Hepatitis C Drug Sofosbuvir Still Effective at 24 Weeks.


New data from 4 phase 3 trials with the hepatitis C (HCV) drug sofosbuvir (SOF) and ribavirin (RBV) show that a 12-week regimen is effective in treating HCV genotypes 1 through 6. Twenty-four-week sustained virologic response (SVR) is essentially identical to 12-week SVR, bolstering confidence that the drug combination represents a cure. Those with genotype 3 infections are better served with a 16-week course of treatment.

The new work extends the results of the studies out to 24 weeks after treatment cessation. Twenty-four weeks was the traditional milestone for HCV treatments, but in recent years, the US Food and Drug Administration and industry have gravitated toward the 12-week time point. However, with new drugs set to greatly affect HCV treatment, it is important to consider this older benchmark, according to Kris Kowdley, MD, director of the Liver Center of Excellence at the Digestive Disease Institute at the Virginia Mason Medical Center in Seattle, Washington, who presented the research here at the American College of Gastroenterology (ACG) 2013 Annual Scientific Meeting and Postgraduate Course.

“We’re in a brave new world of hepatitis C treatments, and we’re very quickly reaching all oral, interferon-free, short-duration regimens, so I think it remains valuable to continue following patients to 24 weeks, and possibly 48 weeks, posttreatment to see if the assumption [of a cure] really holds up. We can also learn more about late relapses and possible questions about resistance,” Dr. Kowdley told Medscape Medical News.

The research drew from 4 phase 3 studies: Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection (NEUTRINO), which enrolled treatment-naive patients with genotype (GT) 1, 4, 5, and 6 infection, each of whom received 12 weeks of SOF, peg-interferon (PEG), and ribavirin (RBV); Phase 3 Study of Sofosbuvir and Ribavirin (FISSION), which enrolled treatment-naive GT 2/3 patients to receive either 12 weeks of SOF+RBV or 24 weeks of PEG+RBV; GS-7977 + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 HCV Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon (POSITRON), which enrolled GT 2/3 patients unable or unwilling to receive interferon, who were randomly assigned to receive 12 weeks of SOF+RBV or placebo; and Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION), which enrolled treatment-experienced GT2/3 patients who received 12 or 16 weeks of SOF+RBV.

For all studies, the primary end point was sustained virologic response (HCV RNA < 25 IU/mL) at 12 weeks posttreatment (SVR12).

In the studies, participants had a mean age of 53 years (range, 19 – 77 years) and a mean body mass index of 28 kg/m2 (range, 17 – 56 kg/m2). Demographics were consistent with those of the HCV-infected population in the United States. Six percent of the participants were receiving opioid replacement therapy.

Table 1. 12-Week SVR Rates

GT 1,4,5,6 GT 2 and 3
NEUTRINO FISSION POSITRON FUSION
SOF/PEG/RBV (n = 327) SOF/RBV (n = 253) PEG/RBV (n = 243) SOF/RBV (n = 207) Placebo (n = 71) SOF/RBV 12 week (n = 100) SOF/RBV 16 week (n = 95)
Overall 91% 67% 67% 78% 0% 50% 73%
GT 2 N/A 97% 78% 93% 0% 86% 94%
GT 3 N/A 56% 63% 61% 0% 30% 62%
Noncirrhotic 93% 72% 74% 81% 0% 61% 76%
Cirrhotic 80% 47% 38% 61% 0% 31% 66%

Compensated cirrhosis at baseline was found in 17% of patients in the NEUTRINO study, 21% in FISSION, 18% in POSITRON, and 33% in FUSION.

In all studies, SVR12 was higher in patients without cirrhosis. Patients with GT 2 experienced higher SVR12 rates than those with GT 3.

SVR 24 rates were similar to SVR 12 rates.

Table 2. SVR12 vs SVR24

SVR12 SVR24
Treatment-naïve patients
GT 1, 4, 5, 6 overall 91% 91%
GT 1 90% 90%
GT 4 96% 96%
GT 5 and GT 6 100% 100%
Treatment-naive and experienced GT 2, 3 patients
Treatment-naive 67% 67%
Interferon unable 78% 78%
Previously treated (12 week regimen) 51% 50%
Previously treated (16 week regimen) 73% 72%

The additional data back up the 12-week SVR. “In all the studies, the 24-week results are almost identical [to the 12-week SVR]. We detected durability of that response,” said Dr. Kowdley. The studies also suggest that interferon is not needed to achieve SVR in genotypes 2 and 3, although Dr. Kowdley said that trials of interferon-sparing regimens are underway.

The results further underscore the anticipation that physicians have toward sofosbuvir and other new drugs. “I think 2 years ago there was a standing-room only meeting in San Francisco, where Pharmasset (which originally developed sofosbuvir), dropped just unbelievable results, and we all thought this was too good to be true,” Tim Little, MD, a physician with Puget Sound Gastroenterology in Seattle, Washington, who attended the presentation, told Medscape Medical News.

“I don’t know that there’s anything incredibly new about (this study), but it’s confirmation that this dramatic result that this very small group of investigators presented is actually real, and I think we can all understand that this is as good as they said it was going to be, or almost as good,” Dr. Little said.

On October 25, an FDA advisory committee unanimously recommended approval of sofosbuvir based on the 12-week results. The FDA is expected to make a decision by December 8.

Source: American College of Gastroenterology (ACG)

Choosing Wisely: ACEP Lists 5 Tests to Question


The American College of Emergency Physicians (ACEP) issued a list of 5 tests and procedures that may not be cost-effective in some situations. The ACEP announced this list, which reflects its participation in the ABIM Foundation‘s Choosing Wisely campaign, at the opening session of their annual meeting in Seattle, Washington.

To lower healthcare costs and improve patient care, ACEP recommends that clinicians avoid these interventions when appropriate, after discussing that decision with patients and educating them regarding the rationale.

“ACEP needed a strategy to determine what emergency physicians could do to improve efficiency and reduce cost without affecting the quality of care we deliver,” ACEP Cost Effectiveness Task Force Chair David Ross, MD, an emergency physician in Colorado and medical director for more than 50 emergency medical services agencies in Colorado Springs, said in a news release. “The challenge also was to identify real cost savings, but also to develop consensus among emergency physicians.”

The ACEP board of directors approved the following 5 Choosing Wisely recommendations for patients seen in the emergency department:

1.      For patients with minor head injury who are deemed to be at low risk for skull fractures or hemorrhage, based on validated decision rules, clinicians should avoid head computed tomography scans. The majority of minor head injuries do not result in brain hemorrhage.

2.      For stable patients who can urinate on their own, clinicians should avoid placing indwelling urinary catheters for either urine output monitoring or patient or staff convenience.

3.      For patients likely to benefit from palliative and hospice care services, clinicians should not delay in engaging such services when available. Early referral from the emergency department can improve quality, as well as quantity, of life.

4.      For patients with uncomplicated skin and soft tissue abscesses successfully treated with incision and drainage, clinicians should provide adequate medical follow-up but avoid antibiotics and wound cultures.

5.      For children with mild to moderate, uncomplicated dehydration, clinicians should avoid giving intravenous fluids before a trial of oral rehydration therapy.

“Emergency physicians are dedicated to improving emergency care and to reducing health care costs,” ACEP President Alex Rosenau, DO, said in a news release. “These recommendations are evidence-based and developed with significant input from experts.”

An expert panel of emergency physicians and the ACEP board of directors reviewed pertinent research and input, including a survey of all ACEP members, before developing the recommendations.

In its Choosing Wisely campaign, the ABIM Foundation aims to facilitate discussion among physicians and patients about appropriate use of tests and treatments and avoidance of these interventions when the harms may outweigh the benefits.

More than 80 national, regional, and state medical specialty societies and consumer groups have joined Choosing Wisely since the campaign began in April 2012, but ACEP held off until February 2013. The delay resulted from potential conflicts of the Choosing Wisely strategy with the unique goals of emergency medicine and from concerns that the campaign does not advocate for medical liability reform.

“Overuse of medical tests is a serious problem, and health care reform is incomplete without medical liability reform,” said Dr. Rosenau. “Millions of dollars in defensive medicine are driving up the costs of health care for everyone. We will continue to encourage the ABIM Foundation and its many partners in this campaign to lend their influential voices to the need for medical liability reform.”

Source: American College of Emergency Physicians.

Lung Cancer Signatures in Blood Samples May Aid in Early Detection.


Lung cancer is one of the most common and deadly types of cancer. Mouse models of lung cancer recapitulate many features of the human disease and have provided new insight about cancer development, progression and treatment. Now, a new study published by Cell Press in the September 13th issue of the journal Cancer Cell identifies protein signatures in mouse blood samples that reflect lung cancer biology in humans.

The research may lead to better monitoring of tumor progression as well as blood based early detection strategies for human lung cancer that could have a substantial impact on disease prognosis.

“In our study, we applied a comparative strategy of genetically engineered mouse models of cancer and integrated data at the genome and protein levels to uncover lung cancer signatures in blood samples that reflect different types of lung cancer, or that reflect signaling pathways driving tumor development,” says senior study author, Dr. Samir M. Hanash, from the Fred Hutchinson Cancer Research Center in Seattle. In order to identify blood protein signatures common to lung cancer, Dr. Hanash and colleagues looked at the proteins in the blood plasma of several different mouse lung tumor models and compared the proteins with those in models of other types of tumors.

The researchers identified individual protein signatures for molecularly distinct types of lung cancer and discovered that the networks of proteins provided insight into the genes that drive tumor development. Further, they identified proteins which were restricted to the blood samples from the lung cancer models and were not previously linked with lung cancer.

The authors went on to demonstrate the relevance of the protein signatures identified in the mouse models to human lung cancer. “We obtained evidence for concordant findings in human lung cancer cell lines and in plasmas collected from subjects with lung cancer at the time of diagnosis and in blood samples collected from asymptomatic subjects prior to diagnosis. These findings point to the power of integrating multiple types of studies and data to uncover lung cancer markers and may lead to early detection strategies for humans as well as strategies for monitoring tumor status in patients with the disease,” says Dr. Hanash.

Source: http://www.sciencedaily.com

 

Some Antihypertensives Linked to Breast Cancer Risk.


 The first observational study of long-term antihypertensive use and breast cancer risk has found that calcium-channel blockers are associated with a more than 2-fold increased risk and that angiotensin-converting-enzyme (ACE) inhibitors are associated with a reduced risk.

These findings come from a study published online August 5 inJAMA Internal Medicine.

Women who had taken calcium-channel blockers for 10 years or more had more than double the usual risk for invasive ductal breast carcinoma (IDC) (odds ratio [OR], 2.4) and for invasive lobular breast carcinoma (ILC) (OR, 2.6). The researchers also observed a possible association between the long-term use of ACE inhibitors and reduced risks for both IDC (OR, 0.7) and ILC (OR, 0.6), although the risk estimate for IDC was within the limits of chance.

No Changes in Clinical Practice Recommended Yet

“We don’t think this should change clinical practice in any way. It was the first study of long-term antihypertensive use. It was an observational study, not a clinical trial. We can suggest an association, but we cannot infer any causal relation at this point,” lead author Christopher Li, MD, PhD, from the Fred Hutchinson Cancer Research Center in Seattle, told Medscape Medical News.

Dr. Li and colleagues interviewed women 55 to 74 years of age from the Puget Sound region — 880 with IDC, 1027 with ILC, and 856 without cancer (control group). Participants were interviewed in person to establish detailed histories of hypertension and heart disease and risk factors for cancer, including family history, obesity, smoking, and alcohol use. The researchers gathered data on the use of antihypertensive drugs, including beginning and end dates of use, drug names, dose, route of administration, pattern of use, and indication.

The antihypertensives included ACE inhibitors, angiotensin-receptor blockers, beta blockers, calcium-channel blockers, diuretics, and combination antihypertensive preparations, regardless of indication.

Calcium-channel blockers are among the most frequently prescribed medications in the United States; they accounted for nearly 98 million of the more than 678 million prescriptions filled in 2010.

Subjects who had used antihypertensives for 6 months or longer and were still using them were classified as current users, subjects who had used them for 6 months but were no longer using them were classified as former users, and subjects who had used them for less than 6 months were classified as short-term users.

In the regression analyses, potential confounders included age, county of residence, other commonly used medications, comorbid conditions (cardiovascular disease, diabetes, hyperlipidemia, depression), alcohol use, and estrogen-receptor status.

Increased Risk After 10 Years

“In examining duration effects for current users, we found an increased risk only in relation to the use of calcium-channel blockers for 10 years or longer, and an increased risk was observed for both IDC (OR, 2.4; 95% confidence interval [CI], 1.2 – 4.9; P = .04 for trend) and ILC (OR, 2.6; 95% CI, 1.3 – 5.3; P = .01 for trend). This association with 10 years or longer of current calcium-channel blocker use did not vary appreciably when results were further stratified by estrogen-receptor status,” the researchers report.

Dr. Li told Medscape Medical News that they were surprised by the magnitude of the risk associated with calcium-channel blockers and by the decrease associated with ACE inhibitors.

“We expected that we might see some increase in breast cancer risk with calcium-channel blockers, but not a more than doubling of the risk,” Dr. Li said. “The suggestion of an association between ACE inhibitors and reduction in breast cancer risk was a very unexpected finding and is worthy of follow-up.”

The mechanism behind the apparent calcium-channel blocker effect is not known, Dr. Li explained, but some researchers suspect that these drugs might increase cancer risk by inhibiting apoptosis.

“First-Rate Study,” But Confirmation Needed

“The data are persuasive because this was a first-rate study: it was population-based, large (1900 case patients and 856 controls), identified cases from the Seattle-area SEER surveillance system, had a high (80%) case response rate, and used best practices in ascertaining medication use from study participants,” Patricia F. Coogan, ScD, from the Slone Epidemiology Center at Boston University, writes in a related commentary.

“Given these results, should the use of calcium-channel blockers be discontinued once a patient has taken them for 9.9 years? The answer is no, because these data are from an observational study, which cannot prove causality and by itself cannot make a case for change in clinical practice,” Dr. Coogan explains.

“If the 2- to 3-fold increase in risk found in this study is confirmed, long-term calcium-channel blocker use would take its place as one of the major modifiable risk factors for breast cancer. Thus it is important that efforts be made to replicate the findings,” Dr. Coogan notes.

“We are cautious and don’t want to read too much into this, since this was the first study to look at long-term use of these medications. We need to see confirmation of the study before making any clinical recommendations,” Dr. Li emphasized.

Source: Medscape.com

Glucose Levels Predict Risk for Dementia.


Higher glucose levels within the nondiabetic range predicted higher risk for dementia.
Observational studies have established an association between diabetes and dementia. In this prospective study from Seattle’s Group Health Cooperative, researchers sought to determine whether average glucose levels in people without diabetes predict development of dementia. The study involved 2067 older adults (mean age 74; 11% with diabetes) who had no evidence of dementia at baseline and who were screened every 2 years using the Cognitive Abilities Screening Instrument. Average glucose levels were estimated using models that incorporated both serial glycosylated hemoglobin and blood glucose values.

During a median follow-up of 7 years, 25% of participants were diagnosed with dementia. Among participants who did not have diabetes, risk for developing dementia increased with increasing average glucose levels, after adjustment for potentially confounding variables. For example, in those whose average glucose level was 115 mg/dL, relative risk for dementia was 18% higher than in those whose average glucose level was 100 mg/dL. Among participants who had diabetes, relative risk for dementia was 40% higher in those whose average glucose level was 190 mg/dL compared with 160 mg/dL.

COMMENT

The prospective nature of this study, in which patients screened negative for dementia at baseline, is a strength. However, unmeasured confounders might have influenced the association between glycemia and dementia, and reverse causality is remotely possible (e.g., lifestyle changes in patients with early subclinical dementia might promote higher glucose levels). If higher blood glucose levels within the nondiabetic range do contribute to development of dementia, the mechanism is unclear.

Source: NEJM

95th annual meeting of the Endocrine Society.


Cognition and testosterone replacement therapy

 

Testosterone replacement therapy in postmenopausal women might preserve cognitive function according to results of a single-centre, double-blind, randomised, placebo-controlled trial presented by Susan Davis (Monash University, Melbourne, VIC, Australia). Women participating in the study were aged 55—65 years, not receiving other hormone replacement therapy, and had normal cognitive function. 92 participants were randomly assigned to receive 220 μg per day of transdermal testosterone gel or placebo for 26 weeks, and were assessed for cognitive function at 0, 12, and 26 weeks. Results of intention-to-treat analyses showed women receiving testosterone treatment scored 1·57 points higher on a 48-point scale for verbal learning and memory than did women in the placebo group, a change roughly equal to the cognitive decline reported over 1 year in a patient with Alzheimer’s disease. Other cognitive measures did not differ between treatment groups. These results suggest that normalising testosterone in postmenopausal women to concentrations found in younger women might help to preserve visual learning and memory abilities with age.

Medicine for a circadian disorder?

Sleep irregularities or restriction are increasingly associated with metabolic dysfunction. Blind individuals unable to perceive light frequently have sleep disorders, such as non-24-h sleep-wake disorder, due to dysregulation of light-regulated circadian rhythms. Steven Lockely (Harvard Medical School, Boston, MA, USA) presented the results of two phase 3 randomised, multicentre, double-blind, placebo-controlled trials that tested tasimelteon to treat individuals that have non-24-h sleep-wake disorder. Tasimelteon is a selective agonist for melatonin receptors MT1 and MT2 hypothesised to entrain the sleep cycles of blind individuals with non-24-h sleep-wake disorder. In the Safety and Efficacy of Tasimelteon (SET) study, 84 patients were randomly assigned to receive tasimelteon or placebo for up to 6 months. Significantly more patients receiving tasimelteon than those receiving placebo were entrained after 6 months of treatment (20% vs 3%, p=0·0171). In the Randomised-withdrawal Study of the Efficacy and Safety of Tasimelteon (RESET), 20 blind individuals with non-24-h sleep-wake disorder who had been entrained with tasimelteon treatment were randomly assigned to continue taking the drug, or switch to placebo, for 2 months. 90% taking the drug maintained entrainment versus 20% taking placebo (p=0·0026), suggesting that continuous treatment with tasimelteon is needed to maintain benefit. Tasimelteon was safe and well tolerated and caused a low incidence of minor adverse events such as nausea, headache, and sleepiness. This drug might also have a role for other indications such as delayed sleep phase disorder or jetlag.

Atorvastatin and paediatric type 1 diabetes

Preliminary results of a randomised controlled trial, presented by J Atilio Canas (Nemours Children’s Clinic, Jacksonville, FL, USA), showed that atorvastatin is safe and effective for reducing LDL cholesterol and other atherogenic lipoprotein particles in children with type 1 diabetes. Children with type 1 diabetes have a high risk of cardiometabolic complications later in life and thus early management of lipoprotein might prove beneficial. After a 3 month run-in period, 42 children with type 1 diabetes were randomly assigned to receive atorvastatin (n=21) or placebo (n=21) for 6 months. At baseline, all randomly assigned children had significantly higher concentrations of lipoprotein subfractions than a control group of healthy children. After 6 months, concentrations of atherogenic lipoproteins had decreased significantly in type 1 diabetic children receiving atorvastatin, whereas those in the placebo group stayed the same or increased. HbA1c concentrations remained the same in both groups. No severe adverse events related to atorvastatin were reported.

Puberty suppression in transgender adolescents

In some countries, adolescents with gender dysphoria can be treated with gonadotropic-releasing hormone analogues (GnRHa) to reversibly suppress puberty, lessening psychological difficulties. Whether such treatment affects the development of other systems, particularly bone, has been unclear. Henriette Delemarre-van de Waal (Leiden University Medical Center, Leiden, Netherlands) presented the results of a study done in the Netherlands in which 126 adolescents aged 12—14 years received GnRHa for up to 4 years, after which they began receiving cross-sex hormones involved in gender reassignment. GnRHa treatment for up to 4 years did not affect insulin sensitivity, or amounts of cholesterol, HDL, or LDL. Normal accumulation of bone mass was slowed with GnRHa treatment, but rapidly recovered to amounts seen in untreated individuals once treatment with cross-sex hormones was started. Studies in progress will address the effects of GnRH treatment on brain development and function.

Endoscopic ultrasound for pNETs

Pancreatic neuroendocrine tumours (pNETs) are the second most common tumour in patients with multiple endocrine neoplasia type 1 (MEN1), and the leading cause of MEN1-related death. Sophie van Asselt (University of Groningen, Groningen, Netherlands) presented results showing that endoscopic ultrasound (EUS) is better than CT or MRI for pNET yearly screening in patients with MEN1. In a prospective, multicentre, cross-sectional study, 41 patients with genetically confirmed MEN1 were screened by CT or MRI, EUS, and 11C-5-hydroxytryptophan PET (11C-5-HTP PET). 102 pancreatic lesions were reported in 35 patients. EUS was more sensitive than CT or MRI, both at the patient level (tumours detected in 97% vs51% of patients) and the lesion level (94% vs 30% of lesions detected). Screening by 11C-5-HTP PET contributed no added value. A limitation of the study was the absence of histological confirmation of the pNETs; follow-up studies will assess clinical outcomes.

Hypoparathyroidism survey reported

Bart Clarke (Mayo Clinic, Rochester, MN, USA) presented results of the PARADOX study, which aimed to characterise in detail the symptoms of individuals with hypoparathyroidism. 374 patients from the USA participated in an internet-based survey that included questions about clinical symptoms and quality of life. The results showed many patients had symptoms not previously thought to be associated with low calcium concentrations, such as mental confusion and exercise and heat intolerance. Despite supplementation with vitamin D and calcium, almost all patients that responded to the survey continued to have symptoms, and 69% had cormorbid disorders including arrhythmias (66%) and kidney stones (35%). Limitations of this study will be addressed in a long-term follow-up, the PARADIGM study, which will involve creating a registry of several thousand patients, not limited to the USA. Trials investigating a new drug for hypoparathyroidism, PTH(1—84), are in progress.

Hospital readmissions for paediatric DKA

US hospital readmissions for paediatric diabetic ketoacidosis (DKA) are frequent, despite being preventable. A retrospective study presented by Faisal Malik (University of Washington, Seattle, WA, USA) assessed data from 42 children’s hospitals: 12 488 patients aged 2—18 years were admitted between 2004 and 2007 and followed up for 5 years. 28·3% of children were readmitted for DKA one or more times within 1 year of a previous admission. Characteristics associated with risk of readmission were age 12 years or older, female sex, mental health disorder, non-hispanic black ethnicity, or having public health insurance. Because each readmission for paediatric DKA costs an average of US$7162, and DKA can be reduced by better education and disease management, scope exists to reduce the number of readmissions.

Androgen replacement for Klinefelter syndrome

Low-dose androgen improves quality of life in Klinefelter syndrome (47, XXY) according to Judith Ross (Alfred I duPont Hospital for Children, Philadelphia, PA, USA) who presented a subset of results from a randomised clinical trial. In addition to hypogonadism and reduced fertility, Klinefelter syndrome is associated with a range of cognitive, behavioural, and motor deficits, some of which might be due to androgen deficiency in childhood. 93 prepubertal boys aged 4—12 years were randomly assigned to receive oxandrolone (n=46) or placebo (n=47) for 2 years. Children were tested at baseline, 1 year, and 2 years with standard questionnaires to assess anxiety and depression; at the same timepoints, parents responded to questionnaires that assessed child behaviour. After 2 years, children that had received oxandrolone had more positive scores for anxiety and depression than at baseline, whereas those in the placebo group scored the same as at baseline. Parents of children in the oxandrolone group documented improvements in several child behavioural measures, whereas parents of children in the placebo group did not report changes. No major adverse events were noted.

Diabetes and mortality after lung transplant

Kathryn Hackman (The Alfred Hospital, Melbourne, VIC, Australia) presented results of a single-centre retrospective study showing that diabetes is a major contributor to mortality in patients who have had a lung transplant. In 367 patients that received a lung transplant between 2001 and 2010, diabetes increased the risk of mortality by five times—more than any other risk factor. Surprisingly, the commonest cause of death was chronic graft rejection rather than diabetic complications. Whether patients had diabetes before or after transplant did not affect outcomes. These results call for more focused efforts to screen and prevent diabetes in patients who have received a lung transplant. Outstanding questions are whether glycaemic control affects graft function, and whether tight glycaemic control might improve outcomes in transplant recipients.

Source: Lancet

Ex-Microsoft manager plans to create first U.S. marijuana brand.


2013-05-30T221549Z_2_CBRE94T1HP600_RTROPTP_2_USA-MARIJUANA-WASHINGTON

A former Microsoft executive plans to create the first U.S. national marijuana brand, with cannabis he hopes to eventually import legally from Mexico, and said he was kicking off his business by acquiring medical pot dispensaries in three U.S. states.

Jamen Shively, a former Microsoft corporate strategy manager, said he envisions his Seattle-based enterprise becoming the leader in both recreational and medical cannabis – much like Starbucks is the dominant name in coffee, he said.

Shively, 45, whose six years at Microsoft ended in 2009, said he was soliciting investors for $10 million in start-up money.

The use, sale and possession of marijuana remains illegal in the United States under federal law. Two U.S. states have, however, legalized recreational marijuana use and are among 18 states that allow it for medical use.

“It’s a giant market in search of a brand,” Shively said of the marijuana industry. “We would be happy if we get 40 percent of it worldwide.”

A 2005 United Nations report estimated the global marijuana trade to be valued at $142 billion. http://www.unodc.org/pdf/WDR_2005/volume_1_web.pdf

Washington state and Colorado became the first two U.S. states to legalize recreational marijuana when voters approved legalization in November.

Shively laid out his plans, along with his vision for a future in which marijuana will be imported from Mexico, at a Thursday news conference in downtown Seattle.

Joining him was former Mexican President Vicente Fox, a longtime Shively acquaintance who has been an advocate of decriminalizing marijuana. Fox said he was there to show his support for Shively’s company but has no financial stake in it.

“What a difference it makes to have Jamen here sitting at my side instead of Chapo Guzman,” said Fox, referring to the fact he would rather see Shively selling marijuana legally than the Mexican drug kingpin selling it illegally. “This is the story that has begun to be written here.”

Shively told Reuters he hoped Fox would serve an advisory role in his enterprise, dubbed Diego Pellicer after Shively’s hemp-producing great grandfather.

The sale of cannabis or marijuana remains illegal in much of the world although countries mainly in Europe and the Americas have decriminalized the possession of small quantities of it. A larger number of countries have decriminalized or legalized cannabis for medical use.

SKEPTICISM

Shively acknowledges that his business plans conflict with U.S. federal law and are complicated by regulations in both Washington state and Colorado. He said he is interested in buying dispensaries that comply with local and state rules and are less likely to attract the scrutiny of authorities.

“If they want to come talk to me, I’ll be delighted to meet with them,” he said of federal officials. “I’ll tell them everything that we’re doing and show them all our books.”

Washington state’s marijuana consultant, Mark Kleiman, said he was skeptical of Shively’s plans, and feared that the businessman is seeking to profit off others’ addiction.

“It’s very hard for me to understand why anybody seriously interested in being in the marijuana business, which after all is against the federal law, would so publicly announce his conspiracy to break that law,” said Kleiman, a professor of public policy at the University of California, Los Angeles.

Emily Langlie, spokeswoman for the U.S. Attorney’s Office in Seattle, referred questions to the Department of Justice headquarters. Department officials did not immediately return calls seeking comment.

Washington state Representative Reuven Carlyle, a Seattle Democrat, sees promise in Shively’s initiative. Any industry emerging from the shadows will inevitably undergo consolidation – and thereby simplify the task of regulators, he said.

“The fact that an entrepreneur is publicly pushing the envelope around a branding and value-based pricing opportunity, I would say that’s in the water in Seattle,” said Carlyle, chairman of the House Finance Committee. “That’s in our DNA … We could have predicted that as much as the rain.”

Shively said he has already acquired the rights to the Northwest Patient Resource Center, a medical marijuana operation that includes two Seattle store fronts. He added that he was close to acquiring another dispensary in Colorado, as well as two more each in Washington state and California, with the owners given the option to retain a stake in their businesses.

“We’ve created the first risk-mitigated vehicles for investing directly in this business opportunity,” he said.

Shively said he ultimately plans to create separate medical and recreational-use marijuana brands. Shively said he also plans to launch a study of the effectiveness of concentrated cannabis oil in the treatment of cancer and other illnesses.

Source: Yahoo news

 

Chemotherapy backfires – causes healthy cells to feed growth of cancer tumours.


Ever since chemotherapy was introduced into the practice of western medicine, doctors and oncologists have been trying to answer this nagging question: Why does chemotherapy seem to work at first, but then cancer tumors cells grow back even more aggressively while the body becomes resistant to chemotherapy?

It turns out that chemotherapy damages healthy cells, causing them to secrete a protein that accelerates the growth of cancer tumours.

This protein, dubbed “WNT16B,” is taken up by nearby cancer cells, causing them to “grow, invade, and importantly, resist subsequent therapy,” said Peter Nelson of the Fred Hutchinson Cancer Research Center in Seattle. He’s the co-author of the study that documented this phenomenon, published in Nature Medicine.

This protein, it turns out, explains why cancer tumors grow more aggressively following chemotherapy treatments. In essence, chemotherapy turns healthy cells into WNT16B factories which churn out this “activator” chemical that accelerates cancer tumor growth.

The findings of the study were confirmed with prostate cancer, breast cancer and ovarian cancer tumors. This discovery that chemotherapy backfires by accelerating cancer tumor growth is being characterized as “completely unexpected” by scientists.

The chemotherapy fraud exposed

As NaturalNews has explained over the last decade, chemotherapy is medical fraud. Rather than boosting the immune response of patients, it harms the immune system, causing tumors to grow back. This latest researching further confirms what we’ve known for years in the holistic health community: That chemotherapy is, flatly stated, poison. It’s not “treatment,” it’s not medicine, and it’s not prevention or a cure. It’s poison with virtually no medicinal value except in perhaps one to two percent of cancer cases.

The No. 1 side effect of chemotherapy is, by the way, cancer. Cancer centers should technically be renamed “poison centers” because they are in the business of poisoning patients with a toxic cocktail of chemicals that modern science reveals to be a cancer tumor growth accelerant!

Source: Nature.