Edith Baker of Plainville faced a devastating reality that patients with advanced cancer inevitably confront. She had stopped responding to conventional treatment. Radiation and chemotherapy could no longer contain her stage 4 bladder cancer. But there was a ray of hope. Baker’s oncologist at Saint Francis Hospital and Medical Center referred her to a clinical trial at UConn Health involving two immunotherapy drugs: the FDA-approved Keytruda (pembrolizumab) from Merck & Co., credited with successfully treating former President Jimmy Carter’s melanoma; and Epacadostat (IDO1 inhibitor), an experimental drug from Incyte Corp.
Almost four years after Protein Sciences began selling its innovative flu vaccine, the Meriden company still struggles to gain a foothold in a marketplace dominated by pharmaceutical powerhouses. Orders for Flublok – the only flu vaccine not derived from eggs – remain well below company goals, and officials haven’t been able to get it into some major pharmacy chains such as CVS and Walgreens. “We’re doing better than last year, but we’re still not doing as well as I would like to do,” said CEO Manon Cox. The company aims to sell 900,000 doses of Flublok by the end of the current flu season in late March, she said. So far, it has sold just 250,000, even as widespread flu outbreaks spread across several parts of the country.
In hospitals across Connecticut and nationwide, workarounds to compensate for medication shortages are daily routines for treating patients – and health experts say it’s not about to change any time soon. Some acute-care drugs in short supply nationally are antibiotics, antipsychotics, intravenous saline, and morphine, according to the most recent shortage list from the U.S. Food and Drug Administration. In Connecticut, hospital officials say they are turning to alternative drugs, rationing supplies, or seeking new suppliers to work around the shortages. At St. Francis Hospital and Medical Center in Hartford, Dr. C. Steven Wolf, chief of emergency medicine, said doctors most recently have been dealing with shortages of dextrose, used to treat dehydration and low blood sugar, as well as intravenous saline and other basic medications.
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.
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.
Nancy Cappello wants all women to receive the same opportunities for breast cancer screening that women in Connecticut have had for years. Cappello, who worked for passage of the state’s 2009 breast density notification law, has taken her cause nationally – advocating for similar legislation in every state and lobbying policymakers in Washington D.C.
Connecticut’s law — the first of its kind in the country — requires radiologists to inform women who undergo mammography if they are diagnosed with dense breast tissue, a condition known to obscure cancer detection. These “inform” reports must reference potential benefits of supplemental screening such as an MRI or ultrasound. So far, 11 states have followed Connecticut’s lead by passing similar laws. According to data collected in Connecticut, ultrasounds have detected breast cancers that mammograms missed.
Connecticut still ranks among the top 20 states in the use of antipsychotic drugs for elderly nursing home residents, but its rate of use has dropped 14 percent since 2011, new government data shows. The percentage of patients receiving antipsychotics in the state’s nursing homes fell from 25.72 percent in early 2011 to 22.38 percent this year, according to new data from the Centers for Medicare & Medicaid Services (CMS). The state now ranks the 18th highest in the country in antipsychotic use – down from 16th highest in 2011, and no longer ranked among the top four states, as it was from 2005-10. Antipsychotic drugs are an important treatment for patients with certain mental health conditions, such as schizophrenia. But the Food and Drug Administration has warned that the drugs have potentially fatal side effects when used in elderly patients with dementia.
Last month, a New York judge struck down New York City’s ban on sugary drinks in containers larger than 16 ounces. Soon after, former vice presidential candidate and reality television star Sarah Palin thrilled a crowd at the Conservative Political Action Conference by pausing her speech to sip from a Big Gulp. Then, freshly-minted Texas U.S. Sen. Ted Cruz proposed a largely ceremonial “Big Gulp Amendment,” which would keep the federal government from limiting soda size, while Mississippi’s governor signed into law a bill that prohibits local governments from regulating sugary drinks. New York’s mayor, Michael Bloomberg, has taken heat for pushing for the soda size ban, though history may treat him more kindly than have conservatives. Science may, as well.
On most Thursdays, a small group of patients assembles at the VA hospital in West Haven because they share a common disease — hepatitis C – and a common treatment — a protocol of new antiviral drugs. West Haven has been one of several veterans’ hospitals nationwide leading efforts to better treat – and hopefully cure — hepatitis C, a virus that is four times more common among veterans than in the general population. Nationally about 4,000 veterans have taken the new antiviral drugs since they went on the market in 2011 costing an estimated $100 million in prescriptions. “People have kind of gulped when they see this [the cost],” said David Ross, the director of the national VA’s HIV, Hepatitis and Public Health Pathogens Program. “But these drugs make a difference.’’
Most of the patients in West Haven are still completing the full year of triple-drug therapy, but early results are promising, VA staff says.