Wednesday, August 26, 2015

Bracelets as Vaccine Reminders

Childhood vaccinations save lives. But vaccine schedules are fairly complex; how is a young uneducated mother in a poor country to remember when to bring her baby back for the next required vaccination? How, even, is the health care worker to know, in places where health care records are not well-kept?

Here's a clever idea; a simple flexible silicon bracelet that can be attached to the child's ankle. The idea came to Lauren Braun, a former Cornell University premedical student, while she was working in Peru one summer. Numbers on the bracelet represent the months when a mother should bring her child back for a vaccination, and symbols represent the various vaccinations needed. When a vaccination is completed the nurse punches out a symbol on the bracelet. And when all symbols are punched out, the child is fully vaccinated and the bracelet is removed. The bracelet costs about 10 cents.

Lauren has tested her idea on more than a hundred children in Peru and says that mothers and nurses seemed to find the bracelets useful. Recently her non-profit organization Alma Sana Inc. raised money through a crowd-funding campaign to fund a controlled study of thousands of mothers and infants in several countries, to prove to the medical community that the idea works. As the Alma Sana website says, "Together lets vaccinate all of the world's children".

It's often the simplest ideas that work best. Way to go, Lauren.

Saturday, August 22, 2015

Treatment of Ductile Carcinoma in situ

Ductile carcinoma in situ (DCIS), also called stage 0 breast cancer, is diagnosed in about 60,000 women every year.  As the name implies, DCIS consists of abnormal cells located in the milk ducts.  In situ - "in its original place" - means that it has not metastasized. Indeed, DCIS may never metastasize.   But cancer is a scary word, and so the natural tendency is to treat all cancers aggressively, just to be on the safe side.  As a result, tens of thousands women who are diagnosed with DCIS each year are choosing to undergo treatments ranging from lumpectomies followed by chemotherapy, to bilateral breast removals.

A study published this month in JAMA oncology suggests that aggressive treatment of DCIS may not be necessary.  The authors of the study examined the medical records of over 100,000 women who had been diagnosed with DCIS.  They found that women who had been diagnosed with DCIS had about the same risk of death from breast cancer in the next 20 years as women in the general population.  In addition, they found that treatment of DCIS with either lumpectomy/chemotherapy or breast removal (mastectomy) did not alter the subsequent death rate from breast cancer.   In other words, treatment of DCIS did not appear to improve the women's survival rate, compared to the general population of women.

The JAMA oncology study is based solely on an examination of medical records, and while it raises an interesting question (Does DCIS need to be treated?), it does not answer it convincingly.  What is needed now is a carefully controlled study in which women diagnosed with DCIS are randomly assigned to either treatment (lumpectomy/chemotherapy or mastectomy) groups or to a control group, and then followed for the rest of their lives.  Such a study would be expensive and take decades.  In the meantime, the choice of how aggressively to treat DCIS, if at all, will continue to rest with the woman diagnosed with DCIS and her physician.

Saturday, August 15, 2015

Developing Vaccines Against Rare Contagious Diseases

This month scientists announced that they now had a safe and effective vaccine against Ebola, the virus that caused a deadly epidemic in three African countries last year. But here's the irony; that same vaccine was shown to be effective in monkeys 10 years ago but then it was never tested fully in humans, and so it was not ready for widespread use in the latest outbreak.

How did this missed opportunity happen? Actually, it's an unintended consequence of how drugs are tested before they are approved for widespread human use. After a drug is shown to be effective (that is, it works against the intended disease or condition), it still must be tested for safety to prove that its benefits outweigh its potential harm. Testing for safety can involve thousands of subjects and can cost drug companies the better part of half a billion dollars. Drug companies are willing to undertake that expense for drugs to treat common, known conditions with lots of potential patients, such a heart disease or diabetes. But they're not willing to take the risk for a disease such as Ebola, which until the latest outbreak had been responsible for just a couple of minor outbreaks. From their perspective, what if they invested 500 million dollars in an Ebola vaccine and then there was never another Ebola outbreak?

The bottom line is that we can't expect drug companies to develop and test vaccines for rare contagious diseases on their own. Recognizing this, some scientists have suggested the creation of a global vaccine development fund of at least 2 billion dollars, to be funded jointly by contributions from governments, philanthropic agencies, and pharmaceutical companies. In all likelihood many of the vaccines might never be needed. It might sound like a waste of money to prepare for disease outbreaks that might never occur, but not compared to the total cost of another outbreak such as Ebola.

Wednesday, August 12, 2015

Contraceptives Reduce the Risk of Uterine Cancer Later in Life

Endometrial (uterine) cancer currently ranks as the 10th deadliest cancer, killing nearly 8,000 women every year in the United States.  It's been known for some time that oral contraceptives reduce the risk of endometrial cancer.  But women tend to take oral contraceptives only for a short period of their life when they are relatively young, and endometrial cancer is not common in younger women.  Is there any protective effect of prior contraceptive use against the development of endometrial cancer later in life, when women are no longer using using oral contraceptives?

To find out, researchers combined the data from 36 previous studies comprising over 27,000 women who had developed endometrial cancer (cancer patients), and nearly 116,000 women who remained healthy (controls).  The median age of cancer diagnosis among the cancer patients was 63 years, generally well after contraceptive use had stopped.   Just over a third of the cancer patients had used oral contraceptives; the median length of use was just three years.

The results of the study showed a clear association between oral contraceptive use and the risk of endometrial cancer later in life.  Greater protection was associated with longer contraceptive use. Overall, women who had used oral contraceptives were 31% less likely to develop endometrial cancer than women who had never used oral contraceptives. The authors estimate that in developed countries, oral contraceptive use has prevented over 200,000 cases of endometrial cancer in just the past decade.

Of course the primary reason for using oral contraceptives is to prevent an unplanned pregnancy.   A long-term reduced risk of endometrial cancer appears to be a very real secondary benefit, however. Although one might suspect that other hormonal methods of birth control such as hormonal implants might also reduce the risk of endometrial cancer, that has not yet been determined.

Saturday, August 8, 2015

Should Kidney Donors be Compensated?

Is it time to seriously consider whether kidney donors should be paid? The idea has always been dismissed out of ethical concerns, but as the need for kidneys and the cost of caring of patients on dialysis continues to rise, opinions are beginning to change. Did you know, for example, that the cost of caring for patients on dialysis now consumes 7% of the entire Medicare budget? Are you aware that some countries DO now compensate kidney donors in one form or another, without any obvious negative consequences?

For an interesting and informative take on this issue, read the well-documented opinion piece in The New York Times by Tina Rosenberg. She covers the subject much better than I could here.

Sunday, August 2, 2015

Updating Processed Food Labels

The FDA has proposed updating the labels that describe the content and nutritional values of processed foods. The new labels will require that serving sizes more realistically describe how much of the food a person actually eats or drinks. In the past, manufacturers could list total calories on the basis of serving sizes as small as 1/2 cup of ice cream or just 8 oz of a soft drink, for example. On the new labels, 12-, 16-, and even 20-oz bottles of soft drinks will all all be called single servings, reflecting the amount a person who purchases these sizes typically consumes at a single sitting.

The FDA proposes that the new labels list "added sugars" - sugars not part of the food naturally, but added during food processing - as a subset of total sugar. Added sugars such as refined sugar and corn syrup are sometimes called empty calories because they have no nutritional value other than calories. Food producers love them because they're cheap ingredients and because they tempt us to buy more of the product. According to the FDA, over-consumption of empty calories is contributing to the current epidemic of obesity and increases the risk of heart disease and type 2 diabetes.

Controversially, the FDA recommends that no more than 10% of a person's daily caloric intake per day should come from added sugars. Based on a typical daily caloric intake of 2,000 calories, that means that a person's total daily consumption of added sugar should be less than 200 calories (50 grams) - the amount in a single 16-oz. soda. The new food labels would require that processed foods list the percent daily value (%DV) of added sugar in a single serving, based on a 2,000-calorie daily diet.

The food processing industry is not happy about the proposed changes, for it will probably mean that the consumer will become increasingly aware of just how much added sugar there is in processed foods. Whether it'll help us cut back is anybody's guess. We'll know the new labels are working when food processors begin producing and promoting some products as having "1/3 less added sugar", like they did with fat when fat was a bad thing.

Tuesday, July 28, 2015

An Inhalable Vaccine Against Ebola?

A recent research study published in the Journal of Clinical Investigation offers hope that a vaccine against the Ebola virus (and perhaps other infectious diseases) can be delivered as an aerosol spray rather than injected. In the study, monkeys were given either an aerosolized vaccine against Ebola via the respiratory tract; the same vaccine in injected liquid form; or no vaccine at all. Four weeks later, all of the monkeys were deliberately exposed to the Ebola virus to see what would happen. The non-vaccinated monkeys died, whereas all of the treated monkeys survived.

At the end of the experiment the vaccinated animals were euthanized and blood and tissue samples were taken for analysis. Antibody titers against the Ebola virus were high in all of the vaccinated animals regardless of route of vaccine delivery, and there were no signs of the Ebola virus. But in addition, the animals that had received the aerosolized vaccine had developed an especially vigorous immune cell response in the lungs. This latter finding is important, because the Ebola virus may infect some of its victims via droplets of aerosolized fluids that enter the lungs. The finding of an enhanced immune cell response in the lungs suggests that an aerosolized vaccine might offer an extra level of protection against Ebola.

But perhaps the biggest advantage of an aerosolized vaccine is that it could be delivered without the assistance of medical personnel. This would be a huge advantage in places such as West Africa (where the recent outbreak of Ebola occurred) because medical personnel are scarce in that region.

An aerosolized vaccine against Ebola has never been tried in humans. Clinical trials in humans will be needed before such a vaccine would become widely available.