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The CMG Voice

New legal battle in fight over the opioid epidemic: suing the Joint Commission

Posted Thursday, November 16, 2017 by Tyler Goldberg-Hoss

Municipalities all over the country have begun filing lawsuits against the manufacturers and distributors of opioid medications, including here in Washington State.

However, in what appears to be a first of its kind, Cities in West Virginia have banded together to sue The Joint Commission, a non-profit accreditation entity, for spreading misinformation about the risks of opioid prescriptions and addiction, in part due to the cozy financial relationship it shared and shares with the manufacturers of the medication.

The Joint Commission is a nonprofit that accredits more than 20,000 health care organizations, including hospitals, across the US. Most every governmental entity in the US recognizes that the Joint Commission accreditation is a condition of licensure and receipt of Medicaid and Medicare reimbursements. The Joint Commission, then, is an authority in the US regarding safe practices in medicine.

The lawsuit claims that, starting with the first Pain Management Standards in 2001, the Joint Commission has downplayed the seriousness of opioid addiction, the result of collaborating on the standards with the makers of the drugs. This includes relying on research for these standards from groups who were accepting drug company money.

It is unclear whether the lawsuit will be successful, and even what “success” means in such a case. Certainly The Joint Commission does not have the deep pockets of some of the defendant manufacturers like Purdue Pharma. However, considering how accreditation from The Joint Commission is necessary for hospitals, it may put pressure on The Commission to relax pain management standards at West Virginia hospitals, so that the hospitals don’t have to choose between keeping their accreditation and prescribing fewer such drugs.

You can read an article on this here:

‘This is just the beginning’: Scope of opioid lawsuits widens to include hospital accreditor

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Does the time of day affect your outcome from open-heart surgery?

Posted Monday, November 13, 2017 by Tyler Goldberg-Hoss

Who would have thunk it?

Researchers in France have recently published the results of a study that looked at the rates of complications in patients who underwent heart valve replacement surgery in the morning versus the afternoon.

The study involved observing about 600 patients who had such surgery for six years. The study found that patients who had surgery in the afternoon had half the risk of a major cardiac event (like a heart attack) as those who had surgery in the morning.

One of the authors of the study suggested that a person’s circadian clock is at least part of the reason. And this isn’t the first time that medical researchers have considered the time of day and how medical treatments work. Other studies have shown that the efficacy of certain cancer treatments and vaccines may be affected by the time of day when the therapy or medicine is given.

These findings may be useful in treating patients in the future. First, scientists are testing whether they can “trick” heart muscle into healing in the way afternoon patients heal regardless of day. Further, it may mean that higher risk patients should be operated on in the afternoon.

You can read an article on these findings here:

Why having surgery later in the day might be better for your health

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If you need kidney or rectal surgery, is robot-assisted surgery better?

Posted Friday, November 10, 2017 by Tyler Goldberg-Hoss

You may have heard by now: robot-assisted surgeries are a real thing. Since the early 2000s, hospitals have been buying these million dollar plus robots, such as the daVinci Surgical System, to assist surgeons in minimally invasive surgeries such as gallbladder removals. These robots use the same or similar access points as a laparoscopic surgery (small holes in the abdomen, through which cameras and other tools are inserted to do the surgery).

When surgeons use these robotic devices, instead of holding on to the tools themselves in a patient’s body (like in a traditional laparoscopic surgery), they manipulate controls outside of the patient’s body, and those controls correspond to movements of surgical tools in the body. While there have been critics of the use of these robots – citing the steep learning curve for surgeons, and the cost – it appears these robots are here to stay, at least in the short term.

Recently The Journal of the American Medical Association (JAMA) investigated the utility of robot-assisted surgeries in the context of both kidney surgery and rectal surgery. They were particularly looking at how the results differed from traditional laparoscopic techniques.

The study looking at kidney surgery found that, between 2003 and 2015 the use of robotic-assisted surgery surged from 1.5% to 27%. There was no significant difference from the perspective of patient safety (similar complication rates), robot-assisted procedures typically took longer and cost more.

Another study looked at the differences between the two approaches in rectal surgery, and in particular, whether there was a difference in the rates of times when surgeons needed to convert the minimally invasive procedure (using just the small holes) to a laparotomy (a large incision through the abdominal wall to gain access to the abdominal cavity).

There are many reasons that laparoscopic surgeries, including those with and without robotic-assistance, are favored in many cases. These reasons include less chance of bleeding, typically shortened recovery time, less scarring, and less postoperative pain.

In that context, all things being equal, surgeons (and patients) who initially start with a minimally invasive technique would prefer not to convert to a laparotomy if possible.

The study found that there was no difference between traditional laparoscopic surgeries and robot-assisted surgeries in the rate such surgeries convert to laparotomies.

These two studies indicate that, while there is potential for robot-assisted surgery to be beneficial to patients in the future, at present, at least in the context of kidney and rectal surgery, no benefit clearly exists.

You can read about the two studies here:

Association of Robotic-Assisted vs Laparoscopic Radical Nephrectomy With Perioperative Outcomes and Health Care Costs, 2003 to 2015

Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer

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Can Herbal Supplements Damage Your Liver?

Posted Monday, November 6, 2017 by Gene Moen

The answer is yes, according to a presentation at the annual meeting of the American Association for the Study of Liver Diseases. Dr. Victor Navarro said at a press briefing that “herbal supplements are a common cause of liver injury.” He went on to say that “there are lots of products that are difficult to identify what they and what they’re used for.”

In a study of drug-induced liver injuries, it was found that 20% were caused by dietary supplements. Many of these products were sold as bodybuilding supplements or weight-loss supplements. There are two ways in which the products can be dangerous: they may include ingredients that are not listed on their labels, or they may be adulterated with additives on purpose (to support for purpose for which it is being marketed, such as for sexual enhancement).

In the study, people with drug-induced liver damage had used over 300 different dietary supplements. Chemical analysis of these products found some with hepatotoxins such as anabolic steroids or other pharmaceuticals, although the labels did not so indicate. One problem with using such “natural” or “herbal” products is that it is assumed there is nothing harmful in them. “Natural” in most people’s minds equates with “harmless.” But, unlike drugs, these supplements are not regulated or approved by the FDA. The companies that make these products often fail to list all of the ingredients or fail to test for toxicities or other problems that can arise from their use.

Physicians studying the causal relationship between the products and liver injuries found that identifying the problem often led to the product no longer being sold, but they are then replaced with a different product or at least one with changed labels. One positive outcome of the studies, according to Dr. Norah Turreault of the University of California San Francisco, is that “it highlights the fact that these herbal products contain ingredients that are unknown to the patients taking them.” The message to consumers is “don’t assume that a ‘natural’ or ‘herbal’ product can only help you — it can also cause serious damage.”

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The community decides what the standard of care in medicine is.

Posted Thursday, November 2, 2017 by Tyler Goldberg-Hoss

Every time I consider a potential new medical negligence case, or think about a case I am currently handling, it is in the context of how I think community members – jurors – will think about the care in question. The reason is, if I file a lawsuit on behalf of a client of mine, the end result will likely be a trial in front of 12 men and women in the county where care occurred.

The first question a jury will likely decide in such a case is whether the health care provider in question met, or fell below, the “standard of care.” This “standard of care”, in essence, is the health care provider’s duty to his or her patient to act reasonably carefully in caring for the patient. If the doctor met the standard of care, she is not negligent. If she fell below the standard of care, she is.

So how does a jury know what the “standard of care” is in a given situation?

Sometimes, it’s obvious. Sometimes the care is bad enough, and both sides know it. In those situations, the cases typically settle out of court.

Often times, though, there is not a particular authoritative text you can point to and say that a doctor or other healthcare provider clearly broke a particular rule.

In those situations, each side hires experts – physicians who practice in similar circumstances as the doctor who provided the care in question – who testify in court about what the “standard of care” is, and whether or not it was met this time. The jury listens to the experts, then deliberates and decides whether they agree with the experts for the patient or for the doctor.

This is an important point. To even get in front of a jury, the patient must offer sufficient expert testimony that the defendant doctor was negligent. However, once that threshold is met, the jury gets to listen to the testimony, and they get to make their own decision. That decision should not be made based on sympathy or bias, but it necessarily must be made on what the jury believes was the “standard of care” in the situation before them, and therefore what it should be in the community going forward.

You see, in Washington, the doctors don’t decide what the “standard of care” is, nor is the standard based on what care is expected by other doctors. It is decided based on what is expected by society – us, the community, and the representatives of it who sit on the jury.

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