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The CMG Voice

Industry Can Have Influence on Clinical Trials

Posted Thursday, December 20, 2018 by Morgan Cartwright

A recent study analyzed 200 industry-funded Phase III and Phase IV trials of vaccines, drugs, and devices during 2014-2017. It found that the academic authors were not solely responsible for more than 30% of the design, conduct, analysis, or reporting of those clinical trials. Instead, there was collaboration between industry personnel, academic investigators, and contract research organizations.

Following up on this study, a survey was sent to a number of authors of papers related to these clinical trials. The results showed that sometimes employees or contractors of the for-profit corporation funding the research do significant work without authorship. This includes undisclosed regulatory agency involvement in trial design, and undisclosed funder or contractor involvement in data analysis.

In total, only 4% of the trials were independent from industry involvement after being funded. This brings up an issue of clinical trials being reliable, truly independent, and in the patients’ best interests. Because the results of these clinical trials can impact millions of Americans, is it sensible for corporate interests to such have influence?

Read here to learn more:

Industry Involvement in Clinical Trials Huge, Often Downplayed

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Causes of Death on Death Certificates Often Incorrect

Posted Monday, December 17, 2018 by Morgan Cartwright

Studies from various states show that somewhere between 30-50% of death certificates list incorrect causes of death. The cause is a result of inadequate processes, training, and/or insufficient information. Unfortunately, many medical associations rely on death certificates for data on causes of death in areas to project and promote certain health guidelines. With such a large number of listed incorrect causes of death, there appears to be a significant possible problem with the underlying data.

The most common cause of death is heart disease, but this doesn’t always tell the whole picture. Many times, patients have underlying conditions that may not show up in the physical examination. Sometimes the patient passes away at a hospital that has no prior medical records to tell the hospital about the patient’s medical history.

In reality, determining causes of death is “part art, part science”, because it often requires a deeper understanding of everything that happened leading up to the death. With anything, you may gain a better understanding over time but many of those who write the death certificate are residents who are still learning the medical conditions.

Furthermore, the death certificates don’t always have the ability to enter the details of the death that are needed to describe the full situation, and instead require residents to conform to limited options. For all these reasons, the causes of death on death certificates should be viewed with this understanding.

A Whopping 1 in 3 Death Certificates list Wrong Cause of Death

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Study of diabetic patients finds link between obesity surgery and a reduction in the risk of serious heart problems

Posted Tuesday, December 11, 2018 by Tyler Goldberg-Hoss

More than 30 million Americans have diabetes, while another 80 million have pre-diabetes. Nearly 1/3 of Americans are classified as obese.

For years, people suffering from obesity have turned to surgery to help when diet and other lifestyle modifications do not work. This includes many stomach-shrinking surgeries, including gastric bypass, gastric sleeve and gastric band procedures.

A recent study, including patients within the Kaiser Pemanente network in Washington State, tracked 20,000 severely obese patients with Type 2 diabetes. In the study, some had obesity surgery and some did not.

The study found that those patients who had the surgery had a 40% lower chance of having a heart attack or stroke within five years versus those who did not have such surgery.

Although the study pointed out it could not prove a causal link between the surgery and the lower risk, it is intuitive that losing weight would also reduce the risk of serious heart problems. Not only that, but researcher also think there may be a connection between how surgeries affect how the body handles insulin and blood sugar.

Although thousands of dollars, obesity surgery is increasingly being covered by insurance. And one of the study’s authors suggested doctors should be discussing surgery as a possibility with their obese diabetic patients.

You can read more about this study here:

Bariatric surgery reduces heart attacks, strokes and death in obese people with diabetes

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Medical Negligence and the Need for Specialized Advocacy at Trial

Posted Monday, December 3, 2018 by Morgan Cartwright

Medical negligence law requires attorneys with the expertise of this area of the law in order to overcome the specific obstacles and challenges that these cases face if they go to trial. One of the most important words in the law of medical malpractice is the word “negligence”.

When you ask individuals to define the term, their definitions and understanding may be far different from the real legal applicable standard. This means that lawyers representing injured claimants have the challenging task of convincing members of society what negligence is in medicine.

Negligence is defined generally as the “failure to exercise the care toward others which a reasonable or prudent person would do in the circumstances, or taking action which such a reasonable person would not.” There are two major obstacles that must be overcome with this definition and how it is preconceived in our society.

First, there is a major difference between medical negligence and general negligence. I’ve asked people to tell me what they think “negligence” means and they often refer to doing something consciously, knowingly, or intentionally.

For example, negligent driving is when someone is driving in a manner that’s dangerous. Oftentimes this is due to some conscious, intentional choice made by the driver. However, medical negligence does not mean intentional. This difference creates a very tough hurdle for medical malpractice claimants because it requires lawyers to change some juror’s preconceived notions that negligence equates to a willful or intentional act.

Second, medical negligence creates a special dilemma because the “reasonable person” is actually a “reasonable doctor”. When a lawyer faces a jury of twelve with no medical professionals, few will know what is required of a reasonable doctor.

Expert witnesses tell the jury about the “standard of care”, which is what a reasonable doctor in the same circumstances would do.

The defendant will present doctors who tell the jury that the defendant met or exceeded the standard of care, while the claimant will present doctors who tell the jury the defendant’s actions fell below the standard of care. This presents a difficult hurdle for the claimant’s attorney, since the claimant has the burden of proof. If he or she cannot convince the jury the plaintiff’s side is right, the plaintiff will lose.

Definition of Negligence

Definition of Medical Negligence in Washington State

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Probability, False-Positives, and What Your Lab Test Result Really Means

Posted Friday, November 30, 2018 by Tyler Goldberg-Hoss

Nearly everyone with experience as a patient in the health care system in the United States is familiar with the concept that doctors (and ARNPs and PAs) will order tests to help them understand what is going on with you and how you can be treated. These often include both lab tests (testing your urine, or your blood) and imaging studies (x-rays, CTs, MRIs).

On its face, this sounds like a good thing – a health care provider gathering data to support his or her decision-making. However, a recent article argues that often times those health care providers don’t correctly interpret the results of tests they order, sometimes leading to patient harm.

The problem involves probability, and the notion of false positives. A false positive test result is one in which the test says you have something you don’t. Given the current state of accuracy in our medical tests, false positives may be more common than you think.

However, it appears health care providers do not account for false positive results as much as they should. So, when a patient tests positive for a particular disease, often times they are treated for it even though they don’t have it. Sometimes this results in no or little harm, but sometimes it results in serious consequences.

Imagine a false-positive test result is acted upon, and surgery is indicated, or chemotherapy is initiated. Or the false-positive test result turns into more tests, including invasive ones, and injury occurs.

Although the author of the article notes there is no simple solution to this problem, one thought is to include on the lab results the percentage of false positives for a particular test, and the probability of a particular patient having the disease tested for.

So, for example, if you are testing for Disease X, and there is generally a 1 in 1000 chance of a person having it, that number could be included in the lab test results, next to the false positive rate for the test (say that is 5%, or 50 out of 1000). An algorithm could even better tailor the chances this particular patient has Disease X by weighing it for factors such as age or weight that may make the chances bigger or smaller.

Even further, simple math with those numbers can show the true chance of having Disease X:

if 1 out of 1000 people have it, that means 50 of the rest (999) don’t have it but test positive for it anyway. That means, of the 1000 people, 51 test positive for it but only 1 person really has it. That means the chances the patient actually has the disease when the test comes back positive is really only 2%.

Instead of a health care provider getting the positive test result back and presuming the patient has Disease X, he or she can then appropriately consider the false positive rate. This would likely lead to less unnecessary testing and treatment, and less patient harm.

Read more here:

What the tests don’t show: Doctors are surprisingly bad at reading lab results. It’s putting us all at risk.

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