Whether it is due to Google’s twisted logic (crossing the term “abortion” with “clinic” based on my postings) or due to malicious tampering, my practice has been labeled an “abortion clinic” if you cross “OKC” with the term “abortion”.
This isFALSEand every effort to correct this travesty is currently being madeby me and IT authorities.I do NOT perform abortions and have never done so.My personal opinion regarding abortion plays no role in my medical practice.
Please contact me if you have any questions regarding this issue but pass along this information to anybody who expressed concern about this false information.
By KIM JANSSEN AND MITCH DUDEK Staff Reporters (Chicago Sun Times) November 12, 2013 3:20PM
He lied and lied and lied.
But after years of living high on the hog as a best-selling author and smooth-talking pitchman, Kevin Trudeau’s fate was sealed Tuesday afternoon in about the time it takes to watch one of his fib-filled weight-loss infomercials.
A federal jury needed less than 45 minutes to find that Trudeau, 50, of Oak Brook, was guilty of criminal contempt of court when he “willfully misrepresented” the contents of his diet book, “The Weight-Loss Cure ‘They’ Don’t Want You to Know About” in three TV ads broadcast in 2006 and 2007.
Though Trudeau shamelessly claimed the book “is not a diet, is not portion control, is not calorie counting” and was a “simple” way to quickly lose up to 100 pounds or more, it in fact required a punishing 500-calorie daily limit; daily injections of a prescription hormone banned for use in diets; multiple colonic irrigation sessions, and strict adherence to dozens of bizarre and quackish rules, evidence showed.
The verdict likely signals a decisive turning point in the government’s decadelong battle to reign in the previously convicted credit card fraudster. In 2004, he agreed to a court-sanctioned deal with the Federal Trade Commission, promising not to make bogus claims about his books.
Trudeau — who portrays himself as a fearless anti-government and anti-food industry campaigner with access to a suppressed “cure” for obesity — has long insisted he’s being unfairly targeted for speaking out.
But his latest conviction comes on the back of an earlier finding that he was in civil contempt of the 2004 court order. U.S. Judge Ronald Guzman told him Tuesday that it’s just further proof that he “lacks respect for the court and the court’s orders.”
Ordering Trudeau taken into custody. Guzman warned he faces a “probable” prison term when he is sentenced, noting that Trudeau — who’s accused of hiding his true wealth in an attempt to dodge a $38 million court fine in a separate but related case — poses a flight risk.
The verdict prompted tears from some of the Trudeau supporters who packed the courtroom, one of whom later compared Trudeau to Nelson Mandela. But Trudeau showed little emotion as he gave up his possessions and was led into custody.
He winced, however, when prosecutor April Perry used her closing argument to sarcastically repeat his TV claim that the book requires “no potions, pills or powders.” Then she shook the collection of packaged supplements that the book actually called for like a set of maracas.
Trudeau’s attorney, Thomas Kirsch, pointed to disclaimers in the ads and to sections of the book in which Trudeau parroted his TV statements as evidence of his “good faith.”
But Perry said the only disclaimer that would have protected Trudeau would have read, “Everything Kevin Trudeau says is a big fat lie.”
Criminal contempt has no maximum sentence, meaning Trudeau faces anything up to life behind bars when he is sentenced, though a far shorter prison term is more likely.
New guidelines would double the number of Americans on cholesterol-lowering drugs.
Dr. Sanjay Gupta of CNN wondered on Twitter whether we are “waving the white flag” when it comes to helping Americans avoid heart disease. Dr. Eric Topol, a cardiologist and chief academic officer of Scripps Health, tweeted that the doubling of patients on statins, which can lower cholesterol by up to 50%, was “not good.”
But the American Heart Association and the American College of Cardiology remained convinced that the 2002 federal recommendations for when to start people on the drugs needed to be updated. About 33% of U. S. adults have high cholesterol, and less than half are receiving proper treatment, despite the fact that elevated cholesterol levels double the risk of heart disease, the number one killer of adults in the U.S.
Under the new guidelines, people without a history of heart disease can start taking statins if they have a 7.5% higher risk of developing heart problems or stroke in the next 10 years, based on their cholesterol levels, blood pressure, weight, gender, race and smoking status. (You can calculate your 10-year risk here. Warning: it’s a little complicated.) That’s a dramatic change from the 20% higher risk that previous guidelines advised.
The new advice also recommends statins for anyone with type 1 or type 2 diabetes, regardless of whether they have additional heart disease risk factors, between the ages of 40 and 75 years old. Diabetes carries a higher risk of heart disease, in part because of the changes in cholesterol levels.
The lower threshold for statin prescriptions is certainly welcome news for their manufacturers; the drugs have been among the most prescribed class in the U.S. in recent years, and in 2013, rosuvastatin (Crestor) topped the list, earning AstraZeneca $5.4 billion in sales, according to IMS Health.
But the dramatic shift also has some heart experts nervous about how the guidelines will translate in doctors’ offices around the country. For those with a history of heart disease, there is little debate about how beneficial statins can be in preventing second events; studies show that the drugs can significantly lower risk of death from heart events. But for healthy individuals who may have some risk factors for future heart trouble, doctors have always been reluctant to prescribe medications when so much of heart disease is preventable, with proper diet and exercise. “For people with no history of heart disease, but who are trying to prevent heart disease, there is already a tremendous amount of overuse of statins in my view in this country,” says Topol. “So my concern is that the new guidelines will lead to potentially even more promiscuous use of these statins than already exists.”
And as unscientific as the target numbers were, at least they provided patients with a goal, and motivation for changing their diet and exercise habits to lower their cholesterol and potentially reduce their dose or get off their statin medications entirely. “I have worries about how to motivate patients when they don’t have numbers as goals,” says Dr. Steven Nissen, department chair of cardiovascular medicine at the Cleveland Clinic. “The targets served a purpose for sure even though they weren’t scientific.”
But since the last federal guidelines for cholesterol treatment were issued in 2002, two things have happened. First, all but one of the currently approved statins came off patent, so the cost of the medications has plummeted; a three-month supply can cost as little as $10.
Second, more studies have emerged indicating the various ways that statins can help the heart. Not only do the drugs restrict cholesterol production in the liver, but they can also lower levels of inflammation, a process that researchers now believe is the final player in the several-act play that is a heart attack, by aggravating unstable plaques in heart vessels that then send clots to constrict blood flow.
And last summer, a team at Harvard Medical School published the most comprehensive analysis on the safety of statins to date. Based on 135 studies submitted by manufacturers of all seven statins to the Food and Drug Administration to earn approval for their medications, the scientists found that compared to placebo pills, statins raised the risk of diabetes by just 9%; other side effects, including muscle pain, cancer and changes in liver enzymes were not statistically significant.
So while most heart experts welcome the fact that cholesterol-level targets are no longer used to determine who should and shouldn’t be on statins, they need to be convinced that the new calculator will be a better tool for making that decision. “It will be a huge educational challenge,” says Nissen. “How do you now tell patients and doctors that you don’t need to know your [cholesterol] numbers any more, that it’s not about getting to a specific goal? Now it’s you either take a statin or you don’t. Everything else goes out the window.”
The new recommendations inch closer to the idea of putting everyone on a statin, a controversial scenario that a few bold scientists have proposed in recent years. As I reported earlier this year:
Dr. David Agus, professor of medicine at the University of Southern California Keck School of Medicine, recommends that everyone over 40 should discuss statins with their doctor, even if they haven’t had heart problems or are at increased risk for heart disease or diabetes. He says that inflammation is driving a number of aging-related conditions, both in the body and brain, and since studies have shown that statins are a powerful way to dampen the inflammatory response, more people might be living longer if they take advantage of statins. Rory Collins, an epidemiologist at Oxford University, caused an uproar last year when he addressed the European Society of Cardiology with a talk entitled, “The Case for Statins In a Wider Population,” and argued that more people should be availing themselves of the medications, just as they do aspirin.
Nissen notes that the guidelines are guidelines, and not binding, although many primary-care physicians may turn to then for help in determining how best to treat their patients.
For doctors who don’t quite know what to do about the new advice, Nissen suggests having discussions with their patients to make individual decisions about whether they need statins. Depending on how high that individual risk is, both doctor and patient can reach some consensus on whether they are comfortable with using statins.
And the recommendations don’t replace diet and exercise, still the best ways to avoid heart disease. It’s just that they aren’t as easy for patients as popping a pill.
CHICAGO (AP) — Testosterone treatments may increase risks for heart attacks, strokes and death in older men with low hormone levels and other health problems, a big Veterans Affairs study suggests.
The results raise concerns about the widely used testosterone gels, patches or injections that are heavily marketed for low sex drive, fatigue and purported anti-aging benefits, the authors and other doctors said.
Men who used testosterone were 30 percent more likely to have a heart attack or stroke or to die during a three-year period than men with low hormone levels who didn’t take the supplements. Hormone users and nonusers were in their early 60s on average, and most had other health problems including high blood pressure, unhealthy cholesterol and diabetes.
The research doesn’t prove that testosterone caused the heart attacks, strokes or death, but echoes a previous study in older men and should prompt doctors and patients to discuss potential risks and benefits of using the products, said study lead author Dr. Michael Ho, a cardiologist with the VA’s Eastern Colorado Health System in Denver.
The nationwide study involved an analysis of health data on 8,700 veterans with low levels of testosterone, the main male sex hormone. All had undergone a heart imaging test and many had risk factors for heart problems, including blocked heart arteries. Risks linked with testosterone were similar in men with and without existing heart problems.
Nearly 26 percent of men using testosterone had one of the bad outcomes within three years of the heart test, compared with 20 percent of nonusers. It’s unclear how the hormone might increase heart risks but possibilities include evidence that testosterone might make blood substances called platelets stick together, which could lead to blood clots, the study authors said.
Previous studies on the supplements’ health effects have had mixed results, with some research suggesting potential heart benefits but none of the studies has been conclusive.
The new study was published Tuesday in the Journal of the American Medical Association.
An editorial in the journal said it is uncertain if the study results apply to other groups of men, including younger men using the hormone for supposed anti-aging benefits.
“There is only anecdotal evidence that testosterone is safe for these men,” said editorial author Dr. Anne Cappola, a hormone expert at University of Pennsylvania and an associate journal editor.
“In light of the high volume of prescriptions and aggressive marketing by testosterone manufacturers, prescribers and patients should be wary” and more research is needed, she wrote.
Annual prescriptions for testosterone supplements have increased more than five-fold in recent years, climbing to more than 5 million and $1.6 billion in U.S. sales in 2011, the study noted.
Dr. Nathaniel Polnaszek, a urologist with Scott & White Healthcare in Round Rock, Texas, said he prescribes testosterone for many men, mostly in their 40s and 50s, with low levels and erectile dysfunction or other symptoms. He called the study “concerning.”
“This is something I’m going to be discussing with my patients,” he said.
Testosterone levels gradually decline as men age, and guidelines from doctors who specialize in hormone-related problems say hormone supplements should only be considered in men with symptoms of low levels, including sexual dysfunction. They’re not advised for men with prostate cancer because of concerns they could make the disease spread, said Dr. Robert Carey, a former Endocrine Society president and a professor of medicine at the University of Virginia Health System.
AbbVie, Inc., makers of one heavily marketed testosterone supplement, AndroGel, issued a statement in response to the study, noting that testosterone treatments are approved by the Food and Drug Administration, and the risks are listed.
Possible side effects shown on the package insert include high blood pressure, blood clots in the legs, and body swelling that may occur with or without heart failure. “This may cause serious problems for people who have heart, kidney or liver disease,” the insert says.
“We encourage discussion between physicians and patients that leads to proper diagnosis based on symptoms, lab tests and a patient’s other health needs,” AbbVie said.
By Bjorn Lomborg, Slate (Project Syndicate) October 2013
For centuries, optimists and pessimists have argued over the state of the world. Pessimists see a world where more people means less food, where rising demand for resources means depletion and war, and, in recent decades, where boosting production capacity means more pollution and global warming. One of the current generation of pessimists’ sacred texts, The Limits to Growth, influences the environmental movement to this day.
The optimists, by contrast, cheerfully claim that everything—human health, living standards, environmental quality, and so on—is getting better. Their opponents think of them as “cornucopian” economists, placing their faith in the market to fix any and all problems.
But, rather than picking facts and stories to fit some grand narrative of decline or progress, we should try to compare across all areas of human existence to see if the world really is doing better or worse. Together with 21 of the world’s top economists, I have tried to do just that, developing a scorecard spanning 150 years. Across 10 areas—including health, education, war, gender, air pollution, climate change, and biodiversity—the economists all answered the same question: What was the relative cost of this problem in every year since 1900, all the way to 2013, with predictions to 2050.
Using classic economic valuations of everything from lost lives, bad health, and illiteracy to wetlands destruction and increased hurricane damage from global warming, the economists show how much each problem costs. To estimate the magnitude of the problem, it is compared to the total resources available to fix it. This gives us the problem’s size as a share of GDP. And the trends since 1900 are sometimes surprising.
Consider gender inequality. Essentially, we were excluding almost half the world’s population from production. In 1900, only 15 percent of the global workforce was female. What is the loss from lower female workforce participation? Even taking into account that someone has to do unpaid housework and the increased costs of female education, the loss was at least 17 percent of global GDP in 1900. Today, with higher female participation and lower wage differentials, the loss is 7 percent—and projected to fall to 4 percent by 2050.
It will probably come as a big surprise that climate change from 1900 to 2025 has mostly been a net benefit, increasing welfare by about 1.5 percent of GDP per year. This is because global warming has mixed effects; for moderate warming, the benefits prevail.
On one hand, because CO2 works as a fertilizer, higher levels have been a boon for agriculture, which comprises the biggest positive impact, at 0.8 percent of GDP. Likewise, moderate warming prevents more cold deaths than the number of extra heat deaths that it causes. It also reduces demand for heating more than it increases the costs of cooling, implying a gain of about 0.4 percent of GDP. On the other hand, warming increases water stress, costing about 0.2 percent of GDP, and negatively affects ecosystems like wetlands, at a cost of about 0.1 percent.
As temperatures rise, however, the costs will rise and the benefits will decline, leading to a dramatic reduction in net benefits. After the year 2070, global warming will become a net cost to the world, justifying cost-effective climate action now and in the decades to come.
Yet, to put matters in perspective, the scorecard also shows us that the world’s biggest environmental problem by far is indoor air pollution. Today, indoor pollution from cooking and heating with bad fuels kills more than 3 million people annually, or the equivalent of a loss of 3 percent of global GDP. But in 1900, the cost was 19 percent of GDP, and it is expected to drop to 1 percent of GDP by 2050.
Health indicators worldwide have shown some of the largest improvements. Human life expectancy barely changed before the late 18th century. Yet it is difficult to overstate the magnitude of the gain since 1900: In that year, life expectancy worldwide was 32 years, compared to 69 now (and a projection of 76 years in 2050).
The biggest factor was the fall in infant mortality. For example, even as late as 1970, only around 5 percent of infants were vaccinated against measles, tetanus, whooping cough, diphtheria, and polio. By 2000, it was 85 percent, saving about 3 million lives annually—more, each year, than world peace would have saved in the 20th century.
This success has many parents. The Gates Foundation and the GAVI Alliance have spent more than $2.5 billion and promised another $10 billion for vaccines. Efforts by the Rotary Club, the World Health Organization, and many others have reduced polio by 99 percent worldwide since 1979.
In economic terms, the cost of poor health at the outset of the 20th century was an astounding 32 percent of global GDP. Today, it is down to about 11 percent, and by 2050 it will be half that.
While the optimists are not entirely right (loss of biodiversity in the 20th century probably cost about 1 percent of GDP per year, with some places losing much more), the overall picture is clear. Most of the topics in the scorecard show improvements of 5 percent to 20 percent of GDP. And the overall trend is even clearer. Global problems have declined dramatically relative to the resources available to tackle them.
Of course, this does not mean that there are no more problems. Although much smaller, problems in health, education, malnutrition, air pollution, gender inequality, and trade remain large.
But realists should now embrace the view that the world is doing much better. Moreover, the scorecard shows us where the substantial challenges remain for a better 2050. We should guide our future attention not on the basis of the scariest stories or loudest pressure groups, but on objective assessments of where we can do the most good.
October 14 , 2013
by: ASRM Office of Public Affairs
Published in ASRM Press Release
Boston, MA- Researchers presenting at the conjoint meeting of the International Federation of Fertility Societies and the American Society for Reproductive Medicine have identified specific effects of bisphenol A (BPA) and phthalates on human reproduction.
These chemicals are used in the manufacture of plastics and other products, accumulate in the environment and human tissues and are known to be endocrine disruptors. While evidence is growing that BPA and phthalates influence the success of couples undergoing IVF, less is known about how these chemicals affect couples who are presumed fertile, who are trying to conceive, and how they affect a woman’s ability to sustain a pregnancy.
In one study, examining BPA and phthalate levels in 501 couples trying to become pregnant, researchers from the National Institute of Child Health and Human Development, Texas A&M Rural School of Public Health, and the New York State Department of Public Health found that phthalate concentrations found in the male partners, but not the females, may be associated with approximately a 20% decline in fecundity.
Couples discontinuing contraception in order to become pregnant were recruited between 2005 and 2009. They were interviewed at the outset, examined, and all individuals provided urine samples for measuring their BPA and phthalate levels. In addition, the couples kept journals on intercourse and lifestyle and the women recorded their menstrual cycles and pregnancy test results.
The researchers found that higher BPA concentrations in the female partner did not lead to decreased fecundity and that, in fact, higher concentrations of a certain phthalate were associated with a shorter time to pregnancy. In the male partners, concentrations of other phthalate chemicals were associated with diminished fecundity and longer time to pregnancy.
– Aggregating ten international reports tracking the use of Assisted Reproductive Technologies (ART) the International Committee for the Monitoring of Assisted Reproductive Technology (ICMART) estimates that there have been 5 million babies born with the help of ART.
The first ART baby was born in 1978. By 1990, there had been an estimated 90,000 births worldwide. By 2000, estimates put the number at approximately 900,000. By 2007, it was estimated over 2.5 million children had been born using ART. Since 2007, it is estimated that approximately 1.5 million babies have born using ART in countries who report their outcomes to ICMART, with another 900,000 in non-reporting countries.
IFFS Board member, Mr. Richard Kennedy said, “This comprehensive report confirms that we now have over 5 million babies born through Assisted Reproduction. More than that, it shows that half of them have been born in the last 6 years. The number of babies born through ART is now about the same as the population of a U.S. state such as Colorado, or a country such as Lebanon or Ireland. This is a great medical success story.”
Debate is raging about Obamacare, and not just in Washington. Out here in Oklahoma we’re grappling with implementation of the Affordable Care Act. Patients. Employers. Hospitals. Doctors. Insurers. All of us.
Here then are one doctor’s predictions about what we will see in the short and medium term for what I see as the unfolding Obamacare era — the biggest domestic health expansion since the enactment of Medicare in 1965.
1. Obamacare is moving ahead, Texas Republican Sen. Ted Cruz notwithstanding. Too many organizations, both inside and outside the government, have invested too much time and money to stop or reverse Obamacare’s changes. We will look back on these defunding attempts as political theater.
2. Medicine has entered the era of big data. You’ll be regularly by your doctor, other health care providers or so-called to obtain recommended tests like mammograms, colonoscopies and vaccinations. Health plans will use statistics on flu shots administered and other elements of preventive care to boast about their efficiency and to jockey for market position.
3. Big data will lead to targeted marketing of medical services. Think Amazon or Netflix. If you take a medication or have a particular condition, you’ll get offers and ads tailored to you as a potential buyer of related goods and services. The federal medical privacy law called won’t constrain this. HIPAA prevents doctors and hospitals from sharing protected health information with other entities without patients’ (or their surrogates’) permission.
But I think drugmakers and others could soon use general information about you to market their products, figuring that because of Obamacare you now have insurance.
4. Patients will be a step closer to becoming true consumers. There will be more price transparency for health care as demand increases, but not enough to fully bargain shop. As a consumer, you will have more opportunity than ever to express your opinions — through focus groups, consumer boards, and online surveys.
Nov. 30, 2012
To me, this is one of the most exciting aspects of the health care overhaul. As an industry, we flunk the customer service test again and again. Too often it’s the patient’s voice that’s heard least when it comes to quality improvement.
5. More people will get insurance. The will be cut in half within four years, it seems to me.
6. By 2020, all states will have expanded their , providing more coverage to the poorest of the poor.
7. The number of nurse practitioners and physician assistants will grow dramatically. Nurse practitioners will continue to gain more independence in practice. A new category of health worker will flourish: the community health worker, a lay combination of social worker and medical provider. In particular, community health workers will help with the of people who account for half the health care spending in the U.S.
8. We will see the rise of the first nationwide health plans. Archaic rules that keep health care local will be modified to eventually allow for consolidation. Like hotel chains, you’ll be able to get health care at the same organization in different cities. The sponsors may be hospitals, say the Cleveland Clinic, or big health insurers, like Aetna. As with hotels and airlines, you’ll have frequent visitor programs, and you’ll be able to amass points toward discounts and perks.
9. The traditional doctor-patient relationship in which a single doctor gets to know you over years will become a luxury. Those who want a personal physician will have to pay extra for that service. Doctors who chafe at the notion of working for big organizations will opt out and choose direct service models, with patients paying them retainer fees.
This last one is the saddest aspect of all our changes, and for me will be the the hardest to accept. It’s distasteful that what most of us have taken for granted is likely to become a perk for the privileged few.
John Henning Schumann is a primary care doctor in Tulsa, Okla., where he teaches at the
August 20 , 2013
by: ASRM Office of Public Affairs
Published in ASRM Press Release
ASRM Comments on the Release of “Infertility and Impaired Fecundity in the United States 1982-2010: Data from the National Survey of Family Growth” from the National Center for Health Statistics
Statement attributable to Richard Reindollar, MD, President-Elect, American Society for Reproductive Medicine.
“The National Center for Health Statistics’ new report, “Infertility and Impaired Fecundity in the United States 1982-2010: Data from the National Survey of Family Growth,” presents some interesting findings. Even though the ages at which women in the United States have their children have been increasing since 1995, the percentage of the population suffering from infertility or impaired fecundity has not increased.
We find this information encouraging. Although increasing age is a risk factor for women experiencing difficulties conceiving, prompt recognition of fertility problems followed by timely and appropriate treatment do help patients become parents. We look forward to NCHS’s release of additional information on the numbers of women receiving infertility services and the types of services they receive. “
Louise Brown, the world’s first test-tube baby, was born 35 years ago today, revolutionizing the field of reproductive medicine and giving infertile women hope that they could become mothers.
Now, the procedure is so common that more than 5 million around the world have conceived babies through in vitro fertilization or IVF.
Brown was born at Oldham General Hospital in Britain on July 25, 1978. Her mother had blocked fallopian tubes, still one of the most frequent causes of infertility in women. But Brown herself, who has a 6-year-old son, never required IVF and just revealed she is expecting a second child.
Today, thanks to the efforts of British Nobel Prize winners Dr. Patrick Steptoe and biologist Robert Edwards, who pioneered the procedure with the birth of Brown, IVF is performed successfully around the world.
ART accounts for slightly more than 1 percent of all U.S. births, more than 61,000 births in 2008, the last year for which there are statistics from the Centers for Disease Control and Prevention.
But despite advances in medical technology, society still stigmatizes women who cannot conceive, according to RESOLVE’s president and CEO Barbara Collura. Insurance coverage varies from state to state, and infertility is often treated as a non-medical condition.
“We’ve had really amazing medical breakthroughs, but I don’t think that 35 years later the discussion of infertility is much more mainstream,” said Collura. “That’s because public understanding is not quite there.”
“A lot has changed,” she said. “But a woman being told right now that she’s having trouble conceiving is going to have the emotions and feelings of loss.”
Many women do not have access to IVF because insurance companies do not cover the costs or they require riders that result in higher premiums. That’s because in many policies it is considered an elective procedure, like plastic surgery.
TRICARE, the company that insures active duty soldiers, and the Veterans Administration (VA) only cover treatments leading up to an infertility diagnosis.
Two bills are currently pending in Congress to bridge the gap for couples who cannot afford the price of IVF. One would allow couples a tax credit, much like the adoption credit for out-of-pocket costs.
A second bill would require the VA to provide IVF and adoption assistance to those whose wounds have rendered them infertile.
One cycle of IVF, which includes medications and all procedures, including cryo-preservation of embryos, can cost anywhere from $12,000 to $20,000, according to Collura.
Using a donor egg can be as much as $35,000 to $40,000. Surrogacy, which in some states includes compensation for the carrier as well as her health care, can exceed $80,000.
Amanda Dodson lives in Dayton, Ohio, a state that does not mandate coverage of IVF. The 29-year-old suffered from several miscarriages due to polycystic ovary disease, and her husband has abnormal sperm.
Thanks to IVF, they now have a 2 1/2-year-old son, Elijah. But the procedure cost upward of $16,000. She works in home care and her husband is a call-center supervisor, so money is tight.
A pediatrician who spent years defending childhood vaccines against the likes of actress/activist Jenny McCarthy has launched an assault on megavitamins and dietary supplements.
“If you take large quantities of vitamin A, vtamin E, beta carotene [or] selenium you increase your risk of , risk of heart disease, and you could ,” says , a researcher at The Children’s Hospital of Philadelphia.
Many large studies in recent years have shown that vitamins and dietary supplements rarely help and often hurt, Offit says. Yet a huge number of people still believe that these products will improve their health. So, Offit says, he decided to challenge the false beliefs of “the church of vitamins and supplements.”
Offit made the remarks during an appearance in Washington, D.C., Monday to promote his latest : Do You Believe in Magic? The Sense and Nonsense of Alternative Medicine.
Offit, an infectious disease specialist and the co-inventor of a rotavirus vaccine, is best known for publicly challenging groups that claim there is a link between childhood vaccines and autism. That effort often pitted him against actress Jenny McCarthy, who for anti-vaccine groups.
One big problem with dietary supplements is a 1994 law that from the tighter scrutiny the FDA applies to its regulation of medicines, Offit says. So the makers of a garlic supplement can say that it “supports cardiovascular health” even though a government study found that garlic supplements didn’t lower cholesterol. Meanwhile, Offit says, patients clearly benefit from a range of FDA-approved statin drugs that actually do what garlic supplements claim to do.
Dietary supplements are often advertised as “natural,” Offit says, even though that term can be misleading. For example, almonds are a natural source of vitamin E. But you would have to eat 17 pounds of almonds to get the amount of vitamin E in a single capsule sold by one supplement maker, Offit says. “So how is this a natural thing to do?”
Offit says doctors are partly to blame for the growing popularity of high-dose vitamins and other dietary supplements. Rather than pushing back against patients who want to take them, he says, doctors have acted like waiters at a restaurant, simply asking, “What would you like?”
Many hospitals also include unproved dietary supplements in their list of medicines available to patients, Offit says. But he says his own institution, The Children’s Hospital of Philadelphia, plans to remove nearly all supplements from its list later this month.
Offit says his attack on dietary supplements has generated a steady stream of hate mail. But he says it’s not as harsh as the hate mail he used to get from people who believe vaccines cause autism. “This is more, I’m ‘a liar and a shill for the pharmaceutical industry,’ ” he says, “not, ‘You’re going to hell.’ ”
Offit has some strong defenders, though, including former President Jimmy Carter and Carter’s wife, Rosalynn. They sat in the front row at Offit’s appearance in D.C. And during a question and answer session, the former president rose to tell Offit: “You’ve been a hero around our house for a long time.”
For more than a decade, doctors have cautioned women about the risks associated with hormone-replacement therapy. But those warnings may have put one group of women at increased risk of dying early, according to the latest study.
Researchers at Yale University say nearly 50,000 women may have died prematurely after they stopped taking hormone-replacement therapy (HRT) to treat menopause symptoms, following a much publicized 2002 study that revealed the treatment increased risk of heart disease and breast cancer.
The 2002 Women’s Health Initiative (WHI) study, a 15-year investigation into the factors that contribute to the health of postmenopausal women, was stopped three years early when a preliminary review of the data showed that women taking the combination of estrogen and progestin had a higher rate of breast cancer, heart disease and stroke than women taking a placebo. The results stunned both the public and the medical community, since doctors had been prescribing the hormones not just to treat menopausal symptoms like hot flashes, but for extended periods of time to protect women against heart disease.
Almost immediately, doctors and public-health officials began shifting women away from such long-term use of hormones, recommending that postmenopausal women restrict hormone use to the few months surrounding menopause to address the most intense symptoms. In 2012, the U.S. Preventive Services Task Force confirmed the WHI trial’s findings, concluding after a review of 51 studies published since 2002 that the risks of HRT outweighed the benefits, which were limited to a reduced risk of fractures
But the WHI scientists had always cautioned that their findings might not be broadly applicable to all women past menopause. They noted that the trial included women who were at least a decade beyond menopause, and that the participants used one specific formulation of HRT called Prempro, which is a combination of conjugated estrogens and a synthetic form of progesterone known as medroxyprogesterone acetate.
The WHI also continued to evaluate women who had had a hysterectomy, and therefore could take estrogen alone; women with an intact uterus are not advised to take estrogen without the protective effect of progesterone since estrogen is linked to a higher risk of uterine cancer. In 2007, the WHI reported that women with a hysterectomy who took estrogen alone had fewer calcium-based plaques in their arteries, and therefore may have enjoyed some protection against heart disease. This finding was supported by a 2011 study published in the Journal of the American Medical Association (JAMA) that found a slightly lower risk of breast cancer and no significantly increased risk of heart disease, blood clots, stroke or early death among women taking estrogen only compared with women with hysterectomies who took a placebo
Based on those results, the Yale scientists decided to study this group of women further, to determine whether widespread coverage about the risks of HRT — the combination of estrogen and progestin — had persuaded these women to stop taking their estrogen-only therapy, and whether that decision impacted their mortality. Could women without a uterus benefit in some way from estrogen-only therapy, and were they putting their health at risk if they avoided the hormone therapy?
Their analysis, published in the American Journal of Public Health, confirmed their suspicions. Before the WHI study, about 90% of women who had a hysterectomy would have relied on estrogen therapy to replace what their reproductive system no longer produced. Following WHI, however, 10% of these women used the hormone, and based on a formula the researchers created to estimate their survival rates, they determined that 50,000 women died during the study period, between 2002 and 2011, prematurely. Dr. Philip Sarrel, professor emeritus of obstetrics, gynecology and reproductive sciences at Yale University School of Medicine and lead author of the study, said in a video discussing the study that none of these women, who were aged 50 to 59 at the start of the study, lived to reach their 70s. Most died of heart disease, bolstering the connection that earlier studies had found between estrogen-only therapy and a lower risk of heart problems among women who had a hysterectomy.
The analysis highlights the challenges in crafting and distributing public-health messages so that they are interpreted correctly and applied to the right people. Following the surprisingly negative effects of HRT that WHI revealed, most in the medical community focused on warning women away from hormone therapy en masse, and the more nuanced message that some women might be able to continue taking estrogen alone became lost in that effort. “All we really knew [in 2002] was that this one kind of HRT used late in menopause resulted in a modest degree of harm,” says Dr. David Katz, the director of the Yale University Prevention Research Center and one of the authors of the new paper. “We developed a cultural aversion to HRT and unfortunately it was shared by doctors and patients alike, and it extended to all women and all forms [of the hormones].”
Katz says it’s not just the media that is responsible for such overgeneralizing — research journals do it too. And he suspects that many patients probably never discussed the results of the 2002 study in depth with their doctors, to determine if the findings applied to them, heightening the perception that hormone therapy of any kind was not a good idea for any postmenopausal woman.
“We would like to think that physicians are a case apart, that we are always guided by high professional standards and meticulously reading the literature,” says Katz. “If that were the case, every doctor would’ve read the WHI study, every doctor would’ve read the 2011 study and we wouldn’t have this problem. But actually the practice of medicine is consumed in the prevailing current in our culture.”
And as is the case with any scientific finding, not everyone in the medical community is convinced that the 50,000 women would have lived had they taken estrogen therapy. But most experts agree that the results should start a serious discussion about how to communicate public-health messages so they are applied to the right populations in the correct way.
“What makes it a challenge is that there is not a simple set of evidence. There is not one truth about estrogen,” says Andrea LaCroix, the co–project director of the Clinical Coordinating Center for the Women’s Health Initiative and author of the 2011 study. “Anytime something is less straightforward and more complicated, it’s difficult in a quick media sound bite to get the message across. We tried very hard when we published that data to show that the findings were different for different age groups of women. In terms of the challenge, I actually agree with these authors that there was a lot of media attention when the 2011 paper came out, but there was not a lot of discussion about translation for women afterwards.
In that spirit, LaCroix says the Yale results should not necessarily drive all women who have had a hysterectomy to take estrogen pills. More research will need to tease apart how estrogen may or may not be contributing to premature death in these women. “I find it incredibly brash in a way and almost arrogant to recommend the use of a pill to prevent death in women when it is totally unproven to do that in women of any age group. If the results of this paper were true and has public-health significance, we would’ve seen deaths in U.S. women age 50 to 59 increase concomitant with the decline in estrogen use,” she says. “The death data exists, and it would be important to do a study relating the decline in estrogen use to changes in mortality directly in our country.”
In the meantime, women should be asking their doctors about hormone therapy, and whether any version of the treatment is right for them. These discussions that could clear up confusion over what the latest data shows about the risks and benefits of hormones. “The primary messenger for all messages ought to be the doctors to the patients,” says Dr. Georges Benjamin, executive director of the American Public Health Association. “The public hears a lot from trusted messengers that may not be knowledgeable.”
The number of middle-aged men with prescriptions for testosterone is climbing rapidly, raising concerns that increasing numbers of men are abusing the powerful hormone to boost their libidos and feel younger, researchers reported on Monday.
Testosterone replacement therapy is approved specifically for the treatment of abnormally low testosterone levels, a condition called hypogonadism. The hormone helps build muscle, reduce body fat and improve sex drive. But a study published in the journal JAMA Internal Medicine found that many men who get prescriptions for the hormone have no evidence of a deficiency at all.
The new study is the largest of testosterone prescribing patterns to date, involving nearly 11 million men who were tracked through a large health insurer. The report showed that the number of older and middle-aged men prescribed the hormone has tripled since 2001.
Men in their 40s represent the fastest-growing group of users. About half of men prescribed testosterone had a diagnosis of hypogonadism, and roughly 40 percent had erectile or sexual dysfunction. One third had a diagnosis of fatigue.
The medical group that sets clinical guidelines for testosterone replacement therapy, the Endocrine Society, recommends treatment only in men who have unequivocally low testosterone levels. That finding requires a blood test. But the new report found that a quarter of men did not have their levels tested before they received the hormone. It was also unclear what proportion of men who did undergo testing actually had results showing a deficiency.
Testosterone therapy can cause thickening of the blood, acne and reduced sperm counts. Many doctors worry that it also raises the risk of heart disease and prostate cancer, though some experts say that those concerns are unproved. Jacques Baillargeon, the lead author of the new research, said that the safety of long-term testosterone use had yet to be established in good studies.
“I think these relatively healthy men who are starting testosterone at age 40 are potentially going to be exposed for a very long time, and we don’t know what the risks are,” said Dr. Baillargeon, an associate professor of epidemiology at the University of Texas Medical Branch at Galveston.
In men, testosterone levels normally begin a gradual decline after the age of 30. The average levels for most men range from 300 to 1,000 nanograms per deciliter of blood. But testosterone levels can fluctuate so greatly depending on so many factors — sleep, the time of day, medication — that many men who fall into the hypogonadal range one day will have normal levels the next.
Some studies estimate that up to 30 percent of men ages 40 to 79 have a true deficiency, though only a small percentage actually develop clinical symptoms like depression, hot flashes and erectile dysfunction.
Dr. Ronald S. Swerdloff, an endocrinologist at the University of California, Los Angeles, and an author of the Endocrine Society’s treatment guidelines, said the recommendations were “quite clear” that treatment is for men who have had blood tests showing a testosterone deficiency, as well as symptoms consistent with the disorder. “I don’t think it’s appropriate for patients to be treated for hypogonadism without chemical evidence to support it,” he said.
Dr. Abraham Morgentaler, a professor of urology at Harvard Medical School and the author of “Testosterone for Life,” said the findings were a good sign that more testosterone deficiencies were being diagnosed and treated. While many doctors worry about the side effects of testosterone abuse, he said, there are also studies showing that men with low testosterone levels have shorter life spans and an increased risk of diabetes, heart disease and osteoporosis.
“Aging is associated with bad vision, bad hearing, bad teeth, bad arteries, bad joints and cancer, and we treat all of these things,” Dr. Morgentaler said. “I think it’s an unfair stretch to say that because something is common or natural that we shouldn’t treat it.”
We look for inspiration and answers after a calamity like the OKC-Moore tornado last night. I got up this morning and realized, while brushing my teeth, that many people 15 minutes south of me currently have no toothbrush or toothpaste to do the same. As I left my house to work, I closed the front door and realized that thousands down in Moore, Oklahoma, just down the road, do not even have a front door…
While trying in vain to wax poetic about the catastrophe, something we often attempt to do when powerless to change the circumstances, I realized that the most powerful thing I can do for the victims in our city, besides spiritual support, is to write a big check and support the rescue and recovery effort – this is by far the most practical deed I can perform at present. The outpour of support for our grieving community is heartwarming. Please don’t stop there, though- contribute financially to those charities that support our effort to return to some semblance of normality! It is the toothbrush and the toothpaste and the wood for the front door that make the difference!
Scientists say they have, for the first time, cloned human embryos capable of producing embryonic stem cells.
The accomplishment is a long-sought step toward harnessing the potential power of embryonic stem cells to treat many human diseases. But the work also raises a host of ethical concerns.
“This is a huge scientific advance,” said , a Harvard stem cell scientist who wasn’t involved in the work. “But it’s going to, I think, raise the specter of controversy again.”
The controversy arises from several factors. The experiments involve creating and then destroying human embryos for research purposes, which some find morally repugnant. The scientists also used cloning techniques, which raise concerns that the research could lead to the cloning of people.
Ever since human embryonic stem cells were discovered, scientists have had high hopes for them because the cells can morph into any kind of cell in the body. That ability means, in theory, that they could be used eventually to treat all sorts of illnesses, including diabetes, Alzheimer’s, Parkinson’s and spinal cord injuries.
So for years, scientists have been trying to use cloning techniques to make embryonic stem cells that are essentially a genetic match for patients. The idea is that such a close match would prevent their bodies from rejecting the cells.
“It’s been a holy grail that we’ve been after for years,” says , a stem cell pioneer at the University of Pennsylvania.
But every previous attempt ended in failure or fraud, leading many scientists to wonder if the goal might be impossible to reach.
Making Personalized Stem Cells
Scientists report Wednesday that they have successfully cloned human embryos from a person’s skin cells. Here’s how they could eventually use the technology to create new therapies for a patient.
Source: Mitalipov Lab/OHSU
Credit: Adapted for NPR by Alyson Hurt
However, of the Oregon Health & Science University and his colleagues never gave up. They succeeded in mice and monkeys. And in this week’s issue of the journal Cell, Mitalipov’s team they finally did it in humans.
“I’m very excited,” Mitalipov says. “It’s a very significant advance.”
The researchers first recruited women who were willing to provide eggs for the research. Next, they removed most of the DNA from each egg and replaced the genetic material with DNA from other peoples’ skin cells.
Then, after a long search, they finally found the best way to stimulate each egg so that it would develop into an embryo without the need to be fertilized with sperm. The key turned out to be a combination of chemicals and an electric pulse.
“We had to find the perfect combination,” Mitalipov says. As it turned out, that perfect combination included something surprising: caffeine.
“The Starbucks experiment, I guess,” quipped Daley. “This little change in the cocktail was what really allowed the experiment to really ultimately succeed.”
Shoukhrat Mitalipov, of Oregon Health & Science University, first cloned monkey embryos before trying his method on human eggs.
That ingredient, plus other tweaks in the process, including using fresh eggs and determining the optimal stage of each egg’s development, Mitalipov says.
The researchers showed that the resulting embryos could develop to a stage where they could produce healthy stem cells containing the genes from the skin cells. They even showed that the stem cells could be turned into other types of cells, including heart cells that in a laboratory dish could pulse like a beating heart.
The work drew immediate criticism because of ethical concerns.
First of all, the Oregon researchers compensated women financially to donate eggs for the experiments — something many in the field have considered ethically questionable.
But beyond that, the creation and destruction of a human embryo is morally repugnant to people who believe an embryo has the same moral standing as a human being.
“This is a case in which one is deliberately setting out to create a human being for the sole purpose of destroying that human being,” says , a professor of medicine and a bioethicist at the University of Chicago. “I’m of the school that thinks that that’s morally wrong no matter how much good could come of it.”
Moreover, Mitalipov used the same method that researchers used previously to clone . That approach raises the possibility that scientists could try to clone a human being.
“This raises serious problems because it is the first actual human cloning,” Sulmasy says. “We already know there are people out there who are itching to be able to be the first to bring a cloned human being to birth. And I think it’s going to happen.”
But Mitalipov dismisses those concerns. He says the embryos he created aren’t the equivalent of a human being because they weren’t fertilized naturally. And his experiments with monkeys indicate that it’s unlikely that they could ever develop into a healthy baby.
“The procedures we developed actually are very efficient to make stem cells, but it’s unlikely that this will be very useful for kind of reproductive cloning,” Mitalipov says.
Other researchers agree with him and argue that the possible benefits of the research outweigh the concerns. “Where you can improve [a patient's] quality of life tremendously through this kind of technology, I personally believe that it is ethical to use material like this,” Gearhart says.
The scientists acknowledge that it will be years before anyone knows whether this step will actually result in treatments that might help patients. In the meantime, it’s clear that the intense debate over embryonic stem cells is far from over.
She doesn’t have cancer yet, but like many women with breast cancer mutations, she had the radical surgery to lower her risk.
Describing her decision as “My Medical Choice,” the 37-year-old actress revealed in an op-ed in the New York Times that she carries the BRCA1 gene mutation, which gives her an 87% risk of developing breast cancer at some point in her life. The abnormal gene also increases her risk of getting ovarian cancer, a typically aggressive disease, by 50%. To counteract those odds, Jolie wrote that she decided to have both her breasts removed.
While radical, her decision to pre-empt any future cancer is a common one, and backed by studies. In 2010, Australian scientists found that women with the BRCA1 or BRCA2 mutations who chose to have preventive mastectomies did not develop breast cancer over the three-year follow-up. What’s more, since the genetic abnormalities increase the risk of ovarian cancer, women who had their ovaries and fallopian tubes removed also dramatically lowered their risk of developing ovarian or breast cancers. TIME’s story about the study explained:
They were 89% less likely to develop ovarian cancer and 61% less likely to develop breast cancer over three years than their counterparts who did not have prophylactic surgery. Among the 250 study participants who underwent preventive mastectomies, none developed breast cancer during the study follow-up. Additionally, a patient’s surgical choice affected overall mortality rates, both cancer related and not: only 3 percent of surgery participants died at the time of the study follow-up versus 10 percent of those who avoided the surgery.
And while the mutations are inherited – a mother with either aberration has a 50-50 chance of passing it on to her children – women who don’t get the mutation are not at increased risk of developing breast cancer, even if they belong to families with a history of the disease. Previous studies had suggested that women who did not have the mutations but had a mother or sister who did, could have up to a five times greater risk of developing different types of breast cancer, which led them to schedule frequent biopsies and even preventive mastectomies. The latest research, however, suggests that’s not necessarily the case. As I wrote in 2011:
But the new study counters those findings, concluding that the risk of breast cancer in women from BRCA families, who do not carry the mutations themselves, are no higher than that of women in families with other types of breast cancer. The study involved more than 3,000 families with breast cancer, including nearly 300 who had the BRCA1 or BRCA2 mutations.
The genetic test for the BRCA mutations isn’t done for every woman, or even for every woman who is at risk of developing breast cancer. Doctors recommend it for those who develop cancer at a young age, or have multiple family members with the disease. It’s expensive – up to $3000 – and insurers require that patients meet a threshold for needing the test before they cover its cost. Jolie is fortunate to be able to afford not just the test but the reconstructive surgery following the procedure as well. But she’s aware that not all women are even aware of the genetic screening and may not be able to afford the testing. She wrote that her goal in announcing her choice to remove her breasts prophylactically is to raise awareness of the test and the treatment options that women have if they are positive for the mutations.
Robert G. Edwards, who opened a new era in medicine when he joined a colleague in developing in vitro fertilization, enabling millions of infertile couples to bring children into the world and women to have babies even in menopause, died on Wednesday at his home near Cambridge, England. Dr. Edwards, who was awarded the Nobel Prize for his breakthrough, was 87.
Robert G. Edwards with the world’s first “test tube baby,” Louise Brown, second from right, in 2008, just before her 30th birthday. With them are her mother, Lesley, and her son, Cameron…
The biggest thing in operating rooms these days is a million-dollar, multi-armed robot named da Vinci, used in nearly 400,000 surgeries nationwide last year – triple the number just four years earlier.
But now the high-tech helper is under scrutiny over reports of problems, including several deaths that may be linked with it and the high cost of using the robotic system.
There also have been a few disturbing, freak incidents: a robotic hand that wouldn’t let go of tissue grasped during surgery and a robotic arm hitting a patient in the face as she lay on the operating table.
Is it time to curb the robot enthusiasm?
Some doctors say yes, concerned that the “wow” factor and heavy marketing have boosted use. They argue that there is not enough robust research showing that robotic surgery is at least as good or better than conventional surgeries.
Many U.S. hospitals promote robotic surgery in patient brochures, online and even on highway billboards. Their aim is partly to attract business that helps pay for the costly robot.
The da Vinci is used for operations that include removing prostates, gallbladders and wombs, repairing heart valves, shrinking stomachs and transplanting organs. Its use has increased worldwide, but the system is most popular in the United States.
April 5 , 2013
by: ASRM Office of Public Affairs
Published in ASRM Press Release
Statement attributable to Linda C. Giudice, MD, PhD, President, American Society for Reproductive Medicine
Washington, DC — ”We are pleased with Judge Korman’s decision ordering FDA to lift its restrictions on access to emergency contraceptives. Restricting over-the-counter access by age has historically been a political decision. We agree with the court that these decisions need to be based on science, not politics. In the field of reproductive medicine, politicians too often seek to substitute their judgment for that of physicians and their patients or the scientific evidence. This results in bad medicine and bad policy. Today’s decision tells the Federal Government that science should guide policy, and we applaud that stance.”
U.S. District Court Judge Edward Korman has ordered the FDA to make levonorgestrel-based emergency contraception available over-the-counter without age or point of sale restriction. U.S. Department of Health and Human Services Secretary Kathleen Sebelius had used her power as Secretary to overturn a recommendation from FDA to remove the age restriction. The court’s decision can be read here: http://www.washingtonpost.com/blogs/wonkblog/files/2013/04/Tummino-SJ-memo.pdf.
The American Society for Reproductive Medicine, founded in 1944, is an organization of more than 7,000 physicians, researchers, nurses, technicians and other professionals dedicated to advancing knowledge and expertise in reproductive biology. Affiliated societies include the Society for Assisted Reproductive Technology, the Society for Male Reproduction and Urology, the Society for Reproductive Endocrinology and Infertility, the Society of Reproductive Surgeons and the Society of Reproductive Biologists and Technologists.
By Monte Morin and Geoffrey Mohan, Los Angeles Times April 5, 2013
President Obama once fretted about the prospect that girls as young as 10 or 11 could walk into a drugstore and buy emergency contraception pills as easily as “bubble gum or batteries.”
With his blessing, the Department of Health and Human Services set aside the advice of medical experts and blocked efforts to allow girls younger than 17 to get the so-called morning-after pill without a prescription.
That age limit is poised to disappear now that a federal judge has cleared the way Friday for girls — and boys — of any age to purchase the medication without having to notify their parents or a doctor.
In a sharply worded ruling that called government regulators “politically motivated and scientifically unjustified,” U.S. District Judge Edward Korman ruled that levonorgestrel-based contraceptives such as Plan B One-Step and Next Choice One Dose should be available over the counter to all customers within 30 days.
“There is no serious health risk associated with use of Plan B as prescribed and intended, much less one that would make restrictions on distribution necessary for its safe use,” Korman wrote.
Unless successfully appealed by the U.S. Department of Justice, the ruling would make contraceptives as readily available to minors as Tylenol or Benadryl. The biggest barrier to access would be the pill’s hefty $50 price tag.
Reproductive rights advocates hailed Korman’s ruling as a victory of science over politics, and said the ruling was a long time in coming for the politically sensitive drug.
“A federal judge has accomplished what two administrations failed to do: make a decision about access to a drug based on medical evidence,” said Michael Halpern, program manager at the Center for Science and Democracy at the Union of Concerned Scientists.
The lawsuit that prompted the order was brought by the Center for Reproductive Rights. On Friday, the center’s president, Nancy Northup, released a statement calling the decision a blow to deep-seated discrimination.
“Women all over the country will no longer face arbitrary delays and barriers just to get emergency contraception,” she said.
Though the ruling noted that both the George W. Bush and Obama administrations had a hand in restricting access, Korman’s action placed reproductive rights groups in the odd position of siding with a Republican-appointed federal judge who had harshly critical words for a Democratic administration.
“This case is not about the potential misuse of Plan B by 11-year-olds,” the judge wrote. “These emergency contraceptives would be among the safest drugs sold over-the-counter,” he noted, and “the number of 11-year-olds using these drugs is likely to be minuscule.”
Justice Department spokeswoman Allison Price said the government was “reviewing the appellate options and expects to act promptly.”
Plan B was the first emergency contraceptive drug approved in the United States and required a prescription when it came on the market in 1999.
The drug, a synthetic hormone, prevents pregnancy by blocking ovulation and impeding the mobility of sperm. It does not cause an abortion in women who are already pregnant; nor does it harm a developing fetus.
In 2006, the Food and Drug Administration allowed adults to buy the drug over the counter but still required prescriptions for those younger than 18.
In late 2011, the FDA was ready to permit the nonprescription sale of the drug to people of all ages, but Health and Human Services Secretary Kathleen Sebelius overruled the agency and continued to require prescriptions for those 16 and younger. She cited concern that the drug had not been tested in girls as young as 11, even though 10% of them are “physically capable of bearing children.”
It was the first time that a Health and Human Services secretary had overruled an FDA decision.
To critics, it seemed that presidential politics was the real reason for Sebelius’ action. The 2012 election was less than a year away.
The Center for Reproductive Rights went to court and argued that the age and prescription requirements limited access to the drug for all women by creating confusion among pharmacists and clerks. Also, because pharmacists kept the drug behind the counter, it was not available outside regular 9-to-5 pharmacy hours.