BB&T Senior

CLEVELAND – This year's Cleveland Clinic Medical Innovation Summit, held in November, drew more than 1,000 attendees to the Cleveland Clinic campus and, according to Delos “Toby“ Cosgrove, MD, president/CEO of the Cleveland Clinic, each of the attendees has at least one thing in common: a concern about the quality of healthcare and the cost of healthcare.

“Nothing could be a bigger topic, excuse the pun, than what are we talking about today – obesity, diabetes and the metabolic crisis,“ Cosgrove said. “It is a national dialogue whether it be around legislation or whether it be around the delivery of healthcare, the problem has magnified enourmously. Two-thirds of the U.S. [population]is overweight and over half is obese . . . we are the fattest country in the world.“

America's weight problem has “major ramifications for healthcare and the economy,“ Cosgrove added, as it is associated with an epedemic of diabetes as well as several other costly diseases, including cancer.

“The cost of healthcare now, 10% is attributed to obesity,“ Cosgrove said. By 2020, it is projected to be 20% of healthcare cost, he added.

“This is a problem that has ramifications for us as an international competitor as far as business is concerned . . . and ramifications of general healthcare and what we must deliver,“ Cosgrove said. He asserted that the obesity problem must be addressed in a “straightforward way.“

Chris Coburn, the executive director of CCF Innovations – the technology arm of the Cleveland Clinic – told attendees that this meeting is taking place in a “period of unprecedented change in America and around the world.“

Coburn noted as the meeting got underway on its first day that it had already drawn more than 1,000 registrants from 12 countries with more than 40 overseas visitors. By the time registration concludes, he added, “we expect to have achieved record registration.“

In introducing his boss, Coburn said Cosgrove is recognized as a “national voice for healthcare reform and someone who has communicated that there are hard choices to be made to improve public health.“ He added that “as a leader of this institution, innovation is being uncovered and rewarded in every aspect of the Cleveland Clinic.“

The first day of this year's summit also included several panel discussions, including “perspectives from the top of the industry“ moderated by Nancy Snyderman, MD, chief medical editor at NBC News.

Panelists declare total war on obesity scourge

America is at war.

But the war that was discussed quite heavily — pardon the pun — in Cleveland last month was not the war on global terrorism but rather a war on obesity that should be declared, if it hasn't already, right here at home.

A panel of executives from the “top of the industry,“ moderated by Nancy Snyderman, MD, chief medical editor at NBC News, examined the obesity threat (and what should be done to combat it) at the meeting.

“To keep our citizens and country financially and physically fit we have to declare nothing less than a war on obesity,“ Stephen MacMillan, CEO of Stryker (Kalamazoo, Michigan), told summit attendees, rasing his voice as he finished the statement. “We spend hundreds of billions of dollars a year defending our country in foreign lands . . . when there is a bigger threat right here at home . . . it's ourselves and our lifestyle and we need to get serious about addressing this.“

MacMillan admitted that Stryker, a company that makes knee implants and other devices that people who are overweight often end up needing at some point in their lives, benefits financially from obesity. Yet he encouraged his fellow industry leaders to “demand attention and focus“ to solving the obesity problem, much in the same way the industry has been able to dramatically increase breast cancer awareness and the importance of early detection.

“It's something significant that we're not going to solve overnight, but that we can solve in a generation.“

To demonstrate his point, MacMillan showed a picture of an NFL player sporting pink accessories last month to raise breast cancer awareness.

“Let's go back one generation. What was breast cancer in this country a generation ago? It was a taboo topic . . . something that people didn't really deal with until it was too late.“

Now, MacMillan noted, professional football players are wearing pink gear on the field to show their support for patients with the disease and breast cancer is being found much sooner because of an emphasis on early detection.

Similarly, he pointed out that seat belt safety is a topic that has dramatically changed since his generation was growing up – back then kids stood in the back of the car and rarely stayed buckled in. “Kids don't get in a car –none of us do – without even thinking about a seat belt,“ these days he said.

“Think about what we achieved in one generation in terms of bringing attention and focus to areas that needed and demanded attention and focus,“ MacMillan said.

Alex Gorsky, worldwide chairman of the medical devices and diagnostics group at Johnson & Johnson (New Brunswick, New Jersey), said the problem of obesity is not just one that impacts the U.S. but is a growing problem in other countries too, including China and Brazil. He also noted that we are “a long way from solving obesity.“

One of the most important things that can be done to address the problem, Gorsky said, is to reduce the stigma that keep people from seeking treatment for their obesity problem.

“Because if they don't get involved with it, it won't work,“ Gorsky said. “It won't be easy; we've got to be in this for the long haul.“

Other keys to helping patients address obesity and diabetes, he mentioned, are understanding the underlying scientific metabolic issues; developing coordinated care models that also address co-morbidities; and helping patients navigate the complex web they have to work their way through while getting treatment.

“Obesity is not simply a lifestyle issue,“ Gorsky said. He noted that there is some debate on whether obesity should even be considered a disease.

Later, Snyderman polled the audience by first asking for a show of hands of who thinks obesity is a disease. Roughly half of the audience members raised their hands. Then, she asked if obesity is a lifestyle and behavior choice. Again, about half of the audience members raised their hands – only this time BB&T noticed that several people who had answered yes to the first question also answered yes to the latter. Perhaps that is the true answer – it is both a disease and a lifestyle choice.

Kevin Sharer, CEO of Amgen (Thousand Oaks, California), agreed with the other panel members that there simply are no easy or quick fixes to the obesity and/or diabetes problem.

As for the latter, Sharer said the health industry really doesn't understand the biology of the disease, which is part of the problem. “All we are doing . . . is modestly treating some of the side effects, in a sense, of this problem. We do not understand diabetes,“ he said, adding that understanding the fundamental biology of the disease is the only way it will ever be solved.

“Fundamentally, unless we get at the real societal issues, the behavioral issues, this is going to be with us for a long time,“ Sharer said.

Snyderman brought race and poverty into the discussion and pointed out that the three panel members are all white men who are not obese, and clearly not poor. “We cannot talk about obesity without talking about race and poverty,“ she said. This is, in part, because people who fall through the cracks – minorities or people without insurance – access the system sicker and later, she said.

Industry experts consider 'best and worst' of reform

What are the best and worst things to come out of the heatlhcare reform legislation that passed earlier this year? That was the question Nancy Snyderman, MD, chief medical editor of NBC News, posed to a panel of industry experts at the meeting. The question turned out to be quite difficult for the panel members to answer, as most of them struggled to find anything good to say about the law at all.

In fact, one member Susan Dentzar, editor in chief of Health Affairs, said the only good thing to come out of it was that “we got a law.“ However, she even prefaced that by saying “the political system cobbled together a bill“ and that “second graders could have done a better job.“

William Plovanic, managing director at Canaccord Genuity (Toronto), said he has not seen an upside to it, judging from the companies he covers. But at least one member tried to look on the bright side of the legislation.

“It gives us an opportunity to move toward a value-based system as opposed to a volume-based system,“ Debra Lappin, president of the Council for American Medical Innovation (Washington), said. “Value in our system will equate with quality.“

Lappin added that it will be increasingly important to demonstrate and be able to measure a return on innovation when introducing a new device to the market place. And, she warned, “don't throw out the medical innovation baby with the bath water.“

Harry Rein, general partner of Foundation Medical Partners (Rowayton, Connecticut), said that with the passage of the healthcare reform legislation it has become increasingly clear that companies will have to be more focused on outcomes and system costs, which he suggested might be the best thing to come out of the new law.

Noting that the topic of the panel discussion was titled “Impact of healthcare reform on medical innovation – A mid-year assessment,“ Lappin said that “we know very, very little“ six months in how the law is going to impact innovation.

“Now is the time for voices to be heard. Now is the time for regulations to be written,“ Lappin said. “We are in the time when voices, I think, count as much if not more than they did when Congress was cobbling this legislation together.“

Plovanic says he sees it, so far, as a “slowdown“ of innovation because now device companies don't know how long it is going to take for a product to get approved, which of course tends to have a negative impact on the ability to raise capital.

Snyderman – who was not at all shy about challenging her panel members Monday to answer tough questions — asked Plovanic what kind of a healthcare system he believed would equal a fair system. After he hesitated to answer, she further asked him to respond from his own personal viewpoint. “Now I really don't want to answer that,“ Plovanic said. Snyderman let him off the hook but laughed and pointed out that he was “blushing.“

Rein said the thing he finds most disappointing about the new law is the blanket health insurance coverage for everybody without taking individual choice into consideration. He added, however, that there should be a safety net for people who fall through the cracks . . . “I just don't think that everybody should fall into that safety net,“ he said.

Clinic unveils Top 10 medical innovation list

By far the most highly-anticipated event at the Cleveland Clinic's annual Medical Innovation Summit is the unveiling of the Top 10 medical innovations expected to have a significant impact on healthcare in the coming year. During an impressive video presentation, a panel of Cleveland Clinic practitioners revealed which technologies made the list for 2011.

As in past years, the team responsible for selecting the list of breakthrough devices and therapies interviewed more than 60 Clinic experts which resulted in nearly 90 nominations of emerging technologies. Ultimately, this list was whittled down to what the team agreed on to be the Top 10 medical innovations for 2011.

The Top 10 medical innovations for 2010 are in order from last to first:

10. Capsule endoscopy for diagnosis of pediatric GI disorders. A safe and painless way for doctors to diagnose the source of hidden bleeding in the GI tract in children. The child swallows a pill-sized capsule that has a miniature camera inside. The capsule weighs less than an ounce and is easy to swallow with a sip of water, cannot be damaged by powerful digestive enzymes of the stomach, and requires no air insufflation or sedation, the clinic notes.

The technology was first approved by FDA for adults in 2001 and in children a few years later. Panelist James Merlino, MD, chief experience officer of the Cleveland Clinic health system, said the capsule is not only capable of diagnosing diseases such as Crohn's disease without surgery, but it can also “make the diagnosis of no diagnosis, which provides reassurance.“

9. Oral disease modifying treatment for multiple sclerosis (MS). Although there are seven FDA-approved drugs that can modify the course of the disease, helping to lessen the frequency and severity of MS attacks, and reduce the accumulation of brain lesions, the drugs must be injected or infused on a regular basis, which is enough to discourage many people from consistently following through with their therapy, the clinic noted.

Richard Rudick, MD, director of the Mellen Center for Multiple Sclerosis Treatment and Research and vice chair of R&D in the Neurological Institute, said one of the most frequently asked questions he hears from patients in reference to the injections is “can't we do this with a pill?“ Now, there is a drug, fingolimod, which is the first pill to show effectiveness in the treatment for MS. He said he does not believe it will entirely replace the injectable drugs in the near term, but that it is expected to be a “billion dollar drug“ in 2011.

8. Exhaled nitric oxide (NO) breath analysis for monitoring asthma. Often, asthma patients are given a lung function exam using a spirometer, a device that measures the amount of air a person can expel from their lungs, and the amount of resistance to airflow throughout the respiratory tract when the person exhales. Now, pulmonary experts are beginning to recognize that these in-office exams tell only part of the asthma story, according to the clinic. Now there is an FDA-approved hand-held diagnostic testing device that measures levels of exhaled NO, which was found to be an asthma biomarker in the 1990s.

Raed Dweik, MD, director of the Pulmonary Vascular Program, said that the technology, while approved in 2003, is just now making the Top 10 list primarily because of physician acceptance and the fact that what was once a desktop device is now hand-held and therefore easier to use in practice. He also noted that the initial device, when it was approved, cost about $50,000 and currently is costs in the $3,000 to $5,000 range and will become “cheaper and cheaper as the technology gets better and better.“

7. Endoscopic weight-loss procedure: Transoral Gastroplasty (TOGA). According to the clinic, the TOGA procedure represents a significant improvement in minimally-invasive bariatric surgery. Instead of making incisions in the abdominal wall, this incision-less option combines two flexible endoscopic staplers passed through the mouth that are used to create a small restrictive pouch in the stomach. After eating a meal, patients are left with a feeling of satiety.

Philip Schauer, MD, director of the Bariatric and Metabolic Institute, said TOGA will likely be performed on an outpatient basis and he thinks it will be available “relatively soon.“ Because only 1% of the people who are eligible for bariatric surgery currently choose that route, he said this non-surgical procedure could help fill that gap.

6. Telehealth monitoring for individuals with heart failure/ implanted wireless cardiac device for monitoring heart failure. According to the Clinic, there are between 500,000 and 900,000 new cases of heart failure (HF) diagnosed each year. Wireless cardiac device monitoring for HF is enabling doctors to monitor patients and adjust patient medications before it is too late. The technology helps to ensure patient compliance to medication schedules and the early detection of signs of decompensation, the clinic noted.

James Young, MD, chairman of the Endocrinology and Metabolism Institute, said that until recently there has been a lot of skepticism about the ability to do this accurately and the utility in terms of benefiting patients. He said that two large trials have driven adoption of the technology and demonstrated convincingly that such monitoring reduces hospital readmissions. “I think you're going to see a paradigm shift towards telehealth monitoring for heart failure,“ Young said.

5. Hepatitis C protease inhibiting drugs. Two advanced drugs in this category are currently awaiting FDA approval and have the ability, according to the clinic, to change the treatment for hepatitis C for patients who have not responded to previous therapies. Both new drugs have been very successful in curing test subjects in clinical trials, which represents a big step forward in battling this disease.

4. JUPITER study: statins for healthy individuals. Many seemingly healthy people are actually at high risk for developing cardiovascular disease. In the JUPITER (Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin) study, participants with normal to low levels of LDL cholesterol (bad cholesterol) and elevated levels of inflammation were randomized to receive a statin or placebo. The study results, first published in 2008, suggest that statin used by the study participants cut their risk of cardiovascular disease and death by almost half compared to study individuals treated with placebo.

“The results were extraordinary and the study was stopped early because of a 44% reduction in death, heart attack and stroke,“ said Steve Nissen, MD, chairman of the Department of Cardiovascular Medicine. He believes that if a person meets the JUPITER criteria (over age 55 and at least one other risk factor) that person should have their hsCRP level tested.

3. First therapeutic cancer vaccine approved by the FDA. Unlike a traditional preventive vaccine (such as a flu or measles vaccine) that revs up the immune system to help prevent infection, sipuleucel-T is a new option, a therapeutic vaccine given to men with advanced prostate cancer to get their own immune systems to develop an immune response against the disease, leading to improvement in survival, the clinic noted.

2. Anti-CTLA-4 drug (ipilimumab): Targeted T-Cell antibody for metastatic melanoma. According to Ernest Borden, MD, deputy director of the Taussig Cancer Institute, this drug is a “clearly significant advance“ in the fight against this disease and is the “first drug to have an impact on survival for patients with advanced melanoma.“ FDA approval of this lifesaving drug is expected by December, the clinic noted.

1. New molecular imaging biomarker for early detection, prevention, and treatment of Alzheimer's disease (AD). Clearly there is an urgency to identify AD sooner, before the patient becomes cognitively impaired. The clinic notes that since the distinctive beta-amyloid plaques and tau tangles of AD are present at least a decade before dementia symptoms become evident in many patients, there is now a global hunt underway to find ways to help identify the initiation of brain damage caused by AD. This new goal of detecting dementia at its very earliest manifestation will then allow steps to be taken to protect the brain before too much damage is done so that people - and their loved ones - never have to experience the “ravages of AD,“ the clinic says.

A new brain imaging compound, AV-45, will make this early detection possible, according to the clinic. After being injected into the patient, the radioactive molecular imaging compound then crosses the blood-brain barrier and binds to any beta-amyloid plaques, the tell-tale sign that is so characteristic of AD. Follow-up imaging by PET allows doctors to peer into the brain and assess it for dyed amyloid plaques.

Michael Phillips, MD, section head of Imaging Sciences, said the imaging compound “gives us potential diagnosis before people become cognitively impaired . . . the only way we're going to help people with Alzheimer's is to treat them then.“

Device makers weigh in on obesity epidemic

If the 1,000-plus attendees at this year's Medical Innovation Summit learned just one thing at the meeting it is that America has an enormous weight problem.

If the statistics alone were not enough to convey the message – two-thirds of the U.S. population is overweight and more than half of the population is obese – perhaps watching a live history-making weight loss surgery performed on a 700-pound man drove it home.

Surgery offers hope for patients who are markedly overweight and unable to lose weight through diet, exercise, and weight loss medication. Several device makers are developing safer weight loss procedures designed to help improve these patients' quality of life and, ideally, improve associated conditions such as diabetes and high blood pressure.

A panel discussion moderated by Philip Schauer, MD, director of the Bariatric and Metabolic Institute at the Cleveland Clinic, highlighted a handful of emerging devices being developed for weight loss surgery. The heads of five California-based companies – BaroSense (Menlo Park), IntraPace (Mountain View), ReShape Medical (San Clemente), Satiety (Palo Alto), and ValenTx (Carpinteria) – participated in the discussion.

The following is a quick rundown of each company's device.

• BaroSense has developed a trans-oral endoscopic restrictive implant system (TERIS). CEO Daniel Balbierz said the cup-like device divides a patient's stomach to create a feeling of satiety. Once implanted, the device is held in place by an anchoring technology. Balbierz says the procedure is versatile, results in clinically meaningful weight loss, and so far has garnered a positive response from patients, particularly females who are attracted to the idea of a “scar-less“ surgery. “The reception has been, frankly, overwhelming.“ Balbierz said.

• IntraPace CEO Chuck Brynelsen said his company is one of the few still developing a gastric stimulation device for obesity. It's “gastric stimulation, but with a twist,“ he said. Brynelsen describes the IntraPace solution, the abiliti, as “a gentler solution for weight loss that incorporates essential components of behavior therapy.“ The device is designed to control appetite, automatically records the patient's eating and exercise habits, and provides the patient with a connection to a social support network. It is implanted laparoscopically and the company is expecting to see patients achieve 40% weight loss after the procedure.

Brynelsen acknowledged that other companies have tried, unsuccessfully, to develop similar procedures, but that IntraPace is trying to learn from those other companies' mistakes. He said his company's device is “not just a gastric stimulator, the approach we take is different.“ That difference, primarily, being a sensor in the patient's stomach to detect eating or drinking, which then prompts the system to deliver electrical impulses to the stomach.

The device can be turned on and off without the patient knowing, he said, however the patient “figures out very quickly if the device is on or not,“ because they will notice a different sensation.

• ReShape Medical has developed a “totally non-surgical“ balloon device that “does not alter the anatomy in any way,“ according to CEO Bill Murray. He said the device, which is placed in the stomach during a fast outpatient procedure under deep conscious sedation, is “truly reversible“ and does not limit a patient's options in the future if they should require a different type of weight loss surgery. The balloon is usually removed after six months. While in the stomach, it is designed to serve as portion control, helping the patient feel full sooner. The balloon occupies existing space in the stomach to reduce its capacity for food.

Murray said that the company feels “very good about the weight loss experienced“ with its device, and that it is a device with potential long term benefits. More than half of patients so far have lost 30 pounds or more. “These are healthier patients to begin with,“ compared to gastric bypass surgery patients, he added.

• Satiety has developed the Trans-oral Gastroplasty, or TOGA, procedure, which involves creating a gastric sleeve so small that when even little amounts of food enter and push against its wall the patient feels a sensation of fullness. The company has already completed a pre-market approval (PMA) study in the U.S. and expects to file its PMA application with FDA by the end of the year, CEO Eric Reuter said.

The TOGA procedure landed on the Clinic's Top 10 list of medical innovations expected to make a big impact on healthcare in 2011. Of the devices highlighted during the panel session, the TOGA procedure is the furthest along on the clinical and regulatory pathway. Hypothetically, it could be approved next year.

• ValenTx has made an endoscopic device designed to mimic a gastric bypass procedure. President James Wright said the device is implanted through the mouth into the stomach to restrict stomach volume. Wright said safety was a top concern when developing the device, which is why the materials used have lived in the gastrointestinal tract before.

Pointing out that most of the devices these companies are developing involve putting foreign bodies inside the GI tract, Schauer asked the panel members what type of safeguards are built into such systems.

Wright said that the ValenTx device is designed for the morbidly obese population and therefore it is intended to be a long-term solution. If for some reason the sleeve needs to be replaced, Wright says it can be done trans-orally as often as necessary.

Balbierz emphasized that TERIS is an “incredibly versatile“ approach and that the device left in body is so small that if it becomes dislodged it would simply pass through the system.

Murray said, again, that the ReShape device has no lasting effect on the patient's anatomy after the balloon is removed, and that it is a reversible procedure. He added that the balloon is designed with methane blue dye so that if the balloon deflates the patient would notice blue urine and know that something had happened. It too is designed to pass if it were to be dislodged for any reason.