A New Test Aims to Objectively Measure Pain. It Could Help Legitimate Sufferers Access the Meds They Need.
Sickle cell patient Bridgett Willkie found herself being labeled an addict when she sought an opioid prescription to control her pain.
"That throbbing you feel for the first minute after a door slams on your finger."
This is how Central Florida resident Bridgett Willkie describes the attacks of pain caused by her sickle cell anemia – a genetic blood disorder in which a patient's red blood cells become shaped like sickles and get stuck in blood vessels, thereby obstructing the flow of blood and oxygen.
"I found myself being labeled as an addict and I never was."
Willkie's lifelong battle with the condition has led to avascular necrosis in both of her shoulders, hips, knees and ankles. This means that her bone tissue is dying due to insufficient blood supply (sickle cell anemia is among the medical conditions that can decrease blood flow to one's bones).
"That adds to the pain significantly," she says. "Every time my heart beats, it hurts. And the pain moves. It follows the path of circulation. I liken it to a traffic jam in my veins."
For more than a decade, she received prescriptions for Oxycontin. Then, four years ago, her hematologist – who had been her doctor for 18 years – suffered a fatal heart attack. She says her longtime doctor's replacement lacked experience treating sickle cell patients and was uncomfortable writing her a prescription for opioids. What's more, this new doctor wanted to place her in a drug rehab facility.
"Because I refused to go, he stopped writing my scripts," she says. The ensuing three months were spent at home, detoxing. She describes the pain as unbearable. "Sometimes I just wanted to die."
One of the effects of the opioid epidemic is that many legitimate pain patients have seen their opioids significantly reduced or downright discontinued because of their doctors' fears of over-prescribing addictive medications.
"I found myself being labeled as an addict and I never was...Being treated like a drug-seeking patient is degrading and humiliating," says Willkie, who adds that when she is at the hospital, "it's exhausting arguing with the doctors...You dread them making their rounds because every day they come in talking about weaning you off your meds."
Situations such as these are fraught with tension between patients and doctors, who must remain wary about the risk of over-prescribing powerful and addictive medications. Adding to the complexity is that it can be very difficult to reliably assess a patient's level of physical pain.
However, this difficulty may soon decline, as Indiana University School of Medicine researchers, led by Dr. Alexander B. Niculescu, have reportedly devised a way to objectively assess physical pain by analyzing biomarkers in a patient's blood sample. The results of a study involving more than 300 participants were published earlier this year in the journal Molecular Psychiatry.
Niculescu – who is both a professor of psychiatry and medical neuroscience at the IU School of Medicine – explains that, when someone is in severe physical pain, a blood sample will show biomarkers related to intracellular adhesion and cell-signaling mechanisms. He adds that some of these biomarkers "have prior convergent evidence from animal or human studies for involvement in pain."
Aside from reliably measuring pain severity, Niculescu says blood biomarkers can measure the degree of one's response to treatment and also assess the risk of future recurrences of pain. He believes this new method's greatest benefit, however, might be the ability to identify a number of non-opioid medications that a particular patient is likely to respond to, based on his or her biomarker profile.
Clearly, such a method could be a gamechanger for pain patients and the professionals who treat them. As of yet, health workers have been forced to make crucial decisions based on their clinical impressions of patients; such impressions are invariably subjective. A method that enables people to prove the extent of their pain could remove the stigma that many legitimate pain patients face when seeking to obtain their needed medicine. It would also improve their chances of receiving sufficient treatment.
Niculescu says it's "theoretically possible" that there are some conditions which, despite being severe, might not reveal themselves through his testing method. But he also says that, "even if the same molecular markers that are involved in the pain process are not reflected in the blood, there are other indirect markers that should reflect the distress."
Niculescu expects his testing method will be available to the medical community at large within one to three years.
Willkie says she would welcome a reliable pain assessment method. Well-aware that she is not alone in her plight, she has more than 500 Facebook friends with sickle cell disease, and she says that "all of their opioid meds have been restricted or cut" as a result of the opioid crisis. Some now feel compelled to find their opioids "on the streets." She says she personally has never obtained opioids this way. Instead, she relies on marijuana to mitigate her pain.
Niculescu expects his testing method will be available to the medical community at large within one to three years: "It takes a while for things to translate from a lab setting to a commercial testing arena."
In the meantime, for Willkie and other patients, "we have to convince doctors and nurses that we're in pain."
Urinary tract infections account for more than 8 million trips to the doctor each year.
Few things are more painful than a urinary tract infection (UTI). Common in men and women, these infections account for more than 8 million trips to the doctor each year and can cause an array of uncomfortable symptoms, from a burning feeling during urination to fever, vomiting, and chills. For an unlucky few, UTIs can be chronic—meaning that, despite treatment, they just keep coming back.
But new research, presented at the European Association of Urology (EAU) Congress in Paris this week, brings some hope to people who suffer from UTIs.
Clinicians from the Royal Berkshire Hospital presented the results of a long-term, nine-year clinical trial where 89 men and women who suffered from recurrent UTIs were given an oral vaccine called MV140, designed to prevent the infections. Every day for three months, the participants were given two sprays of the vaccine (flavored to taste like pineapple) and then followed over the course of nine years. Clinicians analyzed medical records and asked the study participants about symptoms to check whether any experienced UTIs or had any adverse reactions from taking the vaccine.
The results showed that across nine years, 48 of the participants (about 54%) remained completely infection-free. On average, the study participants remained infection free for 54.7 months—four and a half years.
“While we need to be pragmatic, this vaccine is a potential breakthrough in preventing UTIs and could offer a safe and effective alternative to conventional treatments,” said Gernot Bonita, Professor of Urology at the Alta Bro Medical Centre for Urology in Switzerland, who is also the EAU Chairman of Guidelines on Urological Infections.
The news comes as a relief not only for people who suffer chronic UTIs, but also to doctors who have seen an uptick in antibiotic-resistant UTIs in the past several years. Because UTIs usually require antibiotics, patients run the risk of developing a resistance to the antibiotics, making infections more difficult to treat. A preventative vaccine could mean less infections, less antibiotics, and less drug resistance overall.
“Many of our participants told us that having the vaccine restored their quality of life,” said Dr. Bob Yang, Consultant Urologist at the Royal Berkshire NHS Foundation Trust, who helped lead the research. “While we’re yet to look at the effect of this vaccine in different patient groups, this follow-up data suggests it could be a game-changer for UTI prevention if it’s offered widely, reducing the need for antibiotic treatments.”
MILESTONE: Doctors have transplanted a pig organ into a human for the first time in history
A surgeon at Massachusetts General Hospital prepares a pig organ for transplant.
Surgeons at Massachusetts General Hospital made history last week when they successfully transplanted a pig kidney into a human patient for the first time ever.
The recipient was a 62-year-old man named Richard Slayman who had been living with end-stage kidney disease caused by diabetes. While Slayman had received a kidney transplant in 2018 from a human donor, his diabetes ultimately caused the kidney to fail less than five years after the transplant. Slayman had undergone dialysis ever since—a procedure that uses an artificial kidney to remove waste products from a person’s blood when the kidneys are unable to—but the dialysis frequently caused blood clots and other complications that landed him in the hospital multiple times.
As a last resort, Slayman’s kidney specialist suggested a transplant using a pig kidney provided by eGenesis, a pharmaceutical company based in Cambridge, Mass. The highly experimental surgery was made possible with the Food and Drug Administration’s “compassionate use” initiative, which allows patients with life-threatening medical conditions access to experimental treatments.
The new frontier of organ donation
Like Slayman, more than 100,000 people are currently on the national organ transplant waiting list, and roughly 17 people die every day waiting for an available organ. To make up for the shortage of human organs, scientists have been experimenting for the past several decades with using organs from animals such as pigs—a new field of medicine known as xenotransplantation. But putting an animal organ into a human body is much more complicated than it might appear, experts say.
“The human immune system reacts incredibly violently to a pig organ, much more so than a human organ,” said Dr. Joren Madsen, director of the Mass General Transplant Center. Even with immunosuppressant drugs that suppress the body’s ability to reject the transplant organ, Madsen said, a human body would reject an animal organ “within minutes.”
So scientists have had to use gene-editing technology to change the animal organs so that they would work inside a human body. The pig kidney in Slayman’s surgery, for instance, had been genetically altered using CRISPR-Cas9 technology to remove harmful pig genes and add human ones. The kidney was also edited to remove pig viruses that could potentially infect a human after transplant.
With CRISPR technology, scientists have been able to prove that interspecies organ transplants are not only possible, but may be able to successfully work long term, too. In the past several years, scientists were able to transplant a pig kidney into a monkey and have the monkey survive for more than two years. More recently, doctors have transplanted pig hearts into human beings—though each recipient of a pig heart only managed to live a couple of months after the transplant. In one of the patients, researchers noted evidence of a pig virus in the man’s heart that had not been identified before the surgery and could be a possible explanation for his heart failure.
So far, so good
Slayman and his medical team ultimately decided to pursue the surgery—and the risk paid off. When the pig organ started producing urine at the end of the four-hour surgery, the entire operating room erupted in applause.
Slayman is currently receiving an infusion of immunosuppressant drugs to prevent the kidney from being rejected, while his doctors monitor the kidney’s function with frequent ultrasounds. Slayman is reported to be “recovering well” at Massachusetts General Hospital and is expected to be discharged within the next several days.