MedPage today story.
Welcome to the latest edition of the Investigative Roundup, which features some of the best investigative journalism in health care every week.
Malpractice killed my mother
What should have been a routine procedure for a Texas mom instead became a tragic example of medical malpractice, according to reports. V Texas Monthly.
Kimberly Ray had injections in her lower back because of pain from an old injury. But the injections stopped working, so the attending physician recommended a rhizotomy. Ray never woke up after the procedure. Her family ordered an autopsy, which found that she “died as a result of complications from the injection procedure due to pain.”
The family then hired an attorney, whose investigation uncovered red flag after red flag associated with Integrity Wellness, the clinic where Ray sought treatment, and the medical staff associated with it.
First, the CRNA who administered the anesthesia and performed the procedure was wearing a white coat and surgical gown, and the family did not know that he was not a doctor. A medical examiner reviewed Ray's case and said there was a “clear possibility” that her heart stopped beating because the CRNA who gave her the anesthesia administered it in a way that caused “muscle paralysis that prevented the recipient from breathing.”
Another CRNA in the room during the procedure who was assigned to monitor Ray and who failed to notice that she had no pulse and was not breathing, the investigation found, has her own questionable history, as do many of the other medical staff employed by the clinic.
Not to mention the insane billing practices. At another clinic, Ray's insurance billed him $2,000 for the injection. But Integrity Wellness billed a whopping $139,000 for the same service.
Following this tragic incident, Integrity Wellness was renamed Cedarwood Surgery Center in 2021.
Opioid titan avoids major payout
Despite a major multibillion-dollar case against it, the opioid maker has only had to pay a small portion to people harmed by its products. in accordance with ProPublica.
Back in 2013, a whistleblower filed a lawsuit against drug maker Endo Health Solutions, alerting the government to the company's shady business practices. The lawsuit alleged that the company's marketing was “intentionally designed to deceptively manipulate prescribing physicians.”
For example, in the company's early years, salespeople were incentivized to sell as much Percocet as possible to those who generated the most sales of BMW corporate cars. The sales team used flashy tactics to showcase the “unique” properties of its flagship opioid Opana ER, even though the claims contradicted what the FDA said about the drug. Endo also continued to supply opioids to doctors that other businesses had blocked for recklessness.
For ten years, the Department of Justice had a winning case with a lot of evidence against Endo, but it delayed taking action. During this time, Endo manipulated the structure of its business and reorganized its debts to avoid liability.
Although Endo owed about $7 billion, it ended up paying only $200 million. A total of $40 million was divided among the opioid victims, amounting to about $1,000 each (for reference, Purdue Pharma victims will receive anywhere from $3,500 to $48,000 each). Meanwhile, executives shared $95 million in bonuses and lawyers earned $350 million.
Landmark trial thrown into doubt
Fifteen years after a landmark trial of the antiplatelet drug ticagrelor (Brilint), questions about the integrity of the data remain, according to the article. V BMJ.
Ticagrelor is the only P2Y12 inhibitor still under patent and generating huge profits despite a relatively small market share. But the key test underlying its use has been questioned for years. The PLATO clinical trial enrolled 18,624 patients in 43 countries and found that ticagrelor produced better results than its competitor, the older drug clopidogrel (Plavix).
However, a subgroup analysis of only US participants found that outcomes were actually worse, with a 27% higher risk of death from vascular causes, myocardial infarction or stroke, the primary endpoint. AstraZeneca explained this by citing “unusually high doses of aspirin seen almost exclusively in the US,” which did not convince the FDA, which initially denied ticagrelor.
In most of the 43 countries, the sites were controlled by the sponsor itself. However, “in four countries controlled exclusively by nonsponsor personnel—Georgia, Israel, Russia, and the United States—ticagrelor fared worse,” the article said.
The legal proceedings were investigated by the US Department of Justice in 2013, but the investigation was closed a year later. The researchers reviewed the trial data and continued to sound the alarm about the integrity of the data as other trials failed to replicate the results.
