More than 50 years ago, physician Thomas Fogarty devised a balloon catheter that revolutionized a high-risk procedure.

 

Product incubators help physician entrepreneurs bring their innovative ideas to market

GoogleNews.com, June 14, 2010, by Shawn Rhea  –  It has been more than 50 years since Thomas Fogarty, then a medical student at the University of Cincinnati College of Medicine and a scrub technician at the nearby Good Samaritan Hospital, used a knotting technique created by fly fishermen to attach the fingertip of a surgical glove to a long piece of rubber tubing.

The simple device, called a balloon embolectomy catheter, transformed the way surgeons remove blood clots from arteries, turning a high-risk surgery—half of the patients who received it prior to the innovation died—into a significantly safer, minimally invasive procedure.

The year was 1959, and Fogarty, using roughly $600 (about $4,500 in today’s dollars) worth of material he’d borrowed from Good Samaritan Hospital, created the device in his attic and tested it over a matter of months, not years. He eventually patented and licensed the device to Edwards Lifesciences, and it became the gold standard for removing blood clots.

“Back then, there was no medical device amendment” to the Food & Drug Act, says Fogarty, a cardiovascular surgeon who estimates he has since patented more than 100 technologies and has about 10 medical devices on the market. “But that doesn’t mean there weren’t things you had to accommodate. We did bench models and cadaver testing and animal testing—all the things you’d be required to do now” to have a medical device approved.

Much has changed in half a century. Physician inventors working today to develop, test and market medical devices travel a road strewn with a great deal more regulatory twists and turns. What’s more, the cost of getting their inventions to market is exponentially more expensive. Still, regulators, manufacturers and providers all agree that physicians are essential to innovation.

“The basic premise is: Doctors are the end-users of products, and they have a sense of what it takes to fill unmet needs,” says Wayne Poll, medical director of clinical innovation for the OhioHealth Research & Innovation Institute, a medical-technology incubator that helps clinicians develop their products from prototype to market.

Despite their essential roles, medical schools offer physicians little opportunity to arm themselves with the business know-how of medical-product innovation, according to experts in the field. Even academic institutions that are heavily involved in research often sell their technologies before they reach the commercialization stage, giving young innovators few chances to experience moving an idea from concept to market.

“Generally, what happens at universities is they develop platforms and technologies, but don’t commercialize them,” says Poll, a urology surgeon, inventor and founder of the medical-device firm Minimally Invasive Devices in Columbus, Ohio. As a result, he says, potential innovators often have no idea how to advance their inventions. “They really don’t know where to go, and calling up large devicemakers and drug companies just doesn’t work.”

An evolving model

Some organizations are working to change that dynamic, however. Recently, for example, the University of Arizona’s business school began offering a translational research course aimed at teaching medical entrepreneurs how to develop their innovations into usable products.

“Most of my students are business, law and engineering students, but there are a handful of medical students,” says Marvin Slepian, a professor of cardiology at the University of Arizona. Slepian, an inventor and patent-holder of several medical devices used to treat cardiovascular conditions, is also co-founder, chairman and chief medical officer of Tucson, Ariz.-based SynCardia Systems, which produces the Food and Drug Administration-approved Total Artificial Heart. In May, the company realized a major advancement in the technology when Charles Okeke, a 43-year-old patient who’d been confined to the Mayo Clinic Hospital in Phoenix for nearly two years, became the first U.S. patient to be sent home with a portable artificial heart, a device still in the investigational stage.

A growing number of states are also doing their part to spawn innovation. Maryland, Massachusetts, Ohio and Pennsylvania have each established incubators where fledgling medical-products entrepreneurs can tap a variety of resources, including patent lawyers, business advisers and engineers, who help physician inventors develop their products and raise capital.

“Those incubators are really very useful organizations that help entrepreneurs move along,” says Bob Reif, chairman of the business law practice at Epstein Becker & Green and a senior member of the firm’s health and life sciences group.

According to Reif, physicians typically take one of two paths into the world of medical-product innovation: either as a medical-institution faculty member involved with research and development of a technology, or as a “quintessential garage tinkerer” who independently develops a technology.

Either way, innovators who want to see their inventions through to the commercialization stage often lack the financial and market-development resources to do so. “The first stage is finding someone willing to make an investment,” Reif says. “In that first phase, it’s not typically equity investors, but angel investors: family and friends who want to support your work.”

Stephen McCarthy, co-director of the Massachusetts Medical Device Development Center, says his organization’s job is helping medical-product innovators get that help. The 3-year-old organization, known as M2D2, is a state-funded medical technology incubator at the University of Massachusetts’ Lowell and Worcester campuses. The fast-growing organization began in 2007 with a $150,000 feasibility-study investment. M2D2 received $4.6 million in state and institutional funding in support of its current fiscal year and has secured $2.5 million in funding from the National Institutes of Health over the past three years to fund innovators’ research.

“What often happens is the idea reaches the valley of death,” McCarthy explains. A novice innovator will “develop a technology that gets a patent, but then they don’t get it to the point that it’s in a marketable form.”

Physician inventors—even those whose early research was supported by university funding—will reach a point where their technologies need to be translated into formats that can be used by patients. That typically means developing prototypes and formulations, and there aren’t a lot of venture-capital investors who will fund the translational piece, McCarthy says.

M2D2 partners physician inventors with engineers and business experts who help develop the product prototypes and business plans that innovators use to attract venture capital funding. The organization also will help high-risk-product inventors seek small-business innovator funds from the NIH to pay for translational work. “If it’s not high-risk or sexy enough for the NIH, we can use funds we get from the state to match the innovator’s funding for prototype development and clinical trials.”

The Maryland Industrial Partnerships program, known as MIPS, is a state- and privately funded incubator at the University of Maryland that provides similar assistance to in-state medical innovators. “We provide proof-of-concept money for physicians to do translational research,” says MIPS Director Martha Connolly.

Innovators who gain MIPS backing typically receive $100,000 to $200,000 as well as other support services. The organization’s VentureAccelerator program, for example, helps fledgling medical innovators create business plans and secure angel funding and interim executive leadership. A second initiative called the Technology Advancement Program helps startups grow their staffs up to 20 people. It also will provide laboratory and office space, and lend assistance getting a product to market once it receives regulatory approval.

Scott Strome, a head and neck cancer surgeon and chairman of the Otorhinolaryngology Department at the University of Maryland School of Medicine, is among the physician innovators who received MIPS support. Strome’s research into treatments for autoimmune diseases and head and neck cancer began at the University of Maryland. But the researcher and clinician eventually had to spin off his work into a technology startup called Gliknik in order to complete the work of developing his compounds into potential therapies and vaccines.

“We provided funding to offset the cost of translational research,” Connolly says.

A dose of reality

It’s not unusual for university-supported innovators to find themselves in predicaments like Strome’s. The real challenge, says Lynn Brusco, spokeswoman for the state-supported incubator Pittsburgh Life Sciences Greenhouse, is for physician entrepreneurs to limit their role once they are ready to commercialize the innovation.

“A physician researcher typically doesn’t have the business acumen to take a product to market,” Brusco says. “The physician usually doesn’t stay in the role of the CEO. They have to incorporate other people into their companies who’ve been there and know how to avoid pitfalls.”

Brusco says incubators can help by pairing physician innovators with business experts. Pittsburgh Life Sciences, which works with medical-products innovators in a 20-county Western Pennsylvania region, has an executive-in-residence program aimed at facilitating those partnerships. “We bring in high-level executives, pay them an executive-level salary, and they often get to cherry-pick the next venture they want to lead,” Brusco says.

One of the toughest decisions physician innovators will face is stepping back after investing so much time in the development of a technology. But longtime physician entrepreneurs say distance can often be the best thing for an innovator’s future, because it can help mitigate conflicts of interest and allow time to focus on new innovations.

Craig Morgan, an orthopedic surgeon and founder of the Wilmington, Del.-based Morgan Kalman Clinic, says he has had to adjust his business relationships in response to evolving conflict-of-interest rules. Morgan has developed and patented several devices and instruments used in arthroscopic surgery, including a thin suture called FiberWire.

The Naples, Fla.-based devicemaker Arthrex holds the patents for and manufactures many of Morgan’s inventions, and for several years, beginning in 1983, Morgan owned 3% of Arthrex. But the practicing physician says he divested his stake in the company in the late 1980s in response to new physician-ownership rules and conflict-of-interest concerns.

“My arrangement now is I have a yearly consulting-fee stipend and any patents that I develop I assign to them.”

Other physician innovators have opted to walk away from their clinical practices so they can avoid such issues and focus specifically on product development.

“Frankly, it’s a very tough balancing act,” says Poll, who six months ago gave up his Columbus, Ohio-based urology practice to focus on running the OhioHealth Research & Innovation Institute, as well as his company Minimally Invasive Devices. The company holds the patent on several products, including FlowShield, a device Poll developed to help improve visibility during laparoscopic surgery.

“The crush of having to care for your patients can sap your creativity in terms of innovation,” Poll says. “Also, there’s something about the fear of making a mistake with your patients that throws cold water on your creativity, since the assumption is that the first version of your device is not going to be perfect.”

GoogleNews.com, June 14, 2010, Boston, MA  –  It has been previously shown that blue light plays an important role in impacting the body’s natural internal body clock and the release of hormones such as melatonin, which is connected to sleepiness, by affecting photoreceptors in specialized cells in the eye. In new research from Brigham and Women’s Hospital (BWH), researchers have found that green light also plays a role in influencing these non-visual responses. This research is published in the May 12 issue of Science Translational Medicine.

“Over the past decade there have been many non-FDA approved devices and technologies marketed for using blue light therapeutically such as blue light boxes for treatment of Seasonal Affective Disorder and circadian rhythm sleep disorders, and glasses that block blue light from reaching the eye,” said Steven Lockley, PhD, a researcher in the Division of Sleep Medicine at BWH and senior author of the paper. “Our results suggest that we have to consider not only blue light when predicting the effects of light on our circadian rhythms, hormones and alertness, but also other visible wavelengths such as green light.”

In the human eye there is a novel photoreceptor system, separate from the rods and cones used for vision, which detects light and is responsible for non-visual responses, such as resetting the internal circadian body clock, suppressing melatonin release and alerting the brain. These photoreceptors are located in the ganglion cell layer, where there is a specialized subset of cells which are specifically responsive to blue light. Previous research has indicated that these cells are the primary way in which light is detected for the non-visual responses. This new research from BWH shows that cone photoreceptors, which are used for color vision and are most sensitive to green light, also play a role in eliciting non-visual responses.

Researchers enrolled 52 healthy volunteers in a 9-day study in the Intensive Physiological Monitoring unit at BWH, which is free from all time cues including windows, clocks, internet, television or any other indicators for the time of day. Researchers shifted the participants’ schedules so that they slept during the day and were awake in the night, during which time they were exposed to 6.5 hours of either green or blue light to simulate an overnight work shift. The light exposure was timed to reset the internal circadian body clock later than normal, equal to the adaption required to prevent jet lag following a westward flight across time zones.

Researchers measured the effect of the light exposure on melatonin levels and the shift in the timing of the circadian clock. They found that while blue-light is usually the most effective way to stimulate the non-visual responses – especially under bright light conditions- stimulation with green light was also capable of eliciting the non-visual responses under certain circumstances. At the start of the light exposure or when exposed to dim light, green light was equally as effective as blue light at stimulating these non-visual effects, but then the effects died off more quickly over time.

“Our findings suggest that by dynamically manipulating the color, duration and pattern of light, current available light therapies could be optimized and new therapies could be developed. These findings have the potential to play an important treatment role for a number of disorders including circadian rhythm sleep disorders, seasonal affective disorder and dementia. They could also be applied to the use of light as a drowsiness countermeasure, particularly during night shift work, or anywhere were sleepiness might affect performance or present a safety concern,” Lockley said.

This study was funded by the National Institutes of Health and the National Space Biomedical Research Institute.

Brigham and Women’s Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses’ and Physicians’ Health Studies and the Women’s Health Initiative.

About Circadian Rhythm

A circadian rhythm is a roughly 24-hour cycle in the biochemical, physiological, or behavioural processes of living entities, including plants, animals, fungi and cyanobacteria (see bacterial circadian rhythms). The term “circadian” comes from the Latin circa, “around”, and diem or dies, “day”, meaning literally “approximately one day”. The formal study of biological temporal rhythms such as daily, tidal, weekly, seasonal, and annual rhythms, is called chronobiology.

Although circadian rhythms are endogenous, they are adjusted (entrained) to the environment by external cues called zeitgebers, the primary one of which is daylight.

Experimental scaffolding called extracellular matrix has given Cpl. Isaias Hernandez, of Bristol, Conn., back his thigh muscle.

GoogleNews.com, June 14, 2010  –  Pittsburgh is home to exciting new research involving regenerative medicine.

The research is intended to improve the lives of wounded soldiers, but the hope is it will one day help the general public as well.

Three projects have garnered $12 million of support from the Department of Defense. Grants have been given to a Pittsburgh institute to develop skin, bone and muscles.

At a press conference in front of community leaders and donors, military personnel and other scientists, McGowen Institute researchers who work on regenerating tissue were eager to show their work sponsored by the Department of Defense.

One project has given Cpl. Isaias Hernandez, of Bristol, Conn., back something that was taken away by artillery rounds – his thigh muscle. It was ripped down to the bone.

“Before I couldn’t get around and just being able to walk is great especially on my own two legs without any crutches, or canes or a walker,” he said.

With experimental scaffolding called extracellular matrix, he has new muscle. The surgically-implanted scaffolding is infused with proteins to attract stem cells to make the new muscle.

In another project, fibroblasts, a type of cell in skin, are injected to soften hard, tight scars.

“And it is actually the enzymes that are released from those fibroblasts that do that – very similar enzymes to the enzymes that you use when you clean your laundry – enzymatic laundry detergents,” Dr. Alan Russell, of the McGowen Institute, said.

In a third project, a cement made from calcium and phosphate, which are in the body normally, can fill in holes in bones to form new bone – kind of like a high-tech toothpaste.

“As a surgeon, I like the Department of Defense’s attitude about being impatient, wanting to get it to their soldiers quickly,” Dr. Bernard Costello, a craniofacial surgeon at UPMC, said.

In addition to soldiers, it could also help kids with congenital skull deformities.

Going from bench to bedside application in just two years with this grant is unusual. Typically, projects like these would take 20 years.

The researchers hope to start clinical trials in the next couple of years. They are waiting for the go-ahead from the FDA.

DOD leads the way in face transplant research

GoogleNews.com, June 14, 2010, by Charlie Reed  –  Despite the millions of dollars the Defense Department has invested to develop face transplantation surgery for injured troops, the military’s regenerative medicine research aims to make it obsolete.

Instead of replacing a severely disfigured face with that of a donor, the military is researching methods to regrow facial features from scratch using a patient’s own cells.

“We think of transplants as a bridge until we can regrow the tissue,” said Col. Janet Harris, director of the Congressionally Directed Medical Research Program at the Army Medical Research and Material Command, which currently manages $4.4 billion in federal funding.

“Once we can do that, there would be no need for face transplants.”

Established in 2008, the Armed Forces Institute of Regenerative Medicine is partly funding the military’s face transplant program and research. It joins doctors from the military and 28 public and private medical centers for stem cell research focused on using patient and donor cells to reconstruct and reshape the body and reduce transplant rejection.

Research is focused in five main areas: limb repair, craniofacial reconstruction, burn treatments, scarless healing, and help for compartment syndrome repair, a condition related to inflammation after surgery or injury that can lead to increased pressure, impaired blood flow, nerve damage and muscle death.

Successfully regrowing the entire face could be years off because of the complexity of its features and functions, Harris said. Growing new noses, ears and eyelids “is much closer to fruition,” she said.

Clinical trials are under way at Brooke Army Medical Center in Texas to regrow skin for troops burned in combat.

That and advancements in facial prosthetics and other surgical techniques have greatly expanded reconstructive options in recent years.

— Charlie Reed

Ten common but preventable errors


Caring.com, June 1, 2010, by Melanie Haiken  –  The numbers are simply staggering: Every year 1.5 million people are sickened or severely injured by medication mistakes, and 100,000 die. And yet all of those deaths are preventable. What’s the answer? We have to protect ourselves. Here are the ten medication mistakes experts say are most likely to kill or cause serious harm.

1)  Confusing two medications with similar names

It can happen anywhere in the transmission chain: Maybe the doctor’s handwriting is illegible, or the name goes into the pharmacy computer incorrectly, or the swap occurs when the wrong drug is pulled from the shelves. “Most pharmacies shelve drugs in alphabetical order, so you have drugs with similar names right next to each other, which makes it even more likely for someone to grab the wrong one,” says Michael Negrete, CEO of the nonprofit Pharmacy Foundation of California.

According to the national Medication Error Reporting Program, confusion caused by similar drug names accounts for up to 25 percent of all reported errors. Examples of commonly confused pairings include Adderall (a stimulant used for ADHD) versus Inderal (a beta-blocker used for high blood pressure), and Paxil (an antidepressant) versus the rhyming Taxol (a cancer drug) and the similar-sounding Plavix (an anticlotting medication). The Institute for Safe Medication Practices’s list of these oft-confused pairs goes on for pages.

How to avoid it: When you get a new prescription, ask your doctor to write down what it’s for as well as the name and dosage. If the prescription reads depression but is meant for stomach acid, that should be a red flag for the pharmacist. When you’re picking up a prescription at the pharmacy, check the label to make sure the name of the drug (brand or generic), dosage, and directions for use are the same as those on the prescription. (If you don’t have the prescription yourself because the doctor sent it in directly, ask the pharmacist to compare the label with what the doctor sent.)

2)  Taking two or more drugs that magnify each other’s potential side effects

Any drug you take has potential side effects. But the problems can really add up whenever you take two or more medications at the same time, because there are so many ways they can interact with each other, says Anne Meneghetti, M.D., director of Clinical Communication for Epocrates, a medication management system for doctors. “Drugs can interfere with each other, and that’s what you’re most likely to hear about. But they can also magnify each other, or one drug can magnify a side effect caused by another drug,” says Meneghetti.

Two of the most common — and most dangerous — of these magnification interactions involve blood pressure and dizziness. If you’re taking one medication that has a potential side effect of raising blood pressure, and you then begin taking a second medication with the same possible effect, your blood pressure could spike dangerously from the combination of the two. One medication that lists “dizziness” is worrisome enough, but two with that side effect could lead to falls, fractures, and worse.

Be particularly careful if you’ve been prescribed the blood-thinner Coumadin (warfarin), “the king of drug interactions,” according to Pharmacy Foundation of California’s Michael Negrete. “You need just the right amount of Coumadin in your system for it to work properly; too much or too little and you could have serious heart problems such as arrhythmias or a stroke. But so many other drugs interfere with its action that you have to be really careful.”

How to avoid it: Ask your doctor or a pharmacist about potential side effects when you get a new prescription, and make sure the pharmacy gives you written printouts about the medication to review later. Keep all such handouts in a file, so that when you get a new prescription, you can compare the info provided with the handouts from your older prescriptions. If you see the same side effect listed for more than one medication, ask your doctor or pharmacist whether it’s cause for concern.

3)  Overdosing by combining more than one medication with similar properties

Think of this one as the Heath Ledger syndrome, says Michael Negrete of Pharmacy Foundation of California. It’s all too easy to end up with several medications that all have similar actions, although they were prescribed to treat different conditions. “You might have one medication prescribed to treat pain, another prescribed for anxiety, and another that’s given as a sleeping pill — but they’re all sedatives, and the combined effect is toxic,” explains Negrete.

The risk for this kind of overdose is highest with drugs that function by depressing the central nervous system. These include narcotic painkillers such as codeine; benzodiazepines such as Ativan, Halcion, Xanax, and Valium; barbiturate tranquilizers such as Seconal; some of the newer drugs such as BuSpar, for anxiety; and the popular sleeping pill Ambien.

But oversedation can also happen with seemingly innocent over-the-counter drugs like antihistamines (diphenhydramine, commonly known as Benadryl, is one of the worst offenders), cough and cold medicines, and OTC sleeping pills. This type of drug mixing is responsible for many medication-induced deaths, especially among younger adults.

How to avoid it: Pay attention to the warnings on the packaging of over-the-counter medications, and the risks listed in the documentation for prescriptions. Key words are sleepy, drowsy, dizzy, sedation, and their equivalents. If more than one of your prescriptions or OTC drugs warns against taking it while driving, or warns that it can make you drowsy, beware. This means the drug has a sedative effect on the central nervous system and shouldn’t be combined with other drugs (including alcohol) that have the same effect.

4)  Getting the dosage wrong

Drugs are prescribed in a variety of units of measure, units that are usually notated using abbreviations or symbols — offering a host of opportunities for disaster. All it takes is a misplaced decimal point and 1.0 mg becomes 10 mg, a tenfold dosing error that could cause a fatal overdose.

Some of the most extreme dosage mistakes occur when someone mistakes a dose in milligrams with one in micrograms, resulting in a dose 1,000 times higher. This mostly happens in the hospital with IV drugs, but it’s been known to happen with outpatient meds as well. Insulin, the primary treatment for diabetes, causes some of the worst medication errors because it’s measured in units, abbreviated with a U, which can look like a zero or a 4 or any number of other things when scribbled.

Another common problem, says pharmacist Bona Benjamin, director of Medication-Use Quality Improvement at the American Society of Health-System Pharmacists, is getting the frequency wrong — so, say, a drug that is supposed to be given once a day is given four times a day.

How to avoid it: Make sure your doctor’s writing is clear on the original prescription; if you can’t read the dosage indicated, chances are the nurse and pharmacist will have difficulty as well. When you pick up the prescription from the pharmacy, ask the pharmacist to check the dosage to make sure it’s within the range that’s typical for that medication. In the hospital, when a nurse is about to administer a new medication, ask what it is and request that he or she check your chart to make sure it’s the right one for you and that the dosage is indicated clearly. Don’t be afraid to speak up if you think you’re about to get the wrong medicine or the wrong dose.

 

5)  Mixing alcohol with medications

There are plenty of drugs that come with that cute bright orange warning sticker attached, telling you not to drink when taking them. However, the sticker can fall off, or not get attached in the first place, or you might just really need that cocktail and figure it’ll be OK “just this once.” But alcohol, combined with a long list of painkillers, sedatives, and other medications, becomes a deadly poison in these situations. In fact, many experts now say you shouldn’t drink when on any medication without first checking with your doctor.

Alcohol can also have a dangerous interaction with OTC drugs such as diphenhydramine (Benadryl) and cough and cold medicines — and if the cough or cold medicines themselves contain alcohol, you can end up with alcohol poisoning. Alcohol can also compete with certain medications for absorption, leading to dangerous interactions. Mix alcohol and certain antidepressants, for example, and you have the potential for a dangerous rise in blood pressure, while alcohol and certain sedatives such as Ativan or Valium can depress the heart rate enough to put you in a coma.

How to avoid it: When you get a new prescription, ask your doctor or a pharmacist if the medication is safe to take while drinking alcohol. If you’re a heavy drinker and you know it’s likely you’ll drink while taking the medication, tell your doctor. She may need to prescribe something else instead. Also, read the handouts that come with your prescriptions to see if alcohol is mentioned as a risk. And read the labels of all OTC medications carefully, both to see if alcohol is mentioned as a risk and also to see if alcohol is an ingredient in the medication itself.

 

6)  Double-dosing by taking a brand-name drug and the generic version at the same time


With insurance companies mandating the use of generic drugs whenever they’re available, it’s all too common for patients to get confused and end up with bottles of a brand-name drug and a generic version at the same time without realizing it. “For example, a common diuretic is furosemide. The brand name is Lasix. A patient might have a bottle of furosemide and a bottle of Lasix and not know they’re the same thing,” says internist Bruce Mann, M.D. “In essence, the patient is taking twice the dose.” Since generic drugs don’t list the equivalent brand name on the label, you might not spot this unless your brand-name version lists the generic name in the fine print.

How to avoid it: When your doctor prescribes a new medication, make sure you have a chance to go over all the details you might need to know later. Have the doctor write down the name of the drug (brand and generic, if available), what it’s for, its dosage, and how often and when to take it. Try to remember both names for future reference. Also, look up the generic names for each of your brand-name prescriptions and vice versa; then line up all of your medicine bottles and see if you have any duplications.

7)  Taking prescription drugs and over-the-counter or alternative medications without knowing how they interact

It’s easy to think that something you can grab off the shelf at your local grocery or drug store must be safe, but some of the most common OTC drugs can cause serious reactions. A top contender is medicine-chest staple Maalox, meant to calm digestive upset. A new and very popular version, Maalox Total Relief, contains an ingredient called bismuth subsalicylate that can react dangerously with anticlotting drugs, drugs for hypoglycemia, and anti-inflammatories, particularly ibuprofen and other nonsteroidal anti-inflammatories, or NSAIDs.

Another standby to watch out for is aspirin, which thins the blood. If you forget to stop taking aspirin before a surgical procedure, the result can be life-threatening bleeding.

Then there’s the herb Saint-John’s-wort, which many people take for depression. The fact that Saint-John’s-wort can interfere with prescription antidepressants has received a fair amount of attention, but few people know that it also interferes with the liver’s processing of blood thinners such as Coumadin (warfarin) and heart medications such as Digoxin.

How to avoid it: When your doctor is writing out a new prescription, this is also the time to mention or remind her about any OTC meds or supplements you take. Never add a medication without discussing how it interacts with what you’re already taking.

8)  Not understanding interactions between medications and your diet

The most serious culprit in this situation is grapefruit juice, which has unique properties when it comes to inactivating or overactivating medications. Grapefruit juice inhibits a crucial enzyme that normally functions to break down and metabolize many drugs, such as antiseizure drugs and statins used to lower cholesterol. The result? The overloaded liver can’t metabolize the medication, resulting in an overdose, with potentially fatal consequences.

Other less serious interactions to be aware of include coffee and iron; the coffee inhibits absorption. Doctors say they frequently see coffee drinkers who take their iron in the morning with breakfast, yet their anemia doesn’t go away because the iron isn’t absorbed. Grapefruit interactions are serious enough that they’re often listed on medication handouts, but many food and drink interactions aren’t mentioned.

How to avoid it: When you get a new prescription, ask your doctor or a pharmacist whether you should take it with food, without food, and if there are any particular dietary issues to watch out for.

 

 

9)  Failing to adjust medication dosages when a patient loses kidney or liver function

Loss of liver or kidney function impairs your body’s ability to rid itself of toxins, or foreign substances, so medications can build up in the body at higher dosages than intended. According to Bona Benjamin of the American Society of Health-System Pharmacists, a common — and often serious or fatal — mistake that doctors make is not decreasing medication dosages when patients begin to suffer impaired kidney or liver function. There are many medications that doctors shouldn’t prescribe without first ordering liver and kidney function tests, but safety studies show that’s often not happening.

How to avoid it: When you bring home a new prescription, read the fine print to see if liver or kidney function is mentioned. If so, ask your doctor if you’ve had recent liver and kidney function screenings.

 

 

10)  Taking a medication that’s not safe for your age


As we age, our bodies process medications differently. Also, aging brings with it an increased risk of many problems such as dementia, dizziness and falling, and high blood pressure, so drugs that can cause these side effects are much riskier for people over the age of 65.

Since the early 1990s, a research team led by Mark Beers, M.D., has compiled criteria for medications that should no longer be considered safe for those over 65. This list of Inappropriate Medications for the Elderly, known informally as the “Beers List,” is a great resource if you or someone you’re caring for is over 65.

How to avoid it: Take the Beers List to your doctor and ask her to check it against all medications prescribed. Sadly, a recent Beers survey found that among those over 65, more than 16 percent had recently filled prescriptions for two or more drugs on the Beers list, suggesting that many doctors are still uninformed about the risks of these drugs. If you discover that you or a family member over 65 is taking medications that are considered risky, you may need to be proactive and ask the doctor to find alternatives.

NewsBlaze.com, June 1, 2010, by Alessandro De Arcangelis  –  A group of Australian scientists managed to revive a primary component of mammoth blood, revealing, within a research published on Nature Genetics, how the colossal ancestors of modern elephants could survive in the Arctic area.

The researchers of the Australian Center for Ancient DNA of the Adelaide university, along with the colleagues from the university of Manitoba, Canada, managed to recreate the hemoglobin, the protein which carries oxygen, starting from fossil relics of Siberian animals that lived about thirty thousand years ago. “It is the same protein we could have synthesized if we had gone back in time and withdrawn blood from living mammoths… Now we can measure the functions of the animal as if it were still alive”, writes professor Alan Cooper, who led the project.

The ancestors of nowadays’ elephants developed in the warmth of Africa about 7 million years ago. Mammoths were the branch of the family which successfully migrated northward, towards colder regions in Europe, between 1.2 and 2 million years ago, developing smaller ears and tail, as well as a warm fur.

Cooper explains that human hemoglobin, in freezing conditions, cannot deliver sufficient oxygen, which does not reach the extremities of our body, causing frostbite and gangrene. The research shows that mammoth hemoglobin had a radically different structure, which allowed it to function properly even in extremely freezing environments. This helped these ice-age mammals to survive, because they did not have to burn energy to keep the extremities of the body warm, proboscis included. “Evolution operated in real time to develop such an amusing strategy”, writes the scientists. The same approach might have been adopted with other extinct species, such as our far relative, the Neanderthal. By reconstructing the hemoglobin and studying its structure and properties, it will be possible to cast some light upon several human diseases, he adds.

Researchers managed to convert the DNA sequences from mammoth hemoglobin into ribonucleic acid, by injecting it into some normal bacteria, that allowed to re-grow the authentic protein from mammoths. By adopting some physiological tests and molecular modeling, they discovered how they survived, as they had changed the sequence of the protein in the blood. It is always amazing to discover what kind of achievements our science allows us to conquer. The discussion concerning the genetic manipulation and the artificial procreation in general would always represent, and still represents a boiling issue within the investigation of scientists, theologians and philosophers. On the other hand, the subject called “genetic engineering” never managed to attract such big and remarkable attention and stays still far from such a profound research.

This is shocking: artificial procreation regards just a limited group of people, while genetic engineering can potentially regard everyone. It is one of the main topics of future bioethical life. Whenever we face this kind of topics, though, it is necessary to beware of two attitudes which are both unreasonable, while our first actual duty is to make use of our actual reason.

It is unreasonable to think that scientific research represents a law for itself and that it has to be ruled exclusively by the potential achievement of its goal. The emotional echo of such an attitude is the naive exaltation of any new scientific discovery or technical achievement. On the other hand, it is equally unreasonable to reckon that, by principle, every “innovation” has to be refused: the emotional echo of this other attitude is some sort of fear and unmotivated repudiation. What are we asked to do, then?

We have to “resort to the extreme resources of our moral reason in order to take care of this, which is the most delicate among all the topics in an age where the ethical theory is everyday more insecure” (H. Jonas). What is such a “delicate topic”, born from the fact that the medical profession has to face a constant daily confrontation with and against genetics? I would like to stop a bit to answer this question, not to trigger any of those previously expressed attitudes, but simply to get aware of the issue in its real terms. What is the “ethical knot” of genetic engineering?

While, in the past, technology always had to deal with inanimate substances (usually metals), that it would exploit in order to produce non-human instruments for men’s utility, nowadays the situation has become different. Today people can be the direct object of their own engineering and, in particular, technology can affect men’s hereditary physical constitution. This is where the ethical problem resides. There are many ways to face the topic, though, there are many ways to proceed through it and many solutions are offered: they belong to two different attitudes, a positive and a negative one, which are separated by a “watershed”, which collocates them on two opposite and contrary sides. The turning point is provided when we try to answer the following question: as men can be the object of their own engineering, what fundamental criterion can make us distinguish between an intervention of man on a “good” man and a “non-good” intervention? Today the dominant answer appears to be the following: if the prudently foreseen consequences aim to the achievement of welfare for a bigger amount of people, the research-experimentation-intervention has to be undoubtedly approved and reasonably legitimized. It is a consequentialistic-utilitarian criterion, then.

Consequentialistic: what legitimizes the work of the geneticist are the consequences of the work itself. Utilitarian: the consequences have to be meant in terms of utility-welfare of a bigger amount of people. This criterion is broadly criticized and, as it means to perform as exclusive attitude, it is also completely rejected by those who just look at the ethical side of the issue, the exaltation of the absolute valor of every single human being. Under this value, no human being can actually be used as an instrument to achieve any purpose, even if this has an extraordinary moral importance. The person is exalted above any price: its identity cannot fit any utility computing, not even for a set of other human people. Which means: balancing the utility of a single person against the utility of more people, has got no meaning “in humanis”.

The reason why today we have to face such a deep bioethical controversy is that the Western culture lost its unity in the fundamental choice criterion. We live caught in the middle of the contrast between a utilitarian criterion and a personalist one. The ethical meditation regarding genetics has got the merit of unveiling this basic question. From this statement a vital practical corollary is born. If we accept, as a basis criterion, the personalist one, we have to agree on saying that every intervention must have a therapeutic purpose, in relation, then, with the health or the welfare of the person on which science intervenes, otherwise it has to be considered illegitimate.

We notice how molecular biology is revolutionizing medicine. We have to wish, in this scenario, that these new techniques never prevail on clinical schemes and simply fulfill their task as mere instruments of diagnosis, on a different, lower, level from medicine. If we accept the utilitarian criterion, instead, it will be impossible to accept coherently this exclusiveness of the therapeutic purpose or, which is the same, the subordination of molecular biology in relation with medicine.

Another practical corollary is that the externalization and the “uphold” of the so-called “autonomy principle” is fully coherent with the personalist one, but not with the utilitarian one. The principle of autonomy, which is often defined as “non-directivity principle” means and involves the guarantee of respect of individual freedom. Therefore the ethical problem of genetic engineering, more than any other chapter of bioethics, unveils the actual core of nowadays’ bioethical debate: the choice between a utilitarian or a personalist selection criterion.

There is also another dimension of the ethical issue regarding genetic engineering, closely related to the previous one: it is the ethical observation that has to be made on the human body. The question is serious: is the body an essential constituent of a person, so that they are interchangeable and never separable or is it a mere material array which people are given as a condition for the exercise of superior and non-material skills?

In the first scenario, the body is something that I am; in the second one, it is something that I have. If, in our personal consciousness, in the scientific enterprise, the second perspective results to be more reliable, the fundamental question which clearly externalizes the relationship with the body is the following: what can I do with it? Ideally, the technical possibility cannot coherently undergo any limitation from outer instances, such as the ethical one. The issue of corporeality that western culture, from Plato to modern philosophers, has carried in its womb, mind and cultural identity throughout the years as an unsolved problem, gets back to impose itself strongly. In fact, this copresence of subjectivity and objectivity, having and being represents the fundamental paradox of our being “men”, not reducible to a mere organic apparatus, nor to pure spirit.

Obviously, this is not the moment to face, on a purely theoretical level, the problem of the human body. We only have to check how the approach to the ethical problem of genetic engineering changes in accordance with the different perspectives concerning the identity of human body. The consideration of the body as a material system available to the “user” unavoidably takes to a judgment concerning the actual availability of the instrument, which is ideally unlimited. It leads, or, at least, it is not impossible that it leads to some sort of “total biotechnology”. If, on the contrary, the idea of a body-person prevails, the geneticist would not go beyond the purely negative action of correcting or preserving from hereditary deficiencies. In fact, apart from other deeper ethical considerations, he is aware of his position: he must respond to someone on whom he is directly operating and not just about the operation itself. The responsibility concept is doubled, then.

As noticed by the philosopher Hans Jonas, there is a risk, though: “the moral dilemma of any kind of genetic manipulation on man, which goes beyond the pure preservation or correction of hereditary deficiencies is this: the possible accusation by the descendant against the one who created it might not find anyone who could be able to be responsible and pay the price. This is a field which allows us to commit crimes in a total impunity, whose reliability today’s man – who will be yesterday’s man – is absolutely sure of when facing his victims. This forces them – forces any of us – to keep an extreme, scrupulous, caution in applying on men the growing power of biology. Here it is only allowed to preserve from disgrace, not to experiment a new kind of happiness. Our target is the man, not some sort of uber-man. Even if something bigger and definitely metaphysical is being discussed, the simple convenience ethics are sufficient to forbid, already at the beginning, the manipulation of human genotypes. Yes, even if it can sound absurd to the ears of modern men” (Hans Jonas – “Technique, medicine and ethics”).

In conclusion we can only say that the exaltation of a total liberation project is and forever will be eroded by uncertainty. As described by Goethe by means of the philosophy which permeates his most famous character, doctor Faust, who turns his whole life into a challenge against the unknown, freedom, as well as life, has to be conquered every day. There is always the risk of a failure, no certainty is contemplated in an absolute way. Our ethical life will be permeated by desire, risk, dream, hope and doubt. Who’s going to win this individual and collective challenge for and against our contemporary and future ethics? A legalist and formal state of mind or a progressive and, at the same time, fragile one? History will pronounce the last word. Genetic engineering probably owns only the merit of unveiling the problem concerning the legitimacy of the use of our reason to service a liberation process which is definitely too utopian not to leave us in the desert of a delusion.

Alessandro De Arcangelis, the author of two books, is a writer interested in humanities, music, philology and IT. Contact him through NewsBlaze. http://newsblaze.com/story/20100528091444adea.nb/topstory.html

Capra pyrenaica pyrenaica, the Pyrenean Ibex has returned from extinction thanks to cloning. The noble goat went extinct in 2000, but thanks to some foresighted scientists that saw to it to freeze some skin samples in liquid nitrogen, we have preserved the DNA. Of course, the cloning process that we have now isn’t really the most efficient; of the 439 embryos created, only 7 resulted in pregnancies. But, considering that at least 25% of natural human pregnancies result in spontaneous abortions, I don’t think we’re that far behind. Keep in mind, we’re new comers to the game.

Now, if I may go out on a sci fi limb here: imagine a massive animal DNA library. The gene sequence of every animal we can nab is stored in little liquid cooled vials. If we need an animal … for study … or a game feed … we can inject some animal goo into an egg and let it cook. Presto! Instant animal! Of course, this scenario could be viewed as a bad thing … After all, if no animal could ever really go extinct, why would anyone put up an effort to save any?

Of course, as fraking cool as an ibex is, the pièce de résistance of animal cloning will be to bring back the woolly mammoth. We do have mammoth DNA, but unfortunately, the “mammoth stuff” that we do have is severely degraded. There is a team working on reconstructing it, but it will be a challenging project, no doubt.

Mammoths & Mastodons
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