It all started when the U.S. Food and Drug Administration (FDA) approved the use of new imaging instruments for cancer screening, despite some FDA scientists who thought that the machines produced excessive radiation. Five scientists blamed flaws in the review process, and began drafting complaints to other authorities, such as members of Congress and oversight committees. Worried that the employees were leaking information and undermining the FDA, officials began secret surveillance of the scientists’ government laptops, which they used both at work and at home. Spy software recorded keystrokes, snapped screen images, and copied personal e-mails and documents, including communications between the scientists and members of Congress, journalists, and lawyers.
Eric Lichtblau and Scott Shane reported on the FDA’s surveillance in the New York Times.
While federal agencies have broad discretion to monitor their employees’ computer use, the F.D.A. program may have crossed legal lines by grabbing and analyzing confidential information that is specifically protected under the law, including attorney-client communications, whistle-blower complaints to Congress and workplace grievances filed with the government.
Thanks to modern treatments, HIV, though incurable, is far from the death sentence it once was. But it is still a life sentence, coming with the high cost, both personal and economic, of chronic disease, making avoiding infection in the first place a major goal for public health agencies. To that end, after numerous trials, the FDA has now approved Truvada, a combination drug that is already being used to treat HIV, as a preventative.
Modern food packaging has transformed our diets for the better in many ways—fresh-tasting canned tomatoes in January and low rates of food-borne disease are not to be scoffed at. But increasing scrutiny of the materials in the cans, bottles, and vacuum packs you bring back from the store have raised fears that certain chemicals—notably, those like bisphenol A (BPA) that can mimic hormones such as estrogen—may be prompting early puberty in children, among other health problems. Last year, the National Resource Defense Council sued the FDA demanding that the agency respond to a petition to ban BPA in food packaging. Yesterday, the FDA announced that it would not be banning BPA, saying that the science linking the chemical to health risks is not yet convincing. But some companies, responding to consumer desires, are already moving to remove it from their packaging.
It’s a funny thing about clinical trials: they’re set up so that all the subjects taking the drug in question are totally healthy in every other respect and on no other medications. It’s the only way to see if the drug has an effect, but as soon as people start taking it in the real world, well…let’s just say that most patients don’t measure up to the pristine condition of clinical subjects. There are number of factors at work: The average 70-year-old is on seven medications. Many people are on antidepressants more or less continuously. And each of us, by our genetic background, has a slightly different response to a drug.
The database where the FDA keeps the reports doctors make of patients’ unexpected reactions to drugs is a bit of a mess, full of anecdotes and incomplete patient data. However, using algorithms that consolidate all the patients most similar to each other and run comparisons, scientists writing in Science Translational Medicine have managed to pinpointed hundreds of unexpected drug side effects, as well as interactions between drugs.
The most notable interaction they found was that people taking selective serotonin reuptake inhibitors, a very common class of antidepressants, at the same time as thiazides, which treat high-blood pressure, were significantly more likely to develop a heart condition called long QT than people taking either one alone. Long QT can cause fainting, seizures, and sudden death. To double check that the effect was real, they ran an analysis of the medical records of patients at the Stanford hospital. The effect appeared there too. Read More
Diagram for AED electrode placement.
Touted as life-saving devices, some 1.5 million automated external defibrillators (AEDs) are around the US. AEDs are designed to be used by anyone, regardless of training, to restore normal heartbeats after sudden cardiac arrest. And in this life-or-death situation, a surprisingly number of the devices fail.
Between 2005 and 2009, there were 28,000 reports of AED malfunction in the US, representing 1 out of 50 devices in the country. Mark Harris at IEEE Spectrum investigates the cause of these failures. Surprisingly basic engineering errors were responsible for some of the malfunctions, such as parts that are just too imprecise for a matter of life or death:
One AED, the brand name of which the FDA would not disclose, was found to occasionally misdiagnose the heart’s electrical rhythm. It delivered some shocks that weren’t needed and failed to deliver others that were. The culprit was a resistor that could vary in resistance by up to 10 percent of its stated value. “When our engineer looked at this design, it was an instant ‘uh‑oh,’ ” says [Al Taylor of the FDA].
How could regulations on medical devices be so lax? Harris explains a loophole in the FDA regulation system: Read More
A new study by Consumer Reports found arsenic levels that exceed federal drinking water standards in 10 percent of the apple and grape juices tested. The group also found excessive levels of lead in 25 percent of grape and apple juices. Arsenic and lead are both poisonous and can cause health problems, especially in pregnant women, infants, and young children. Kids drink a lot of juice—more than one-third drink more than recommended by pediatricians. Although there is no technical limit for these chemicals in most juices and foods, these levels found in five brands exceed the 10 parts per billion allowed in drinking water for arsenic and the 5 ppb allowed for lead (find detailed information about individual brands tested here in a PDF). Consumer Union, Consumer Reports’ advocacy arm, called for the Food and Drug Administration to establish maximal safe levels for these contaminants in juices. Several studies suggests that chronic exposure to arsenic and lead—even at levels below water standards—can result in serious health problems, the group said.
President Barack Obama will sign an executive order today aimed at reducing the number of drug shortages; between 2005 and 2010, the number of such shortages jumped from 61 to 178. Most of the drugs reported as coming up short are generic, injected medications like cancer drugs, antibiotics, and nutritional shots for hospitalized patients. Many of the shortages are due to manufacturing delays or quality control problems, like syringes found to contain glass particles or to be contaminated with microbes. The executive order will require the Food and Drug Administration to speed review of applications for changes in manufacturing protocol or to use new or different drugs in certain circumstances.
The order also instructs the FDA to work with the Department of Justice to report possible instances of price gouging, which could lead to prosecution of companies that illegally horde certain medications or overcharge for certain drugs in times of shortage. In one instance, a company charged $990 per vial for a leukemia drug that normal fetches only $12—an 80-fold markup.
Steroids. Human growth hormone. EPO. The cast of characters implicated in major athletic doping scandals are familiar to fans who follow major sports. Nor are accusations of doping anything new to Lance Armstrong, the seven-time champion of the Tour de France and most famous American participant in a sport constantly marred by scandal.
Armstrong has always denied the doping charges, and he continues to in the wake of a major investigation published this week by Sports Illustrated. But this time around, reporters Selena Roberts and David Epstein allege something new: That Armstrong illegally acquired and took an experimental drug called HemAssist, which never got beyond clinical trials.
So what is this stuff? HemAssist, developed by Baxter Pharmaceuticals, belongs to a group of drugs called hemoglobin-based oxygen carriers, or HBOC. Simply, they are blood substitutes, ones that mimic the structure of hemoglobin—the protein in red blood cells that transports oxygen. According to a scientific source we spoke to, who researched these drugs for years but preferred to provide background anonymously, the drugs mimic the structure of hemoglobin to more than 99 percent, and can deliver oxygen the way natural hemoglobin does.
Biotech researchers have been developing HBOCs for decades because of their exciting potential applications. For example, these blood substitutes could be taken out on a battlefield where stocks of real blood could not be refrigerated and preserved, and given to wounded soldiers to send a rush of oxygen to their critical organs like the brain and the heart. That ability to pack an oxygen punch is what makes HBOCs a tempting target for a doper.
Embryonic stem cell treatments are edging closer to mainstream medicine. An experimental treatment just approved for clinical trials may provide hope to the 10 to 15 million elderly patients in the United States who suffer from a common form of macular degeneration, which causes gradual blindness.
The biotech company behind the treatment, Advanced Cell Technology, Inc., previously won FDA approval to try an embryonic stem cell treatment on patients with a rare, juvenile form of macular degeneration. The new FDA-approved trial will use similar techniques, but targets a much broader patient base.
“ACT is now the first company to receive FDA clearance for two hESC (human embryonic stem cell) trials, and is now a true translational leader in the field of regenerative medicine,” said chief executive Gary Rabin. “It marks a major step forward, not just within the stem cell sector, but, potentially for modern healthcare techniques.” [AFP]
Embryonic stem cell treatments are finally breaking out of the lab and arriving in the clinic. In October, the first federally approved trial of a treatment derived from these controversial cells got underway in patients with spinal cord injuries. Now, the FDA has approved a second trial, this one to test a treatment for a rare disease that causes serious vision loss or blindness.
The company behind the trial, Advanced Cell Technology, will test the safety and efficacy of the treatment on 12 patients.
The trial will examine the safety of a therapy for Stargardt’s Macular Degeneration, an inherited juvenile eye disease affecting an estimated 1 in 10,000 young people in the US. As the disease progresses, a layer of the retina called the retinal pigment epithelium (RPE) degenerates, causing vision loss. It’s hoped the new therapy would also work for other types of macular degeneration, a widespread cause of blindness, particularly in the elderly. [Nature blog]