Whither the Dinosaur Industry?

by John J. Otrompke, JD

Should human agency clone a dinosaur? Perhaps surprisingly, the question is not whether it is plausible to bring back the legendary giant, but whether it is desirable to do so. This essay comes to a conclusion that may surprise you.

Before I begin with a bioethical analysis, however, the most important thing I can write today is to tell anyone reading this that the a federal agency recently announced a notice and comment period, and I want absolutely everybody here to do something about it. This is not the usual agency we’re all used to dealing with, the FDA, but another one some of us don’t hear about so often, the U.S. Department of Agriculture, and the notice-and-comment period I’m referring to was about proposed regulations for the treatment of elephants in captivity. And the treatment of elephants, it turns out, has everything to do with whether people should clone a dinosaur (and how many).

Throughout the long history of elephants’ exploitation by humankind, there has been no act of cruelty or deprivation inflicted on elephants which was not also inflicted on humans. In fact, the similarity in the litanies is almost eerie.

So, even though the USDA some time ago closed the notice-and-comment period on elephants, they have not announced any new rules yet, so everybody reading this should nonetheless send in a respectful letter, seriously commenting on this important issue.

For What Benefit?

According to experts, scientists have recovered much of the DNA of the ancient dinosaurs. At first glance, the notion that humankind could clone dinosaurs, a phenomenon which is nearly scientifically possible, seems attractive. But why should human beings do so, assuming we could?

Is it for the dinosaur? By most reports the process of cloning a dinosaur would be long, and involve numerous errors, and many euthanized animals that had been malformed or ill-treated. Upon successful completion of this remarkable venture, what would be the result?

Would people clone one or two dinosaurs, and relegate them to a zoo? If so, it remains to be seen whether the dinosaur would be happy. It is the conclusion of this meditation that if the result were to clone simply one or more dinosaurs, who would then be unhappy, then dinosaur cloning should not take place. But some animals appear to respond to zoos differently from others.

Alternatively, perhaps a very, very large tract of the planet somewhere could be forested somewhere and set aside for dinosaurs, and other animal species, and it is this outcome that this essay hesitatingly, but seriously advocates. Otherwise, perhaps it could be an amphibian dinosaur that could be cloned and put in Lock Ness; I understand they already have problems over there in Lock Ness.

This essay takes the position that if the mission were to clone a live population of dinosaurs, who would then be permitted to repopulate sustainably, then that would be a benefit to the dinosaurs. Doing this is an interesting idea, but I don’t think anyone is ethically obligated to do this, should it be possible.

Is it for other animal species? This essay takes the position that by cloning dinosaurs, humankind should become capable of reestablishing other extinct species, this might be a benefit to the animal species, depending on the relationship and the environmental circumstances.

Is it for humankind? Truly, the awesome project of cloning a dinosaur assumes seemingly miraculous, impossible proportions, similar to the lunar voyages. Also, beyond sheer titillation, this project would likely involve an immense expansion of human knowledge in a wide variety of realms.

But beyond pure science, does the marvelous nature of such a project accomplish anything else for people? One thing it would accomplish would be to establish the relative scarcity of impossible achievements in the university. Perhaps by accustoming human beings to such achievements, people might become accustomed to making much more immediate demands of other ventures thought unattainable, including, perhaps most notably, a nonviolent humanity, and perhaps getting it.

Is it Urgent? Perhaps because of the sorry history of human maltreatment of animals, the question of whether people ought to clone a dinosaur is close to being indeterminable, and according to philosopher William James, ethics says you shouldn’t guess in these cases, unless compelled to by circumstances. If people might some day lose the ability to clone a dinosaur, or if it might contribute to the solution of other emergencies, then people should do it.

Who Should Clone

If you conclude that people should clone a dinosaur, then who should do it? Right away, three stakeholders are ruled out: science, industry, and the federal government. Science should not be permitted to undertake this venture without input from other sources, while big business and the government lack the institutional legitimacy to do it.

Nonetheless, the scope of the venture is most comparable to that of the space missions, so perhaps it should be modeled on the NASA programs, only this time involving other countries, perhaps under the auspices of the United Nati ons.

Next Up: Nonetheless, the next essay assumes that the entity involved in cloning the dinosaur is a company, private or non-profit, and describes what the regulatory framework for such cloning should look like, as well as what regulatory framework a development company should follow.

MEDICAL ROBOTICS MAGAZINE

Welcome to the on-line portal of Medical Robotics magazine!
Our first print issue was released in March, and plans for a second issue are in ther works!
MR is indexed by the U.S. Library of Congress and features the work of first-line robotic surgeons, researchers, businesspeople and consultants, in the fields of robotic surgery, rehabilitation robotics, medicine, research and more!
All contents (c) 2008 John J. Otrompke, JD
John_Otrompke@yahoo.com

Success In Robotic Surgery: Not Just the Institution, but Patient Selection is Key

An Interview with Dr. Raul Parra, the Pioneering Partial Nephrectomist

By John J. Otrompke, JD

Many institutions are learning that establishing a successful robotic surgery program can be a hospital-specific endeavor, with a smooth roll-out often depending on whether the hospital is really a good fit with the robot. But in terms of what really counts- improving outcomes for patients with cancer- perhaps it takes a robotic surgeon to establish the important role of patient selection in getting the best cure rate possible.

“It’s all about patient selection,” said Dr. Raul Parra, MD, chief of the department of urology at Cooper University Hospital. “For example, when we do a robotic partial nephrectomy, we limit the cases to tumors less than four centimeters, whereas for larger tumors we are embarking on doing total removal in selected patients.” To date, Parra and his institution have done 21 partial removals, and in doing so, have accumulated the largest experience right now in the country.

The team has also performed about a half dozen total removals, which are a relatively new technique, said Parra, who will deliver a talk on rolling out a robotic surgery program at a medical robotics conference in Philadelphia this June.

Parra’s superior experience is paying dividends in the form of a presentation at the annual meeting of the American Urological Association in Orlando this month, as well as a recent manuscript to the Journal of Urology, comparing the team’s first ten robotic partial nephrectomies to a contemporary group which performed ten open partial nephrectomies.

“Both sets of procedures were done by me during same the period of time,” Parra said. “We found that cancer control, or the ability to remove the entire cancer from the kidney was the same. Robotic surgery is as effective as open surgery to eradicate cancer. Additionally, the operative time was equal to or less than open surgery,” said Parra, who added that the group started using robotic surgery for kidney procedures in September of 2007, and data for the study was gathered between September and November of 2007.
The hospital had already been using the Da Vinci for prostate cases for five years, he said.

The Educated Patient

Having the latest therapies available for patients diagnosed with a serious condition is important from a business point of view, Parra said. “In my experience,
patients who are diagnosed with tumor in the kidney do some sort of research and investigate, then prefer those surgeons providing minimally invasive surgery. The main advantage is that conventional laparoscopic surgery is like operating in two dimensions, like watching TV, and it is very difficult to perform certain maneuvers, in particular suturing,” said Parra. The same difficulties are lessened with robotic procedures, which is more comparable to doing an open case,” he added.

“In today’s health care environment, in the major metropolitan areas, those institutions that are not doing robotic surgery, will probably be at a disadvantage, because patients are very savvy,” said Parra.

Robotic surgery is also preferable from an efficiency standpoint. “In my experience, robotic surgeries for the kidney are taking no more than to do them open, and sometimes less time. And they take significantly less time than for laparoscopic procedure,” said Parra noting that his work showed the average time for a robotic partial nephrectomy is less than two hours, compared to sometimes more than three hours to do them laparoscopically,” he said.

With Parra’s evidence and experience beginning to mount, he said his institution is looking into buying a second Da Vinci. “Now our experience with partial nephrectomies is almost 25 patients, and we’ve done a total of 400 total robotic procedures. The results are very encouraging,” he added. The institution is considering the second Da Vinci primarily because of demand, he said.

The demand for robotic surgery could create a dilemma for some institutions.
“The problem we face is that market forces are such that institutions that want to compete with the one across street, if they’re not going to have a high-volume place you’re not going to have the same outcomes. You’re not going to improve over the results that you have now, and it places a significant burden on the shoulders of administrative departments, the legal department, physicians and everybody, to get by the learning curve,” said Parra, noting the evidence in the literature that shows that it takes between fifty and 100 cases for a surgeon to become adept at performing a robot prostatectomy. “And in my opinion, if you don’t make the prostatectomies, you should not be attempting to operate on the kidney which is significantly more complex, because the kidney is very deep within the abdominal cavity, is well-vascularized and is very fragile,” Parra added.

As one way of dealing with the important learning curve issue, Parra said he was instrumental in creating at his institution all agreed on a strict mentoring program, prior to implementing the roll-out of the robotic surgery program. “Any of the surgeons in this hospital who wants to use the robot has to take a certified course provided by Intuitive Surgical in how to work the machine, and has to perform at least five procedures, beginning with the easier ones, while supervised and trained by an experienced robotic surgeon,” he said.

Parra noted that as the popularity of robotic surgery grows, improvements to the device itself will continue. “For instance, I think the robot is a very large, cumbersome piece of equipment, and it takes up a lot of space. In the future, the Da Vinci will be miniaturized, and more incorporated into the operating room. Improvements in ergonomics and size are all within the current technology,” Parra added.

Rolling Out a Robotic Surgery Program:

Dr. Dieter Bruno, Intuitive Proctor and Experienced Robotic Surgeon, Teaches How to Manage a Successful Roll-Out

A Complex Endeavour with the Potential for Astronomical Success
By John J. Otrompke, JD

In any newly developing field, greater experience assumes a role of greater importance. But in a field like robotic surgery, where not only a hospital’s fiscal health and reputation, but patients’ lives, can be at stake, having real experience can be something of a rarity.

That’s why Dr. Dieter Bruno, MD, a practicing robotic surgeon and a proctor for Intuitive Surgical, has drawn on his wealth of personal experience to modify the training process for physicians new to using the robot.

“I originally started in robotics before there were fellowships or training courses, because it was only a couple of years after the robots had been FDA-approved in this country,” said Bruno, who was the first urologist in North Carolina to use the Da Vinci when the program was first rolled out at East Carolina University in Greenville in 2002.

Bruno will be speaking at a robotic surgery conference in June in Philadelphia, on rolling out and managing a robotic surgery program.

“We set up model back then was very different,” said Bruno. “I was in private practice, but at an academic institution. After a course by Intutive we started doing cases, and we got specialists such as ob/gyn, general surgery, cardiac surgeons and urologists, and we helped each other because we all understood about the robot.”

Bruno was one of about seven physicians at the university who first began using the robot, but of the five physicians in Bruno’s urology practice, he was the only one who began learning robotic surgery.

Since that beginning, Bruno, who practices surgery at four different California hospitals, has performed well over 100 robotic prostatectomies, and if you add kidney surgeries and pyeloplasties, that number is much higher.

Partly due to Bruno’s influence, today’s training programs are structured much differently. "In the past cases were difficult because you had to struggle through an entire case on your own. Now with the adoption of robotics into training programs learning is easier because residents and fellows can do part of a case and work on specific skill sets. However, there is a difference between doing a full case 10 times and being able to do a part of 10 different cases. In the old paradigm by the time you had been involved in 10 cases you had a reasonable amount of experience because you had to struggle through the entire endeavor," he said.

A Systems Approach

“When rolling out a robotic surgery program, people need to take a step back and say, ‘This is an expensive piece of equipment.’ Unless the whole health care system understands, the program is doomed to failure. There are institutions that bought a robot and never did a case,” Bruno added.

Everybody from the Board of Directors to the operating room nurses, recovery and floor nurses should be facile with using the system.

“This really requires many different points of contact. But when it is done well, the success is really just astronomical,” Bruno said.

Part of that is improvement in the reimbursement picture for robotic surgeries, Bruno said, which has definitely improved the profitability for hospitals. “Economics becomes a very complicated issue depending on what point you start assessing your data. The bill for robotic surgery is higher, but when you look at being a center of excellence, it allows you to get a secondary gain,” he said.

It used to be the case that there were no codes specifically for a robotic procedure. Today, the picture varies from one insurance company to the next. “The actual surgeon fees aren’t significantly higher, but the hospitals really do better, because they get reimbursed a lot more,” said Bruno. “I may get a few hundred dollars more than when I did an open procedure, but the hospital may get many thousands more,” he added noting that reimbursement by certain Blue Cross plans may go as much as 45% more for a robotic than a traditional open surgery case.

In addition, quality and outcomes for patients are better using a Da Vinci, Bruno said. “In the prostate model, you have better chances of negative margins, and a better likelihood that there will be a curative operation. And data for continence from large series shows that people who undergo a robotic operation will get a return to continence sometimes as much as six to nine months earlier,” he added.

Just what does it take?

In addition to sound business planning, relevant training and a well-honed surgical team, a successful roll-out also requires a certain degree of marketing. “You need to start working with marketing early, to do a dual-phase rollout, and know how to market your program to the medical community that services your hospital,” Bruno said. “The area that I’m in is high-income, so everybody knows about the Da Vinci. But in other areas, you can talk to patients all you want about robot, robot, robot, but if they go back to their primary care doctor and haven’t heard of it, then what are you going to do?”

In sum, having a successful roll-out requires not only a good environmental fit, but the willingness to make it work. “A lot of what goes into the success of a program depends on what goes on behind closed doors, before the institution ever buys it. It takes a significant commitment to get a good core group of surgeons. Some hospitals offer a multidisciplinary approach. But other hospitals I go to don’t give a darn about marketing the robot,” Bruno said.

An Interview with Dr. Rahuldev Bhalla, MD

In Robotic Surgery Center of Excellence, Stony Brook's
Executives Rely on Bhalla's Commitment

By John J. Otrompke, JD

Dr. Rahuldev Bhalla, MD, director of robotic surgery at Stony Brook University Medical Center in New York brings a unique perspective to rolling out a robotic surgery program. Bhalla not only directs the robotic surgery program at Stony Brook beginning in August of last year, but also started another program at a state university across the river in New Jersey, between 2004 and 2007.

Yet comparing the two programs is like comparing apples to oranges, largely because of differences in institutional support.

“The roll-out here was a lot more smooth not only because I knew what to expect, but because both the dean and the CEO here are very into having this robotic program succeed. At the other hospital there was not as much support,” said Bhalla, who will be speaking on how to ensure a successful roll-out of a robotic surgery program, at a conference on robotic surgery in Philadelphia this June.

“It is imperative that the hospital has a vision or a plan,” said Bhalla. “Listen, we’re the only tertiary care center in Suffolk County, serving most of Long Island. We’re going to be able to deliver health care at 2010 levels. In addition our urology program is one of the top fifty in the whole country,” he said.

But even when environmental circumstances are right for a new roll-out, the institution has to figure out how the program will fit in with the rest of the hospital. “It takes operating room time, money to buy the machine it, and resource support. You initially have to be able to take a big hit financially,” said Bhalla, who noted that total costs for starting up with a Da Vinci ‘S’, such as Stony Brook has, run between $2.2 and $2.5 million, inclusive of all services, instruments and related costs. “But we’re doing the community a service by having this here,” he said.

Bhalla stated that he is getting a lot of work out of his institution’s Da Vinci, with 80% of the institution’s urology cases being done robotically. Thirteen urologists practice at Stony Brook, Bhalla said.

Qualified physicians are mandatory, he added. “You definitely need someone who’s skilled and going to bring a reputation here because if you go through the learning curve and have a fault, you’ll get a bad reputation and not get any more referrals,” he said.

Nevetheless, opportunities abound in robotic surgery, even outside the treatment context. Stony Brook, for example, has a large robotics program on the university side as well, developing robotics for lung cancer. Bhalla himself is involved with research to add tactile feedback to the Da Vinci system’s other advantages.

Surgeons May Turn to A New Biotechnology Product to Solve the Problem of Interoperative Bleeding

Recothrom: A Tool in the Minimally-Invasive Surgeon's Toolbox

By John J. Otrompke, JD

In advance of the 5th Annual Global Bioindustrial and Bioprocessing Forum, biotech company ZymoGenetics announced the results of a Phase II trial examining its newly-FDFA approved product Recothrom in the treatment of 71 serious burn injury patients on April 30th.

Recothrom is a recombinant product which may serve as a substitute for bovine thrombin. “Recothrom is an alternative to bovine plasma, which works with other proteins in the body to help start the clotting that stops bleeding,” said Susan Specht, director of corporate communications at Seattle-based ZymoGenetics.

The burn news was announced at the meeting of the American Burn Association in Chicago. The patients in the study had wound sizes of approximately 15% of the patient’s total body surface area.

Bovine thrombin, the earlier product for oozing and bleeding wounds, was approved in the early 1940s, and was grandfathered in by the FDA, but carried a black box warning until its most recent FDA review and approval in 2007, for an ultra-filtration process that removes non-thrombin proteins. However, Recothrom also showed lower immunogenicity in a Phase II clinical trial, Specht says. In Phase III trials prior to FDA approval, Recothrom has so far been tested in spinal surgery cases, liver resections, peripheral artery bypass, and arterio-venous graft construction.

It may be the rare robotic surgeon to admit that intraoperative bleeding can be a problem in these cases, but as the range of surgical procedures in which robots may be an option expands, it5 is wise to remember that Recothrom may be just another device in your toolkit.

ZymoGenetics, which was formed in 1981, has also outlicensed a number of drugs prior to its breakthrough with Recothrom, and has other novel products in development, such as Atacicept, which is aimed at treating autoimmune disease by blocking two factors, April and BLyS, without totally depleting B-cells like some drugs.

Other products in development at ZymoGenetics include Interleuken-21 and Peg Interferon Lambda, which is aimed hepatitis C.