Mail-Order Drugs and Supplements Degrade in Transit Heat

Researchers have identified many chemicals that should be beneficial to health in a variety of ways. For instance some should help fight cancer, others should reduce heart disease. Often researchers present plausible stories about the mechanism through which the positive effects occur. But one puzzle is that empirical (observational) evidence often suggests that the positive effects occur when the chemicals are consumed in foods, but not when it is consumed in pill, capsule, powder or liquid supplements. One speculation is that sometimes the chemicals in food are complemented by other as-yet-unidentified chemicals that enable or enhance the main chemical’s effects. These other chemicals are as-yet-unidentified “adjuvants.”

But the evidence in the story quoted below stimulates an alternative speculation. Consumers know when food has gone bad by its taste, smell, texture, and appearance. inform consumers when the food has gone bad and should not be consumed. With pills, such direct evidence is harder to perceive. So consumers are more likely to swallow pills that have gone bad than they are to swallow food that has gone bad.

When the F.D.A. approves a drug, after expensive testing, we assume that the drug is good for us. We let down our guard and trust the drug. If instead we operated under the caveat emptor rule, we would buy our drugs and supplements from physical stores that have a reputation for logistical excellence (for instance Walmart and Costco).

the F.D.A. is not good at protecting us, and because we trust them, we are no longer good at protecting ourselves.

(p. A1) Mail-order pharmacies say that their packaging is weather resistant and that they take special precautions when medication “requires specific temperature control.” But in a study published last year, independent pharmaceutical researchers who embedded data-logging thermometers inside simulated shipments found that the packages had spent more than two-thirds of their transit time outside the appropriate temperature range, “regardless of the shipping method, carrier, or season.”

. . .

(p. A17) The Times spoke to more than a dozen patients who had received medications they suspected were damaged by heat and humidity during transportation, some of whom experienced serious medical issues after consuming the drugs. Most said they had received their medications in manila envelopes or plastic shipping bags with no additional insulation. They spoke about finding pill bottles in metal mailboxes or tossed onto their front porches, leaving them unsure of how long the drugs had been baking in the sun. Others said they routinely stayed home to watch for drop-offs but found that the medications arrived already warm to the touch.

. . .

In Missouri, Loretta Boesing received a shipment of a liquid immunosuppressant medication for her son, who had a liver transplant, in 102-degree weather in only a plastic envelope. Soon after, his health began waning, and his body began to reject the liver. During a two-week hospital stay, he began receiving the medications from the hospital pharmacy instead and began to recover.

Several years after the ordeal, Ms. Boesing’s insurance changed, and the new services were administered by CVS Caremark. She filed several appeals to the company to allow her to continue picking up the medication at the hospital pharmacy. But the request was denied, she said, and the medication again arrived without an ice pack, warm. She said her son’s liver lab tests had begun to elevate again.

She wept on a call with a CVS Caremark representative, which she recorded and shared with The Times. “I am begging you right now: Please do not let me lose my son,” she says on the call.

Michael DeAngelis, a spokesman for CVS Health, said he was not able to comment on the specific case because of patient privacy laws but added that the company customizes its packaging using a “sophisticated algorithm” that accounts for both F.D.A. and manufacturer data.

“There are hundreds of different possible packaging combinations that we can use to help mitigate weather and temperature issues,” he said.

Ms. Boesing went on to start the nonprofit group Unite for Safe Medications.

Rebecca Nierengarten, 39, of Maplewood, Minn., was in medical school when she fell ill with a dangerous autoimmune disease that causes extreme muscle weakness. She said her insurance company had forced her to switch from hospital infusions of an immunoglobulin product called Privigen to home delivery of the drug, and every summer, her condition worsened so drastically that she could not stand up from a chair without assistance and struggled to swallow.

“It’s a protein medication — proteins denature with heat,” she said. “If you have a biology degree, you know that.”

. . .

Researchers have been aware of potential effects of heat exposure on medications since at least the 1990s. Between June and August of 1996, United States Pharmacopeia — the nonpartisan group that sets national standards for drug handling — packaged and mailed electronic temperature and humidity indicators to various parts of the country to determine whether drugs were being subjected to worrisome conditions.

The results, shared with a task force of the National Association of Boards of Pharmacy, showed that more than 90 percent had exceeded the appropriate temperature range and that more than a quarter of those had been exposed to what was considered “excessive heat,” above 104 degrees Fahrenheit. The packages were also exposed to significant spikes in humidity.

But representatives from the Pharmaceutical Care Management Association, which lobbies for the pharmacy benefit managers that oversee drug benefits for many insurance plans, were present at the meeting, and the task force decided against acting.

In the more than two decades since, global temperatures have risen, and so have the number of people who receive medications by mail through the big pharmacy benefit managers, many of which are owned by companies that also own mail-order pharmacies.