This blog is all about current FDA approved drugs to treat the hepatitis C virus (HCV) with a focus on treating HCV according to genotype, using information extracted from peer-reviewed journals, liver meetings/conferences, and interactive learning activities.
Risk Of Developing Liver Cancer After HCV Treatment
Ischemic stroke may be added to the list of health risks already associated with the recreational street drug spice, a team of neurologists from the University of South Florida (USF), in Tampa, suggests.
In a new report, the authors discuss the cases of 2 young and previously healthy siblings aged 26 and 19 years who experienced acute ischemic stroke shortly after smoking the Schedule I synthetic marijuana known as spice. Imaging results suggested the strokes may have been embolic.
The lead author of the article, Melissa J. Freeman, MD, said that all the tests they ran on the siblings to determine whether they were genetically predisposed to developing blood clots came back negative.
"We're proposing that perhaps it's a cardioembolic etiology, because smoking the synthetic marijuana spice has been associated in the medical literature with myocardial infarction and seizures," Dr. Freeman, a USF vascular neurology fellow, told Medscape Medical News. "If people are having heart attacks from it, perhaps there is a cardiac reason for the strokes."
The study was published in the December 10 issue of Neurology.
Spice-Associated Effects
The authors cite tachycardia, vomiting, agitation, confusion, and hallucinations as common side effects of smoking spice, adding that national news media outlets have also reported on spice-associated deaths within the past several months.
Patient A, a 26-year-old man, was brought to the emergency department with sudden-onset dysarthria, expressive aphasia, and weakness in his right face and arm.
He was found to have a clot in the left middle cerebral artery (MCA), which was confirmed by computed tomographic angiography, and was treated with tissue plasminogen–activator (tPA). He improved clinically and did not return for his follow-up visit, they write.
Patient B, a 19-year-old woman, was recognized by staff members as the sibling who had visited her brother on his previous admission. Magnetic resonance imaging showed a large MCA distribution infarction, with punctate infarcts in the right cerebral hemisphere, "suggestive of a proximal embolic event," the authors note. "She did not arrive within the window for tPA."
She stabilized neurologically, but at the last office visit, she still had right hemiparesis and expressive aphasia, they note.
Although both patients tested positive for regular cannabis and had in the past smoked conventional marijuana, each reported that they had smoked spice shortly prior to onset of the stroke and that they had obtained the drug from the same supplier.
The active ingredient in the spice smoked by the siblings in this report was JWH-018, a chemical compound first developed in the mid-1990s. But different compounds are constantly being developed by spice manufacturers, Dr. Freeman said. That makes them harder to regulate and more dangerous for users, she said.
"The chemicals might be slightly different on a molecular level and therefore wouldn't be part of the group that is considered illegal," said Dr. Freeman. "There is so much that is unknown, which is part of the problem. If it were one specific compound, it would be a lot easier to research."
Limitations to the findings listed by the authors in the article include possible unidentified contaminants in the product the siblings consumed and the fact that an unknown genetic mechanism could have caused the stroke, given the relationship of the patients.
Anything Pot Can Do…
In an editorial accompanying the publication, John C. M. Brust, MD, from the New York Neurological Institute and Columbia University College of Physicians and Surgeon, New York City, points out that many synthetic cannabinoids have several times the potency or efficacy of tetrahydrocannabinol (THC), the active ingredient in natural marijuana.
Citing 59 reported cases of marijuana-related strokes in the medical literature, Dr. Brust concluded by saying, "If marijuana can cause ischemic stroke, and if anything pot can do spice can do better, neurologists will likely encounter increasing numbers of spice-associated strokes in the years ahead."
In the meantime, Dr. Freeman encouraged doctors who see stroke patients who are not within the age range of people normally considered at risk for stroke to ask whether they have smoked spice recently.
"I think it should be reported, because we won't be able to figure anything more out unless we have more information," she said. "I think it's very important that they screen high school– and college-aged students. The prevalence of younger people smoking the substance is so much higher than I thought it would be."
The National Geographic Channel is offering a series of broadcasts entitled Drugs, Inc, which examines the $350 billion-a-year global drug industry from all angles. Both video excerpts (provided below) are from the "Designer Drugs" episode. The first video clip investigates synthetic drugs in the UK, the second clip takes us to Israel with a masked drug dealer talking about selling "hagigat" a designer drug similar to bath salts. The next installment of the episode will air Thursday September 5th @ 4:00PM EST.
Chicago, one of the biggest open-air crack and heroin markets in America, is at saturation point. It's an addict's dream as dealers compete with high purity drugs sold in very affordable quantities. The result: record levels of overdoses and homicides as gangs fight over drug turf. Go inside the deeply entrenched and violent world of the city's drug-corner industry.
A synthetic compound found in illicit drugs known as "bath salts" may be more addictive than methamphetamine (meth), new research suggests.
A set of tests showed that after a group of rats were exposed to the chemical 3,4-methylenedioxypyrovalerone (MDPV), they went on to press a lever for a single intravenous infusion of MDPV significantly more times than they did for meth — across a wide range of doses.
When the number of times a lever needed to be pressed for an additional infusion was increased, the rats emitted an average of 60 presses for meth but an average of 600 presses for MDPV.
"If you consider these lever presses a measure of how much a rat will work to get a drug infusion, then these rats worked more than 10 times harder to get MDPV," lead author Shawn M. Aarde, PhD, research associate at the Scripps Research Institute (TSRI) in La Jolla, California, said in a release.
He added that some of the rats made 3000 lever presses for a single infusion of MDPV.
The researchers note that reports on human users of "bath salts" have suggested that effects from the drug can last a long time, even after use stops. So they hope to soon begin assessing the long-term behavioral effects of MDPV in new studies.
"MDPV looks like it's going to stick around as a recreational stimulant because it is so potent," said coinvestigator Michael A. Taffe, PhD, associate professor at TSRI, in the same release.
The study is published in the August issue of Neuropharmacology.
Direct Comparison
Dr. Taffe and coinvestigator Tobin J. Dickerson, PhD, also from TSRI, began assessing the dangerous effects of cathinone derivatives, including MDPV, several years ago.
"The drugs had not yet been scheduled, and we were able to work out how to synthesize them in sufficient quantities for animal testing," said Dr. Dickerson.
These investigators have published 5 other studies over the past year that examined the effects of both MDPV and mephedrone.
For the current study, the investigators sought to directly compare major stimulant effects from MDPV with effects from meth in a group of 40 rats with surgically implanted intravenous catheters.
All rats were trained to press levers, initially to receive food pellets and later to receive drug infusions.
The investigators recorded the number and amount of self-infusions as well as any unusual behaviors after MDPV administration.
Greater Potency
Results showed that MDPV in self-administered doses of 0.01 to 0.50 mg/kg/infusion had "greater potency and efficacy" than meth in doses of 0.1 to 0.25 mg/kg/infusion.
Several repetitive behaviors observed in the rats after higher doses were reminiscent of human MDPV users, including tooth-grinding, compulsive skin-picking, and excessive licking.
In fact, some of the rats could not be interrupted as they repeatedly licked the clear plastic walls of the housing chambers.
"These data support a clear inference that the relatively novel stimulant drug of abuse, MDPV, poses a high risk of abuse liability" that may be greater than that of meth, write the researchers.
The investigators report that they are now setting up studies to assess the long-term behavioral effects of MDPV, as well as new members of first-generation cathinone derivatives.
"We'd like the ability to predict, for example, which ones have the highest abuse potential, which are more likely to have long-term toxicity issues, and which carry high risks of acute lethal consequences," said Dr. Taffe.
The study was funded by grants from the US Public Health Service. The study authors have disclosed no relevant financial relationships.
Feb. 13, 2013 -- Kidney damage is now among the growing list of serious health effects associated with using synthetic marijuana.
Also known as Spice, Spice Gold, and K2, synthetic marijuana has been marketed as various herbal mixtures and sold as incense, bath additives, and air fresheners. They contain synthetic cannabinoid, which mimics the effects of the natural ingredient in marijuana that causes a high.
These products have also been linked to birth defects, changes in behavior, chest pain, and heart attack.
A study at the University of Alabama, Birmingham, involved four previously healthy young men who developed short-term kidney damage, called acute kidney injury. All had used synthetic marijuana.
The men were members of the same community and had symptoms of nausea, vomiting, and abdominal pain over nine weeks.
Three of the men also had an abnormally small amount of urine, and the fourth had a decrease in blood flow to the kidney. Three underwent a test that showed a condition called acute tubular necrosis. Left untreated, this can cause the kidneys to shut down.
All four recovered their kidney function, and none required dialysis.
In the study, researchers note a "dramatic increase" in the use of synthetic marijuana products in the past five years. The relatively low cost ($20 per gram) and the fact that they don't show up on routine drug tests are cited as the main reasons for their growing popularity.
In the first half of 2010 there were 567 cases of synthetic marijuana use reported by U.S. poison control centers in 41 states, compared to 13 cases in 2009.
The researchers also note that use is growing despite laws banning these products in about 40 states. "This is partly because new synthetic preparations that are not covered by legislation continue to be made and are available on the streets sometimes days after the legislation against prior preparations is introduced," the researchers write.
Synthetic marijuana is typically smoked, but it can also be inhaled and ingested.
The products often include several additives. The researchers write that it is likely that an additive, rather than the synthetic cannabinoid, caused the acute kidney injury.
'Bath Salts' Ingredient More Powerful, Dangerous Than Cocaine
Caroline Cassels
Oct 19, 2012
A synthetic chemical commonly found in illicit drugs known as "bath salts" is potentially more powerful and dangerous than cocaine, new research suggests.
An animal study conducted by Michael Baumann, PhD, a senior scientist at the National Institute on Drug Abuse (NIDA), showed that the chemical methylenedioxypyrovalerone (MDPV) prolonged the effects of the neurotransmitters dopamine and norepinephrine by blocking reuptake at brain nerve cells, resulting in hyperactivity, rapid heart rate, and increased blood pressure.
The researchers note that although the study was conducted in rodents, the findings may explain the highly addictive and dangerous nature of bath salts in humans, because MDPV is the chief substance found in the blood and urine of emergency department patients who have overdosed on this drug.
"Our preclinical findings may have important implications for people who take bath salts products for recreational purposes. The potent blockade of dopamine uptake caused by MDPV predicts that the drug has a high risk for abuse, whereas the potent blockade of norepinephrine uptake portends dangerous cardiovascular stimulation," the authors write.
"Patients admitted to emergency departments for bath salts overdose who have toxicological verification of MDPV consumption, display symptoms, including agitation, psychosis, violent behavior, hypothermia, and tachycardia," they add.
The study was published online October 17 in Neuropsychopharmacology.
According to the study, the abuse of psychoactive bath salts is a growing public health concern. Yet, the researchers note that little is known about their pharmacology.
The investigators assessed MDPV and related drugs with respect to neurochemistry, locomotor activity, and cardiovascular parameters in rats.
They found that MDPV blocks the uptake of dopamine and norepinephrine. They also found that, like cocaine, MDPV inhibits the clearance of endogenous dopamine but that MDPV has a more potent effect.
The investigators also report that MDPV is "at least 10 times more potent than cocaine at producing locomotor activation, tachycardia, and hypertension in rats."
"The robust stimulation of dopamine transmission by MDPV predicts serious potential for abuse and may provide a mechanism to explain the adverse effects observed in humans taking high doses of 'bath salts' preparations," they add.
The authors have disclosed no relevant financial relationships.
Neuropsychopharmacology. Published online October 17, 2012.
Hello folks,
Welcome to HCV rewind, a weekly digest of news, research and a look at today's headlines.
This week we've been given a glimpse into research on liver cancer, HCV drugs in development (Gilead single pill study), disease progression, disease mortality, diabetes, and news coming from the International AIDS Conference. Also in the media, the number of states linked to the suspect in hepatitis C outbreak at Exeter hospital continues to rise. Last but not least, the US district court in Washington DC, rules a controversial stem cell therapy offered at US clinics should be regulated.
We begin with a disturbing, but significant hepatitis C study published in the Journal of InfectiousDiseases. According to the paper the overall mortality from liver related disease and non-liver conditions - including some cancers- was found to be significantly increased in people with chronic hepatitis C. The Full text is available to the public through open access, and includes an accompanying editorial.
In The News
19/07/2012
Hepatitis C may increase deaths from both liver-related and other diseases
In a long-term study of people infected with the hepatitis C virus (HCV), researchers found increased deaths from both liver-related and non-liver related diseases in patients with active infections who had not cleared their infection.
The study, published in the Journal of Infectious Diseases and available online, found increased mortality in patients with chronic HCV infection—that is, with detectable levels of HCV genetic material, or RNA, in their blood—suggesting that chronic HCV infections, even in people who have no symptoms, can lead to increased mortality from liver disease or a variety of other causes. The findings highlight the importance of people getting tested for HCV antibodies and for active HCV infection—and of evaluating patients for antiviral treatment when they are found to have an active HCV infection, even when they feel well.
HCV infects more than 170 million people globally and has been shown to cause such liver diseases as cirrhosis and hepatocellular carcinoma. Many infected patients have no symptoms and are not aware of infection until after irreversible liver disease has occurred. In addition, several diseases not related to the liver have been linked to HCV. However, nearly two-thirds of patients can be cured of their HCV infection with currently available antiviral therapy.
Chien-Jen Chen, ScD, and researchers from the Genomic Research Center in Taipei, Taiwan, enrolled more than 23,000 adults in Taiwan in their study and followed them from 1991 to 2008. Blood samples were collected at study entry and at follow-up health examinations. Researchers found increased mortality from liver- and non-liver-related diseases—including cancers of the esophagus, prostate, and thyroid, as well as circulatory and renal diseases—among those infected with HCV. Mortality was higher in HCV-infected participants with detectable serum levels of HCV RNA, indicating they had active infections; subjects with previous infections who only had HCV antibodies, but not HCV RNA, in their blood did not have increased mortality on follow-up.
According to Dr. Chen, "The findings implied that the serum HCV RNA level is an important marker for clinical decisions in the management of HCV-infected patients." Dr. Chen suggested that HCV-infected patients may benefit from treatment with antiviral and immunomodulating agents to promote viral clearance.
The investigators concluded that their findings have significant implications for clinical practice and public health—namely, that individuals seropositive for HCV RNA should be followed intensively and urged to be evaluated for antiviral therapy. In addition, they noted, testing to determine serum HCV RNA level by a sensitive assay is essential for clinical management of HCV-infected patients.
Dr. Chen and his colleagues cautioned that some non-liver-related diseases are too rare to accurately determine their risk in connection with HCV infection. They suggested that a collaborative study with a large sample size would be needed in order to further investigate the full spectrum of diseases associated with HCV.
In an accompanying editorial, Kenrad E. Nelson, MD, of Johns Hopkins University in Baltimore, noted that overall mortality was significantly increased from liver-related and other causes compared to uninfected patients from the same communities in the study. The findings indicate that, although some who are infected with HCV can cure their infection without treatment, most people who are infected and who have no symptoms develop chronic infections and are at increased risk of death from HCV, Dr. Nelson said.
Many patients with HCV infection go undiagnosed, and among those whose infection is detected, "few are medically evaluated and effectively treated," Dr. Nelson added. Although treatment for HCV infection is improving dramatically, he noted, a significant reduction in HCV-related mortality will require that screening measures are greatly expanded.
Fast Facts:
Overall mortality in patients infected with hepatitis C virus (HCV) was significantly increased from both liver-related and other diseases compared to uninfected patients from the same communities.
Compared to people who had never been infected with HCV, mortality was higher in HCV-infected patients with detectable levels of HCV RNA in their blood on follow-up, but not in patients with inactive infections—those who were positive for HCV antibodies but whose blood was free of HCV RNA.
Diseases not related to the liver that were observed in this study included cancers of the esophagus, prostate, and thyroid, and circulatory and renal diseases.
Most people with chronic HCV infection don't know they are infected because the infection is often without symptoms. However, chronic HCV can be curable with treatment, so people should be screened and considered for treatment if they have chronic HCV infection.
Liz Highleyman, Editor-in-Chief and Publisher at HIV and Hepatitis, examines the study results in detail:
Over years or decades, chronic hepatitis C can progress to serious liver disease including cirrhosis, hepatocellular carcinoma, and end-stage liver failure. But the effect of HCV infection on non-liver-related illness and death has not been extensively studied.
Mei-Hsuan Lee from Academia Sinica in Taipei, Chien-Jen Chen from the Genomic Research Center, and fellow investigators with the R.E.V.E.A.L.-HCV Study Group looked at associations between HCV infection and liver-related and non-liver deaths...
CONCORD, N.H. (AP) — A dozen hospitals in seven states are scrambling to identify people who might have been infected with hepatitis C by a traveling medical technician who was charged a week ago with causing an outbreak in New Hampshire.
With details of David Kwiatkowski's resume still emerging, a hospital official in Arizona said he had been fired from her facility in April 2010, after he was found unresponsive in a men's locker room with syringes and needles. Kwiatkowski was treated at the hospital, and tests showed he had cocaine and marijuana in his system, said Monica Bowman, chief executive officer of the Arizona Heart Hospital...
In Michigan, officials at Oakwood Annapolis Hospital in Wayne noted that there was no indication that Kwiatkowski had hepatitis C when he was employed there from January to September 2007, and that he passed at least two drug tests during that time. State health officials said they are still looking into other locations where Kwiatkowski worked and what steps, if any, they need to take....
Twenty-five former patients at St. Francis Hospital in Poughkeepsie, N.Y., where Kwiatkowski worked for three months in late 2007 and early 2008, have been asked to get tested. In Kansas, state health officials are sending letters to about 460 patients who were treated at the cardiac catheterization lab at Hays Medical Center from May 24, 2010, to Sept. 22, 2010. The state also is setting up an informational website, and the hospital has set up a telephone hotline...
In Maryland, hundreds of patients are being contacted by the four hospitals where Kwiatkowski worked between May 2008 and March 2010. None of the four, which include The Johns Hopkins Hospital and a Veterans Affairs hospital in Baltimore, reported that Kwiatkowski was fired or that his behavior raised red flags...
At Houston Medical Center in Warner Robins, Ga., CEO Cary Martin the identification process hasn't been completed yet. Kwiatkowski worked in the cardiac cath lab there from October 2010 to March 2011 but did not have access to the hospital's medication system, he said....
Contributing to this report were Associated Press writers Felicia Fonseca and Paul Davenport in Arizona, Kate Brumback in Atlanta, Ben Nuckols in Washington, David Runk in Detroit, John Hanna in Topeka, Kan., and JoAnn Loviglio in Philadelphia.
Video - Jul. 26, 2012
US Attorney: Hepatitis C Case 'Unprecedented'
A federal prosecutor said Tuesday he expects to bring more charges against a traveling medical technician accused of infecting 30 patients with hepatitis C in New Hampshire.(/AP)..
This week Clinical Care Options released "part one" of an online quiz containing 35 questions on treating hepatitis C, answered by nine world-renowned hepatology experts, to review the quiz and links,click here. When CCO goes live with part two and three, I'll be sure to post a link.
July Issue Of CDL
Digital Liver Disease Journal - "Clinical Liver Disease" Third Issue Is Out
Visitors are able to view videos, full data, and download files in either HTML or PDF formats
Disease Progression In hepatitis C
NIH scientists identify likely predictors of hepatitis C severity
Scientists at the National Institutes of Health have identified several factors in people infected with the hepatitis C virus that may predict whether the unusually rapid progression of disease from initial infection to severe liver conditions, such as cirrhosis, will occur. Knowing whether a patient's condition is likely to deteriorate quickly could help physicians decide on the best course of treatment. Continue reading...
Pharmaceuticals
Gilead Begins Single Pill Hepatitis C Study For 2014 Approval By Michelle Fay Cortez and Ryan Flinn on July 27, 2012
Gilead Sciences Inc. (GILD) said it plans to start a combination study of two drugs in a single pill to treat hepatitis C by the end of the year, putting it on track to request U.S. regulatory approval for the medicine in 2014.
Gilead, which spent $10.8 billion to acquire one of the medicines, GS-7977, plans to combine it with another, GS-5855, in a trial of 800 patients starting in the fourth-quarter, said Norbert Bischofberger, chief medical officer of the Foster City, California-based company, in a conference call yesterday. If the combination is effective, the company could apply for regulatory approval in the middle of 2014, Bischofberger said.
Gilead is among several drugmakers racing to develop new hepatitis C treatments that act more quickly with fewer side effects than the current standard of care. The goal is to provide doctors and patients with simpler, more effective treatments, Bischofberger said.
The company aims for a therapy that “will clearly be a one pill, once daily, maybe a 12 week course,” for patients with all different types of hepatitis C, Bischofberger said. “That’s our goal. We are very close.”
Some analysts say Gilead is now clearly in the lead for a better hepatitis drug.
MINYANVILLE ORIGINAL Shares of Gilead Sciences rose as much as 6% Friday on sentiment, once again, that the biotech company is in the lead position for a better hepatitis C treatment.
Gilead is performing multiple studies to test an experimental drug, but the trial that is possibly the most intriguing looks at a combination therapy that rolls two medicines into a single pill. Gilead hopes to advance tests of its lead hepatitis drug GS-7977 in a combination with another company medicine, GS-5885. Wall Street analysts and investors are excited about the potential for this combination as a highly effective, safe, single pill. If all goes well in studies, the company may apply for US approval by 2014.
“This probably puts them in the lead,” ISI Group analyst Mark Schoenebaum says.
Hepatitis C is a liver-wasting virus that affects millions of people. Gilead is in a highly competitive race for a better hepatitis treatment with rivals such as Bristol-Myers Squibb (BMY), Abbott Laboratories (ABT), Merck (MRK), Vertex Pharmaceuticals (VRTX), Idenix Pharmaceuticals (IDIX), and Roche (RHHBY).
Shares of Gilead were up 5% to $54.41 in late-morning trading. The stock is up 33% this year.
The company is likely to apply for US approval of GS-7977 next year. But the combo pill with the two drugs signals potential for an even more superior treatment compared with the current standard of care. Currently, medicines are taken with an injection of interferon, an immune booster that can have nasty side effects. The goal of all the next-generation hepatitis drug programs is to develop a treatment that doesn’t require interferon. A single pill to treat the virus would be a real breakthrough.
“It’s the ultimate frontier in (hepatitis) therapy,” Gilead’s chief scientific officer Norbert Bischofberger told investors on a conference call late-day Thursday. “That’s what we want to pursue.”
Bristol-Myers CEO Lamberto Andreotti has said Gilead should test GS-7977 with his company’s drug, daclatasvir. Like GS-5885, daclastasvir is among a class of drugs called NS5A inhibitors. GS-7977 is known as a nucleotide polymerase inhibitor.
Gilead execs say they want to go forward with their own drug rather than testing with Bristol-Myers.
Before we begin our formal remarks, we want to remind you that we will be
making forward-looking statements that contains certain assumptions, risks and
uncertainties that are beyond our control.
These risks include the possibility that our actual financial results may
differ materially from the revised guidance we are presenting today.
The possibility of unfavorable results from our clinical studies, including
those evaluating the GS 7977, and GS 5885 in various patient populations and the
possibility that we may be unable to compete our clinical studies and regulatory
filings or obtain regulatory approvals in currently anticipated timelines.
A description of these risks can be found at our latest SEC disclosure
documents in our recent press releases. Gilead does not undertake any obligation
to update these forward-looking statements made during this call.
Related@ Gilead Sciences-Second Quarter 2012 Financial Results . FDA grants fast track designation for Idenix HCV therapy
The US Food and Drug Administration (FDA) has granted fast track designation
for Idenix Pharmaceuticals' IDX719 to treat chronic hepatitis C infection
(HCV).
IDX719 is an NS5A inhibitor that demonstrated pan-genotypic activity in a
recent proof-of-concept clinical trial in genotypes 1-4, treatment-naive HCV
patients.
Idenix president and chief executive officer Ron Renaud said the receipt of
fast track designation from the FDA for IDX719 reflects the critical need for
new treatment regimens to address HCV infection.
"As previously reported, we are on track to initiate a phase II combination
study of IDX719 with IDX184, our other lead HCV product candidate, by the end of
this year," Renaud added.
The fast track program allows a company to file a new drug application on a
rolling basis, which permits the FDA to review the filing as it is received,
rather than waiting for the entire submission prior to commencing the review
process. Source
The company's candidate IDX184 is the principle value driver at this point. Although IDX184 is considered to be less potent than the leading HCV nuclear clinical candidate (Gilead Sciences' GS-7977), the available data suggest that IDX184 would be successfully developed, thereby unlocking significant value in Idenix shares...
"While the wholly-owned key asset IDX184 is not a best-in-class nucleotide ("nuc") polymerase inhibitor, we think its high barrier to resistance will confer value in alternative DAA combos, with data in 2013 driving estimates higher and solidifying its scarcity among late-stage nucs," UBS analyst Matthew Roden wrote in a note to clients...
Idenix has the only unencumbered nuc in late-stage clinical development, as well as IDX719, a potentially best-in-class pan-genotypic NS5a inhibitor in phase-1 trials as well. IDX719 targets the HCV non-structural 5A (NS5A) protein presents a second clinical stage asset, and could be differentiated among the NS5a class in terms of potency and pan-genotypic activity.
The company has also planned to begin trials with a combination of IDX 719 and IDX 184 towards the end of this year. "Given the potential for both classes to become backbone therapies in HCV (and potentially form an all-IDIX pan-genotypic combo), we believe the Idenix pipeline has considerable scarcity value, and will attract large pharma or biotech partners," the analyst noted. In addition, Idenix holds significant intellectual property in nuc chemistry, and may have rights to other nucs in HCV.....
GSK wins FDA priority review for Promacta supplemental new drug application to treat thrombocytopenia in adult patients with chronic hepatitis C virus infection
July 26
GlaxoSmithKline (GSK), Ligand Pharmaceuticals' partner, has gained FDA
priority review status for the supplemental new drug application for Promacta to
treat thrombocytopenia in adult patients with chronic hepatitis C virus
infection.
Eltrombopag, known by the brand name Promacta in the US and Revolade in the
European Union and other countries, is indicated for thrombocytopenia in
patients with chronic immune (idiopathic) thrombocytopenia.
The risks associated with Promacta include hepatotoxicity, bone marrow
reticulin formation and risk for bone marrow fibrosis, thrombotic/thromboembolic
complications, hematologic malignancies, and cataracts
A priority review designation is given to drugs that are considered to offer
major advances in treatment or provide a treatment where no adequate therapy
exists, if approved.
Under the Prescription Drugs User Fee Act, the goal for completing a priority
review is six months.
Ligand is a biopharmaceutical company with a business model that is based
upon the concept of developing or acquiring royalty revenue generating assets
and coupling them to a lean corporate cost structure. Source
Liver Cancer
Medscape published data on the importance of early diagnoses of HCC, and the excellent survival rate for patients who underwent curative treatments. View Full Text @ Medscape, or click here to read only the discussion/conclusion.
Survey: Surgeons Play to Strengths in Early Hepatocellular Cancer
Therapy for early HCC with well-compensated cirrhosis is controversial; there is little agreement on when resection, transplantation, or radiofrequency ablation becomes the best approach. Choice of therapy for early HCC often depends on the surgeon’s repertoire of techniques and the therapeutic services the hospital offers, based on the findings of a web-based survey of centers that had at least five HCC cases per year..Continue reading..
Liver Cancer - Clinical Trials
Jennerex begins Phase 2 HCC trial of JX-594 PBR Staff Writer Published 26 July 2012
Jennerex has treated the first patient in a Phase 2 clinical trial of
intravenous treatment with JX-594 for patients with advanced hepatocellular
carcinoma (HCC) who have not received treatment with sorafeni.
The multinational, single-arm, open-label study of JX-594 is administered
weekly by intravenous infusions in sorafenib-naive patients with advanced HCC.
The trial will be conducted in South Korea, US and Europe.
The radiographic response rate based on modified RECIST and modified Choi
criteria is the primary objective of the study and the patients will
subsequently be followed for progression-free survival and overall survival.
Jennerex research and development president and chief medical officer David
Kirn said unlike other treatments in the class, JX-594 can be administered
intravenously, and it has the ability to target tumors systemically and,
therefore, has the potential to impact both metastatic and primary tumors.
"In our previously reported randomized Phase 2 dose-ranging study in HCC with
intratumoral delivery, we showed a statistically significant benefit in overall
survival in the high dose group, which we believe was due, in large part, to the
systemic delivery of JX-594 at that dose level," Kirn added. Source
Failures
Combination of Tarceva, Nexavar fails to meet main goal of Phase III liver cancer study
Bayer, Onyx Pharmaceuticals and Astellas announced Monday that a late-stage trial investigating the combination of Tarceva (erlotinib) and Nexavar (sorafenib) failed to meet the main goal of a late-stage trial in patients with unresectable hepatocellular carcinoma (HCC).
Hepatocellular carcinoma - Brivanib Phase III Does Not Meet Overall Survival Primary Endpoint
Bristol-Myers Squibb Company today reported the result of the phase III BRISK-FL clinical trial of the investigational agent brivanib versus sorafenib as first-line treatment in patients with advanced hepatocellular carcinoma (HCC; liver cancer). The study did not meet its primary overall survival objective based upon a non-inferiority statistical design
Worth A Click
For the savvy HCV patient who strives to stay abreast of the latest research, Healio offers news and education in the field of gastroenterology, hepatology, infectious disease and more. The site alleviates the daunting task of breaking down either full text articles or abstracts found in medical journals online by publishing the same research in easy to comprehend articles. Here are a few articles offered at Healio this week.
**After visiting the site a few times free registration is required
Hepatitis C Drug Development Goes from Pony Ride to Rocket Launch
The in depth report includes the following topics; HCV drug resistance, DAA drug-drug interactions, nucleosides and nucleotide polymerase inhibitors, HCV protease inhibitors, the next generation of drugs, HCV quad therapy, treating genotypes 1-4, SVR-4 ,SVR-12, interferon free therapy and much more.... Click here to read the article....
World Hepatitis Day
On 28 July 2012 people around the world will come together to mark World Hepatitis Day and raise awareness of viral hepatitis. Coordinated by the World Hepatitis Alliance since 2007, World Hepatitis Day was officially recognised by the World Health Organization on May 2010 and it’s now one of only four disease related official days.
Hepatitis kills around one million people every year. Millions more suffer immediate sickness or long-term ill health. World Hepatitis Day provides an opportunity to recognise viral hepatitis as a major global health problem in order to advance prevention and control.
Hepatitis C: A “silent killer”
Encourage patients to get tested for World Hepatitis Day, July 28
The liver disease hepatitis C is a major health issue in the United States—as much as 5 million Americans have hepatitis C, approximately four times the amount of people with HIV. It’s the leading cause of liver cancer and the most common reason for liver transplantation in the country. What’s more surprising is that 75% of people with hepatitis C don’t know it yet.
Hepatitis C has been called a “silent epidemic” in a Department of Health & Human Services report because it often has no symptoms and can go decades without detection. In the meantime, serious liver damage or even liver cancer may occur.
Recent CDC studies have reported that deaths from hepatitis C are on the rise. In 2007, there were more than 15,000 deaths in the United States from hepatitis C, surpassing the 13,000 deaths from HIV/AIDS in the same year.
People born from 1945 through 1965 have a greater prevalence of hepatitis C than the general population. In fact, 82% of people with the disease in the country are members of the baby boomer generation, and 73% of the deaths from hepatitis C occur in this group.
Those at increased risk for hepatitis C include people who had blood transfusions before 1992, people with tattoos, people who used I.V. drugs even once, and those who work in a health care setting. Certain populations, including African Americans and Hispanics, are also affected by hepatitis C at a significantly higher rate than the general population.
The good news is that for many patients, hepatitis C can be cured, unlike other chronic diseases such as hepatitis B and HIV/AIDS.
Screening for hepatitis C is not currently part of routine testing. Many patients who think they have been tested have not. CDC recently released draft guidelines recommending that all baby boomers have a simple, one-time antibody test to screen for hepatitis C. According to a CDC-sponsored study, such age-based screening could identify more than 800,000 additional cases of chronic hepatitis C infection and, when followed by treatment, could reduce the number of deaths by an additional 121,000 over risk-based screening.
Around 216,000 people in the UK are chronically infected with hepatitis C.
A Health Protection Agency (HPA) annual report into the infectious disease revealed an increase in hospital admissions and deaths for End Stage Liver Disease (ESLD) and liver cancer - both of which are related to hepatitis C.
In 2010 there were 1,979 hospital admissions, compared with 612 in 1998, while deaths have risen from 98 in 1996 to 323 in 2010.
In 2011, 9,908 new diagnoses of hepatitis C were reported to the HPA in England, up from 7,892 cases in 2010, however the HPA said the rise is thought to be due to changes in laboratory reporting.
The report, Hepatitis C in the UK, looks at the future burden of hepatitis C-related infections and national progress in tackling the infection. It was produced to coincide with World Hepatitis Day on July 28.
Dr Helen Harris, a hepatitis expert at the HPA, said: "Many of the 216,000 people who are chronically infected with the virus are unaware of their infection. Therefore, it is vital that we continue to monitor the true burden of infection to help focus public health action on getting these people diagnosed and into treatment.
"Although our latest report shows that we are having a number of successes in our fight against hepatitis C, many people continue to become seriously ill from this preventable infection, which is usually treatable if caught early enough.
"We must therefore redouble our efforts and continue to develop new schemes to raise awareness in at-risk communities and ensure that individuals who may have been exposed to the virus are tested, diagnosed and treated early, before they become seriously ill."
Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV). The virus causes inflammation of the liver and, when left untreated, can result in chronic liver disease, liver failure, or death. Because the liver is able to work even when damaged, many people are unaware they have the disease at first because they have no symptoms. It is only when the liver becomes seriously damaged that symptoms occur and people report to their doctor.
Charles Gore, chief executive of The Hepatitis C Trust, said: "Hepatitis is closer than you think In the UK, a 'see no evil, hear no evil, speak no evil' attitude prevails and many people are needlessly dying. We simply must increase testing." Read more...
Bristol-Myers Squibb Foundation Marks World Hepatitis Day 2012 with New Grants Focused on Hepatitis B and Hepatitis C Patient Empowerment in China and India
Foundation's Delivering Hope(TM) program wins Asia's Best CSR Practices Award
NEW YORK, Jul 26, 2012 (BUSINESS WIRE) -- The Bristol-Myers Squibb Foundation
has awarded four new grants totaling US $1.69 million to improve prevention,
care and support of hepatitis B (HBV) and hepatitis C (HCV) in China and India
as part of its Delivering Hope(TM) program. The grants, announced to coincide
with World Hepatitis Day on July 28, support initiatives to empower hepatitis
patients to take an active role in disease management and advocacy. This focus
on patient empowerment recognizes the significant health disparities that exist
in these countries but also the progress that has been made to address them
through disease awareness efforts and education targeted to the health care
community.
Continue reading @Bristol-Myers Squibb
By: Barbara Morse Silva| NBC 10 Published: July 25, 2012ted:
July 25, 2012 - 5:45 PM
WHO-Prevent hepatitis C: Avoid unsafe injections , use of illicit drugs, tattoos, piercings, acupuncture performed with contaminated equipment
Hepatitis C is a contagious liver disease that results from infection with the hepatitis C virus. It can range in severity from a mild illness lasting a few weeks to a serious, lifelong illness.
The hepatitis C virus is usually spread when blood from an infected person enters the body of a susceptible person. It is among the most common viruses that infect the liver.
Every year, 3–4 million people are infected with the hepatitis C virus. About 150 million people are chronically infected and at risk of developing liver cirrhosis and/or liver cancer. More than 350 000 people die from hepatitis C-related liver diseases every year.
Two More Men with HIV now Virus-Free. Is This a Cure?
Two men unlucky enough to get both HIV and cancer have been seemingly cleared of the virus, raising hope that science may yet find a way to cure for the infection that causes AIDS, 30 years into the epidemic....
Study finds gaps in services for heterosexual men with HIV
July 27- Study finds heterosexual men feel existing HIV-related programs and services don't meet their needs and are geared primarily or exclusively toward gay men and heterosexual women who are living with the virus...
XIX International AIDS Conference
22-27 July 2012 Washington D.C., USA
Conference website
The entire AIDS 2012 programme is available online through the Programme-at-a-Glance (PAG). Links to abstracts, slide sets with audio, rapporteur reports and e-posters will be added as they are available.
Gilead HIV drug as good as Merck's Isentress: study
Gilead Sciences Inc said its elvitegravir, a component of the company's important four-drug Quad HIV treatment currently awaiting an approval decision, demonstrated similar efficacy and tolerability to Isentress in difficult-to-treat patients...Continue reading...
Stem Cells
The US district court in Washington DC, rules a controversial stem cell therapy offered at clinics should be regulated...
Ruling frees FDA to crack down on stem cell clinics
It's official: stem cells are drugs. At least, that's the opinion of the US district court in Washington DC, which has ruled that the Food and Drug Administration (FDA) has the authority to regulate clinics offering controversial stem cell therapies...
Treatments in which stem cells are harvested from bone marrow and injected straight back into the same patient are deemed part of routine medical practice - not regulated by the US government. But if the cells are subjected to more than "minimal manipulation", the FDA maintains that the therapy becomes a "drug", which must be specifically approved for use...
A U.S. Food and Drug Administration advisory panel recommended Roche Holding AG's Lucentis eye drug for treatment of diabetic macular edema, a leading cause of vision loss among working-age people.
The FDA advisory committee of outside experts on Thursday recommended both 0.3 milligram and 0.5 milligram doses of the drug after reviewing clinical research showing it clearly helps diabetic patients who suffer from the vision-robbing condition.
However, some panel members expressed concern about evidence linking higher doses of the drug to adverse events including death....Continue reading..
Healthy You
Coffee: The Original Wonder Drug?
Medscape Features A Slideshow On The Benifits Of Coffee, published July 24, 2012
The best part of waking up...is reducing your risk of neurodegeneration. And depression, and cancer, and cardiovascular disease... It's becoming increasingly clear that coffee is more than just a morning routine. The body of data suggesting that the world's most widely used stimulant is beneficial in a variety of mental and medical conditions is growing at a staggering rate. A recent study published in the New England Journal of Medicine found that coffee consumption lowered all-cause mortality by over 10% at 13-year follow-up.[1] Based primarily on recent Medscape Medical News coverage, the following slideshow reviews the potential medical and psychiatric benefits of coffee consumption.
Liver Disease
The liver might help break down coffee, but coffee might protect the liver (in some cases). Evidence suggests that coffee consumption slows disease progression in patients with alcoholic cirrhosis and hepatitis C and reduces the risk of developing hepatocellular carcinoma.[30-33]A 2012 study reported that coffee intake is associated with a lower risk for nonalcoholic fatty liver disease (NAFLD),[34] while other recent work found that coffee protects against liver fibrosis in those with already established NAFLD. Click here to view the slide presentation
Minority Women: Latinas' Cirrhosis and Liver Disease Rates High
July 26
In the United States, the most common causes of cirrhosis are drinking too much alcohol and hepatitis. Although Latinas have lower rates of alcohol use than other groups of women, they still have high rates of cirrhosis. This may be explained, in part, by nonalcoholic fatty liver disease (NAFLD), which is common in Latinos and can cause cirrhosis. NAFLD is a buildup of fat in the liver in people who drink little or no alcohol. Ethnicity may play a role in the tendency of Latinos to develop NALFD. This group also has high rates of obesity and diabetes, which are among the risk factors for NAFLD. Continue reading.....
Health Care Reform
How will the Affordable Care Act affect your health care?
In 2010, President Obama signed the Affordable Care Act (ACA) into law. Commonly known as health care reform, the ACA provides new insurance coverage for millions of uninsured Americans.
The ACA also puts strong patient protections into place and provides tools to help citizens understand their health care options. Many protections and reforms have already been put into place. Most of the large coverage expansions will take place in 2014.
The law is generally meant to ensure that many more Americans will be able to have secure and affordable health insurance. It will also mean that people will have clearer information about their insurance choices, and insurance companies will be held more accountable for delivering quality health care.
As soon as the ACA was signed into law, people who oppose it started to challenge the law in the courts and through media. One of the lawsuits made its way to the Supreme Court and in late June 2012, the Court delivered its decision.
The Supreme Court decision
The Supreme Court reviewed the ACA and upheld most parts of it. The part that requires all Americans to get health insurance (called individual mandate) was found to be constitutional. However, the court found that the penalty for not having insurance must be imposed as a tax.
Before the ACA was signed into law, insurance companies could deny coverage to someone on the basis of pre-existing conditions like HIV or hepatitis C and gender. They could also raise premiums based on age and where someone lives. Now, because the individual mandate was upheld, these types of insurance discrimination are no longer in danger of being stripped from the law.
The Supreme Court also upheld the Medicaid expansion part of the ACA. This will provide federal funding to help states expand their Medicaid programs to serve all adults under 138% of the federal poverty level (FPL), or about $15,000 per year for one person.
However, the Supreme Court did not uphold the part that says Congress could withhold funding if states refuse to expand their Medicaid programs. Although it doesn’t make sense for a state to refuse these large amounts of funding (100% in the first three years), unfortunately several governors have already said they will not expand their Medicaid programs.
The problem with this is that about half of all people who would get new coverage under health care reform (including people with HIV) will rely on Medicaid. If a state refuses this federal funding, its low-income individuals would continue to be unable to access health insurance coverage, which is exactly what health care reform is trying to address.
The Supreme Court decision and people with HIV
The decision to uphold the individual mandate is a victory for people living with HIV and others who have been shut out of the health insurance market. The ban on insurance discrimination against adults with pre-existing conditions will begin in 2014. This means that people living with HIV and/or hepatitis C will be able to get affordable, quality health care and specialized treatment.
As for Medicaid, the good news is that many states will expand their programs, allowing people with HIV to get Medicaid coverage sooner. (Currently, most people have to become disabled to use it.) The bad news is that people with HIV who live in states that don’t expand their Medicaid will continue to be unable to afford health insurance and forced to rely on insufficient health care services. Estimates indicate that 50–70% of uninsured people with HIV will depend on Medicaid expansion and will continue to get suboptimal or no health care without those services.
Currently, only about half of Americans with HIV regularly see their doctors and only 1 out of 4 are taking HIV medications. Medicaid expansion would allow low-income people with HIV to find the quality health coverage they need in order to ensure continuous care. Research shows that early access to treatment gives people the opportunity to stay healthier and reduce the likelihood of transmitting HIV to others.
What to expect as we move towards 2014
Learning about these changes in health care programs may seem overwhelming to you. And rightly so. Changes will differ quite a bit state by state, and much of how your health care will look is being decided at the state level. Health care providers, advocacy organizations, and even state and local governments are all struggling to prepare for these transitions in HIV care.
We are all in this learning process together. We can assume that there will be hiccups along the way. Below are links to two different timelines of the changes that we can expect. It will also be important to check at your state level for the timeline in your own state.
Although these changes can be difficult to understand, the ACA will solve many issues that people living with HIV currently face. People with incomes above 138% FPL (about $15,000 per year) who have had problems getting insurance will be able to purchase it through a new market place called an Exchange.
The Exchange will be a place where people can compare plans and choose the one that is best for them. If an individual’s income is below 400% FPL (about $44,500 per year), they will receive financial help from the federal government to buy their insurance.
People with incomes below 138% FPL will be eligible for Medicaid. For the first time everyone will be eligible regardless of disability status. Also people will be allowed to have a savings account of any amount and still qualify. As of now, it is unclear what will happen if there are states that do not choose to expand their programs.
It is very important to note that health care reform does nothing to help people with HIV who are undocumented. It does not end the five-year Medicaid waiting period for most new immigrants. However, new immigrants will be able to purchase insurance coverage in the Exchanges. We will all have to continue advocating for quality care for immigrants living with HIV in the US.
We don’t expect these transitions to occur without any problems. And we all have a lot of work to do to ensure that implementation of the ACA meets the needs of people with HIV. Despite these expected challenges, health care for people with HIV will be strengthened after full implementation of health care reform.
How can I begin to prepare for changes?
Here is a list of things you can do to start to prepare for changes over the next couple of years:
Begin to educate yourself about where you currently get your health care coverage.
Find out if you will experience any changes in coverage; many will not but many others will.
Begin to educate yourself about the insurance coverage you think you will gain. People with HIV have been historically shut out of health care coverage and have much to learn about these new systems.
Stay involved with the implementation of health care reform by joining www.hivhealthreform.org and the monthly webinars offered there.
Begin to find out if there is anyone planning for changes for people with HIV at your local or state level. Check your local HIV planning council or contact local, regional or state HIV agencies.
Keep talking to your provider, clinic and/or doctor about their plans for health care reform.
Stay involved in what is going on. If you come across an unfavorable change in your care or notice something that could use improvement, contact organizations or officials to make your voice heard.
The former legal high mephedrone, also known as meow meow, is as ‘addictive as cocaine’ reported the Mail. The effects of the drug, which the paper says has been blamed for a series of ‘cannibal attacks’ have recently been studied in mice…Continue reading..
Posted: 05/21/2012
Last Updated: 1 hour and 5 minutes ago
• By: Brendan Keefe, bkeefe@wcpo.com
FLORENCE, Ky. - This story ends with a grandmother walking into a gas station to buy illegal drugs.
But it begins with her grandson overdosing on a synthetic drug that was legal at the time.
Chris Allen had purchased a tiny silver envelope at a corner store in Florence. It contained a substance known as synthetic marijuana, but the reaction he had was more like an overdose of PCP or LSD.
The 19-year-old spent the next three months in a mental hospital.
"He acted like he was talking to people who weren't there," said James Ruehl, the Independence police officer who responded to Chris's overdose. "You see guys having to be taken to the hospital on the first time use, off of one joint."
Calls to poison control centers about reactions to synthetic marijuana doubled last year to more than 7,000.
Part of the problem for police is that in many cities and states, these potent drugs are still considered legal.
Not only are they powerless to confiscate synthetic drugs from teens and other users, police can't stop stores from selling it openly.
"When it can be bought on any street corner, it makes it difficult," Officer Ruehl said.
The drugs were initially created by scientists in a laboratory for legitimate research, but overseas chemists were able to make copies for recreational use.
Now those synthetic drugs enter the United States as a white powder that is eventually liquefied and sprayed onto a natural herb called demania. Packages sold as incense or bath salts are labeled "not for human consumption," but the products are smoked or inhaled like marijuana.
US Customs finds shipments of synthetic drugs at the DHL facility in Erlanger nearly every night. Officers are intercepting the powder at the rate of half a ton per year at CVG.
"Very potent, very harmful," is the way Customs Officer Geoffrey DeWitt described a kilo of synthetic drugs he bagged into evidence. "And in the wrong hands, it could kill people."
The importation of synthetic drugs was first discovered by a Cincinnati-based U.S. Customs agriculture inspector, Stephen Bishop. No one had seen the material before, and Bishop decided to send it to the Customs lab in Chicago for analysis.
That's when chemists realized overseas labs were poisoning America's children.
The Drug Enforcement Administration took emergency action last year, classifying several synthetic drugs as Schedule I controlled substances. The formulations go by names like JWH-210 and AM-2210.
Ohio followed with its own ban, listing each of the compounds by name, making them illegal in the state. Kentucky had a similar law.
But the foreign chemists simply changed a single molecule in each formula, bypassing all the bans. The flow of drugs -- and the legal sale of them at stores and online -- resumed with little pause.
"We hadn't seen this before," said Dr. William Wagner, a top chemist at the Customs lab in Chicago, as he looked at the latest version of a synthetic drug on his instruments.
Designers had replaced an ordinary carbon molecule in a banned formula with an exotic tetramethylcyclopropane ring.
The change made the drug legal, in part because no one had ever seen it before. But it also made it more dangerous.
"We call them designer drugs," said Dr. Wagner, "because they're designed specifically in the chem lab to skirt the law."
The shiny foil packets have colorful graphics and sell under several brand names like K2, Spice, Mad Hatter, and Dead Man Walking. We found a 3-gram packet selling for $20 under the counter at a Florence gas station.
"These gas stations are making a profit at the cost of our children," said Chris Allen's grandmother, Patricia. "We've got to stop this stuff."
Patricia helped raise her grandson who suffered brain damage after smoking synthetic marijuana, and now she's on a mission to get an "umbrella ban" on all synthetic drugs in Florence and elsewhere.
She has gone door-to-door handing out flyers to warn other parents and grandparents, many of whom had never heard of K2 or Spice.
Then Patricia took her case to directly to the Florence City Council.
"Some of them have the effect of an old drug called LSD," Patricia said as council members and Florence's mayor paid full attention.
The police chief in Florence, Tom Szurlinski, echoed Patricia's concerns, reporting to council, "the minute our legislature would outlaw one of those chemical compounds, some chemist would come in and change one little piece, and that now is not illegal."
Chief Szurlinski then surprised Patricia Allen with the news that Kentucky Governor Steve Beshear had just signed emergency legislation banning all synthetic drugs in the commonwealth, not just a list of specific compounds.
"Any synthetic is now illegal to possess or sell," Chief Szurlinski said. "So I think what the legislature's done is exactly what Mrs. Allen is looking for."
Patricia seemed satisfied, but this grandmother wanted to see for herself.
She thanked the council, then got in her car and drove to a Florence gas station less than a mile and a half from the council chambers.
While the police chief and council members discussed development issues on the other side of I-71/I-75, Patricia emerged from the store with a 3-gram vial containing an herb labeled "incense" and "not for human consumption."
Patricia described the transaction, "I went in and I said 'do you have any Spice?' and he said 'yeah,' and I said 'you got more than this?' and he said 'sure, I've got a whole counter full.' "
Patricia called the police, and officers informed her she could be arrested for possession under the new law. She returned the vial and asked for her money back, but not before showing the clerk a copy of the actual Kentucky House bill -- now law -- banning the sale of synthetic marijuana.
"It's against the law to sell the product that you just sold me," Patricia told the clerk. He replied, "it's against the law?"
Florence police couldn't arrest the clerk if they wanted to -- not just because they weren't there to witness the sale -- but because the new law does not apply to store employees who are unaware the products they're selling are banned.
Chief Szurlinski's officers are now going store to store to let clerks know about the new ban, and the chief promises swift enforcement in the coming weeks.
Part of the problem is the labels don't say what's inside, so it's possible even this latest ban in Kentucky may be unenforceable at times. Right now there are evidence samples on the shelf of the Kentucky Crime Lab still waiting to be tested after several months. Meanwhile, the chemists have already moved on to new formulas.
Patricia said that's the real problem.
"One of the things that makes them so dangerous is that we don't know what's in them," she concluded.
Copyright 2012 Scripps Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
It was the best of times, it was the worst of times. I remember fondly those days of my youth, waiting in the rain for concert tickets to Crosby, Stills, Nash & Young, Santana and Jethro Tull.
I hitchhiked everywhere, with my headband in place, and tie dyed shirt hanging over my bell-bottoms hoping to cop a ride.
At the tender age of sixteen I moved out of my parents home, into in a one bedroom apartment with six girlfriends, eating hot pizza for dinner, and scarfing down the leftovers for breakfast.
My parents had no idea the danger I was putting myself in, either did I.
The Drugs
Yes, I am a baby boomer, like most people from this generation I found that in my youth drugs were readily available. I had no idea that a one-time experiment with IV drugs some twenty years earlier would expose me to such a devastating health risk in the future.
For me, a good Catholic girl-most days, I somehow knew judgment day would one day come. I often asked myself how I escaped the consequences of my youth, I didn't because in 1999 I was diagnosed with hepatitis C.
Busted.
According to Dr. John Ward, hepatitis chief at the Centers for Disease Control and Prevention, one out of every 33 baby boomers are infected with hepatitis C.
Baby Boomers At Risk
Born Between 1945 and 1965
Shared needles or other drug-injection equipment.
Received a blood transfusion, blood product or organ before 1992.
Received a blood clotting product before 1987.
Baby boomers are at risk for contracting the virus through blood transfusions during the 1970s and 1980s. Effective bloodscreening for the virus wasn't developed until a first generation ELISA test was introduced in 1990. Between 1990 and 1992, there were some cases of hepatitis C transmitted through the blood supply as this screening test was not sufficiently sensitive to catch all infected blood. By 1992, a second generation HCV antibody test was introduced which significantly reduced the risk of HCV transmission via the blood supply. Patients who have had a blood transfusion prior to 1992 should be tested for HCV.
The Parents
Twenty or thirty years ago my parents, like the the majority of parents, were oblivious to the magnitude of accessibility our generation had to drugs. I was trusted.
Today parents are not that native, the days of Ward and June Cleaver are long gone. With 24 hour cable news and access to the Internet parents know the score. Awareness for HIV, hepatitis B and C has slowly made its way into the family home. However, this loud and clear warning of chronic blood borne infections often goes unheard by our youth, just as it did generations earlier.
I have paid dearly for my small moment in time. The upside of my experience? Baby boomers make the best parents, we know how to be an effective " nark ".
The kids that are using right now are not aspiring drug addicts. Frankly, neither were we. These kids start out by experimenting, getting caught up with the feeling they get from the first injection which turns into two, then three, and ends with addiction. As parents it's up to us to stop this downward trend, before history repeats itself. Or has it already?
Hepatitis C Infection Continues In Our Children
Fast forward to March 2012, according to an article published a few days ago-
"The incidence of hepatitis C infection is increasing among adolescents and young adults in Pennsylvania, just as it has in other areas in the United States, according to surveillance data for 2003 through 2010."
During that 7-year period, the number of reports of newly recognized confirmed or probable cases of hepatitis C past or present infection among those aged 15-34 years increased from 1,384 to 2,393, representing a near doubling of the rate of cases (from 43 to 72) per 100,000 population, Dr. Sameh W. Boktor reported in a poster at the International Conference on Emerging Infectious Diseases.
Hepatitis C is nearly 10 times more transmissible by a shared needle than HIV. In the United States, every year 15,000 people are newly infected with hepatitis C through sharing syringes and contaminated injection equipment. Sharing this contaminated equipment can transmit the virus - the first time - or - only time - its used.
Hepatitis C is the most common chronic blood borne infection in the United States, with 35,000 to 185,000 new cases diagnosed per year. Recently the CDC reported that hepatitis C–associated deaths are now more common in the United States than HIV-related deaths.
Why heroin use is once again increasing
One drug of choice is/was Oxycontin, the drug has become known as “Oxy” or “Hillbilly Heroin” and "White Collar" heroin. IV-oxycontin users crush up the pill and inject a diluted Oxycontin mix. To
discourage misuse of the drug in 2010 the FDA demanded a new formulation of Oxycontin. The drug manufacturer Purdue Pharma L.P., changed the drug by making it difficult to crush and inject. The pill no longer dissolves in water, instead it becomes a thick goopy material.
In California the prescription pain medication is becoming one of the most abused and misused drugs. On the street the drug is expensive, the price ranges from 20 to 40 dollars a pill. In Ottawa, Canada Oxycontin is the third most common used drug among addicts. The top two drugs are cocaine, including crack cocaine and marijuana.
The difficulty of injecting Oxycontin has played a roll in the increase use of heroin. Oxycontin users can no longer inject the drug, and heroin isn't as potent when snorted, so IV use increases. In this 2011 video Dr.Todd S. Carran discusses the rise in heroin use in Ohio, reporting that for adolescents, heroin is as easy to buy as a pack of cigarettes. Reuters reported in 2011 that in Massachusetts hepatitis C infections are increasing in the white youth population, fueled by the increase use of heroin and other injection drugs.
New synthetic drugs
Today heroin is still easily accessible, along with a new list of dangerous drugs including bath salts, spice, salvia and a new synthetic drug known as "Jewelry Cleaner" which also is called, " Eight Ballz" and " Cosmic Blast". More on the drug here.
I am grateful that the biggest part of my job as a parent is complete. These new drugs, although often not injected have a whole new list of dangers. The only way a parent, loved one, or friend can recognize drug use or addiction, is to become knowledgeable about the drugs available on the streets.
So, we begin with an update below on the health dangers of bath salts. The video and article is from Virginia Commonwealth University. In a study from the University researchers found that "Bath salts can produce similar but stronger effects than off-the-street methamphetamine, cocaine or both."
A few months ago we read about a woman who injected the street drug under the skin causing a flesh-eating disease, read more here at Medscape. Also, over at Medscape is a slide-show to aid clinicians in identifying, and managing this "new face of abused drugs". When I watched the slide-show I thought to myself if clinicians need help, what about the parents. I sort of borrowed the photos, and text, adding them to the blog below.
Bath Salts Update: New Research, New Evolution
Eric Peters
VCU Communications and Public Relations petersem@vcu.edu
3/9/2012
In 2010, following legislation to halt a nationwide surge in the legal sale and use of synthetic marijuana, a new and far more dangerous group of legal designer drugs emerged.
The use of these new designer drugs, which are commonly referred to as bath salts and still available everywhere from the Internet to convenience stores and head shops, quickly rose to epidemic
The New York Times reported, “Some of the recent incidents include a man in Indiana who climbed a roadside flagpole and jumped into traffic, a man in Pennsylvania who broke into a monastery and stabbed a priest, and a woman in West Virginia who scratched herself ‘to pieces’ over several days because she thought there was something under her skin.”
The active ingredients in bath salts were identified soon after use began to spread, but studies involving the effects of those chemicals on the brain, especially in tandem with one another, were never extensively explored until now.
Researchers at Virginia Commonwealth University this month presented their findings from such a study, which reveals the neurological reasons bath salts can produce similar but stronger effects than off-the-street methamphetamine, cocaine or both.
While these designer drugs are labeled as bath salts, they are anything but, and were never intended to be used as such.
The two main active ingredients in bath salts are Methylenedioxypyrovalerone (MDPV) and mephedrone, and VCU researchers found that it is the combination of these two chemicals that contributes to many of the negative effects of bath salts.
“It’s like a double punch,” says Louis J. De Felice, Ph.D., one of the researchers on the VCU study. “It’s as if a person were to take methamphetamine and cocaine at the same time.”
The mephedrone acts like methamphetamine by releasing dopamine into the brain while the MDPV acts like cocaine by preventing dopamine from being absorbed back into the brain.
“So that means the dopamine is out there, but unlike in a natural situation, it’s not able to be taken back up again,” explains De Felice.
Additionally, De Felice and colleagues discovered that the excess dopamine is likely to remain, along with the stimulating effects, long after the chemicals were removed.
The researchers at VCU only studied these long-lasting stimulating effects up to 30 minutes after removal of the chemicals, but have additional research planned that might help identify this phenomenon as the reason behind bath salts’ lingering psychotic and physical effects that sometimes last for days or weeks.
It was because of these negative effects that many bath salt variations had been outlawed throughout much of the U.S. by early 2011, but they remained easy to acquire through the Internet. According to the American Association of Poison Control Centers, there were more than 6,000 calls to poison control centers pertaining to bath salts in 2011, more than10 times the number in 2010.
Another problem, says Rutherfoord Rose, Pharm.D., director of VCU’s Virginia Poison Center, is that as soon as one ingredient or designer drug is outlawed, another takes its place.
“Substances like 2ce, 2ci and 25i have become the newest thing since bath salts were outlawed in most states,” he says. “They appear to have similar effects to the ingredients in bath salts, but in some cases we’ve seen the effect to be even more severe, producing refractory seizures, convulsions and bleeding in the brain.”
Rose says when it comes to new drugs like these, as the case once was with bath salts, his center relies on verbal reports from friends and users to identify what has been ingested because labs simply can’t test for new and emerging drugs that haven’t yet been identified and studied.
So the fight continues and researchers such as De Felice and his colleagues push forward, studying, identifying and working as quickly as possible to publish research that sheds light on how and why these chemicals are so dangerous.
Drug abuse remains a major public health problem worldwide as people continue to use or abuse "old drugs" such as alcohol, marijuana, cocaine, and opioids. Making the news lately, however, are novel substances that have attracted potential users with promises of "legal" highs and easy access via the Internet.
Clinicians need to be aware of the emerging trends in alcohol and other drug abuse, especially if they are not up to date on the new recreational drugs on the scene in their own communities.
How can clinicians identify and manage the "new face of abused drugs"? This slideshow provides healthcare providers with an at-a-glance introduction to the clinical challenges posed by patients using and abusing novel substances.
Images courtesy of WikiCommons and Getty Images/Thinkstock
Bath Salts – MDPV, Mephedrone (Rosenbaum CD, et al.[1])
What Are They? "Bath salts" may appear to be white powder or crystals to add to bath water, but the term actually refers to amphetamines and cathinones (synthetic derivatives of the stimulant found in the khat plant) that are sold in clandestine packaging to avoid detection by law enforcement. MDPV and mephedrone often are the active compounds, with effects similar to those of ecstasy (MDMA).
Street slang terms and product names include - drone, bubbles, meow-meow, MCAT, Ivory Wave, Vanilla Sky, Cloud 9, Red Dove, and White Rush.
Who Is Most at Risk?
Use is most prevalent among teens and young adults who wish to avoid drug detection while enjoying what used to be a "legal high." Before the US Drug Enforcement Administration acted to make bath salts illegal in September 2011, these substances were sold at gas stations, head shops (retail drug paraphernalia outlets), and record stores. Users still can purchase the products online.
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Bath Salts – cont (Rosenbaum CD, et al.[1])
Clinical Presentation
Sympathomimetic effects (eg, elevated pulse and blood pressure; diaphoresis; agitation; and, with long-term use, psychotic features) may predominate.
Drug Screen Availability
Cathinones will not appear on standard immunoassays for drugs of abuse (DOA). Amphetamines may be detected with DOA immunoassay, and both substances are detectable with gas chromatography–mass spectrometry (GC-MS) analysis.
Patient Management Summary
Management includes supportive care. Benzodiazepines are useful for agitation and psychosis. Patients who have used amphetamines such as MDMA may present with serotonergic symptoms requiring supportive care or treatment with benzodiazepines or cyproheptadine. Patients with severe agitation and vital sign abnormalities may require intensive monitoring and care.
Herbal Marijuana Alternatives and Synthetic Cannabinoids
(Rosenbaum CD, et al.[1])
What Are They?
These "incense" products contain herbal plant matter adulterated with synthetic cannabinoids and are usually smoked. Baybean, beach bean, blue lotus, lion's ear/tail, wild dagga, Indian warrior, and dwarf skullcap are examples of the herbal ingredients. Synthetic cannabinoids include JWH-018/073/200, CP-47,497, and RCS-4. Spice, K2, Chill Zone, Sensation, Chaos, Aztec Thunder, Red Merkury, and Zen are some of the common brand names.
Who Is Most at Risk? Users typically range in age from 14 to 50 years. Although 5 synthetic cannabinoids are now illegal in the United States,[2] these products are still widely available in gas stations and head shops and via the Internet, owing to reformulations to skirt the federal ban. Military personnel and others who must undergo regular drug testing (eg, for marijuana) know that these "legal highs" may be undetectable.
Herbal Marijuana Alternatives and Synthetic Cannabinoids – cont (Rosenbaum CD, et al.[1])
Clinical Presentation
Clinical effects include hypertension, tachycardia, nausea, vomiting, agitation, anxiety, paranoia, seizures, and suicidal ideation.
Drug Screen Availability
Synthetic cannabinoids are undetectable using standard DOA immunoassays directed at tetrahydrocannabinol, the active ingredient in cannabis. Analysis with GC-MS can identify specific synthetic cannabinoids in a patient's urine, but only under highly restrictive circumstances.
Patient Management Summary
Management includes supportive care. Symptoms are typically short-lived (< 24 hours), but some cases have required bilevel positive airway pressure and admission to the intensive care unit for respiratory distress (Rosenbaum CD. Unpublished data).
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Salvia divinorum (Rosenbaum CD, et al.[1])
What Is It? Salvia divinorum, a hallucinogenic herb belonging to the mint family, contains the hallucinogen salvinorin A. Traditionally, the Mazatec Indians of Oaxaca, Mexico, chewed or brewed Salvia divinorum as tea to facilitate spiritual encounters; it is now being used recreationally worldwide. Salvinorin A is inactive after ingestion; as a result, users seeking a high must chew or smoke the leaves.[3]
Who Is Most at Risk?
Young adults, adolescents, and anyone with access to the Internet who is interested in avoiding drug detection via this "legal high" (in some states) are considered at most risk.
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Salvia divinorum – cont (Rosenbaum CD, et al.[1])
Clinical Presentation
Users report potent open- and closed-eye hallucinogenic effects. Unlike other hallucinogens, salvinorin A does not have serotonergic activity. Instead, its affinity for the kappa opioid receptor may cause sedation, analgesia, gastrointestinal hypomotility, aversion, and depression.
Drug Screen Availability
Salvinorin A is not detected by standard DOA immunoassays. Salvinorin A can be detected in urine and saliva using GC-MS analysis.
Patient Management Summary
Management includes supportive care. Because salvinorin A acts solely at kappa opioid receptors, in theory it should not cause respiratory depression, although respiratory monitoring is prudent.
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Khat (Cathinone) (Rosenbaum CD, et al.[1])
What Is It? Khat (Catha edulis) is a plant whose leaves and twigs are chewed for their reported amphetamine and euphoric effects. Common in Yemen, Somalia, and Ethiopia, khat abuse has now spread beyond its geographic and historic roots as a result of online information and sales. Cathinone is the main active ingredient.
Who Is Most at Risk?
Anyone with access to the Internet may obtain khat. In 2006, 10 million people were estimated to have used the drug.
Clinical Presentation
Amphetamine-like effects produce agitation, tachycardia, hypertension, and psychosis.
Drug Screen Availability
Cathinone cannot be detected by DOA immunoassay. However, GC-MS analysis can detect cathinone and synthetic cathinone derivatives.
Patient Management Summary
Management includes supportive care, benzodiazepines, and sympatholytics.
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Insufflation of Oral Medications
What Is the Emerging Issue?
Crushing and insufflating ("snorting") an oral medication allows immediate bioavailability of far larger doses of the drug than would be available from ingesting an intact tablet. Some newer, so-called "abuse-resistant" formulations can be crushed but with difficulty.
Who Is Most at Risk?
Populations at greatest risk include young people experimenting with drugs and long-term or habitual drug users who have developed a tolerance to their typical oral medication.
Clinical Presentation
Nasopharyngeal necrosis (destruction of the nasal septum, soft or hard palate, and other facial structures) has been reported from insufflation of opioid analgesics as well as other drugs.[4-6]
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Insufflation of Oral Medications (cont)
Drug Screen Availability
Detection depends on the drug used. Opioids (eg, hydrocodone, oxycodone, oxymorphone, hydromorphone, propoxyphene, and tramadol) cannot be detected by DOA immunoassays. Methylphenidate is also uncommonly detected by DOA immunoassays. GC-MS analysis and opioid-specific immunoassays are commercially available to detect opioids but often require special ordering and testing.
Patient Management Summary
Management of drug effects should be directed at the specific xenobiotic involved. Opioid intoxication may be managed with naloxone, whereas intoxication with stimulants, such as methylphenidate, may require benzodiazepines.
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Energy Drinks
What Are They? Energy drinks are flavored, typically sugar-sweetened beverages that manufacturers claim enhance energy and performance. These drinks contain as much as 360 mg/L of caffeine (roughly the equivalent of 3-4 cups of coffee), along with other ingredients that act as stimulants (eg, guarana, taurine, ginseng, and L-carnitine).
Who Is Most at Risk?
Populations most at risk are young people and others seeking to stay awake for personal, school-, or job-related reasons.
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Energy Drinks (cont)
Clinical Presentation
Caffeine (1,3,7-trimethylxanthine) is a structural analog of adenosine and a functional adenosine receptor antagonist. Presynaptic alpha-1 antagonism causes catecholamine release and adrenergic surge. Symptoms of caffeine intoxication can range from mild nausea and palpitations to severe, protracted vomiting; cardiac dysrhythmias; and seizures.[7,8]
Drug Screen Availability
Caffeine may be detected by specific testing with GC-MS analysis; it is not detected by DOA immunoassay.
Patient Management Summary
Supportive care should include intravenous fluid resuscitation, antiemetics, and sympatholytics.
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Methoxetamine (Rosenbaum CD, et al.[1])
What Is It?
Methoxetamine (MXE) is an analog of ketamine ("special K"). Both drugs share structural similarity with phencyclidine (PCP).
Who Is Most at Risk?
Methoxetamine use is popular in the United Kingdom but has the potential for wider use via Internet sales. Little is known about the users or specific patterns of abuse, other than that the drug can be injected intravenously.[9,10]
Clinical Presentation
The clinical experience with methoxetamine is limited to self-report and advertising. Users reported abusing the drug for its euphoric and hallucinogenic effects but may experience opioid effects such as respiratory depression, vomiting, diarrhea, anxiety, and paranoia. Classically associated with ketamine, nystagmus may be observed. One case report describes a 19-year-old who injected methoxetamine intravenously and later presented with semistuporous mental status, agitation, ataxia, hypertension, and tachycardia.[10]
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Methoxetamine – cont (Rosenbaum CD, et al.[1])
Drug Screen Availability
Methoxetamine may not be detectable via GC-MS analysis. The DOA immunoassay directed at PCP detection also may not identify methoxetamine.
Patient Management Summary
No specific management of methoxetamine intoxication has been described at this time. However, similar management to that for ketamine, PCP, or opioid intoxication should be used. Suggested strategies may include supportive care, intravenous fluid resuscitation, benzodiazepines for agitation, and respiratory support.
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Piperazine Derivative (Rosenbaum CD, et al.[1])
What Is It?
Piperazine was initially designed as an antihelminthic but was discovered to have stimulant properties. Many different piperazines exist (eg, BZP, CPP, MBZP, MeBP, MeOPP, MeP, and TFMPP). They are often sold as pills or powders containing a mixture of multiple drugs.
Who Is Most at Risk?
Young adults, especially those involved in club culture, may be most attracted to this designer "party pill," or "legal ecstasy" as it is sometimes known on the street.[11] Piperazine abuse has been extensively identified in Europe and New Zealand.[12,13] Young males, typically in their twenties (age range 13-44 years), use piperazines for their amphetamine or stimulant-like effects, especially when attending dance clubs and possibly as a means to avoid withdrawal from amphetamines.[13,14] Given the availability of these drugs on the Internet, their popularity will likely spread to the United States to demographics beyond just the "club scene."
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Piperazine Derivative – cont (Rosenbaum CD, et al.[1]) Clinical Presentation
Sympathomimetic and serotonergic effects may predominate owing to the ability of piperazine to impair serotonin reuptake and directly stimulate serotonin receptors.
Drug Screen Availability
Piperazines are not detectable by typical immunoassay testing, but they may be detectable via GC-MS or liquid chromatography-MS analysis.
Patient Management Summary
Benzodiazepines for agitation and intravenous fluid resuscitation should form the foundation of supportive care, directed in a manner similar to that for other sympathomimetics.[11] If serotonergic effects are observed, supportive care and possibly antiserotonergic medications, such as cyproheptadine, may be indicated.
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Author
Christopher D. Rosenbaum, MD, Assistant Professor, University of Massachusetts Medical School; Attending Physician, Department of Emergency Medicine, Division of Medical Toxicology, University of Massachusetts Medical Center, Worcester, Massachusetts
Christopher D. Rosenbaum, MD, has disclosed the following relevant financial relationships:
Received income in an amount equal to or greater than $250 from: UpToDate
Reviewer
Edward W. Boyer, MD, PhD, Professor of Emergency Medicine, Director of Toxicology and the Toxicology Fellowship, Department of Emergency Medicine, Division of Medical Toxicology, University of Massachusetts Medical Center, Worcester, Massachusetts
Edward W. Boyer, MD, PhD, has disclosed no relevant financial relationships
