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Thursday, September 8, 2016



Are They Being Inactivated by Sloppy Shipping and Storage?

by Hannah F. Elson, Ph.D.

I remember reaching for a bottle of vitamin capsules on the supermarket shelf, and noticing how warm the bottle felt. The spot light in the ceiling was shining right on that part of the shelf, warming all the illuminated bottles. The store manager was grateful to be informed about this. Several B vitamins (thiamine, pantothenic acid, folic acid) as well as vitamin C break down at high temperatures. Another time, I opened a bottle of capsules containing glucosamine and chondroitin sulfate, and noticed a very unpleasant odor. The capsules were hard to swallow because of this mildly putrid smell. The manufacturer’s customer service representative said this could happen if the bottle was inadvertently heated. Clearly the drug had degraded. He sent me some coupons for new bottles, but I was lost as a customer for that brand. This got me thinking, how often are the non-prescription over-the-counter drugs we buy subjected to unexpected heating during their storage in hot warehouses, on hot loading docks, or shipment in hot trucks?

It is so convenient to order on-line and have our parcels waiting at the door. Prescription drugs can be ordered this way, as well as non-prescription drugs and supplements. No chasing down our favorite product brands from store to store. But there is a down side. If the temperature outside is very hot and the shipment is not refrigerated, many drugs will degrade. It can get very hot inside a non-air-conditioned delivery truck, or sitting on a sunny loading dock, or outside our front door in the summer!

Many drugs are unstable at high temperatures. Heat may break down their chemical structures into inactive forms. Higher temperatures may also encourage reaction with oxygen or water in the air, and result in inactive products, if not actually dangerous ones. Examples of temperature-labile supplements include isoflavones, fats and oils, most vitamins, and some ingredients in herbs. Manufacturers of prescription drugs do temperature stability tests, and if they find the drug is unstable at high temperatures, they use cold chain shipping to keep the drug from degrading, since the FDA requires that the drug be fit for its purpose. There are no such requirements for all the vitamins and herbal supplements that people are taking. Some drugs’ labels advise storing in a cool place, but the distributors don’t ship on ice. The stores that sell these items don’t necessarily keep them refrigerated.

Anecdotally, I found that if I buy soy isoflavones in a store, sometimes they work and sometimes they don’t at reducing hot flashes. Certainly there are quality variations in manufacturing to explain this, and over the years, I have found a reliable brand. However, if I buy these soy isoflavones from a drugstore on the web in the summer time, they don’t ever work, no doubt due to the high heat during shipment. I phoned the site’s Customer Service and offered to pay for refrigerated shipping, but they don’t offer it. All they will do is refund or replace the item that doesn’t work. When shipping in the summer time, the inside of a delivery truck can get extremely hot. Cartons of these supplements can sit on a hot loading dock awaiting transport. Then they get to a store, and they are inactive in the summer, active in the winter. Customers trying out a product will find that it sometimes works, and sometimes doesn’t. Anyone who gets a product that has no activity will not buy it again, and is lost as a long-term customer.

The NIH has been testing the efficacy of nonprescription herbals and supplements. A clinical trial testing the drug may get some shipments that are active and some that are inactive due to heating during the shipment, and this can confound their results. It may explain why different trial results are so conflicting. It may explain why some drugs show so little activity above the placebo. The NIH is funding five research centers, receiving a combined total of $35 million, for a five year study to study to test natural supplements such as black cohosh (used to relieve menopause-related hot flashes), fenugreek (for diabetes and several other ailments), resveratrol (for cardiac health), and milk thistle (for Hepatitis C). Attention to cold chain shipping would make these studies more reliable.

Friday, June 12, 2015

Avoid Mammography done with X-Rays; Use UltraSound or MRI

It is a constant battle for the woman who does not want x-ray mammography. The medical establishment is slow to move to new techniques and away from x-rays. First, they have a monetary investment in their expensive x-ray equipment, their CT scanners, and their traditional radiological training. Secondly, they do not want the risk of using new methods that have not been recommended by their professional societies, or they would be at increased risk of liability if there is a bad outcome. Third, they do not want to miss a diagnosis, again for fear of being sued, and will order as many x-ray films as they need to diagnose a breast tumor. For a woman with dense breasts, that are difficult to analyze with x-rays, this can produce a hefty dose of radiation.


X-ray diagnostics and treatment methods became prominent in the 20th century, but shouldn’t belong in our 21st century. We know that x-rays, high energy ionizing radiation, can cause breaks in DNA, our genetic material. These breaks, if not repaired, can cause mutations and cancer. Yes, we have our body’s repair systems to repair the radiological damage. But sometimes the repair systems fail, especially if we are old or weak or sick. A study of mammary cells exposed to x-rays in culture showed that older cells accumulated more DNA breaks than younger cells.1   Ironically, older patients tend to get sicker than the general population, and therefore get more x-ray diagnostics and treatments. They also develop more cancer.  Women with dense breasts, who require more x-ray films, get more breast cancer.2 Pardon my skepticism that this is a coincidence.


Some women have known defects in their repair systems, namely those with mutations in the BRCA1 and BRCA2 genes.3 As a result, they are more likely to develop breast cancer at an early age from just natural background radiation. So what does our medical community recommend? More frequent screening with x-rays to check for breast cancer. What insanity! They recommend increased screening for cancer with an agent that can cause cancer, on a patient who is less able to fix the damage that causes the cancer. When x-rays were the only diagnostic method available, this made some sense. It was worth the risk of causing future cancers to have the benefit of knowing if there were already a cancer present, so it could be treated. Now, however, with several non-ionizing screening tools available, it is not necessary to put up with this added risk.


MRI (magnetic resonance imaging) is a safe non-ionizing radiation method that is actually more sensitive than x-ray mammography.4   It is useful for women with dense breasts, whose cancer is not so easily detected by x-rays. However, MRI has not been used for general screening because the method is much more expensive than traditional x-ray mammography. An MRI may cost over $1000, compared to an x-ray series for about a hundred dollars.  There is a new fast MRI method that in some institutions costs only $350.5  Another plus for MRI is that this method does not require the painful breast compression that is required for x-ray mammography, where the breast is placed between two glass plates that are squeezed together. If breasts are dense, the squeezing is greater, as the technician tries to get clearer images. 


MRI does have its negatives.  One is that a contrast agent has to be injected. Another is that older machines are uncomfortably noisy, even with ear plugs. Inquire if your clinic is using a modern, quiet machine.


Another non-ionizing method for breast cancer screening is ultrasound. It has become well characterized, depending for accuracy on having well trained technologists. There is a  3-D ultrasound method approved by the FDA in January 2014 that holds much promise.


Ladies, insist on MRI or ultrasound. If enough of us do, the resulting increase in use of these alternatives should eventually drive the costs down.





1 Laia Hernández, Mariona Terradas, Marta Martín, Purificación Feijoo, David Soler, Laura Tusell, and Anna Genescà, PLoS One. 2013; 8(5): e63052.

2 Warwick J, Birke H, Stone J, Warren R, Pinney E, Brentnall AR, Duffy SW, Howell A, Cuzick J, Breast Cancer Res. 2014 Oct 8;16(5):451.

3 Rosen EM, Pishvaian MJ, Curr Drug Targets. 2014 Jan;15(1):17-31.

4 Lord SJ, Lei W, Craft P, Cawson JN, Morris I, Walleser S, Griffiths A, Parker S, Houssami N, Eur J Cancer. 2007 Sep;43(13):1905-17.

5 Kuhl CK, Schrading S, Strobel K, Schild HH, Hilgers RD, Bieling HB, J Clin Oncol. 2014;32:  2304-2310. 


NIH summary:

Friday, June 7, 2013

Participate in Lipase Reduction Experiment

For the mom whose milk turns rancid too quickly,

I have a suggestion for a way to reduce lipase activity in breast milk, but I need as many of you as possible to try it and see if it works. This is an on-line recruitment for an informal clinical trial.

Right now, the recommended method is to scald the milk to destroy lipase activity. I have also suggested trying to keep the milk as cold as possible starting with time of collection, to minimize the lipase activity.

Scalding the milk destroys the lipase, which is a protein, and this works. The problem is that it also destroys many beneficial proteins, like Antibodies, and it destroys many vitamins, like Vitamin C. Another, easier way, to destroy only the proteins is to shake the milk up so that it foams. Proteins are denatured (stretched out and destroyed) on the surfaces of air bubbles and oil/water interfaces. A textbook says that lipase is also destroyed at these interfaces. What I don't know is whether the lipases are such tough proteins that they can refold and regain their activity. Will you help find out if lipase activity can be reduced just by shaking the milk?

The experiment:  collect your milk as you normally do and set aside two small amounts. Shake one fraction vigorously up and down for half a minute. Sniff both fractions to make sure they smell fine. Put both fractions in the refrigerator overnight. The next day, smell them both. Did the shaking prevent the shaken fraction from smelling bad, while the unshaken fraction smells rancid? (When lipase digests fat, free fatty acids are produced. The fatty acids smell this way. Note that these free fatty acids are okay for baby to eat and the milk is not really spoiled. Milk banks in hospitals will gladly take it and very young babies will drink it.) 

If this works, it is an easier method than either scalding or keeping everything very cold. While shaking destroys the protein antibodies, just the way scalding does, at least it preserves the vitamins, and is much simpler to do. It is a trade. The feedings that use the stored milk will have fewer of the beneficial antibodies, but they will at least have all the other benefits of maternal milk over formula. There could still be other direct feedings to provide the baby with mom's antibodies.

Just collect milk into cold containers, shake them vigorously, then freeze. If the lipase is inactivated, you can warm the milk for feeding. If not, keep the milk cool.

Please let me know if this works for you.


Wednesday, June 5, 2013

Procedure for Reducing Breast Milk Lipases and Avoiding "Sour" Milk

Here is a summary article on some methods we have found that allowed pumping and storing breast milk in the presence of high lipase activity. Keeping everything cold, even during collection, helped my daughter deal with the lipase. Please let me know if it helps you.


Some mothers have the experience that their baby will not accept their breast milk that has been pumped in advance and stored. Most breast milk will taste fine if pumped and then stored even at room temperature overnight, or refrigerated for a few days, and subsequently frozen. For some mothers, however, the milk may taste bad after it has been allowed to sit at room temperature for just a few minutes.

This can have several important financial consequences. A working mother anxious to provide only breast milk to her baby may decide to give up pumping, and stay home to nurse her baby. We have one friend who quit her law practice so that she could stay home and nurse her baby after it rejected her bottled breast milk that had been pumped in advance.

Another consequence occurs in the Neonatal Intensive Care Unit (NICU). If a baby is born prematurely and spends time in the NICU, and the mother plans to pump her milk so she can go back to work, the nurses will not release the baby to go home until it demonstrates that it is strong enough to finish a whole bottle of milk. Even if they had scalded the milk, if the milk had already gone rancid, the baby will not drink beyond the point of being ravenous. The baby may have to stay in the NICU a much longer time than is necessary. Not only is this a great expense to the parents or insurance company, it is an unhappy time for the family that wants to take the baby home.

The culprit is the breast milk lipase enzymes. These lipases are more active in some women for an unknown reason. These enzymes are beneficial for the baby, as they will convert the milk fats to sugar and free fatty acids, assisting in their digestion. The fatty acids are neutralized to salts, and that is the definition of a soap (a salt of a fatty acid) and the milk tastes soapy. With further digestion to fatty acids the milk will taste rancid. It is not spoiled but just tastes bad. According to several mothers, the baby will not usually reject soapy-tasting milk until a good fraction of the lipid has been broken down. Some babies may be fussier about the taste than others.

Several solutions have been tried to reduce or remove the lipase activity. One solution is to scald the milk to inactivate the lipases. However, this reduces some of the beneficial immunoglobulins and vitamins in the milk. Freezing the milk in household freezers will slow the lipase activity, but will not eliminate it, and the milk will taste bad with time. However, it is the best solution for your milk if it can be used within a few days. You will need to check it periodically to see how long your milk will stay good under your home conditions.

Reasoning that the lower the temperature, the slower an enzyme works,we have found that keeping the milk as cold as possible at all times will sufficiently reduce the lipase activity so the milk will not taste bad. This means cooling the milk while pumping, getting it frozen as quickly as possible, storing it in as low a temperature as possible, quick-thawing the milk, and serving it cold in a thermos baby bottle.

Here is a procedure for keeping everything cold:

For pumping the milk, have the collection bottle and all components that may contact the milk pre-cooled. Keep the pumped milk cold during collection. The collection bottle can be wrapped with a commercially available cold pack or cold wrist wrap and secured by Velcro. The collection bottle can also be kept in an ice-water bath, consisting of ice cubes floating in a tub or jar of water. You may have to place the water bath on a table, and adjust your seat height so the bottle rests in the ice water bath.  You may need to weigh the bottle down with a wrist or ankle weight, or an adjustable weighted bottle cape (photo). Finally, you can cut a hole in a fitted top to a plastic tub so that the top will hold down the empty bottle.

You can store the milk in the collection bottle or transfer it to pre-cooled storage containers or bags that are commercially available for frozen breast milk storage.

Move the milk to a freezer as soon as possible. Ideally, you would have a separate chest freezer that is not opened too often. Standard freezers operate around -20 degrees centigrade, but the lower you can set the temperature the better. Some low level lipase activity continues even in the freezer, unless it gets down to -70 degrees centigrade. Commercial freezers are available that cool to -70. These are expensive, but a NICU could have one of these for the breast milk they store. At home, avoid if possible a freezer with an automatic defrost cycle, because the lipases can work faster if the milk warms up, or thaws, while the freezer defrosts. Don't store the milk in the door of an upright freezer, where the temperature warms up every time the door is opened.

When the milk is needed, thaw it quickly by holding the container under the faucet with lukewarm water running, gently twirling and swirling. Do not shake the milk, as this will produce bubbles which destroy many of the beneficial proteins (enzymes and antibodies, for instance).*

Transfer the still cool milk to a pre-chilled baby thermos bottle, which is commercially available (photo). Our baby accepted the cold milk, but this may take some getting-used-to for your baby.
Everyone's milk is a little different in the amount of lipase activity it contains, and you will learn just how long your milk can be stored in your freezer before it tastes too bad for your baby to drink. Experts say your milk composition changes with your baby's needs, and with time your baby may not require as much help with its digestion, and your milk's lipase activity will decrease. Expect the problem to go away with time.

In spite of the taste, the milk is still completely nutritious, and milk banks or local NICUs will accept the milk that you can no longer use because of the taste. They can use it for infants that are fed by tubes. Please donate it.

*The high surface tension at the gas-liquid interface of an air bubble will cause proteins to denature, and to lose activity that depends upon their structural integrity. Some refolding may occur, but much activity is lost. On my other blog on this site I ask you to participate in an experiment to see if shaking will reduce lipase activity in pumped milk, since lipases are protein enzymes.