Wednesday, August 16, 2017

"President Trump buoyed the white nationalist movement on Tuesday as no president has done in generations."

So says the New York Times, and for once, the Times and Klan leaders agree.

But perhaps the most alarming take on the events of this past week are in the New Yorker, where Robin Wright discusses the possibility of civil war with experts experienced in assessing such risks in other countries. She writes:

America’s stability is increasingly an undercurrent in political discourse. Earlier this year, I began a conversation with Keith Mines about America’s turmoil. Mines has spent his career—in the U.S. Army Special Forces, the United Nations, and now the State Department—navigating civil wars in other countries, including Afghanistan, Colombia, El Salvador, Iraq, Somalia, and Sudan. He returned to Washington after sixteen years to find conditions that he had seen nurture conflict abroad now visible at home. It haunts him. In March, Mines was one of several national-security experts whom Foreign Policy asked to evaluate the risks of a second civil war—with percentages. Mines concluded that the United States faces a sixty-per-cent chance of civil war over the next ten to fifteen years. Other experts’ predictions ranged from five per cent to ninety-five per cent. The sobering consensus was thirty-five per cent. And that was five months before Charlottesville.

Tuesday, August 15, 2017

A new kind of awareness campaign



Anyone familiar with modern drug marketing knows the role played by disease awareness campaigns. To sell Detrol, you sell overactive bladder. To sell Lyrica, you sell fibromyalgia. To sell Paxil, you sell social anxiety disorder. Raising awareness of a condition is a means of selling a treatment for it.

But Vanda Pharmaceuticals is trying something new. To sell its branded antipsychotic, Fanapt, Vanda is trying to raise awareness of a common antipsychotic side-effect called akasthisia -- the extreme restlessness and agitation that leads many patients to stop taking antipsychotics. Presumably, Vanda believes that Fanapt is less likely to cause akasthisia than its competitors. Commercials like this one lead viewers to Vanda's akasthisia awareness website, gotakasthisia.com.

You can get the details from Fierce Pharma.

Wednesday, August 9, 2017

Dr. James Marion Sims, who experimented on slaves

The memorials to Confederate generals are coming down. Lake Calhoun, originally named for the Great Nullifier, has been rebranded. Isn't it time to fix those memorials to yet another son of South Carolina, James Marion Sims, the father of modern gynecology and a researcher whose subjects happened to be slaves?

Susan Reverby writes:

On a quiet side of Central Park on 5th Avenue and 103rd Street, just across from the New York Academy of Medicine in East Harlem, stands the larger-than-life Sims (1813-1883). His 14-foot marble statue, erected in 1894, was the first for a doctor in the United States, and it moved to this site in 1934. He is considered the father of modern gynecology. His claim to inventing the speculum that made possible the visualization of the vagina, and his 1840s surgeries on slave women to correct fistulas in their vaginal walls that allowed urinary and fecal material to continuously drip, made him famous. These tears often happen in very young mothers and from obstructed long labor, or in women with deformed pelvises from rickets, lack of proper nutrition, syphilitic ulcers, or serious infections. While this horrific damage, which leads to further infections, terrible smells, and social isolation, is now seen primarily in parts of Africa, it was a common problem for all women in the 19th century, especially before caesarean sections could be performed safely. They were seen especially frequently as a byproduct of slavery that enforced rape and demanded pregnancy of newly pubescent women.

Sims, born in South Carolina, was practicing in Montgomery, Alabama, when enslaved women with this malady came to his attention. In an effort of surgical bravado, Sims operated on nearly a dozen black women, three of whom we only know as Anarcha, Betsey, and Lucy. In an era when anesthesia for operations was just beginning to be used, and doctors debated whether white women and women of color felt pain as intensely as white men did, these multiple surgeries were done without the benefit of loss of sensation. As Sims himself would declare, “Lucy’s agony was extreme,” and Anarcha endured more than 13 attempts to close her fistula. After years of experimentation, and eventually the proffering of opium to his subjects to lessen their pain, make them less likely to complain, but also keep bowel movements limited, Sims found a way to remove the necrotized tissue and sew up these fissures with silver wire sutures. In 1853, he moved to New York, founded the Women’s Hospital, and became a world-renown celebrity physician who operated on royalty, served as president of the American Medical Association, and aided in the establishment of the first New York cancer institute.

Reverby thinks it is time to set the record straight on Sims, and rightly so. She writes, "Perhaps it is time to remove the signs on the granite pedestals that announce Sims’ surgical talent in New York, and at least explain to other generations how such success was achieved on the bodies of others."  But Harlem is not the only place to house a monument to Sims.  There is a memorial on the grounds of the state capitol in South Carolina (pictured above) as well as in Montgomery, Alabama.  Shouldn't Southerners be told the full story about Sims as well?

Monday, August 7, 2017

Turner vs Quacks

From the Star Tribune:

The clinics offer futuristic-sounding treatments for everything from eye problems to osteoarthritis.

Listed on a government website, they present the opportunity to participate in clinical trials to test the potential of one of the most promising tools in medicine — the body’s own stem cells. It’s an attractive pitch for many patients, even though some of the clinics charge $6,000 and up to participate.

Now, with a national debate raging over the future of one of the hottest frontiers in 21st-century medicine, a University of Minnesota bioethicist has taken center stage in questioning whether many of these services are legitimate.

“You have these businesses that don’t have meaningful clinical research going on,” the U’s Leigh Turner said in an interview. “There is a risk for fraud, in that people may be charged thousands of dollars to get an intervention that has no chance” of working.

Turner has emerged as a major critic of the clinics, some of which he says have flawed procedures that allow bias to distort the results of treatment studies. He also says allowing clinics to list studies can imply government approval, lending false legitimacy to marketing pitches.

“My concern is that you basically take clinicaltrials.gov and transform it into a marketing platform,” Turner said.

The rest is here.

Tuesday, August 1, 2017

Using poor, uninsured minorities to test the safety of experimental drugs

My latest article on the topic, in Clinical Trials. Here is how it begins.

In 2004, a pharmaceutical researcher in Alabama offered a paycheck to 21 clients of a Mobile homeless center in exchange for testing an experimental smallpox vaccine. These people could expect little medical benefit from the study, of course. Smallpox was eradicated in 1980, and in the absence of a bioterrorist attack on Mobile, it was unlikely that clients of a homeless center there would need protection from it. But medical benefit was not really the point. The main purpose of these studies was to see if the experimental vaccine carried unpleasant or dangerous side effects.

In some ways, studies like this are not unusual. Pharmaceutical companies routinely pay desperately poor subjects to test the safety of experimental products. In this case, however, 2 of the 21 subjects had to be hospitalized, one of them for acute myocarditis — an inflammation of the heart muscle that can cause sudden death. A third subject contracted pericarditis. It did not help that the research team lost this subject’s medical files for two years, one of many blunders that attracted federal scrutiny. When the Food and Drug Administration (FDA) investigated in 2007, it found a host of risky research practices ranging from careless record-keeping to dubious recruiting procedures, as well as little meaningful oversight by the Institutional Review Board. The FDA eventually disqualified the researcher in 2008, effectively barring him from doing any more studies. But he continues to practice medicine in Alabama, marketing sexual enhancement procedures as "Dr. Orgasm."