Sunday, October 30, 2011

Medical Device Approval vs F.D.A. Whose Side Are You On?

Last week, I attended a 2 day medical conference in Cleveland on obesity. It was a heavy seminar, which I would rate 8 on a (bathroom) scale of 1-10. Interestingly, the majority of the speakers appeared to have BMIs (body mass indices) within the normal range. Coincidence? I suspect discrimination against rotund academicians. I’m sure that if any attorneys were in attendance, that a proper legal response would have been promptly initiated. They would take the matter on a contingency fee basis, or in a more novel approach, fees could be linked to excess body weight so that each pound that was unfairly discriminated against would be fully and fairly compensated. I’ve been told that I think like a lawyer. Is this a compliment I should graciously accept or a slur that warrants a lawsuit for defamation?

The conference was excellent and I hope to incorporate what I have learned into my practice. My community gastroenterology practice is ever expanding, and I don’t mean my patient volume.

There were lectures on exercise, nutrition, commercial diets, bariatric surgery, medications and medical devices. There was a fascinating lecture given at the conference’s conclusion by a banker who works with venture capitalists. He lamented that the F.D.A. was a major impediment against product innovation and delivering products to market. Investors and companies pour millions of dollars into start-ups or toward medical device research and are frustrated by what they believe are unreasonable governmental obstacles or migrating goal posts. He stated that this was not simply his personal view, but was a widespread view across the industry. Some of the consequences of this policy include:

  • Suffocation of of many small device companies and entrepreneurs
  • Diminishing competition to foreign device companies
  • Loss of investor confidence resulting in scarcer funds to fuel research and development
  • Encourages corporations to pursue ‘safe’ projects where F.D.A. approval is achievable but medical benefit is marginal
  • Harms the public by preventing or delaying new medical treatments from reaching them
A senior Cleveland Clinic physician offered a spirited rebuttal of the banker’s view stating that the system, while imperfect, is fundamentally sound. He pointed out various examples where recent medical devices were found to be seriously flawed which have cost millions of dollars and patients’ lives. Failing metal on metal hip appliances is the most recent example of the risk of under regulation. Indeed, it sounds horrendous for patients to have to undergo repeat hip surgeries because their new metal hips will soon be out of joint.

Earlier this year the Institute of Medicine (IOM) advised the F.D.A. that the system for approving medical devices should be scrapped, as it was too lax. The F.D.A., who commissioned the study, didn’t accept the IOM’s recommendations. Perhaps, they believe the agency can reform itself from within, always a dicey prospect.

Of course, a proper balance needs to be established between protecting the public and stimulating vigorous innovation. It seems to me that we are out of balance. We must recognize that no system will be perfect and please all players in the game. While we all strive to protect the public, if we tolerate no risk, then there will be no new products, devices or medications coming to us. How much risk is reasonable? There is no single answer here as most of us would tolerate more risk depending upon the circumstances. We accept more risk as the stakes increase.

While industry and the government have different interests and agendas, ultimately they both hope to serve the public good. Failed devices harm patients and harm industry by eroding the public trust.

All of us accept risk in our daily lives. Should the federal highway speed limit be lowered to 35 miles per hour? Why not? Wouldn’t this save lives? Wouldn’t this be worth some added travel time for all of us?

The political aspects of the medical device approval controversy were discussed in a New York Times article earlier this week which is worth a perusal.

Do you want more civil liberty protections or do you favor more power for intelligence gathering? Do save wildlife and forests or promote development and job creation? Do you want more public safety or do you want more medical innovation? It’s vexing to navigate through these tortuous conflicts.

We are being presented with a version of Trick or Treat. Each side claims to offer the treat and disparages the other as a trickster. It’s not quite that simple, is it?

Whose side are you on?

Sunday, October 23, 2011

Could Herman Cain Have Survived Obamacare? 9-9-9 Man With A Plan Speaks Out

Photo Credit

Herman Cain gleefully shouts to adoring crowds that he now has a target on his back. Amazingly, this non-pol has vaulted to the front of the back, leapfrogging over career politicians who have been running for president and other political offices for years. Can Cain go the distance? Does he have the right stuff? With a 'wink' toward Genesis, is Cain ‘able’?

He is derided over his 9-9-9 plan by folks who are scared that his bold and innovative reform proposal is attracting voters. They are more frightened that his plan may actually work. Critics point out or invent flaws in his proposal, trying to chip away at the edifice. Carping is a lot easier than constructing.

I’m not an economist and I have no idea if the 9-9-9 plan should be championed or stuffed into a pizza box and recycled. Increasingly, the public believes that whatever flaws and inadequacies 9-9-9 may have are preferable to the deficiencies and abuses of the current tax system.

Reform threatens the status quo whose agents will push back hard for all the wrong reasons.

A Whistleblower reader could use the above statement to challenge my numerous posted arguments against Obamacare, claiming that I am the hypocritical whiner who is clinging to the status quo and attacking medical reform.

This argument would have some merit if I accepted that Obamacare was truly reform, which I do not. Simply (mis)labeling the law as the Patient Protection and Affordable Care Act, doesn’t make it so. Over the years, I have been amused by the labels that legislators assign to the laws they sponsor. These names are often sanitized sheep’s wool covering up rotting carcasses.

Here are some other labels for Obama’s health care reform law that just missed the cut.
  • Phase 1 Government Takeover of Health Care Act
  • Medical Malpractice Attorneys Protection Act
  • Medical Private Practice Unaffordable Act
  • Medicaid Expansion Act
  • Pandering to Medicare Beneficiaries Act
  • Government Rationing of Health Care Act
  • Hassle Doctors Out of the Profession Act
  • The Democratic Party Protection Act
Of course, nothing is all good or all bad. There are elements of Obamacare that I do support. I do not think folks should be discriminated against for pre-existing medical conditions. I agree that everyone should have access to medical insurance coverage. I zealously support comparative effectiveness research, which I don’t think has a prayer to succeed against the medical industrial establishment. I support the objective of improving medical quality, but reject the pay-for-performance and related charades that will diminish quality and demoralize and punish doctors.

Herman Cain, like his GOP rivals, all promise to bury Obamacare if elected. Cain, a Stage IV colon cancer survivor believe that had Obamacare been the law of the land when he was ill, that he might have ascended prematurely to heaven.

If I had been under Obamacare, and a bureaucrat had been trying to tell me when I could get that CT scan, that would have delayed my treatment. I was able to get the treatment as fast as I could based upon my timetable, and not the government's timetable. That's what saved my life.

While Cain’s pronouncement may be hyperbole, patients should be concerned about the intended destination of today’s medical ‘reformers’. While the law is called the Patient Protection and Affordable Care Act, I think the law will strive for affordability at the expense of patient protection.

The government wants to shrink the pie and yet promises that we will all be satisfied. Which candidate today understands pies best?

This post is not a political endorsement. Herman Cain has not yet earned my support, but I’m glad he’s at the table. The ferocity of attacks against him convinces me that he has a valuable voice in the conversation. At the very least, it has forced the other candidates to defend their policies and positions. Competition breeds excellence. Let the games begin.

Sunday, October 16, 2011

Ten Questions to Ask Your Doctor?

The blog, Shots, posted a question primer to prepare patients for medical office visits with their doctors. A reaction to this appeared on Glass Hospital, where John Schumann offered his own wry version of the question list. My less wryer, and more drier response appears below.

While I agree with Shots that education is power, a closer look at the question list demonstrates that the intent to educate may obfuscate instead.

First, the post is entitled, Ten Questions to Ask Your Doctor, suggesting that patients arrive at their physician’s office armed with 10 inquiries spanning a spectrum of medical knowledge and philosophy including medical treatment strategy, physician qualifications, risks of treatment, medical treatment alternatives, choice of hospitals and even how to spell the names of their medications. (I guess Shots believes that spelling counts!)

Some of the questions sound reasonable, but could patients make sense out of the answers? For example, Shots suggests asking which hospital is best for my needs? Patients often are focused on the choice of hospital, when they should be more interested in which physicians will be caring for them. While the hospital matters, it’s much more important who will be performing your surgery, then where it will take place. Are patients equipped to evaluate hospital quality anyway? Is a good reputation or a shiny exterior a true surrogate for medical quality? Patients often have a negative view of a hospital based on an isolated anecdote, which they may not have even experienced first-hand.

Another suggested question is how many times have you done this procedure? Will this provide useful information for patients? I agree that for many medical procedures, a higher case volume means a lower risk of complications. But, will it enlighten a patient to know that the gastroenterologist has performed 2000 colonoscopies or 5000 or 10,000? Better questions, which can’t be quantitatively answered, would be how many times have you done this procedure well, or, how many of your procedures were truly medically necessary? I object to Shots’ version of the ‘how many’ question which simplistically reduces medically quality measurement to a check-off form, paying homage to the deities who gave life to the pay-for-performance beast. What really counts can’t be counted. Paradoxically, what can be counted, will count.

In addition, if you bring your doctor the 10 question list, be prepared for some frustration when your office visit ends and you’ve only covered the first 3 items on the list. There may not be time left for you to discuss the issue that brought you t see your doctor in the first place. It may take a few visits and a fair amount of dialogue for you to understand your physician’s philosophy and style of medical practice. This important information can’t be acquired by taking a multiple choice test or answering a series of questions.

The question list on the blog Shots is a guide that needs to be prioritized. You simply can’t cover them all in a single visit, and you shouldn’t have to. Experienced physicians know that patients often want to cover every last medical concern and we will often begin a visit with a question from our own ‘top ten list’. What are the 1 or 2 issues that we need to cover today?

Any questions?

Sunday, October 9, 2011

Health and Wellness Programs: Medicine or Marketing?

Shark Cartilage: Cancer Cure?

There’s a new term that has entered the medical lexicon. The word is wellness. Hospitals and medical offices are incorporating this term into their mission statements, corporate names, business cards, medical conferences and other marketing materials. The Cleveland Clinic Foundation has appointed a Chief Wellness Officer, an intriguing fluffy title that does not clearly denote this individual’s role and function. This is deliberate, as the word wellness is designed to communicate a ‘feel good’ emotion, not a specific medical service.

Just a click or two on Google will lead you into the wellness universe. Here’s a sampling.

  • Institute of Sleep and Wellness
  • Wellness Institute of America
  • Naturopathic Wellness
  • National Wellness Institute
  • Physicians Health and Wellness Center
  • Physicians Wellness Group
There’s even a sponsored ad on Google where one can search for physicians, presumably trained in the medical specialty of wellness. I was dismayed that my name didn’t appear in a wellness search of the Cleveland, Ohio region. Does this mean that I don’t offer my patients health and wellness?

Where is all of this wellness coming from?

It’s coming from marketing departments who understand the public mood. While conventional physicians view complimentary medicine warily, the public can’t swallow it fast enough. Patients want a softening of the medical profession and are willing to accept new genres of care based on promises, testimonials and faith. I admit that much of what my colleagues and I prescribe and recommend is based on scant medical evidence. I don’t have satisfying treatments for irritable bowel syndrome or chronic abdominal pain. I understand why such patients look beyond me and my colleagues for healing and relief. They are spending billions of dollars on herbs, colonic hydrotherapy, Reiki, massotherapy, holistic medicine, naturopathy, aromatherapy, biomagnetism, guided imagery, medication and homeopathy.

 Hospital and medical marketers may not know how to cure disease, but they sure can count. The vast majority of Americans have pursued alternative medicine for one reason or another. The medical establishment has expanded its healing mission to gain access to this huge and growing market. Conventional hospitals, where cardiac catheterizations and colonoscopies are performed, now offer a variety of wellness programming to extend their branding into the surrounding communities.

I think that we are risking a wellness overdose, and there is no antidote. My concern is that it confuses the public between ways to improve their lifestyles and state of mind and actual medical care and treatment. I concede that many alternative medical treatments make folks feel better, but I’m not sure they cure disease. There’s a danger in medicine when faith overtakes reason. An extreme example is when cancer patients were spending precious time and resources for shark cartilage or other high cost alternatives that have no scientific basis. These opportunities exploit desperate people who have no way out. They shouldn’t have to spend money to pray for a miracle. They can do that for free, and they should.

I know there is spirited belief and support for unconventional medicine to complement traditional medicine’s failings. If they want to turn skeptics like me into believers, then they’ll have to pursue a more conventional approach. Test your treatments in high quality clinical trials. If scientific studies determine that these treatments, or any therapies, offer no benefit, then abandon them rather than assail them as flawed and biased studies.

I’m in favor of any intervention that makes people feel good, provided it is safe and doesn’t exploit folks. Just because the word medicine is in the label, doesn’t make it so.

Sunday, October 2, 2011

Secret Shoppers in Doctors' Offices: Placebo Medicine for Physicians

Physicians are still debating whether prescribing placebos is ethical. Dissenters argue that this is dishonest and would erode trust between patients and their physicians. If the practice were to gain acceptance, then physicians’ credibility would be diminished. Patients would wonder whether the medicines their doctors are recommending are evidenced-based or fraudulent.

Patients can now push their own snake oil right back onto their physicians. I learned that the ‘secret shopper’ mechanism for quality assessment has been introduced into the medical profession. I first read about this in the March/April 2010 issue of the Journal of Medical Practice Management, a periodical that I suspect is not widely read by physicians.

Folks are hired as pretend patients and are dispatched to doctors’ offices and hospitals to document their findings. Their mission is to assess office staff, appointment issues and the waiting room experience. I wonder if soon they will add encore performances and will subject themselves to Pap smears and rectal examinations to assess doctors’ clinic skills and techniques directly.

Surprisingly, the American Medical Association’s Council on Ethical and Judicial Affairs endorsed the practice, although many physicians objected.

I agree that these pseudopatients could improve office quality by highlighting flaws that have not been recognized or remedied. Yet, I cannot support the stealth tactics of this quality control method. On its face, it is dishonest. It also costs medical practices and institutions time and money attending to people who are masquerading as actual patients. If the secret shopper strategy did gain traction in medical quality assessment, could it be used as an investigative tool by malpractice attorneys? Finally, the concept is wholly unprofessional using a technique that is generally used in large big box retail establishments and restaurants. It is demeaning that physicians are already being evaluated on Angie’s List and the Zagat survey, as if we are automobiles or toaster ovens.

The federal government has now indicated that it will initiate its own secret shopper program to gauge how difficult it is for patients to gain access into primary care physicians' offices.  Big Goverment becomes Big Brother.  Hours after this stealth plan was boldy announced, it was rescinded in a Big Retreat.

Let's make a deal.  Don’t make an appointment to see me unless you truly are seeking medical care. In return, I’ll never prescribe you a sugar pill. This will strengthen the trust between us, the foundation of a successful doctor-patient relationship.

Add this