Amanda at the finish line of the Rock & Roll Las Vegas Half-Marathon, a Team Challenge event to benefit the Crohn’s and Colitis Foundation of America.

When I signed up for my first half-marathon, which took place recently on the Las Vegas strip at night, I knew I was in for a tremendous challenge. But I had no idea I would be finishing the 13.1 mile race while battling a small bowel obstruction.

While this setback easily could have sidelined me from the race, it made me all the more determined to see it through. The idea of letting down all the people who supported me for this event with kindness and generosity was more painful, to me, than the obstruction itself.

You see, this was Team Challenge, a fundraising event for the Crohn’s and Colitis Foundation of America (CCFA), a cause I truly believe in not only for myself, but for the millions of other people around the globe who suffer from these diseases, collectively known as inflammatory bowel disease (IBD).

One of the brighter parts of my Team Challenge experience was the opportunity to meet in person someone who has become a personal hero because of everything he does for IBD patients, Dewey Thom. I met Dewey about a year ago through a mobile app called GI Monitor. When I felt a major obstruction building the night before the race, Dewey was the one I called in the middle of the night for advice. Between him, our CCFA team manager and our coach, I was quickly put in touch with a gastroenterologist from the University of California Los Angeles who was volunteering his time and services during the event.

The following is what Dewey shared on GI Monitor a few days after the race: “To fully appreciate Amanda’s accomplishment you should know that she has been largely on an Ensure diet for months, and not able to fully train … She fought off an obstruction Saturday night in the wee hours of the morning, with full onset of symptoms including nausea, bloating, pain etc., probably ‘slept’ for a few hours that morning, then with CCFA doc clearance was able to fully complete 13.1 miles.”

Dewey knew I was determined to finish the Team Challenge half-marathon regardless of training or fundraising shortcomings, because he knows how much it means to me to finally be able to actively fight back against Crohn’s and colitis.

In the past year, bowel obstructions have become a near-constant part of my life. A complication, I believe, from the multiple surgeries I went through ten years ago for ulcerative colitis. To read more about my battle with the disease click here.

“And notwithstanding being short of her fundraising requirement, she made her way to Vegas and crossed the finish line, hurdling those challenges with grace and aplomb,” Dewey said. “And if you have the means or desire to help her to her goal, I include her page here as she’s too modest to. Hell of a job Amanda. I cheer your accomplishment and thank you for your endurance!”

Not so much about how proven prevaricator Petrino finally lied his way into the ranks of the unemployed, although I did enjoy reading statements such as this classic from SI.com writer Michael Rosenberg: “The . . . university is shocked to discover that its lying-weasel football coach is a lying weasel.”

Rather, the extensive coverage of the circumstances of Petrino’s self-inflicted fall from grace led me to revisit a question that touches on truth-telling in the medical arena. It got me thinking about the reports I had seen a few weeks back on studies indicating that a considerable number of physicians regularly lie to their patients, apparently with few qualms about doing so.

Clearly the misadventures of Petrino serve as quite the metaphor for the inadvisability of being less than truthful. In the coach’s case, that left him with a well-documented reputation as someone not to be trusted, even though he had led the Arkansas program to considerable recent success.

So I went back and dug out some of the reports on the docs-lying-to-patients study originally reported on back in February. That study of U.S. physicians indicated that many among them lie to their patients and/or withhold information about medical mistakes, while also failing to disclose their financial relationships with medical companies.

The findings were reported in the February issue of the journal Health Affairs, and Dr. Lisa Iezzoni, professor of medicine at Harvard Medical School (Boston) and director of the Mongan Institute for Health Policy at Massachusetts General Hospital (Boston), who was the lead author of the article, said the results don’t bode well for healthcare that should be focused first on the needs of patients.

“It really is important for patients to have complete information about their prognoses if they’re going to make informed decisions,” Iezzoni said.

While the thought that there are some physicians who see little wrong with not being truthful with their patients or their caregivers as to the extent of their conditions is unsettling, I’m bothered even more by the cavalier attitude so many seem to have toward disclosure of financial relationships with drug and device companies. That type of thinking is downright disturbing, and should raise some interesting conflicts with new, highly specific disclosure laws due to take effect next year in the form of the Physician Payment Sunshine Act. For those docs who don’t get it, that’s “Sunshine,” as in shining light upon.

Another national survey released about the same time as the Mass General study found that nearly all orthopedic surgeons admitted practicing “defensive” medicine – the ordering of unnecessary tests, procedures and referrals – to avoid future liability. In the study, that was presented during the February annual meeting of the American Academy of Orthopaedic Surgeons (Rosemont, Illinois), some 96% of the more than 1,200 orthopedic surgeons who responded admitted ordering tests, procedures or hospital admissions primarily to avoid possible malpractice lawsuits.

The study shows that physicians “are clearly concerned about malpractice issues and they’re adjusting their practice procedures based on that fear,” said study lead author Manish Sethi, MD, co-director of the Vanderbilt Orthopaedic Institute Center for Health Policy (Nashville, Tennessee). Douglas Lundy, MD, chairman of the AAOS Medical Liability Committee, added that defensive medicine not only drives up the cost of patient care, but also “limits patient access to specialty care, neither of which is in the interest of our patients.”

So on the one hand we have physicians being less than truthful with their patients and on the other those in some specialty areas who simply opt not to provide care to higher-risk patients.

What’s a body to do? Well, I truly don’t have an answer for the “sorry, no care” crowd, but as for the lying weasels – oops, that was for Coach Petrino – my suggestion as a patient advocate, which is based on my own experience as a patient, is to emphasize to the docs with whom you have ongoing relationships that you’re interested in hearing the truth.

That should especially apply to your medical condition, but let him or her know that it also means you don’t want to be prescribed a drug or a procedure whose basis for use is the physician’s relationship with a company.

I liked a comment I read on this subject, uttered by Eric Campbell, PhD, research director at the aforementioned Mongen Institute and another co-author of the study: “I think patients need to be empowered to have very frank discussions with their doctors about the levels of truthfulness they expect from physicians and their healthcare team. It’s not unreasonable to begin a discussion with your doctor and say, ‘Look, I want you to be as honest as you possibly can. If an error occurred on my case, I would like to know about it.’”

Yes indeed.

(Jim Stommen, retired executive editor of Medical Device Daily, is a freelance writer focusing on healthcare issues.)

Hopefully not lost in all the comings and goings of more than 8,500 people at the J.P. Morgan Healthcare Conference in San Francisco last week were some important take-home messages about the future of med-tech, a future that promises many challenges for the industry, but also many rewards for those willing to follow promising trends.

1. Healthcare Information Technology is going to be big this year and probably into the foreseeable future. This is the final year in which hospitals and physicians can demonstrate meaningful use and get maximum healthcare dollars under the stimulus, so there should probably be some clarification coming as to which vendors are  winners and which are losers. Additionally, the marriage of smartphones and remote monitoring technologies will continue, but will HIPAA compliance rules put a damper on this rapid integration?

2. Continuing on its current course, healthcare reform in the U.S. will further drive hospitals and surgeons to cut costs, which means that anything not deemed “cost effective” will in all likelihood not be utilized by either group. The downturn in the U.S. economy has also contributed to this trend.  Additionally, the rapid rise in high deductible, high co-pay health plans has shifted much of the financial burden  for healthcare onto the consumer, which will  bolster the trend towards looking for cost efficiencies to all three groups.

3. The lure of international markets to offset problems in both the U.S. and Europe will be of interest to both current med-tech companies and those that invest in the sector. At the meeting, there were tracks on two days dedicated to China and Asia as a whole. Other areas with  a rising, and potentially enormous, middle class that could afford more expensive healthcare are India and Brazil.

4. The med-tech excise tax of 2.3% on all U.S. device sales has yet to kick in (it is slated to take effect in January 2013). The average EPS hit to large-cap stocks is 3.7%. For small-cap stocks, the hit ranges from 6% to 13%, depending on the company’s U.S. exposure and where it is on the profitability curve. There is still hope that this tax percentage can be lowered, especially for the innovative small-cap companies that are the lifeblood of the med-tech industry in the domestic market

Through September  2011,  med-tech outperformed the market by nearly 3%, according to J.P. Morgan. However, 4Q11 was a disaster. Indeed, it was the worst quarterly performance in the sector (-8.5% vs. S&P 500) in more than a decade. If things are going to improve in the sector, either fundementals will need to stabilize and then improve, or there will need to be increasing levels of interest from strategic or financial sponsors.

As the saying goes, there are things we know we don’t know, but here are three things we do know, namely guidances that will affect device makers. One of these might have the effect of making some clinical trials less expensive, but another could put the brakes on provider training even in first-in-human studies unless the sponsor is willing to roll out a training protocol for all physician users in the post-market setting.

FDA to put brakes on surgeon training?

FDA issued a mid-August draft guidance for device clinical trials indicating antipathy toward a sponsor’s training of doctors in trials unless the sponsor is willing to do the same for doctors in routine practice. This would seem to apply even to studies engaged prior to the pivotal clinical trial.

The draft also reintroduces the boilerplate pertaining to the standard of “least burdensome,” which had been omitted from a number of documents issued by the agency over the past 18 months. This guidance defines the phrase as “a successful means of addressing a pre-market issue that involves the most appropriate investment of time, effort and resources on the part of industry and the FDA,” seemingly adding FDA to the bodies subjected to the least burdensome requirements.

NIH updates 1995 financial conflict guidance

The Department of Health and Human Services recently cut in half the threshold for reports on potential financial conflicts of interest (FCOI), but it appears that publicly funded research institutions will not have to post all financial relationships on a website, but make the information available when requested.

The Aug. 23 NIH statement indicates that the new threshold for determining “significant financial interest” will for the most part be reset from $10,000 to $5,000, and a subsequent passage states that before an institution spends any government monies, that institution must “post on a publicly accessible web site information” on significant financial interests “of senior/key personnel” for whom a conflict might be imputed, seemingly eliminating the need to routinely post information online for all clinical researchers at that institute.

FDA draft guidance for risk-based clinical trial monitoring

FDA released a late August draft guidance for clinical trial monitoring that opens the door to less granular monitoring of clinical trials via the “greater use of centralized monitoring methods.”

FDA says there is a consensus regarding risk-based monitoring processes that “are more likely to ensure subject protection and overall study quality” by zeroing in on “the most critical data elements,” rather than on “routine visits to all clinical sites” in pursuit of “100% data verification.”

Among the features of centralized monitoring cited by FDA is the use of data checks to ensure the completeness of data from case report forms, but the guidance also states that sponsors should consider identifying higher-risk sites for on-site monitoring as well. The draft recommends further that sponsors or CROs use statistical analyses “to identify data trends not easily detected by on-site monitoring.”

Several exceptions pertain here, including trials with adaptive designs, trials that call for “multiple device placement,” and trials that are not blinded.

By MARK McCARTY

Medical Device Daily Washington Editor

Dear Interventional Cardiologist,

Worried about Medicare reimbursement for the Next Great Stent? Concerned that FDA’s massive regulatory girth will squash your drug-eluting balloon groove? Not to worry. Here are the top 10 reasons you should be thrilled with your choice of specialty.

Number 10: PCI numbers are flat of late, but just watch that Baby Boom fill your waiting room in the years to come.

Number 9: The transradial (through the wrist) route is gaining acceptance as an approach to coronary intervention.

Number 8: Americans aren’t getting any skinnier!

Number 7: The latest hospital in-patient payment system proposed by the Centers for Medicare & Medicaid Services would slightly increase payment for PCI procedures in fiscal 2012.

Number 6: Abbott (Abbott Park, Illinois) recently won a CE mark for its bioresorbable stent, the BVS. Can FDA really afford to be more than two years behind? I don’t think so!

Number 5: Someday – probably in the not-too-distant future – really rich dog owners will decide their mutts deserve the best, too.

Number 4: Intravascular ultrasound.

Number 3: The American Heart Association just came up with a list of nearly two dozen catheter-based treatments that should be considered for pediatric heart disease.

Number 2: Percutaneous delivery of heart valves, and …

The Number 1 reason interventional cardiologists should be happy with their choice of specialty: Who in their right mind really wants to have their chest cracked open?

About eight years ago I had major colorectal surgery following a pretty wicked battle with ulcerative colitis. Basically the surgeon had to take out my entire colon, creating a stoma (artificial opening in the abdomen wall through which the end of the intestine is brought). I wore an ileostomy bag for 15 months before having a “take down” surgery so that I no longer needed the bag – in other words, they rerouted me. Don’t you just have all sorts of lovely images in your head right now?

Anyway, as a med-tech reporter, I occasionally come across a story about a new technology in the GI space designed to improve colorectal surgery or to make life a little easier for ostomy patients. Take the AOS-C1000 colostomy management system in development by Stimatix GI (Misgav, Israel) for instance. The AOS-C1000 is an artificial sphincter designed to allow individuals to discreetly manage their colostomy without the need to wear a traditional ostomy pouch. The company also plans to make a similar device for ileostomates (like I used to be) and urostomates. This could be the first major breakthrough in ostomy care in more than 50 years.

Don’t get me wrong, I’m thrilled to see these advancements being made and I’m happy for the patients whose quality of life will be greatly improved by it. But I can’t help but wish this technology had been available eight years ago. So yeah, sometimes I get a little green-eyed with med-tech envy.

I’m already bracing for Digestive Disease Week (May 7 – 10) when the latest R&D efforts on the GI horizon will be unveiled in Chicago. But all kidding aside, it really is exciting to see medical innovation taking place in any sector, but particularly the GI space because it hits so close to home.

In the study, major strokes were higher for TAVR at both 30 days (3.8% vs. 2.1%) and one year (5.1% vs. 2.4%). At 30 days major vascular complications also were much more common after TAVR (11% vs. 3.2%), but the TAVR group’s rates were much lower for major bleeding (9.3% vs. 19.5%) and new-onset irregular heart rhythms of atrial fibrillation (8.6% vs. 16%).

Matthew Reynolds, MD, director of economics and quality of life research at Harvard Clinical Research Institute and a cardiologist for the VA Boston Healthcare System who presented the study results, noted that the patient population in the clinical trial was unusually old and sick for a clinical trial. “The mean age was 83, there was a very high prevalence of coronary artery disease and previous bypass surgery and about one-quarter had advanced lung disease. Despite this, the patients treated with TAVR did remarkably well.”

When asked how many patients will be affected by TAVR once it is FDA approved, Smith said “thousands” initially, and soon “tens of thousands,” but that it would probably be several years before the impact reaches hundreds of thousands.

Still, while Smith said that the results clearly show that TAVR is an excellent alternative to surgical AVR in high-risk patients, he noted that recommendations to individual patients “will need to weigh the appeal of avoiding open-heart surgery, with its known risks, against less invasive TAVR with different and less well understood risks, as well as the absence of long-term follow-up. He also noted that “future trials will help delineate the role of TAVR in intermediate risk patients.”

The pressure to put the Sapien into intermediate risk patients will be overwhelming, and not just from patients needing the procedure. Larry Biegelsen a med-tech research analyst with Wells Fargo Securities, wrote in a note that once the Sapien, and a comparable device developed by Medtronic (Minneapolis) called the Corevalve, are cleared for sale in the U.S., they could generate sales of $2.4 billion and account for more than one in three aortic valve repairs by 2015. Numbers like that will certainly remind investors and doctors of the halcyon days of the drug-eluting stent craze of the early 2000s.

The genie may already be out of the bottle. Already researchers are talking to officials at the FDA and other regulatory agencies worldwide about including less risky patients in future studies. The procedure is now used in people who have about a 10% risk of dying in the hospital, and there are plans to lower that to a 4% risk in the U.S. and 3% in Europe.

Still, the results should improve with time because the study used Edwards’s first-generation device and 19 of the 26 centers had no prior experience with it. And when the only other alternative is open-heart surgery, many people will leap at the chance to have the procedure, even though open-heart surgery has proven to be extraordinarily effective, with death rates of less than 1% and the valves implanted via the procedure lasting for a quarter century.

Ralph Brindis, MD, president of ACC, and an interventional cardiologist at Kaiser Permanente (Oakland, California), agreed that the technology has great promise but also cautioned his colleagues in the field regarding dissemination of the new technology in order to ensure safety and efficacy for patients.

“This is a truly game-changing clinical trial. There are a huge amount of patients that are not getting therapy.  It will take a while to ramp up experience in the centers, and we as a profession have to be responsible,” Brindis said. “This is a landmark technology but not everyone should be doing this. How can we as a society responsibly put together proper programs of diffusion of these new technologies?”