False medical advertising

Hundreds of stem cell clinics in the United States are offering expensive treatments for conditions ranging from heart disease to orthopedic problems. But little science exists to substantiate the effectiveness or even safety of these therapies, and regulators are starting to crack down on false advertising and dangerous experiments occurring at these clinics.

Last week, New York Attorney General Letitia James filed a lawsuit against Park Avenue Stem Cell (PASC), a for-profit facility operated in New York City by plastic surgeon Joel Singer, for misrepresenting its scientific backing. The suit against PASC accuses it of giving patients the false impression that its procedures are effective, approved by the U.S. Food and Drug Administration, and endorsed by several prestigious scientific and medical organizations. In promoting the clinic, Singer makes it sound like the company conducts established research studies. At one time, its website said it engaged in patient-funded research. But, the lawsuit notes, usually universities and hospitals conduct clinical trials funded by drug developers and government agencies, not the patients who participate.

“Misleading vulnerable consumers who are desperate to find a treatment for serious and painful medical conditions is unacceptable, unlawful, and immoral,” James said in a statement.

Health insurance companies generally do not cover stem cell therapies, which they consider experimental. PASC charged patients nearly $4,000 per procedure, which used stem cells obtained from the patients’ own fat tissue. Many patients paid for multiple procedures.

More than 700 stem cell clinics like PASC have sprung up in recent years. In October, the Federal Trade Commission fined stem cell clinics millions of dollars for deceptive advertising. The FDA is trying to shut down clinics that peddle unapproved stem cell therapies, starting with those posing the biggest threat, such as doctors who inject stem cells directly into the eye or brain, former FDA Commissioner Scott Gottlieb said in a recent interview with Medscape. Officials have linked stem cell treatments to several cases of blindness and at least 12 serious infections.

But it isn’t just private, for-profit facilities that are cashing in on the new treatments. “Across the country, clinicians at elite medical facilities are lining their pockets by providing expensive placebos,” Leigh Turner of the University of Minnesota’s Center for Bioethics told Medscape.

Peter Marks, director of the FDA Center for Biologics Evaluation and Research, noted a broad spectrum of stem cell therapy providers exists, ranging from legitimate university scientists leading rigorous clinical trials to doctors who promote stem cells “for just about anything.” Hospitals operate somewhere in the middle, he said.

The FDA said stem cell therapies potentially hold great promise for the future, and it remains committed to advancing the field of cell-based regenerative medicine. “We’re implementing new policies to make it more efficient to safely develop these promising new technologies,” the agency said in a statement. “At the same time, we’re also focusing more resources on enforcement when we see companies skirt safety measures and put patients at risk.”

Measles vaccine mandates

Attorneys said Wednesday they plan to sue New York City by the end of the week for instituting a measles vaccine mandate in a heavily Orthodox Jewish neighborhood. Mayor Bill de Blasio declared a public health emergency Tuesday over a measles outbreak in Brooklyn’s Williamsburg section, where officials have documented more than 250 cases since September.

Although the city can’t legally force anyone to get a vaccination, people who don’t could face fines of $1,000. Donna Lieberman, executive director of the New York Civil Liberties Union, called the order an extreme measure that raises civil liberties concerns about medical treatment. Earlier this week, the city ordered religious schools and day care programs to ban unvaccinated students or risk forced closure.

While controversy boiled in Brooklyn, a judge in Rockland County in New York City’s northwestern suburbs last week lifted an emergency order issued March 26 that banned unvaccinated children from public places for 30 days. The judge ruled that the number of measles cases in the neighborhood, a confirmed 166, did not meet the legal requirement for an emergency order.

Ed Day, the Rockland County executive who issued the order, called the judge’s decision “very wrong-headed,” expressing concern for the well-being of pregnant women and children who could suffer life-threatening complications from the highly contagious illness. —J.B.

Surgery with no knives

A team of researchers has developed a molecular surgery process that uses tiny needles, electrical currents, and 3D molds to reshape living tissue with no incisions, scarring, or recovery time. The procedure takes about five minutes and only needs local anesthesia. The technique could potentially make it possible to reshape an ear or a nose, repair immobile joints, fix a deviated septum, repair shortening and hardening of muscles and tendons following a stroke, or even offer a noninvasive alternative to laser eye surgery.

The low-cost procedure involves using electrical current to make hard cartilage tissue flexible and then mold it to the desired shape. Cartilage is the flexible connective tissue found in the nose, outer ear, and joint surfaces.

“Once the tissue is floppy, you can mold it to whatever shape you want,” said lead researcher Michael Hill, a chemistry professor at Occidental College in Los Angeles. The researchers presented their findings April 2 at the national meeting of the American Chemical Society in Orlando, Fla.

The team tested the method on a rabbit with ears that normally stand upright. They used a mold to bend one ear into the desired new shape. Then they inserted microneedle electrodes into the bent portion of the ear and applied an electrical current to briefly soften the cartilage without damaging it. Once they turned the current off, the cartilage hardened into the new shape.

The researchers are also experimenting with other types of tissue like tendons and corneas. In animal studies, they painted electrodes on contact lenses, put them on the animals’ eyes, and applied a current to temporarily soften the cornea and change its curvature, a technique that could correct nearsightedness. —J.B.

Artificial muscle power

Researchers have developed a light-sensitive, shape-shifting material that could help develop artificial muscles that can flex and relax in response to light on the skin. The scientists designed their new substance so that when they shined a blue LED light on it, the molecules folded into pleats like an accordion.

When they incorporated the material into a gel and exposed it to the blue light, the same accordion effect caused the gel to shrivel to one-tenth of its original size and expand again when the light was off. Next, the researchers put the gel on a strip of electrical tape with a piece of wire attached to a small weight at the end. When they hung the tape in front of the blue light, the gel lifted the weight, which was about 30 times its mass.

The team is experimenting with making the gel stronger, more elastic, and faster-moving. The researchers have also produced gels that respond to different wavelengths of light. Red or near-infrared light can penetrate human tissue, a necessary property if researchers want to use the material to make artificial muscle. —J.B.