Forget using Ginkgo biloba for dementia.

A recent study found that ginkgo biloba did not improve cognitive function compared to placebo. This was a well-designed, 6 year randomized controlled trial. This proves my usual skepticism for dietary supplements. An interesting study to do would be to compare ginkgo biloba and Forrest's Namenda (memantine), and see how both do against placebo. In the meantime, better going back to using post-its and refrigerator notes.

JAMA. 2008 Nov 19;300(19):2253-62. Ginkgo biloba for prevention of dementia: a randomized controlled trial.

FDA Medical Devices Approval

A recent meta-analysis suggested that FDA-approved high risk medical devices often have lacking support data. Many devices' support data had no randomization, no blinding, no controls, and often based on a single study. Though I have not read the entire article, it should be important to note that "soft" evidence does not mean no evidence. Furthermore, many drugs, such as generics, also go through a relatively simple approval process. For instance, generic drugs' ANDA often only needs BA/BE data, with no efficacy trials. Moreover, the BE data only looks at AUC, no cmax, tmax, or overall PK profile. Despite all this, generics often work as well as the brands! Also, many devices are probably "followup" or "me-too" devices and would not need extensive data for efficacy/safety support. Finally, if regulatory stringency is increased, the cost of development will increase, stifling innovation, driving up healthcare costs.

JAMA. 2009;302(24):2679-2685. Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices

Antibiotic Resistance

With recent news of highly drug-resistant TB and MRSA, one has to wonder if it's just a matter of time before antibiotics stop working altogether. The obvious solution that most experts agree on is controlling the use of antibiotics. In addition, we would need to come up with newer antibiotics through research and innovation. That is all the more reason there should be increased federal NIH funding for scientific research and decreased corporate taxes in order to stimulate private R&D. With deadly infections on the rise, it is vital that we combat these easily curable conditions.

Reflection on Heme Oncology Rotation

This 6-week rotation from Nov-Dec was very fulfilling. There were ~13 patients to be followed daily. I learned a lot about the various chemotherapy treatments for various kinds of leukemias. Frequently, patients will go through nadir and neutropenia after chemo, which activates a cascade of events/protocols. I’ve also learned a lot about the complications from these chemotherapies. Some patient cases are extremely complicated, which facilitates the learning process. This rotation fit in very nicely with my AML project. Now I have context on how the patients are like and the clinical ramifications of AML. On a more practical level, it was very grueling. It involved near 12-hour shifts daily + 1 day/weekend. On top of this, I was flying around the country for fellowship interviews and applications. It definitely tested my organizational abilities.

Childhood Asthma GWAS

A new study published in the Jan 7th issue of New England Journal of Medicine used an Illumina chip to do a GWAS (genome wide association study) and found a link between some genes and childhood asthma using around 1700 subjects. Huge study with an expensive chip. Study must have been very expensive. The thing I like about these gene chips is that so much data is generated that you can get many papers out of these data. Even though the paper only discussed one gene, they can probably look back and find some other genes to look at later on, and maybe even other diseases if they have the patient's medical records. Wow, it's a gift that keeps on giving :) Though I'm by no means an expert statistician, the association kind of makes me wonder if it's by chance alone. I know the p-value must have been great, but one still wonders...

Sleiman PM, Flory J, Imielinski M, Bradfield JP, Annaiah K, Willis-Owen SA,
Wang K, Rafaels NM, Michel S, Bonnelykke K, Zhang H, Kim CE, Frackelton EC,
Glessner JT, Hou C, Otieno FG, Santa E, Thomas K, Smith RM, Glaberson WR, Garris
M, Chiavacci RM, Beaty TH, Ruczinski I, Orange JM, Allen J, Spergel JM,
Grundmeier R, Mathias RA, Christie JD, von Mutius E, Cookson WO, Kabesch M,
Moffatt MF, Grunstein MM, Barnes KC, Devoto M, Magnusson M, Li H, Grant SF,
Bisgaard H, Hakonarson H. Variants of DENND1B Associated with Asthma in Children.
N Engl J Med. 2009 Dec 23. [Epub ahead of print] PubMed PMID: 20032318.

Breast Cancer Screening

With the recently released breast cancer screening recommendation from the US Preventive Services Task Force (USPSTF) and AHRQ conflicting against those of the American Cancer Society, what is a woman to do? I don't think there is a right answer - there are no tests that is absolutely 100% accurate. There's always a possibility of false (+), and the more people you test, the higher false (+) rate - simple probability. I think each individual is different, so a woman should speak to her doctor about their particular situation and use the recommendations as a guide, not rules to follow blindly.

Healthcare Reform and Medicare Drug Price Negotiation

It's about time that our health care system is being closely examined for inadequacies. Though this process so far has been torturous, with the votes looking non-partisan and strictly along party lines, it is still great news that something is finally being done to take care of the uninsured. It's a relief that medicare drug price negotiations are (largely) off the table. In our great free-market system, price negotiations will not only artificially lower the cost of medication at the expense of shareholder return, it will also stifle innovation that has characterized the drug industry.

C.V.

Kuo-Hsiung Yang, M.S.

kuo.yang (AT) ucsf.edu

Seeking post-Pharm.D fellowship positions in industry, particularly early phase clinical trials / PK/PD.

Education and Training

2006 - Present Pharm.D Candidate, 2010, Pharmaceutical Sciences Pathway

University of California, San Francisco

2004 - 2005 M.S. Biology, Developmental Neuroscience

University of California, San Diego

2000 – 2004 B.S. Biology, Animal Physiology / Neuroscience

University of California, San Diego

Professional Licensure/Certification

2007 – Present Pharmacy Intern

California Board of Pharmacy

2007 – Present Basic Life Support / Cardiopulmonary Resuscitation

American Heart Association

2006 – Present Immunization Certification

University of California, San Francisco, School of Pharmacy

Professional Experience

2007 – Present Pharmacy Intern, Inpatient and Outpatient

Kaiser Permanente, Oakland, CA

Provided patient counseling on medications at both hospital discharge and in a retail environment. Completed automated pyxis machine refills and patient cassette refills. Filled, checked, and dispensed prescriptions. Also conducted periodic audits of controlled narcotics for DEA compliance.

Preceptors: Tam Hoang, Pharm.D and Geoffrey Reeves, Pharm.D

2005 – 2006 Technical Analyst, Regulatory Affairs

Amphastar Pharmaceuticals, CA

Prepared and compiled documents for Abbreviated New Drug Application (ANDA) FDA submissions. Optimized Standard Operating Procedures (SOP) for company operations. Conducted primary literature search for Investigative New Drug Applications (INDA).

Research

2009 Glutathione-S-transferase polymorphism may predict response to Acute Myelogenous Leukemia (AML) chemotherapy treatment.

Pharmaceutical Sciences Pathway Project

University of California, San Francisco

Conducted statistical analysis on patient survival and toxicity due to genetic polymorphism in glutathione-S-transferase. Searched primary literature to identify candidate genes responsible for response to chemotherapy treatment for AML, with a special interest in busulfan metabolism and disposition. HapMap database was used to select tag-SNPs (single nucleotide polymorphism) for genotyping by obtaining genotypic data from various ethnic populations. Used GEO (gene expression omnibus) to obtain and analyze gene expression and phenotypic data from microarrays. Compiled survival and other clinical phenotypic data from medical records for genetic correlation studies.

Preceptors: Kathleen M. Giacomini, Ph.D. and

Charalambos Andreadis, M.D.

2007 OCT-2 Transporter polymorphism and response to metformin treatment in healthy patients.

Pathways to Careers in Clinical and Translational Research (PACCTR) Fellowship Project

University of California, San Francisco

Reviewed and submitted clinical research protocols for institution review board (IRB) submission. Learned basic study design techniques and relevant statistical issues. Received Training in Clinical Research (TICR) completion certificate.

Preceptor: Kathleen M. Giacomini, Ph.D

Publications

2009 KH Yang, SW Yee, C Andreadis, and KM Giacomini

Busulfan Pharmacogenetics Pathway

Pharmacogenomics Knolwedge Base (PharmGKB)

Online Database (In Submission)

2009 S. Euteneuer, K.H. Yang, E. Chavez, et.al, Glial cell line derived neurotrophic factor (GDNF) signals via both neuronal cell adhesion molecule (NCAM) and the receptor-tyrosine kinase Ret in the inner ear’s spiral ganglion. Journal of Neurochemistry (In Submission)

Clinical Rotations

2009 (In progress) Leukemia, Bone Marrow Transplant

UCSF Medical Center, San Francisco, CA

Preceptor: Courtney Yuen, Pharm.D, BCOP

2010 Long Term Care

(To be completed) Laguna Honda Hospital, San Francisco, CA

Preceptor: Michelle Fouts, Pharm.D, BCPS, CGP

2010 General Medicine

(To be completed) UCSF Medical Center, San Francisco, CA

Preceptor: Eunice Tam, Pharm.D

Honors & Awards

2007 Pathways to Careers in Clinical and Translational Research (PACCTR) Fellowship

This fellowship provided an introduction to clinical research and stimulated students to acquire further training in clinical research. Fellows were required to take courses (Designing Clinical Research and Responsible Conduct in Research), choose a faculty mentor at UCSF and complete a research project. Recipients of this fellowship must have submitted a complete research proposal for consideration.

Community Service

2007 – 2008 Phi Delta Chi Pharmaceutical Fraternity, Treasurer

Organized fundraising activities for community service purposes. Managed finances for ongoing operations.

2004 – Present Make-A-Wish Foundation

Lead wish team to interview families and coordinated the wish granting process.

Special Skills

STATA Statistical Software

WinNonlin Pharmacokinetics Software

Chinese Mandarin Fluency in Speaking and Reading