Partnerships will advance personalized medicine - page 2
“It’s going to be a year where big pharma and healthcare systems will be combining different types of solutions to give better healthcare,” New or improved drugs will be combined with new or improved... Read More
Feb 22, '16Quote from yhl1975"The first complaint was filed in September to the Centers for Medicare and Medicaid Services by a former Theranos employee. It accused the company of instructing employees to continue to test patients' blood using Theranos' devices even though there was evidence of 'major stability, precision, and accuracy' issues."After these reports, Walgreens suspended their plans to roll out Theranos testing services in their stores, and the press reported that Safeway cancelled a $350 million agreement to use Theranos testing technology amid doubts about its accuracy." I am not expert, and I have subjective filing that Theranos are cheaper then any other companies.
Products manufactured for medical or food use must be produced in facilities designed and operated according to Good Manufacturing Practice (GMP) regulations.
Theranos just a threat to all other companies. This small company is a new "Industrial Revolution" in blood diagnostic area.
The second complaint was filed earlier this month to the FDA by another former employee. It said a study submitted by Theranos last year for a herpes test was extremely problematic because of improper research protocols. While the tests were being run, parts of the devices used on the tests were modified, which can change the results to favor the company."
US health regulators investigating complaints about Theranos - Business Insider
"The report, which published online late Wednesday, also contends that some results were so inaccurate that 'patients would have to be dead for the results to be correct,' the source said ... The Journal article, written by investigative reporter John Carreyrou, describes how, in one instance, 'two types of equipment gave different results when testing for vitamin D, two thyroid hormones and prostate cancer. The gap suggested to some employees that the Edison results were off, according to the internal emails and people familiar with the findings.'"
Bloodwork darling Theranos under fire
You're certainly entitled to your "filing," but there are serious questions about Theranos' new equipment and testing procedures, and have been for some time (I've been following this story since it first broke back in October). The FDA and CMS found serious regulatory and practical problems with Theranos' practices. CMS declared "immediate jeopardy" at one point, which means that they found the organization's practices were putting people's lives in (immediate) jeopardy. I've worked as a CMS surveyor in the past, and declaring IJ is a big deal, and not something that is done casually or lightly. You have to have solid evidence and be prepared to defend your decision in administrative court if the organization/facility chooses to contest the finding. There's more to this than other lab companies not wanting competition.
Feb 22, '16Never too late to do well. I am sure Theranos will improve the standards and all will be better. Yaari reported in 2006 that saliva testing for anti-HCV antibodies yielded a sensitivity of 100% and a specificity that was “similar or better” when compared to serum testing.
(J Virol Methods. 2006 Apr;133(1):1-5. Epub 2005 Dec 19. Detection of HCV salivary antibodies by a simple and rapid test.Yaari A, Tovbin D, Zlotnick M, Mostoslavsky M, Shemer-Avni Y, Hanuka N, Burbea Z, Katzir Z, Storch S, Margalith M. Department of Virology, Soroka University Medical Center, POB 151, Beer Sheva 84101, Israel. PMID 16360219)
I am not sure if saliva testing is used for HCV testing. Lab technicians still do IV labs testing and the testing procedure is dangerous to the staff. I am not sure , may be there is no need for IV testing any more.
Feb 23, '16While the idea of needing only a miniscule amount of blood or saliva to run tests is certainly appealing and most probably something we will see in the next few decades, Theranos still has a long way to go in terms of its ethics and reliability of tests.
And although Yaari et al. did expand upon previous work, their sample size only included 26 anti-HCV seropositive patients and 11 sero-negative. When classified by PCR, there were only 18 anti-HCV positives. They also identify the limits of the study saying that saliva testing “most probably” only detects the active disease HCV and future studies should include a larger sample size with more HCV-PCR positive and false HCV-negative subjects.
My brother works for Elsevier. I can email anyone the full text article if they like.
With these results it looks as though salivary analysis for HCV could be useful in very high risk populations but as of 2012, no salivary method of testing HCV has been approved by the FDA although OraSure has a method that is widely used in Europe and matches immunoassay results 97% of the time.
That being said, I would think that testing HCV through blood samples is still warranted. Particularly if someone tends to be lower risk. Finally, I may be missing something, but how is HCV testing dangerous for staff?
References (I apologize for the non APA/mixed format. I was literally copying and pasting these citations):
Detecting viruses by using salivary diagnostics
Dr. Paul L.A.M. Corstjens, Dr. William R. Abrams, Dr. Daniel Malamud
J Am Dent Assoc. Author manuscript; available in PMC 2014 December 11.
Published in final edited form as: J Am Dent Assoc. 2012 October; 143(10 0): 12S–18S.
Article PubReader PDF–89KCitation
Drobnik A, Judd C, Banach D, Egger J, Konty K, Rude E. Public health implications of rapid hepatitis C screening with an oral swab for community-based organizations serving high-risk populations. Am J Public Health. 2011;101(11):2151–2155. doi: 10.2105/AJPH.2011.300251. published online ahead of print Sept. 22, 2011. [PMC free article] [PubMed] [Cross Ref]
J Virol Methods. 2006 Apr;133(1):1-5. Epub 2005 Dec 19. Detection of HCV salivary antibodies by a simple and rapid test.Yaari A, Tovbin D, Zlotnick M, Mostoslavsky M, Shemer-Avni Y, Hanuka N, Burbea Z, Katzir Z, Storch S, Margalith M. Department of Virology, Soroka University Medical Center, POB 151, Beer Sheva 84101, Israel. PMID 16360219
Feb 23, '16As dialysis RN in the past and as OASIS outpatient detox/rehab RN , most of my clients unfortunately at high risk for HIV,HEP B,C other.I refused to be exposed to any blood in my job any more. I feel comfortable to test urine and saliva with gloves and other protection as needed. The reality is , I am evaluating delusional/psychotic patients (MICA patients) and to prick them or to be near them with needs, I fill uncomfortable. My managers accepted my fears and "HR" could not find any other RN/LPN/NP to do labs in our program and other "sister" programs. Most of my patients refuse to do labs and it is other topic how psych medication could be prescribed and followed up without levels and other.
I was asked by our management to think about any other idea how fast/easy/comfortable for the client to test Hep c, b. The management will consider the costs and the benefits.
From all information here, I understand that unfortunately still no any experience with any labs/new technology . I hope others will add information. Thank you. All information here is interesting and helpful.Last edit by yhl1975 on Feb 23, '16
Feb 24, '16Quote from yhl1975You just starting refusing to do your job because you felt "uncomfortable"? And your managers were okay with that? Why on earth didn't you get fired? Or, if you feel "uncomfortable" performing the regular duties of your job, at least have the decency to resign and find a job where you don't have to actually take care of sick people, and let them hire someone willing to do the job.As dialysis RN in the past and as OASIS outpatient detox/rehab RN , most of my clients unfortunately at high risk for HIV,HEP B,C other.I refused to be exposed to any blood in my job any more. I feel comfortable to test urine and saliva with gloves and other protection as needed. The reality is , I am evaluating delusional/psychotic patients (MICA patients) and to prick them or to be near them with needs, I fill uncomfortable.
Feb 24, '16I explained regarding Addiction PMHNP work in OASIS programs in NY in my other post.
Any addictions nurse practitioners out there? Can I please get your input?
No any NPs responds yet.
I hope this posts will be regarding Partnerships will advance personalized medicineLast edit by yhl1975 on Feb 24, '16
Feb 24, '16Addiction psychiatry " court mandated field " is not a dream for nurses and physicians yet. In this program I work with social workers and counselors that had a dream to work in this field. MD's that come to work in this field usually have experience in addiction in privet practice (that could be temporally slow). When they come to work part time to OASIS they expect "clinical presentations/ research presentations/ case study discussions " and other. The reality is different. The clients are the same clients as in privet clinics, but much more visits per day and there is no any support with preauthorization's, pharmacy follow up and other. As for nursing job in OASIS, since there is a difficulty to find nurses in NY in addiction, many programs decided not to nave a nurse. Pt. can bring physical and no any health education provided.
I resigned several times, I am there once a week/twice a week as per diem. We are looking for NP's/PA's /LPN''s/RN''s' and nobody wants to work. The new staff comes and goes. My job is to do following: health assessments/ referrals for full physicals /labs/ x-ray and patient education per my contract. This is not union position, so as Per diem , I can do what my contract was sighed for. And yes, my managers ok with my decision. For labs/medication management for HIV and Hep B/C other-my directors sighed the contract with Ryan Center
William F Ryan Community Health Network
Mar 3, '16Human cytochrome P450 and personalized medicine.
"Personalized medicine has become a hot topic ascribed to the development of Human Genome Project. And currently, bioinformatics methodology plays an essential role in personal drug design. Here in this review we mainly focused on the basic introduction of the SNPs of human drug metabolic enzymes and their relationships with personalized medicine. Some common bioinformatics analysis methods and latest progresses and applications in personal drug design have also been discussed. Thus bioinformatics studies on SNPs of human CYP450 genes will contribute to indicate the most possible genes that are associated with human diseases and relevant therapeutic targets, identify and predict the drug efficacy and adverse drug response, investigate individual gene specific properties and then provide personalized and optimal clinic therapies. "
Chen Q1, Wei D.( 2015)
I think, the personalized medicine will give some "light" to psychiatry /oncology/immunology treatments protocols, since many patients have too much side effects and the "adherence" /compliance to finish the treatment plan are so low.
May be you have any personal experience with blood work/ privet laboratory or other.
Mar 14Update on Theranos and CEO, Elizabeth Holmes:
Theranos CEO Holmes, ex-president Balwani charged with massive fraud