Pay-to-Play Clinical Trials
Federal regulators are paying more attention to “pay-to-play” clinical trials that offer admission for a price, STAT reports.
The FDA confirmed to STAT that it asked an advisory committee to consider how the research community should think about these kinds of trials, and the panel is now drafting recommendations, according to the story. The National Institutes of Health has asked the committee to assess whether its existing guidance to patients considering a clinical trial would apply in this situation.
Both groups’ actions follow the HHS Secretary’s Advisory Committee on Human Research Protections’ (SACHRP) consideration of pay-to-participate trial guidance. SACHRP is expected to release guidelines at its next meeting in December, or the following one in March. It took an interest in the subject last year following a plan in Florida to charge seniors a fee — as high as $285,000 — to enroll in a trial of “young blood” infusions for preventing aging.
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There are no data on whether or not these types of trials are increasing, but more examples have cropped up recently, including another trial of “young blood” that charged about 80 people $8,000 each for infusions, and a clinic in Panama enrolled 20 autistic children in a stem cell trial that charged parents $7,200, STAT reports.
While FDA regulations permit a clinical trial “entry fee” in certain situations, the concern is that this could serve as a rouse for an entity looking to profit from desperate patients.
Rationing Immune Globulin Infusions
Hospitals and other clinics are running short on immune globulin (IG) infusions, and some have started to ration treatment, the Wall Street Journal reports (subscription required).
In late June, Cincinnati Children’s Hospital sent letters to 150 families of patients who get regular IG infusions that the hospital would suspend or reduce treatments, conserving supply for those with life-threatening conditions. Massachusetts General Hospital has also cancelled many infusion appointments, and it was initially down to 10% of its normal supply, the WSJ reports.
Takeda Pharmaceuticals, a major IG manufacturer, advised doctors in December not to start new patients on two of its products, Cuvitru and Hyqvia, because inventories were low, and Pfizer notified customers in June that they would receive minimal or no supply of its IG product Octagam through July.
IG is used to treat immune, muscle, and nerve disorders, and the shortage has patients concerned. One 23-year-old patient with autonomic neuropathy who is now on a waiting list for treatment told the WSJ he’s concerned about his pain coming back, and the mother of a 3-year-old with juvenile dermatomyositis, whose treatments have been suspended since July, said she’s worried about her daughter getting an infection or having a flare-up.
Small Pharmacies = Big Opioid Pushers
Half of all the opioid pills distributed in the U.S. from 2006 through 2012 were handled by just 15% of pharmacies, the Washington Post reports.
The worst offender: Shearer Drug in Clinton County, Kentucky, purchased nearly 6.8 million pills that contained hydrocodone and oxycodone during that time. That translated to 96 pills per year for every woman, man, and child in this county of 10,000.
Coming in second was Hardin County Discount Pharmacy in Illinois (almost 2.8 million pills, or 90 per resident annually), followed by Arnzen’s Kamiah Drug in Idaho (nearly 2.3 million pills, or 88 per resident each year). Every one of the Post’s top 10, as ranked by pills per county resident per year, was an independent drugstore located in a rural area.
These pharmacies handled large volumes of opioids during an epidemic of abuse in the U.S., and, “until now, have largely avoided publicity for their roles in the epidemic,” according to the article.
The findings come from analysis of the DEA’s Automation of Reports and Consolidated Orders System (ARCOS), which tracks every pain pill distributed in the U.S. The Post and HD Media, which publishes the Charleston Gazette-Mail in West Virginia, fought a year-long battle for access to the database, and a judge recently ordered the release of seven years’ worth of its records. For this latest story, reporters traced the path of the more than 70 billion pain pills distributed to about 83,000 pharmacies.
Surprise Medical Bills for Vets
An internal Department of Veterans Affairs report finds that vets’ care at facilities outside of VA hospitals isn’t always covered the way it should be, according to Axios.
Many vets’ claims were incorrectly denied after they sought care in non-VA emergency departments, the Office of the Inspector General determined. It estimated that 17,400 veterans were billed for care that the VA should have covered, totaling about $53 million in “surprise” medical bills.
That total would have been even higher if all the hospitals went on to bill veterans for their denied claims; about 61,000 veterans were at risk of getting such bills, according to the report.
Claims processing errors were largely to blame for the incorrect coverage denials, the report found.
Date: August 20, 2019
Source: MedPage Today