Another Breathalyzer to Detect Disease

First there was BreathLink, described as a breathalyzer for the detection of breast cancer and pulmonary tuberculosis. It's been 6 years since I first highlighted the concept of using breathalyzers for disease detection (see this blog July 4, 2011). BreathLink is currently undergoing extensive clinical trials. If all goes well, it may receive final FDA approval as a diagnostic test within another year or two.

Now there's another one, called Breath Biopsy. This one is at an earlier stage of development but is somewhat broader in scope. Breath Biopsy is, in effect, a platform to detect virtually any volatile organic compound (VOC) that might appear in the breath in a disease state. Current clinical trials about to get underway to validate Breath Biopsy tests for early-stage lung and colon/rectum cancers, and it is being considered for the possible detection of cancers of the bladder, kidney, esophagus, pancreas, prostate and brain. Several other possible uses have been proposed, including evaluating how patients with chronic obstructive pulmonary disease (COPD) are responding to treatment, and even studying a patient's microbiome - the bacteria in their digestive system - to determine which drugs might work best on their specific disease.

Compared to blood tests and biopsies, breath analysis would be safe and cheap. But before any breathalyser-based tests can be approved by the FDA, they will have to demonstrate their accuracy and reliability in extensive clinical trials. As the experience with BreathLink has shown, regulatory approval can take years or even decades, not days or months. You may encounter a breathalyzer test in your lifetime, but don't hold your breath.

A New Method for Treating Ventricular Tachycardia

One of the consequences of the damage to a heart caused by infection or a heart attack is scarring of cardiac muscle tissue. In some cases the scarring leads to a type of arrhythmia called ventricular tachycardia, in which the patient suffers from a rapid and uncontrolled heart rate and a feeling of dizziness and lightheadedness. The standard treatment is generally a surgical procedure, in which the scarred region is burned off via a catheter inserted into the heart. But the surgical procedure carries some risk, and in some patients it just doesn't work.

An experimental non-invasive technique offers hope to these patients. Borrowing a technique used to treat cancer patients, the new procedure uses targeted radiation to ablate the offending tissue. During the procedure the patient wears a vest that incorporates 256 electrocardiogram leads as opposed to the usual 10, allowing precise targeting of the region to be ablated.

The procedure seems to work well - the first five patients went from more than 6,500 episodes of tachycardia in three months to just four episodes in a year, according to an article in The New York Times. Further research will be needed to determine the long-term consequences and safety of the procedure, but some day, targeted radiation could become the method of choice for patients suffering from ventricular tachycardia.

The F.D.A. Cracks Down on Fake Opioid Addiction Treatments

Once again, the largely unregulated dietary supplements industry earns itself another black eye. The latest scam is products that purport to ease the symptoms of opioid withdrawal. Who stoops so low as to prey on victims of opioid addiction?

Case in point; a product called Opiate Detox Pro. The company's website claims that its ingredients ease opioid withdrawal symptoms, despite the fact that the company cites no research to back up its claim and has no intention of ever conducting any research. The company says that if the product doesn't work, the user can get his/her money back. Big deal!

The F.D.A. shouldn't have to keep ferreting these guys out and cracking down on them, but such is the current lack of effective regulation of dietary supplements in general. Anyone is free to market dietary supplements, as long as they don't claim to treat a specific medical condition.

With any dietary supplement, its buyer beware.

Digital Pills

The FDA recently approved a pill that will send an alert when the pill is actually taken, according to a recent article in The Inquirer. The pill contains a tiny sensor about the size of a grain of sand. When the pill is swallowed, acid in the stomach activates the sensor to send a signal to a skin patch worn by the patient. The patch then notifies a cell phone that the medication has been taken.

The first digital pill is expected to contain a drug used to treat schizophrenia and other serious illnesses - conditions in which patient compliance is often an issue. But one can envision all kinds of uses of the technology. Of course the pill raises issues of privacy and of how the ability to collect data about your pill use might lead to coercion. What if, for example, health insurers were to "incentivize" you by lowering the price for pills with sensors to get you to use them? How would they use the data they could collect on you? What if they were to insist on receiving data about your medication compliance as a condition of future health care? These are issues that should be considered before digital pill use becomes widespread, not after.

On the other hand, digital pills might be a real help for people who want to be compliant but just can't remember to take their medications, such as the aged. Like any new technology, it'll be how we use it that will determine its ultimate usefulness.

Of course, pills with embedded sensors will cost more, too...

First U.S. Baby Born After a Uterine Transplant

It was bound to happen sooner or later. A U.S. woman who was born without a uterus has just given birth to healthy baby after doctors at Baylor University transplanted a uterus into her last year, according to an ABC news report.

Transplant doctors see it as a significant advance, and indeed it may be. Once perfected, the technique could offer hope to women who for whatever reason do not have a functioning uterus and so cannot experience pregnancy and childbirth. However, it is important to note that the technique is still in the research stage. Several of the very few uterine transplants performed so far have had to be removed because they failed.

I've written about some of the ethical and financial issues related to uterine transplants before (see this blog, Nov. 23, 2015 and Feb. 29, 2016). What do you think?

A More Effective Shingles Vaccine

Shingles is a condition characterized by an itchy, painful rash that can last for weeks. It's caused by the same virus that causes chickenpox in children. In adults who had chickenpox as children, the virus can re-emerge later in life, causing shingles. Nearly a third of all untreated adults over 50 are likely to develop shingles at some time in their life.

There has been a vaccine against shingles, called Zostavax, since 2006. However, Zostavax has proven to be only 51% effective in preventing shingles. Consequently, many people who were vaccinated with Zostavax still came down with shingles.

Now there's a new, improved vaccine against shingles, according to a press release from GlaxoSmithKline. Last month the Advisory Committee on Immunization Practices recommended the new vaccine, called Shingrix, even for adults who have already been vaccinated with Zostavax.

Shingrix is reported to be 97% effective; nearly twice as effective as Zostavax.  Shingrix may be better in another way, too. Whereas the older vaccine consisted of live but attenuated (weakened) viruses, Shingrix consists of just a subunit of the virus, making it much less likely that the body will have a negative reaction to it.