Superpower wishful thinking or there oughta be a law….

April 18, 2012Carole 2 Comments »

Maybe it’s just the 24/7 political news cycle in an election year making me cranky, but the current drive to repeal women’s rights on various issues and reproductive rights specifically makes me want more protective regulation for infertility patients, not less. The US Healthcare system is one of the most contentious areas of debate in this election year. I can’t speak to the whole healthcare system but there is plenty to improve on in the way we deliver reproductive services, particularly infertility services.

Because there are (apparently) a lot of citizens out there who are aghast at the thought of helping people get pregnant on some shared healthcare dollar, we have a system that is largely market driven, with little of the safety features that are built in for patients seeking other kinds of health services. This market-driven approach is particularly corrosive when applied to fertility services because there are so few patient protections. Put another way, what keeps us safe from healthcare cowboys? You have heard of these bad actors, they make the papers when something goes terribly wrong. These docs who promise patients anything –for a price.  The marketing is slick and patients expectations are “well-managed”- which sometimes means that even when the doc screws up, the patient believes they are at fault so they don’t sue.

I am actually strongly in favor of tort reform because the current system tends to create an adversarial relationship between patients and doctors from the get-go which does not promote transparency and good medical care. But in exchange for tort reform, there must be a better system in place to curtail extreme medical practices.

In the non-infertility healthcare market, most  services are covered by insurance and insurance companies are notoriously conservative in what they will cover. If it hasn’t been in use and proven, they typically call it research and don’t cover it. So what happens?- docs don’t offer the crazy out-there stuff, it has to be somewhat proven if they want to get paid. That’s the patient’s first layer of protection. Don’t get me wrong, I am all for clinical research  to advance the field and try new things but it has to be called research and the protections afforded to human research subjects have to apply. The protections for research subjects are expected to be even higher than for routine medical care offered to patients.

The history of IVF is a series of unproven clinical procedures (in science, we call this experimentation) on patients. To this day, there is no tax payer-funded US research on infertility procedures. The original IVF pioneers breathed a sigh of relief when Louise Brown, the first IVF baby,  was born with the requisite number of toes and fingers and only one head. They really didn’t know what they were doing. They breathed another sign of relief when the first IVF kids proved they could be fertile and have kids. The same goes for intracytoplasmic sperm injection (ICSI). In clinical use since 1993, and rapidly becoming the primary, if not only, insemination method for many clinics, it skipped over being experimental and studied and went right to clinical use. We (or should I say other non-US countries who can use tax dollars ) are still collecting long-term outcome data on these children. That means the oldest ICSI baby is just of age and we are still debating the long-term effects, if any, of being conceived via ICSI.

Medical licensing is the other way the extremes of medical practice are controlled. The bar may be high to initially obtain the medical license but the bar to lose that license is still higher. One of my professional colleagues, a malpractice attorney, wryly remarked that unless a physician sleeps with his patients (and they complain about it) or until patient corpses are so prevalent they can be stacked like cord wood, there typically isn’t sufficient actionable evidence to revoke a medical license. There is generally a lot of good will and presumed good effort that is attributed to licensed physicians. Most of them hold up their end of the bargain but there are some real stinkers out there and the current system does little to reign them in. There is a lot of latitude in what is considered the standard of medical care, arguably because it is a medical art, not pure science.  Still, you would hope scientific evidence of efficacy should precede most, if not all, medical intervention.

Reproductive clinics are not licensed in the US, as they are in other countries, so there are no required medical standards that must be adhered to for a clinic to stay in operation. The facility may be duly inspected for building safety, but no one is empowered to close the clinic because they aren’t following some (to be determined)  standard of care for provision of ART services.  One problem in the ART medical field is there is no universal agreement on standards of care. Resistance to universal standards is promoted by a vocal subset of physicians who apparently believe that they alone have the “secret sauce” to cure infertility and their rates will go down if they do IVF according to some universal standard. There is no “secret sauce”.  Good programs are built on non-secret science-driven medicine carried out by dedicated professionals who put patients, not money, first.  The closest thing to universal medical standards in the US are the voluntary Practice Guidelines published by professional societies such as the American Society for Reproductive Medicine (ASRM) and the Society for Assisted Reproductive Technologies (SART).

Unfortunately, clinic accreditation is also no guarantee of quality. In order to achieve voluntary accreditation, programs may elect to be inspected by Joint Commission or the College of American Pathologists (CAP), to validate that their standards are being followed.  In my experience, inspectors are not omniscient and some are not competent so achieving accreditation based on passing inspection doesn’t entirely assure patients can that their program is following the highest standards. Some physicians don’t truly endorse these standards and consider inspections  (and compliance) as an interference in both their professional license-given right to practice medicine and their business goals in a market-driven arena of healthcare.

In twenty years of working in the IVF field, I have encountered very good physicians doing very good work and unfortunately,  some that shocked me with their callous disregard for their patients and exceptional high regard for themselves and their own financial self-interest. Below are some of the jaw-dropping comments I have heard over the years which reflect a less than compliant attitude toward regulation and standards, paraphrased of course.

  • Don’t worry about compliance with standards, the next inspection isn’t for two years.
  • Regarding donor eligibility screening required by the FDA: The FDA can’t tell me what to do; they are interfering with my right to practice medicine as I think is best based on my license and my experience.
  • Yes, we know the previous lab director lied to the inspector about having written protocols for everything we do in the lab, but we don’t think writing protocols up is a priority, we won’t be inspected again for two years.
  • We don’t need written protocols for training or a training program;  “see one, do one”  has always worked for us.
  • If this lab error happens again, don’t tell me about it.
  • Techs creating false medical records??- we call that a clerical error.

So, if I had super powers, I would give inspection agencies that inspect ART clinics real teeth to enforce standards. I would want physicians to develop and abide by professional standards and CLIA regulated standards in order to stay in business, not just for voluntary accreditation. I think licensing clinics would additionally protect patients and should be required. If infertility services were covered by insurance plans, this  layer of oversight would also reign in outlier practices. I would use tax-payer dollars to fund prospective research on ART outcomes. None of these initiatives would interfere with the good work done by good physicians because they are already doing the right things for the right reason, but it may reign in or eliminate the bad apples.  In short, I would stack the deck in the patient’s favor since if we can’t guarantee a “cure” for infertility, at least we should do no harm, right?



© 2012, Carole. All rights reserved.

2 Responses to this entry

  • LisainSK Says:

    All I can say is “Wow”…yes, there certainly needs to be some regulation in the Reproductive Medicine arena…in the US and in Canada (where I live). But having this discussion from an insider such as yourself…I guess I just want to believe that once a person throws on a white jacket and calls him/herself a doctor one should feel as though they (and the unborn babies) are in good hands. Guess I shouldn’t be so naive and fight for regulation.

  • Carole Says:

    Hi LisainSK,
    Thanks for your comment. Medicine is no different than any other field of human endeavor. There are really good people working in the field and others who are not. Because the relationship between physician (and rest of healthcare team) and patient is so important to good health and the treatments are so intimate, it is especially painful if this trust is breached. I wish the good docs would push for more accountability for their colleagues who give ART a bad name. In lieu of that, patient education and possibly more regulation is the best we can do. In the meantime, ask questions until you feel you have enough information to make good decisions. If you don’t feel like you are in good hands, don’t be afraid to move on to another program. Not all programs are the same. Best Wishes, Carole

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