Contributor: Kristie Hayes
Jaws Kills Cancer?!
A three-year study at the University of Aberdeen in Scotland funded by the U.K.-based Association for International Cancer Research is going to determine if shark antibodies stop the growth of breast cancer. Shark’s blood contains the antibody IgNAR which has smaller areas that attach to viruses compared to human antibodies. It is hoped that the small size allows them to get into spaces that human antibodies cannot. The focus of this study will be on breast cancers that test positive for the HER receptor, which is currently treated with Herceptin. The goal is to have an alternative drug for those women who develop resistance to Herceptin.
New Focus in Diabetes Research
Researchers at Boston Children’s Hospital appear to have discovered the root cause of type 1 diabetes, also known as juvenile diabetes. It most commonly affects kids and young adults who cannot produce insulin that tissues need to use glucose. Hundreds of pathways were analyzed from animal models but it was the ATP/P2X7R pathway that was tied to the disease. This pathway tells T-cells to attack the pancreas containing made of islets of alpha and beta cells. Normally functioning beta cells produce insulin. While treatments targeting this pathway are years away, researchers are excited about having a specific target they can develop treatments for. Current treatments involve insulin injections and islet cell transplants which require lifelong immunosuppressant drugs to prevent rejection.
Same Drug As in MAssachusetts
Testing of drug vials taken from Main Street Family Pharmacy, a specialty pharmacy in Tennessee has shown bacterial and fungal contamination. Reports of skin abscesses in individuals in North Carolina and Illinois who received injections of the steroid methylprednisolone acetate prompted the investigation. No cases of meningitis have been reported like those linked to the same drug made at Massachusetts compounding pharmacy last year. The Food and Drug Administration and the Centers of Disease Control are working together to determine the species of fungi and bacteria. The pharmacy’s license was put on a three-year probation and they were fined $25,600. Compounding pharmacies make special and personalized drug formulations in small batches and are regulated by the states where they reside.
Affects GABA and Glutamate
Geneticists have found that inhibiting Neuregulin-1 (NRG1) gene in mice designed to overexpress the protein eliminated symptoms of schizophrenia. Mouse models for schizophrenia were overactive, forgot things they just learned and could not block out background noise. The NRG1 protein is critical for brain development and activates a protein called LIMK1. LIMK1 activation reduces the activity levels of the neurotransmitters GABA and glutamate. Higher than normal levels of NRG1 is found in a small number of individuals with the mental illness. Current treatments target neurotransmitters, chemical messengers, helping neurons communicate. NRG1 levels in blood are an accurate reflection of brain NRG1 levels. It is hoped that both NRG1 and LIMK1 can be targeted to treat some with schizophrenia.
Is Aspirin Good for Your Skin?
A twelve year study that involved asking 59,806 50 to 79 year old women about diet, medication and lifestyle, including sun exposure, found that taking aspirin two times a week lowered their risk of melanoma by 20 percent. The risk was further decreased by taking over a longer period of time; the women taking it at least five years had a 30 percent decreased risk compared to and 11 percent lower risk in those who had been taking it for one to four years. Previous research has linked other NSAIDs to a lower risk of various cancers. Researchers hypothesize that they work by decreasing inflammation which leads to the abnormal growth of cells. Future studies will determine if it is prevents melanoma by comparing the rate of melanoma in women who regularly take it and those who do not.
Wet Digits Grab Wet Objects Best
When we sit in a tub or pool too long, the nervous system constricts our subcutaneous blood vessels at the tips of our fingers and toes resulting in that pruney that makes one think they are aging at an accelerated rate. But results from research out of New Castle University in England demonstrate that those wrinkles help us grip wet objects better. Participants picked up wet marbles and lead weights; some had wet hands that had been soaked for 30 minutes and some had dry hands. The group with wet hands picked up the objects 12 percent faster than those with dry hands. Evolutionarily speaking, this may have allowed human to obtain food from streams and wet vegetation and not slip in the rain.
Reading As Birth Control?
A six year study in Philadelphia following 12,339 seventh grade girls in the public school system found an inverse relationship between reading skills and the risk of teen pregnancy. Researchers looked at the girls’ reading tests scores and found that 21 percent of the girls who scored below average gave birth as teens compared to 12 percent and 5 percent of those with average and above average scores, respectively. Latino and Black girls were more likely to get pregnant as well as those living in poverty. Once these factors were accounted for, girls with below average reading scores were 2.5 more times likely to get pregnant. Teen pregnancy is a concern because pregnant teens and their babies often have more health issues and teen moms are more likely to drop out of high school.
Pot a Risk Factor and Relief
Results from a new study in Dutch teens supports previous research that found a complicated relationship between marijuana use and the likelihood of psychotic symptoms. Over 2,000 Dutch teens took surveys about pot use at around 14, 16 and 19 years old and took psychosis vulnerability tests. Approximately 44 percent of teens said they used pot. Researchers found a bidirectional relationship with pot use and psychosis. Sixteen year olds who smoked were more likely to have psychotic symptoms at 19 and those who had symptoms of psychosis at 16 were more likely to use pot three years later. Researchers believe that genetics in addition to smoking pot may be another risk factor for psychosis while it can also be argued that someone who experiences psychotic symptoms may self-medicate with pot.
Creating Compensation Fund
After being shut down and investigated in relation to 39 deaths and over 600 people who fell ill due to fungal contamination of the steroid they made, the New England Compounding Center (NECC) has filed for Chapter 11 bankruptcy. The Massachusetts-based pharmacy was shut down in October, all the drugs they made recalled and inspections revealed numerous problems that compromised sterility. There had been a history of problems with this pharmacy that have been recorded as long ago as 1999 but harsh sanctions were never filed. Compounding pharmacies are regulated by the state as opposed to the FDA. The NECC has reported between 1 and 10 million dollars in assets and plan to create a fund to compensate the victims.
One Protein with Two Functions
A new study has found that inadequate levels of a protein essential for healthy skin may play a role in eczema, specifically atopic dermatitis. Oregon State University research have found that the Ctip2 protein has two important functions in the skin; making fat cells to keep skin properly functioning as a barrier by keeping it healthy and hydrated, and inhibiting the release of TSLP by skin cells leading to inflammation. Experiments in mice designed to have no Ctip2 found that their levels of TSLP were 1,000 times higher than the controls. TSLP is not normally found in human skin. Eczema occurs when the skin cannot protect itself and when inflammation increases. It is hoped that new, more personalized treatments that increase Ctip2 can be developed.
Hair Before Health
Results of a new study suggest that some Black women avoid exercise because they want to mess up their hair. One hundred and three Black women who came to the Wake Forest University dermatology clinic took a survey about exercise. Over 50 percent exercised less than 75 minutes a week, less than the recommended 150 minutes by the U.S. Department of Health and Human Services. About 33 percent of the women surveyed said their hair was a reason they did not exercise and half thought about changing it so they could. An itchy scalp and dandruff were also factors. Hair care for Black women is laborious and costly, and many avoid sweating so they only have to wash their hair weekly to keep their style.
Idea of Understandable Unclear
A new study has found that the medication guides that come with the drugs people pick up at the pharmacy are not understandable as required by the Plain Writing Act of 2010, largely because the law does not define understandable. Researchers had 449 people read three medication guides and answer questions about them. The scores ranged from 25 percent in those with the lowest literacy level to 65 percent for those with the highest. The guides were written at a tenth and eleventh grade reading level. Some suggest making them at a fourth to eighth grade level which is difficult. Previous research found that guides were on average 2,000 words, had no summary section and only one out of the 185 guides studied met the "suitability" guidelines for medical education materials.
To Prolong or Not Prolong Life?
People with terminal cancer that saw a three minute video demonstrating CPR were less likely to opt for aggressive end-of-life care. A study involving 150 cancer patients believed to have less than a year to live had CPR and what would be done if they were successfully revived described to them. Then 70 were randomly picked to watch a three minute video showing how it is done. Seventy-nine percent of those that watched the video said they did not want CPR compared to half in the description only group. Ninety percent of the video group found it helpful and researchers believe that the video reinforces the information people receive from their doctors. Some doctors believe that the topic of end of life should be approached by asking if CPR lines up with the patients’ goals and values.
Better Behavior with Iron
Results from a Swedish study involving 285 infants born on the small side of normal (4 pounds, 7 ounces to 5 pounds, 8 ounces) may benefit from iron supplements. Researchers set them up in three groups at six weeks; one milligram of iron per kilogram (mg/kg)of body weight , two mg/kg body weight and a placebo group until they turned six months. At 3 and one half years old, they were compared to kids who were a normal weight at birth. The placebo group had more behavioral issues including controlling emotional reactions, anxiety and depression, problems sleeping and paying attention compared to those on drops and healthy controls. Researchers will continue to follow these kids and believe the results justify giving smaller weight babies iron supplements to aide brain development.
Risk Before and After Surgery
While being overweight puts people at risk of needing knee replacement surgery, a new study finds that many gain weight post-operatively. The study involving 917 patients who had knee-replacement surgeries found that almost a third gained at least five percent of their body weight five years later. The goal after surgery to reduce pain, increase mobility and strengthen the knee through physical therapy. But many have managed the pain by reducing their activity, and these results suggest it does not go up after surgery. Typically patients are in their 50s and 60s, a group that has a tendency to gain weight. But even those who lose weight have the surgery have a tendency to gain weight post-op, likely because they stopped after meeting their goal weight for surgery.
Regulators Clamping Down
Regulators in Massachusetts have shut down three other pharmacies, as it flexes its muscles in the aftermath of a fungal meningitis outbreak that was tied to poor practices at the New England Compounding Centers which killed 36 and injured 541. One pharmacy, Oncomed, was temporarily shut down because of possible problems with the way they store chemotherapy drugs. Pallimed Solutions and Whittier Pharmacist were partially shut down for making a drug with the wrong components and violating sterile technique, respectively. The Massachusetts Department of Public Health has changed the rules so that they have more oversight of compounding pharmacies and added three new members with different healthcare backgrounds. All the pharmacies are cooperating with regulators to correct these problems.
The Multitasking Blues
Results from a study conducted by psychologists at Michigan State University have found a direct correlation between depression and anxiety with the number of screen devices used at one time. Three hundred and nineteen college students were surveyed and those who used two screens simultaneously were about two times more likely to say there were depressed and anxious. These results lend support to the hypothesis that “second screening” causes stress, but there is still a question as to whether the anxiety or depression is a result of the technology or vice versa. This study is important since a Nielson report revealed that 40 percent of Americans watch TV and use a mobile device at least once a day. Future studies will determine if certain devices are more strongly linked to these feelings.
More Drinking, More Dopamine?
Results from a study published in the Proceedings of the National Academy of Science suggest that a gene involved in dopamine release may be associated with binge drinking in teens. RASGRF-2 knockout mice did not release dopamine from neurons in the ventral tegmental area (VTA) area of the brain. Dopamine is a neurotransmitter brain cells release when we do something that feels good, also known as the “reward” system. A study in teenage boys found a RASGRF-2 variant tied to more brain activity associated with the VTA and dopamine release, and at 16, those with the variant drank alcohol more often. Alcohol abuse kills 2.5 million people around the world annually and is predicted to lead to the early deaths of 210,000 people over the next twenty years in England and Wales.
More Alive at Year Five
Two studies have found an association between metformin and increased survival in ovarian cancer patients. The first involved 239 women on metformin for diabetes, the drug’s intended use. All of them were undergoing the same chemotherapy treatment. Five years after being diagnosed with cancer, 67 percent were still alive compared to 48 percent not on the drug. Another study with a more diverse cohort observed that 73 percent of ovarian cancer patients who took metformin were alive after five years compared to 44 percent of the control group. This was not seen with any other diabetic drug and previous research indicates metformin could be used to treat a variety of cancers. It is hypothesized that metformin alters the cancer cells’ metabolism of glucose which causes them to starve.
Blood Vessel Damage Blamed
Results from a retrospective study has found that diabetes doubles the risk of hearing loss. The studies spanned a period of 34 years and looked at data from 7,377 diabetics and 12,817 health controls. A study in 2008 that looked at over 11,000 people yielded similar results. Confounding factors such as age and noisy environments were not taken into account in these studies and future studies will look at these as well. Researchers still believe that diabetics may be at a greater risk for hearing loss and should be screened at an earlier age than non-diabetics. One hypothesis is that elevated levels of glucose damage the ears’ blood vessels. It has been established that diabetics are a greater risk of nerve damage, vision loss, kidney problem and cardiovascular disease.
Other Factors More of a Risk
A retrospective analysis of 55 studies found that HPV was present in laryngeal cancer tissue of 28 percent of participants, translating into a five times higher risk of developing it compared to those who test negative. But the overall risk was still low considering approximately 50 percent of people who are sexually active are infected at some point and the rates of infection in the cancerous tissues varied widely from study to study. Doctors say bigger risk factors are heavy drinking and/or smoking which is typically part of the profile of someone with laryngeal cancer. While doctors cannot say how many laryngeal cancers are possibly caused by HPV, they believe vaccinating boys and men against the virus would help in reducing the risk.
The Cry of Autism
Results from a small study involving 39 six month olds indicate that the pitch of their cry due to pain may increase the risk of developing autism. Twenty one had an older sibling with the condition which increased their risk. Using computer-aided analysis, it was found that those with the higher pitches and greater changes in pitch were those at greatest risk of autism. Three of the children who were diagnosed with autism by three had the cries with the highest pitch, tensest sound and more background noise. Previous research showed that one year olds at high risk of autism made atypical sounds and cries. If larger studies support these results, doctors could use this trait as part of a comprehensive screening for autism so that intervention can begin much earlier which improves outcomes.
Nurses Do It Better
Results from a retrospective study found that when nurses are in charge of telling the elderly and at-risk adults know about flu and pneumonia vaccines and giving them, they are more likely to get them. With the flu shot, a 44 percent increase in the odds of a person getting it when given by a nurse was observed. The likelihood of people getting a pneumonia vaccine given by a nurse more than doubled. One hypothesis is that doctors' time is taken up by dealing with their patients' chronic health issues in the office but the nurse has time. Researchers feel that there is still room for improvement and hope to combine several approaches that are shown to be successful such as reaching out to patients via text and phone calls.
History of Problems
Dozens of lots of the generic cholesterol-lowering drug Lipitor is being recalled by Ranbaxy Pharmaceuticals because of possible contamination with tiny glass particles. This is part of a history of problems going back to 2006 which include performing safety tests wrong and lying about the results. The Food and Drug Administration told Ranbaxy in early 2009 that new applications to sell drugs in the U.S. made by the problem factories would not be considered. But when the generic patent expired on November 30, the FDA allowed the company's Ohm Laboratories factory in central New Jersey to make it. The company currently operates under a consent decree which requires they improve their manufacturing practices and allow an independent party to oversee and review them for three to five years.
Calls, Visits, ER Trips Higher
Results from a new study challenge previous research demonstrating that giving patients access to their medical records online reduces office visits and phone calls. A study conducted by Kaiser Permanente Colorado in Denver compared 44,321 insured members who accessed their medical records online and had their doctor’s email with those who did not. The online medical record group went to the doctor more, called more and made more trips to the emergency room. Researchers hypothesize that patients who look at their records online identify more health issues or those who use online services are also more likely to make a trip to the doctor. Researchers hope these results can help them design online tools for people with chronic disease so they only have to come in if there is a problem.
Prescription Not Necessary
The American College of Obstetricians and Gynecologists (ACOG) and scientists at a non-profit research group recommend that drug regulators make birth control pills available over-the-counter (OTC) to increase women’s access and prevent unplanned pregnancies. Researchers say it is justified because 50 percent of pregnancies are unintended and cost taxpayers 11 billion dollars a year. It is been established as a very effective contraceptive and previous research has shown that the women are more likely to use it when it is OTC and that they make good decisions when weighing the small risk of side effects. One major concern is that if it is OTC, it may be expensive and likely be ineligible for 100 percent coverage under the Affordable Care Act.
What Went Wrong?
A Republican-controlled congressional panel has given the Food and Drug Administration until the end of November to put documentation together showing their role in overseeing The New England Compounding Center (NECC) before agreeing to new regulations. The NECC shipped out a contaminated steroid that led to an outbreak of fungal meningitis that has made about 500 people sick and killed more than 30. Investigators found poor conditions in room that should have been sterile to make the preservative free drug. Compounding pharmacies have fought hard to leave regulation up to the state, but some argue this will happen again if nothing changes. Both parties in the Democratic-controlled Senate are willing to pass rules that could significantly change how these pharmacies are regulated.
Mail That’s Good for Your Health
A study involving 29 doctors and 435 patients at a higher risk of cardiovascular disease (CV) found that mailing their assessments to them increased the use of drugs to lower their cholesterol, a risk factor of CV disease. Researchers selected patients that were not being taking drugs for elevated cholesterol. Twenty-two percent of those that got letters after their doctors were notified of their risk, known as the intervention group, saw a significant reduction in cholesterol compared to only 16.1 percent of those who did not. While researchers saw an improvement in the intervention group, they felt more could be done. Another study in progress is trying to determine if a letter plus a telephone call will give people that extra motivation to take steps to lower their cholesterol levels.
Head Bumps & Bug Sprays
New research links head injuries and pesticide exposure to a significantly higher risk of Parkinson’s disease (PD), a progressive neurological disorder that alters movement, walking and coordination. The study involved 357 people with PD and 754 healthy individuals. Scientists collected data by relying on self-reports of head trauma causing unconsciousness for five minutes or more and home and work addresses determined the distance from pesticides sprayings since 1974. Twelve percent of people knocked unconscious had PD and 47 percent had been exposed to the pesticide paraquat. Each event independently increased the risk, but having both factors tripled it. One theory is that brain injury increases inflammation which compromises the blood-brain barrier, enhancing the pesticide’s effects.
It's a Bird. . .In the Pharmacy!
Unsterile conditions have been found at Ameridose, the compounding pharmacy affiliated with the New England Compounding Center (NECC) which came into the spotlight after a contaminated steroid led to a fungal meningitis outbreak affecting over 400 people and killing more than 32. Ameridose voluntary shut down while NECC was being investigated. Problems included a bird flying around, leaks dripping water and disrepair in rooms that should be sterile. Drug potency tests were not being performed and complaints mostly related to the labor-inducing drug oxytocin, the painkiller fentanyl and the blood thinner heparin were not classified and documented correctly. A company spokesperson said it has been six years since they had contamination problems and they will address all the current issues.
97 Percent of Cancer Cells Died
New research has found that treating different types of prostate cancer cells with resveratrol makes them more susceptible to radiation treatment. Researchers found that by adding the compound found in red wines and grape skins increases perforin and granzyme B, two proteins that need to be present to kill tumor cells. Ninety-seven percent of the tumors treated with resveratrol died when treated with radiation which was significantly higher than the control cells. While resveratrol is available over the counter, it is broken down so efficiently in the body that a huge amount would have to be ingested, leading to unwanted side effects. Studies in animals will have to be conducted before clinical trials and researchers will have to find effective ways to deliver the drug to the tumor.
Detects Risk Years in Advance
A three-year study conducted in Sweden has found that elevated levels of the pro-inflammatory protein SFRP4 increase the likelihood of developing type 2 diabetes and are present years before it develops and could be used as a marker in screening. Blood samples were taken from people over the study period and 37 percent of those with a higher than average SFRP4 level developed diabetes compared to nine percent in those with levels below average. These results confirmed previous in vitro studies. One possible mechanism of type 2 diabetes is chronic low-grade inflammation attacking beta-cells which prevent them from secreting enough insulin the tissues need to take up glucose. It is hoped that if people know their risk before having the disease, they will make changes to reduce it.
Risks Far Outweigh Benefits
A study conducted in Taiwan has found that the drug meth which does a lot of harm to the body is able to fight off the flu. Researchers took human lung epithelial cells and incubated them with different meth concentration levels before infecting them with H1N1. At the 30 hour and 48 hour time points, cells treated with meth had a lower viral load, and an indirect correlation between the concentration of meth and H1N1 was observed. Previous research has suggested that HIV infection is easier in those abusing meth over a long period of time, and the initial goal was to determine how resistance to influenza was lowered by the drug. Because the risks of taking meth far outweigh any benefit, the next step is to look for less dangerous compounds that can act in the same away against the flu.
Can Delay It for Years
A study looking at the heart health of people 45 and older found that among the healthiest 55 year olds 1 in 3 are still at risk of developing heart disease. The healthiest people were those that did not have diabetes, high cholesterol, and hypertension and did not smoke. While the results may seem disheartening, researchers do not want baby boomers living a healthy lifestyle to stop. They also found that healthy 45 and 55 year olds got an extra 14 and seven years of a healthy cardiovascular system, respectively. Even though the prevalence of heart disease and related deaths have dropped around the world in the last few years, about 82 million people are living with cardiovascular disease and is still the number one killer in America.
Lower Fatigue and Less Ready
A study analyzing 216 surveys filled out by orthopedic surgeons-in-training at the Harvard Orthopedic Combined Residency Program over a six year period found that work limits reduce fatigue and feeling prepared. With the goal of reducing medical errors due to fatigue, the Accreditation Council for Graduate Medical Education limited the work week of residents to 80 hours with a minimum of 10 hours off between shifts. More time off did not mean more sleep but almost half as many residents said fatigue affected their work compared to those with no work hour limits. Residents under the new hours gave themselves a lower rating about their own preparedness to make clinical decisions. Researchers say laws regulating residents' work hours will have to balance the pros and cons.
Changing Fonts Can Change Minds
New research suggests that reading biased information in a hard-to-read font can reduce their confirmation bias, a phenomenon where they pay more attention to arguments that favor their views. Participants read a very biased argument on capital punishment in easy-to-read or hard-to-read font. Higher polarization was seen in liberal and conservatives who read it in easy-to-read font. Next, people read documents complimenting or criticizing a defendant’s behavior in a hard-to-read or easy-to-read font. They were then presented with evidence in a mock trial. People who read accounts in hard-to-read font were able to separate what they read about his behavior, good or bad, from their analysis of the evidence. The hard-to-read font forced people to slow down and see the other side’s argument.
Here's to Higher Viral Loads
Results of a new study published in the Journal of General Internal Medicine found that 51 percent of individuals with HIV skipped their medications when they drank alcohol, mainly because of fear that the combination would be toxic which is not true for those with healthy liver function. Researchers asked participants about drinking and taking medications at the same time and choosing one over the other. Monthly pill counts and phone calls measured adherence to their drugs and drinking behavior, respectively. Of the 51 percent who skipped their pills to drink, half said they would wait until they cleared the alcohol before taking their next dose. The greatest concern is those who skipped their drugs had higher viral loads and lower levels of CD4 cells, the immune cells that HIV targets.
Will Allow for More Oversight
As FDA officials continue to investigate what led to fungal contamination of a steroid used to treat back pain made by The New England Compounding Center, officials in the state have tightened regulations. It was found that the pharmacy failed to create a sterile environment in which to make the preservative-free steroid methylprednisolone acetate. Bacterial contamination has been found in two others. Officials made regulations that give the state more oversight on compounding pharmacies. State health officials will continue to work with federal health officials to prevent outbreaks such as this which has made close to 400 people sick and killed 28. State-wide investigations have led to the shutdown of three compounding pharmacies in the state.
Four Lots Tested Positive
Inspectors in Massachusetts have found bacterial contamination in four recalled lots of two other drugs made by The New England Compounding Center, whose poor practices led to a meningitis outbreak that was traced back to a contaminated steroid they made. Three batches of the steroid betamethasone and one batch of a heart drug called cardioplegia tested positive for different types of bacteria. The impact on human health is not known at this point and no bacterial infections linked to these drugs have been reported. Fungal infections in two people who had cardiac surgery are being investigated to determine if there is a link. The FDA is testing these lots for fungal contamination. The fungal contamination of methylprednisolone acetate has claimed 28 lives so far and made 386 sick so far.
Prior Violations Never Corrected
On the heels of a third compounding pharmacy being shut down in Massachusetts after one shipped out contaminated steroids that led to fungal infections in 338 people and 25 deaths so far, inspectors from The Florida Department of Health halted production in one of their own. Rejuvi Pharmaceuticals claims to make “bio identical hormones” and other injectable drugs, including ones given through the intestines. The October inspection found that rules and statutes related to "cleanliness of the prescription department, the dispensing of medications, the compounding of medications, and record keeping" were violated. Problems were discovered on previous inspections and made known to the company. State agencies regulate compound pharmacies, but some think the FDA needs more authority over them.
Shutdown Number Three
State-wide inspections by Massachusetts health inspectors have led to a third pharmacy, Infusion Resource, being shut down after finding conditions that could compromise drug sterility. The New England Compounding Center was shut down on October 3 due to contamination of a steroid that led to fungal infections in hundreds of people and over 20 deaths. Its sister company Ameridose voluntarily shut down 16 days later. Inspectors did not find contaminated drugs, but 40 patients and their doctors were contacted and told to return any drugs made by Infusion Resource as a precautionary measure. Lauren Smith, the commissioner of the Massachusetts Department of Public Health, explained the state-wide inspections were necessary to improve public safety and oversight of the industry.
Even the Autoclave Was Dirty
Health officials from the FDA investigating conditions that led to the contamination of methylprednisolone acetate made by the New England Compounding Center found that staff documented cases of mold and bacterial growth in supposedly sterile rooms about four dozen times since January. The outbreak has made 338 people sick and killed 25. In addition to a leaky boiler and dirty floor mats, the air conditioning that regulates temperature and filters the air to prevent bacterial growth was turned off every night. Even the autoclave, used to sterilize equipment, had a "greenish yellowish discoloration." No preservatives are added, so it has to be made under sterile conditions. Compounding pharmacies are generally regulated by the state, but the FDA will step in to assist with serious problems.
Doctors Paid, Studies Edited
After reviewing over 5000 pages of documents, a U.S. Senate Committee has found that Medtronic paid around 210 million dollars to doctors to conduct and author studies on Infuse and heavily edited the journal articles but did not disclose this in the articles. Infuse is a genetically engineered protein designed to be used in spinal surgeries in place of a bone graft from the pelvis. Medtronic said Infuse was the better technique which was not true and none of the 13 studies sponsored by the company reported any side effects. Medtronic denies allegations of influencing studies and did not agree with the way the payments to physicians were described. The U.S. Food and Drug Administration approved Infuse for use in 2002, and in 2011 it brought in approximately 800 million dollars in sales.
Shows Who Benefits the Most
People with colon cancer that contains a mutated PIK3CA gene that is tied to its growth and spread may benefit the most from aspirin, according to results of research out of Harvard Medical School. Over 900 people diagnosed at different stages of the disease were given a survey every two years and tested for a mutation. Over 13 years, the risk of death by taking aspirin was cut by 82 percent and only two of the 62 people with the mutation in their tumors died within 5 years compared to 23 of the 90 people with the mutation who did not take aspirin. There was no difference between baby and regular aspirin and a test for the gene is cost effective and could be done in most cancer centers. Future studies will only involve those with the mutation to determine if aspirin affects the outcome.
Stricter Regulations Promised
Not sterilizing methylprednisolone acetate long enough and not waiting for sterility tests results before shipping out the drugs contributed to the fungal contamination at the New England Compounding Center that has affected over 300 people and caused 24 deaths. Officials saw dirty mats and a leaky boiler next to a room that should have been strictly guarded against contamination. Past complaints never led to any discipline event though they did reach a settlement with the Massachusetts Board of Registration in Pharmacy and the U.S. Food and Drug Administration in 2006. Massachusetts Governor Duval Patrick promised stricter regulation of its 25 compounding pharmacies, including annual inspections and requiring them to report interactions with federal officials to state health officials.
Safety. . .OK!
Concern over the increasing number of serious injuries related to cheerleading has prompted the American Academy of Pediatrics (AAP) to issue a policy statement in hopes of reducing the risk. Leading one’s school in team spirit has evolved into a sport that incorporates complex acrobatics and gymnast-level tumbling. The most common types of cheerleading injuries are sprains and strains. While at the bottom of the list in terms of girls’ high school sports injuries, for over two decades the sport is responsible for 66 percent of catastrophic injuries such as paralysis, brain damage or death. Some of the AAP's recommendations include official designation as a sport so coaching standards can be set, access to good practice facilities and performing stunts on a spring/foam floor or grass turf.
Just over 300 Cases
Fungal contamination of a steroid used to manage pain made by the New England Compounding Center, a Massachusetts-based pharmacy, has led to 304 cases of fungal meningitis and 4 cases of joint infections. Seventeen states are affected and 23 people have died. All the pharmacy’s drugs have been recalled but it is estimated that 14,000 people were injected with the steroids, beginning May 21, 2012. Seventy-six clinics in 23 states are notifying all patients and scientists say that symptoms of meningitis can show up over a month after being infected. Anyone who had an injection of methylprednisolone acetate should watch for headache, fever, dizziness, light sensitivity, a stiff neck, nausea, numbness, slurred speech, pain and redness or swelling at the site of injection. It is not contagious.
Catching Up to the Girls
Previous research established that puberty in girls is starting earlier, and results from a new study suggest the same trend in boys. The studied involved collecting data from the American Academy of Pediatrics Pediatric Research in Office Settings (PROS) research network on the pubertal characteristics of over 4100 boys. Compared to several decades ago, it was found that boys were experiencing stage 2 genital and pubic growth six months to 2 years earlier. Black boys were hitting this stage at an average age of 9.14 years compared to White and Latino boys at 10.14 and 10.4 years, respectively. Study authors do not why this is occurring or how this will affect public health. The large study in 1997 demonstrating earlier onset of puberty in girls was also conducted by PROS.
"An Abundance of Caution"
The Food and Drug Administration has widened its investigation into the New England Compounding Center in Farmington, Massachusetts to include another steroid used in eye surgeries and a drug used in heart operations “out of an abundance of caution." Two heart transplants patients treated with one of their drugs later developed fungal infections, and officials are looking at the steroid triamcinolone acetonide. The fungal meningitis outbreak due to contaminated methylprednisolone acetate has affected 15 states, making 214 people sick and been linked to 15 deaths. Health officials want doctors to contact patients who got any injection of drugs made by the company. The meningitis outbreak shut down the company that custom-mixes several types of drugs and led to all drugs being recalled.
Cells Make the Vaccine
A vaccine that trains the immune system to target and kill cervical cancer cells shows promise, according to results from a small study of 18 women who had lesions surgically removed. Its design is based on research that found that most of the 10 to 25 percent of women who cleared moderate to severe precancerous lesions had elevated levels of T cells targeting the cancer-promoting E6 and E7 oncogenes. Fourteen developed an immune response against cervical cancer cells after three VGX-3100 injections which lasted for two years with no serious side effects. The vaccine, aided by a brief electrical pulse, puts small pieces of DNA into the cells that reproduce them. The manufacturer, Inovio, is conducting a phase 2 trial with women whose precancerous lesions that have not received treatment.