Charlotte's Web: An Update

I hope that you are all doing well. Attached a link to an article titled " Use of medical marijuana could be months away" highlighting the difficulties of writing the rules governing the growth, production, sale and use of a cannabis extract called 'Charlotte's Web." A series of public workshops and hearings last summer resulted in controversial proposed state regulations, which were challenged in court, and on November 14th an administrative law judge struck down 13 of the rules prepared by state health officials. Miami based Costa Farms, the Florida Medical Cannabis Association and others had challenged the Health Department's plan to use a lottery to help license the five agricultural nurseries that would grow and distribute the medical marijuana strain designated to treat intractable seizures and OTHER chronic medical conditions. Judge David Watkins agreed that the lottery idea was "vague" and "arbitrary." Furthermore, he endorsed the claim by critics that it could spur unqualified growers to take a chance on getting selected only because they wanted to participate in the emerging lucrative pot business bonanza. During contentious public hearings Health Department officials argued that the lottery approach was needed to avoid lengthy legal fights over how nurseries were to be selected. The judge also threw out a Health Department provision that would have nurseries to pair with other companies to become eligible for a license. That decision precluded for the time being the efforts of "investors" and other gold diggers to elbow their way into this golden business. Meanwhile, the Health Department reported that at least eight doctors statewide have taken a doctor-training program and now are qualified to certify that patients may use the marijuana extract. Would like to know how many of those are addiction specialists. The office also has created a computer registry to track the program. Well, more tho be reported and I will keep you posted about the progress in that matter. Wish you all a Happy New Year. Yours Bernd

The Marijuana Cartel

Attached a link to an article titled "Marijuana ads signal new strategy in push to legalize" highlighting the growing political power of the marijuana lobby . Its tactics are based on a scorched earth policy: anyone who is considered critical of their goals has to get out of their way. In the case of Democratic Rep. Debbie Wasserman Schultz is portrayed as the unlikely villain, a politician willing to send sick marijuana-using patients to prison. She found herself the target in television advertisements that ran in Florida last month, part of a new trend in the pot wars. What was her sin: she called for evidence based marijuana treatment as a condition for her support of medical marijuana. Of course this is being considered heresy because the pot lobby is interested in sales and big profits without any scrutiny by regulators or the FDA. Patient safety measures are not required because pot is safe. Got it?! So lets buckle up because we all will be the target of the new marijuana cartel. Yours Bernd

Overdose Death Decline

Attached a link to an article titled " Prescription Overdose Deaths in Florida Plunge After Tougher Measures, Report Says" reporting that the death rate from prescription drug overdoses in Florida fell by 23 percent from 2010 to 2012, according to a report by the Centers for Disease Control and Prevention. The Morbidity and Mortality Weekly Report states that during 2003–2009, the number of deaths caused by drug overdose in Florida increased 61.0%, from 1,804 to 2,905, with especially large increases in deaths caused by the opioid pain reliever oxycodone and the benzodiazepine alprazolam. In response, Florida implemented various laws and enforcement actions as part of a comprehensive effort to reverse the trend. This report describes changes in overdose deaths for prescription and illicit drugs and changes in the prescribing of drugs frequently associated with these deaths in Florida after these policy changes. During 2010–2012, the number of drug overdose deaths decreased 16.7%, from 3,201 to 2,666, and the deaths per 100,000 persons decreased 17.7%, from 17.0 to 14.0. Death rates for prescription drugs overall decreased 23.2%, from 14.5 to 11.1 per 100,000 persons. The decline in the overdose deaths from oxycodone (52.1%) exceeded the decline for other opioid pain relievers, and the decline in deaths for alprazolam (35.6%) exceeded the decline for other benzodiazepines. Similar declines occurred in prescribing rates for these drugs during this period. The report also emphasizes that " the temporal association between the legislative and enforcement actions and the substantial declines in prescribing and overdose deaths, especially for drugs favored by pain clinics, suggests that the initiatives in Florida reduced prescription drug overdose fatalities." This should serve as evidence that a well designed and executed public policy can improve public health and safe lives. Therefore, we must push for increased funding for such measures including the Prescription Drug Monitoring Program (PDMP) which is a valuable and essential tool in protecting patients from accidental overdose. Happy 4th of July.

Amendment 2 and the Democratic Party

The Amendment 2 debate is heating up and even within the ranks of the Democratic Party dissent is surfacing. According to an article published in yesterdays Miami Herald U.S. Rep. Debbie Wasserman Schultz expressed her concerns that the proposed constitutional amendment “is written too broadly and stops short of ensuring strong regulatory oversight from state officials.”“Other states have shown that lax oversight and ease of access to prescriptions can lead to abuse, fraud, and accidents,” said her statement, first reported by the Tampa Bay Times. “Also, given Florida’s recent history in combating the epidemic of ‘pill mills’ and dubious distinction as having among the highest incidents of fraud, I do not believe we should make it easier for those seeking to abuse the drug to have easy access to it.” Wasserman Schultz, pointing out that she’s a “cancer survivor, mother and lawmaker,” said that she’s “acutely empathetic to the suffering of people with terminal illnesses and chronic pain. My view is that approval of the use of marijuana as a medical treatment should be handled responsibly and in a regulated manner that ensures its approval does not do more harm than good.” Her concerns expressed were immediately sharply criticized by a John Morgan, a trial lawyer and a major Democratic donor, who blasted the national party’s chair, U.S. Rep. Debbie Wasserman Schultz, as an “irritant” who is becoming “irrelevant” after she voiced concerns about a medical marijuana proposal he helped put on Florida’s ballot this November. I applaud Rep. Wasserman Schultz for her principled stance on this issue and to remind us that common sense should prevail. Yours Bernd

Wasserman Schulz and Amendment 2

The Amendment 2 debate is heating up and even within the ranks of the Democratic Party dissent is surfacing. According to an article published in yesterdays Miami Herald U.S. Rep. Debbie Wasserman Schultz expressed her concerns that the proposed constitutional amendment “is written too broadly and stops short of ensuring strong regulatory oversight from state officials.”“Other states have shown that lax oversight and ease of access to prescriptions can lead to abuse, fraud, and accidents,” said her statement, first reported by the Tampa Bay Times. “Also, given Florida’s recent history in combating the epidemic of ‘pill mills’ and dubious distinction as having among the highest incidents of fraud, I do not believe we should make it easier for those seeking to abuse the drug to have easy access to it.” Wasserman Schultz, pointing out that she’s a “cancer survivor, mother and lawmaker,” said that she’s “acutely empathetic to the suffering of people with terminal illnesses and chronic pain. My view is that approval of the use of marijuana as a medical treatment should be handled responsibly and in a regulated manner that ensures its approval does not do more harm than good.” Her concerns expressed were immediately sharply criticized by a John Morgan, a trial lawyer and a major Democratic donor, who blasted the national party’s chair, U.S. Rep. Debbie Wasserman Schultz, as an “irritant” who is becoming “irrelevant” after she voiced concerns about a medical marijuana proposal he helped put on Florida’s ballot this November. I applaud Rep. Wasserman Schultz for her principled stance on this issue and to remind us that common sense should prevail. Yours Bernd

Medical Marijuana Issue

I hope that you are doing well. Attached an article written by Bruce Grant who was the director of the Florida Office of Drug Control and now serves as the chairman of the Leon County drug prevention coalition. His excellent editorial was published in the Miami Herald on 05/22/2014 and I urge you to read the article in it entirety. He clearly and eloquently states that: " If you liked Big Tobacco, you are going to love Big Marijuana. Expect the same slick ads that neglect to mention dangers in order to get our kids hooked as a key long-term strategy for profiteers. Just look at Colorado to see Florida’s future with legalization. Pot shops will replace pill mills. Physicians will abuse their prescribing privileges for marijuana just as they did when over-prescribing deadly legal narcotics. The medical marijuana ballot initiative would turn Florida into Colorado. The bill that just passed the Legislature allows cannabis oil to those truly sick who need it, but we don’t need to allow further legalization. The world is dangerous enough for kids without sanctioning another intoxicating drug to trip them up. The real effect of medical marijuana in Florida will be to jeopardize the safety and drug-free future of our most precious resource — our youth. Current drug prevention efforts will be stymied leaving us with thousands of pot shops, more teenagers smoking pot and more deadly car wrecks. That won’t be on the ballot in November, but it should be on every voter’s mind." Yours Bernd

Drug Abuse: An African Perspective

I just returned from a speaking tour in South Africa where I visited Cape Town, Durban, Port Elizabeth, Johannesburg and Pretoria. Its a truly exciting, modern and vibrant country but the country is still struggling with poverty, social injustice and a rising violent crime rate. Drug abuse is rampant among the black population. According to South African healthcare experts 11% (5.7million people) of the South African population will suffer from an addiction disorder in their lifetime. Other experts estimate that the number of addicts already exceeds 15% of the population. Drugs of choice include whoonga (mixture of heroin and dagga), along with the rising use of heroin, cocaine (crack) and tik (methamphetamine). Whoonga – also called wunga or nyaope – is a potent and highly addictive mixture of marijuana, heroin and HIV medications. Nyaope is a whitish powder - low-grade heroin mixed with ingredients such as rat poison and sometimes even crushed-up medicine for people with HIV. Sprinkled on top of marijuana, it is a highly addictive, life-wrecking drug cocktail. I think its important for us to follow the international variations of drug abuse because with globalization and international travel "exotic" drug combinations can travel fast, too. Yours Bernd

Medical Marijuana

Medical marijuana is now going mainstream and that's to a large extent due to the efforts of physicians and journalist such as Sanjay Gupta. Gupta is the creator of a CNN program titled "Weed" which is being screened on CNN. Having watched this emotionally charged program I can only come to the conclusion that the world, according to Gupta, can be divided into "good" marijuana social entrepreneurs and "bad" cold-hearted doctors and scientists. Those doctors and scientists come across as cerebral and unemotional whereas the poor patients and their advocates are featured as the vanguards of medicine and science. In Sanjay Guptas's world individual case reports supersede any clinical study and the subjective improvement of individuals is served as clinical evidence. Yes, it is true that case reports, defined as the scientific documentation of a single clinical observation, have a time-honored and rich tradition in medicine and scientific publication. Yes, case reports and series have a high sensitivity for detecting novelty and therefore remain one of the cornerstones of medical progress BUT there findings have to be validated by rigorous randomized clinical trials!! This applies to marijuana, too. Systematic review and meta-analysis of double-blind randomized controlled trials that compare cannabis preparation to placebo are often not as convincing as the case reports of marijuana use may suggest. For example, a systematic review and meta-analysis of double-blind randomized controlled trials that compared any cannabis preparation to placebo among subjects with chronic pain revealed that cannabis treatment is moderately efficacious for treatment of chronic pain, but beneficial effects may be partially (or completely) offset by potentially serious harms. More evidence from larger, well-designed trials is needed to clarify the true balance of benefits to harms. These forms of critical differentiation are missing in Dr. Gupta's reporting. Meanwhile Dr. Guptas proudly declared that he wants to "double down" on his reporting and we will have to endure more of his unscientific rants. But don't worry! CNN will win big in the primetime viewership rating scale and can thereby charge higher advertising rates on Gupta's programs. What can we learn? Marijuana is big business for all involved, except for us doctors who have to clean up the mess and get paid pittance from the health insurance companies for our efforts. Yours Bernd

Medical Marijuana in Florida

The proponents of medical marijuana are gaining political strength and support and have almost unlimited financial support to promote their issues. Therefore, its important to keep abreast of the latest developments and news: In today's Miami Herald an article titled "Medical marijuana poised for ad-war win" reports that a January 2013 poll found medical-marijuana support at 70 percent. A Kitchens Group survey in July found 71 percent approval. Public Policy Polling surveys in October and this January, respectively, found 62 percent and 65 percent support. And Quinnipiac University’s poll in November found the highest support for the concept, 82 percent. Florida attitudes have been changing along with the nation’s. In November, a Quinnipiac University survey found that 48 percent of registered voters favored legalization for adults and 46 percent were opposed. The Republican state Senate district poll, conducted last month by the Tarrance Group, found that 47 percent of likely voters favored outright legalization and 48 percent opposed legalization. And voters strongly backed lighter prison sentences for nonviolent drug offenders. A major difference between the two polls: The Tarrance poll was in selected Republican-held state Senate districts where voters are more conservative; the Quinnipiac survey was a statewide survey that polled all types of voters.The Senate poll indicated that support for Charlotte’s Web stood at 79 percent in favor, 18 percent opposed — mirroring support for the broader medical-marijuana effort. Compared with a similar GOP Senate poll in April, support shifted a net 24 percentage points in favor of Charlotte’s Web. Voters by 65-28 percent favored reducing prison sentences for nonviolent drug offenders and, by 78-15 percent, they supported prison-diversion programs for those convicted of nonviolent crimes. BUT its also important to understand that the argument that medical marijuana leads to complete legalization can be a potent tool to defeat the proposed amendment. In my opinion it crucial to point out that the proponents of medical marijuana are painting a very rosy picture of marijuana's alleged medical benefits claiming treatment success for diabetes,multiple sclerosis, cancer and glaucoma. District 25 Florida House Representative Charles David "Dave" Hood, Jr., a Republican, even suggest that the federal government knew about its benefits since 1975 but continued to ban the medical application of marijuana! This is a blatantly false and misleading statement based on conspiracy theories. As medical professionals we should emphasize that there are VERY limited known medical applications and that clinical trials are necessary to verify and substantiate those claims. Furthermore, we should inform the public that we do have FDA approved cannabinoids available in the US for > 20 years! Dronabinol (Marinol) FDA approved in United States as Schedule I drug for appetite stimulation (1992) and for nausea (1985); moved to Schedule III effective July 2, 1999. Nabilone (Cesamet) Originally approved by the FDA for use in the US in 1985, but removed from the market until re-approved by the FDA on May 15, 2006 and made available in US pharmacies on Aug. 17, 2006. Other products could follow IF clinical efficacy, indications and safety can be established and verified. In my opinion the Florida House and Senate engages in legislative malpractice by approving a form of medical marijuana for the treatment of epilepsy WITHOUT clinical trials and the absence of any research that is needed to protect patients from potential adverse effects and harm. If physicians would engage in such behavior we would be sued by the very law firm which supports the legislation of medical marijuana. As a result of this legislation licensed marijuana dispensaries, often owned and operated by non-medical "social entrepreneurs", would engage in the practice of medicine without a license by dispensing a medical marijuana strain to a group of highly vulnerable children suffering from intractable seizures. Who will be responsible for long-term follow up of potential adverse effects??? Who will be hold liable for potential harm? Legislation by emotion is plain and simple insane!! We must engage in the battle and focus on the fact that if medical marijuana is approved then the camel is getting his nose under the tent and legalization will eventually follow soon. Furthermore, we must make it loud and clear that medical marijuana will seep into the adolescent population and will cause grave long-term harm. Lets not give up the fight!! Yours Bernd

Guns and Public Safety

Now, not only doctors but also insurance companies are prohibited from asking question about gun ownership. Instead of focusing on reducing insurance premiums our representatives in Tallahassee are pleasing their NRA supporters and are obsessively defending alleged Second Amendment violations. For starters: SB 424 would allow state regulators to fine or impose penalties on auto or property insurance companies that "refuse to issue, renew, or cancel a policy" because the policyholder owns a gun. It also prohibits the insurance company from disclosing to third party if the policyholder has a gun. HB 255 is going further by allowing policy holders to sue if an insurer takes such action. On the Florida Senate Senate Banking and Insurance Committee as well as on the Florida House Insurance and Banking subcommittee only ONE Senator and ONE House committee member voted against it! Soon insurance companies have to remove firearm questions from their screening application. Policy holders can now stock their household with assault weapons and thousands of rounds of ammunition to prepare for WW III, or to shoot rowdy neighbors. But wait, it gets better. Soon you can have your own gun range in your backyard. What could possibly go wrong with that! This is insane!!! Yours Bernd

Weapons in Doctors Offices

Attached a link to an article titled " Two dead, third person in hospital after shooting in suburban West Palm" reporting a fatal shooting which took place in the waiting room of a doctors office in West Palm Beach. The shooting occurred during what has been a particularly violent week in Palm Beach County. It was the county’s fifth homicide since Monday and the sixth overall in 2014. It was also the second time this week that local authorities have investigated a murder-suicide, and the third time in seven days that gunmen shot at other people, then killed themselves. As a physician and owner of a busy family medicine clinic I have encountered several patients who carried concealed weapons (handguns, knives) in my office which I discovered during a routine physical exam. I am a gun owner and concealed weapon permit holder myself, but I consider carrying a weapon in a doctors office as inappropriate and potentially dangerous. The fact remains that most healthcare professionals are unarmed and feel intimidated by a patient carrying a loaded weapon. According to Florida firearms regulations a carry license is valid everywhere other than in a few specially-defined areas which include airports, schools, universities, courthouses, establishments licensed to dispense alcoholic beverages for consumption on the premises,career centers, any meeting of the governing body of a county, public school district, municipality, or special district and any meeting of the Legislature or a committee thereof Why should doctors office not be included in the long list of specially-defined prohibited areas"? Why should legislators enjoy the freedom of not being killed by gunfire but doctors should continue working under the threat of guns? Why do neither representatives of organized medicine nor legislators have the intestinal fortitude to stand up and denounce the NRA which blocks all reasonable gun safety measures? Meanwhile, I informed my patients that I do not permit the carrying of any kind of weapons in my office and do not care if my decision backfires. Yours Bernd

Medical Marijuana

Attached a link to an article titled "Florida lawmaker agrees to work to legalize medical marijuana high in cannabidiol" published in yesterday's Tampa Bay Times reporting that Florida legislators agreed to file a bill to legalize the medical use of marijuana that has a high content of the chemical compound cannabidiol to "treat" severe epileptic seizures in children. The families pleaded with lawmakers to legalize strains of marijuana such as "Charlotte's Web" saying it is their last, best hope of relieving the uncontrollable seizures in their medically fragile children. The strain is high in cannabidiol or CBD, the ingredient that controls seizures, but is low in tetrahydrocannabinol, THC, the compound that creates a high. Their emotional pleas convinced the chairman of the legislative committee of the Florida House to support such a bill. Naturally, any opponent of such a move will be considered a heartless and uncaring individual. Most probably, the medical ethics of of physicians opposing such a decision will be questioned, too. But lets consider the facts: Charlotte's Web is a strain of medical marijuana developed in Colorado by the Stanley brothers and featured in the 2013 CNN documentary "Weed", hosted by Sanjay Gupta. It is named after Charlotte Figi, who experienced an immediate and remarkable reduction of her epileptic seizures after her first dose of medical marijuana at five years of age. The sudden publicity of this specific strain of medical marijuana is based on anecdotal evidence only but is now being used to justify the use of medical marijuana in general. Well meaning proponents of clinical research point out that such clinical research is blocked by strict Federal laws. Therefore, they call for reclassification of marijuana to facilitate the kind of rigorous evaluation that’s needed to determine the appropriate, physician-supervised doses and uses of medical marijuana. But before we join the chorus singing the praise of medical marijuana we should step back and analyze the facts. I recommend reading an article published in the Epilepsy Curr. 2013 Mar-Apr; 13(2): 81–82 titled " Slim Evidence for Cannabinoids for Epilepsy" which concluded that no reliable conclusions can be drawn at present regarding the efficacy of cannabinoids as a treatment for epilepsy. The dose of 200 to 300 mg daily of cannabidiol was safely administered to small numbers of patients, for generally short periods of time, and so the safety of long term cannabidiol treatment cannot be reliably assessed. The authors base their assessment of the efficacy of marijuana, or one of marijuana's constituents in the treatment of people with epilepsy on an exhaustive search of the Cochrane Epilepsy Group Specialized Register (May 15, 2012), the Cochrane Central Register of Controlled Trials (CENTRAL issue 4 of 12, and the Cochrane Library 2012),MEDLINE (PubMed, searched on May 15, 2012), ISI Web of Knowledge. This Cochrane review searched for direct evidence that cannabinoids can prevent human seizures in studies using the only acceptable standard, the randomized controlled trial. The researchers identified four studies, with a total of 48 patients randomized to placebo or to 200–300 mg of cannabidiol per day. This particular cannabinoid has few psychotropic effects and is not a controlled substance. Overall, these studies demonstrate the short-term tolerability of this treatment, with the only noted adverse effect being drowsiness in one study. Except for one study that reported two of four treated patients becoming seizure free for 3 months, the studies either reported no benefit, or the effect was not clearly stated. Methods of randomization or determining outcome were inadequate or not clearly detailed.Marijuana itself has major shortcomings as an epilepsy treatment. Its psychotropic action can only be regarded as an adverse effect. It is a biological product containing multiple compounds with unclear, possible, anti- or pro-convulsant effects, delivered in varying amounts from dose to dose. Long-term safety has not been adequately investigated. The authors correctly stated that new treatments for epilepsy are sorely needed. Cannabidiol or other individual cannabinoids with minimal adverse effects could be extracted and given in precise doses in rigorously designed, blinded, randomized clinical trials to test efficacy and safety. In my opinion this is the only reasonable route for development of new antiepileptic drugs. Legislative efforts, as well intended they may be, cannot substitute for the gold standards of scientific evidence. Unfortunately, nobody seems to have the fortitude to stand up and to defend those principles in public. I am afraid that medical science will have to succumb to populism and the efforts to create quick fixes and miracle cures. But at what price? Looking forward to your comments. Yours Bernd

Judges Says No To Drug Test

The U.S. District Court handed Gov. Rick Scott a defeat on Dec. 31 when it struck down a law requiring drug screening of welfare recipients unconstitutional.The Miami Herald reported in a article titled "Scott vows to fight drug-test ruling" that federal judge Mary Scriven granted summary judgment on behalf of Luis Lebron, who at the outset of the 2011 case was a 35-year-old Navy veteran, college student and single father from Orlando. Lebron refused to submit to a drug test arguing that requiring him to pay for and submit to one is unreasonable when there is no reason to believe he uses drugs. Lebron was represented by the American Civil Liberties Union of Florida The judge rules that the mandatory urine drug test violate the Fourth Amendment's protection against unreasonable searches.In her ruling judge Scriven relied heavily on the 11th Circuit of Appeals opinion which cited previous U.S. Supreme Court rulings that restricted mandatory urine drug tests by government agencies to employees working at dangerous jobs or in jobs where school children were involved. Scott signed a law in 2011 to drug test recipients of Temporary Assistance to Needy Families. But the court issued a preliminary injunction a few months later. While the law was in effect from July through October 2011, about 2.6 percent -- or 108 of 4,046 people -- tested positive for drugs, the most common being marijuana. In my opinion an appeal will be an exercise in futility and a waste of precious tax payers money.