Leech Therapy

Her family had the presence of mind to keep the detached piece on ice, and rush it with her to the hospital. Specialists worked for 15 hours to reattach the missing features, using 358 medicinal leeches to restore circulation to the reattached flesh. They exhausted the local leech supplier’s stock, and had to have more rushed in from the UK.

Leeches look like a slimy, oversized worm with a flat stomach and a sucker at each end. They’re usually green, brown, or greenish brown in color. A full grown leech can be almost 8 inches long – the largest ever discovered was 18 inches. The rear sucker is mostly used for movement, while the front contains a “jaw” with teeth.

Medicinal leeches are distinguished by the presence of not one but three saw-like jaws with 100 sharp teeth on each jaw, all the better to bite you with. There are several species of medicinal leeches, including American and Mexican, but the English one is most commonly used. The jaws leave a bite mark that looks like an upside-down Y inside of a circle.

Leech bites aren’t as painful as one would imagine (they are said to feel like a mosquito bite), largely because leech saliva contains an anesthetic-like substance. Once firmly attached, the leech also secretes a powerful blood thinner called hirudin, and proceeds to suck out 4 to 6 times its body weight in blood.

The first record of leeches being used medicinally dates back to 200 BC in Greece. Leeches reduce blood coagulation and congestion, not just by feeding and the blood thinner they secrete, but by the steady bleeding that occurs after they detach. The medicinal use of leeches has seen a resurgence in recent years, particularly in microsurgery (surgery done under a microscope). Leeches are also used in reconstructive surgery to stimulate circulation in reattached limbs and skin grafts, and to treat a number of conditions including abscesses, arthritis, thrombosis and even glaucoma.

Leech collecting and selling is a little known but time-honored profession. The British poet William Wordsworth wrote about his encounter with a leech collector in 1802. Today’s medicinal leeches are grown in hygienic “farms” using processes like reverse osmosis and ultra violet light sterilization.

In their natural state, leeches prefer muddy fresh water pools and ditches, preferably full of weeds. In Wordsworth’s time, many of the leech gatherers used to collect leeches by wading into the water and letting them attach to their legs (often leading to anemia). Others used old horses as leech bait.

The FDA approved the medicinal use of leeches in 2004, and labels them a medical device. Hundreds of thousands of them are sold in the US each year, and millions are sold in Europe. Mechanical leeches that dispense the anti-coagulant heparin and mimic the action of leeches have been developed, but are not yet available.

FDA Bldg 62

Dapaglifozin proved as effective as current oral diabetes medications in otherwise healthy diabetics, but was not as effective in those with impaired kidney function. The panel’s primary concern was a potential risk of breast and bladder cancers. In a two-year study, there were nine cases of bladder cancer and nine cases of breast cancer in the just under 5478 patients taking the new diabetes medication, compared to only one case of bladder cancer and one case of breast cancer in the 3156 patients in the control group.

There were also indications of possible kidney damage, and increased risks of genital and urinary tract infections. The advisory panel also complained of insufficient data on which patient population the diabetes drug was best suited to, and on potential interactions with other medications.

Dapaglifozin belongs to a class of medications called SGLT2 inhibitors. SGLT2 inhibitors work by inhibiting the return of glucose filtered by the kidneys to the blood stream, redirecting the glucose through the urinary tract to be excreted in the urine. It’s believed the resulting high sugar levels in the urine is the cause of the increase in genital and urinary tract infections.

One advantage of SGLT2 inhibitors is that they work independently of insulin injections, allowing for more freedom in combining them with other diabetes medications. People taking dapaglifozin in clinical trials also lost an average of five pounds, and experienced a slight drop in blood pressure.

The panel recommendation will not only likely result in the FDA rejecting the diabetes medication, but it will also effect the approval of similar SGLT2 inhibitors being developed by a number of other major pharmaceutical companies, including Johnson & Johnson, GlaxoSmithKline, Boehringer Ingelheim and Eli Lilly.

The panel is calling for more clinical studies of the proposed diabetes drug. The FDA will make a final decision by the end of October, 2011, but given the panel’s request for more trials, the approval of dapaglifozin is expected to be about two years away.