Tuesday, March 21, 2017

No more questions about Kaler's job performance, please

From KSTP:

University of Minnesota officials have stopped asking the public what they think about President Eric Kaler’s job performance – a decision that comes a year after his approval ratings dropped by double digits.

5 EYEWITNESS NEWS found the university removed questions about Kaler from its annual market research last year. The university had included Kaler’s approval rating every year dating back to at least 2011.

“We determined that asking a question about one individual, when many don't know who the president is, makes little sense,” Evan Lapiska, a university spokesperson said in an email Tuesday.

Lapiska said the Office of the President was involved in the decision to remove questions about Kaler from the survey.

Friday, March 17, 2017

Journalists talk to patients in studies gone wrong. Shouldn't oversight bodies?

From my latest article in IRB: Ethics and Human Research, "Why Research Oversight Bodies Should Interview Research Subjects."

The first psychiatric drug Robert Huber took was an experimental one. In July 2007, Huber went to a Minneapolis emergency room feeling panicked. His ears were ringing and he thought he might be hearing voices. Very soon, Huber found himself on a locked psychiatric ward with a diagnosis of paranoid schizophrenia. A psychiatrist at the University of Minnesota confined him to the unit under an emergency 72-hour hold.

The emergency hold had not expired when the psychiatrist asked him to enroll in a research study. “Immediately, they were on me to do experimental medications, non-FDA approved—and I had never been on medications in my life,” Huber later told a reporter. “Then they say you have a giant medical bill and if you do the research, you won’t have this giant medical bill.” The study, sponsored by Solvay Pharmaceuticals, was for an unapproved antipsychotic drug called bifeprunox. Huber signed a consent form and was later released from the locked unit, but within weeks, the Food and Drug Administration (FDA) had rejected bifeprunox for marketing approval, citing its lack of efficacy and the death of a research subject in Europe.

The study continued despite the FDA’s decision. Huber began having excruciating abdominal pain and returned to the emergency room three times. He even considered suicide. Finally, he dropped out of the study and sought medical care elsewhere. Several months later, Solvay Pharmaceuticals halted all bifeprunox studies and stopped development of the drug.

In May 2014, almost seven years after Huber was enrolled in the bifeprunox study, his story aired on a local television station. The television report appeared at a time when the University of Minnesota was facing intense public scrutiny for the suicide of another psychiatric research subject. The university declined an on-camera interview but defended itself with a statement about Huber that read in part, “His medical record shows extreme anxiety and paranoia, a history of head injuries and lengthy battle with alcoholism. It is highly inappropriate for him to be put in the media spotlight as a spokesperson for clinical trial safety.”

Under pressure, the University of Minnesota eventually conducted or commissioned three reviews of Huber’s treatment—by the institutional review board’s (IRB’s) executive committee, by a newly established Research Compliance Office, and by FTI Consulting, an external firm hired by the university. None of the reviews found any significant fault with the way Huber was treated. The IRB’s executive committee ruled that Huber’s consent had not been compromised in any way by the fact that he had been involuntarily confined under a 72-hour hold when he was enrolled. A letter to Huber stated, “You were not pressured or coerced to enroll in this study.”

Whether or not these decisions were fair, an important procedural question remains unanswered. Should Huber have been allowed to speak to the internal and external bodies that were investigating his experience? None of the three bodies tasked with reviewing the case actually interviewed him. Instead, they relied solely on a review of written records. The director of the university’s human research protection program explained, “Standard practice for investigating complaints about mistreatment of research subjects allows for but does not require the interview of witnesses.”

Such a policy is not unusual. Most oversight bodies (including IRBs and the FDA) distinguish between routine audits, which are typically done periodically to determine compliance with federal regulations or institutional policy, and for-cause audits or investigations, which are usually triggered by a suspicion of research misconduct, failure of compliance, or mistreatment of research subjects. Most bodies have explicit policies for proceeding with for-cause investigations, detailing who should conduct the investigation (typically the IRB, the office of research compliance, or a special committee), which written documents should be reviewed, and the procedures that should be followed.

Some policies state that investigators should interview the principal investigator of the study in question. But they usually say nothing about research subjects themselves. The same appears to be true for federal investigators. While a spokesperson for the FDA says that FDA inspectors sometimes do contact human subjects, she also says that the interviews are typically not mentioned in the FDA’s Establishment Inspection Reports. The FDA compliance manual for bioresearch monitoring inspections of clinical investigators makes no mention of interviews with research subjects.

Reliance on written documents is one of the key features of modern bureaucracy, as Max Weber pointed out over a century ago, and research oversight is nothing if not bureaucratic. But is there a solid rationale for this practice? Limiting an investigation to written documents and interviews of the study team has the advantage of convenience, but it hardly seems fair to research subjects, many of whom will want to give a firsthand account of their experiences. Just as important, failing to interview subjects has the potential to influence the judgments of investigative bodies by distancing them from the human impact of serious mistreatment.

The rest of the article is here.

Tuesday, March 14, 2017

"A story of claims and counterclaims, of truths and untruths, and finally, a story of two cancers - one physical, one moral."

From The Otago Daily Times:

Ron Jones does not hold back in his account of events around the "unfortunate experiment'' at National Women's Hospital. A few pages into the introduction he describes it as one of the "most serious unethical peacetime experiments of the 20th century." Despite having already read millions of the words written about this experiment, which ran from 1966 until 1988, Doctors in Denial: The forgotten women in the "Unfortunate Experiment" shocked me anew.

Sunday, March 12, 2017

“Unlike many Trump nominees, he's actually highly qualified to destroy the agency he's meant to lead.”

Julia Belluz explains why Scott Gottlieb is a terrible choice to lead the FDA:

According to the public interest group Public Citizen, “Gottlieb is entangled in an unprecedented web of Big Pharma ties.” He currently serves or has served on five pharmaceutical companies’ boards, including GlaxoSmithKline, and was recused from meetings and decisions while serving as FDA deputy commissioner because of these conflicts.

“Between 2013 and 2015, Gottlieb received a total of at least $413,000 from multiple pharma and medical device companies, most for consulting and speaking fees,” Public Citizen reported.

He’s also partner at a large venture capital firm, New Enterprise Associates, a senior principal at the investment bank TR Winston, and partner at the hedge fund Arcoda Capital Management — all health care–centric finance groups.

He’d need to resign from the pharmaceutical boards, and get rid of stock in companies he’d regulate at FDA. But severing those ties isn’t that easy, Daniel Carpenter, a Harvard professor who wrote a history of the FDA, told Vox. “These are not relationships whose influence just disappears once he resigns from a corporate board.” He added: “If [Gottlieb] is confirmed, he would be the most interest-conflicted commissioner in American history, by far.”

Tuesday, March 7, 2017

"His career as a healer also seems inspired by what accountants would call a 'near-broke' experience"

From Mike Mullen in City Pages, on spiritual leader and Chanhassen resident Mas Sajady:

He claims his “abilities” stem from two near-death experiences — a warehouse accident that left him with a “crushed jaw,” and a near-drowning in Belize. The incidents granted the former computer programmer heightened senses, pure peace, and the power to “edit” time, “deleting” moments people wish hadn’t happened, and helping them create new futures both rich and successful.

He administers to tens of thousands of people online. According to testimonials on mas-sajady.com, his mind-opening programs have fixed everything from sciatica to scoliosis to dizzy spells to shortness.

“I have GROWN 2 inches,” one woman wrote.

Another went from “not having money to put gas in my car” to “earning almost $400,000 in my business” in six months.

Aside from spiritual imbuement, Sajady’s site lists hundreds of serious medical issues he can help with. A seven-session, four-hour “frequency clinic” will “specifically work on eliminating the frequencies of cancer and its root causes from your blueprint.” A bargain at $180.

“Healing MAStery” includes six one-hour meditation lectures and six 20-minute question-and-answer sessions by phone. Cost of these eight hours of enlightenment: $1,200.

But Nygard and two other women have come to believe Sajady’s taking advantage of people, producing more negative energy than positive. Each came to this realization only after spending thousands of dollars.

They’ve filed complaints with the Minnesota Department of Health, claiming Sajady fails to give out a state-mandated “Client Bill of Rights,” a proviso informing customers that their practitioner “may not provide a medical diagnosis,” among other warnings. They further claim he’s practicing medicine without a license.