Beach, said he was not thinking about pill mills. The law aims to scrutinize rules that drive up regulatory costs and stop businesses from coming to Florida. As for the impact on pill mill rules, Gaetz said: "The benefits of the rulemaking bill outweighs some of the modest inconveniences." It appears to me that Mr. Gaetz lives in another universe than most of us have to live in. In his world reality has to be adapted to fit his political theory. In his world government regulation can only do harm and never do good. In his world pain clinics are successful businesses contributing to the overall economy and more regulations will drive them away from our state. He seems to forget that the regulations were carefully crafted by Democrats and Republicans to PROTECT our citizens from those unscrupulous businesses, which contribute to the DEATH of seven Floridians a day!! Now the proposed rules must be submitted to the Legislature by Feb. 4 to qualify for consideration. Those that don't make it would have to wait until the 2012 legislative session. I am not only outraged by this political checkmate but also deeply concerned about its adverse impact on public health. This issue is too important to allow politicians to gamble away the lives of Florida’s citizen. We need to return to pragmatism and sound reasoning to address and resolve the problem of prescription drug abuse in Florida. Ideological grandstanding will only worsen the situation. We do not have much time left and the clock is ticking.

Bernd Wollschlaeger,MD,FAAFP,FASAM
Board certified Family Physicians & Addiction Specialist
Member of the Prescription Drug Monitoring Implementation and Oversight Task Force

Friday, November 19, 2010

Synthetic Cannabinoid Testing

Attached some important information regarding synthetic cannabinoid testing.
Yours
DrBW

Redwood Toxicology Laboratory announces oral test for three synthetic cannabinoids

(11/18/2010)
News release
Santa Rosa, CA - Redwood Toxicology Laboratory, Inc. (RTL) announced it now offers one of the first lab-based tests for the detection of synthetic cannabinoids JWH-018, JWH-073 and JWH-250 in oral fluid/saliva.

Synthetic cannabinoids are compounds functionally similar to Δ9-tetrahydrocannabinol (THC), the principle active ingredient of cannabis, and are widely abused throughout the U.S. These chemicals are sprayed on herbal material and sold as "synthetic marijuana" under a variety of brand names.

RTL currently tests for synthetic cannabinoids JWH-018 and JWH-073 metabolites in urine, and very high positive rates (30 - 35%) have been found in court-ordered juvenile probation departments throughout the U.S. RTL's percent positive information and epidemiological data should prove useful to policymakers trying to pass legislation to control and ban the distribution, sale and use of synthetic cannabinoids.

The manufacturers of these products are constantly changing the psychoactive ingredient(s) to get around existing laws, and synthetic cannabinoids like JWH-250, JWH-019, JWH-081 and CP47 497-C8 are now found in various preparations. However, RTL's high positivity rate on JWH-018 and JWH-073 indicate they are still the main psychoactive chemicals used.

RTL's new synthetic cannabinoid oral fluid test will utilize the most sophisticated, sensitive and specific equipment and technology available, LC/MS/MS (liquid chromatography/mass spectrometry/mass spectrometry) to provide parent drug confirmation of JWH-018, JWH-073 and JWH-250.

"The high positivity rates that we are finding in urine really emphasize the need to offer more laboratory analytical solutions to detect the predominant synthetic cannabinoids in biological fluids," said Sumandeep Rana, Scientific Director, RTL. "That's why we developed and validated an analytical method to detect JWH-018, JWH-073 and JWH-250 in saliva."

Added Rana: "A wide array of parent synthetic cannabinoids can be detected in saliva, and we are working on adding more compounds to the saliva test. Saliva is easier, more convenient and less invasive to collect than blood and urine. It's difficult to adulterate or dilute and ideal for recent-use detection. Plus, the use of saliva allows us to stay current with the ever-changing array and combinations of synthetic cannabinoids being manufactured and distributed by designer drug 'chemists'."

Wayne Ross, Chief Toxicologist for RTL said, "Our lab is at the forefront of researching and identifying synthetic cannabinoids. In an effort to monitor and deter use and abuse of these compounds, RTL is continually testing products distributed on the Internet and in outlets such as gas stations and 'head shops'."

More information, including a list of synthetic cannabinoids, is available athttp://www.redwoodtoxicology.com/services/synthetic_cannabinoid_testing.html.

Saturday, October 30, 2010

New Synthetic Drugs: What Do You Need To Know?

Attached a link http://online.wsj.com/article/SB10001424052748704763904575550200845267526.html to a very interesting article published in today's Wall Street Journal entitled "In Quest for 'Legal High,' Chemists Outfox Law."
In the article the reporter describes how a wave of laboratory-adept European entrepreneurs see gold in the gray zone between legal and illegal drugs and in 2009 have produced in Europe 24 new "psychoactive substances" , almost double the number reported in 2008, according to the Lisbon-based European Monitoring Centre for Drugs and Drug Addiction, or EMCDDA .New substances tend to hit Europe before the U.S. and other markets, in part because European consumers are more accustomed to buying drugs online. Strong trade links between Europe and southeast Asia, where many of the drugs are made, also play a role. According to the narcotic experts quoted in the article many of the novel drugs are manufactured in China, where they say lax regulation makes it easy for companies to produce and export a cornucopia of chemicals. Les Iversen, chairman of the U.K.'s Advisory Council on the Misuse of Drugs, which advises the government on new substances, says customs officials at Heathrow Airport recently seized a large shipment of white powder from China that was labelled "glucose" but contained mephedrone. China also supplies raw ingredients to manufacturers located elsewhere. Mr. Llewellyn says he buys his raw ingredients online from Chinese suppliers, who charge rock-bottom prices and ask few questions about his business. The powders and liquids arrive by plane in 1-kilogram sacks and 25-liter drums and go to a warehouse in Glasgow before being shipped to his labs. Chinese officials say the country is taking steps to control the flow of new drugs. On September 1, China began regulating mephedrone as a "category I psychotropic substance," which means anyone importing or exporting it needs a special license. In a written statement, China's State Food and Drug Administration said it has "strengthened monitoring of the situation in the country," and is ready to work with other countries to "exchange information, share resources and jointly respond to new emerging problems of drug abuse."
What can we do? Stay informed and educated about those "new wave" synthetic drugs, how to recognize their effects and how to test for their presence in urine toxicology or hair sampling tests.
Looking forward to your comments.
Yours
Bernd

Sunday, October 24, 2010

DMT in the News

Attached a link http://www.cnn.com/2010/CRIME/10/23/dc.georgetown.meth/index.html?iref=allsearch to a very interesting article posted on CNN.

The report states that

"Authorities have arrested two Georgetown University students and another person in connection with a suspected drug lab found inside a dormitory Saturday morning, the Metropolitan Police Department said. The three males, each at least 18, face charges of possession of drug paraphernalia, said Officer Hugh Carew, a spokesman for the police department. The third individual was a campus visitor. None was identified. Police said that shortly before 6 a.m., they received a call about a foul odor at Georgetown's Harbin Hall. Initially, police thought the lab was for producing meth but later said it was used to make Dimethyltryptamine, a hallucinogenic drug commonly known as DMT."

What is DMT?

N,N-Dimethyltryptamine (DMT) is a naturally occurring hallucinogenic drug of the tryptamine family. This drug is found not only in many plants,[3]but also in trace amounts in the human body, where its natural function remains undetermined. Structurally, it is analogous to the neurotransmitterserotonin (5-HT) and other hallucinogenic tryptamines such as 5-MeO-DMT, bufotenin (5-OH-DMT), and psilocin (4-HO-DMT). DMT is created in small amounts by the human body during normal metabolism by the enzyme tryptamine-N-methyltransferase.

How does it work?

DMT can produce powerful entheogenic experiences including intense visuals, euphoria, even true hallucinations (perceived extensions of reality). DMT is generally not active orally unless it is combined with a monoamine oxidase inhibitor (MAOI) such as a reversible inhibitor of monoamine oxidase A (RIMA), e.g., harmaline. Uninhibited, the human body metabolizes DMT too rapidly for oral administration to be effective. Other means of ingestion such as smoking or injecting the drug can produce powerful hallucinations and entheogenic activity for a short time (usually less than half an hour), as the DMT reaches the brain before it can be metabolized by the body's natural monoamine oxidase. Taking a MAOI prior to smoking or injecting DMT prolongs and potentiates the effects.


How can we test for DMT?

I am not aware of any drug tests that would show DMT usage. It is not one of the SAMHSA-5 standardly tested for in the basic drug test, nor is it included in the extended drug tests. It is not chemically similar to any of the drugs tested for, so should not trigger the tests as another substance.

I look forward to your comments , input and suggestions.

Yours

Bernd

Saturday, October 23, 2010

Malpractice Reform; A Fresh Start

Attached an interesting article published in the New York Times on October 20th, 2010.
In this article Peter Orszag, the former director of the White House Office of Management and Budget, emphasizes that Congress (Democrats AND Republicans alike) " missed an important opportunity to shield from malpractice liability any doctors who followed evidence based guidelines in treating their patients." He argues that malpractice reform, i.e.liability insurance reform, could encourage doctors to adopt new evidence more quickly.
He continues stating that instead of imposing caps on liability a far better strategy would be to provide safe harbor for doctors who follow evidence based guidelines. In such circumstances ANYONE who could demonstrate that he/she has followed the recommended course for treating a specific illness or condition could NOT be held liable! To successfully transform our broken malpractice system he suggests taking the following steps:

1. Organizations like the American Medical Association and the Institute of Medicine could also be called upon to issue the needed evidence-based standards for malpractice immunity.
2. Approach to reform will require larger investments in research into what works and what doesn’t. Fortunately, both the health care reform act and the 2009 economic stimulus act provided additional financing for such comparative effectiveness medical research, and the health care act provides for a Patient-Centered Outcomes Research Institute to coordinate the work.
3. Develop and fund information technology solutions that quickly suggest best-practice methods of treatment.
4. Align financial incentives for delivering higher-quality care and and to shift Medicare’s payments toward “fee for quality” rather than “fee for service.”

In my opinion we should discuss these ideas, ask for federal funding to start pilot projects and to actively support any such initiatives.
Unfortunately, organized medicine is focusing on liability caps as the ONLY solution for malpractice reform ignoring and discarding ANY other approaches to address and resolve this important issue. At this point in time progressive physicians and other healthcare professionals should form partnerships and alliance to counter this dogmatic position. Healthcare professionals should consider seeking representation in partnership with ALL participants in the healthcare delivery process including PAs,ARNPs,Nurses and hospital administrators and to engage in strategic planning sessions to develop rational responses to increasing complex problems.
This requires new leadership with the ability to listen, to tolerate other opinions and to seek a compromise based on the most common denominator.
Discussing malpractice reform also requires the inclusion of legal professionals and to engage the trial bar in the deliberations.
We must move from confrontation to collaboration and to stop dividing the world into "friends" and "enemies" of medicine.
Maybe just a dream but the opportunity to change is still present.
Yours
Bernd


October 20, 2010
Malpractice Methodology
By PETER ORSZAG

The health care legislation that Congress enacted earlier this year, contrary to much of today’s overheated rhetoric, does many things right. But it does almost nothing to reform medical malpractice laws. Lawmakers missed an important opportunity to shield from malpractice liability any doctors who followed evidence-based guidelines in treating their patients.

As President Obama noted in his speech to the American Medical Association in June 2009, too many doctors order unnecessary tests and treatments only because they believe it will protect them from a lawsuit. Instead, he said, “We need to explore a range of ideas about how to put patient safety first, let doctors focus on practicing medicine and encourage broader use of evidence-based guidelines.”

Why does this matter? Right now, health care is more evidence-free than you might think. And even where evidence-based clinical guidelines exist, research suggests that doctors follow them only about half of the time. One estimate suggests that it takes 17 years on average to incorporate new research findings into widespread practice. As a result, any clinical guidelines that exist often have limited impact.

How might we encourage doctors to adopt new evidence more quickly? Malpractice reform could help — possibly a lot.

The academic literature tends to play down the role of medical liability laws in driving up health care costs. Doctors themselves, however, almost universally state that malpractice statutes lead to extraneous testing and treatment.

It is also conceivable that because such laws usually focus on “customary practice” — that is, a doctor who has treated a patient the way most other doctors in the area would is considered safe from accusations of malpractice — they create a strong contagion effect among doctors. The laws, no matter how weak or stringent, may therefore explain why doctors in some parts of the country generally adopt much more intensive approaches than those in other areas do.

The traditional way to reform medical malpractice law has been to impose caps on liability — for example, by limiting punitive damages to something like $500,000. A far better strategy would be to provide safe harbor for doctors who follow evidence-based guidelines. Anyone who could demonstrate that he has followed the recommended course for treating a specific illness or condition could not be held liable.

The health care reform act that Congress passed earlier this year included a modest set of state pilot projects, including one in Oregon that is intended to experiment with this approach. But these pilots are small; the project in Oregon, for example, has only $300,000 in financing.

What’s needed is a much more aggressive national effort to protect doctors who follow evidence-based guidelines. That’s the only way that malpractice reform could broadly promote the adoption of best practices.

Congress has taken a step in this direction before. As Prof. James Blumstein of Vanderbilt University Law School has pointed out, a little-known provision in the Social Security Act amendments of 1972 provides immunity from malpractice liability to doctors who treat patients in conformity with the standards set forth by so-called quality improvement organizations — nonprofits under contract with Medicare that work to improve care. The provision remains in force, though those organizations have yet to set such standards.

Organizations like the American Medical Association and the Institute of Medicine could also be called upon to issue the needed evidence-based standards for malpractice immunity. But no matter which body is put in charge of certification, this approach to reform will require larger investments in research into what works and what doesn’t. Fortunately, both the health care reform act and the 2009 economic stimulus act provided additional financing for such comparative effectiveness medical research, and the health care act provides for a Patient-Centered Outcomes Research Institute to coordinate the work. It’s a good start.

Better technology would help, too. Your doctor’s computer should be able to not only pull up your health records (after you have approved such access) but also quickly suggest best-practice methods of treatment. The doctor should then be able to click through to read the supporting research. Subsidies in the stimulus act help doctors pay for this kind of technology.

A final step toward improving standard medical practice will be to better align financial incentives for delivering higher-quality care. Hospitals now lose Medicare dollars, for example, if they succeed in reducing readmissions. Medical professionals should be given incentives for better care rather than more care.

The health care reform act already includes measures that enable policymakers to shift Medicare’s payments toward “fee for quality” rather than “fee for service.” My next column will discuss these measures, which get far less credit than they should, in more detail.

Opponents of the act are generally off base in criticizing investments in improved care. In complaining about the missed opportunity to reform medical malpractice laws to promote evidence-based medical practice, on the other hand, the critics are entirely on target.

Peter Orszag, the director of the White House Office of Management and Budget from 2009 to 2010 and a distinguished visiting fellow at the Council on Foreign Relations, is a contributing columnist for The Times.

Tuesday, October 12, 2010

Keep it Simple and Stupid: Rick Scott's Healthcare Plan and the FMA

“Florida is not a physician-friendly state to practice medicine because of the high cost of medical liability insurance and excessive lawsuits,....the FMA PAC supports Rick Scott for Governor because he shares our goal of increasing access to quality health care for all of Florida’s citizens. Rick Scott is not afraid of taking on personal injury lawyers and shaking up the status quo in order to get things done for the people of Florida.”


President of the FMA PAC, Dr. Madelyn Butler



I tried to understand Rick Scott's healthcare plan and ideas, which convinced the Florida Medical Association Political Action Committee to endorse him as Gubernatorial Candidate.
First, I searched on his web site and found the following:

* On Abortion: "I believe that abortion is wrong and Roe versus Wade should be overturned."
o What shall I tell a woman who is pregnant but unmarried, unemployed, on food stamps and lives with friends or relatives?
o Teenagers who were raped or married women who were sexually attacked by their husbands?
o Should government tell women and doctors what to do and how to lives their lives?
* On Health Care:
o "As a businessman, I know I am held accountable for results, and I held the people in my company accountable for results, too. Delivering quality care at a lower cost to patients was a top priority when I ran Columbia/HCA, and when I started Solantic urgent care facilities here in Florida....In the 1990’s, we were able to transform the hospital industry and prove that free market health care can deliver high quality care at a lower cost to patients."
+ That’s it? We just have to emulate the Columbia/HCA model and open a couple of Solantic Urgent Care centers and we solve all healthcare problems? Guess, I can shred all my healthcare economics test books and magazines, join Rick Scott's model and everything will be just fine. How naive or stupid can anyone be to believe that? Obviously, the FMA PAC does!
o "Rick believes that our health care system should focus on choice, competition, accountability and personal responsibility."
+ So I will have the choice of choosing between an unaffordable health insurance policy or none?
+ Accountability and personal responsibility only applies to the consumers of healthcare but not Rick Scott who just made " some mistakes in his life."

o "Most recently, Rick led the fight to defeat President Obama’s government-run public option. As the founder of Conservatives for Patients’ Rights (CPR), an advocacy group dedicated to the free market principles of choice, competition, accountability and personal responsibility in health care, he was instrumental in defeating the public option plan that would have led to socialized medicine."
+ Fear mongering and painting the government as the boogeyman trying to enslave citizens is a silly and dangerous tactic which just reveals that Rick Scott and friends have no other arguments to offer to resolve the critical problem facing us today and in the near future: how to provide affordable healthcare for an aging population suffering from chronic diseases that consume already 75% of all health care spending.
* On healthcare management experience:
o " I’ve made mistakes in my life...I learned very hard lessons from what happened and those lessons have helped me become a better businessman and leader."
+ That’s it! Mistakes imply taking personal responsibility and not blaming others (i.e. Columbia/HCA) for it. These are the lessons he brings to the table and those character traits make him the knight in shining armor for the FMA PAC?


So what can I say about the FMA PAC decision to endorse Rick Scott? A sad day for Florida's doctors. A sad day for medicine.

Yours

Bernd

Sunday, October 3, 2010

Prescription Drug Prices

In todays Miami Herald State Representative Juan C. Zapata calls for a mandated use of generic drugs for Medicaid and other state-funded programs http://www.miamiherald.com/2010/10/03/1854185/mandate-use-of-generic-drugs-for.html . He is correct saying that the use of generic drugs will slow down the predicted explosive growth of Medicaid expenditures but the mandated use of generic drugs addresses only ONE aspect of the problem. According to a New York Times article , Drug Makers Accused of Ignoring Price Law,” http://www.nytimes.com/2010/10/03/us/03drug.html , drug manufacturers consistently defy complying with a federal law that requires them to provide the government with pricing data needed to calculate discounts on medications prescribed for Medicaid recipients. More than three-fourths of drug manufacturers did not fully comply with the law requiring them to provide price data. They are supposed to file monthly and quarterly reports on what wholesalers paid them for drugs eventually sold to retail pharmacies. Without price data, the federal government cannot compute rebates, and states may be unable to collect them. As a condition of having their drugs covered by Medicaid, pharmaceutical companies must agree to provide discounts in the form of rebates. Drug companies pay the rebates to state Medicaid programs. The federal government and the states share the cost of Medicaid — roughly $400 billion in the last year — and share the savings that result from the rebates. Under the health care law, the minimum rebate on brand-name drugs dispensed to Medicaid recipients was increased to 23.1 percent of the average manufacturer price, from 15.1 percent. The minimum rebate on generic drugs was increased to 13 percent, from 11 percent. The Congressional Budget Office estimates that the changes could save the federal government more than $35 billion over 10 years. Major drug companies are already reporting adverse effects on their revenues. However, drug companies stand to gain many customers with the scheduled Medicaid expansion in 2014. What can be done to address this problem? Under federal law, the government can impose penalties of $10,000 a day on a drug manufacturer that fails to provide the information “on a timely basis. According to the Inspector General at the Department of Health and Human Services the federal government has had this authority since 1990 but has not used it! Why not? We must control and limit the rising healthcare costs and drug manufactures must understand that they can be either be part of the problem, or part of the solution. We also should lift the limitation on prescription drug re-importation and stop the unscrupulous use of antipsychotic drugs, which generate over $14 billion in revenue for drug manufacturers. Otherwise, we have no choice but to resort to rationing of healthcare services and prescription drugs.

Yours
Bernd

Saturday, September 11, 2010

Prescription Drug Monitoring Program

Update:

Last month I presented at the Prescription Drug Abuse Summit in Tampa (see attached article)
I also serve on the Program Implementation and Oversight Task Force and we prepare the launch of the Prescription Drug Monitoring Program on December 1st. We will have a Taskforce meeting in Tallahassee next week to discuss details of the pending launch.
Lots of work has to be done to educate doctors and to lower the resistance threshold. Unfortunately, we are facing push-back from the medical community regarding the prescription drug monitoring program. Those who resist its implementation raise privacy issues and (of course) consider it as "further government intrusion into the practice of medicine." I want to emphasize that this is NOT a Republican vs. Democrat issue but a PATIENT SAFETY and PUBLIC HEALTH issue!! We all should stand together in support of the program and work towards its successful implementation.
Attached you also find the rule which implements the Prescription Drug Monitoring Program.
Again, we need to convince doctors to use the program, otherwise we won't resolve the problem and many more Floridians will die!!
Yours
Bernd


August 27, 2010

Prescription drug abuse summit held in Tampa
By Nicole Hutcheson, St. Petersburg Times Staff Writer
At a summit in Tampa, medical professionals air concerns about a new state tracking program.

TAMPA - Come December, medical professionals will have a new tool to determine whether a patient is abusing prescription drugs.

But some worry that the Prescription Drug Monitoring Program, a new state system that tracks narcotic dispensing, will add a burden to their already heavy workload. Others question the privacy aspect of the new rules.

"Many physicians are very concerned about another regulatory issue," said Dr. David Weiland, vice president of medical affairs at Bayfront Medical Center in St. Petersburg. "To me, any regulation can be a barrier to real patients receiving adequate treatment for their pain."

The monitoring program was a hot topic at this year's Drug Abuse Summit hosted by Associates in Emergency Medical Education, a Lutz company that trains medical professionals. More than 140 people - including doctors, prosecutors, law enforcement officials and drug abuse counselors from across the country - attended the daylong event Friday at the Marriott Waterside in downtown Tampa.

"The goal is to come up with answers as a whole," said Sharon Kelley, executive director of Associates in Emergency Medical Education. "There is no one solution to this, you have to bring all the players together."

The drug monitoring program dominated many of the event's sessions, including how doctors should use the system and how to comply with federal privacy laws. The legislation, sponsored by Sen. Mike Fasano, R-New Port Richey, is meant to cut down on doctor shopping and overprescribed narcotics.

Here's how it would work: When doctors or pharmacist dispense pain pills, such as oxycodone, amphetamines and Xanax, they must report it to a centralized database. When the database goes online, pharmacists and doctors statewide will be able to search it to determine if their patients have received a similar prescription in the past. They have 15 days to report to the system, and failure to do so is a misdemeanor.

"A doctor will be able to look at the prescription history of their patient no matter which doctor they've been to," said Bruce Grant, director of the Governor's Office of Drug Control. "It's an added safety measure."

The statewide database is expected to cost about $12 million to get up and running by December. The Department of Health is implementing the system, but the law prohibits using state money for implementation. A combination of federal grants and private money raised by the Prescription Drug Monitoring Program Foundation is being used to fund the program. Funding is on track, Grant said.

More than 40 other states have such a system.

But there remained an air of hesitance among some at Friday's event. Their questions included: What would stop a patient from traveling across state lines to receive pain medicine? Would it violate any privacy laws? And how will law enforcement access the database?

Claude Shipley, project director for the state's Office of Drug Control, tried to quell concerns.

"There is this urban legend myth that you will be in violation of HIPAA (Health Insurance Portability and Accountability Act) using PDM (prescription drug monitoring)," Shipley said. "There is no civil liability. The statue is very clear on that."

Law enforcement would be able to get information from the system if it has an open investigation involving a doctor or patient.

Dr. Bernd Wollschlaeger, a family practitioner in North Miami, spoke in support of the monitoring program. He has been using an electronic prescription system for the past seven years.

On Friday, he told of a 47-year-old woman who needed help ending an oxycodone addiction.

Wollschlaeger started her on Suboxone, a medicine that helps patients with opiate withdrawal symptoms.

After researching his electronic prescription system, he learned that the woman was still receiving hydrocodone from her gynecologist. She had withheld that important information. After Wollschlaeger confronted the patient, they began a more honest discussion, he said.

"This served as a tool to start this dialogue. I didn't point the finger at the patient, but this gave me the tools I needed," he said. "(Prescription drug monitoring) will bring transparency, not policing."

Nicole Hutcheson can reached at nhutcheson@sptimes.com or (813)226-3405.

Prescription Drug Monitoring Program Issues

Comments:

Attached some of my concerns regarding the rules governing the Prescription Drug Program:

* "3) All dispensers will electronically report data to the Program's database not more than 15 days after the controlled substance has been dispensed.."
o Result: Organized drug purchasers and traffickers will go from clinic to clinic to buy drugs within the 15-days period and those clinics will delay reporting to the legal limit to allow their "clients" to purchase drugs because that's were the money comes from. These are the facts on the ground. How can we stop that? By lobbying for a reporting requirement within 24-hour time period. Every time I create an electronic prescription during a routine patient interaction in the exam room the prescription data is automatically being submitted to the e-prescribing database. E-prescribing software vendors (such as Allscripts) should upload all controlled substances directly to the monitoring program.
* "4) Data not accepted by the database system due to a substantial number of errors or omissions shall be corrected and resubmitted to the database by the reporting dispenser within five days of receiving written notice that the submitted data was unacceptable."
o Result: Crafty and clever dispensers may intentionally submit incorrect data, await the written notice and then resubmit the data after five days. Meanwhile, they can continue to serve the commercial drug dealers. Whats the penalty mechanism? How many times can they submit incorrect data without being fined?

Furthermore, one of my colleagues pointed out that the rules do not provide for fines, penalties, license suspension/revocation, or anything else for offenders, and especially for repeat offenders. The item above is limited to "failing to report", but does not cover purposeful misbehavior as described in my comments.
The way this is written,it allows dutiful physicians to look up and see if their patient is trying to scam them. It does NOT provide the department or law enforcement very easy tools to find and prosecute "pill mills", who are actually the real public health problem.

I am looking forward to your comments.
Yours

Bernd

Sunday, August 22, 2010

FMA Off Base Fighting Reform

The recently published OpEd succinctly characterizes the Florida Medical Association's policy vis-a-vis healthcare reform.
The authors concluded that
"The FMA's challenge to the AMA was the old guard denouncing the new. But the new way is what mainstream patients, doctors and the people who pay the bills for care desperately need. It is coming, and the FMA should get on board or out of the way."
In a NEJM (N Engl J Med 2009;360: 2495-2497) article Fisher et al clearly defines the positions we as physicians can take.
“ In the face of this uncertainty, physicians have a choice: to wait and see what happens or to lead the change our country needs. We'd prefer the latter....Physicians can become our most credible and effective leaders of progress toward a new world of coordinated, sensible, outcome-oriented care in which they and their communities will be far better off. Defending the status quo is a bankrupt plan, and physicians have an opportunity to help us all see beyond it."
I wholeheartedly agree with this conclusion.
Yours
Bernd


Guest column: Florida Medical Association is off base fighting reform

Source URL: http://jacksonville.com/opinion/letters-readers/2010-08-19/story/guest-column-florida-medical-association-base-fighting

At an Orlando meeting last week, Florida Medical Association members fumed that their parent, the American Medical Association, isn't adequately representing Florida's private practice doctors.

After talk of secession, they settled for writing a stern letter urging the AMA to straighten up.

The FMA dustup began with a resolution written by Douglas Stevens, a Fort Myers cosmetic surgeon - you can't make this stuff up - complaining that the AMA's support for recent reforms was "a severe intrusion in the patient-physician relationship and allows government control over essentially all aspects of medical care."

He wrote that it will "relegate physicians to the role of government employees ... and essentially end the profession of medicine as we know it."

A St. Petersburg neurological surgeon, David McKalip, added that without AMA support, reform would have died.

Well, no. Stevens might have had two reform provisions in mind.

One uses subsidies to encourage doctors to obtain electronic health record technologies, so patient information can be easily exchanged and unnecessary or redundant services can be reduced.

Some data would be submitted to a federal repository, so doctors can better understand how effectively they practice compared to their peers and how to improve if needed.

Of course, physicians opposed to these rules could opt to avoid patients whose care is paid for with public dollars. But we think most doctors will welcome the opportunity to modernize their care.

The second bone of contention was a well-intentioned but flawed 1997 Medicare formula, the Sustainable Growth Rate, which tied physician payments to the growth of the U.S. economy. If Medicare physician spending exceeded the target in one year, then payment the following year would be reduced.

But every year, Congress has delayed the payment reductions. Now, in 2010, the accumulated cuts would be 21.2 percent.

Congress is reluctant to spend the additional $200 billion to forgive the cuts. American specialists, who make triple the salaries of their primary care colleagues, are bound to see smaller Medicare checks.

In the past, we've had many differences with the AMA, which was often more focused on physicians and their economic prosperity than on patients and theirs, especially as health insurance costs relentlessly grew four times faster than the economy.

Through a specialist-dominated reimbursement advisory committee, the AMA urged Congress to pay specialists more at the expense of primary care physicians. So it is not far-fetched to lay much of the current health care cost crisis at the AMA's feet.

But recently, the AMA became more progressive. It mounted a three-year campaign for universal coverage. It supported government's efforts to reward the meaningful use of modern computerized tools and the best medical science in clinical practice.

They are incredibly important to us, but over the last half century, American physicians have been handsomely, even often excessively, rewarded.

But now, the system that has been hugely wasteful must find ways to reduce costs while improving quality, and make sure that care is accessible to everyone. These imperatives are emerging just as data and information tools are becoming more available. Health care will become more like a market than before.

Medical practice is changing profoundly, mostly for the better. Doctors will still be highly valued, but many may earn less.

The FMA's challenge to the AMA was the old guard denouncing the new. But the new way is what mainstream patients, doctors and the people who pay the bills for care desperately need.

It is coming, and the FMA should get on board or out of the way.

Brian Klepper of Atlantic Beach and David Kibbe, a physician from Chapel Hill, N.C., write on health care policy, market dynamics and technology.

Sunday, August 15, 2010

Impaired Physicians

In a recently published article " Physicians reluctant to report impaired colleagues, study says,"(amednews.com) the author summarizes the findings of a national survey of 2,000 physicians. The survey results were published in the July 14th edition of JAMA " Physicians' Perceptions, Preparedness for Reporting, and Experiences Related to Impaired and Incompetent Colleagues."
Unfortunately, the key findings are troubling:
  • Just 64% of physicians completely agreed that they had an obligation to report all impaired or incompetent doctors. The rest of the physicians either "somewhat agreed" that they were obliged to report problem colleagues or disagreed that they had such a responsibility.
  • The most common reason for not reporting incompetent or impaired colleagues was physicians "thought someone else was taking care of the problem," the study said. Some physicians said reporting would be fruitless, while 12% feared retribution.
Only 17% of respondents had direct knowledge of an impaired or incompetent physician. The question remains if this is due to ignorance or choice.
What can we do? Doctors need to be better educated on how to report problem colleagues and their ethical responsibility to do so. Those who do report should be kept in the loop on how a colleague's case is progressing, and that the reporting process should be confidential.
Looking forward to your comments.
Yours
Bernd

Monday, July 26, 2010

Prescription Drug Abuse and Impaired Drivers

Attached you find an article published in the New York Times (July 25th,2010) highlighting the exponentially growing problem of prescription drug abuse as it relates to driving under influence.


The article emphasizes that :

"There is no reliable data on how many drivers are impaired by prescription drugs, but law enforcement officials say the problem is growing so quickly that states are putting hundreds of police officers through special training to spot signs of drug impairment and clamoring for better technology to detect it."

"Even the prevalence of drug-impaired driving is unknown, since many states combine the arrest data with that for drunken driving."

".. persuading a jury to convict someone of impaired driving due to prescription drugs remains difficult except for the most egregious cases ...because most people on the jury will also likely be taking prescription drugs for some ailment."

I recommend reading the article. As addiction treatment professionals we should get involved in guiding law enforcement officials and legal experts to address this growing public health issue.
Looking forward to your comments.
Yours
Bernd




Drivers on Prescription Drugs Are Hard to Convict

By ABBY GOODNOUGH and KATIE ZEZIMA

The accident that killed Kathryn Underdown had all the markings of a drunken-driving case. The car that hit her as she rode her bicycle one May evening in Miller Place, N.Y., did not stop, the police said, until it crashed into another vehicle farther down the road.

The driver could not keep her eyes open during an interview with investigators, according to the complaint against her, and her speech was slow and slurred. But the driver told the police that she had not been drinking; instead, the complaint said, she had taken several prescription medications, including a sedative and a muscle relaxant.

She was charged with vehicular manslaughter and driving under the influence of drugs — an increasingly common offense, law enforcement officials say, at a time when drunken-driving deaths are dropping and when prescriptions for narcotic painkillers, anti-anxiety medications, sleep aids and other powerful drugs are rampant.

The issue is vexing police officials because, unlike with alcohol, there is no agreement on what level of drugs in the blood impairs driving.

The behavioral effects of prescription medication vary widely, depending not just on the drug but on the person taking it. Some, like anti-anxiety drugs, can dull alertness and slow reaction time; others, like stimulants, can encourage risk-taking and hurt the ability to judge distances. Mixing prescriptions, or taking them with alcohol or illicit drugs, can exacerbate impairment and sharply increase the risk of crashing, researchers say.

“In the past it was cocaine, it was PCP, it was marijuana,” said Chuck Hayes of the International Association of Chiefs of Police. “Now we’re into this prescription drug era that is giving us a whole new challenge.”

The police also struggle with the challenge of prosecuting someone who was taking valid prescriptions.

“How do we balance between people who legitimately need their prescriptions and protecting the public?” said Mark Neil, senior lawyer at the National Traffic Law Center, which works with prosecutors. “It becomes a very delicate balance.”

Some states have made it illegal to drive with any detectable level of prohibited drugs in the blood. But setting any kind of limit for prescription medications is far more complicated, partly because the complex chemistry of drugs makes their effects more difficult to predict than alcohol’s. And determining whether a driver took drugs soon before getting on the road can be tricky, since some linger in the body for days or weeks.

Many states are confronting the problem as part of a broader effort to keep so-called drugged drivers, including those under the influence of marijuana and other illegal drugs, off the road.

“We have a pretty clear message in this country that you don’t drink and drive,” said R. Gil Kerlikowske, President Obama’s top drug policy adviser, who wants to reduce drugged-driving accidents by 10 percent over the next five years. “We need very much to have a similar message when it comes to drugs.”

There is no reliable data on how many drivers are impaired by prescription drugs, but law enforcement officials say the problem is growing so quickly that states are putting hundreds of police officers through special training to spot signs of drug impairment and clamoring for better technology to detect it.

Even the prevalence of drug-impaired driving is unknown, since many states combine the arrest data with that for drunken driving. Mr. Kerlikowske points to a 2007 survey by theNational Highway Traffic Safety Administration, which screened 5,900 nighttime drivers around the country and found that 16.3 percent tested positive for legal or illegal drugs.

The tests could not determine which drivers were impaired by drugs, but Mr. Kerlikowske said the results suggested a problem that had “flown below the radar” for too long.

“You don’t want to scare people,” he said, “but you certainly want to make them aware of the dangerousness. You can be as deadly behind the wheel with prescription drugs as you can with over-the-limit alcohol, and you are responsible for your own actions.”

In interviews, law enforcement officials around the country said anyone who drives while taking prescription drugs is at risk of arrest, not only those who drive recklessly. In one recent case near Bangor, Me., a pickup truck on a rural road was not swerving, speeding or otherwise hinting that its driver was impaired. A police officer stopped the truck because of its noisy muffler, then saw that the driver’s eyes were bloodshot and his speech slurred.

A Breathalyzer test found that the driver, Chester Annance, had not been drinking. Yet he was arrested based on the officer’s suspicion that he was on drugs, and a blood test later found opiate painkillers in his system.

Mr. Annance was convicted this month of driving under the influence of drugs. He received seven days in jail, a three-year license suspension and a fine. He is appealing the conviction.

“You don’t need to wait for a crash to happen before you charge someone,” said R. Christopher Almy, the district attorney in Bangor.

Defense lawyers say that in their zeal to make a statement about drug-impaired driving, the police are casting too wide a net and unfairly punishing people who are taking prescriptions as directed.

Tara Jenswold-Schipper, an assistant attorney general in Wisconsin, said she usually stuck to cases where drivers had mixed drugs, exceeded the proper dose or taken controlled medications without a prescription.

In one such case in that state, a former physician slammed his S.U.V. into a Honda Accord in April 2008, killing the pregnant driver and her 10-year-old daughter. Prosecutors said the physician, Mark Benson, had high levels of the sleep aid Ambien in his system, as well as Xanax, an anti-anxiety drug, and oxycodone, an opiate painkiller. Mr. Benson was sentenced to 30 years in prison.

Defendants can try to prove that they did not realize their medication would affect their driving, prosecutors said, but that argument may not hold up if the bottle had a warning label.

“Would you go home and start a chain saw and cut down a tree?” said Lt. Col. Thomas C. Hejl, the assistant sheriff in Calvert County, Md. “Why should you get behind the wheel of a vehicle when the same medication has the same side effects?”

Unable to prove impairment with blood tests, prosecutors in drugged-driving cases rely heavily on the testimony of “drug recognition experts,” law enforcement officers trained to spot signs of impairment in drivers. But there are only about 7,000 such officers nationwide, Mr. Hayes said, not nearly enough to respond to every traffic stop that may involve drugs.

“When they are involved,” he said of the experts, “our chances of convicting people are much higher.”

But persuading a jury to convict someone of impaired driving due to prescription drugs remains difficult except for the most egregious cases, said Douglas F. Gansler, the attorney general in Maryland.

“Because most people on the jury will also likely be taking prescription drugs for some ailment,” Mr. Gansler said, “whether it’s Lipitor or allergy pills or whatever it might be, they might think, ‘I don’t want that to become criminal.’ ”

Sunday, July 11, 2010

Use of Synthetic Marijuana on the Rise:

Attached you find an article from today's New York Times highlighting the increasing use of synthetic marijuana (K-2) and the efforts to curb the metastatic spread of these substances. A food store next to my office sells it as incense to teenagers and I have tried convincing the shop-owner to stop its sale. Her argument " if I stop selling it the kids go to the other guy around the corner and I loose customers."
I urge you to read this article and to consider what actions FSAM can take to suggest state regulation. I would NOT wait for the FMA to step in because government regulation is not part of their political agenda. This is an urgent public health issue and we need to act fast.
Looking forward to your comments.
Yours
Bernd

Factsheet:

+ Often marketed as incense, K2 — which is also known as Spice, Demon or Genie — is sold openly in gas stations, head shops and, of course, online. It can sell for as much as $40 per gram. The substance is banned in many European countries, but by marketing it as incense and clearly stating that it is not for human consumption, domestic sellers have managed to evade federal regulation.
+ K2’s active ingredients are synthetic cannabinoids — research-grade chemicals that were created for therapeutic purposes but can also mimic the narcotic effects of tetrahydrocannabinol, or THC, the active ingredient in marijuana.
+ K2 does not show up on drug tests, and users say that while they would like to know what is in it, they would take their chances if it means a clean urine test.




New York Times, Sunday, July 11, 2010:

Synthetic Marijuana Spurs State Bans
By MALCOLM GAY

ST. LOUIS — Seated at a hookah lounge in the Tower Grove district, Albert Kuo trained his lighter above a marbleized glass pipe stuffed with synthetic marijuana Inhaling deeply, Mr. Kuo, an art student at an area college, singed the pipe’s leafy contents, emitting a musky cloud of smoke into the afternoon light.

Mr. Kuo, 25, had gathered here with a small cohort of friends for what could be the last time they legally get high in Missouri on a substance known popularly as K2, a blend of herbs treated with synthetic marijuana.

“I know it’s not going to kill me,” said Mr. Kuo, who likened the drug’s effects to clove cigarettes. “It’s a waste of time, effort and money to ban something like this.”

On Tuesday, Gov. Jay Nixon, a Democrat, signed a bill prohibiting possession of K2. Missouri is the nation’s eighth state this year to ban the substance, which has sent users to emergency rooms across the country complaining of everything from elevated heart rates and paranoia tovomiting and hallucinations.

Investigators blame the drug in at least one death, and this month, Gov. Mike Beebe of Arkansas, a Democrat, signed an emergency order banning the substance. Similar prohibitions are pending in at least six other states, including Illinois, Louisiana, Michigan, New Jersey, New York and Ohio, according to the National Conference of State Legislatures.

“It’s like a tidal wave,” said Ward Franz, the state representative who sponsored Missouri’s legislation. “It’s almost an epidemic. We’re seeing middle-school kids walking into stores and buying it.”

Often marketed as incense, K2 — which is also known as Spice, Demon or Genie — is sold openly in gas stations, head shops and, of course, online. It can sell for as much as $40 per gram. The substance is banned in many European countries, but by marketing it as incense and clearly stating that it is not for human consumption, domestic sellers have managed to evade federal regulation.

“Everybody knows it’s not incense,” said Barbara Carreno, a spokeswoman for the federal Drug Enforcement Administration. “That’s done with a wink and a nod.”

First developed in the lab of a Clemson University chemist, John W. Huffman, K2’s active ingredients are synthetic cannabinoids — research-grade chemicals that were created for therapeutic purposes but can also mimic the narcotic effects of tetrahydrocannabinol, or THC, the active ingredient in marijuana.

In a statement, Mr. Huffman said the chemicals were not intended for human use. He added that his lab had developed them for research purposes only, and that “their effects in humans have not been studied and they could very well have toxic effects.”

Nevertheless, pure forms of the chemical are available online, and investigators believe that many sellers are buying bulk quantities, mixing them with a potpourrilike blend of herbs and labeling the substance K2.

“It’s not like there’s one K2 distributor — everybody is making their own stuff, calling it K2 and selling it, which is the most unnerving aspect,” said Dr. Christopher Rosenbaum, an assistant professor of toxicology at the University of Massachusetts who is studying the effects of K2 in emergency room patients.

The American Association of Poison Control Centers reports that so far this year there have been 567 K2-related calls, up from 13 in 2009. But investigators add that no one is really certain what is in K2, and people are arriving at emergency rooms with symptoms that would not normally be associated with marijuana or a synthetic form of the drug.

“I don’t know how many people are going for a box of doughnuts after smoking K2, but they’re sure getting some other symptoms,” said Dr. Anthony Scalzo, a professor of emergency medicine at the St. Louis University who first reported a rise in K2-related cases and is collaborating with Dr. Rosenbaum in researching K2’s effects. “These are very anxious, agitated people that are requiring several doses ofsedatives.”

Dr. Scalzo, who is also the medical director for the Missouri Poison Control Center, added that although tests had found cannabinoids in K2, it was unclear “whether the reaction we’re seeing is just because of dose effect, or if there’s something in there we haven’t found yet.”

That question remains at the center of an investigation into the death of David Rozga, an Iowa teenager who last month committed suicideshortly after smoking K2. Mr. Rozga, 18, had graduated from high school one week earlier and was planning to attend college in the fall.

According to the police report, Mr. Rozga smoked the substance with friends and then began “freaking out,” saying he was “going to hell.” He then returned to his parents’ house, grabbed a rifle from the family’s gun room and shot himself in the head.

“There was nothing in the investigation to show he was depressed or sad or anything,” said Detective Sgt. Brian Sher of the Indianola Police Department, who led the investigation. “I’ve seen it all. I don’t know what else to attribute it to. It has to be K2.”

But many users say they are undaunted by reports of negative reactions to the drug. K2 does not show up on drug tests, and users say that while they would like to know what is in it, they would take their chances if it means a clean urine test.

The Missouri ban, which goes into effect Aug. 28, prohibits several cannabinoids that investigators have found in K2 and related products. Nevertheless, investigators and researchers say that bans like the one in Missouri are little more than “Band-Aids” that street chemists can sidestep with a slight alteration to a chemical’s molecular structure.

“Once it goes illegal, I already have something to replace it with,” said Micah Riggs, who sells the product at his coffee shop in Kansas City. “There are hundreds of these synthetics, and we just go about it a couple of them at a time.”

Investigators say that a more effective ban might arise once the Drug Enforcement Administration completes its review of cannabinoids, placing them under the Controlled Substances Act. Currently, however, only one such substance is controlled under the act, though the agency has listed four others as “chemicals of concern.”

“It’s hard to keep up with everything,” said Ms. Carreno of the D.E.A., adding, “The process of scheduling something is thorough and time consuming, and there are a lot of gifted chemists out there.”

Meanwhile, states are largely on their own when it comes to controlling this new breed of synthetic cannabis, which often comes down to a game of cat-and-mouse where law enforcement agents, politicians, users and their families must formulate new responses as each iteration of a drug comes to market.

“Where does a parent go to get answers?” asked Mike Rozga, who said he learned of K2 only after his son’s death. “We talk to our kids about sex. We talk to our kids about drugs, and we talk to our kids about drinking and being responsible. But how can you talk to your kids about something you don’t even know about?”

Sunday, July 4, 2010

Raves, Ecstatsy and Overdose Deaths

Attached two interesting articles of concern:

1. Wall Street Journal, 07/03/2010: Out in the Open: Raves and Ecstasy http://online.wsj.com/article/SB10001424052748704699604575343133677383828.html#

"Twenty years after their heyday as an underground phenomenon, the drug-fueled dance parties known as raves are making a comeback as massive, commercial events. But a recent wave of ecstasy-related deaths and hospitalizations tied to such events have left some officials skeptical about their makeover.Unlike the original raves in the late 1980s and early '90s, which were often staged without permits in hard-to-find patches of desert or abandoned industrial warehouses, today's version has gone aboveground. The drug of choice for many attendees is still ecstasy, an illegal stimulant/hallucinogen also known as MDMA that is often cut with other substances. Taken as a pill or powder, the drug, whose full chemical name is 3,4-methylenedioxymethamphetamine, can induce euphoria and doesn't typically cause the kind of traumatic overdose symptoms associated with drugs such as heroin. But ecstasy can cause dehydration—potentially a serious health problem for people dancing all night in hot, cramped conditions. Doctors say many ecstasy-users end up in emergency rooms because they try to combat dehydration by drinking too much water, causing water intoxication—which can lead to seizure and coma.
This represents another challenge for physicians to diagnose and treat. Hopeffully, we can reduce the adverse publich health effect by educating adolescents in schools and at home.

2. Miami Herald, 07/01/2010, Experts fear new wave of addiction, http://www.miamiherald.com/2010/07/01/1709624/experts-fear-new-wave-of-addiction.html

While drug-related deaths across Florida rose an alarming 20 percent last year over 2008, South Florida saw a notable decrease in two key areas of substance abuse: cocaine and heroin.
Still, addiction experts say, there is an indication that the nation's sixth-largest metro area could be on the verge of a new wave of addiction unseen since the cocaine craze of the early 1980s. Two separate reports released this week by James C. Hall, director of Nova Southeastern University's Center for the Study and Prevention of Substance Abuse, and the Florida Medical Examiners Commission, show more than 8,600 deaths in Florida in 2009 in which victims had at least one prescription drug in their system that contributed to their passing. That's up from about 6,200 drug-induced deaths in 2008.
What's more, both reports say almost all the increase in drug deaths -- especially in Broward and Miami-Dade counties -- is due to a disturbing and relatively new trend of drug abusers mixing opiates and narcotics like heroin and cocaine with opioids -- prescription drugs like oxycodone -- or simply switching indiscriminately from one to the other.
Fort Lauderdale and St. Petersburg far outpaced every other city in Florida in terms of prescription drug deaths.
In Broward County last year, 225 people died with large amounts of oxycodone in their bodies; 57 had morphine in their systems, 60 were high on methadone, 46 on hydrocodone, and 27 on propoxyphone, for a total of 415 opioid-related deaths in Broward, compared to 342 such deaths in 2008.
Among the 2009 Broward County totals, 62 percent took lethal doses of opioids before their deaths, and 91 percent had at least two drugs in their systems at the time of death -- typically a combination of opioids and cocaine.

We must continue to push for a moratorium on narcotic dispensing in doctors offices and support revocation of licensure for ANY physician who prescribes or dispenses scheduled drugs in LARGE quantities WITHOUT treatment rationale. For example: its almost routine for certain "doctors" - or better drug dealers in a white coat- to prescribe 180-500 Oxycontin Tablets for one patient on one prescription for one month!!!
How is that possible? Because everyone involved in this process makes big $$$$.
This has to stop but obviously nobody has the will to stand up and call it what it is: drug dealing!!

Yours
Bernd