Illegally manufactured fentanyl is found in heroin, cocaine, methamphetamine and in counterfeit pills. As a result, many people may not know they're ingesting fentanyl, leading to an accidental poisoning.

Objectives:  To estimate the effects on cervical mucus, ovarian activity and theoretical contraceptive protection of a 6-hour delay and of missing one norgestrel 0.075 mg progestogen-only pill.


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Results:  Of 91 potential participants screened, 52 started the study and 46 provided complete data for each intervention cycle. Fourteen participants (30%) ovulated in each of the two intervention cycles, with four during the delayed pill cycle and two during the missed pill cycle having an abnormal luteal phase. Seven participants in the delayed pill cycle, and six with a missed pill had elevated cervical mucus scores temporally associated with the intervention. However only two women, one in the delayed pill cycle and one in the missed pill cycle, had cervical mucus scores in the range considered favorable for fertility.

Implications:  This biomedical study suggests that taking a norgestrel 0.075mg progestogen-only pill 6 hours late or missing one pill have little effect on ovarian activity or cervical mucus and may not jeopardize contraceptive efficacy. Correlation with typical use outcomes is necessary to confirm pregnancy risk with delayed or missed norgestrel intake.

Background and objectives:  Dialysis patients have a high burden of co-existing diseases, poor health-related quality of life (HR-QOL), and are prescribed many medications. There are no data on daily pill burden and its relationship to HR-QOL and adherence to therapy.

Design, setting, participants, & measurements:  Two hundred and thirty-three prevalent, chronic dialysis patients from three units in different geographic areas in the United States underwent a single, cross-sectional assessment of total daily pill burden and that from phosphate binders. HR-QOL, adherence to phosphate binders, and serum phosphorus levels were the three main outcome measures studied.

Results:  The median daily pill burden was 19; in one-quarter of subjects, it exceeded 25 pills/d. Higher pill burden was independently associated with lower physical component summary scale scores on HR-QOL on both univariate and multivariate analyses. Phosphate binders accounted for about one-half of the daily pill burden; 62% of the participants were nonadherent. There was a modest relationship between pill burden from phosphate binders and adherence and serum phosphorus levels; these associations persisted on multivariate analyses. There was no relationship between adherence and serum phosphorus levels.

Conclusions:  The daily pill burden in dialysis patients is one of the highest reported to date in any chronic disease state. Higher pill burden is associated with lower HR-QOL. There are many reasons for uncontrolled serum phosphorus levels; increasing the number of prescribed pills does not seem to improve control and may come at the cost of poorer HR-QOL.

The officers also said that successful investigations depend on a collaborative approach, with a prosecutor involved from the beginning. Investigations can be expensive; undercover visits to buy pills alone require a lot of cash, and investigators also need money for surveillance equipment and overtime.

HOW DOES IT WORK?

"Pill mill" clinics come in 'all shapes and sizes' but investigators say more and more are being disguised as independent pain-management centers. They tend to open and shut down quickly in order to evade law enforcement. Although the problem is nationwide with recent arrests in New York, Ohio, and Chicago, Drug Enforcement Administration officials believe the highest concentration of pill mills are in Florida and Texas.

In May 1960, the FDA approved the sale of a pill that arguably would have a greater impact on American culture than any other drug in the nation's history. For women across the country, the contraceptive pill was liberating: it allowed them to pursue careers, fueled the feminist and pro-choice movements and encouraged more open attitudes towards sex.

Alex Sanger: The meeting with Gregory Pincus was a nirvana for my grandmother. It must have been absolutely stunning finally to find a man of science who understood the basic science of reproduction. Pincus told her that hormones held the key to a contraceptive pill. But the research would cost much more than the few thousand dollars Sanger had available. Without millions, he explained, the pill would remain only a dream.

Narrator: As the pill project stalled, the country was in the midst of the largest baby boom in its history. Most women were married by age 19, and more than half of them were pregnant within the first seven months.

Margaret Marsh, Historian: Gregory Pincus wasn't a physician, he was a scientist. And so he could give the pill to as many rabbits as he wanted to. Rabbits everywhere could take this pill. But he couldn't give the pill to women. He wasn't a doctor. He couldn't run a clinical trial on human beings.

The success of the covert experiment, however, was only a first step. Getting the pill to market would require approval from the Food & Drug Administration, and that would entail a large-scale human trial. In exasperation, Katharine McCormick, asked, "Where can we find a cage of ovulating females?"

Andrea Tone: In the mid-1950s Puerto Rico was one of the most densely populated countries in the world and it was important for researchers who wanted to promote the pill to be able to say, look, it worked in Puerto Rico with a population that was undereducated and poor. Therefore if it worked there, it can work anywhere.

Narrator: The women would take a pill with 10 milligrams of progesterone, to stop ovulation, and a smaller amount of estrogen to ease discomfort. Doctors knew little about the consequences of hormones. The volunteers knew even less.

Elizabeth Siegel Watkins, Historian: Informed consent, the way we understand it today, did not exist in the 1950s. Trials were much less closely regulated than they are today. Uh, a...a useful example to look at would be the polio pill vaccine. And think about the fact that two million school children were signed up to test this largely unknown vaccine to see if it worked against polio or not. People were much more receptive to medical science and to its products and were much more willing to participate in programs to, to see whether they would work or not.

Alex Sanger: They probably dismissed it in their mind, "Well there's something wrong with the patient," and there was nothing wrong with the pill. They didn't want to hear about what might be wrong because they...they were so, they just felt so strongly that this pill was necessary for women's well-being.

Narrator: Pincus had such confidence in the new drug -- he gave it out to members of his own family. All that remained was to persuade G. D. Searle to become the first pharmaceutical company to market the pill.

Elizabeth Siegel Watkins: By the 1950s, Roman Catholics made up twenty-five percent of the American population. And the drug companies were very scared that if they produced and marketed a birth control pill, not only would Catholics not buy the pill, but they would boycott all the other products made by that company.

Loretta McLaughlin: I mean the cat's out of the bag. More women overnight developed menstrual disorders than you could possibly believe. I mean this pill was being prescribed everywhere because everyone knew that the real effect of the pill was to suppress ovulation.

Loretta McLaughlin: Can you imagine having a pill that had nothing to do with illness, nothing to do with treatment, not that you would take once or twice, but that you might take for the next twenty years. Think of the market.

Dr. Philip Ball, Physcian: It was the fashionable thing to be on the pill. And so rapidly uh, women picked this up all over the country and uh, within a few years half the...half the women that were in the childbearing age were on the pill, so it seemed.

Elizabeth Siegel Watkins: U.S. News & World Report warned about sexual anarchy. What's so interesting about this coverage is that while, you know, some saw the pill as the decline of western civilization and others saw it just merely as...as shoring up American civilization, there...they shared the idea that...that sex outside of marriage was a bad thing. And whether they thought the pill would contribute to it or not contribute to it, both sides, both conservatives and liberals tended to agree that um, women should not be promiscuous.

Margaret Marsh: He said, look, he said, this doesn't put a barrier between sperm and egg. All it does is artificially create a safe period. And the Catholic church says it's okay to have intercourse during your safe period. Well, if you take a pill that guarantees you a safe period, what's the difference? And he thought it was a pretty good argument.

Dorothy Roberts: Black women did respond by saying that they understood the reasons for their concerns, but that black women had to make these decisions for themselves. And in the end, black women decided to use the pill in equal numbers as whites.

Narrator: John Rock would grow distant from his Church. He died in 1984, at the age of 94. In the wake if the encyclical, millions of Catholic women would defy Church teaching on contraception, using the pill in equal numbers as non-Catholics.

Philip Ball, Journalist: The doctor was blind, the patient was blind and the doctor was deaf and dumb too. You had fifteen million women that weren't ill to start with, and you gave them a pill and now they were ill. Not all of them, but some of them. And that was a new ball game.

Joan McCracken: I remember reading about that some woman died. They had a stroke. But I wanted to believe so much that it wasn't the birth control pill, that it was like, they probably did something else. You know, it couldn't have just been the birth control pill. Because I still believed they would not give you something that harmed you. 006ab0faaa

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