Breaking News from NAFC 2009

First Embryonic Stem Cell Trial Using Humans

In addition to ongoing research into the use of muscle stem cells as a treatment for stress urinary incontinence, the FDA approved earlier this year the first human trial using embryonic stem cells as a medical treatment. Geron Corporation will conduct clinical trials at up to seven medical centers with paraplegic patients who have the use of their arms but not their legs. They will be injected with embryonic stem cells to determine the safety of the treatment and its ability to create sensation and movement. If successful, this could mean a new treatment for Parkinson’s disease patients and, down the road, relief for incontinence and overactive bladder.

Study Shows Link Between Urinary Drug and Cataract Surgery Complications

A study recently published in The Journal of the American Medical Association (JAMA) shows a significant increase in the possibility of serious complications for men after cataract surgery who have been taking tamsulosin hydrochloride, sold as Flomax®. The study focused on men 66 years and older in Ontario who had cataract surgery from 2002-2007. Of the 96,128 men studied, 7.5 percent had serious complications following surgery if they had been taking Flomax at least 14 days before surgery. This compared to 2.7 percent if they had not taken the drug. While the drug’s ability to relax smooth muscle in the prostate and bladder helps so many men with urinary problems, it apparently has a negative effect on the eye’s iris and can lead to retinal detachment, a lost lens, or inflammation.

The maker of Flomax, Boehringer Ingelheim Pharmaceuticals Inc., stated that the medication’s information insert advises consumers to tell their eye surgeons before cataract surgery that they are taking the drug. An editorial calling for a “black box warning” on the medication appeared with the study in JAMA. The study did not find complications with other similar medications.

With nearly two million cataract surgeries performed annually in the United States, it is definitely an important discussion for men to have with their physicians if surgery is a possibility.

New Drug for BPH

Watson Pharmaceuticals recently launched RAPAFLO™, a new selective alpha blocker, for treatment of the signs and symptoms of benign prostatic hyperplasia (BPH), or enlarged prostate. At the American Urological Association’s (AUA) Annual Conference in Chicago in late April, the company presented clinical trial results demonstrating that the new treatment improved the irritative and obstructive urinary symptoms associated with BPH. A common side effect from the drug is retrograde ejaculation – an orgasm with reduced semen – which, according to Watson, should reverse when treatment ends. The information insert will also carry the warning regarding cataract surgery, as outlined in the preceding story.

Pfizer Announces Financial Help for Unemployed Americans

On May 14, 2009, Pfizer Inc. announced that it has instituted a program to help newly unemployed, uninsured Americans and their families continue their medications at no cost. MAINTAIN (Medicines Assistance for Those who Are In Need) will cover the cost of Pfizer medicines for up to one year with the following eligibility criteria:

• The primary wage earner has become unemployed since January 1, 2009;

• They have been taking a Pfizer medicine for at least 3 months prior to unemployment and enrolling in the program;
• They have no prescription coverage; and
• They can attest to financial hardship.

Qualified patients will receive their Pfizer medications at no cost for up to 12 months or until they regain prescription coverage, whichever occurs first. The program includes more than 70 Pfizer medications.

Consumers can apply by calling the Pfizer Helpful Answers
toll-free number at 1-866-706-2400 or online
at www.PfizerHelpfulAnswers.com.

Injection Could Offer OAB Relief

Researchers at the Mayo Clinic in Jacksonville, Florida, are investigating an alternative treatment for overactive bladder (OAB) in women. The treatment involves infusing a solution containing Botox and dimethyl sulfoxide directly into the bladder. The 25 women participating in the Mayo study had used oral medications for OAB symptoms without success. The trial was done in two phases, with some women receiving a 66 percent solution strength and others receiving the solution at full strength. No side effects were reported and patients reported improvements in symptoms and quality of life. Researchers say that further study is needed to determine how long the treatment is effective, but lead physician Steven P. Petrou is hopeful a substitute for a daily OAB pill may be possible.

Interstitial cystitis, painful inflammation of the bladder’s lining, is the only human use for dimethyl sulfoxide that is FDA-approved, although there are unproven claims of its effectiveness for treating such conditions as arthritis, infections, and wounds.

New National Survey Shows that Overactive Bladder Symptoms are Pervasive and Difficult to Manage

Results from a nationwide online survey of women ages 40 to 65 show that the symptoms of overactive bladder (OAB) are compromising their sense of normalcy and making their complicated lives even more difficult to manage. The survey, recently conducted for NAFC by Kelton Research and sponsored by Medtronic, Inc., compared women who have experienced symptoms of OAB to women in the same age group overall. Both groups of women say that physical health is more important than emotional health when it comes to living a normal life. In fact, nearly nine in 10 women in each group say that being healthy is a prerequisite to achieving a sense of balance in life – far more than those who report needing adequate levels of money or time to achieve balance. Despite a trying economy, more than one in four (26 percent) women with OAB are more concerned about managing their OAB symptoms than saving for retirement. An overwhelming majority (78 percent) of women with OAB who have sought treatment did so because they were frustrated with living with the symptoms. Unfortunately, almost half (49 percent) of women with OAB do not think they will ever be able to completely control their symptoms.

While lack of effectiveness from medications is blamed by one-third of patients, dissatisfaction with current OAB treatment approaches could be due, in part, to the lack of communication about the topic between patients and physicians. Sixty percent of the women with OAB admit they’d be more comfortable discussing menopause with their doctor than talking about OAB symptoms. Unfortunately, almost three in four (74 percent) women with OAB say that they waited longer than they should have to finally seek treatment after their first symptoms.

“This data demonstrates that a considerable number of middle-aged women are frustrated with their OAB treatment,” said Nancy Muller, executive director of NAFC. “There needs to be more public education so people are made aware of their options for OAB treatment beyond just medications. Clearly, there’s room for more engagement for discussion by primary care providers with their patients.”