Category Archives: Biotechnology

A states obligated to provide expensive hepatitis C drugs?

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By Michael Ollove
Stateline

A handful of federal lawsuits against states that have denied highly effective but costly hepatitis C drugs to Medicaid patients and prisoners could cost states hundreds of millions of dollars.

The drugs boast cure rates of 95 percent or better, compared to 40 percent for previous treatments. But they cost between $83,000 and $95,000 for a single course of treatment.

The class actions, all filed in the last eight months in federal courts in Indiana, Massachusetts, Minnesota and Pennsylvania, present a series of extremes: a deadly epidemic, a treatment that can stop the disease in its tracks, and an enormous price tag.

At least 3.5 million Americans have hepatitis C, a virus spread through blood-to-blood contact that is usually contracted through the sharing of needles or other equipment to inject drugs.

Left untreated, hepatitis C slowly destroys the liver. Medicaid beneficiaries, a low-income population, have a slightly higher rate of hepatitis C infection than the privately insured, and the rate among prisoners is 30 times higher than in the general population.

The U.S. Food and Drug Administration approved the first of the new drugs, Sovaldi, in 2013. Since then, the FDA has also approved two other drugs, Viekira Pak and Harvoni.

But because the drugs are so expensive, state Medicaid programs and prisons have been restricting them to people in the advanced stages of the disease. Continue reading

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NIH scientists discover genetic cause of rare allergy to vibration

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3d ChromosomeFrom the National Institutes of Health

Scientists at the National Institutes of Health have identified a genetic mutation responsible for a rare form of inherited hives induced by vibration, also known as vibratory urticaria.

Running, hand clapping, towel drying or even taking a bumpy bus ride can cause temporary skin rashes in people with this rare disorder.

By studying affected families, researchers discovered how vibration promotes the release of inflammatory chemicals from the immune system’s mast cells, causing hives and other allergic symptoms.

Their findings, published online in the New England Journal of Medicine on Feb. 3, suggest that people with this form of vibratory urticaria experience an exaggerated version of a normal cellular response to vibration.

“The findings from this study uncover intriguing new facets of mast cell biology, adding to our knowledge of how allergic responses occur.” — Anthony S. Fauci, M.D, Director, NIAID Director.

The study was led by researchers at the National Institute of Allergy and Infectious Diseases (NIAID) and the National Human Genome Research Institute (NHGRI), both part of NIH. Continue reading

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Gene’s effect on brain connections may play role in schizophrenia, study

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Suspect gene may trigger runaway synaptic pruning during adolescence

From the National Institutes of Health

Versions of a gene linked to schizophrenia may trigger runaway pruning of the teenage brain’s still-maturing communications infrastructure, NIH-funded researchers have discovered.

“Normally, pruning gets rid of excess connections we no longer need, streamlining our brain for optimal performance, but too much pruning can impair mental function,”

The site in Chromosome 6 harboring the gene C4 towers far above other risk-associated areas on schizophrenia’s genomic “skyline,” marking its strongest known genetic influence. The new study is the first to explain how specific gene versions work biologically to confer schizophrenia risk. — Psychiatric Genomics Consortium

People with the illness show fewer such connections between neurons, or synapses.  The gene switched on more in people with the suspect versions, who faced a higher risk of developing the disorder, characterized by hallucinations, delusions and impaired thinking and emotions.

“Normally, pruning gets rid of excess connections we no longer need, streamlining our brain for optimal performance, but too much pruning can impair mental function.”

“Normally, pruning gets rid of excess connections we no longer need, streamlining our brain for optimal performance, but too much pruning can impair mental function,” said Thomas Lehner, Ph.D., director of the Office of Genomics Research Coordination of the NIH’s National Institute of Mental Health (NIMH). “It could help explain schizophrenia’s delayed age-of-onset of symptoms in late adolescence/early adulthood and shrinkage of the brain’s working tissue. Interventions that put the brakes on this pruning process-gone-awry could prove transformative.” Continue reading

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State prisons turn to telemedicine to improve health and save money

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Video CameraBy Michael Ollove
Stateline

CONROE, Texas — Texas prison psychiatrist Pradan Nathan recalls an unsettling face-to-face session with a dissatisfied patient about a dozen years ago at a maximum security prison in East Texas.

The large man, a member of a notorious prison gang, insisted Nathan prescribe him a particular medication. Nathan said he didn’t need it.

“I’m going to stab you to death the next time you come in here,” the prisoner growled.

Nathan feels a lot safer these days. He sees up to 16 patients a day from a suburban Houston office here, using an audio console, a camera and a monitor to treat inmates at two state prisons — including one with a death row — at least 30 miles from where he sits. He’s still threatened occasionally, but now it’s from a comforting distance.

Though some prisons used telemedicine as early as the 1980s, its use has dramatically increased with the arrival of vastly improved technology, electronic medical records, and pressure to control ever rising medical costs.

Needless to say, he’s a big fan of telemedicine.

He’s not the only one. Most states have turned to telemedicine to some extent for treating prisoners — often in remote areas, where many prisons are located — because it allows doctors to examine them from a safe distance. It enables corrections officers keep potentially dangerous inmates behind bars for treatment rather than bearing the cost and security risk of transporting them to hospitals. And because more doctors are willing to participate, it makes health care more available for inmates. Continue reading

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Does your favorite supplement contain an illegal drug? Search this database to find out.

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supplementsThe news website Vox.com has created a searchable database which you can use to find out if the supplement you’re taking (or thinking about taking) contain an illegal drugs.

From Vox’s story:

Americans spend more than $30 billion on supplements each year. Supplements are now the most common form of alternative medicine, and many of these pills promise to do incredible things, from boosting memory and building muscles to burning fat fast.

There’s just one problem: These pills are barely regulated. Supplement makers don’t need to prove their products are safe or even effective before putting them on store shelves.

And while supplements are supposed to be accurately labeled, a Vox review of government databases, court documents, and scientific studies uncovered more than 850 products that illegally contain hidden ingredients — including banned drugs, pharmaceuticals like antidepressants, and other synthetic chemicals that have never been tested on humans.

To read the Vox article and search its database go here.

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Heavy use of CT scans raises concerns about patients’ exposure to radiation

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(Illustration by Kai Ti Hsu for The Washington Post)

(Illustration by Kai Ti Hsu for The Washington Post)

By Sandra G. Boodman
KHN/Washington Post

Jean Hanvik decided that enough was enough.

When a painful intestinal inflammation flared in 2014, the 55-year-old benefits communications consultant balked at her doctor’s recommendation that she undergo another abdominal CT scan — her fourth in eight years.

“I’d just read about how abdominal CTs are one of the highest-risk tests [in terms of radiation exposure] and should not be repeated unless there was a major change,” said Hanvik, who lives in Minneapolis.

In the past, antibiotics and a bland diet had quelled her recurrent diverticulitis.

Hanvik said she wanted to follow that approach again but avoid a scan, which contains about 10 millisieverts (mSv) of radiation, the rough equivalent of 200 chest X-rays or 1,500 dental X-rays.

Like X-rays and PET scans, CT scans use ionizing radiation, which can damage DNA and cause cancer.

“I don’t think she appreciated my uncharacteristic behavior,” said Hanvik, adding that her primary care doctor reluctantly agreed, but made her promise to return within 48 hours if she did not improve. Hanvik got better, as she had previously.

Hanvik’s newfound assertiveness and her questions about the necessity of a CT scan reflect a growing awareness of the potential pitfalls of diagnostic imaging, which in the past two decades has exploded into a $100 billion-a-year business.

Imaging has aided diagnosis and helped many patients avoid exploratory surgery, but it has also spawned concerns about misuse. Experts cite ballooning costs, including from duplicate procedures, potential harm from the tests themselves and the overtreatment of harmless conditions found during scans.

These “incidentalomas” — so named because they are found unexpectedly — include benign lung and thyroid nodules and other common conditions that can lead to unnecessary and expensive workups as well as treatment that can cause complications.

Much of the attention has focused on computed tomography, or CT, scans, which use hundreds of X-rays to create detailed three-dimensional images that enable doctors to see things previously visible only through a biopsy or surgery.

Like X-rays and PET scans, CT scans use ionizing radiation, which can damage DNA and cause cancer. Two other imaging technologies, MRI scans and ultrasound, do not use radiation. CTs are used for a plethora of reasons, among them finding kidney stones, evaluating chest pain and detecting tumors or other abnormalities. Continue reading

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Infertility treatments not associated with increased risk of developmental delay – study

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Infertility treatments do not appear to contribute to developmental delays in children

From the National Institutes of Health

IVF egg thumbNIH researchers find no risk by age 3 from in vitro fertilization, other widespread treatments.

Children conceived via infertility treatments are no more likely to have a developmental delay than children conceived without such treatments, according to a study by researchers at the National Institutes of Health, the New York State Department of Health and other institutions.

The findings, published online in JAMA Pediatrics, may help to allay longstanding concerns that conception after infertility treatment could affect the embryo at a sensitive stage and result in lifelong disability.

The authors found no differences in developmental assessment scores of more than 1,800 children born to women who became pregnant after receiving infertility treatment and those of more than 4,000 children born to women who did not undergo such treatment.

“When we began our study, there was little research on the potential effects of conception via fertility treatments on U.S. children,” said Edwina Yeung, Ph.D., an investigator in the Division of Intramural Population Health Research at NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). “Our results provide reassurance to the thousands of couples who have relied on these treatments to establish their families.” Continue reading

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You can buy insulin without prescriptions – but should you?

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Carmen Smith now gets the insulin she needs via her doctor’s prescription. When she lacked health insurance, buying a version of the medicine over the counter was cheaper, she says. But it was hard to get the dose right. (Photo by Lynn Ischay for NPR)

By Sarah Jane Tribble
Ideastream

As anyone who needs insulin to treat diabetes can tell you, that usually means regular checkups at the doctor’s office to fine-tune the dosage, monitor blood-sugar levels and check for complications. But here’s a little known fact: Some forms of insulin can be bought without a prescription.

Carmen Smith did that for six years when she didn’t have health insurance, and didn’t have a primary care doctor. She bought her insulin without a prescription at WalMart.

“It’s not like we go in our trench coat and a top hat, saying, ‘Uh I need the insulin,’” says Smith, who lives in Cleveland. “The clerks usually don’t know it’s a big secret. They’ll just go, ‘Do we sell over-the-counter insulin?’”

Smith keeps the tools for controlling her diabetes in this kit, which contains metformin, syringes, fast-acting insulin for daytime use and slow-release for overnight. (Photo by Lynn Ischay for NPR)

Smith keeps the tools for controlling her diabetes in this kit, which contains metformin, syringes, fast-acting insulin for daytime use and slow-release for overnight. (Photo by Lynn Ischay for NPR)

Once the pharmacist says yes, the clerk just goes to get it, Smith says. “And you purchase it and go about your business.”

But it’s still a pretty uncommon purchase.

Smith didn’t learn from a doctor that she could buy insulin that way. In fact, many doctors don’t know it’s possible.

When she no longer had insurance to help pay for doctors’ appointments or medicine, Smith happened to ask at WalMart if she could get vials of the medicine without a prescription. To figure out the dose, she just used the same amount a doctor had given her years before.

It was a way to survive, she says, but no way to live. It was horrible when she didn’t get the size of the dose or the timing quite right. Continue reading

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STD researchers turn to Google

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Screen Shot 2015-12-11 at 8.59.33 AM

Where Are STDs Rampant? Google Wants To Help Researchers Find Out

By Mary Chris Jaklevic
KHN

With sexually transmitted diseases on the rise, researchers at the University of Illinois at Chicago think they might have a powerful new weapon to fight their spread: Google searches.

The nation’s leading search engine has quietly begun giving researchers access to its data troves to develop analytical models for tracking infectious diseases in real time or close to it. UIC is one of at least four academic institutions that have received access so far, along with the U.S. Centers for Disease Control and Prevention.

Researchers can mine Google data to identify searched phrases that spiked during previous upticks in a particular disease. Then, they measure the frequency of those searches in real time to estimate the number of emerging cases. For instance, a jump in gonorrhea might coincide with more people searching “painful urination” or other symptoms.

“If this works, it could revolutionize STD surveillance,” said Supriya Mehta, an associate professor of epidemiology at the UIC School of Public Health. Continue reading

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Local officials push manufacturers to pay for drug disposal

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pills-spill-out-of-bottle

By Sarah Breitenbach
Stateline

Each month Monty Scheele, a pharmacist in Lincoln, Nebraska, sends a big box of unused medications to be incinerated.

He collects the drugs at his three pharmacies from customers who may be cleaning out their medicine cabinets or abandoning a prescription after an adverse reaction. His effort is part of a program using state and local funds to keep medications from polluting water supplies and out of the hands of people who might misuse them.

New rules allow pharmacies to collect unwanted controlled substances; some local officials want drugmakers to pay for drug disposals.

But drug disposal is expensive — the Nebraska program spends $10 per pound to ship and destroy medication — and some states and municipalities want drug companies to pick up the tab.

Six municipalities in California require drugmakers to pay for take-backs. Nine states — California, Florida, Maine, Maryland, Minnesota, New York, Oregon, Pennsylvania and Washington — have considered similar measures. Another such proposal is in front of the Massachusetts Legislature.

Proponents say these laws, which are similar to programs that require manufacturers to pay for electronics recycling, would make it easier for patients to dispose of prescriptions. But drugmakers oppose the local mandates and warn that disposal costs could be passed on to patients through higher drug prices. Continue reading

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