MedPage Right this moment story.
Welcome to the newest version of Investigative Roundup, highlighting among the greatest investigative reporting on healthcare every week.
Malpractice Killed Mother
What was purported to be a routine process for a Texas mother as a substitute turned a tragic instance of medical malpractice, in response to reporting in Texas Month-to-month.
Kimberly Ray had been getting injections within the decrease lumbar area for ache from an outdated damage. However the injections stopped working, so her supplier really helpful getting a rhizotomy. Ray by no means awoke from the process. Her household ordered an post-mortem, which discovered she “died on account of issues following an injection process for ache.”
The household then employed a lawyer whose investigation discovered crimson flag after crimson flag related to Integrity Wellness, the clinic the place Ray sought therapy, and the medical employees related to it.
For one, the CRNA who administered anesthesia and carried out the process wore a white coat and scrubs and the household did not notice he wasn’t a health care provider. A medical skilled reviewed Ray’s case and stated there was a “distinct risk” that her coronary heart had stopped as a result of the CRNA who gave her anesthesia administered it in a manner that precipitated “muscle paralysis that will stop the recipient from respiration.”
The opposite CRNA within the room in the course of the process, who was tasked with monitoring Ray and failed to note she had no pulse and wasn’t respiration, has his personal questionable historical past, the investigation discovered — as did most of the different medical employees employed on the clinic.
To not point out insane billing practices. At a distinct clinic, Ray’s insurance coverage was billed $2,000 per injection. However Integrity Wellness billed a whopping $139,000 for a similar service.
Since this tragic case in 2021, Integrity Wellness has since been renamed to Cedarwood Surgical Middle.
Opioid Titan Averted Main Payout
Regardless of having a sturdy multi-billion greenback case towards it, an opioid maker solely needed to pay a fraction to the folks harmed by its merchandise, in response to ProPublica.
Again in 2013, a whistleblower filed a lawsuit towards the drug producer Endo Well being Options alerting the federal government to the corporate’s shady enterprise practices. The lawsuit charged that the corporate’s advertising was “purposely designed to fraudulently manipulate prescribing physicians.”
As an example, in earlier years on the firm, salespeople have been incentivized to promote as a lot Percocet as doable with these making probably the most gross sales profitable BMW company automobiles. The gross sales staff had flashy ways to show “distinctive” options of their flagship opioid, Opana ER, regardless of that these claims contradicted what the FDA had stated in regards to the drug. Endo additionally continued to provide opioids to medical doctors whom different companies had blackballed for being reckless.
For a decade, the DOJ had a profitable case with a wealth of proof towards Endo — but it delayed in taking motion. In that point, Endo manipulated its enterprise construction and rearranged its money owed to keep away from accountability.
Whereas Endo owed as much as $7 billion, in the long run it solely needed to shell out $200 million. Simply $40 million was break up between opioid victims, which is about $1,000 every (for reference, Purdue Pharma victims are set to obtain anyplace between $3,500 to $48,000 every). In the meantime, executives break up $95 million in bonuses and attorneys raked in $350 million.
Landmark Trial Questioned
Fifteen years since a landmark trial for the antiplatelet drug ticagrelor (Brilinta), questions of information integrity stay, in response to an article within the BMJ.
Ticagrelor is the one P2Y12 inhibitor nonetheless beneath patent and makes an outsized revenue, regardless of comparatively small market share. However the pivotal trial underpinning its use has been questioned for years. The PLATO scientific trial concerned 18,624 sufferers in 43 nations and located that ticagrelor led to higher outcomes than its competitor, the older drug clopidogrel (Plavix).
Nonetheless, a subgroup evaluation of solely U.S. individuals discovered that it truly did worse and had a 27% increased danger of loss of life from vascular causes, myocardial infarction, or stroke — the first endpoint. AstraZeneca defined this away citing “an unusually excessive aspirin dose seen virtually completely within the U.S.,” which did not persuade the FDA, who initially denied ticagrelor.
In a lot of the 43 nations, the websites have been monitored by the sponsor itself. Nonetheless, “Within the 4 nations completely monitored by non-sponsor personnel — Georgia, Israel, Russia, and the U.S. — ticagrelor fared worse,” the article acknowledged.
The trial was probed by the U.S. Division of Justice in 2013, however the investigation was dropped a yr later. Researchers reviewed the trial knowledge and continued to lift the alarm about knowledge integrity and different trials failed to duplicate the outcomes.