How Genomics and Clinical Data Intertwine

John Quackenbush Harvard, John Quackenbush Dana Farber

John Quackenbush, Ph.D.

John Quackenbush, Ph.D., is a leader in genomics research.  A professor of Computational Biology and Bioinformatics and Principal Investigator at the Harvard School of Public Health and the Dana-Farber Cancer Institute,  he recently spoke with us to discuss the latest research on how genes can influence patient care.

By using better diagnostics, we’ll be able to better predict the progression of disease and be able to create treatment plans with better outcomes for patients.  Watch the video below for more specifics.

Some of the topics covered with Dr. Quackenbush include some pointed commentary, including:

  • Genomics isn’t Big Data, but that’s not the point
  • The complex relationship between genetics and  disease
  • Is it too early for consumer genetics?
  • How research of future treatments can help clinicians today
  • Obesity, diabetes and genetics
  • Obamacare, funding and the state of research

Sermo Speaker Series

A fixture of Sermo for several years, our Speaker Series brings experts from around the healthcare industry to provide exclusive content to Sermo and its membership.  This blog post is a preview of a more in-depth Speaker Series engagement Dr. Quackenbush will be providing as he engages our members directly in a few weeks.

What do you think about genomics in the clinical setting?  Have you used it in your practice to help your patients?  Are you looking forward to what will come down the road in just a few years?  If you’re an M.D. or D.O., please join our upcoming Sermo Speaker Series discussion and other conversations inside Sermo.



How Prescriptions Get Switched Legally

prescription reading directions

Nearly ¾ of Americans say they’d be concerned if their medication was switched without their consent or the consent of their doctor. However, a common practice called therapeutic substitution allows pharmacists to switch a patient’s drugs as long as they’re in the same pharmaceutical class.

What is Therapeutic Substitution?

Therapeutic substitution is designed to reduce costs to drug plans by limiting coverage to the cheapest product. This can affect patients starting a new medication or those who are filling a prescription they’ve had for some time.

The policy assumes that medications in the same therapeutic class are interchangeable because their mechanisms of action don’t differ significantly, despite slight differences chemically.

Pharmacists can fill the cheaper option without consulting the physician or patient.

This practice is regulated and varies for each state according to their individual Pharmacy Practice Act. There are essentially four different options:

  • The positive formulary approach – a list of generic drug products are provided that can be substituted for one another
  • The negative formulary approach – a list of drug products is provided for which substitution is NOT allowed.
  • Combined positive and negative formularies – both of the above lists are provided
  • A “nonformulary” approach – pharmacists must ensure that substitutions are made within the requirements of state law (often as defined by Orange Book A-rated products)

In addition, health insurers often offer incentives to pharmacies to participate in this practice. This often leads to individual pharmacists having to meet certain quotas or goals on how much money is saved or how often a certain drug was substituted.

How does this affect patients?

The American Academy of Family Physicians strongly opposes states allowing therapeutic substitution. Therapeutic differs from generic substitutions because generic substitution can only be done legally if the product contains the same chemical components as the brand name product. They must be bioequivalent.

The risks of therapeutic substitution can be high as the replacement drug may not work as well, or it might work differently. It could have different side effects, and/or interact differently with other medication or foods.

Potential benefits include lower cost, and possible convenience (you may have to take it less often, etc).

What should patients do?

While pharmacies are regulated by the insurance companies in terms of having to fill a cheaper prescription option, patients do still have control over what medications they use. It’s important to always pay attention to the prescription your doctor provides and what prescription is actually filled.

If you find a prescription has been substituted:

  • Ask you pharmacist why. Is the other drug not covered by your insurance? Or is this one just cheaper?
  • Contact your doctor to see if they feel the switch is okay. For many drugs and patients, the change may have no negative effects.
  • If you talk to your doctor and they do not advise the switch, have them re-write the prescription or contact the pharmacy and specify that no substitutions can be made for medical reasons

If you do proceed with switching your medication, be sure you review if there is any change in potential side effects or interactions, so you know what to look out for.

As a physician do you think substitutions are acceptable or should they be avoided? Have you ever had an issue with a patient outcome because of a switched medication? We’ll be discussing this and more clinical topics inside Sermo, if you’re an M.D. or D.O. please join us.


Should Physicians Be Drug Tested?

should doctors be drug tested, should physicians be drug tested

Greg House M.D. is a fictional character, a mastermind diagnostician with a vicious Vicodin addiction. During the series, we watched his slow transition from user to abuser, from clean to relapse, as he struggled with his demons and his pills.

In fact, physicians have about the same addiction rates, or slightly higher, than the general public. Overall about 10 percent of physicians have suffered through an addiction problem at one point in their careers.

Physicians Face Different Addiction Issues

There is a significant difference between the drugs of choice for doctors and non-doctors. Physicians abuse prescription drugs five times more than the lay public. One study found that 69 percent of physicians with an addiction problem chose prescriptions.

According to an NIH study, physicians’ addictions can often be more advanced than the general public before detection. The researchers write, “This delay in diagnosis relates to physicians’ tendency to protect their workplace performance and image well beyond the time when their life outside of work has deteriorated and become chaotic.”

Should we drug test doctors?

A recent poll shows public support for drug testing physicians. Currently, a few hospitals require drug testing, either upon hire or randomly during employment. Our own Sermo Physician Poll shows that only 35% percent of physicians support drug testing for their profession.

California is currently validating signatures for a ballot question voters will likely see this fall. The bill is modeled after Federal Aviation Administration drug testing policies and would require random drug testing with hospital privileges and testing after adverse events such as preventable death.

A trio of physicians wrote in JAMA this past year that drug testing should be mandatory, especially after sentinel events where a patient dies unexpectedly or suffers serious harm from medical treatment.

Is It the Right Thing To Do?

The physicians inside Sermo who were opposed to the idea stated privacy rights and the dire consequences physicians face if caught. They argued for compassion over punishment.

One surgeon said, “In every drug related case of impairment that I have seen in the last 35 years or been directly involved with, the professional who was having an issue gave obvious clues that were addressed by their colleagues or superiors prior to any patient harm.”

A family practitioner noted, “this seems to be a completely misguided ‘solution’ to a problem that may be real, but has a lot of other, and more effective, potential solutions.”

The ACLU opposes any drug testing citing high program costs, inaccuracy of tests, and privacy issues.

What do you think? Should we test physicians and other health care practitioners (HCPs)? If not, why should HCPs be exempt from drug testing?  This topic has generated a lot of conversation inside Sermo, if you’re an M.D. or D.O. please join us inside.

Kids and Screen Time

kids watching tv

Children spend more time watching a screen than they do with parents, teachers or any other influence. The siren call of a glowing blue electronic device can have dire consequences; from sleep disruptions and obesity to psychological health, we need to look at how screen time affects our kids.

Sleep Disturbances

A recent study of 1,700 children between the ages of two and nine found a direct correlation between screen time and sleep disturbance. Children slept 20 percent less with 1.5 hours of TV per day and sleep loss continued to increase with additional screen time. Sleep duration did recover with fewer viewing hours.

Parental Monitoring is Key

Another study published last month in JAMA Pediatrics found that increased monitoring by parents reduced children’s total screen time. Better monitoring meant children slept better and performed better in school. Researchers found that adequate sleep correlates to lower body mass index (BMI). Finally, with less exposure to violence through screen time, children had increased positive behavior and decreased aggressive behavior.

Are Age Limits Realistic?

A co-author of the 2011 American Academy of Pediatrics (AAP) screen viewing guidelines came out publicly last month to question the stance that there should be no screen time for children under the age of two. Explaining that the guidelines were formed well before their 2011 publication, Dimitri Christakis, M.D., M.P.H writes, “The timing is notable because the iPad debuted in April 2010, meaning that the statement was drafted with no knowledge that such a device would ever exist.”

He continues, “There are many ways in which iPads and traditional toys differ from traditional passive media. Therefore, there is a strong theoretical foundation to posit that the AAP recommendations regarding medical for children younger than the age of two years should be be applied to these newer media.”

While Christakis would still advocate for an engaging book over new media, he wonders if there is a small place for devices that actively engage young children and can help them grow developmentally.

What Can Physicians Do?

Entertainment media comprises up to seven hours of a child’s day. The AAP suggests:

  • Limiting screen time to no more than one-to-two hours per day
  • Watching television with children so care-givers can guide content
  • Keeping screens out of childrens’ bedrooms
  • Encouraging outdoor play, reading and other hobbies

As a physician, do you discuss screen time with your patients and their families? Have you noticed a correlation between obesity and/or behavioral issues and screen time? Do you think there are any positives to screen time? This is a big topic of conversation inside Sermo, if you’re an M.D. or D.O. please join us.


Is Autism Really 1 in 68? We look at the numbers

autism puzzle pieces

The CDC made headlines last month when they announced that Autism rates have risen by 30 percent, now one in 68 children can expect an autism spectrum disorder (ASD) diagnosis.  Headlines blared, parents expressed grave concern, and calls for “solutions” echoed around the internet.

But let’s all take a breath. The first 2007 CDC report estimated autism at one in 150 children. These revised numbers look at data through 2010, but a lot has happened since then.

Diagnosis Creep

Our Sermo physicians have discussed the phenomena of diagnosis creep. As the medical community learns more about ASD there is a spike in diagnoses. Essentially cases that previously would have been dismissed, now receive a diagnosis. Other suggested reasons for the increase in diagnosis:

  • Children receive ASD diagnoses from providers who are not properly trained
  • An increase in older parents may contribute to the problem
  • An increase in maternal stress during pregnancy

It’s a whole new DSM-5

The fifth edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) released nearly a year ago changed several aspects of autism.   The criteria for diagnosis simplified and raised the bar for those who fit the newly named autism spectrum disorder. The Task Force Chairs discussed the reasons for their changes here. One reason for the changes was to tighten and clarify the diagnosis of what is and isn’t autism.

The DSM-5 also recommends that those who received an autism spectrum diagnoses under DSM-IV-TR guidelines be grandfathered and continue with treatment and support options already in place.  The current guidelines should apply only to new diagnoses.

Columbia researchers completed a systematic literature review and meta-analysis to see the impact of the new guidelines. The study found 31 percent fewer ASD diagnoses using the DSM-5 compared with its predecessor, the DSM-IV-TR.

Is This Even a Responsible Study?

The CDC’s data is four years old and doesn’t reflect the recent DSM-5 changes. Early indications are that the diagnoses will decrease significantly under the new guidelines. Did the CDC act responsibly when they released this study, knowing the parameters are outdated?

As a physician what do you think about the changes in criteria? Have you found the new guidelines more helpful or did you prefer the DSM-IV-TR? We will be discussing this inside Sermo, if you’re an M.D. or D.O. please join us.