FDA Lays the Smackdown on Illegal Stem Cell Clinics

FDA is cracking down on stem cell clinics that market unapproved products and don't meet good manufacturing practice requirements. On behalf of the agency, the Department of Justice filed two complaints in federal court this week seeking permanent injunctions against a Florida-based clinic and a California-based clinic.  “Cell-based regenerative medicine holds significant medical opportunity, but we’ve also seen some bad actors leverage the scientific promise of this field to peddle unapproved treatments that put patients’ health at risk. In some instances, patients have suffered serious and permanent harm after receiving these unapproved products," said FDA Commissioner Scott Gottlieb, MD. The agency said Sunrise, FL-based US Stem Cell Clinic ignored the violations outlined in an August 2017 warning letter and failed to come into compliance with the law, continuing to sell unapproved stem cell products. FDA also said US Stem Cell Clinic was found to be in violation of current good manufacturing practice requirements, including some that could impact the sterility of their products and put patients at risk.  FDA also filed for a permanent injunction against Rancho Mirage, CA-based California Stem Cell Treatment Center, which also has a Beverly Hills location, and Rancho Mirage, CA-based Cell Surgical Network Corp., along with Elliot Lander, MD, and Mark Berman, MD. According to the agency's complaint, Berman and Lander control t...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news

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Authors: Villena-Suarez JR, Vicente W, Taxa L, Cuéllar L, Nuñez-Butrón MT, Villegas V, Castillo M, Castañeda CA Abstract Tuberculosis (TB) is a major public health problem that, due to the clinical variability of its presentation, can be confused with cancer. The aim of this study was to identify the clinical-radiological characteristics and to describe the methodology that allowed to achieve a TB diagnosis in patients referred to the National Institute of Neoplastic Diseases (INEN) with a presumed diagnosis of cancer between 2014 and 2016. The study included 170 patients (52.4% men) wit...
Source: Revista Peruana de Medicina de Experimental y Salud Publica - Category: International Medicine & Public Health Tags: Rev Peru Med Exp Salud Publica Source Type: research
CONCLUSIONS. : These results are encouraging in terms of the immunomodulating effect of this Peruvian medicinal plant and justify the continuation of their study for a potential clinical application. PMID: 29924278 [PubMed - in process]
Source: Revista Peruana de Medicina de Experimental y Salud Publica - Category: International Medicine & Public Health Tags: Rev Peru Med Exp Salud Publica Source Type: research
CONCLUSIONS. : Neoadjuvant therapy with dose-dense carboplatin and paclitaxel achieved an elevated frequency of optimal cytoreduction. The post-surgery levels of carcinoembryonic antigen 125 and optimal cytoreduction were independent factors of progression-free survival and overall survival. PMID: 29924276 [PubMed - in process]
Source: Revista Peruana de Medicina de Experimental y Salud Publica - Category: International Medicine & Public Health Tags: Rev Peru Med Exp Salud Publica Source Type: research
CONCLUSIONS: . Excess weight, abdominal obesity, and high cholesterol were the most prevalent risk factors in women. The metabolic syndrome component with the highest prevalence in community kitchen users in a district of Lima is abdominal obesity. PMID: 29924275 [PubMed - in process]
Source: Revista Peruana de Medicina de Experimental y Salud Publica - Category: International Medicine & Public Health Tags: Rev Peru Med Exp Salud Publica Source Type: research
Authors: Cegielski JP Abstract Multidrug-resistant (MDR) tuberculosis (TB) emerged shortly after introduction of rifamycins in the 1960s; isoniazid resistance had already emerged by the mid-1950s. Without these two drugs, tuberculosis is very difficult and costly to treat, with unacceptably high rates of treatment failure, death, loss to follow-up, and no known preventive treatment. Global attention first focused on MDR TB in the early 1990s when nosocomial outbreaks with high case fatality rates were reported in many countries. Prevalence data for MDR TB on a global scale first became available in 1997. In 2016, a...
Source: Revista Peruana de Medicina de Experimental y Salud Publica - Category: International Medicine & Public Health Tags: Rev Peru Med Exp Salud Publica Source Type: research
Bisexual men have the highest rates of risk factors for heart disease of any men. This is driven in part by the fact poor mental health is twice as common among them as straight men, an NYU study shows.
Source: the Mail online | Health - Category: Consumer Health News Source Type: news
Researchers from the Fred Hutchinson Cancer Research Center, Washington, found that unprocessed meats, such as steak, are more strongly linked to the condition than bacon.
Source: the Mail online | Health - Category: Consumer Health News Source Type: news
A new  studyhas found that false positive breast cancer biopsies are costing healthcare facilities over $2.1 billion annually. This high false positive rate and the consequential expenses highlight the need for improved breast cancer diagnostic protocols and technology.Researchers from IBM Watson Health and Seno Medical looked at health care claims filed between 2011 and 2015 from 875,000 women to understand the rate of follow-up procedures after mammography and breast exams. They found that between 2012 and 2015, 8,732,909 patients received diagnostic mammograms, 6,987,399 underwent breast ultrasounds, and 1,585,856 ...
Source: radRounds - Category: Radiology Authors: Source Type: blogs
Adding rasagiline to riluzole did not extend survival, the primary endpoint, in amyotrophic lateral sclerosis, but post hoc analysis suggests it may benefit those deemed'fast progressors. 'Medscape Medical News
Source: Medscape Today Headlines - Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news
Researchers recently published a study on attitudes to longevity that is reminiscent of the 2013 Pew survey. When asked, people want to live a little longer than their neighbors, at the high end of the normal life span for old individuals today. When asked how long they want to live given the guarantee of perfect health, people pick a number close to the maximum recorded human life span. This sounds like a collusion between the instinctive desires for first conformity and secondly hierarchy, deeply entwined with the human condition, present in all of our primate cousins, a self-sabotaging gift from our evolutionary heritag...
Source: Fight Aging! - Category: Research Authors: Tags: Activism, Advocacy and Education Source Type: blogs
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