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Jack Sisson's Life Ethics Blog

We must find new ways through many ethical issues, especially regarding bioethics, medical ethics, and criminal justice. Jack Sisson's 'Life Ethics' blog focuses on numerous areas of concern, including the philosophical and ethical dilemmas surrounding stem-cell research, abortion, medical research, and health care.


From Digital Journal: 

Every day we hear about dangerous drugs and medical devices. The U.S. Food and Drug Administration (FDA) routinely reports on investigations, warnings, injuries and recalls. Unfortunately much of the press surrounding these drugs and devices fails to highlight the fact that a growing number of these products are injuring one specific group, women.
Drugs like bisphosphonates, birth control medications as well as devices like transvaginal mesh and metal-on-metal hip implants are created for and/or marketed toward women. All of these products have had ongoing reports of dangerous risks and injuries to the very users they are supposed to be benefitting.
Why is this happening? Each drug and medical device has its own specific set of possible side effects and associated injuries, but there is a common thread underlying all of the products that safety advocates believe may be the reason for the concerning injuries suffered by women users. These products are not being adequately tested for the people they are supposed to be helping.
Although they are made for women, many of these medical products are not designed for women or tested on women before flooding the market. As a result, poorly designed products, many with known complications, are readily available for unsuspecting women.
Another issue is that although serious injuries have been reported by users, the FDA has been slow to act and require a change by manufacturers. In the meantime, product manufacturers have been able to reap financial benefits at the expense of women's health and safety.
Products Dangerous to Women
Of the growing number of unsafe drugs and medical devices hurting women, certain products have an increasing number of reported risks and injuries.
Birth Control - Yaz, Yasmin
Yaz and Yasmin are two popular birth control medications that contain drospirenone, a manmade hormone that imitates the effects of progesterone. The pills inhibit ovulation and thus prevent pregnancy. When the product was initially made available to the public, it was very popular due to marketing highlighting its ability to clear up acne and lessen other hormonal side effects. Bayer is responsible for the Yaz line of birth control and had slick marketing campaigns while downplaying any evidence that it had a higher percentage of side effects than many other birth control pills. In fact, Bayer has been repeatedly admonished by the FDA for misleading advertisements and, more recently, watered down warnings.
However, label warnings failed to caution women and prescribing doctors of the dangerous risks and potential side effects associated with using the drug. Drospirenone-containing birth control medications, such as Yaz, Yasmin, Ocella, Beyaz, Gianvi, Zarah, Loryna and Seyda have an increased risk of side effects such as:
- Deep Vein Thrombosis
- Stroke and heart attack
- Blood clots
- Pulmonary embolism
- Gallbladder and kidney disease
These complications can have long-term health effects and in some cases, even death may be the result.
Due to the number of complications that have been connected to using drospirenone-containing drugs, the FDA required manufacturers to include the increased risk of blood clots on warning labels and to run corrective advertisements for overstating the drugs' effectiveness in treating hormonal side effects and downplaying dangerous risks of side effects.
Numerous studies have also been conducted on the safety of birth control pills, like Yaz and Yasmin. In fact, the results of two studies published in the British Journal of Medicine revealed that women taking these types of birth control medications were 2-3 times more likely to develop blood clots than women taking other types of birth control drugs. Drug labels in Europe require this type of warning information and knowledge of the associated dangers is widespread among European doctors. However, in the U.S., birth control medications containing drospirenone continue to be sold and strongly marketed to women on television. Although studies on the dangers continue, safety advocates fear the FDA's response has been sluggish.

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Prescription drug abuse may make a good story — but it's a killer, according to Kentucky Attorney General Jack Conway.
He should know. When the hit cable TV show "Justified" was in development he sat down with the writers and helped steer them in the right direction.
He was running for U.S. Senate at the time and raising money in Santa Monica, Calif., where he met Sarah Timberman, one of the executive producers of the FX series "Justified," the third season of which is currently winding down. Their conversation went something like this, according to Conway, who visited the Tri-county area Monday to talk about prescription drug abuse.
"Naturally you're talking a lot about the prescription pill epidemic, right?" he asked.
"What are you talking about?" Timberman replied. "We thought the big drug problem would have been heroin."
"No it's prescription pills. You've got people who have hijacked FedEx trucks and everything in eastern Kentucky. We've got pharmacists in eastern Kentucky who are behind bullet-proof glass."
That got her attention, and she asked him to allow her writers to pick his brains, which is how he wound up in "this huge conference room with a dozen people. I sat there for 45 minutes to an hour and answered questions about crime in eastern Kentucky. About what it looks like to go into a deep mine. About the prescription pill epidemic. They were taking copious notes. I gave them a total primer on crime in eastern Kentucky. And then this show comes on and it's a huge hit."
While it may make an entertaining story, the drugs are no joke, which is what he told students at Union County High School on Monday, in the company with two parents who have lost children to drugs.
"Not a lot of people know that we're going to lose more people to prescription drug overdoses this year than we lose from traffic accidents," Conway said. "It happened last year. The data is starting to tell us that one in five kids is using prescription pills for an off-label purpose. We saw the number of overdose deaths going up. Young people think that because a doctor prescribed it and there's a label on it, it won't hurt you.
"We lose over 1,000 people a year to prescription pill overdoses. That's more than we lose on our highways. And we think that's under-reported" because only about half of accidental deaths get entered into the state medical examiner's system.
Xanax, hydrocodone and oxycodone cause more deaths than alcohol, heroin or cocaine, he said. "Those are the three leading things found in the bloodstream of those reported deaths." Oxycontin, a time-released form of oxycodone, is particularly dangerous, he said, because when it is crushed it releases all of the drug at once. And some people's bodies can't handle it.
Part of the problem, he said, is that the state tool for tracking drugs is ineffective. KASPER, which stands for Kentucky All-Schedule Prescription Electronic Reporting, would be moved from the Cabinet for Health and Family Services to the attorney general's office if House Bill 4 passes, but it's being fought by the medical community, he said.
Other major provisions of the bill would require doctors to participate (only about 25 percent currently do), stop pain management clinics from dispensing drugs, and require that such clinics be owned by physicians or health care facilities. It would also limit mail order sales. "You don't need to be shipping a 90-day supply of oxycontin or hydrocodone when about half of it typically ends up on the street," he said.
KASPER also needs to have the ability to communicate with similar systems in other states, he said. That's particularly important in border towns such as Henderson, where "you need to know what's going on in Illinois and Indiana. Because it's very easy to ride over and get the pills elsewhere."
Henderson County residents who accompanied Conway to his Morganfield appearance included science teacher Ashley Bailey and students Laura Kirk, Dallas Dohrn, Riley Thompson and Amanda Keown, who are part of a program at Henderson County High School to combat substance abuse. "I made them a promise to come do one of those events in Henderson."

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From USA Today:

Officials at drugmaker Merck & Co. say they will take more time to decide what to do about an experimental blood thinner that gave disappointing results in a second big study.

The study was aimed at preventing repeat heart attacks and strokes in people who had already suffered one or were in danger of one because of hardened arteries in their legs.

The drug, vorapaxar, lowered the risk of those problems but also raised the risk of major bleeding, including dangerous bleeding in the head, which largely canceled out the drug's benefit.

Results of the study were discussed Saturday at an American College of Cardiology conference in Chicago and published by the New England Journal of Medicine.

Merck had hoped vorapaxar would become a blockbuster alternative to Coumadin, sold generically as warfarin and one of the most commonly used heart drugs in the world. It's tough to get warfarin's dose right — too little and a clot can form and cause a heart attack; too much and dangerous bleeding can occur in the stomach or elsewhere in the body.

The company-sponsored study involved more than 26,000 patients in 32 countries. All were given usual heart medicines plus aspirin, and half also received daily vorapaxar pills.

Safety monitors stopped part of the study last year after seeing higher rates of bleeding in the head among people with a history of stroke who were on the experimental drug. The study continued in the rest of the participants.

After three years, about 9% of those given vorapaxar had suffered a heart attack or a stroke or had died from heart-related causes versus more than 10 percent of those not given the drug. Moderate or severe bleeding occurred in about 4% of those on vorapaxar versus just more than 2% of the others, said the study's leader, Dr. David Morrow of Brigham and Women's Hospital in Boston.

Among those with a history of heart attack — two-thirds of study participants — the drug had a net benefit, though, leaving the possibility that Merck might pursue seeking federal approval to sell it for these patients.

However, several experts not connected with the study said the drug's relatively modest benefit and likely high cost would make it a tough sell even if it were allowed on the market.

"This is not a drug that I would put in my personal medicine chest," said Dr. Eduardo Marban of Cedars-Sinai Medical Center in Los Angeles.

Merck officials said they would discuss the results with more scientists before deciding next steps.

Visit USA Today.

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From Arcadia Patch:

...What sent me to my local Planned Parenthood office recently was the contraception Mirena, an IUD that contains the hormone levonorgestrel, commonly used in birth control and the morning-after pill.
I had it placed more than three years ago following the birth of my son. A year into it, I began having health problems; my hair started falling out, acne plagued my skin, I experienced occasional urinary tract infections and my stomach swelled.
While I immediately recognized a few of these afflictions as possible side effects of the IUD, hair loss wasn't listed as a side effect in the literature given to me by my doctor. Although it’s now included on Mirena’s Web site, one must search for the information. With no answers as to what was going on at the time, I felt something was terribly wrong with me.
Depression inevitably followed. 
While even the elderly men on both sides of my family sport healthy heads of hair, mine was now coming out in clumps and a bald spot was developing front-and-center.
I’m 30 years old.  
Upon scouring the Internet, I began to see a common theme: Women losing hair following a Mirena insertion. I knew it was time to get the thing removed, despite a previous assurance from my doctor that Mirena wasn't the cause of my hair loss. 
Attempting to schedule an appointment with my doctor's office, which is inconveniently located several miles from my house, but is the closest gynecologist to me covered by my insurance, I was told I would have to wait three weeks to be seen.
So I called my local Planned Parenthood office and my IUD was out the following morning. 
I was not asked to pay a dime, and following a survey inquiring about the quality of my visit, I was sent home with a bag of condoms and plenty of information on other birth control options, including a hormone-free IUD. 
That was less than a week ago. My hair has stopped falling out, though it may take a year to grow back and regain its healthy sheen. My acne is calming down and even my stomach has already flattened. I’m not a scientist and can’t be 100 percent sure all that these maladies were caused by my birth control, but I feel free.
Because, what is freedom without informed choices?
When pharmaceutical companies or even the government deprive a woman of information, she is robbed of the opportunity to make the decision that’s right for her.
We don’t need the government marching into our doctor’s office — as so many conservatives are all too quick to point out until it comes to a woman’s uterus — we need them protecting us from harmful pharmaceuticals, a task given to the Food and Drug Administration.
Citizens can report a possibly dangerous drug or device to the FDA by visting the agency's Web site, as I did regarding my side effects caused by Mirena.
Perhaps something will come of it but in the meantime, I am once again grateful to Planned Parenthood. It remains a truly unique and invaluable resource at a time when religious views are affecting policies regarding birth control. Access to contraception isn't a question of women’s rights to be evaluated by a panel of old men and virgins. It's a health issue....

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