乌鸦传媒

Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.

Stanford President Faces New Scrutiny Over Alzheimer's Research

Colleagues are alleging that an internal review previously found "falsified data" in Stanford President Marc Tessier-Lavigne's Alzheimer's research, .

The allegations have been brought to light as Tessier-Lavigne, who became Stanford's president in 2016, has been under investigation by the university's Board of Trustees since late November, the Stanford Daily reported. The outlet noted it previously "revealed concerns that several other papers he had co-authored contained altered imagery."

"But these latest allegations, about a different paper, are more serious because they involve what was once considered a promising treatment target for Alzheimer's disease – and because people involved in the review allege that Tessier-Lavigne tried to keep its findings hidden," the article stated.

The research in question dates back to 2009, when Tessier-Lavigne was a top executive at Genentech. At the time, Tessier-Lavigne was the primary author of a paper published in the journal Nature that "claimed to have found the potential cause for brain degeneration in Alzheimer's patients," the article stated.

However, after a number of unsuccessful attempts to reproduce the research, the paper became the subject of an internal review by Genentech, the Stanford Daily reported, citing "four high-level Genentech employees at the time," three of whom spoke to the outlet on the condition of anonymity. "The scientists ... said that the inquiry discovered falsification of data in the research, and that Tessier-Lavigne kept the finding from becoming public," it stated.

Specifically, the paper had included "several experiments claiming to show that the amino-terminal fragment of the amyloid precursor protein (N-APP) binds to death receptor six (DR6) and that this bind causes neurodegeneration," according to the article. "But later-published studies by Tessier-Lavigne's lab and other research groups show this conclusion was inaccurate."

"A crystal structure – a type of labor intensive experiment that determines the exact arrangement of atoms – published in 2015 proved that APP, the complete protein, binds to DR6 at the E2 site," the Stanford Daily reported. "The N-APP fragment used in the 2009 research did not include the E2 site, meaning that DR6 could not have bound to the fragment and caused the results described in the paper."

Tessier-Lavigne has denied the allegations brought forth by the former colleagues, the Stanford Daily reported. And Genentech said in part in a statement provided to the Daily that "as part of our diligence related to these allegations, we reviewed the records from that November 2011 [Research Review Committee] meeting and saw no allegations of fraud or wrongdoing." The company did acknowledge to the Daily that, "given that these events happened many years ago ... our current records may not be complete."

Doctors 'Groomed' to Overuse Vascular Devices

A review of text messages, a whistleblower lawsuit, and an internal investigation have revealed that medical device giant Medtronic "allegedly 'groomed' doctors to overuse its vascular products in patients at a veterans hospital," .

Each time a doctor places a foreign device in a patient's body, it carries a risk of complication such as clots or even amputation. But text messages contained in a recently unsealed whistleblower lawsuit revealed a doctor's aggressive approach to treating blockages in a patient's leg vessels, ProPublica reported. The text messages were a back-and-forth between a Medtronic representative, who was looking on and texted her colleague "a play-by-play."

Within reach for the doctor at the Robert J. Dole Veterans Affairs Medical Center in Wichita, Kansas, were Medtronic products, such as tubes with blades to shave deposits off of artery walls as well as stents to widen blood vessels and balloons coated with therapeutic drugs, ProPublica wrote. And the text message chain read in part: Rep – "Just used 12 [drug-coated balloons]!!" Colleague – "Does that mean I owe u $$."

The text messages "give a window into the way money and medicine mingle in the booming business of peripheral artery disease," ProPublica wrote.

"Representatives from companies are often present during vascular procedures to guide doctors on how to use their complex devices," ProPublica added. And, "This kind of access has the potential to influence treatment plans, as companies and their representatives profit when more of their product is used."

The whistleblower lawsuit, filed by a sales representative for a competing medical device company, alleges an illegal kickback scheme between Medtronic and hospital employees that included "steakhouse dinners, Apple electronics and NASCAR tickets," as well as a "lucrative contract with the hospital," ProPublica reported.

"Independent from the whistleblower suit, internal investigators at the Wichita facility have also examined the treatment patterns of its vascular patients in recent years and found numerous cases where medical devices were used excessively," ProPublica wrote.

Medtronic declined to answer ProPublica's questions, citing ongoing litigation, but a spokesperson told the outlet that the allegations levied against the company are false. VA Press Secretary Terrence Hayes told ProPublica in part that the VA is "conducting an extensive review of patient care" at the Kansas facility, and that, so far, it has not found any "quality of care issues."

Battle Over Orphan Drug Program Leaves Patients in the Lurch

Lore Wilkinson, a 91-year-old from Rochester, Minnesota, relies on a prescription drug to help her walk and talk while battling a rare muscle disease, . For more than a decade, the drug cost her so little she didn't even use insurance to pay for it. However, now Medicare is shelling out some $40,000 for a one-month supply, and Wilkinson fears being left with a $9,000 copayment.

"Wilkinson, like millions of other people with rare diseases nationwide, is caught up in an ongoing legal and political debate about how the U.S. supports pharmaceutical companies and their research," KHN wrote. "The FDA made its latest move in the tug of war in late January by saying it would largely ignore a U.S. court ruling involving Firdapse, the drug Wilkinson needs."

In 2018, Firdapse was approved by the FDA as an "orphan drug," which rewards companies for developing treatments for rare diseases, KHN noted. That has included an entitlement to seven years of exclusive rights to the marketplace.

After Catalyst Pharmaceuticals was granted exclusive market rights for Firdapse, that meant Wilkinson and other patients with Lambert-Eaton myasthenic syndrome (LEMS) could no longer obtain a similar drug from another company free of charge, KHN reported.

In 2019, amid patient uproar regarding costs, the FDA granted another company the right to market a competitive product for a subset of pediatric patients, KHN reported. However, that decision was met with a lawsuit filed by Catalyst against the federal government.

Though the 11th Circuit sided with Catalyst in 2021, the FDA more recently moved to "effectively disregard the court's decision," KHN noted.

"Still, the multiyear saga highlights lingering questions about orphan drug exclusivity and how the FDA's policies may influence drug prices," KHN wrote. "At issue is the Orphan Drug Act, a 1980s-era law that incentivizes drug companies to research and develop rare-disease drugs. And it's not the first time the orphan drug program has raised concerns."

As for Wilkinson's advice for Congress. "They have to change the law," she told KHN.

"Pharmaceutical companies should only win orphan drug status and be given exclusivity when they develop 'a really new medication, not just by changing one molecule,'" KHN wrote of Wilkinson's advice.

Comment