Category Archives: Biotechnology

Standard treatment better than potential alternative for unexplained infertility


Clomiphene more effective than letrozole for achieving pregnancy,  study finds

From the National Institutes of Health

IVF egg thumbTreatment with clomiphene, a standard therapy for couples with unexplained infertility, results in more live births than treatment with a potential alternative, letrozole, according to a study of more than 900 couples conducted by a National Institutes of Health research network.

The study authors undertook the comparison because earlier findings had suggested that letrozole might achieve as many live births as other treatments, but result in fewer multiple pregnancies.

Moreover, a 2014 study by the same network found that letrozole was more effective than clomiphene for achieving pregnancy in women with another infertility disorder, polycystic ovary syndrome. The study appears in the New England Journal of Medicine. Continue reading


Contraceptive implant under microscope amid questions of safety, altered trial data

Portrait of Kimberly Lira at her home in Peoria, Az.

Portrait of Kimberly Lira at her home in Peoria, Az. (Photo by Nick Oza for KHN)

By Roni Caryn Rabin

Kim Hudak was a young mother who was done having children when she volunteered for a clinical trial to an experimental birth control implant designed to make her sterile without tube tying surgery.

But soon after Hudak, 28 at the time, got the Essure implants in 2000, she said she developed health problems, including severe pelvic and lower back pain, difficult menstrual periods and pain during intercourse.

She complained to researchers at the Cleveland Clinic and was told her problems were not related to the implant. In an affidavit to the Food and Drug Administration, Hudak alleges that answers she gave researchers in response to questions about pain, adverse health effects and even whether her period was late had been altered on her medical record, without her knowledge. Those statements were part of the usual data collection for FDA approval of the device.

“I realized something could go wrong in a clinical trial, but I thought they would take care of me, and that if something wasn’t right, they’d fix it,” said Hudak, who eventually had a hysterectomy to remove the implants in 2013 and has filed a claim against Essure’s manufacturer for compensation for her injuries.

Hudak is one of several clinical trial participants who say that when they experienced complications with the implant, doctors and nurses ignored or belittled their symptoms, insisted they could not possibly have been caused by Essure, and referred them elsewhere for treatment. Continue reading


Tylenol maker sought to block new safety regulations


New Court Docs: Maker of Tylenol Had a Plan to Block Tougher Regulation

by Jeff Gerth and T. Christian Miller ProPublica, Sep. 21, 2015, 8 a.m.

Extra Strength Tylenol Caplets_0Recently filed court documents show the makers of Tylenol planned to enlist the White House and lawmakers to block the Food and Drug Administration from imposing tough new safety restrictions on acetaminophen, the iconic painkiller’s chief ingredient.

An executive with McNeil Consumer Healthcare 2013 which counts Tylenol as its flagship product 2013 told the board of directors for parent company Johnson and Johnson about a campaign to “influence the FDA” and block recommendations made by an agency advisory panel in 2009.

It may be time to let members of Congress to put some pressure on FDA . . .

About 150 Americans a year die by accidentally taking too much acetaminophen, the active ingredient in Tylenol. The toll does not have to be so high. Read the story.

After Dr. Janet Woodcock, the FDA’s top drug regulator, put off meeting with McNeil executives, the company’s president, Peter Luther, sent out an August 2009 email.

“We’re being too nice and too worried about stepping on FDA’s toes. It may be time to let members of Congress to put some pressure on FDA,” Luther wrote to other top executives. “We have to make this our top priority and pull out all stops.” Continue reading


Teamwork key to reducing diagnostic errors, report


By Julie Appleby

Almost every American will experience a medical diagnostic error, but the problem has taken a back seat to other patient safety concerns, an influential panel said in a report out today calling for widespread changes.

Diagnostic errors — defined as inaccurate or delayed diagnoses — account for an estimated 10 percent of patient deaths, hundreds of thousands of adverse events in hospitals each year and are a leading cause of paid medical malpractice claims, a blue ribbon panel of the Institute of Medicine (IOM) said in its report.

Photo courtesy of Sanja Gjenero
Continue reading


Surge in statin use among very elderly without heart trouble raises doubts


HeartBy Lisa Gillespie

Many doctors are choosing a better-safe-than-sorry approach to heading off heart trouble in very elderly patients.

Inexpensive statin drugs are given to millions of people to reduce cholesterol, even many who do not show signs of heart disease.

But a recent study has found that seniors with no history of heart trouble are now nearly four times more likely – from 9 percent to 34 percent – to get those drugs than they were in 1999.

Here’s the catch: For patients of that age, there is little research showing statins’ preventive heart benefits outweigh possible risks, which can include muscle pain and the onset of diabetes.  There have only been a handful of studies that included the over-79 population, according to a review in the American Journal of Cardiology in 2012. Continue reading


If you’re 60 or over, you need the shingles vaccine


 Don’t wait, vaccinate! Learn about shingles.By Kory B. Fowler, M.D.
Medical Director, Intermountain Region

Shingles is not fun.  In fact, it’s downright awful.  It starts with a tingling or burning sensation on the skin along one side of the body, followed by an extremely painful rash consisting of bumps, blisters or crusting. Hundreds of thousands of Americans 60 or over suffer from shingles each year, and the worst part is they don’t have to. Continue reading


Ouch! Vaccination rates for older adults falling short


Vaccine SquareBy Phil Galewitz

Three out of four Americans older than 60 don’t get a shingles vaccine to protect themselves from the virus’ miseries: rashes over the face and body, stinging pain that can last for weeks or months and the threat of blindness.

Sometimes people must feel a pound of pain – someone else’s – to take a shot of prevention. Dr. Robert Wergin tells of one elderly patient with shingles who came to his Milford, Neb., office this summer. “I’m sorry, doc, I should have listened to your advice to get the shot,” the man said. A few weeks later, the man’s wife and brother, both in their 60s, visited Wergin, asking for the vaccine.

One in three seniors each year skips the flu vaccine.
Four in 10 seniors are not vaccinated for pneumonia.
Nearly half of seniors are not immunized for tetanus

“It’s amazing how once people see the disease up close, getting the vaccine suddenly raises up on their list of priorities,” said Wergin, president of the American Academy of Family Physicians.

The shingles vaccine is not the only shot that public health officials are struggling to persuade older Americans to get. Continue reading


To make better policy, states seek better death certificates


454px-EddieSchneider_DeathCertificateBy Michael Ollove

Robert Anderson may know more about death than anybody else in the United States.

Anderson is chief of mortality statistics for the Centers for Disease Control and Prevention. Information about death flows into his suburban Maryland office from all over the country, detailing not only how many Americans have died—2,596,993 in 2013—but the causes of those deaths.

Researchers use the information to learn what kills Americans, and public officials use it to craft policies to improve health and safety.

Researchers use the information in death certificates to learn what kills Americans, and public officials use it to craft policies to improve health and safety.

On the best certificates, the information is accurate and complete. That would mean, for example, that the death certificate would say not only that someone had died of a drug overdose, but that the drug had been heroin.

If the departed had died of cardiac arrest, the certificate would say that death resulted from a heart attack and it would disclose that the person had been a lifelong smoker and overweight.

Unfortunately, many death certificates are incomplete or inaccurate. When multiplied across thousands and thousands of cases, such gaps can translate into a faulty understanding of mortality in the United States, and affect how money is spent on research and prevention. Continue reading