**Lasker Forum on Ethical Challenges in Biomedical Research and
Practice**

**[Surgery]{.underline}**

**Case Study**

**For Discussion Only**

**May 2003**

***Background.*** Dr. Wizbang is a cardiac surgeon with both medical and
engineering degrees who devotes his academic career to improving the
efficacy and safety of surgical procedures. He has made an international
reputation as a surgical innovator. He holds many surgical device
patents and his surgical techniques and devices routinely become
standard in the cardiovascular field. His surgical program, which is
based at a leading university teaching hospital, is routinely inundated
with requests by other surgeons seeking training in advanced surgical
techniques and his residency program is one of the most popular in the
country. Hospitals and surgeons know that if they can offer the advanced
surgical procedures perfected by Dr. Wizbang, they can expand their
practices and their professional revenues. Consequently, competition in
this field is intense.

***Dr. Wizbang Innovates***

Dr. W.'s newest innovation involves a technique and modified
microsurgical devices for a new form of non-invasive cardiac surgery.
This system is intended to allow surgeons to perform heart surgery
without opening the chest and without stopping the heart. Normally,
cardiac surgeries require that the chest be cut open from the clavicle
to the abdomen, the breastbone split apart, and the rib cage spread open
to expose the heart. Because of this massive intrusion into the chest,
many of the complications and most of the trauma, pain, and
rehabilitation time are attributed to this aspect of cardiac surgery. To
eliminate the open chest complications, Dr. W. and other surgeons had
previously developed surgical devices and techniques that allowed many
of the same surgeries to be performed with so-called "closed chest" or
"minimally invasive" techniques. These techniques involve the use of
mini-cameras and surgical tools on wires that are passed to the heart
through several small chest wall incisions. Surgeons manipulate the
surgical tools and view the operative site indirectly by looking at a
monitor that contains the images from the mini-cameras. Both open and
closed chest cardiac surgeries require that the heart be stopped during
the cutting and sewing phases of the procedure. First, drugs are used to
stop the heart's beating and to cool the organ. Then, a cardiopulmonary
bypass machine is used to oxygenate and circulate the patient's blood
while the heart is stopped. The principle risks of the bypass aspect of
the surgery are brain and kidney damage from lack of adequate blood
perfusion and a generalized inflammatory response that can damage many
organs.

Dr W.'s current innovation allows him to avoid both the open chest and
bypass complications. He has perfected in animals the ability to perform
closed chest cardiac surgeries while the heart is still beating. This is
considered a major achievement but takes considerable surgical skill
since operating on a beating heart makes it much more difficult to cut,
guide instruments, and sew with precision. Dr W.'s breakthroughs are
especially important since cardiac surgeries are more often performed on
older and sicker patients who are at higher risk from both the open
chest and bypass procedures. Dr. W. is looking forward to introducing
his new techniques and to the resultant decline in mortality and
morbidity associated with many cardiovascular surgical procedures.

1.  Should the first people who submit to new surgical procedures be
    considered human subjects or patients?

2.  Does Dr. W. have a responsibility to submit his surgical procedure
    innovations to the medical school IRB[^1] and proceed with his
    initial human surgeries under a research protocol? What would be
    gained by going this route? What lost?

3.  Even if he does not proceed under an IRB-approved research protocol,
    does Dr. W. have an obligation (to the surgical profession? to
    prospective patients?) to collect and disseminate clinical practice
    outcome data on his new procedure?

***The surgical devices***

The surgical tools developed by Dr. W. for the new procedure are
approved by the FDA through a process in which the devices are shown to
be substantially equivalent to approved marketed devices used for closed
chest surgeries. This FDA approval process does not require that the
devices undergo safety and efficacy testing in humans prior to
implementation. The devices are eligible for this accelerated approval
process since Dr. W. had modified existing approved devices to fit the
needs of beating heart surgery. The device innovations are coupled with
Dr. W.'s advances in surgical technique (Dr. W. uses the devices in
different numbers and in different ways), which is an unregulated
process. The device approval application is sponsored by a company
formed by Dr. W. He had raised venture capital funds to create the
company to sell the new devices in a surgical set, the first of which
will be marketed for use in coronary artery bypass graft (CABG)
surgeries. The market for these surgeries is growing as the population
grows older. By age 60, one of every three men and one of every 10 women
show clinical signs of coronary artery disease and are potential
candidates for CABG procedures. So many of these procedures were being
done that the company consultants believe that yearly sales of the
surgical kits could exceed \$750 million.

As a company founder, Dr. W. was issued stock options, he took a board
seat, and he continued to advise the company. However, he is not active
in day-to-day operations, preferring to spend his time in academic
medicine. Because of Dr. W.'s other commitments, he is unable to spend
as much time with the company as planned and it takes longer than
expected for the company to perfect the quality control necessary to
manufacture Dr. W.'s devices. Eventually, some small modifications cure
the quality control problems and the devices are approved for sale by
the FDA. However, Dr. W. keeps rejecting the devices produced by the
company, preferring to use his own. Although company managers assert
that there is no significant difference between company tools and those
from Dr. W.'s lab, Dr. W. maintains that only he knows the import of the
discrepancies. This frustrates company managers who need to get products
to market given that cash reserves are dwindling and the board of
directors is reluctant to dilute share ownership by seeking a second
round of financing. The company managers seek the advice of other
surgeons, some of whom trained with Dr. W., and are told that the
company's devices are perfectly acceptable for the intended purpose.
Some of the feedback also suggests that Dr. W.'s recalcitrance is not
due to quality problems but to general business disagreements with his
corporate partners. One such disagreement involves the company plan to
assemble a surgical training team for new surgeon customers and some
suspect that Dr. W.'s ego has convinced him that no one can train others
to do the procedure as well as he can.

> 1\. What does this case suggest about the impact of academic-corporate
> collaborations on the introduction of novel medical technologies?

***Surgical success and training***

As Dr. W. continues to operate on cardiac patients using his new
procedure, his results become the marvel of the cardiovascular surgical
field. His CABG success rates, for instance, were at first lower but
have risen to well above the national norm. Similarly, his rates of
adverse surgical events, although initially higher, have fallen to well
below the norm. In the past several hundred patients, no deaths have
been attributed to the procedures he performed when national statistics
suggest that there could have been as many as four. Hospital time and
post-operative rehabilitation have significantly shortened in Dr. W.'s
CABG patients. Patients are now coming from everywhere for the procedure
and the wait list is growing. This situation pleases the hospital
administrators immensely and they begin to market the fact that theirs
is the only hospital in the world where this procedure is performed. In
addition to the safety and efficacy benefits, the hospital touts the
fact that the hospital bill is often much lower than usual and, despite
the fact that physician fees are higher, the overall cost of the
procedure is up to \$10,000 less than for other hospitals. Dr. W.'s
residents who have completed their training are also starting to perform
the new CABG procedure at other hospitals, thus increasing the
popularity of the surgery.

In the meantime, the company knows that Dr. W. is making an important
point when he claims that he alone has the skills to obtain the results
he is getting and to train others. If the devices are to be a success,
other surgeons will need to develop a comparable level of skill.
Research has consistently shown that higher CABG surgical volume
correlates to better clinical outcomes and lower death rates, both for
hospitals and surgeons. Therefore, surgeon customers of the company will
need to be trained in order to achieve a certain level of skill and
experience so that the company can successfully sell its surgical tool
kits. One of the important aspects of the training includes getting
surgeons comfortable using the surgical microscope cameras developed for
the procedure. Along with ultrasound equipment, several of these are
needed in order for surgeons to visualize the area of operation. These
cameras are connected to monitors suspended above the operating table
requiring the surgeons to continually look up at the monitor while
manipulating the instruments inside the patient's chest. Dr. W. has
become very adept at this visually and tactically indirect process as
have most of the new generation of surgical residents. However, the
majority of veteran cardiac surgeons are familiar with direct
visualization techniques; the ones used in open chest procedures. Others
who have some familiarity with arthroscopic surgical procedures do not
have training in the use of the multiple cameras and they need to
acquire quick reflexes in order to operate on a beating heart. The
company knows that the market for the surgical took kits, therefore,
depends on the number of surgeons who can adapt to the new tools and
techniques before they start performing human surgeries. One other
complication that the company faces is that, as Dr. W. keeps doing these
surgeries, he is continually modifying and improving his own methods and
tweaking his tools accordingly. And he has very little time to update
the corporate training team.

1.  Given the need for skill development, what should the company do to
    ensure that its products are used safely and effectively? Should the
    company be the sole determinant of how the new tools and techniques
    are introduced into medical practice? What responsibilities do
    physicians and hospitals have in this process? Are there other
    entities or organizations that should participate? Should there be
    any formal, enforceable procedures?

***Patient selection***

Many of the surgeons trained on the use of the devices for this new
surgery are interested in setting up their own programs to provide
beating heart closed chest procedures.

1.  What kind of patients should be selected for the first cases in
    these new programs?

2.  What disclosures to patients should the physicians make with regard
    to his or her experience with the new procedure? For instance, what
    should the first patients be told? Should surgeons disclose that
    they are on a learning curve or that other surgeons may have more
    experience and therefore better outcomes? As a matter of policy,
    should patients bear the burden of asking about these issues, or
    should surgeons disclose such information?

3.  Whose responsibility is it to determine what disclosures are
    appropriate?

***Surgeons' experience and company response***

News of the innovative procedure and its potential benefits spreads
after Dr. W. publishes his post-learning curve results. The company is
busily putting surgeon customers through a costly training program
(using live pigs as surgical models) and assisting with and monitoring
the outcomes of the first human procedures performed. In the beginning,
more surgeons applied than could be accommodated, despite the fact that
the company had been able to introduce efficiencies and streamline its
training program from 4.5 to 2.5 days. After one year's experience,
company executives have good news and bad news. The marketing campaign
was initially very successful and physician and hospital demand for the
training and surgical tool kit was higher than expected. Some of the
surgeons have embraced the new technique and are reporting outcomes that
approach those of Dr. W. Hospitals where these surgeons practice have
become magnets for patients seeking the improved outcomes. However,
other surgeons have begun to complain that the procedure takes much
longer than expected, placing patients at greater anesthesia risk.
Outcomes are sometimes worse than for the conventional surgery and there
have been some surgical injuries. Those surgeons with disappointing
results have either given up and returned to the prior open-chest
procedures or continue to complain to the company that it has not done
enough to prepare surgeon trainees, especially since they keep hearing
of Dr. W.'s modified techniques, which they feel have been withheld from
company training.

When company executives question their unhappy customers about the
objections, most comments relate to a few themes \-- that
dissatisfactions are caused by "learning curve" issues, that the
surgeons lack good supporting OR teams, that professional jealousy
exists regarding colleagues with better outcomes, and that some surgeons
are blaming the company for inadequate training. In addition, some
surgeons and hospitals complain that the company charges too much for
the training and they are not able otherwise to obtain training.
Clearly, it is not feasible for the company to extensively re-train its
surgeon customers or to tailor training to individuals with different OR
set-ups. But, where is the line between enough training and too little?
The company continues to struggle with both the lack of uniformity in
physician acceptance and outcomes and with the fact that sales,
initially high, have recently started to fall below projected levels.
Company investors are becoming restless about the drop in company
performance and the overall failure of the company to return a profit.
In addition, the company board is nervous that, if even one of the
injured patients sues, the legal damages could result in a severe
financial set-back for this fledgling company.

1.  Since the devices cannot be marketed without training in the
    associated surgical techniques, what does this case suggest about
    the role of corporations in the introduction into medical practice
    of innovative surgical devices and techniques?

2.  Whose responsibility is it to protect the interests of patients
    potentially imperiled by the introduction of new surgical techniques
    that aim to replace well-established procedures?

[^1]: An IRB is an Institutional Review Board whose purpose is to review
    and monitor biomedical research involving human subjects. An IRB has
    the authority to approve, require modifications to, or disapprove
    research. The fundamental purpose of an IRB review is to ensure that
    subjects are given the opportunity to provide informed consent, that
    the risks to subjects is minimized, and that the rights and welfare
    of human research subjects are otherwise protected.