Five Connecticut physicians have received letters from the U.S. Food and Drug Administration (FDA) alleging that they may have purchased unapproved drugs that put patients at risk of adverse health consequences, documents obtained by C-HIT show. The FDA documents show the five doctors were alerted as part of a wide-reaching federal probe involving Gallant Pharma International Inc., which sold more than $12.4 million in unapproved chemotherapy and injectable cosmetic drugs in the United States before the government shut down the operation in 2013. The letters to the doctors, dated April 1, 2015, say that “In addition to putting patients at risk, receiving misbranded or adulterated drugs and devices in interstate commerce and delivering or offering to deliver those drugs and devices to (or use on) others violates federal law.”
None of the doctors has been charged with wrongdoing, and only one acknowledged receiving the letter from the FDA. The case comes to light as drug companies and pharmacies are urging Congress and law enforcement officials to crack down on an increasing number of dangerous unapproved and counterfeit drugs being sold to doctors and consumers nationwide. Sales of counterfeit drugs and drugs not approved by FDA have soared into a multi-billion dollar industry with the growth of the Internet, and drug companies say efforts by governments to tackle illegal online drug sales are not sufficient.
The high cost of insulin, which has risen by triple-digit percentages in the last five years, is endangering the lives of many diabetics who can’t afford the price tag, say Connecticut physicians who treat diabetics. The doctors say that the out-of-pocket costs for insulin, ranging from $25 to upwards of $600 a month, depending on insurance coverage, are forcing many of their low-income patients to choose between treatment and paying their bills. “Some of my patients have to make the choice between rent or insulin,” said Dr. Bismruta Misra, an endocrinologist with the Stamford Health Medical Group. “So they spread out taking insulin [injecting it less frequently than a doctor has prescribed] or don’t take it.”
Experts and recent studies point to drug companies’ long-standing patents and the lack of generic or “biosimilar” insulin as key reasons why the drug is so expensive. A study by Philip Clarke, a professor of health economics at the University of Melbourne in Australia, reported that the price of insulin has tripled from 2002-2013.
The number of syphilis and chlamydia cases increased statewide last year as the number of gonorrhea cases dropped slightly, according to newly released figures from the Centers for Disease Control and Prevention (CDC). Nationally, the number of cases involving all three common sexually transmitted diseases increased for the first time since 2006, the CDC reports. The 2014 Sexually Transmitted Disease Surveillance Report, which was released in November, shows that, nationally, the number of reported cases of syphilis increased 15 percent over the number reported in 2013. The number of gonorrhea cases rose 5 percent last year, and reported chlamydia cases increased by 3 percent. Statistics for the state show a slightly different picture.
Every week for the past 7½ years, the U.S. Food and Drug Administration has identified an average of two dietary supplements being sold to consumers that were “tainted” and “potentially hazardous,” a C-HIT analysis of data reveals. The supplements contained prescription drug ingredients, controlled substances or untested pharmaceutical ingredients, which is prohibited by federal law and “can pose considerable dangers to consumers,” including stroke, liver damage, kidney failure and death, according to the FDA. C-HIT’s analysis of FDA data reveals 615 dietary supplements that were identified as tainted since Jan. 1, 2008. In the first half of this year alone, 59 tainted dietary supplements were posted on the FDA’s site.
As the federal government advocates increased use of generic drugs, concerns are mounting about the U.S. Food and Drug Administration’s oversight and the quality or effectiveness of some generics. In the last eight months, the FDA has acknowledged that two generic versions of the attention-deficit/hyperactivity disorder drug Concerta it approved may not work as effectively as the brand-name product. The agency told the drugs’ manufacturers to confirm their effectiveness or withdraw them from the market. The FDA also is looking into findings by a researcher at Boston’s Brigham and Women’s Hospital that generic versions of Pfizer’s cholesterol-lowering drug Lipitor manufactured outside of the U.S. contains impurities that inhibit the drug’s therapeutic effect. The FDA said that, as a number of popular drugs come off patent through 2015, it lacks the resources to independently police generics.