Disparities

After Trials With Yale Researchers, FDA-Approved Treatment To Delay Type 1 Diabetes Brings Hope

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The Food and Drug Administration’s recent approval of the first treatment that would delay the onset of type 1 diabetes ignited joy and hope among families impacted by the chronic, incurable disease. A clinical study found immunotherapy treatment with the drug teplizumab postponed the onset of type 1 diabetes (T1D) among at-risk children and adults for an average of two years, and for one patient, 11 years and counting. “Half the people in the study are way beyond two years,” says Yale University’s Dr. Kevan Herold, who has been working on a cure for T1D for 30 years. People with T1D have to manage the disease 24/7 or risk dangerously low or high blood sugar levels and long-term complications, said Herold, the clinical trial’s principal investigator. Before participating in a clinical trial at age 9, Claire Wirt, now 16, had antibodies that put her at risk of developing T1D within two years.

Nasal Spray Offers Hope For Severely Depressed Patients

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Some Connecticut hospitals and doctors and a clinic are starting to treat severely depressed patients with a new nasal spray called Spravato, touted as the most significant federally approved depression medication since Prozac was approved in 1987. Spravato, which received Food and Drug Administration (FDA) approval in March, has raised hopes for preventing suicides and relieving depression after other treatments have failed. But there are concerns about possible side effects, including drug abuse, elevated blood pressure and heart rate, sedation, and hypersensitivity to surroundings. The nasal spray is prescribed for treatment-resistant depression after at least two other antidepressants haven’t worked and is given with an oral antidepressant. It is only administered in restrictive clinical settings to reduce potential for abuse and side effects.

Women's Health

ADHD Drug Use Rises Sharply Among Young Women

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A growing number of reproductive-age women are taking prescription medication to treat attention-deficit/hyperactivity disorder (ADHD), data show, but doctors warn the effects of such drugs on pregnancies are largely unknown. The number of privately insured women nationwide between the ages of 15 and 44 who filled a prescription for an ADHD medication soared 344 percent from 2003 to 2015, from 0.9 percent to 4 percent, according to Centers for Disease Control and Prevention (CDC). ADHD medication use increased among all age brackets within that group and in all geographic regions, data show. The biggest spikes were seen in women ages 25 to 29, among which medication use jumped 700 percent, from 0.5 percent in 2003 to 4 percent in 2015. The second-largest increase was among women ages 30 to 34, which had a 560 percent increase from 0.5 percent to 3.3 percent, according to the CDC.

Recent E. Coli Outbreak Underscores Flaws In Food-Recall Process, Critics Say

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A fatal outbreak of E. coli contamination that recently hospitalized at least 26 people in the U.S. and Canada—including two in Connecticut—shows that the federal government is failing to adequately protect people from consuming recalled foods, lawmakers and consumer advocates say. The outbreak that sickened the two Connecticut residents and 16 others nationally, including 1 person in California who died, was probably caused by eating “leafy greens,” but a specific leafy green couldn’t be identified, the Centers for Disease Control and Prevention (CDC) reported. The Canadian government’s Public Health Agency announced on Dec. 11 that the outbreak was linked to romaine lettuce. Maura Downes, the communications director for the Connecticut Department of Public Health, confirmed that two state residents were sickened by the E. coli outbreak.

Fines & Sanctions

Drug Company Falsely Claimed Patients Had Cancer, Feds Allege

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 A former executive of Insys Therapeutics has been criminally charged for leading a special “reimbursement unit” at the company that defrauded insurers into paying for a potent opioid pain medication by falsely claiming patients had cancer and other conditions needed for pre-approval. Elizabeth Gurrieri, a former manager of reimbursement services for Arizona-based Insys, was charged with wire fraud conspiracy in a criminal complaint filed in federal court in Boston. The complaint sheds light on a Connecticut case involving a Derby nurse who has been charged with taking kickbacks from Insys in exchange for prescribing the company’s fentanyl spray, Subsys. The nurse, Heather Alfonso, has been cooperating with investigators in Boston and Connecticut in an ongoing probe of Insys’ sales tactics. The complaint against Gurrieri notes that patients needed prior authorizations from insurance companies to cover the costs of Subsys, an expensive drug approved by the Food and Drug Administration in 2012 for the management of breakthrough pain in patients with cancer who already were receiving opioid pain treatment.

I-Team In-Depth

Insys Sales Manager Charged In Kickback Scheme

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Fifteen months after a Derby nurse admitted taking drug-company kickbacks in exchange for prescribing a powerful opioid painkiller, a former district sales manager for the company was arrested Thursday on federal charges that he helped to orchestrate the kickback scheme. Jeffrey Pearlman, of Edgewood, NJ, who was district sales manager for the New York region for Insys Therapeutics through 2015, and the sales representatives he managed “induced certain physicians, advanced practice registered nurses (APRNs) and physician assistants to prescribe the pharmaceutical company’s fentanyl spray by paying them to participate in hundreds of sham ‘Speaker Programs,’” according to a release from the U.S Attorney’s Office for Connecticut. The scheme “defrauded federal healthcare programs” of millions of dollars that was paid out improperly for the drug, Subsys, which is approved for use only in cancer patients with breakthrough pain. Federal prosecutors allege that Pearlman “personally profited” from the scheme through inflated quarterly bonuses he received that were based, in large part, on the sales results of the employees he managed. Pearlman, who is no longer employed by Insys, could not be reached for comment Thursday.

I-Team In-Depth

CDC Data Show High Incidence Of Foodborne Illness Outbreaks In State

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Connecticut had the highest total number of foodborne illness outbreaks in New England from 2005 to 2014, according to federal data – a distinction that experts say is fueled by better reporting, while higher rates of certain pathogens also may contribute. An analysis of data from the Centers for Disease Control and Prevention (CDC) show that Connecticut had 2,259 cases of foodborne illness in 154 single-state outbreaks in that 10-year period. For five of those years, Connecticut reported more single-state outbreaks than any other New England state. For eight years, its outbreak count exceeded that of its more populous neighbor, Massachusetts. And for nine of those years, it topped New Jersey.

Women's Health

Essure Contraceptive Under FDA Review After Public Outcry

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When Alyson Hannan, 44, decided she was done having children, she chose Essure, a non-surgical permanent birth control option approved by the Food and Drug Administration. The day the tiny metal coils were inserted into her fallopian tubes in her doctor’s office is one that she can’t forget, said Hannan, regional sales director for Met Life who underwent the procedure on Sept. 11, 2014. “I will never forget that date. None of us will.”

Hannan is among tens of thousands of women, now referred to as “E-Sisters,” who have banded together on Facebook to share their stories of adverse health problems, including allergic reactions, chronic pelvic pain, device migration, hair loss and headaches.

Fines & Sanctions

Case Against Derby Nurse Involves Potent Painkiller

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Federal charges against Derby nurse Heather Alfonso center on a powerful and addictive painkiller called Subsys, which has been heavily marketed by the Arizona-based manufacturer Insys Therapeutics, federal officials confirmed Wednesday. Alfonso, 42, of Middlebury, pleaded guilty Tuesday in U.S. District Court in Hartford to receiving $83,000 in kickbacks from January 2013 until March 2015 from a pharmaceutical company that makes a drug used to treat cancer pain. In pleading guilty, Alfonso admitted that the money she was paid influenced her prescribing of the drug, according to the U.S. Attorney’s Office for Connecticut, which is prosecuting the case. Receiving kickbacks in exchange for billing charges to a federal health care program is illegal. While the company and drug are not named in the indictment, a prosecutor revealed in court Tuesday that the case involves Subsys and Insys Therapeutics.

Women's Health

The Fuss Over The Female Libido Pill

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If you are a man and your ability to have sex is flagging, the market offers a host of prescription medications for treatment. If you are a woman and find yourself in a similar situation, you have no Food and Drug Administration-approved treatment available to you. Yet researchers say that up to a third of adult American women suffer from some kind of sexual dysfunction. One drug, flibanserin, was recently resubmitted for approval to the FDA, which has turned it down twice already. When that non-hormonal drug first entered the public consciousness, the press quickly labeled it “female Viagra,” but that’s not accurate.