Most Pharmaceutical Executives Against FDA Approving Drugs Solely on Their Safety

fda-logo-804463

Business Insider reports the Food and Drug Administration is “headed for a major revamp under the Trump presidency.” The article reports that “the response from industry executives and experts has been against cutting regulations that would make the FDA approve drugs solely based on their safety.”

From the news release of the American Association for Justice.

Posted in Medical & Health Resources or Issues | Leave a comment

St. Jude Suspends Pacemaker Implants Over Battery and Data Issues

st-jude-nanostim-7x4

Reuters reported St. Jude Medical Inc. “said it has notified doctors to stop implants of” its Nanostim leadless cardiac pacemaker (LCP), “citing reports of problems with electronic data reporting caused by a battery malfunction that could put patients at risk.” While there have been no reported injuries, “the company warned” that “of a total of 1,423 Nanostim devices implanted worldwide, 1,397 remain in service and represent a potential risk to patients.” The Minneapolis Star Tribune provides additional coverage.

From the American Association for Justice news release.

Posted in Medical & Health Resources or Issues | Leave a comment

Congressman Asks Prosecutors to Investigate Olympus Over Scope Infections

Duodenoscope

The Los Angeles Times reports that Rep. Ted Lieu (D-CA) “is calling for Japanese prosecutors to investigate Olympus Corp. for not warning American hospitals that its medical scope was transferring lethal bacteria to patients.” In a letter, Lieu “asked Secretary of State John Kerry to request that Japanese authorities probe the Tokyo-based manufacturer for civil or criminal misconduct.” The Times reports “that Olympus was told by experts in 2012 that the design of a device called a duodenoscope was flawed” and “warned European hospitals about the possibility of patient infections, but not those in the U.S.” According to the FDA, “as many as 350 patients at 41 medical facilities worldwide were infected or exposed to contaminated scopes made by Olympus or two other companies from January 2010 to October 2015.”

From the news release of the American Association for Justice.

Posted in Medical & Health Resources or Issues | Leave a comment

Heart Surgery Device Tied to Deadly Infections

20_det_heater_c_v1_

Kaiser Health News reports on mycobacterial infections acquired by some heart surgery patients that involved the Sorin 3T heater-cooler device. Kaiser reports that regulators knew of the association for 14 months before issuing guidance to hospitals and patients. While “about 60 percent of U.S. hospitals that do heart surgeries rely on the Sorin 3T heater-cooler device…five other manufacturers sell heater-coolers in the U.S., and FDA officials say they share similar design features that make them prone to contamination.” Suzanne Schwartz, an associate director at the FDA’s center for regulating medical devices said, “This is an evolving story in terms of new information that became available as a result of ongoing studies and efforts in the U.S. as well as outside the U.S. It might seem to have taken a fair amount of time, but one of the challenges has been raising awareness in the health care community that this is a problem that needs to be addressed.” FDA spokeswoman, Angela Stark, “said the agency received at least two reports of infection tied to heater-coolers in 2009 and 2010.”

From the news release of the American Association for Justice.

Posted in Medical & Health Resources or Issues | Leave a comment

Survey Finds 18% of People Who Use Over-The-Counter Sleeping Pills Do So Daily

maxresdefault

The NBC Nightly News broadcast reported “18 percent of people who say they have taken over-the-counter sleep aids in the past year did so on daily basis,” according to a survey by Consumer Reports. Doctors say that the medicines – which often contain diphenhydramine – “can be dangerous” when used for more than two weeks, causing liver and kidney damage. The Healthcare Product Association warned that “these drugs are approved by the FDA to treat occasional sleeplessness, not long term sleep disorders or insomnia.”

From the news release of the American Association for Justice.

Posted in Medical & Health Resources or Issues | Leave a comment

Lawsuit Accuses Three Drugmakers of Conspiring to Increase Insulin Prices

aid598861-728px-Give-Insulin-Shots-Step-8-Version-3

The New York Times  reports a lawsuit was filed against Eli Lilly, Novo Nordisk, and Sanofi, accusing them of “conspiring to drive up the prices” of insulin. The three drugmakers have allegedly been “raising the list prices of their products in near lock step, prompting outcry from patient groups and [physicians] who have pointed out that the rising prices appear to have little to do with increased production costs.”

The Washington Post reports the lawsuit was filed by 11 patients and “claims that drug companies have been increasing the list price of insulin in order to grow their discounts without lowering the overall price tag.” According to the plaintiffs, “those actions violate the Racketeer Influenced and Corrupt Organizations Act and state consumer protection laws.”

Additional coverage is provided by STAT .

From the news release of the American Association for Justice.

Posted in Medical & Health Resources or Issues | Leave a comment

Insulin Prices Have Risen About 400% Over The Last 10 Years

insulin

NBC Nightly News reported on “outrage over the soaring cost of” insulin, which “has risen some 400 percent in the last decade, although the drug has been around for nearly 100 years.” NBC News correspondent Jo Ling Kent explained that the high prices of insulin are leaving some “desperate patients” to plead “online saying they can’t afford the insulin they need to live.” Pharmaceutical makers are putting the blame for high prices on “insurance companies, saying more patients have high deductible plans, meaning they must pay more for drugs out of pocket.” Kent pointed out, “All three insulin makers tell NBC News they’re working to make insulin more affordable.” Meanwhile, “Consumer Reports recommends if you don’t have insurance, check prices at Walmart and Costco” and “contact patient assistance programs like needymeds.org.”

The NBC News website quotes Aaron Kesselheim, MD, JD, MPH, associate professor of medicine at Brigham and Women’s Hospital, who said, “Prices are set by the pharmaceutical companies at whatever the market will bear.” NBC News also points out that makers of insulin “have played ‘follow the leader’ with price hikes.” Currently, there is “no generic for insulin” to offer a lower-priced alternative.

From the news release of the American Association for Justice.

Posted in Medical & Health Resources or Issues | Leave a comment

St. Jude Warns Implanted Defibrillators Could Stop Working Due to Faulty Battery

fortify-assura-2

The Wall Street Journal reports that St. Jude Medical warned that a battery defect could lead hundreds of thousands of its implanted defibrillators to rapidly lose power and stop working. Thus far, two deaths have been linked to the problem. According to the Food and Drug Administration and the company, the devices could quit functioning with only 24 hours notice.

Bloomberg News reports that the “premature battery depletion has been seen in fewer than 1 percent of the devices, the company said in letters sent to doctors and patients on Tuesday.” In addition to the two deaths, “47 others reported dizziness or fainting.” The company’s warning covers devices “made before May 2015, which are in use in about 350,000 people worldwide.” In an interview, St. Jude Medical CMO Mark Carlson said the company was “recommending that patients utilize remote monitoring, to enable their physicians to monitor their devices’ performance over time.”

The AP reports that the problem “is caused by buildup of deposits around lithium batteries.” The company “says it fixed the issue in May 2015 and removed all affected devices from distribution and hospital inventories.”

From the news release of the American Association for Justice.

Posted in Medical & Health Resources or Issues | Leave a comment

FDA Updates Label of MS Drug to Include Warning of Potential Liver Injury

Tecfidera-Logo1-660x158

Reuters reports the Food and Drug Administration has updated the prescription label for Biogen’s Tecfidera (dimethyl fumarate) “to include a warning of potential liver injury that could require hospitalization.” The updated label clarifies that “signs of liver injury resolved when those patients stopped taking the medicine.” According to a Biogen spokesperson, there have been 14 patients taking Tecfidera who reported liver injury out of the approximately 230,000 patients treated with the drug.

From the news release of the American Association for Justice.

Posted in Medical & Health Resources or Issues | Leave a comment

Clinical Trials “Systematically Understated” Potential Harms of Weight-Loss Drug, Researchers Say

alli-diet-pills-product-image

STAT reports that a new analysis published in PLOS Medicine found that the weight-loss drug Alli (orlistat) “has been propped up by problematic clinical studies that ‘systematically understated’ the drug’s potential harms.” According to researchers “who reviewed data summaries and published journal articles,” they “found that seven drug trials funded by the drug maker Roche in the 1990s downplayed the frequency of apparent side effects like diarrhea or incontinence.”

From the news release of the American Association for Justice.

Posted in Medical & Health Resources or Issues | Leave a comment