Nixing the Need for the Needle
New technology for delivering drugs is doing away with one of the most feared, yet enduring, symbols of modern medicine -- the hypodermic needle.
In January, drug giant Pfizer won approval to market inhalable insulin, a product that in three years is expected to produce $1 billion annually as diabetics abandon injections.
The breakthrough is one of the most high-profile advances yet among a small cadre of physicians committed to eliminating -- or at least dramatically reducing -- needle use in medical treatments. Despite entrenched needle use among doctors, researchers are moving ahead with a number of injection alternatives, from micro-needles too tiny to inflict pain, to new forms of pills capable of delivering drug payloads orally.
"This is a big bone of contention with me," said John Patton, chief scientific officer of Nektar Therapeutics and co-inventor of the first FDA-approved inhalable insulin. "The medical profession does not think needles are a problem for people after they get used to them, and that it's just something that they can deal with. They just don't realize that people don't like needles at all."
In 1853, doctors first pierced human flesh with a needle attached to a syringe to deliver morphine. Since then, needles have saved countless lives by facilitating blood transfusions and by delivering vaccines to protect people from the ravages of polio, measles and mumps, among many other diseases.
At the same time, needles are responsible for an alarming number of medical injuries. According to the Centers for Disease Control and Prevention, health-care personnel fall victim to 385,000 needle-stick injuries annually. That's 1,000 injuries every day, spreading more than 20 pathogens, with hepatitis B, hepatitis C and HIV being the most common. That's only counting injuries in hospitals. Even more happen in nursing homes and private doctor's offices, or during at-home care. Plus, the CDC estimates that 50 percent of needle injuries go unreported.
Then there's the fear factor. All of us instinctively shrink from needles, although most can overcome the flight reflex in order to undergo necessary medical treatments. But a surprisingly large minority of people suffer a form of needle phobia so extreme that they would rather let severe injuries and illnesses go untreated than get stuck with a pointy piece of metal.
Family physician Dr. James Hamilton is the author of the only large, peer-reviewed study on the phenomenon, "Needle Phobia: A Neglected Diagnosis," published in the August 1995 issue of The Journal of Family Practice. Hamilton, who himself suffers from needle phobia, found that the malady is often overlooked or not taken seriously by doctors, although it may affect up to 10 percent of the population.
Keith Lamb, another needle-phobia sufferer who is co-writing a book on the condition with Hamilton, said he's interviewed 1,500 people with severe needle phobias, and almost all of them have encountered doctors who don't take their issues with needles seriously.
As an illustration of how this phobia can play out, Lamb describes how he responded to a serious knee injury he suffered in 2004. He twisted and tore his knee and doctors recommended surgery. But he said he couldn't bear the thought of the IV necessary for anesthesia. As a result, he suffered with a mangled knee for three months before he could find an anesthesiologist who would put him under without the IV.
Before that, he willingly ran the risk of septicemia because he could not abide the Novocain shots necessary to perform badly needed dental work.
"I don't understand how anyone could not understand the fear," said Lamb, an emergency medical technician who maintains a website on needle phobia. "Somebody coming after you with a needle should make everyone afraid."
Those who share Lamb's terror often don't take their medicine. Sometimes they avoid medical care altogether.
"You can make the best drug in the world, but if the patient doesn't take it, it's useless," said Mark Prausnitz, an associate professor at the Georgia Institute of Technology and inventor of the microneedle.
Prausnitz and fellow Georgia Tech electrical and chemical engineer Mark Allen have developed several prototypes of a microneedle device. It features an array of up to 400 tiny needles made of silicon, metal or polymer, each of them from 1 to 1,000 microns in size. They can be solid and coated with a drug, or hollow. They are virtually painless, Prausnitz said.
One study, he said, tested 150-micron-long needles, which is about the width of two hairs. "That study found that the subjects could not tell the difference between a smooth, flat surface simply pressed against them and the microneedle injected into the skin," Prausnitz said.
Hypodermic needles persist at least partly because they are inexpensive and entrenched in medical care. But they've been tough to replace for treating illnesses like diabetes for other reasons. It's exceedingly difficult to get large molecules, like insulin, human growth hormone, morphine and vaccines, to stay in the body. When taken orally, the human stomach usually gobbles them up before they can get into the bloodstream. Inhaled, the lungs readily cough them out. So injecting them directly into the bloodstream has been the only known effective delivery method.
Nektar's Exubera formula circumvents the problem by transforming insulin into tiny, freeze-dried particles small enough to bypass the upper parts of the lungs. They then burst open to release the insulin once they enter the lungs' inner sanctum.
Ventaira, another company trying to get around the needle, is delivering drugs including insulin in an inhalable form. Instead of dry-freezing drugs, Ventaira's Mystic technology uses an aerosol to carry the drug to the lungs, and controls the delivery amount using an inhaler device armed with a tiny circuit board.
"We can program things into the device that would make it much easier for patients to use," said Ventaira CEO Leslie Williams.
Scientists at Depomed are redefining the pill, and the company's technology might also play a part in eliminating the needle in many treatments. Depomed's pill starts off small, but after it's swallowed, the same polymers used to make soft ice cream fluffy cause the tablet to expand to about the size of a nickel. The larger pill can't get past the upper gastrointestinal tract (where most drugs are absorbed), so it hangs out there and slowly releases the drug rather than rapidly passing through the digestive system.
The technique leads to fewer doses and fewer side effects. One of the company's FDA-approved drugs is Proquin XR, its version of antibiotic ciprofloxacin.
Cipro was already available orally. But due to the way the expanding pill works, it's possible that peptides and proteins that are typically delivered intravenously could make their way into the bloodstream using Depomed's technology, said John Fara, the company's CEO.
"We could probably deliver these (large molecules) and have enough absorbed to have an effect," Fara said. "Then you have to ask the question about all of the compounds given intravenously: 'Could they be given orally?'"
Other companies like Sontra Medical and 3M are working on ways to use patches and ultrasound to open up the skin without a needle, and diabetics might once again be the benefactors.
"For diabetics, we're working on a product to get glucose readings without having to do finger sticks," said Sean Moran, Sontra's chief financial officer.
Powder Med has developed a "gene gun" that shoots DNA-coated microscopic gold particles into the epidermis, without a needle, activating immune cells beneath the skin. The device employs a cassette that can be custom-rigged with, for example, the latest version of flu going around. The painless procedure takes minimal training and can be self-administered. Early studies for a flu vaccine are promising.
But syringe-fearing author Lamb says these solutions address only 5 percent of the problem that needle-phobic people face. Their biggest challenges are having blood drawn or an IV inserted, situations that are routine when it comes to diagnosing many diseases and preparing for surgery or even marriage.
"I have never heard of any technology -- I can't even envision anything that could ever fix that problem," he said.
In these cases, patients need to find a way to cope with the fear and pain. Some needle phobics, like Lamb, specifically mind the pain. For them, topical anesthesia can help (although that didn't work for Lamb when he needed cortisone shots in his knee). Others just can't look at the needle, while some can be calmed by hypnosis or a soothing environment.
Anesthesiologist Dr. Michael Entrup, chair of anesthesiology at the Lahey Clinic in Burlington, Massachusetts, said he has encountered very few needle phobics, but one of them is his 14-year-old son.
"I have to put (anesthetic) cream on him if he's going to get a vaccine or anything," Entrup said. In severe cases where topical anesthetics don't cut it, Entrup said he's willing to try other methods, like letting the patient inhale the anesthesia first, then inserting the IV. (Anesthesiologists prefer to insert the IV first in case the sedative lowers blood pressure to a dangerous level and requires a quick dose of medication.)
"Any concern a patient has about any aspect of their anesthesia, whether it's the IV or whether they'll have pain or be sick to their stomach or whether they might need a blood transfusion," Entrup said, "they should discuss it with their anesthesiologist prior to (the procedure)."
Here's the original Wired News posting: http://www.wired.com/news/technology/me ... page_next1
It's got some nice pictures of these devices.