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What are the key allegations in the WSJ stories on Theranos in October 2015?

The key allegations in the John Carreyrou WSJ article of Oct 15, 2015 (1) on Theranos are aboutAlleged Clinical Laboratory Improvement Amendments (CLIA)-mandated proficiency tests (PTs) cheating (see extended quotes* from 1 at end of the answer).Alleged test protocol violations (allegedly inappropriately diluting test samples when they shouldn't) when using traditional machines (see extended quotes** from 1 at end of the answer).Why are these two the key allegations? Because they raise the most important and alarming suspicion about Theranos, namely, can we trust their test results? Less important issue is whether they were using their proprietary nanotainers to collect blood samples for the tests they offer as they claimed to have done.Cost, convenience, and test accuracy and reliability are the main elements to successfully challenge incumbents in the clinical blood diagnostics space. In the US, incumbents such as Quest and LabCorp already have accurate and reliable tests so a newcomer needs to prove they do too. Who cares about cost and convenience if test results are inaccurate? Certainly not me nor those dear to me.How could regulatory authorities assess if clinical testing labs generate accurate data? There are two steps.First, such labs need to be accredited. In the US, clinical labs that perform clinical laboratory testing on humans get accredited, i.e., CLIA-88, by the credentialing regulatory authority, Centers for Medicare and Medicaid Services (CMS), which falls under the United States Department of Health and Human Services.'Congress passed the Clinical Laboratory Improvement Amendments of 1988 to set criteria to improve the quality of clinical laboratory services. The goal of this law was to standardize laboratory testing across the United States in all sites conducting testing on human specimens for health assessment or for the diagnosis, prevention, or treatment of disease. Failure to comply with these requirements may result in sanctions by the Health Care Financing Administration (HCFA***), whose task is that of implementing CLIA-88' (2).*** in 2001, HCFA morphed into the current CMS.Second, once accredited, CLIA-certified clinical labs are required to enroll and participate in a Proficiency testing (PT) program administered by the CMS (3, 4).PT is conducted 3 times a year with 5 tests (analytes) per time.Test scores should be >80%, i.e., the results the lab generates in at least 4 of those 5 tests should meet previously established consensus acceptance criteria.Unsatisfactory test performance for a particular analyte on 2 consecutive PTs or for 2 out of 3 triggers sanctions against that lab.The regulations that oversee PT specify (5):'Section 353(d)(1)(E) of the Public Health Service Act requires the laboratory to “treat proficiency testing samples in the same manner as it treats materials derived from the human body referred to it for laboratory examinations or other procedures in the ordinary course of business, except that no proficiency testing sample shall be referred to another laboratory for analysis as prohibited under subsection (i)(4)”. Additionally, this requirement is emphasized in the CLIA regulations at §493.801(b). A laboratory is not to test PT samples on more than one instrument/method unless that is how they test patient specimens. Repeated analysis of PT samples is not appropriate unless patient specimens are similarly tested'.Mandatory PTs are the mechanism to ensure clinical lab tests are accurate (2):'Successful participation in a CLIA-88 approved proficiency testing program is mandated. Proficiency testing determines how well a laboratory’s results compare with those of other laboratories that use the same methodologies and can identify performance problems not recognized by internal mechanisms. Proficiency testing samples are tested along with the laboratory’s regular workload by staff who usually perform the testing using routine methods...Written procedures of the proper handling, analysis, review, and reporting of proficiency testing materials are required. There must be evidence of the identification and review of problems discovered through the use of this program and the documentation of corrective actions taken.When the laboratory uses different methodologies or instruments, or performs testing at multiple testing sites, a system has to be in place that evaluates and verifies the comparability between these test results...This must be documented biannually'.When a clinical testing lab uses, or claims to use, proprietary technologies it claims have no peers, as Theranos claims it does (see 6; the interview with Jonathan Krim at WSJ.D Live on Oct 21, 2015), they need to have a system in place to evaluate and verify comparability of their test results with standard tests. The key allegation pertaining to PT suggests either Theranos didn't or was trying to circumvent such comparisons. Either is a form of PT cheating (1, see * below). Key questions are:For a given analyte, was Theranos testing both patient and PT samples on their proprietary systems or not?For a given analyte, was Theranos testing patient samples on their proprietary system but PT samples on another system?If the former, then those PT results should be comparable to standard PT results for the same analyte, i.e., Theranos should have developed a transparent system for regulators to assess such comparisons. OTOH, the latter would be a 'violation of the state and federal requirements' (1). This last bit brings us to the current conundrum regarding CLIA guidelines in general and to PTs in particular.Realizing that the 1988 CLIA guidelines lack substantial regulatory oversight of technologies that evolved in subsequent decades, the FDA published draft guidelines on October 3, 2014, noting (7),'In summary, the FDA has determined that the following attributes of modern LDTs [Laboratory Developed Tests], which are not attributes of the types of LDTs offered in 1976, create potential increased risk for patients in the absence of appropriate oversight. Many modern LDTs are:• manufactured with components that are not legally marketed for clinical use• offered beyond local populations and manufactured in high volume• used widely to screen for common diseases rather than rare diseases• used to direct critical treatment decisions (e.g., prediction of drug response)• highly complex (e.g., automated interpretation, multi-signal devices, use of non-transparent algorithms and/or complex software to generate device results)However, FDA recognizes that, as with all IVDs [In vitro Diagnostic Devices], there is a wide range of risks associated with the wide variety of LDTs. Thus, FDA believes that a risk-based approach to regulatory oversight of LDTs is appropriate and necessary to protect patient safety. A comprehensive framework that describes FDA’s enforcement policy for different classes and categories of LDTs will help provide clarity to LDT manufacturers and protect patients'.Tests performed using Theranos' proprietary technologies including Edison, i.e., LDT, fall into this grey area. As the Wired's Nick Stockton highlighted in his Oct 21, 2015 article, this grey area currently incompletely regulated by CLIA guidelines led to the FDA, 'increasing its oversight of lab developed tests' (8). These loopholes apply to Theranos' technology and the way they're used/could be used. By submitting their tests for approval by the FDA, Theranos is not so much going above and beyond the norm as they repeatedly claim but rather merely following the mandate of a rapidly evolving regulatory landscape that's finally trying to come to grips with the explosion in healthcare-related technological innovations over the past decade.The irony is that the FDA's increased focus on goings-on in this arena likely had originally nothing to do with concerns about Theranos, which is after all nothing but a traditional clinical lab and not biotech in the classical sense of the word. Rather, the FDA appears to have been extremely alarmed about the rise of DTC (Direct-to-Consumer) genomic tests. Witness their warning letters to Pathway Genomics in 2010 (9) and 2015 (10), and to 23andMe in 2013 (11). Two years later, 23andMe is coming out of the tunnel, having changed its research focus to drug discovery by partnering with Genentech (12).Yet, however the Theranos unraveling began, unravel it certainly has. In that regard, John Carreyrou's follow-up WSJ article of Oct 16, 2015, contained even more damaging information (13) since it alleges that FDA inspectors recently made an unannounced visit to Theranos' offices followed by an audit by CMS. 'Food and Drug Administration inspectors recently showed up unannounced at Theranos, the person familiar with the matter said... Since the inspection by FDA officials, Theranos has also been audited by the Centers for Medicare and Medicaid Services, the main regulatory overseer of clinical labs, according to people familiar with the matter.' (13). In the US medicine and healthcare space, an unannounced visit by FDA inspectors is as bad as it gets.* From 1: 'Whether labs buy their testing instruments or develop them internally, all are required to prove to the federal Centers for Medicare and Medicaid Services that they can produce accurate results. The process is known as proficiency testing and is administered by accredited organizations that send samples to labs several times a year.Labs must test those samples and report back the results, which aren’t disclosed to the public. If a lab’s results are close to the average of those in a peer group, the lab receives a passing grade.In early 2014, Theranos split some of the proficiency-testing samples it got into two pieces, according to internal emails reviewed by the Journal. One was tested with Edison machines and the other with instruments from other companies.The 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.Senior lab employees showed both sets of results to Sunny Balwani, Theranos’s president and chief operating officer. In an email, one employee said he had read “through the regulations more finely” and asked which results should be reported back to the test administrators and government.Mr. Balwani replied the next day, copying in Ms. Holmes. “I am extremely irritated and frustrated by folks with no legal background taking legal positions and interpretations on these matters,” he wrote. “This must stop.”He added that the “samples should have never run on Edisons to begin with.”Former employees say Mr. Balwani ordered lab personnel to stop using Edison machines on any of the proficiency-testing samples and report only the results from instruments bought from other companies...In March 2014, a Theranos employee using the alias Colin Ramirez alleged to New York state’s public-health lab that the company might have manipulated the proficiency-testing process.Stephanie Shulman, director of the public-health lab’s clinical-lab evaluation program, responded that the practices described by the anonymous employee would be a “violation of the state and federal requirements,” according to a copy of her email.What the employee described sounded like “a form of PT cheating,” Ms. Shulman added, using an abbreviation for proficiency testing. She referred the Theranos employee to the public-health lab’s investigations unit'.**From 1: 'In addition to the 15 tests run on the Edison system, Theranos did about 60 more on traditional machines using a special dilution method, the former senior employee says. The company often collected such a small amount of blood that it had to increase those samples’ volume to specifications required by those traditional machines, former employees say...For tests done with dilution, the process caused the concentration of substances in the blood being measured to fall below the machines’ approved range, three former employees say. Lab experts say the practice could increase the chance of erroneous results.Most labs dilute samples only in narrow circumstances, such as when trying to find out by how much a patient has overdosed on a drug, say lab experts.“Anytime you dilute a sample, you’re adulterating the sample and changing it in some fashion, and that introduces more potential for error,” says Timothy R. Hamill, vice chairman of the University of California, San Francisco’s department of laboratory medicine. Using dilution frequently is “poor laboratory practice.”'.BibliographyThe Wall Street Journal, John Carreyrou, Oct 15, 2015. Hot Startup Theranos Has Struggled With Its Blood-Test TechnologyFetsch, Patricia A., and Andrea Abati. "The clinical immunohistochemistry laboratory: regulations and troubleshooting guidelines." Immunocytochemical Methods and Protocols. Humana Press, 2010. 399-412.Page on gpo.govEhrmeyer, Sharon S., and Ronald H. Laessig. "Has compliance with CLIA requirements really improved quality in US clinical laboratories?." Clinica chimica acta 346.1 (2004): 37-43. Page on researchgate.netProficiency Testing ProgramsTheranos CEO Elizabeth Holmes Goes on Stage at WSJDLive 2015 — Live BlogPage on fda.govWired, Oct 20, 2015, Nick Stockton. Fixing the Laws That Let Theranos Hide Data Won’t Be EasyPage on fda.govPage on fda.gov 23andMe, Inc. 11/22/13Forbes, , Oct 14, 2015, Matthew Herper. 23andMe Wins A Second Life: New Business Plan Scores $115 Million From InvestorsThe Wall Street Journal, John Carreyrou, Oct 16, 2015. Hot Startup Theranos Dials Back Lab Tests at FDA’s BehestThanks for the A2A, Jay Wacker.

Can NUCCA (National Upper Cervical Chiropractic Association) chiropractic adjustments significantly lower high blood pressure according to webMD?

I am skeptical after having investigated what webMD quoted.Here is why:I checked out the paper that formed the basis of the WebMD article [1].At first blush, the paper seems to report a randomised double-blind controlled clinical trial (RCT) which is considered the gold standard of clinical investigation.Fifty hypertensive patients with the condition of “positive preliminary screening for evidence of Atlas misalignment” were enrolled and randomised to either treatment or sham procedure, that is, the patient thinks he is being treated but in fact he receives a placebo-type treatment. By the way, the “Atlas” is the vertebra that links the skull to the spine.After 8 weeks of treatment the blood pressure change was assessed, and was indeed impressive, with the intervention group reducing their systolic pressure by 17mmHg. Even after correction for the 3 mmHg drop in the control group, the remaining 14 mmHg are still impressive…BUT there are a couple of serious question marks.First, the claim of double-blindness is obviously bogus. Double blind means that neither the patients nor the practitioners knew who received the treatment and who received the placebo.With a treatment procedure that “requires special training” and is as elaborate as this chiropractic intervention I would seriously hope that the practitioners who administer the treatment know whether they are giving treatment or sham.It is impossible to more than single-blind this set-up. As a mitigating argument I would accept if the researchers had let a colleague, who was “blind” to the patients’ group status, perform the blood pressure measurements at baseline and follow-up. But nothing of that sort has been mentioned.So, we have to live with the nagging question to which extent the inevitable bias of pro-chiropractic investigators may have influenced the BP measurements at follow-up.This type of slip-up – claiming “double blind” when it is not – tends to trigger my visceral bullshit alarm, which is why I dug a little deeper, and which brings us to:Second, when you compare the figures on tables 1 and 2, there is an inexplicable difference of the baseline systolic blood pressures in the control group.Table 1 reports 149.9 mmHg, whereas table 2 reports baseline sBP to be 145.3. That is a highly significant difference at p<0.01. So which is which?In mitigation it has to be said that neither of these 2 values differs significantly from the mean baseline sBP of the intervention group.That raises the question whether this is just a typo (which I do not believe, as a typo should affect only one digit, not 2) or whether there was some manipulation of data in between the first analysis for table 1 and the outcome analysis reported in table 2. If the paper’s reviewers had been any good, they should have noticed.Also, the reporting of blood pressure at decimal accuracy is rather unusual, as we cannot measure BP beyond a single digit. So, if the investigators apply this level of accuracy, why did they not report the standard deviations (SD) for their outcome measurements and the between-group differences?Not only did they omit the SD, they didn’t offer standard errors or any other measure of spread of the distribution. That is an absolute No-No in statistical reporting. It forces the reader to simply believe the investigators when they claim significance.Third, one of the exclusion criteria was history of previous Atlas adjustment. When you exclude hypertensive patients who previously had an Atlas adjustment, and who obviously didn’t benefit from that treatment in terms of reduced blood pressure, you exclude exactly those who would most likely not show any response to the investigated procedure of Atlas adjustment. Some of them would have ended up in the intervention group (assuming that randomization was truly “random”) and thereby watered down the effect of the intervention.Fourth, in the results section on page 350 they state in brackets that 36% of the control group – those who received the sham treatment - experienced a blood pressure lowering effect of >8mmHg.When more than a third of a placebo group show such a significant effect, then I would expect a discussion of the potential reasons for such an unexpected finding. Again, no explanation is offered.These are exactly the questions that the WebMD author should have raised before writing a glowing endorsement of a procedure that is not even recognised in clinical medicine.Because, mind you, what chiropractors call vertebral subluxation is not a medical condition at all. In medicine subluxation is a partial joint dislocation that is visible on X-ray exams.In the chiropractors’ universe of alternative medicine subluxation is a misalignment of a joint that they define as such but that can’t be seen on X-ray.If you want to try whether the treatment of such “mis-alignment” lowers your blood pressure, then by all means, go ahead. As long as the chiropractor does not totally unhinge your spine, the worst outcome should be no change to BP. And if you are that lucky, then keep checking your blood pressure because you still don’t know how long the effect lasts.One more thing: the paper is 12 years old. It has been cited by only 18 other papers since then, all of them from chiropractic authors. Don’t you think someone in medicine would have noticed by now if this treatment was indeed superior to any drug or intervention of our current anti-hypertensives arsenal?Bibliography1. Bakris G, Dickholtz M, Meyer PM, Kravitz G, Avery E, Miller M, Brown J, Woodfield C, Bell B. Atlas vertebra realignment and achievement of arterial pressure goal in hypertensive patients: a pilot study. J Hum Hypertens 2007;21:347–352.

It is a good idea to say I want to go to medical school on my application to an engineering school (I want to be a chemical engineer)?

Q. It is a good idea to say I want to go to medical school on my application to an engineering school (I want to be a chemical engineer)?Will the fact that I won’t want to say in the chemical engineering field be a “con” on my application? I plan to apply to some big name schools, including Harvard, Stanford, and Columbia.A. Some schools offer Engineering Pre-med curriculum and keep students on track of the needed prerequisites, MCAT, EC’s etc for successful application (for example the University of Arizona.)Columbia University also has a robust engineering pre-med program. Harvard has strong premed advising office. So does Stanford. Although neither geared towards engineering/premed aspirants.The question is: Why do you want a Chemical Engineering Degree and how useful will it be to you in the long run? Second, knowing engineering grade deflation, are you willing to have your GPA suffer and possibly self deselect from pursuing a medical career?For most people, getting accepted to medical school is the ultimate goal. This often requires stellar GPA and decent MCAT scores.A high engineering GPA is difficult to achieve. Although medical school admission committees make an allowance for the difficulty of the major, a low GPA despite best effort will jeopardize any hope of acceptance to medical school.Most people cannot do both. It’s either engineering/no med school or medical school and a more lenient major (perhaps humanities).Engineering to Medicine: The Road Less TraveledPosted by Jonathan Haughton onJanuary 12th, 2014Making the CommitmentGetting an MD isn’t like obtaining other advanced degrees such as a PhD, MS or MBA. You cannot study part time or get it paid for by a company. It is a full-time affair for which you must be completely committed for at least four more years after your undergrad (and probably more for residency/fellowship training). Medical school isn’t cheap either, so you must be prepared to take on (or add to your undergrad) debt.How to Do itYour undergraduate engineering classes (usually) will not cover all of the general course requirements for medical school. This means you’ll have to carefully plan your coursework in order to satisfy the engineering and pre-med curricula as well as any general education classes your school requires. It is not easy but definitely do-able and working with an advisor to develop a multi-year plan will help. Pre-med requirements can vary between schools but will at least include physics I/II, chemistry I/II, organic chemistry I/II, biology I/II and an English or literature class. For those beginning to think about medicine after already completing two or more years of their undergraduate degree, taking an extra year to finish all the coursework and prep is not uncommon. This extra time can also be used to study for the dreaded MCAT.The MCAT is the medical school equivalent of the SAT or ACT you took in high school. It must be taken before you can apply, so this usually means the summer before your senior year. There’s a myriad of references, guides and avenues of support for this ranging from free practice tests to intensive classroom courses. Contrary to popular belief, this test is not about rote memorization. Almost all groups of questions are accompanied by a passage. So if you have a very basic understanding of the scientific principles and equations but excellent problem solving, you will do great. The key words here are understanding and problem solving. Memorizing the equations is pointless, they will give them to you on the test, spend your time understanding each equation’s components. This is a great opportunity for engineering students to show off their problem solving skills!So you’ve finished the courses and taken the test, what now? The application process is started about a year before your planned enrollment date. So, if your graduating in 2014, you would apply in the summer or early fall of 2013. Thankfully, there is a standard application for all schools called the AMCAS, but plan on getting secondary applications specific to each school and working on them into the fall. Then save up some money and pray for interviews.Where Engineering Falls ShortThese days medical schools are looking more and more at extracurricular activities in addition to metrics like MCAT score and GPA. This included things like research, volunteering, shadowing and other jobs. Engineering coursework doesn’t always provide enough time for all of this stuff, but if you pick carefully, the right extracurricular can give you an excellent experience with a smaller time commitment. Academic research can be a volunteer or paid experience, and when done during the academic year, can mesh well with your class schedule since research labs are typically close to classroom buildings so you can go there before, after or in-between classes.The extra pre-med courses have also been known to give engineers some trouble. For many, it is tough adjusting to biology type classes, as they are much more memorization based and less analytical in nature. There is no easy solution for this. Figure out what works for you (flashcards, re-writing notes, etc.). This is also the stuff more likely to be seen on the MCAT, so pay extra special attention to the material.When it comes to the interview, some claim engineers don’t fare as well. Anyone in engineering has heard the stereotype that engineers aren’t the most social of people. While that’s an outdated view of the field, it can be used to your advantage during an interview or application essay. By having an outgoing personality and being animated, lively, witty and generally sociable, you defy the stereotype and make yourself look that much better the to the admissions board or interviewer.All that being said, medical schools look very highly upon engineering applicants. They understand that to be a legitimate applicant, the engineering student has given it their 110%, as evidenced by their ability to succeed in such a demanding major in addition to coursework and extracurricular activities. A career in medicine will be time consuming, stressful and at times you will doubt your ability, but in the end extremely rewarding and well worth it. So, it’s just like a degree in engineering!SummaryThe problem solving skills and engineering mindset so thoroughly developed during your undergraduate degree can prove to be an incredibly useful tool for solving medical cases. The human being is an isolated system, and once that system is defined, you can apply your knowledge of that system to create a solution, just like any engineering question. The rational and systematic route of thinking honed during any study of engineering is ideal for a career in medicine.About the authorChris Bobba received his B.S. in Chemical Engineering for the University of Rhode Island in 2013. He is currently an MD/PhD student at the Ohio State University pursuing his PhD in Biomedical Engineering. Current research interests include the intersection of organ conditioning/regeneration techniques and surgical/transplant medicine.University of Arizona College of EngineeringAcademic Focus AreasUA chemical engineering is one of only a few approved College of Engineering pre-med programs. The three academic focus areas prepare students for careers in a broad range of industries.Environmental is focused on increasing environmental safety in industry and reducing emissions and contaminants in the environment.Biomedical centers around modernizing disease diagnostics and treatment.Pre-medical prepares students to succeed in medical schoolResearch OpportunitiesUA chemical engineers are finding better ways to protect and repair the environment, improve the human condition, and ensure sustainability. And chemical engineering students tend to make the most of studying at a Tier-1 research institution. In fact, more than 90 percent of chemical engineering undergraduates are estimated to be involved in research at some point during their time at the University.Researchers are advancing processes, technologies and understanding in the following areas, for example:Algae-based biofuelsWater treatment and reuseClean semiconductor manufacturingDesalinationSolar energyDrug deliveryCancer detection and treatmentClimate changeOutside the ClassroomNot only is undergraduate research a mainstay of UA chemical engineering, but also many students do internships. Additionally, clubs and organizations play an important role in students’ personal and professional development, strengthening leadership, teamwork and communication skills.The honor society Omega Chi Epsilon promotes creativity, entrepreneurship, professionalism and camaraderie among chemical engineering students. The American Institute of Chemical Engineers hosts social events and provides opportunities for mentoring, tutoring and professional networking. And, in the UA Home Brew club, students put chemical engineering skills to the task with craft brewing techniques.Career PathsUA chemical engineering is known for getting students where they want to go, whether it is a prestigious medical or graduate school somewhere in the world or a career in any number of industries – manufacturing, pharmaceuticals, healthcare, design and construction, pulp and paper, petrochemicals, food processing, specialty chemicals, polymers, biotechnology, or environmental health and safety.Columbia University Premedical CurriculumPREMEDMedical, dental, and other health professional schools prefer that undergraduates complete a four-year program of study toward the bachelor's degree. All health professional schools require prerequisite course work, but they do not prefer one type of major or scholarly concentration. Students with all types of engineering backgrounds are highly valued.It is important to note, however, that each medical school in the United States and Canada individually determines its own entrance requirements, including prerequisite coursework and/or competencies. Each medical school also sets its own rules regarding acceptable courses or course equivalents. It is therefore essential that students plan early and confirm the premedical requirements for those schools to which they intend to apply. The Engineering curriculum covers many of the prerequisite courses required by medical schools, however, in addition to completing the mathematics, chemistry, and physics courses required by the First Year– Sophomore Program, most schools ask for a full year of organic chemistry, a full year of biology, a full year of English, a semester of statistics, and a semester of biochemistry. Advanced Placement credit is accepted in fulfillment of these requirements by some schools but not all. Students are responsible for monitoring the requirements of each school to which they intend to apply. Generally, students with Advanced Placement credit are strongly advised to take further courses in the field in which they have received such credit.In addition to medical school requirements, all medical schools currently require applicants to sit for the Medical College Admissions Test (MCAT). A new format of this exam was introduced in the spring of 2015, for which recommended minimum preparation is:One year of general chemistry and general chemistry labOne year of organic chemistry and organic chemistry labOne year of introductory biology and biology labOne year of general physics and physics labOne semester of introductory psychologyAs you prepare for this path, you should consult regularly with both your assigned adviser and one of the premedical advisers in the James H. Christine Turk Berick Center for Student Advising. These individuals will help to guide you in your course selection and planning, and introduce you to extracurricular and research opportunities related to your interests in health and medicine. Preprofessional Advising maintains an online list of many different clinical volunteer and research opportunities across New York City and beyond. Exploration of the career and sustained interactions with patients is viewed by many medical schools as essential preparation and therefore students are strongly encouraged to spend time volunteering/working in clinical and research environments before applying to medical school.Students must apply for admission to health professional schools more than one year in advance of the entry date. Students who are interested in going directly on to health professional schools following graduation should complete all prerequisite courses required for the MCAT by the end of the junior year. It is entirely acceptable (and most common) for students to take time between undergraduate and health professional school and thus delay application to these schools for one or more years. Students planning to apply to medical or dental school should be evaluated by the Premedical Advisory Committee prior to application. A Premedical Advisory Committee application is made available each year in December. For more information regarding this process and other premedical-related questions, please consult with a premedical adviser in the Berick Center for Student Advising or peruse their websiteFAQ for Preprofessional AdvisingMaking the Cut: The Real Pre-med Requirements (Harvard University Crimson)The story of droves of students entering college expecting to be pre-med, but later switching tracks—whether because of the rigor or the draw of other disciplines—is a familiar one. However, at Harvard unique factors play into this whittling down of aspiring doctors.by LIBBY R. COLEMAN Sep 26, 2013Students file one-by-one into the green seats of Science Center B’s lecture hall. They sit down, pulling out laptops or legal pads, sometimes problem sets to complete in class. A constant hum of gum chewing, chair-shifting, and text notifications is amplified against the walls.The room has yet to quiet down when Life Sciences 1a, Harvard’s 448-person introduction to chemistry, molecular biology and cell biology, begins with an unwelcome announcement.There will be a “little quiz” in section. Students in the packed lecture hall respond to the news with a loud groan.“Don’t you want to know how things are going?” molecular and cellular biology professor Robert A. Lue calls back. The class responds with a resounding “No!”Lue reasons, “It’s important to diagnose how everyone’s doing.” He tailors his word choice to the make-up of the class. Diagnosis is a familiar concept to these students, many of whom are interested in attending medical school.Often taken as the first of many pre-med required classes, LS1a introduces Harvard freshmen to the academic life of a pre-med. While many of the students in the lecture hall believe that they will go to medical school, between one and two thirds of them will end up dropping the program.The story of droves of students entering college expecting to be pre-med, but later switching tracks—whether because of the rigor or the draw of other disciplines—is a familiar one. However, at Harvard unique factors play into this whittling down of aspiring doctors.Although Harvard offers a robust pre-med advising program in the Houses, many pre-meds struggle freshman year, when they say that advising is less structured. Later on, a variety of factors—from alternate disciplines and academic communities that are perhaps less grade-obsessed or more diverse, to more lucrative careers that require less up-front time investment—draw students away from the path towards medical school.Learning The RopesThe Office of Career Services estimates that a quarter of the incoming class each year is “exploring medicine.” This data is based on annual attendance at Opening Days events aimed at students considering pre-med and pre-health careers.However, popular wisdom among Peer Advising Fellows says that the proportion is closer to 50 percent. “Half of them are pre-med, or more,” says Khin-Kyemon Aung ’14, who is a PAF and president emeritus of the Harvard Pre-medical Society.OCS estimates that, ultimately, 17 percent of a given class will apply to medical school.As is the case at most of its peer institutions, Harvard does not offer a pre-med concentration, secondary, or citation. Rather, the school suggests that students take a particular set of classes before taking the MCAT or applying to medical school.Currently, most medical schools require students to take one year of biology, one year of general chemistry, one year of organic chemistry, one year of general physics, and one year of English. On top of these requirements, medical schools expect applicants to have leadership experience and strong extracurriculars.These requirements offer some framework, but the open-endedness can leave students unsure of how to navigate their courses or envision what it means to be a strong candidate for medical school.“They would like to come in here and have us just hand them a checklist,” says Robin Mount, Director of Career, Research, and International Opportunities at OCS. “But there isn’t the checklist for life.”While all undergraduates benefit from advising, freshman pre-meds seem to be particularly in need of guidance. Myths abound regarding both Harvard’s pre-med track and the medical school application process.Though OCS advises that there is no correct pre-med mold, Aung has noticed that many pre-meds spend freshman year trying to live up to what they believe pre-meds should do.“You’re asking: ‘What should I be doing?’” Aung says. “Everyone’s very eager and enthusiastic and it’s great, but it also leads to individuals really wanting to follow the set path.”Christian Ramirez ’15 entered Harvard expecting to be pre-med after spending time on his parents’ farm in rural Ecuador. He came face-to-face with the lack of health care in the region, which sparked the idea that he might want to later work for Doctors Without Borders.So, falling in step with his fellow pre-meds, Ramirez enrolled in LS1a his freshman fall. Ramirez’s freshman advisor, with whom he had little contact, quickly approved his course selection.“My freshman advisor really didn’t do much, to be completely honest. I don’t even remember his name,” Ramirez says. “He told me to take things that I already knew I had to take as a pre-med.”In hindsight, Ramirez realizes that he should have instead taken the alternative course, Life and Physical Sciences A, a more foundational class that also fulfills pre-med requirements.However, Ramirez explains that “people are coming into this with the idea that they’re too good for LPS A.”After his freshman fall, Ramirez decided to quit the pre-med track when he realized he no longer wanted to be a doctor. On top of disliking LS1a, Ramirez also discovered a passion for studying classics. In making his decision, he did not reach out to Harvard’s pre-med advising network.Although pre-med advising for freshmen exists in the form of OCS drop-in hours, pre-med events, and freshman advising (albeit without mandatory scheduled check-ins), the system requires students to be proactive about seeking advice.“As a freshman, I had no idea what to do,” says Katie C. Gamble ’15, a social studies concentrator, Peer Advising Fellow, and former pre-med. She wears a sweatshirt after staying up late to finish a paper for a social studies course. “You definitely have to do some work to get access to the advising,” she says. “It’s great and it’s there but you have to know what you’re doing to get to it.”Without a highly structured advising system, freshmen are more likely to worry that, for example, a bad grade in one class spells disaster for their medical school application. Their preconceptions about the model pre-med student are more likely to inform their decisions about classes, extracurriculars, and whether to be pre-med at all.Kruti B. Vora ’17 volunteered at Newton-Wellesley Hospital the summer after ninth grade. She loved it and the experience inspired her to pursue a career in medicine.However, two weeks into the school year, Vora says that she is still unsure how pre-med advising works.“I don’t know too much yet about pre-med advisors and who I’m supposed to talk to specifically about pre-med advising,” Vora says. “I saw some things at the Activities Fair that would pair me with hospitals and volunteer activities.”One such group is the Harvard Pre-medical Society, whose purpose is to be “a student-run organization at Harvard College committed to providing educational support and volunteer opportunities for the campus pre-medical community.”Grace ’15, who was granted anonymity by The Crimson because she did not want her comments to affect medical school applications, decided to be pre-med sophomore year. She has noticed that Harvard’s peer pre-med advising cannot fill in all of the gaps left by an incomplete freshman advising system. “The Pre-med Society has to use their own people and they have juniors and seniors who mentor freshmen, but seniors and juniors haven’t applied to medical school, so it’s really just a shot in the dark,” Grace says.Grace believes that if she had entered her freshman year as a pre-med, she would have dropped out. “I would have done all those things I think you’re supposed to do and wouldn’t have done the things I’m interested in like theater because I would have thought, ‘No, I have to do the pre-med stuff to get into medical school,’” Grace says.Harvard’s pre-med advising is led by the OCS’s two pre-medical advisors, Oona B. Ceder ’90 and Sirinya Matchacheep. Students say that meeting with Ceder and Matchacheep can be remarkably helpful. But the two of them are responsible for all pre-med students at the College, not just freshmen, which means that younger students sometimes take a backseat to those who are currently applying to medical school.“If you want an appointment with them, it’s often backed up for weeks,” Aung says.The choice to have less structured freshman pre-med advising stems from Harvard’s philosophy that students should keep their options open freshman year, as well as its commitment to providing a liberal arts education.“If we had pre-med advisors—this is the way everything is at Harvard—we’d have people saying where are the pre-law, where are the engineering advisors?” Mount says.Once in the House system, students are each assigned a pre-med tutor, which results in more individualized guidance and support than freshman year. “Harvard’s pre-med advising within the House system is incredibly strong compared to other schools,” says Joshua H. St. Louis ’09, who is now in his last year of Tufts’ MD/PhD program. The House advising system offers assistance including mock interviews, personal statements, and advice on application deadlines.However, many freshmen drop out of pre-med before they are even given access to the strong Harvard House advising network. At the cost of encouraging greater exploration, pre-meds are left largely on their own freshman year to grapple with the realities of being pre-med.A Lack of CommunityMany of those who have remained on the pre-med track find that there is a lack of community and pride among pre-meds. These students explain that strongly identifying as pre-med will lead peers to judge them as cut-throat, intense, and grade-obsessed. Therefore, they often socialize outside of the pre-med community, prioritizing their concentration or their extracurriculars.“You want to express your passion for medicine, but you don’t want to be a stereotypical pre-medder,” says Anna ’16, a pre-med who was granted anonymity by The Crimson because she did not want her comments to affect medical school applications. “It creates a very anti-intellectual community.”For Grace, being identified as pre-med takes on the form of an insult. “People are like, ‘Do you do social studies?’ And I’m like, ‘Oh my gosh I wish, thank you for thinking that. I wish I was that cool,’” Grace says. “It’s kind of a badge of shame to be called a pre-med.”Because of the negative connotations surrounding the pre-med personality, many students on the track to medical school actively seek out the company of non-pre-meds. St. Louis says that as an undergraduate, he “found [pre-meds] to be super stressed out and always wearied.” He remembers working with a friend in Cabot Science Library on Friday afternoons alongside a table of pre-meds, sobbing and breaking down as they worked frantically up until the 5 p.m. problem set deadline.St. Louis ultimately decided to distance himself from the pre-med community: Of his four roommates at Harvard, only one other was pre-med. Because his concentration—Organismic and Evolutionary Biology—and his roommate’s—Mind, Brain, and Behavior—were not the quintessential pre-med concentrations like Molecular and Cellular Biology and Neurobiology, they didn’t have much contact with pre-meds outside the required curriculum.St. Louis says that many of his friends who were devoted to helping people wound up falling off of the pre-med track, whereas those who stuck with it were largely driven by money or parental pressures. “I felt like most of them weren’t really going into medicine for the same reasons that I was,” St. Louis says, referring to his peers who continued on the pre-med track.Hillary ’13, who was granted anonymity because she did not want her comments to affect medical school applications, also expressed discomfort with the motivations of her fellow pre-meds. “You’ve got everyone trying to get A’s in a class where they give out like five to ten percent A’s and the rest B’s and a few Cs,” Hillary says. Although she stayed with the pre-med program, this mindset meant that she “didn’t want to be around pre-meds 24/7.”Although Hillary originally declared MCB as her concentration, she later switched to History and Science, which she says has fewer pre-med students. “I wanted to experience other people, and experience other concentrations,” Hillary explains.For some pre-meds, the fragmented nature of Harvard’s pre-med community causes them to rethink their intent to apply to medical school. “I think I’ve realized, if I really don’t like the pre-med culture, then med school is really just a bunch of pre-meds. That’s all there is...It makes me re-evaluate if that’s a culture I want to be in for the next however many years,” Grace says.For Grace, this lack of camaraderie might be endemic to a program in which few students are fully engaged in their coursework. “I think every concentration has one or two requirements people aren’t thrilled about but have to do. But pretty much every pre-med class, people aren’t excited about.”A For Application“One could argue pre-med students do obsess on the specificities of the grade,” Lue says, referring to his LS1a students. “Because pre-med students are worried about their ability to get into medical school, there may be a little bit more focus on that.”Harvard’s advising staff emphasize that one or two bad grades will not sink a medical school application. According to OCS’s medical school admissions data, Harvard pre-med applicants with a 3.50 GPA or higher had a 93 percent acceptance rate to medical schools in 2012.Ceder says that she sees “many students who come in with a couple of B minuses or a C+ or even a B or a B+ and they’re concerned that this is now going to keep them out of medical school.” Medical schools, she says, are more interested in “the passion vocation piece”—commitment to a sport, for example—than simply straight A’s.But pre-med students are not just concerned about getting into a medical school: They want to get into the best medical schools.As a result, students often choose concentrations and courses based on what will do the most to boost their GPA. “When you’re choosing Gen Ed, you’re choosing them to get A’s. Generally people will be like, ‘I just need the A for medical school,’” says Sasha ’14, who was granted anonymity by The Crimson because she did not want her comments to affect medical school applications.In the lab component for some of her pre-med courses, Hillary encountered lab partners who were driven almost entirely by their medical school aspirations. “If you didn’t do the one extra question on the lab report, you were a bad lab partner and would bring down the whole group and then the whole group wouldn’t get an A and then everybody would be upset,” Hillary says.One consequence of this obsession with good grades is a less intellectually diverse pre-med community. “I think they’re discouraging people who could potentially bring something new to the table in terms of scientific innovation,” Ramirez says.If Not Med School…Harvard students are also pulled away from the pre-med track by the appeal of more lucrative jobs, such as finance or consulting, which hire straight out of college. These career paths offer the dual incentive of high compensation and immediate reward. Students are looking at earning between $50,000 and $100,000 the year after graduation, rather than paying tuition for four years of medical school, followed by a residency of up to seven years.Gamble, who was pre-med until the end of her freshman year, says that the delayed benefits of medical careers played into her decision to pursue an alternate path. In high school, she worked with a reconstructive surgeon. While learning the ropes, Gamble encountered a 35-year-old resident with two children, which “really threw [her] off,” Gamble says. She had trouble imagining herself trying to raise a family while still training for her profession.She is now aiming to get a job in consulting after graduation. “It’s something I discovered that I really, really like a lot,” Gamble says. “I know I obviously want to do something I love, but I also want to make a fair wage.”“I realized that kind of career timeline didn’t align with what I want in a career,” Ramirez says, echoing Gamble. “Time for me is really important, and I don’t want to wait until I’m forty.”For those students who decide to delay applying to medical school—whether to take a break from academics, or to help finance their medical school tuition—the timeline to becoming a doctor is even longer. As a result, many Harvard students decide to get consulting or finance jobs because of the compensation, with the full intent of later applying to medical school.In addition, these companies often don’t have any structured requirements for their entry-level positions. “I know people with no business experience who started consulting after graduating,” says Jen Q. Y. Zhu ’14, who decided to stop being pre-med with one requirement left.Pre-med students have to weigh the cost—in both time and money—of pursuing a medical career against the attractiveness of other careers that can promise larger paychecks immediately.Is it Worth It?Clearly, not all pre-meds who enter Harvard expecting to be pre-med will graduate and go to medical school. According to Ceder, one of the OCS advisors, students must ask themselves, “Do I need the MD to do what I want to do?”For many, the answer is no. Some have become disillusioned, others discouraged, the path to medical school looking less attractive than they had first imagined.This shift away from the pre-med track is already apparent for some at 2:30 p.m., when Robert A. Lue’s LS1a lecture is about to go overtime. A few students quickly pack up their bags and climb over their peers to head elswehere. Most, however, stay to hear the professor’s final thoughts. After all, the concepts might appear on a future exam.After a few moments, Lue wraps up and Science Center B becomes fully alive again. Students huddle afterwards. Some talk about pre-labs. Others admit that they “weren’t paying attention the whole first half.”Most ReadRecord 39,494 Apply to Harvard College Class of 2021Univ. Subcomittee Considers Mimicking Housing at Yale

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