The Food and Drug Administration said from 2006 to 2008 it received 35 reports of severe cartilage damage in patients who were given pain pumps after joint surgery. Nearly all the reports involved patients who had shoulder surgery; more than half needed additional surgery, including joint replacement. Now, federal regulators are demanding changes to labels on the devices.
The Companies making pain pumps have 30 days to propose language that includes a warning about the potential for cartilage destruction, according to an FDA spokeswoman.
“The significance of this injury to otherwise healthy young adults warrants notification to health-care professionals,” the FDA said in a notice to doctors and other health care professionals Nov. 13.
APP, Stryker and Hospira all make the pain pumps. The anesthetics in the FDA’s alert include bupivacaine, marketed as Sensorcaine or Marcaine, and lidocaine. These anesthetics, the FDA noted, have been used safely in single injections for many years without any reports of cartilage decay.
Reports about decaying cartilage after shoulder surgery, when the pumps were involved, began surfacing several years ago, followed by studies in medical journals on orthopedic surgery and sports medicine. If you have suffered severe cartiledge damage as a result of these pumps, contact a Jacksonville Personal InjuryAttorney.
The U.S. Food and Drug Administration is expanding its nationwide alert to consumers about tainted weight loss pills that contain undeclared, active pharmaceutical ingredients.
“These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages,” said Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA.
“Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the health of the American public.”
A recent article from the Associated Press is reporting that more people are putting their faith in alternative medicine. The occasion for such reportage is the FDA’s release of its first guidelines for good manufacturing practices in the supplemental industry, an aspect of modern health culture that is unregulated in this country. Concerned interest groups say the rules are flimsy. However, this is the first step to give the FDA more presence in this growing field.
The article is mainly skeptical about the possible health benefits of alternative medicines. The rise in popularity is attributed to the public’s growing distrust of the medical industry. Interestingly, the AP reporter focuses on prescription drugs.
“Mainstream medicine and prescription drugs have problems, too. Popular drugs such as the painkillers Vioxx and Bextra were pulled from the market after serious side effects emerged,once they were widely used by consumers. But at least there are regulatory systems, guideline-setting groups and watchdog agencies helping to keep traditional medicine in line.”
Unfortunately, the safeguards cited above are not as reliable as we would like to believe. In her book, The Truth About the Drug Companies, Dr. Marcia Angell draws upon her extensive experience as editor of the New England Journal of Medicine to reveal some of the ways drug companies evade regulations and prevent objective research for the sake of their profit margins.
Perhaps the most disturbing of these methods is the use of CROs (contract research organizations) to conduct the clinical trials that are the brick and mortar of any drug’s claim to legitimacy. Clinical trials are how drugs get FDA approval and doctor support before you are prescribed anything. CROs are for-profit companies that cater to the drug company’s need for data and reports, the paper life of their industry. Because of this financial relationship, the CROs are less committed to presenting evidence and objective analysis. More likely, the purpose is to make the drugs look better than they are by skewing data. This is as simple as altering dosage, suppressing unwanted data, or overemphasizing the positive results.
The result of such activities is clear. In the AP article, Dr. Josephine Briggs, who directs the federal agency that studies supplements and unconventional therapies, said “If we had highly effective, satisfactory conventional treatment we probably wouldn’t have as much need for these other strategies and as much public interest in them.”
Michael E. Seelie is a board certified civil trial attorney practicing personal injury and products cases in Jacksonville, Florida.