Tag Archives: FDA

Controlling the Costs of Innovation: Let’s Refocus and Remember The Patient

In a controversial study released this week, Tufts University’s Center for the Study of Drug Development estimates that the cost to bring a new drug to market exceeds nearly 2.6 billion dollars.  The study, which was 40% funded by industry has been criticized for over estimating these costs in favor of industry and misrepresenting some cost estimates.  While we will not know fully the extent of the methodology of the study until later in 2015 when it is published in a peer reviewed journal, these preliminary findings were released in advance and have already begun to spur debate.

However, irrespective of these criticisms, I believe that the study does have merit and brings an important issue forward—is the FDA stifling innovation with excessive fees and paperwork?  Are smaller, less well funded researchers/corporations unable to significantly contribute without partnering with big pharma? Who will ultimately bear the increased cost of drug development?

Innovation is what has always made healthcare in the US great–it is what separates us from the rest of the world.  For decades, the US has been able to attract talent from throughout the world and this has resulted in numerous “game changing” breakthroughs in medicine.  Through continued development of new drugs, new technologies and new ways to better treat disease, we are able to improve outcomes and reduce death from preventable disease.  The US has always been a place where others from around the world have come to incubate and grow ideas.  Now, it appears that innovation must come at a substantial cost–the increasing capital required for drug development as well as taxes on medical device companies only serve to squeeze out the “small guys with big ideas” and limit our ability to continue to produce new, more effective therapies and cures.  In addition, these additional costs to the pharmaceutical industry are not simply added to their bottom line–they are pushed on to the healthcare consumer as well as Federally funded healthcare plans.  Ultimately, the taxpayer bears the brunt of the increased cost.

The process of drug development is long and arduous.  Government regulation, politics and greed have served to make it even more difficult.  Physicians in academic medicine, scientists, pharmacologists and leaders in industry have learned to partner and share ideas in order to bring basic science principles from the bench to the bedside—ultimately translating ideas into cures.  Certainly, big pharma is in place to make profits and increase market share.  But as costs increase, many drug makers are putting less and less profit back into research and development.  Growth can become stagnant and new ideas may never reach the bench or bedside.  Federally funded research–such as NIH grants–face big cuts and budgets are often embroiled in political battles.  Legislators use research dollars as bargaining chips and fund projects that appeal only to a particular interest group or a group of favored donors.  We must find a better way to promote medical innovation and reward research.  We must find better ways to choose the most promising projects for funding.  We must be good stewards of the R & D dollar and make every single investment count.

As with most things in medicine, we must always pause and remember to focus on the patient.  Advocating for the patient suffering with disease is the reason most of us became involved in medicine in the first place.  Whether the study from Tufts over-estimates the cost of development or not, it should still serve as a wake up call to us all.  We must work to control the cost of developing new therapies—we must limit excessive taxation, we must promote entrepreneurship and begin to fix the current system of FDA approval for new therapies.  We must separate politics from medicine and streamline processes—eliminate paperwork and promote efficiency–if we are to continue to lead the world in medical innovation.  We must continue to make room for the “small guy with the big ideas”–If we do not–ultimately it will be our patients that suffer in the end.


Evaluating and Implementing New Technologies: Are We Allowing PR and Marketing To Outweigh Concerns Over Patient Outcomes?

Now, more than ever, hospitals are competing.  Competing for doctors, competing for patients, competing for technology and services.  On television and radio, there are commercials that tout the experience or super-advanced technological offerings of one hospital system over other competing institutions in a given area.  Marketing and “show and tell” ads are aimed at the medical consumer in order to bring them thru the doors to seek care.  Sometimes hospital systems purchase technologies that are likely not cost effective (or even equal in efficacy to older technologies)  in order to “keep up with the Jones” across town.  Some of these expensive devices quickly end up under a layer of dust in the corner of a storeroom (after the TV commercials have been filmed of course).  More concerning, however, is that at the time some of the devices are purchased, no active staff member has been trained to use them.

As most good businessmen and women are trained to do, hospital administrators quickly begin to push for the equipment to be utilized in order to produce an acceptable return on investment (ROI).  Physicians are sent to “training courses” in order to gain experience by observing a number of cases in a center that has become adept at their use.  Although there are some limited “hands on” experiences, nothing substitutes for intensive training and proctoring in the operating room under the tutelage of an experienced surgeon (not a weekend course in Mexico).

A great example is the advent of the DaVinci surgical robot technology.  In the last several years a big selling point for hospitals in my area was the ability to showcase a “robot surgery”. With the introduction of the Da Vinci surgical system, every institution in my area began scrambling to be the first to offer the “robot”.  Physicians began to familiarize themselves with the technology and devise ways in which to utilize the device in their surgical practice.  In my institution, cardiologists and cardiac surgeons began to collaborate in order to find ways to utilize the device in the implantation of Bi-ventricular Implantable Cardioverter Defibrillators (specialized pacemakers that protect from sudden cardiac death and improve heart failure symptoms).  We found that the minimally invasive attempt to attach the special device to the left ventricle often resulted in a prolonged, ultimately open (standard) procedure in order to get the job done.  We abandoned the technique due to the fact that the previous techniques were clearly superior.  Other specialties such as urology were able to find applications such as prostate surgery that seemed to work well in the appropriate patients.  But, this is not always the case–reports have surfaced across the country involving the use of the robotic approach in less than ideal candidates.

Don’t get me wrong, innovation is never a BAD thing–however, pushing patients to have procedures with a particular piece of equipment in order to gain experience or satisfy hospital administrators certainly is.  As reported last year in the New York Times, many patients have suffered harm and had serious complications related to inexperienced operators.  Even more disturbing is that sales representatives for companies such as DaVinci have been implicated in manipulating surgeons and surgical schedules in order to gain cases and increase company revenue.  (see my blog about salesmen in the OR here)

In the New York Times this week, an article investigating the  concerns of robotic surgeries was published.  It appears that the company responsible for the DaVinci device may have been underreporting adverse events related to its use.  In medicine, the collection of data is essential to advancing the science.  When new techniques are utilized, it is critical that we are able to examine both the positive and the negative outcomes in order to learn how best to apply new techniques in order to improve the health of our patients.  There have been numerous studies of the DaVinci system and its effectiveness (and complications) conducted over the last 10 years and many have demonstrated serious flaws and generated real concerns.  In fact, as mentioned in the New York Times article, an anonymous survey of surgeons in 2010 reported a 56% rate of “irrecoverable operative function”.

In what industry or business is a 56% failure rate acceptable??? Certainly NOT in medicine when human lives are concerned.  What exactly is the FDA doing about this?  It seems that they have issued a “stern letter of warning” to physicians and hospitals concerning underreporting of complications related to robot surgeries–sounds like “double secret probation” from National Lampoon’s Animal House to me….

We must rethink how we evaluate new technologies and HOW and WHEN we adopt them.  Innovation is key–we must continue to test and evaluate new ways to treat disease in order to advance care for our patients.  But HOW we go about this process is the critical piece of the puzzle.  Rather than looking for the latest and coolest new “toy”, we must carefully examine risk and benefit of these new technologies before we completely abandon the tried and true therapies of old.  FDA regulation is likely NOT the best answer–good judgement and real concern for patient safety by physicians and healthcare systems is more likely to produce better decisions about best practices and standard of care in the future.