My mother was astonished when I told her about the national Open Payments database that was launched by the Affordable Care Act. “You mean I can see all the money drug companies have given to a doctor? Even my doctor?” We plugged her doctor’s name into the database and up it popped, associated with a number of payments. He had recently prescribed an expensive, brand-name drug for my mother; she had questioned whether a cheaper, older alternative might be just as good. It turned out that her doctor had received payments from the company producing that brand-name drug.
I don’t know, of course, if her doctor’s recommendation had been influenced by these payments or if his choice represented the best medication for her. What I do know is that my mother lost trust in her care provider at that moment.
Many people have looked up their internist or surgeon in the Open Payments database. My guess is that few have looked up their pathologist. A study that I recently carried out with several colleagues suggests that they should.
Many people benefit from the services of a pathologist like me, even if they don’t often see us in person. We are responsible for most of the laboratory testing that takes place, including the diagnosis of nearly every cancer.
Today, pathologists don’t restrict themselves to just diagnosing disease. Through the use of tests called “companion diagnostics,” pathologists also help determine whether a patient may be eligible for specific targeted treatments, such as Herceptin for breast cancer or Keytruda for a variety of cancers.
These powerful drugs come with hefty price tags. Modern cancer treatments routinely cost more than $100,000 per year. The manufacturers of these drugs and their companion diagnostic testing know that pathologists play an essential role in determining who gets these costly drugs.
Our recent analysis of Open Payments data showed that about 1 in every 4 pathologists receives money or other benefits from drug and medical device companies. About 40 percent of the total money to pathologists came from companies producing companion diagnostics or the treatments that follow from these tests. That’s a lot of industry payments for doctors who don’t prescribe a single drug. The biomedical industry, however, is not a careless investor. Given the high cost of drugs like Keytruda and others whose use depends on companion diagnostics, even a small influence over the pathologists who may act as gatekeepers for them can produce an enormous return on investment for the industry.
Although some pathologists receive tens of thousands of dollars from industry, the average industry payment to them is low, less than $100. But that doesn’t mean these payments have little or no influence. Previous research has shown that even meals worth $20 or less may affect physician decision-making.
How might industry payments influence pathologists’ decisions? We can turn to many different tests to diagnose a disease. Which tests are used, and how many, are often up to our discretion. A surgeon or other doctor sends us your tissue, we run the tests we deem appropriate, and you get the bill. Imagine taking your car to a mechanic and not getting a say in what repairs get done. This is the situation with much of laboratory testing.
Here’s a common example that may add hundreds of dollars to a patient’s bill. During an endoscopy, often performed for abdominal pain or other gastrointestinal symptoms, the physician usually takes biopsies of the patient’s stomach. A pathologist will examine this tissue to help determine the cause of the patient’s symptoms. Some pathologists routinely perform additional tests to detect a precancerous change called Barrett’s esophagus or an infection with Helicobacter pylori, a key cause of ulcers. Other pathologists think these tests are necessary only under special circumstances. It is in these gray areas of clinical practice that conflicts of interest arising from industry payments may affect care.
With the rise of precision medicine, the gray areas in cancer treatment may widen. For example, the drug Keytruda, which recently received a groundbreaking FDA approval, is the first cancer treatment approved for a particular genetic alteration rather than for a type of cancer. Keytruda can be used to treat any solid tumor that has a biomarker known as microsatellite instability-high or mismatch repair deficient.
To detect these changes, a pathologist runs a companion diagnostic test. But this opens up an area of clinical discretion: Now that nearly any cancer could potentially be eligible for this expensive treatment, who should we run the test on and when? There is no right answer yet, but I don’t want to see financial influence from pharmaceutical companies playing a role.
Even the interpretation of tests could be subtly influenced by industry payments. Unlike routine automated laboratory tests, cancer-related testing, including companion diagnostics for treatment, is an interpretive process that relies on a pathologist’s judgment. Every pathologist I know has great integrity in trying to render correct diagnoses, but unconscious influences can affect any of us.
Potential conflicts of interest among oncologists are receiving increased attention, especially in light of the skyrocketing cost of cancer drugs. But let’s not ignore the many clever ways that the drug and device industries are influencing medical decision-making for their profit. It seems wherever you turn in medicine, industry payments are there. Pathology is no exception.
Some say that physician-industry partnerships lead to lifesaving innovation. I don’t want to discount the role of industry in producing medical advances. Yet the payments to pathologists that we looked at are not for research. They are largely for meals, travel, speaking engagements, and consulting fees. These methods are commonly employed as a way to influence physicians.
The relationship between physicians and industry has been described as a “closed financial loop.” The type of relationship that most worries me is when a company that produces a drug or a test pays a doctor for consulting or meals or the like, and that doctor simultaneously has a role in prescribing that drug, running that test, or writing related clinical guidelines. Unfortunately, this scenario is common in pathology and throughout medicine.
What’s the solution to this conundrum? I believe that disclosure and self-regulation are good places to start. Perhaps pathologists should include any relevant conflicts of interest in the reports they issue with their diagnoses. Our profession should also create guidelines for how to manage financial conflicts of interest, especially when it comes to companion diagnostics for expensive cancer drugs.
If doctors are going to maintain and improve patient trust in this emerging era of transparency, all specialties should confront their cozy relationships with the pharmaceutical and medical device industries.ry.