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