In a survey of 511 nonsmokers and 510 smokers ages 18 and older, HealthDay reports that two-thirds support reducing nicotine levels in cigarettes to non-addictive levels.

Researchers also found that 77 percent would support the reduction to non-addictive levels if doing so would reduce the number of children who became addicted to cigarettes.

According to study author Gregory Connolly, director of the Center for Global Tobacco Control at the Harvard School of Public Health, a ban on cigarettes was supported by 43 percent of survey respondents.

The study was published online in the American Journal of Public Health.

When a teen brain is first exposed to cocaine, it launches a defensive response designed to minimize the drug’s effects. As reported in Science Daily, in two recent studies, Yale and other scientists have identified key genes that regulate this response and demonstrate that interfering with this reaction dramatically increases a mouse’s sensitivity to cocaine.

Study results were published in the Journal of Neuroscience.

Research has demonstrated that vulnerability to cocaine is much higher in the teen years, when the brain is developing. Earlier studies at Yale have shown that in adolescence, neurons and their synaptic connections change shape when first exposed to cocaine through molecular pathway regulated by the gene integrin beta1, critical to the development of the nervous system of vertebrates.

As Anthony Koleske, professor of molecular biophysics, biochemistry and neurobiology, and senior author on both papers, elaborates, “This suggests that these structural changes observed are probably protective of the neurocircuitry, an effort of the neuron to protect itself when first exposed to cocaine.”

In the latest study, Yale researchers reported when the pathway was knocked out, mice needed about three times less cocaine to induce behavioral change than mice with the pathway still in place. The findings suggest that the relative strength of the integrin beta1 pathway among individuals may explain why some cocaine users become addicted to the drug while others escape its worst effects, the authors suggest.

“If you were to become totally desensitized to cocaine, there is no reason to seek the drug,” Koleske said.

The study found that exposure to nicotine, either from the mothers smoking cigarettes or from nicotine replacement therapy, was linked to a significantly increased risk of colic in their babies, ranging from 30 to 60 percent, HealthDay reports.

Researchers looked at data based on more than 63,000 interviews with mothers, who participated in the Netherlands-based study, with interviews conducted during pregnancy and six months after the moms gave birth to their babies.

The findings concluded that 8 percent of the babies had colic. About 74 percent of the moms didn’t smoke; 24 percent reported that they did smoke; 2 percent of the moms said they smoked and used nicotine replacement therapy, while 0.3 percent of the women used nicotine replacement therapy alone.

“The theory is that there are nicotine receptors in the GI [gastrointestinal] system and nicotine receptors that alter serotonin and these alterations affect the babies after birth, causing colic,” said Dr. Jennifer Wu, an Obstetrician-Gynecologist at Lenox Hill Hospital.

Dr. Wu added that the causes of colic aren’t well understood, nor are the reasons why nicotine might raise the risk of colic. Prior research has also shown smoking to be associated with colic. However, these studies do not prove cause and effect.

At issue are three bills targeting legally sold synthetic drugs that mimic the effects of marijuana, cocaine and other controlled substances, but are marketed as safe alternatives to their illegal counterparts. The contested legislation would make illegal the use, possession and sale of certain chemicals used in production of synthetic drugs.

Manufacturers of the substances import them into the United States labeled as, among other things, incense, bath salts, snow remover and plant food.

“It is time for the Senate to take action,” said Senator Chuck Grassley of Iowa, the Senior Republican on the Senate Judiciary Committee and a sponsor of one of the bills. “We cannot let the will of just one Senator obstruct the will of many.”

“One Senator shouldn’t be able to prevent a vote on something that 99 percent of Americans want, that directly affects their health and safety and the health and safety of their children,” said Senator Charles Schumer (D-NY) sponsor of another bill aimed at synthetic drugs.

The Senate Judiciary Panel passed three measures by voice vote in July of last year, while the House of Representatives passed a companion bill in December on a bipartisan vote of 317-98.

The bad news is that while cigarette use has decreased, sales of cigars have increased dramatically. Current data show that cigar rates appear to be highest among 18-25 year olds, with most of these smokers using little cigars and cigarillos. Maryland’s recent Youth Tobacco Survey found that in 2010, an alarming 79 percent of high school students reported using a tobacco product other than cigarettes. In Maryland, from 2001 to 2011, the total number of cigarette packs sold dropped by 33.6 percent. During the same 10 year period, sales of cigars increased by more than 176 percent. Other states surveying cigar use are seeing similar trends. 

There are several reasons contributing to an increase in cigar use. There’s a mistaken belief that cigar products are less harmful than cigarettes. Little cigars and cigarillos are less expensive than cigarettes, sold individually and available in an array of sweet and candy-like flavors that appeal to youth. The Maryland study found that more than 76 percent of high school cigar smokers used flavored cigars, which mask the harsh taste of the tobacco and toxins and make addiction easier. 

Cigars of all sizes contain many of the same harmful compounds as cigarettes and can be just as addictive. They pose significant health risks similar to cigarettes, including cancers of the mouth, lung, esophagus and larynx. And, cigars contain more tobacco than cigarettes. They burn longer, giving off greater amounts of harmful secondhand smoke. 

What can be done? The Family Smoking Prevention and Tobacco Control Act, which granted FDA the authority to regulate tobacco products, explicitly addressed cigarettes and smokeless tobacco, but not cigars. Congress gave the FDA the ability to expand its authority to all tobacco products including cigars. Legacy® encourages the FDA to assert jurisdiction over cigars and apply many of the same restrictions on cigarettes to cigar products, including banning of all flavored products, requiring graphic warning labels, restricting advertising and marketing of cigars and taking measures to reduce youth access. What do you think?

Diane Canova
Vice President, Government Affairs
Legacy®

Study findings show that the proportion of kids who started drinking alcohol more than doubled from 11 percent to 25 percent, and the proportion of those who started binge drinking tripled from 4 percent to 13 percent.

Teens being exposed to movies that feature alcohol use led to 28 percent of kids drinking alcohol and of those teens, 20 percent moved on to binge drinking, noted the survey. Researchers also underscored that the association was not only seen with movie characters who drank on-screen, but also with alcohol product placement throughout the movies.

Other factors that were associated with underage drinking were, coming from a family where parents drink and where alcohol was available in the home, but this finding was not linked to progression to binge drinking.

“Product placement in movies is forbidden for cigarettes in the U.S.A., but is legal and commonplace for the alcohol industry, with half of Hollywood films containing at least one alcohol-brand appearance, regardless of film rating,” James Sargent, of Norris Cotton Cancer Center, Dartmouth Medical School and colleagues wrote in the report.

The foam renders all types of chemical and biological agents harmless, according to officials at Sandia’s Chemical & Biological Systems, the makers of the decontamination foam.

Sandia’s decontamination foam is comprised of a collection of mild, nontoxic and noncorrosive chemicals found in common household products, such as hair conditioner and toothpaste. It contains both surfactants, which lift agents off a surface, and mild oxidizers, which break down the agent’s molecules into nontoxic pieces that can be washed down a household drain like detergent or dish soap.

According to the Department of Justice, the chemicals used to cook meth and its byproducts produce toxic fumes, vapors and residues that have lasting effects to local neighborhoods and the environment. Anyone exposed to these byproducts, especially children, could suffer serious health problems and prolonged exposure to meth byproducts may cause cancer, damage the brain, the immune system and may result in birth defects.

Illegal meth labs are a growing problem in America and the U.S. Drug Enforcement Administration’s Clandestine Meth Lab registry lists thousands of locations across the country where law enforcement agencies have found chemicals or paraphernalia linked to either clandestine drug laboratories or meth lab dumpsites.

Incidents related to meth production, including seizures of labs, dumpsites or chemical and glassware, increased to 11,239 in 2010, after falling to 6,095 in 2007, according to the Drug Enforcement Administration.

House Bill 2388 passed 6-2 by a budget subcommittee on human services and now moves on to the full House, reports The Oklahoman. Before receiving money through the federal cash-assistance Temporary Assistance for Needy Families program, it would require adult applicants to be tested for drug use. About 5,000 adults get assistance from the program.

The bill’s main author, Rep. Guy Liebmann, said its purpose is to stop government money from going to people who spend it on illegal drugs, adding its similarity to a 2011 Florida law that has been challenged in federal court. 

The state currently screens clients for drug and alcohol abuse and requires testing if the screening indicates it is necessary. Individuals who test positive, currently five percent, are sent for treatment but not allowed to receive the benefit, said Sandra Harrison, Oklahoma’s Department of Human Services’ chief administrative officer. She added that the assistance is revoked if the individual stops going to work or school.

Oklahoma joins the growing number of states considering drug testing for welfare recipients. A group of lawmakers in Kansas are supporting a proposal that would require one-third of welfare recipients to undergo random drug screening. Officials in Pennsylvania announced they are introducing a new drug testing program for certain welfare recipients. Pennsylvania’s program will randomly test those with a felony drug conviction within the past five years, and those on probation for such crimes. A program introduced in Florida last year to test all welfare recipients was blocked by a federal judge.

A common drug found in cold and allergy medication, pseudoephedrine is used to make methamphetamine.

Tulsa World reports that all of the state’s 27 district attorneys back the proposal. However, a measure making the pill for a prescription didn’t make it through a Senate subcommittee last week. Other measures are awaiting a House committee. 

One district attorney, Tim Harris, from Tulsa County, said it will take “political courage” to get the measure passed.

The governors’ petition asserts that there is a “consensus of medical opinion concerning medical acceptability of cannabis amongst the largest groups of physicians in the United States.” In support of this statement, the petition cites the American Medical Association’s (AMA) alleged “reversal” of its position that marijuana should remain a Schedule I substance. However, contrary to the governors’ petition, the AMA does not believe that there has been sufficient research to justify making herbal marijuana itself available as a prescription medication: “Despite more than 30 years of clinical research, only a small number of randomized, controlled trials have been conducted on smoked cannabis.”¹

Furthermore, while the AMA’s Report does state that the Schedule I status should be “reviewed,” it limits the purpose of such review to the “goal of facilitating clinical research and development of cannabinoid-based medicines, and alternate delivery methods.”² AMA does not recommend that marijuana should be rescheduled in order that it can be directly prescribed and dispensed in its raw form to patients. In fact, the AMA recommendation goes on to caution: “This should not be viewed as an endorsement of state-based medical cannabis programs, the legalization of marijuana, or that scientific evidence on the therapeutic use of cannabis meets the current standards for a prescription drug product.” In the body of its report, AMA further clarified its position:

The future of cannabinoid-based medicine lies in the rapidly evolving field of botanical drug substance development, as well as the design of molecules that target various aspects of the endocannabinoid system. To the extent that rescheduling marijuana out of Schedule I will benefit this effort, such a move can be supported.³

The term “botanical drug substance” is derived from an FDA guidance document: “Guidance for Industry: Botanical Drug Products.”⁴ It refers, not to herbal plant material, but to extracts or similar preparations of the active botanical components. Rather than accepting that marijuana meets the “current, modern accepted standard for what constitute medicine,” the AMA is essentially stating that research into crude marijuana plant material is a dead end.

Rescheduling is not necessary to make marijuana products available for research

A committee of the California Medical Association recently called for the rescheduling of marijuana “so it can be tested and regulated.” However, it is not necessary for marijuana to be rescheduled in order for legitimate research to proceed. Schedule I status does not prevent a product from being tested and researched for potential medical use. The FDA (and its Controlled Substances Staff or CSS) will allow an investigational product containing a controlled substance (including Schedule I substances) to be tested in clinical (human) trials if there is adequate evidence of safety from non-human studies.⁵ The CSA imposes stringent security, record keeping, and other requirements, but these apply equally to Schedule I and Schedule II substances.

Under the CSA, the only differences between Schedule I and II are rather technical:⁶ Before granting a Schedule I research registration, the DEA will separately inquire whether the FDA believes that the researcher is qualified and competent and the trial design will elicit scientifically valid data.⁷ A Schedule I research registration must be renewed each year, whereas research registrations for other controlled substances are valid for 3 years. Schedule I research registrations are protocol, as well as substance, specific. By contrast, a Schedule II registration is valid for research into all Schedule II substances and protocols. Physicians, if they possess registrations to prescribe and administer products containing controlled substances, may conduct research (if permitted by the FDA and the relevant ethics committee) on any Schedule II substance; they need not obtain a separate research registration from DEA.

These additional Schedule I restrictions can delay a research program but are not insurmountable. Furthermore, it may be possible to make minor amendments to the CSA to “equalize” Schedule I and Schedule II research requirements without necessitating a rescheduling of marijuana. Now that would be an interesting thing for governors and the CMA to call for, but apparently neither seemed bothered enough to do the homework required to make such an argument.

Today, Schedule I research certainly does go forward. In a recent pharmaceutical company-sponsored human clinical study investigating a product derived from marijuana extracts, the DEA registered approximately 30 research sites in the U.S. and also registered an importer to bring the product into the U.S. from the U.K., where it was manufactured (this is for a drug called, Sativex, which combines two of marijuana’s active ingredients). What other research projects are happening? That will be the subject of a soon-to-be released report I am working on – stay tuned.

We should also mention the marijuana-based medications already on the market today. Dronabinol (Marinol ®) and Nabilone (Cesamet ®) are concentrated, synthetic versions of the most active ingredient in marijuana – THC – taken as a pill. They are in Schedule III and Schedule II, respectively, and they have been shown to be effective in the treatment of nausea and vomiting caused by chemotherapy in people who have already taken other medications without good results. These have undergone FDA’s process and are completely legal under the Controlled Substances Act.

By contrast to the careful and detailed structure of the Controlled Substances Act, the governors’ petition offers no criteria or guidelines that would clearly identify the scope of legitimate “medical use.” The CMA report also misstates the facts. At present in California, and several other states, it is widely recognized that the concept of “medical use” of marijuana is highly questionable. For payment of a small cash sum, almost anyone can obtain a physician’s “recommendation” to purchase, possess, and use marijuana for alleged medical purposes. Indeed, numerous studies have shown that the most customers of these dispensaries do not suffer from chronic, debilitating conditions such as HIV/AIDS or cancer and are instead otherwise healthy individuals.^8,9 Both sides of the argument agree that this system has essentially legalized marijuana for recreational use, at least amongst those individuals able and willing to buy a recommendation.¹⁰ The governor’s petition would potentially expand that system on a national scale, permitting any physician in any state to prescribe any form of marijuana for any medical condition. The CMA call, while a great way to generate publicity on legalization, is also predicated on a false assertion that the only way to do research into marijuana is to legalize the drug. Sadly, vociferous calls for rescheduling and legalizing like these simply further muddle and confuse an already highly charged debate.

Kevin A. Sabet, PhD, Policy Consultant and Assistant Professor, University of Florida, College of Medicine, Division of Addiction Medicine, Department of Psychiatry. To read more from Dr. Sabet, visit www.kevinsabet.com or follow him on Twitter @kevinsabet.

[1] Id. at p. 15.

[2] AMA, Council on Science and Public Health, “Use of Cannabis for Medicinal Purposes,” http://www.ama-assn.org/resources/doc/csaph/i09csaph3ft.pdf (2009) (hereinafter AMA Report).

[3] Id. at p.16.

[4] http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070491.pdf.

[5] In order for any investigational product to move into advanced clinical research (and ultimately to new drug approval), many additional criteria must be met. Robust data must demonstrate a product’s pharmacological activity, quality (including consistent composition, extent of impurities, and stability), toxicity of various types, and efficacy in a particular patient population for a specific medical condition.

[6] See AMA Report, page 9.

[7] 21 U.S.C.§823(f).

[8] O’Connell, T and Bou-Matar , C.B. (2007). Long term marijuana users seeking medical cannabis in California (2001–2007): demographics, social characteristics, patterns of cannabis and other drug use of 4117 applicants. Harm Reduction Journal,  http://www.harmreductionjournal.com/content/4/1/16.

[9] Nunberg, Helen; Kilmer, Beau; Pacula, Rosalie Liccardo; and Burgdorf, James R. (2011) “An Analysis of Applicants Presenting to a Medical Marijuana Specialty Practice in California,” Journal of Drug Policy Analysis: Vol. 4: Iss. 1, Article 1. Available at: http://www.bepress.com/jdpa/vol4/iss1/art1.

[10] According to Allen St. Pierre of NORML, “in California, marijuana has also been de facto legalized under the guise of medical marijuana.” See Transcript of Don Lemon CNN Television Show with Kevin Sabet and Allen St. Pierre: http://transcripts.cnn.com/TRANSCRIPTS/0905/09/cnr.04.html. Accessed January 22, 2012.